Art. No. 2.511129 Rev: V1.2 *2.
511129*
User Guide
TRUSCOPE touch mini
User Guide
Sales and Service information
The SC HILL ER Sales and Servi ce cent re network is wo rld -wide. Fo r the address o f you r local distributor,
contact your nearest SCHILLER subsidiary.
In case o f di fficult y, you can find a com plete list o f all distributors and subsidiaries on o ur internet
site:
http://www.schiller.ch
Sales information can also be obtained from:sales@schiller.ch
Distributor
SCHILLER AG Phone: + 41 (0) 41 766 42 42
Altgasse 68 Fax: +41 (0) 41 761 08 80
CH-6341 Baar, Switzerland E-mail: sales@schiller.com.my
Web: www.schiller-asia.com
Art.No. Rev. Date Note
2.511129 V1.1 30.03.2017 Changed to Schiller format
2.511129 V1.2 08.05.2017 Updated as per Biolight comments 08.05.2017
Manufacturer
Guangdong Biolight Meditech Co. Ltd.
No. 2 Innovation First Road, technology innovation coast, Hi -tech zone
519085 Zhuhai, Guangdong, China
Phone: +86-756-3399935 3399900
Fax: +86-756-3399911
E-mail: overseas@blt.com.cn
CE mark
EC Representative Name:
Shanghai International Holding Corp. GmbH (Europe)
EC Representative Address:
Eiffestrasse 80, 20537 Hamburg Germany
Art. No. 2.511129 Rev: V1.2
Issue Date: 08.05.2017
I
User Guide
Preface
This manual describes instructions to use the TRUSCOPE Touch Mini
Monitor. Please ensure this manual is available at a convenient location, for
any reference by the user.
Before installing and using the device, ensure all users read the information
presented in this manual.
To improve reliability and performance, the manufacturer reserves the right to
make changes in the device, including hardware or software, without any prior
notice. Ensure you are referring to the latest User Manual, specific to the
Device that has been purchased.
This manual contains exclusive information protected by copyright laws. No
part of this manual should be photocopied or translated into other languages,
without the consent of the manufacturer.
The content of this User Manual is subjected to amendments without
notification.
Document No.: J/M1000-O-003- 021
Revision number: V1.0
Release time: Nov.2017
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User Guide
Liabilities of the Manufacture r
Only under the following c ircumstances, will the manufacturer be
responsible for the safety, reliability and performance of the device.
All the installation, upgradation, readjustment, renovation or repairs
are conducted by the personnel certified by the manufacturer.
The electrical sa fety status at the insta llation s ite of the device
conforms to the national standards;
The device is used in accordance with the operation procedures.
Conventions :
Bold Italic text is used in this manual to quote the referenced chapter or
sections.
【】is used to enclose screen texts.
→ is used to indicate operational procedures.
Signs in this manual:
Indicates a potential hazard or unsafe practice that, if
not avoided, will result in death or serious injury.
Indicates a potential hazard or unsafe practice that, if not
avoided, could result in minor personal injury or
product/property damage.
Provides application tips or other useful information to
ensure that you get the most from your product.
III
User Guide
Contents
Chapte r 1 Ge ne ral Introduction .................................................................................... 1
1.1 Intended Use .............................................................................................................. 1
1.2 Contraind ications ...................................................................................................... 1
1.3 Main Unit ................................................................................................................... 3
1.4 Measurement Modules ............................................................................................. 8
1.5 Equipment Symbols .................................................................................................. 8
Chapte r 2 Safety.............................................................................................................. 11
2.1 Safety Information .................................................................................................. 11
2.2 General Safety ......................................................................................................... 13
2.3 Important Notes for Safety .................................................................................... 15
2.4 Safe Operation Conditions ..................................................................................... 17
Chapte r 3 Basic Ope rations .......................................................................................... 19
3.1 Unpacking and Checking ....................................................................................... 19
3.2 Getting Started ........................................................................................................ 20
3.3 Shutting off the Monitor ........................................................................................ 21
3.4 Standby Mode.......................................................................................................... 22
3.5 Networked Monitor ing ........................................................................................... 22
3.6 Work Mode .............................................................................................................. 22
3.7 Screen Display ........................................................................................................ 23
3.8 Using the Smartkeys ............................................................................................... 24
3.9 Setting Measurement Modules .............................................................................. 26
3.10 Using Mouse.......................................................................................................... 27
3.11 Using Soft Keyboard ............................................................................................ 27
3.12 General Setting ..................................................................................................... 27
Chapte r 4 Use r Inte rface ............................................................................................... 31
4.1 Disp lay Style ........................................................................................................... 31
4.2 Screen Layout .......................................................................................................... 32
Chapte r 5 Alarm.............................................................................................................. 39
5.1 Alar m Category ....................................................................................................... 39
5.2 Alar m Level ............................................................................................................. 40
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User Guide
5.3 Alar m Indicators ..................................................................................................... 40
5.4 Alar m Status Symbol .............................................................................................. 43
5.5 Setting Alarm Volume ............................................................................................ 43
5.6 Parameter Alarm ..................................................................................................... 44
5.7 Paus ing Alar ms ....................................................................................................... 45
5.8 Alar m Reset ............................................................................................................. 46
5.9 Latching Alar ms ...................................................................................................... 46
5.10 When an Alar m Occurs ........................................................................................ 46
5.11 Alar m when power is lost .................................................................................... 47
Chapte r 6 Patie nt Manage me nt ................................................................................... 48
6.1 Admitting a Patient ................................................................................................. 48
6.2 Quick Admitting a Patient ..................................................................................... 49
6.3 Edit Patient Infor matio n ........................................................................................ 49
6.4 Discharging a Patient ............................................................................................. 49
Chapte r 7 ECG ................................................................................................................ 51
7.1 Introduction ............................................................................................................. 51
7.2 Safety Information .................................................................................................. 51
7.3 Monitoring Procedure ............................................................................................ 52
7.4 ECG Disp lay............................................................................................................ 57
7.5 Setting ECG ............................................................................................................. 58
7.6 ST Monitoring ......................................................................................................... 59
7.7 Arrhythmia Monitoring .......................................................................................... 61
7.8 QT Analyze Setup ................................................................................................... 65
Chapte r 8 Res piration Rate (Res p) ............................................................................. 66
8.1 Introduction ............................................................................................................. 66
8.2 Safety Information .................................................................................................. 66
8.3 Monitoring Procedure ............................................................................................ 66
8.4 Resp Display............................................................................................................ 68
8.5 Setting Resp............................................................................................................. 68
Chapte r 9 SpO 2 ................................................................................................................ 70
9.1 Introduction ............................................................................................................. 70
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9.2 Safety Information .................................................................................................. 70
9.3 Monitoring Procedure ............................................................................................ 72
9.4 SpO 2 Display ........................................................................................................... 72
9.5 Setting SpO 2 ............................................................................................................ 73
9.6 Measurement Limitations ...................................................................................... 74
Chapte r 10 Te mpe rature (Te mp) ................................................................................. 76
10.1 Introduction ........................................................................................................... 76
10.2 Safety Information................................................................................................ 76
10.3 Monitoring Procedure .......................................................................................... 77
10.4 Temp Disp lay ........................................................................................................ 77
Chapte r 11 NIBP ............................................................................................................. 78
11.1 Introduction ........................................................................................................... 78
11.2 Safety Information ................................................................................................ 78
11.3 Measurement Limitatio ns .................................................................................... 79
11.4 Measurement Mode .............................................................................................. 79
11.5 Monitoring Procedure .......................................................................................... 80
11.6 NIBP Display......................................................................................................... 82
11.7 Setting NIBP.......................................................................................................... 83
11.8 NIBP Calibratio n .................................................................................................. 84
Chapte r 12 Free zing ....................................................................................................... 85
12.1 Freezing Wavefor m .............................................................................................. 85
12.2 Reviewing Wavefor m ........................................................................................... 85
12.3 Releasing Freezing ............................................................................................... 86
Chapte r 13 Revie wing .................................................................................................... 87
13.1 Reviewing Graphic Trends .................................................................................. 87
13.2 Reviewing Tabular Trends ................................................................................... 88
13.3 Reviewing NIBP Measurement Results ............................................................. 90
13.4 Reviewing Parameter Alarm................................................................................ 90
Chapte r 14 Calculations ................................................................................................ 93
14.1 Drug Dose Calculation ......................................................................................... 93
14.2 Hemodynamic Calculation .................................................................................. 94
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14.3 Nephrid ium Calculatio n....................................................................................... 96
14.4 Ventilatio n Calculation ........................................................................................ 98
14.5 Oxyge nation Calculation ................................................................................... 100
Chapte r 15 Batte ry ....................................................................................................... 102
15.1 Introduction ......................................................................................................... 102
15.2 Installing a Battery ............................................................................................. 103
15.3 Optimizing Battery Performance ...................................................................... 103
15.4 Checking Battery Performa nce ......................................................................... 104
15.5 Disposing Batteries ............................................................................................ 105
Chapte r 16 Mainte nance and Cle aning .................................................................... 106
16.1 Equip ment Maintena nce .................................................................................... 106
16.2 Equip ment Cleaning ........................................................................................... 107
16.3 Cleaning of the Monitor..................................................................................... 108
16.4 Cleaning and Disinfection of Accessories ....................................................... 108
16.5 Maintenance frequency ...................................................................................... 110
Chapte r 17 Accessories ................................................................................................ 112
Appe ndix A Product Spe cifications ........................................................................... 114
A.1 Safety Specifications ........................................................................................... 114
A.2 Environmenta l Specifications............................................................................. 114
A.3 Phys ical Specifications ....................................................................................... 115
A.4 Power Specifications ........................................................................................... 115
A.5 Hardware Specifications ..................................................................................... 115
A.6 Measurement Specifications ............................................................................... 118
Appe ndix B Factory Defaults ..................................................................................... 126
B.1 Monitor Defaults .................................................................................................. 126
Appe ndix C Alarm mess ages ...................................................................................... 131
C.1 Monitor Alarm Messages .................................................................................... 131
Appe ndix D Troubles hooting ...................................................................................... 136
D.1 Common Failure Analysis and Troubleshooting .............................................. 136
Appe ndix E Guidance and M anufacture r’s Declaration of EM C ...................... 138
VII
User Guide
Chapter 1 General Introduction
1.1 Intended Use
The monitor is inte nded to be used for monitoring, displaying, reviewing,
storing and alarming of multip le physio logical parameters of patients, including
ECG, Heart Rate (HR), Respiration Rate (RR), Temperature(Temp), Pulse
Oxygen Saturation(SpO2), Pulse Rate(PR), Non- invas ive Blood
Pressure(NIBP), ST segment monitoring is not applicable to neonates.
It is intended to be used in various hospital rooms such as Coronary Care
Unit,Intens ive Care Unit,Neonatal Intensive Care Unit and Operating Room to
provide additiona l infor mation to medical and nursing staff about the
physiological condition of the patient.
The monitor is inte nde d for use only by clinical professionals or unde r
the ir guidance. It mus t only be use d by pe rsons who have rece ive d
ade quate training in its use. Any unauthorize d or unt raine d pe rsonne l
should not operate this device.
1.2 Contraindications
Whe n conducting de fibrillation, it is impe rative to use only the ECG
electrodes and ECG cables specified by manufacture r.
To avoid burns, whe n the e lectrotome ope ration is pe rforme d, the
electrodes s hould be place d near the middle be twee n ESU grounding
pad and e lectrotome . The electrotome s hould be applie d as far as
possible from all othe r ele ctrodes , a dis tance of at le ast 15 cm/6 in is
recomme nde d.
Whe n us ing the ESU de vice , avoid placing the electrodes ne ar the ESU
grounding pad. Else, inte rfe re nce will affect the ECG signals. The
monitor s hould be place d as far away as poss ible from the ope rating
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User Guide
table . Powe r cord and the ECG cables s hould be place d away from
each other and should not run in parallel.
The meas ure me nt of Res p is not applicable for patie nts wit h e xcessive
motion. This may cause errors in Resp alarm.
Do not use the Monitor and SpO2 se nsor during M agne tic Resonance
Imaging (MRI). Induce d curre nt could cause burns .
Do not use the SpO2 se nsor on a limb whe re the NIBP cuff is applie d.
During Cuff Inflation, this may res ult in inaccurate SpO2 reading due
to blocked blood flow.
Do not conduct SpO2 me as ure me nt on the finge r s meare d with nail
polish. This will lead to unreliable SpO2 measure me nts .
The following factors may influe nce the accuracy of measure me nts :
——Incorre ct sensor application or use;
——Significant le vels of dys functional he moglobins (s uch as
carboxyhe moglobin or methe moglobin);
——Intravas cular dyes such as indocyanine green or methyle ne blue;
——Expos ure to excessive illumination,
——Excessive patient movement;
——Low perfus ion;
——Electromagnetic interfe re nce , such as MRI device;
——Electros urgical units.
——The patie nt has hypote ns ion, severe vasocons triction, seve re
anemia, or hypothe rmia;
Do not me as ure NIBP on patie nts wit h s ickle-cell disease or any
condition where skin damage has occurre d or is expected to occur.
Use clinical judge me nt to decide whe the r to pe rform fre que nt Auto
BP me as ure me nts on patie nts with seve re blood clotting dis orde rs
because of the risk of hematoma in the limb fitted with the cuff.
Use clinical judge me nt to decide whe the r to pe rform Auto BP
measure me nt on the patients of thrombasthe mia.
Do not use the NIBP cuff on a limb with an intrave nous infus ion or
arte rial cathe te r in place. This could cause tiss ue damage around the
catheter when the infus ion is slowed or blocked during cuff inflation.
NIBP me as ure me nt is not possible during he art rate extre mities of less
than 40 bpm or greate r than 240 bpm. Also NIBP me as ure me nt is not
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User Guide
possible if the patient is on a heart-lung machine.
The measure me nt may be inaccurate or not possible:
——with excessive and continuous patie nt move me nt s uch as s hive ring
or convuls ions ;
——if a regular arterial pressure pulse is hard to detect;
——with cardiac arrhythmias ;
——with rapid blood pressure changes;
——with seve re s hock or hypothe rmia that re duces blood flow to the
periphe ries;
——because of an edematous extremity.
Ope rating high fre que ncy e lectros urgical e quipme nt in the vicinity of
the monitor may produce inte rfe re nce and cause incorrect
measure me nts .
1.3 Main Unit
1.3.1 Front View
1
3 10
5 6 7 8 9
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User Guide
1. Alarm indicating lamp
When a phys iologica l alar m occurs, this lamp will light up as defined
below:
High level alarm: the lamp quickly flashes red.
Medium level alarm: the lamp slowly flashes yellow.
Low level alarm: the lamp lights yellow without flashing.
When a technical alarm occurs, this lamp will light up as defined below:
High level alarm: the lamp quickly flashes red.
Medium level alarm: the lamp slowly flashes yellow.
Low level alarm: the lamp lights yellow without flashing.
2. Display screen
3. Power button
4. Power indicating lamp
This LED glows green or orange, depending on the status as follows:
Green: When the AC mains is connected.
Orange: When the AC ma ins is not connected and monitor is powered
by battery.
Off: When the AC mains is not connected.
5. Battery charging indicating lamp
Light up: When the battery is being charged.
Off: When the battery is fully charged or no battery in monitor.
6. 1 Press this button to pause or reactive the alarms.
7. Press this button to freeze or defreeze waveform.
8. Press this button to start or stop NIBP measurement.
9. Press this button to go back to the main interface.
10. Trim Knob
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User Guide
The Trim Knob is used for controlling the User Interface:
Turn left or turn right to move the cursor.
Press down to perform an operation, such as open a menu dia log or
select one option.
1.3.2 Side View
Left side:
1.NIBP connector
2. SpO 2 connector
3.TEMP connector
4. ECG connector
5. Handle
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User Guide
Right side:
3
4
1. Handle
2. Network: Standard RJ45 socket. It is used for connection with the central
monitoring system provided by manufacturer.
3 USB socket: Connect to USB device, such as mouse,keyboard.
4 DC input socket
The powe r adapte r mus t be provide d or designate d by manufacture r (see
accessory lis t). If use anothe r powe r adapte r, it s hould be ve rifie d,
otherwise electric shock may occur and cause patient death.
In orde r to preve nt poor contact due to accumulate d dus t, re gularly clean
the contact point according to actual application condition. Before
cleaning, the monitor mus t be powe re d off. Whe n cleaning, wipe the point
with medical cotton dippe d in medicinal alcohol.
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User Guide
1.3.3 Bottom View
1. Cushion Pads
1.3.4 Rear View
1. Handle
2. Speaker
3. Battery slot
4. Ventilation holes
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User Guide
The USB socke t can only be connecte d to the e quipme nt with s tandard
USB devices/cables.
Additional e quipme nt conne cte d to the Device, must comply with the
res pective IEC or ISO s tandards (e.g. IEC60950 for data processing
equipme nt). Furthe rmore all configurations s hall comply wit h the
re quire me nts for me dical e lectrical sys te ms (see IEC 60601 -1 or clause 16
of IEC60601-1 3rd, res pectively). The pe rs on connecting additional
equipme nt to this device is the re fore res pons ible for the e ntire sys te m to
comply with the safety re quire me nts of Me dical Ele ctrical Sys te ms .
Atte ntion is drawn to the fact that local laws take prio rity ove r the above
me ntione d re quire me nts. If in doubt, cons ult your local re prese ntative or
the technical service departme nt.
The ope rator s hould not touch these socke ts and the patie nt
simultaneous ly.
1.4 Measurement Modules
The monitor can support the following modules:
ECG module: ECG module.
Temp module: Temperature module.
SpO 2 module: SpO 2 module.
NIBP module: NIBP module.
1.5 Equipment Symbols
Symbol Symbol Note Symbol Symbol Note
Attention: Consult
Short for “
accompanying documents ECG
“Electrocardiogram”
(this manual).
Short for “Pulse Oxygen
Dangerous voltage SpO2
Saturation”
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User Guide
Symbol Symbol Note Symbol Symbol Note
Alternating current TEMP Short for “Temperature”
Short for “Non-invasive
Manufacture date NIBP
. Blood Pressure”
USB socket Computer network
Manufacturer SN Serial number
Degree of protection against
LOT Batch code IPX1
ingress of liquid
Do not re-use REF Catalog number
Use by date
Temperature limitation
[YYYY- MM- DD]
Humidity limitation Pressure limitation
Symbol for the marking of
Refer to this user‟s electrical and electronics
manual. devices according to
Directive 2002/96/EC.
Frangibility, Be careful Avoid drench, Keep dryness
This end keep upward
CE mark
while moving or storing
Stacking layer limit.
Same packing maximum stacking layers, N represents the number
of layers limit. (N is 6).
Symbol marked on a tag attached to the supply cord of the monitor
Hospital
to warn that the supply cord should be connected to the sockets
Only
which are Hospital Only to achieve grounding reliability.
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User Guide
Symbol Symbol Note Symbol Symbol Note
Defibrillation-proof Type CF applied part
Warning: The protection against the effects of the discharge of a
cardiac defibrillator is dependent upon the appropriated cable
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User Guide
Chapter 2 Safety
2.1 Safety Information
No modification of this e quipme nt is allowe d without autho rization by
the manufacture r. If this e quipme nt is modifie d, appropriate ins pe ction
and testing must be conducte d to ensure continue d safe operation.
Before putting the sys te m into ope ration, ve rify that the monitor,
connecting cables and accessories are in corre ct working orde r and
operating condition.
To avoid the ris k of e lectric s hock, this e quipme nt mus t only be
connecte d to a supply mains with protective earth
Whe re the inte grity of the e xte rnal prote ctive conductor in the
ins tallation or its arrange me nt is in doubt, e quipme nt s hall be
operate d from its internal electrical power source
To avoid explos ion hazard, do not use the monitor in the prese nce of
flammable anes the tics or othe r flammable s ubstance in combination
with air, oxygen-enriche d environme nts, or nitrous oxide.
Do not ope n the monitor hous ings ; e lectrical s hock hazard may e xis t.
All se rvicing and future upgrades mus t be carrie d out by the
personne l traine d and authorize d by manufacture r only.
Whe n us ing the monitor with Electros urgical Units (ESU), make s ure
prescribe d safety precautions are in place.
Do not come into contact with the patie nt during de fibrillation.
Otherwise serious injury or death could result.
Do not re ly exclus ively on the audible alarm s ys te m for patie nt
monitoring. Adjus tme nt of alarm volume to a low leve l or s witching it
off may res ult in a hazard to the patie nt. Re me mbe r that alarm
settings s hould be cus tomize d according to diffe re nt patie nt s ituations
and always kee ping the patie nt unde r close s urve illance is the mos t
reliable way for safe patient monitoring.
The phys iological data and alarm messages dis playe d on the monitor
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User Guide
are for re fe re nce only and cannot be dire ctly use d for diagnos tic
interpre tation.
To avoid inadve rte nt disconne ction, route all cables in a way to
pre ve nt a s tumbling hazard. Wrap and secure excess cabling to avoid
risk of entangle me nt or strangulation by patient or personne l.
To e ns ure patie nt safe ty, use only parts and accessories s pecifie d in
this manual.
At the e nd of its se rvice life, the monitor, as we ll as its accessories ,
mus t be dis pose d of in compliance wit h the guide lines re gulating the
dis posal of s uch products . If you have any questions conce rning
disposal of the monitor, please contact us.
Magne tic and e lectrical fields are capable of inte rfe ring wit h the
prope r pe rformance of the monitor. For this reas on make s ure that all
exte rnal devices ope rate d in the vicinity of the monitor comply wit h
the re levant EM C re quire me nts. Mobile phone , X-ray e quipme nt or
MRI devices are a possible s ource of inte rfe re nce as they may e mit
higher levels of electromagnetic radiation.
Before connecting the monitor to the powe r line , che ck that the
voltage and fre que ncy ratings of the powe r line are the same as those
indicate d on the monitor’s label or in this manual.
Always ins tall or carry the monitor prope rly to avoid damage cause d
by drop, impact, strong vibration or other mechanical force.
Ens ure the Ame rican mains plug whose ground is in the s ame plug
with its two othe r cords , is plugge d to a “Hos pital Only” s ocket. The
supply cord s hould be connecte d to the s ockets which are “Hos pital
Only” grade, to achieve grounding reliability.
The monitor s hould be locate d whe re one can e asily see the s cree n and
access the operating controls .
Kee p this manual in the vicinity of the monitor so that it can be
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User Guide
accessed convenie ntly when needed.
The software was deve lope d in compliance wit h IEC 62304. The
possibility of hazards arising from software errors is minimize d.
This manual describes all fe atures and options . Your monitor may not
have all of them.
2.2 General Safety
The monitor is ne ithe r a the rape utic de vice nor a de vice that can be use d
at home.
1.Safety precautions for installation
Connect the power cord to a properly earthed socket. Avoid connecting it
along with devices like air conditioners which switch ON and OFF.
Avoid placing the monitor in locations where it easily shakes or wobbles.
There should be enough space around the Monitor so as to guarantee
normal ventilation.
Make sure the amb ient temperature and humid ity are stable and avoid the
occurrence of condensation in the operation process of the monitor.
Never ins tall the monitor in an e nvironme nt whe re flammable anes the tic
gas is present.
2. Monitor conforms to the safety require ments of IEC 60601-1. This monitor
is protected against defibrillation effects.
3. Notes on symbols related to safety
Type CF applied part, defibrillation protected
The unit d isplaying this symbol contains an F- Type iso lated
(floating) applied part, providing a high degree of protection
against shock and is defibrillator-proof.
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User Guide
The type CF applied parts provide a higher degree of protection
against electric shock than that provided by type BF applied
parts.
Warning:The protection against the effects of the discharge of
a cardiac defibrillator is dependent upon the appropriated cable
Warning:The protection against the effects of the discharge of a
cardiac defibrillator is dependent upon the appropriate
connected cable/accessories.
4. When a defibr illator is applied on a patient, the mo nitor may have trans ient
disorders in the disp lay of wavefor ms. If the electrodes are used and placed
properly, the display of the monitor will be restored within 10s. Dur ing
defibrillation, please note to remove the electrode of chest lead and move the
electrode of limb lead to the side of the limb. The electrode of the defibr illator
should not come into direct contact with the mo nitoring electrodes. Please
ensure the monitor is reliably grounded and the repeatedly used electrodes are
kept clean.
Whe n conducting de fibrillation, do not come into contact wit h the patie nt,
the bed and the monitor. Else, serious injury or death can occur.
5. To guarantee the safe operation of the monitor, the monitor is provided with
various replaceable parts, accessories and consuming materia ls (such as
sensors and their cables, electrode pads). Please use the products provided or
designated by the manufacturer.
6. Monitor only guarantees its safety and accuracy under the condition that it
is connected to the devices provided or designated by manufacturer. If the
monitor is connected to other undesignated electrica l equip ment or devices,
safety hazards may occur for causes such as the cumulatin g of the leakage
current.
7. To guarantee the normal and safe operation of the monitor, a preventive
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User Guide
check and maintenance should be conducted for the monitor and its parts
every 6-12 months (including perfor mance check and safety check) to verify
the instrument can work in a safe and proper condition and it is safe to the
medical personnel and the patient and has met the accuracy required by
clinical use.
The monitor does not contain any parts for re pair by use rs . The re pair of
the instrume nt mus t be conducte d by te chnical pe rsonne l authorize d by
manufacture r.
2.3 Important Notes for Safety
Patient Connections
The monitor can only be applied to one patient at one time.
Interfe re nce
Do not use mobile phone in the vicinity of the monitor. High leve l of
electromagnetic radiatio n emitted from such devices may result in strong
interference with the monitor performance.
Protection against ingress of liquid
To avoid electric shock or device ma lfunctio n, liquids must not be allowed
to enter the device. If liquids have entered the device, disconnect the device
and have it checked by a service technician before it is used again.
Accuracy
If the accuracy of any va lue displayed on the monitor or printed on a
printout paper is questionable, determine the patient‟s vita l signs by
alternative means. Verify that the equipment is working correctly.
Alarm
Do not rely exc lus ively on the audib le alarm syste m for patient monitoring.
Adjustment of a larm vo lume to a low leve l or switching o ff dur ing patient
monitoring may result in a hazard to the patient. Reme mber that the most
reliab le method of patient monitoring combines close personal surveillance
and correct operation of monitor.
The functions of the a larm syste m for monitoring the patient must be
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User Guide
verified at regular intervals.
Before Use
Before putting the syste m into operation, please vis ually inspect all
connecting cables for signs of damage. Dama ged cables and connectors must
be replaced immediately.
Before using the system, the operator must ver ify that it is in cor rect
working order and operating condition.
Periodically, and whenever the integr ity of the product is in doubt, test all
functions.
Cables
Route all cables away from patient‟s throat to avoid possible strangulation.
Disposal of package
When disposing the packaging material, please observe the required
applicable waste control regulations and keep it out of children‟s reach.
Explosion hazard
Do not use this equipme nt in the presence of fla mmable anesthetics, vapors
or liquids.
Leakage curre nt test
When interfacing with other equipment, a test for leakage current must be
performed by qualified biomedical e ngineering personne l before using with
patients.
Battery
The device is equipped with a battery. The battery discharges even when the
device is not in use. If you do not use the battery for a long time, store the
device with a fully charged battery and take out the battery, so that the service
life of the battery will not be shortened.
Disposal of accessories and device
Disposable accessories are inte nded for single use only. They should not be
reused as performance could degrade or contamination could occur.
The service life of this monitor is 5 years. At the end of its service life, the
monitor, as well as its accessories, must be disposed of in comp lianc e with the
guidelines regulating the disposal of such products. If you have questions
concerning disposal of products, please contact manufacturer or its
representatives.
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User Guide
EMC
Magnetic and electrica l fie lds are capable of inter fering with the device.
For this reason, make sure that all external devices operated in the vicinity of
the monitor comply with the rele vant EMC requirements. X- ray equipment or
MRI devices are a possible source of interference as they may e mit higher
leve ls of electromagnetic radiation. Also, keep mobile phones or other
telecommunication equipment away from the monitor.
Instruction for use
For continuous safe use of the monitor, it is necessary that listed
instructions were followed. However, instructions listed in this manual
can not supersede established medical practices concerning patient care.
Loss of data
Should the monitor at any time temporarily lose patient data, close ly
observe the patient conditions or use alternative monitor ing devices until
monitor function is restored.
When the AC power to the monitor is not available, the monitor will switc h
to the internal battery DC power.
When the monitor loses Mains power and has turned off, if the monitor
does not automatically resume operation within 60s, restart the monitor us ing
the power switc h. Once monitoring is restored, you should verify correct
monitoring state and alarm function.
Intende d for use in conjunction with other medical devices
The monitor can be used together with high- frequency Electro Surgica l Unit
and defibrillator.
2.4 Safe Operation Conditions
Methods of sterilization or Sterilization: not applicable
disinfection recommended by Dis infectio n: Refer to Maintenance and
the manufacturer Cleaning Chapter
Electromagnetic interference No mobile telephone nearby
Electrosurgica l interference No damage to device
damage
Diather my instrume nts Displa yed values and prints ma y be disturbed or
influence erroneous during diathermy
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User Guide
Defibrillation shocks The monitor specifications fulfill the
requirements of IEC 60601-1, IEC 60601- 2-27,
IEC 60601-2-49
ECG electrode, ECG lead wires, SpO2 sensor,
Applied parts
Temperature probe, NIBP cuff
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User Guide
Chapter 3 Basic Operations
3.1 Unpacking and Checking
1. Unpacking
Before unpacking, exa mine the packing case carefully for signs of damage.
If any damage is detected, contact the carrier. If the packing case is intact,
open the package.
2. Remove the monitor and accessories carefully.
3. Keep all the packaging materials for future use in transportation or storage.
4. Check the monitor and accessories
Check the monitor and its accessories one by one in accordance with the
packing list. Check to see if the parts have any mechanical damages. In case
of problems, please contact us or our agent.
Kee p the packing mate rials out of childre n’s re ac h. Dis posal of the
packing mate rials s hould conform to the applicable was te control
regulations .
The monitor might be contaminate d during s torage and trans port.
Before use, ple ase ve rify whe the r the packages, es pe cially the package
of dis pos able accessories, are intact. In case of any damage, do not
apply it to the patient.
Please place the M onitor on a horizontal and s table s upporting plane .
Avoid placing the monitor in locations whe re it eas ily s hakes or wobbles .
Ens ure e nough s pace around the monitor s o as to guarantee normal
ventilation.
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Please e ns ure the monitor is working unde r the s pe cifie d conditions ; Else,
the technical s pe cifications me ntione d in this manual will not be me t,
leading to damage of equipme nt or other unexpecte d results.
3.2 Getting Started
3.2.1 Checking Device
Device self- test check: After pressing the power switch, the monitor will
begin an automatic self- test process. Dur ing this process, the visua l alar m
LED‟s will illuminate in sequence from red to ye llow, and then tur n off. The
device will produce a sound of “Dang” and the logo will also appear on the
screen.
3.2.2 Starting the Monitor
3.2.2.1 Powe ring the Monitor
1. Connect the power adaptor to the DC input socket of the device. Then
connect the power adapter to the power cord. Plug the power cord to the Mains
Source marked “Hospital Only”. The blue adapter ind icator lamp will light up.
If you are using battery power, ensure that the battery has suffic ient power for
monitoring. When using the battery for the first time, you must charge it, as per
instructions given in Battery chapter.
3.2.2.2 Monitor Startup
1. Press the power switch. About 8s later, the monitor ‟s alarm la mp will glow
Orange and the logo appears on the screen. Once the lo go disappears, the
device will begin an automatic self- test process (see chapter 3.2.1). After
about 10s, the monitor displays the main interface screen.
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User Guide
If the monitor is me chanically damage d, or if it is not working prope rly,
do not use it for any monitoring proce dure on the patie nt. Contact your
service personne l.
The monitor does not have mains s witch. The monitor is s witche d
comple te ly only by unplugging the powe r cable from the AC powe r
source.
Mains plug is inte nde d to be use d as is olation de vice from the s upply mains.
Please always ensure mains plug is easily accessible.
3.2.3 To Start Monitoring
1. Decide what parameters should be monitored or measured.
2. Install required modules or sensors.
3. Check whether the installation of modules or sensors is correct.
4. Check whether all settings are correct.
5. Start monitor ing on a patient. For detailed information, refer to the related
chapters.
3.3 Shutting off the Monitor
Please follow the below steps to shut off the monitor:
1. Confirm that the patient monitoring is finished.
2. Disconnect the cables and sensors from the monitor.
3. Confirm that the monitoring data is stored or cleared.
4. Press the power switch, a power off tips will appear to ask „Do you want
to shutdown the machine‟. Press „Yes‟ to shut off the device.
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3.4 Standby Mode
Standby mode can be used when you want to temporarily interrupt
monitoring.
To enter standby mode:
Select【M ain Me nu】s martkey→【Standby】, then select【 Yes 】to enter the
standby mode. Or directly select【Standby】 in the touch smartkeys area, then
select【 Yes 】to enter the standby mode. Under standby mode, the monitor will
suspend alarm for patient, and all waves and numerics will disappear but all the
settings and patient data will be retained.
To resume monitoring:
Press any button on the device or turn the trim knob to exit standby mode
and resume monitoring.
3.5 Networked Monitoring
If the user intends to connect the monitor to the central monitoring system,
plug the network cable into the network socket at the back of the monitor.
This monitor can only be conne cte d to the ce ntral monitoring s yste m
provide d by manufacture r. Do not atte mpt to conne ct this monitor to
other Central Monitoring Systems.
The sys te m s oft ware will pe riodically inte rrupt to send data to the
central monitoring system, to keep the data trans miss ion stable.
3.6 Work Mode
The device has four work modes for different clinical applications.
If you want to change the operation mode, you can select【MainMe nu】
smartkey above the touch smartkeys area. Then select 【Work Mode 】 to
select the operation mode you need.
Monitor Mode (Monitor) : The norma lly operation mode to monitor
the patient.
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User Guide
Demo Mode (Demo): To give some demo screens. User should input
the password to enter the mode.
Configuration Mode(Config): User needs to input password to enter
this mode. The mode is for the specia l configuration personnel in
hospital or the senior users to configure the monitor.
Maintenance Mode (Mainten.): User needs to input password to
enter this mode. This mode is only for the service personnel.
3.7 Screen Display
The monitor adopts a displa y screen of high- resolution TFT LCD.
Measurement numer ics, waveforms, patient info, alar m area and menu can be
displayed on the screen. Standard screen is shown as follows:
1 2
3 4
1) Patient info area
Shows the room number, bed number, patient na me, patient category and
paced status of patient.
2) System status area
Shows the current time, battery status, alarm status and so on.
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User Guide
3) Technical alarm area
Shows technical alarm messages and prompt messages.
4) Physiological alarm area
Shows the phys iologica l alar m messages, medium- level and low- leve l
alarm messages displa y on the left, while the high- leve l a larm messages
display on the right.
5) Paramete r and waveform area
It consists of various parameter areas, and shows measureme nt numerics
for each parameter module. Label disp lays on the top le ft corner of each
parameter area. When you c lose or open some parameter module, the
parameter area on the screen will be rearranged automatically.
Shows the wavefor ms of each phys io logical parameter. Label disp lays on
the top le ft corner of each waveform area. When you close or open some
waveform, the waveform area on the screen will be rearranged automatically.
6) Area of smartkeys
Shows smartkeys, these smartkeys are used to conduct some common
operations.
3.8 Using the Smartkeys
The position on the screen where a focus may stay is referred to as the
smartkey. Through a s martkey, you may quickly enter some menus or execute
some operations. The s martkeys of the monitor ma y be divided into the
following types:
Waveform smartkey
An area where any wave form stays is the smartkey; you may se lect a
waveform area to enter a setting menu of the corresponding waveform.
Paramete r smartkey
An area where any parameter stays is the smartkey; you may se lect a
parameter area to enter a setting menu of the corresponding parameter.
Smartkeys
Smartkeys at the bottom of the screen may be configured, through which
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User Guide
some functions may be quickly executed. These smartkeys vary with d ifferent
configurations.
For example, if you want to enter【M odule Set】menu, you shall touch the
position shown as follows:
To configure the smartkeys on the screen by the following ways:
Select【M ain me nu】s martkey→【Smartke y De fine 】, select the smartkeys
you want to display on the screen.
The symbols on the smartkeys are shown as follows:
Smartkey Smartkey Note Smartkey Smartkey Note
Previous page Next page
Patient Manage Trend Review
Screen Layout (Change
Alarm Setup
screen)
Alarm Reset Standby
Start STAT NIBP
Start NIBP measurement
measurement
Stop NIBP measurement Wave Freeze
NIBP Review Volume
Brightness Tabular Trends
Discharge the current patent Caculation
Module Set
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User Guide
3.9 Setting Measurement Modules
3.9.1 Setting Measurement Modules
Select【M odule Set】smartkey to enter the module config window, shown
as follows. Depending on different configuration, your monitor will displa y
different contents.
Parameter measurement modules which are configured by user are
displayed in above window, and label d isplays near the corresponding
connector of module.
Open or close some paramete r
To open or close some parameter, take T1 for example:
——To open T1 measurement: select T1 module in【Module Se t】menu , fro m
the menu that appears, select【Activate】.
——To close T1 measurement: select T1 module in【Module Set】menu, fro m
the menu that appears, select【Deactivate】.
3.9.2 Using Labels
Depending on the configuration of your monitor, you can measure ECG,
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User Guide
Resp, SpO 2 , PR, NIBP, multiple Te mp, simultaneous ly. The monitor uses labels
to distinguis h between the m. All setting contents related to the parameter (such
as parameter color, waveform color, wave scale and alar m setting) are stored in
each label. You can alter the label of Te mp parameters. Detail operatio ns are as
follows:
Changing Temp Label
1. Select【M odule Se t】smartkey to enter the Module config window in
which you can select the Temp label you want to alter. A module config
window pops up.
1. Select 【Change Label】to rename the temp. Options are as follows:
Label Description Label Description
T1 Non-specific temperature Trect Rectal temperature
Tesoph Esophageal temperature Tblad Bladder temperature
Tnaso Nasopharyngeal Tskin Skin temperature
temperature
Ttymp Tympanic temperature
3.10 Using Mouse
The monitor supports a plug and play USB-interface mouse.
While using mouse, you should take care of the following:
The left key of a mouse is the major key, and the right key of the mouse is
the secondary key.
To click the major key of a mouse is equiva lent to the operation of pressing
trim knob.
3.11 Using Soft Keyboard
The monitor displays a soft keyboard to input data. This keyboard supports
Chinese and English.
3.12 General Setting
3.12.1 Adjusting the screen brightness
1. Select【Brightness】or select【Main menu】→【Brightness 】.
2. You can set the screen brightness to a value between 1 and 10. 1 is the
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User Guide
minimum brightness and 10 is the maximum.
If the monitor runs on batteries, choose a lower level brightness to save
the power. When the monitor enters standby mode, the screen brightness is
automatically set to the lowest level.
3.12.2 Adjusting the volume
1. Setting the QRS volume
Select【Volume 】smartkey→【QRS Volume 】, or select【QRS Volume 】
in ECG or SpO 2 parameter area. The QRS volume can be set to silence or a
value between 1 and 6. Sile nce means the QRS volume is turned off and 6 is
the maximum volume.
2. Setting the alarm volume
Select【Volume 】smartkey→【Alm Volume 】, or select【M ain Me nu】
→【Alm Setup】→【Alm Volume 】. The volume can be set to a value between
X and 6. X is the minimum alar m vo lume and 6 is the maximum vo lume.
Silence means the alarm volume is turned off.
3.12.3 Setting the Date and Time
User can configure the system date and time. The user is advised to set
system time before beginning to monitor a patient. If the configuration is to be
set dur ing the process of monitoring, the user is advised to switc h off the
monitor after exiting the current window and then restart it. The time for the
revision takes effect after the current window is exited.
To set the date and time:
1. Select【M ain Menu】smartkey→【Sys te m Time Setup】.
2. Select【Date Format】, it can be set to【Month/Day】or【Day/Month】.
3. Select【Time Format】, it can be set to【24h】or【12h】.
4. Select【 Ye ar】, 【Month】,【Day】,【Hour】,【M in】,【Sec】to setup
the current time.
Changing the date or time will affect the s torage of tre nds and eve nts .
This may result in loss of data.
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User Guide
3.12.4 Configuration Management
Select the curre nt configuration
You can select the user-defined configuration to be the current
configuration. Select 【Main Me nu】smartkey→【Config Manage】→【Se lect
curre nt Config】. Depending on patient category and requireme nt, it can be
set to current config.
Setup the default configuration
If User has modified certain settings (especia lly at the time of changing
patients) but deems these are not necessarily suitable or proper, the default
setting o f factory can be restored to ensure the device settings are suitable for
monitoring.
To restore the factory configuration:
Select【Main Me nu】smartkey→【Config Manage 】, select【Se lect De fault
Config 】 in the menu popped up. Depend ing on patient category and
requirement, it can be set to factory config.
Import user configuration
When the device is connecting with USB device s, the configuration of the
patient can be imported from the USB device.
Export user configuration
When the device is connecting with USB device s, the configuration of the
patient can be exported to the USB device.
Save the user configuration
While monitor ing, you can change the setting of monitor as necessary, and
save the changed settings as user configuration. The monitor can save many
user configurations. This can be defined using customized names by the user.
The settings of the monitor should be first adjusted in line with the
requirement, to ensure that the monitor ‟s settings are suitable for the
monitored patient.
To save the user configuration:
1) select【M ain Me nu】smartkey【Config Manage】, select【Save Use r
Config】 in the popped up me nu, and then enter the na me customized by
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User Guide
user.
2) select【OK】to confirm it.
The configuration name cannot be blank whe n saving curre nt
configuration. Else, the custom configuration will not be saved.
Delete the user configuration
To delete the saved user configuration:
Select【M ain Menu】s martkey→【Config Manage 】,select【 Dele te Use r
Config】 in the popped up me nu. Select the user configuration required, and
select【OK】to confirm it.
If diffe re nt alarm presets are use d for the same or s imilar e quipme nt in
any single area, a potential hazard may exist.
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User Guide
Chapter 4 User Interface
4.1 Display Style
Display style of user interface can be set according to your need.
Including:
——Screen brightness:
——Display color of wave and parameter:
——Parameter and wave to be monitored.
4.1.1 Screen Brightness
For details, please refer to chapter 3.12.1.
4.1.2 Parameter Color
1. Select【Main Menu】smartkey→【Scree n Setup】;
2. Select【Parame te r Color Se tup】, click the color block of corresponding
parameter, and then select the color according to your need fro m the popped
menu.
4.1.3 Selecting Parameter
You can select the parameters to be disp layed according to the require ment
of monitoring and measurement.
1. Select【Module Set】smartkey.
2. From the popped menu, you can select the parameter to be displayed
according to your need.
3. Select【OK】to confirm it, then the screen will be adjusted automatically.
Besides, you can close a wavefor m display by below methods:Select a
ware area, and select【Close Wave】in the menu.
4.1.4 Waveform Setup
You can exchange the positions of some wavefor m A for the other
waveform B, and also can add the display of some waveform C under the
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User Guide
waveform A. The setting method is as follows:
1. Select the waveform A and enter the setting menu of the waveform A.
2. Select 【Exchange Wave 】, and select the label of the waveform B from the
options, then it will exchange position with waveform A.
3. Select【Add Wave】, and select the label of the waveform C from the
options. The screen will be rearranged automatically, and the selected
waveform C will be inserted under the waveform A.
4.2 Screen Layout
You can set the screen layout as required. The setting method is as follows:
1. Select the【Main Me nu】smartkey→【Scree n Layout】or select【Scree n
Layout】smartkey.
2. Select one screen according to your need.
The following are the disp lay interface of screens, which may diffe r from
those on your monitor.
Standard Screen
To enter standard screen:
Select【M ain Me nu】s martkey→【Scree n Layout】→【Standard】.
Or select【Screen Layout】smartkey→【Standard】.
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7-lead
To enter 7-lead screen:
Select【M ain Menu】smartkey→【Screen Layout】→【7-lead】.
Or select【Screen Layout】smartkey→【7-lead】.
The ECG waveforms of 7- lead are displa yed in the waveform disp lay area,
they are I, II, III, aVR, aVL, aVF, and V- respectively.
Big Numerics
To enter big numerics screen:
Select【M ain Me nu】smartkey→【Scree n Layout】→【Big Nume rics 】.
Or select【Screen Layout】smartkey→【Big Numerics 】.
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User Guide
On big numer ics screen, you can select any parameters on screen, conduct
some parameter settings and observe the parameter as required.
At the same time, a wavefor m will be displayed under the parameter area
if the monitor can measure a waveform for the parameter.
OxyCRG
To enter OxyCRG screen:
Select【M ain Menu】s martkey→【Scree n Layout】→【OxyCRG】.
Or select【Screen Layout】smartkey→【OxyCRG】.
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User Guide
The graphic trend of HR, SpO 2 and Resp within 16 minutes are
displayed under the waveforms.
NIBP Review
To enter NIBP review screen:
Select【M ain Menu】s martkey→【Scree n Layout】→【NIBP Revie w】.
Or select【Screen Layout】smartkey→【NIBP Review】.
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The recent groups of NIBP measurement results are displa yed below the
waveforms.
HI RES Trend
To enter high resolution trend screen:
Select【M ain Me nu】s martkey→【Scree n Layout】→【HI RES
Trend】.
Or select【Screen Layout】smartkey→【HI RES Trend】.
HI RES
Trend
The HI RES Trend graph relevant to the parameters is displa yed on the
left corner of the wavefor m, it shows the graphic trend for some time of each
parameter. Label and duration of trend display above each trend, while scale
displays on the left.
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User Guide
Select a HI RES Trend of parameter to enter the setting menu, and select
【Trend time】to select the trend time length of the HI RES Trend.
Other Bed screen
To enter other bed screen:
Select【Main Me nu】smartkey→【Scree n Layout】→【Othe r Be d】.
Or select【Screen Layout】smartkey→【Othe r Bed】.
1 2
After your monitor is connected to the central monitoring system, you can
realize other bed monitoring by selecting the monitors for other beds in the same
network. The other-bed-monitoring screen can display all the parameter data of
other bed and a certain physiological parameter waveform. You can select at most
10 other-bed monitors to constitute “another-beds-monitoring group”.
The other-beds- monitoring screen in the above figure consists of the following
parts:
1. Patient’s information region: Display patient‟s room number, bed number,
and other information;
2. Information dis play setting region: Display the device numbers of the set
other-bed monitors and whether they are receiving data.
3. Other-bed-monitoring region: Display all the physiological parameter data
and a certain physiological parameter waveform.
To perform other-bed monitoring, you can do the following:
1) Select the Other-Bed-Monitoring window, and then choose the device number
you need in the ejected list;
2) Select【Select Wave 】to display a certain physiological parameter waveform of
the selected other-bed monitor in the other-bed-monitoring window; and
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3) Lastly, select 【Start/Stop】to receive data and start other-bed Monitoring To
stop other-bed monitoring, select 【 Start/Stop 】 again. After that, data
receiving will be stopped, and so will the current monitoring.
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User Guide
Chapter 5 Alarm
Alar m refers to a prompt given by the monitor to the medica l personne l,
through visua l, audib le and other means, upon encounter ing abnormal vita l
signs or when there are technical problems.
The monitor ge ne rates all the audible and vis ual alarms through the
speake r, alarm lamp and dis play. Whe n the monitor powe rs on, the alarm
lamp will light up once and the s pe ake r will give a bee p, which indicates
the alarm system of the monitor are in working order.
5.1 Alarm Category
According to the nature of a larm, the alar ms can be classified into three
categories: Physiological alarms, Technical alarms and Prompt messages.
Physiological alarms
Physio logical a larms are triggered by a monitored parameter value that
violates set alar m limits or an abnormal patient condition. Phys io logical alar m
message are displayed in the physiological alarm area.
Technical alarms
Technical alarms are triggered by a device malfunction due to improper
operation or system problems. The proble ms may result in system abnorma l
operation or irresponsib le monitoring parameters. Technical a larm message
are displayed in the technical alarm area.
Prompt messages
Prompt messages are not alar m messages. Apart from the phys iolo gica l and
technica l alarm messages, the monitor will show message s ind icating the
system status.
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5.2 Alarm Level
According to severity o f alar m, the monitor ‟s phys iolo gical alar ms are
classified into three categories: High le vel alarms, Medium le vel alarms and
Low level alarms.
High leve l a larms : Ind icate that the patient is in a life threatening s ituation
and an emergency treatment is necessary. This is the highest level alarm.
Medium leve l a larms : Ind icate that the p atient‟s vita l signs appear
abnormal and an immediate treatment is required.
Low level a larm: Ind icate that the patient‟s vital s igns appear abnormal and
an immediate treatment may be required.
The leve ls of some phys iologica l alarms are predefined at the factory and
cannot be changed by users. While some levels of phys io logical alar ms can
be changed by users.
The monitor ‟s technical a larms are classified into three categories: high
level,medium level and low level.
The levels of technical alarms are predefined before the monitor leaves
the factory and can not be changed by users.
5.3 Alarm Indicators
When an alarm occurs, the monitor will ind icate it through the following
means:
Alar m tone: According to alar m leve l, speaker in the monitor gives alar m
sound in different tone.
Alar m la mp: According to alar m leve l, alarm la mp on monitor flashes in
different color and speed.
Alarm message: Alarm messages are displayed on the screen.
Flashing numeric: The numeric of parameter in alarm flashes.
The concre te prese ntation of each alarm pro mpt is re late d to the alarm
level.
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5.3.1 Alarm Tone
The different leve l alarms are indicated by the system in fo llowing different
audio ways:
Alarm level Audible prompt
High “DO-DO-DO------DO- DO, DO-DO-DO------DO-DO”
Medium “DO-DO-DO”
Low “DO-”
The interburst interva l for all audible alarm s ignals can be set in the
【System Alm Setup】, but this can only be operated by maintainer.
Select【M ain Me nu】s martkey→【Work Mode 】→【Mainte n.】, enter
the password.
Then Select【Main Me nu】smartkey→【M ainte n.】→【Syste m Alm Se tup】
→【Alm Sound Type】, you can select types of 【ISO】
When the type is select as【ISO】, the interva l cannot be set, it was
defaulted as follows:
1. 【(Low) Alm Sound Inter.】: 25s
2. 【(Med) Alm Sound Inter.】: 15s
3. 【(High) Alm Sound Inter.】: 10s
5.3.2 Alarm Lamp
When a phys io logical alar m occurs, the alarm leve ls are ind icated in the
following different visual ways:
Alarm level Visual prompt
High Alarm lamp flashes in red at 2 Hz.
Medium Alarm lamp flashes in yellow at 0.5 Hz.
Low Alarm lamp lights on in yellow without flashing.
When a technica l alarm occurs, the alarm leve ls are ind icated in fo llowing
different visual ways:
Alarm level Visual prompt
High Alarm lamp flashes in red at 2 Hz.
Medium Alarm lamp flashes in yellow at 0.5 Hz.
Low Alarm lamp lights on in yellow without flashing.
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Whe n multiple alarms of diffe re nt leve ls occur at the same time, the
monitor will sele ct the alarm of the highes t leve l and give vis ual and
audible alarm indications.
5.3.3 Alarm Message
Physiological alarm
1) Phys iolo gical alarm messages are disp layed in the phys iologica l alarm area.
2) The “*” symbol before the alarm message match the alarm leve l as follows :
High level alarms: ***
Medium level alarms: **
Low level alarms: *
3) The system uses different background colors for the alar m message to
match the alarm level:
High level alarms: red
Medium level alarms: yellow
Low level alarms: yellow
Technical alarm
1) Technical alarm messages are displayed in the technical alarm area.
2) The “*” symbol before the alarm message match the alarm leve l as follows :
High level alarms: ***
Medium level alarms: **
Low level alarms: *
3) The system uses different background c olors for the alar m message to
match the alarm level:
High level alarms: red
Medium level alarms: yellow
Low level alarms: blue
Prompt messages
1) Prompt messages are displayed in technical alarm area or the corresponding
parameter area.
2) Prompt messages have no color and visual and audible alarm indication.
When multiple alarms occur at the same time, the alar m messages will be
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displayed in the alarm area in turn.
Select the phys io logical alar m or technica l area, an alarm message
window will pop up, you can observe the alarm message from it.
5.3.4 Flashing Numeric
When a phys io logical alarm occurs, the numer ic letters of the phys iologica l
parameter flashes.
5.4 Alarm Status Symbol
The alarm sound is off.
The alarm is suspended.
The parameter alarm is off.
5.5 Setting Alarm Volume
Select【M ain Menu】s martkey→【Alm Se tup】→【Alm Volume 】, you
can set the alarm vo lume of system. The volume can be set to 【 Sile nce】or a
value between X and 6. X can be set as Sile nce, 1, 2, 3, 4, 5, 6. X is the
minimum alar m vo lume and 6 is the ma ximum vo lume. (The minimum alar m
volume X can be set in the Maintenance Mode with password, the password
can only be get from the factory.)
When the volume set to 1~6, the volume symbol is displayed as “ ”,
and if the vo lume set to sile nt, the symbol will change to “ ” disp layed in
the middle of the screen.
Or select【Volume】/【Alm Setup】smartkey→【Alm Volume 】to set the
alarm volume.
The auditory alarm sound leve l s hould not be se t to less than ambie nt
leve ls as this may impe de the ope rator from re cognizing the alarm
conditions delaying patient treatme nt.
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5.6 Parameter Alarm
The setup for parameter alarm is in the ir setting menus. In the me nu for a
specific parameter, you can view and set the alarm limit, alarm status. The
alarm setting of parameter is independent from each other. Or you can select
【Main Menu】smartkey→【Alm Setup】to set the parameter alarm.
For the parameters whose alar m switc h is set to ON, the alar m will be
triggered when at least one of them exceeds alarm limit. The fo llowing actions
take place:
1. Trigger audible and visual alarm according to alarm level;
2. Alarm message is displayed in the physiological alarm area;
3. The numeric of parameter in alarm flashes.
When a parameter alarm is off, a symbol “ ” will be displa yed near the
parameter. If the alarms are turned off indiv idua lly, they must be turned on
individually.
5.6.1 Alarm Switch(only for configuration mode)
Select 【Alm Switch】 in each parameter setting menu to set the alarm
switch of them. You can select【 On】or【 Off】. When a parameter alar m is off,
a symbol “ ” will be displayed near the parameter. If the alar ms are turned
off individually, they must be turned on individually.
5.6.2 Alarm Level
Select【Alm Le vel】in the setting me nu of each parameter, you can view
and set the alarm le vels of present parameters. The leve l can be set to【Low】,
【Med】or【High】.
5.6.3 Alarm Limit
Setting Individual Alarm Limits
The alar m limit can be set in each parameter setting menu, you can select
【Hi Lmt】, 【Lo Lmt】to set the alarm limit for each parameter. The alar m
limit is adjustable, Phys io logical alar m will be triggered when the measur ing
value exceeds the set limit.
Setting All Alarm Limits
Select【Main Me nu】smartkey→【Alm Setup】→【Alm Limit】to set
the alarm limits of all present parameters.
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User Guide
Medical pe rs onne l s hould se t the alarm limits of parame te rs in line
with the clinical e nvironme nt a nd e xis ting clinical expe rie nce. Before
monitoring, ple ase confirm whe the r the alarm se tting is s uitable for
the monitore d patient.
The use rs can not set the alarm limit ove r the exte me values, that will
render the alarm system useless.
If diffe re nt alarm presets are use d for the same or s imilar e quipme nt
in any single area, a potential hazard may exist.
Limit Display
1. Select【Main Menu】smartkey→【Scree n Setup】;
2. Select【Limit Dis play】,you can select 【On】to display the alar m limit or
【Off】to close it.
5.7 Pausing Alarms
By pressing the button on the front panel of the monitor, all alar m
indicators of the monitor can be suspended:
——The alarm lamp and alarm sounds are all suspended.
——The parameters of physiological alarm stop flashing.
——The alarm message in the physiological alarm area will not be displayed.
——The rema ining time and the icon will be shown in the phys iological
alarm area.
——The alarm message in the technical alarm area will not be displayed .
The default duration o f alar m paused is 2 min, and the duration time can be
selected as 【 1min】, 【2min】,【3min】,【 5min】in the maintenance mode
with password. After the alar m paused time ,the monitor will automatically
cancel the alarm paus ing. Press again the button , the alar m pausing can be
cancelled by manual operation.
After returning to the norma l status, whether the alar m still exists is
dependent on whether the alar m condition is met. But when pressing the
button , the alarm o f lead- off/sensor-off will auto matically turn into a
prompt message.
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User Guide
5.8 Alarm Reset
Press the button on the front pane l of the monitor; you can
acknowledge all active physiological and technical alarms:
——The auditory alarms are all shut off.
——Visua l alar m signa ls for latching alar m conditions that no longer exist are
cease.
——The visua l alar m s ignals for any existing alar m conditions will continue as
long as those alarm conditions exist.
——The parameters of physiological alarm keep on flashing.
——The alarm of lead-off/sensor-off turns into a prompt message.
After acknowledging the alarms, if a new technical a larm or phys iologica l
alarm occurs, the monitor will enable the visual and audible alarm once again.
5.9 Latching Alarms
The physiological alarms are classified into Latching and Non-latching.
Latching alar ms: Even if the alarm cause has been cleared, the system still
prompts the alarm of the parameter until you acknowledging the alarm.
Non- latching alarms : After clearing the cause of parameter alar m, the
system will not prompt the alarm of the parameter.
All the technica l alarms are non- latching a larms. All phys iologica l
alarms are non- latching alar m except for the Arrhythmia alarms. The
Arrhythmia a larm can be set to non- latching alar m or latching alar m only in
the Maintenance Mode or Service Mode using a password.
5.10 When an Alarm Occurs
Whe n an alarm occurs , you s hould always check the patie nt’s condition
first.
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Check the alarm message that appears on the screen. It is required to
identify the alarm and take appropriate action according to the nature of the
alarm.
1. Check the patient‟s condition.
2. Identify alarming parameter and alarm category.
3. Identify the cause of the alarm.
4. Silence the alarm, if necessary.
5. When cause of alar m has been addressed, ensure the alarm system is
working properly.
You will find the alar m messages details for the individual parameters in
Appendix C Alarm message.
5.11 Alarm when power is lost
Upon loss of power, when device is powered up, the alar m settings prior to
the power loss are restored.
If you want to restore either the alarm settings from the default settings,
please enter the alarm setting menu to select the setting.
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User Guide
Chapter 6 Patient Management
6.1 Admitting a Patient
The monitor displays phys iologica l data and stores it in the trends as soon as
a patient is connected. This lets you monitor a patient who is not yet admitted.
However, it is very important to admit patients properly. If a patient is admitted
in the monitor, it is advised to discharge the current patient before admitting a
new patient. Or else, the data of next patient will be stored in t he current
patient‟s data.
To admit a patient,
1. Select【Patie nt Manage.】smartkey→【Admit Patie nt】,and then select【 Yes 】
to discharge the current patie nt and admit a new patient. The patient info
window will be popped up.
2. Enter or select the patient information:
——MRN: Enter the patient‟s medical record number (MRN);
——First Name: Enter the patient‟s first name;
——Last Name: Enter the patient‟s last name (family name);
——Gender: Choose【Male 】or【 Fe male 】;
——Patient Type: Choose the patient category, either【Adult】,【Pe diatric】
or【Neonate】;
(The patient category setting determines the algorithm the monitor uses to
process and calculate some measurements, the safety limits that apply
for some measurements, and the alarm limit ranges.)
——Paced: Choose【Yes 】or【No】. An icon will be displayed in the
patient info area on the screen when choosing【 Yes 】, if not, will be
displayed. (You must choose【Yes 】if your patient has a pacemaker.)
——Room No.: Enter the patient‟s room number;
——Bed No.: Enter the patient‟s bed number;
——Age: Enter the patient‟s age;
——Height: Enter the patient‟s height;
——Weight: Enter the patient‟s weight;
——Blood Type: Enter the patient‟s blood type.
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【Patie nt Type】and【 Pace d】s tatus will always contain a default value,
re gardless of whe the r the patie nt is admitte d or not. Use rs mus t
confirm whethe r the default value is suitable for the monitore d patient.
For pace d patie nts , you mus t se t【 Pace d】 to【 Yes】. If it is incorre ctly
set to【No】 , the monitor could mis take pace pulses for re gular QRS
comple xes and fail to alarm during asystole.
For non-pace d patie nts , you mus t set【 Pace d】to【No】, othe rwise, the
syste m cannot de te ct the arrhythmia relate d to Ve ntricular Pre mature,
and will not conduct ST analysis.
6.2 Quick Admitting a Patient
Use“Quick Admit ”only if you do not have the time or information to fully
admit a patient. Complete the rest of the patient information details later.
To quick admit a patient,
1. Select【Patie nt Manage.】smartkey→【Quick Admit】, and select【 Yes 】
in the window popped up to discharge the previous patie nt and admit a new
patient.
2. Set【Patie nt Type】and【Pace d】, the patient status changes to admitted.
6.3 Edit Patient Information
After a patient has been admitted, you can edit the patient information in
following ways:
1. Select【Patie nt Manage.】smartkey→【Pat. Information】.
2. Edit the patient information from the popped up menu.
6.4 Discharging a Patient
You should always perform a discharge before start of monitoring a new
patient, even if your previous patient was not admitted.
To discharge a patient,
1. Select【Patie nt Manage.】smartkey→【Discharge Pat.】.
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2. In the popped up menu, you can:
——Directly select 【 OK 】 , the monitor will return ma in screen after
discharging the patient.
——Choose【 Standby】, and select【OK】, the monitor will enter standby mode
after discharging the patient.
——Select【 Cance l】to cancel the discharge operation and return main screen.
When the patient is discharge d, his history data will be deleted too.
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Chapter 7 ECG
7.1 Introduction
Before mechanical systo le, the heart firstly produces electrical excite ment,
which results in biolo gical current, and conducts the current to the body
surface through tissue and humour. Different potentia l changes take place at
various parts of the body, thus body- surface potentia l differences are formed.
Record the changing potential differences to form the dyna mic curve, i.e.
ECG, also called body-surface ECG or regular ECG.
Through many e lectrodes connected with ECG cables, the monitor
examines the changes of body- surface potential caused by the heart of patient,
observes the ECG activities, records the ECG wave form, and calculates the
HR. The monitor can achieve 3- lead, 5- lead monitoring, and has the function
of ST-segment monitoring and arrhythmia analysis.
7.2 Safety Information
It is impe rative to only use the ECG e lectrodes a nd cables provide d by
manufacture r or s pecifie d in this manual. Use rs s hall use the e lectrode
which has little polarization voltage and little contact resistance.
Whe n the e lectrode polarize d voltage is too high, the monitor will
indicate the abnormal state by alarm system.
Before connecting the ECG cables to the monitor, please che ck if the
lead wires and cables have bee n worn out or cracke d. If so, the y
should be replaced.
Whe n you are connecting the ele ctrodes or the patie nt cable , make
sure that the conne ctors ne ve r come into contact with othe r
conductive parts, or with e arth. In particular, make s ure that all of
the ECG ele ctrodes are attache d to the patie nt, to preve nt the m from
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contacting conductive parts or earth.
Please check the skin whe re the e lectrodes are place d, re place the
electrodes or relocate the electrodes in case of skin allergy occurs.
Whe n conducting de fibrillation, it is impe rative to only use the ECG
electrodes and cables specifie d by manufacture r.
Do not touch the patient, bed or the monitor during defibrillation.
The monitor is prote cte d agains t de fibrillation e ffect. Whe n applying
de fibrillator to the patie nt, the monitor will e xpe rie nce trans ie nt
dis orde rly waveforms . If the e lectrodes are use d and place d corre ctly,
the dis play of the monitor will be res tore d wit hin 10s. During
de fibrillation, the chest leads s uch as V1 ~V6 s hould be re move d and
such limb e le ctrodes as RA, LA, RL, LL s hould be move d to the s ide
of the limbs.
Inte rfe re nce from ins trume nts near the patie nt and ESU inte rfe re nce
can cause proble ms with the ECG wave.
The monitor cannot be dire ctly applie d to he art and cannot be use d
for the measure me nt of endocardio ECG.
7.3 Monitoring Procedure
7.3.1 Skin Preparation for Electrode Placement
Good electrode- to- skin contact is important for a good ECG signal, as the
skin is a poor conductor of electric ity. It is necessary to deal with the skin
properly before placing the electrodes. The steps are shown as follows:
1. Select sites with intact skin, without impairment of any kind.
2. Clip or shave hair from sites as necessary.
3. Gently abrade the skin to remove dead skin cells to improve the conductivity
of the electrode site.
4. Wash sites thoroughly with soap and water, leaving no soap residue.
(We do not recommend using ether or pure alcoho l, because this dries the skin
and increases the resistance.)
6. Dry skin thoroughly.
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7.3.2 Placing Electrode
1. Preparation before electrode placeme nt
1) Skin preparation (refers to Chapter 7.3.1);
2) Check if the buttons on the electrodes are clean and free of damage;
3) Place the electrodes on the body of patient. Before attaching, smear some
conducting cream on the electrodes if the electrodes are not electrolyte
self- supplied;
4) Connect the cable leads to the electrodes through the butt ons of the
electrodes.
For patie nts who tre mble a lot or patie nts wit h es pecially we ak ECG
signals , it might be difficult to e xtract the ECG s ignals, and it is eve n
more difficult to conduct HR count. For seve re ly burnt patie nts, it may
not be possible to stick the e lectrodes on and it may be ne cessary to use
the s pe cial pin-s hape e lectrodes. In case of bad s ignals, care s hould be
taken to place the electrodes on the soft portions of the muscle.
Che ck the irritation cause d by each ele ctrode to the skin, and in case
of any inflammations or alle rgies, the e lectrodes s hould be re place d
and the use r s hould re locate the e lectrodes e ve ry 24h or at a s horte r
interval.
Whe n the ele ctrotome ope ration is pe rforme d, the ECG leadwires
should be inte rt wis te d as much as poss ible. The monitor s hould be
place d far from the ope rating table. Powe r wires and the ECG lead
cables should be partitione d and should not be in paralle l.
2. Electrode Placeme nt
3-Lead
Take the AHA standard as an example, when conducting 3- lead ECG
monitoring, use 3- lead ECG cable. The three limb- leads of RA, LA and LL as
shown in below figure, will be placed on the rele vant locations. This
connection can establish the lead of I, II, III.
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RA LA
LL
5-Lead
Take the AHA standard for examp le, when conducting 7- lead ECG
monitoring, use 5- lead ECG cable. The four limb- leads of RA, LA, RL and LL
as shown in below figure, will be placed on the relevant locations. This
connectio n can establish the lead of I, II, III, aVR, aVL, aVF; according to
actual needs, chest lead V can be placed on any of the locations between
V1 ~V6 , respectively making one lead of V1 ~V6 established.
RA LA
RL LL
Place electrodes for a surgical patient
While plac ing electrodes for a surgical patie nt, the type of s urgery should
be considered, for instance, as to a chest surgery, the chest lead electrodes can
be placed at sides or backside of chest. Moreover, while using a surgica l
electrotome, in order to reduce the influence of artifacts to ECG waveform,
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the electrodes can be placed at left and right shoulders, close to le ft and right
sides of abdomen; the chest lead electrodes can be placed at left side of chest
midst. Please avo id placing the electrode at the upper arms, else the ECG
waveform will become very small.
To avoid burns, whe n the e lectrotome ope ration is pe rforme d, the
electrodes s hould be place d near the middle be twee n ESU grounding
pad and e lectrotome . The electrotome s hould be applie d as far as
possible from all othe r ele ctrodes , a dis tance of at le ast 15 cm/6 in is
recomme nde d.
Whe n us ing the ESU de vice , avoid placing the electrodes ne ar the ESU
grounding pad, e lse, inte rfe re nce will influe nce the ECG s ignals . The
monitor s hould be place d far from the ope rating table . Powe r wires
and the ECG cables s hould be partitione d and s ho uld not be in
paralle l.
The following table shows the ECG electrode label to identify each
electrode and its associated color of AHA and IEC standards.
Electrode Electrode Electrode Electrode
labels colors labels colors Placeme nt
(IEC) (IEC) (AHA) (AHA)
Directly below the clavicle
R Red RA White
and near the right shoulder
Directly below the clavicle
L Yellow LA Black
and near the left shoulder
N Black RL Green On the right lower
abdomen
F Green LL Red On the left lower abdomen
On the fourth intercostal
C1 Red V1 Red space at the right sternal
border
On the fourth intercostal
C2 Yellow V2 Yellow space at the left sternal
border
Midway between the V2
C3 Green V3 Green
and V4 electrode positions
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On the fifth intercostal
C4 Brown V4 Blue space at the left
midclavicular line
On the left anterior axillary
C5 Black V5 Orange line, horizontal with the V4
electrode position
On the left midaxillary
C6 Violet V6 Violet line, horizontal with the V4
electrode position
7.3.3 Connecting ECG Cable
Plug the ECG cable into the ECG connector. An ECG waveform and numer ic
appears on the monitor display.
7.3.4 Selecting Leads
Depending on the patient to be monitored, you shall select the proper leads
as required.
1. Select ECG parameter area, enter ECG parameter setup menu, select【Lead
Type】.
2. You can select【3 lead】,【5 lead】.
7.3.5 Checking Paced Status
It is important to set the paced status correctly when you start monitor ing
ECG.
If the【Pace d】status has been set to【Yes 】, the icon will be shown
on the screen. If the syste m detects paced signa l, the symbo l “ ︱ ” will be
marked on the ECG wave.
To change the paced status, you can select【Patie nt Manage.】smartkey→
【Pat. Information】, and set the【Pace d】status in the popped up menu.
For pace d patie nts , you mus t set【 Pace d】to【 Yes】. If it is incorrectly
set to【No】, the monitor could mis take pace pulses for regular QRS
comple xes and fail to alarm during asystole.
Some pace pulses can be difficult to re ject. Whe n this happe ns , the
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pulses are counte d as a QRS complex, and could res ult in an incorre ct
HR and failure to de tect cardiac arrest or s ome arrhythmias . Kee p
pacemake r patients unde r close observation.
For non-pace d patie nts , you mus t set【 Pace d】to【No】, othe rwise, the
syste m can not de tect the arrhythmia re late d to Ve ntricular
Premature(including PVCs count), and will not conduct ST analysis.
7.4 ECG Display
The following figure shows the ECG display screen, the display on your
monitor may be looked slightly different.
Waveform Display
Lead 1mV scale ECG wave Pace pulse mark
label
起搏脉冲标志
If the【Pace d】status has been set to【Yes 】and the system detects paced
signal, the paced pulse “ ” will be marked on the ECG wave. (As it shown
above)
Paramete r Display
HR value
Heartbeat
HR unit
icon
HR
alarm limit
报警限
If the monitor doesn‟t obtain an effective HR va lue by ECG measuring,
the PR value will be displayed instead here.
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7.5 Setting ECG
7.5.1 Setting ECG Parameter
Select the ECG parameter area to enter the ECG parameter setting menu.
Setting ECG Mode
The ECG mode can be selected as required, including【 Use r】
【Diagnos
, is 】,
【Monitor】and【Surge ry】.
【Monitor】: Use under the normal measurement.
【Diagnos is 】: Use when diagnostic quality is required. The unfiltered ECG
wave is displayed so that changes of waveform are visible.
【 Surge ry 】 :Use while the signa l is distorted by high- frequency or
low- frequency interference. During a surgery, selecting the mode 【Surge ry】
can reduce artifacts and the inter ference from e lectro- surgical units. Under
norma l measureme nt conditions, selecting 【Surge ry】ma y suppress the QRS
complexes too much so as to interfere the ECG analysis.
【User】: Users can manually set the switches of various filters as required.
The states of the filter unde r various ECG modes
Filter
Drift filter HUM filter EMG filter
ECG mode
Diagnosis Off Optional Off
Surgery Intense On Intense
Monitor Mild On Mild
User Optional Optional Optional
Unde r the mode of【 Surge ry】and【M onitor】, the s tate of the filte r cannot
be re gulate d. Only unde r the state 【Diagnos is】of【 Use r】can the state be
re gulate d. Ple ase select【M onitor】 during monitoring a patie nt, se lect
【Surgery】 unde r the state of great interfe re nce.
Setting QRS Volume
The monitor will give out QRS sound according to HR value. Select 【QRS
Volume 】in the ECG setting menu to change the QRS volume. The volume can
be set to a value between 1 and 6, and also can be silenced.
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Setting the Primary Lead
Select【Primary Lead】 in ECG parameter setting menu, and you can set
the primary lead as required, the wave of primary lead will be displayed on
the top of the screen.
7.5.2 Setting ECG Waveform
Select one ECG waveform to enter the ECG wave setting menu.
Setting Wave Gain
If ECG wave on the screen is too sma ll or be cut muc h, you shall se lect 【
Wave Gain】in the ECG setting menu to change the amplitude of ECG wave.
The options are【Auto】,【0.25×】,【0.50×】,【1.00×】,【2.00×】 and 【
4.00×】.When selecting【Auto】, the monitor will adjust the amplitude of ECG
wave automatically.
Setting Wave Speed
Select【Wave Spee d】in the ECG setting me nu, and select proper sweep
speed in the options.
Setting Wave Cascade
Select【Wave Cascade 】in the ECG setting menu, you can set this wave as
cascade display or not.
7.6 ST Monitoring
The monitor performs ST segment analysis on normal and atria lly paced
beats and calculates ST segment elevations and depressions.
ST segment monitoring fuction is not applicable to neonates.
The clinical s ignificance of the ST segment analys is should be determined
by a physician.
Some clinical conditions may make it difficult to achieve re liable ST
monitoring, for example :
——If you are unable to get a lead that is not noisy;
——If the patient is continuously ventricularly paced;
——If the patient has left bundle branch block;
—— If arrhythmias s uch as atrial fib/flutte r are prese nt, which may cause
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an irregular baseline;
You s hould cons ide r s witching ST monitoring off if these conditions are
present.
7.6.1 Switching ST On and Off
Select【ST Setup】 in the ECG setting menu, fro m the popped up window
select【ST Anal. Switch】, it can be set to【On】or【Off】.
7.6.2 ST Display
ST
numerics
ST segment are displayed on the right of ECG parameter area of screen.
The quantity for ST segments disp laying on the screen depends on the current
lead type, and it also depends on the quantity of parameters displaying on the
screen.
A positive ST value ind icates ST segment elevation; a negative va lue
indicates depression.
7.6.3 Setting ST Alarm
The ST alar m limit of each lead can be set in ST analys is setting menu,
and in this menu, you can also set alarm switch, alar m level and alar m print
switch.
7.6.4 Adjust ST point
The ST value for each beat complex is the vertica l difference between the
ISO point and the ST point, as shown in the figure below. The isoelectric (ISO)
point provides the baseline, the ST point is at the midpoint of the ST segment.
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User Guide
In the ST ana lys is menu, select【Adjus t ST point】, the QRS complex
will be displa yed on the popped up window, the two vertical lines indicate
the position of ISO point and ST point. Set the R wave peak as the reference
point for ST measurement.
The ST measurement points and ISO point need to be adjusted when you
start monitoring, and if the patient's heart rate or EC G morphology changes
significantly.
You can select【ISO】or【ST】and then adjust the point right and left.
Whe n conducting ST analys is, the sys te m will not cons ide r abnormal QRS
comple x.
7.7 Arrhythmia Monitoring
Arrhythmia analys is provides infor mation on your patient‟s condition,
including heart rate, PVC rate, rhythm, and ectopics.
7.7.1 Switching Arrhythmia Analysis On and Off
Select【ARR Analys is】in ECG setting menu, and set【ARR Analysis 】
to【On】or【 Off】.
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7.7.2 PVCs Display
PVC Count
PVC count ind icates the quantity of PVC occurring within 1 minute. When
the PVC quantity in 1minute exceeds the set alarm limit, the monitor will
indicate alarm message “Multi PVCs”.
7.7.3 Setting Arrhythmia Alarm
Select 【ARR Analysis 】→【ARR Alm Se tup】in the ECG setting menu,
in the popped up menu, you can set the alarm status for each Arrhythmia,
including alar m switch, alarm level and alarm print switch. You can select
【ALL ARR Alm-Res ume Default】,【All ARR Alm-Alm Switch】,【ALL
ARR Alm-Alm Leve l】and【All ARR Alm-Alm Print】to set the alar m status
for all arrhythmia.
Arrhythmia can be analyzed by the monitor is shown in the following table:
Applicable
Arrhythmia Type Abbreviation Alarm Level
Patient Type
ASYSTOLE ASY All Default High
VENT FIB/TACH VF/VT All Default High
PAC PAC Non-paced Default medium,User selectable
RUN PVCs RUN Non-paced Default medium,User selectable
COUPLET CPT Non-paced Default low,User selectable
BIGEMINY BGM Non-paced Default low,User selectable
TRIGEMINY TGM Non-paced Default low,User selectable
R ON T ROT Non-paced Default low,User selectable
TACHY TAC All Default medium,User selectable
BRADY BRD All Default medium,User selectable
MISSED BEAT MIS Non-paced Default low,User selectable
ST Elevation STH Non-paced Default low,User selectable
ST Depression STL Non-paced Default low,User selectable
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Applicable
Arrhythmia Type Abbreviation Alarm Level
Patient Type
PNP PNP Paced Default medium,User selectable
PNC PNC Paced Default medium,User selectable
NOISE NOS All Default low,User selectable
V-TACH VT Non-paced Default High
VPB VPB Non-paced Default low,User selectable
Frequent PVCs PVCH Non-paced Default low,User selectable
VENT BRADY VBRD Non-paced Default medium,User selectable
EXTREME TACHY ETAC All Default medium,User selectable
EXTREME BRADY EBRD All Default medium,User selectable
NON-SUSTAIN VT NSVT Non-paced Default medium,User selectable
VENT RHYTHM VRHY Non-paced Default medium,User selectable
PAUSE PAUSE All Default medium,User selectable
IRREGULAR HR IRHR All Default low,User selectable
7.7.4 Arrhythmia Relearning
Initiating Arrhythmia Relearning Manually
During monitor ing, if you have any question on the analys is result o f
arrhythmia, you can start the arrhythmia relearning manually. Select 【ARR
Analysis 】in the ECG setting menu, and select【Arr. Re learning】. Then, a
prompt message of “ARR is relearning” will be disp layed in the technica l
alarm area.
Automatic Arrhythmia Relearn
The arrhythmia relearning can be automatically started in the fo llowing
cases:
1. The arrhythmia function is switched on;
2. The lead type is changed manually;
3. After lead-off, reconnect the lead;
4. The primary lead is changed.
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7.7.5 Arrhythmia Review
Select【ARR Analysis 】in the ECG setting me nu, and then select【ARR
Review】to view the Arrhythmia events happened before. Shown as follows:
In the ARR Review window, you can:
——Select an ARR event and then select【De lete 】to delete the event.
——Select or to turn up or turn down the displaying window.
——Select an ARR event and then select【Wave 】to enter the ARR Wave
window which is as follows:
In the area of smartkeys whic h is under the the ARR Wave window, you
can:
——Select or to shift ARR waveform leftwards or rightwards.
——Select or to turn page up or down.
——Select or to shift ARR waveform to the first or last page.
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7.8 QT Analyze Setup
You can achieve the patient QT analyze by following the steps as follows:
1. Select【QT Analyze Setup】 in ECG setting menu, and set【QT Analyze
Setup】to【On】or【Off】.
2. Select the alarm setup to【On】or【Off】as what you want.
3. Select other option to what you want.
When all the selections are finished, the HRinterface will show as follows:
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Chapter 8 Respiration Rate (Resp)
8.1 Introduction
For the Respiratory Measurement (Resp), the monitor measures the thoracic
impedance between two ECG electrodes on the patie nt‟s chest. Changes in the
impedance due to thoracic moveme nt produce the Resp wavefor m on the
monitor screen. The monitor counts the wavefor m cycles to calculate the
respiration rate (RR).
8.2 Safety Information
For the sake of safety, all the leads on the ECG cable mus t be
connecte d to patient.
Whe n monitoring Res p, the ECG cable with e lectrotome -proof mus t
not be used.
The me as ure me nt of Res p is not applicable for patie nt wit h excessive
motion, otherwise it may cause the mistake of Resp alarm.
8.3 Monitoring Procedure
1. Connecting ECG Cable
To monitor Resp parameters, only the ECG cable is required.
2. Placing Resp Electrodes
Refer to chapter 7. 3. 1 for s kin preparation a nd electrode placement. It is
unnecessary to use other electrodes for monitoring Resp, but it is very
important to place the electrodes properly. The Resp signa l is always measured
between two of the ECG electrodes. If you are us ing standard ECG electrode
placeme nt, Resp is measured between the RA and LL e lectrodes or between the
RA and LA electrodes.
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In orde r to ge t the best Res p wave forms, whe n us ing RA and LA
electrodes for me as uring Resp, it is advise d to place the m horizontally;
when using RA and LL electrodes, it is advised to place them cornerways.
Optimizing Lead Placeme nt for Resp
If you want to measure Resp and you are already measur ing ECG, you may
need to optimize placement of the two electrodes between which Resp will be
measured for some patients. Repositioning ECG electrodes fro m standard
positions, results in changes in the ECG waveform and ma y influence ST
monitoring.
Cardiac Overlay
Cardiac activity that affects the Resp wavefo r m is called cardiac overlay. It
happens when the Resp electrodes pick up impedance changes caused by the
rhythmic blood flow. Correct electrode placement can he lp to reduce cardiac
overlay: avoid the liver area and the ventric les of the heart in the line between
the Resp electrodes. This is particularly important for neonates
Lateral Chest Expans ion
Some patients, especia lly neonates, expand their chests laterally. In these
cases it is best to place the two Resp electrodes in the right midaxillary and left
lateral chest areas at the patient‟s maximum point o f breathing move ment to
optimize the Resp wave.
Abdominal Breathing
Some patie nts with restricted chest moveme nt breathe mainly abdominally.
In these cases, you may need to place the left leg e lectrode o n the left abdomen
at the point of maximum abdominal expansion to optimize the Resp wave.
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8.4 Resp Display
Waveform Display
Respiratory wave
Paramete r Display
RR unit
RR value
RR
alarm limit
8.5 Setting Resp
8.5.1 Setting Resp Parameter
Select Resp parameter area to enter Resp parameter setting menu.
Setting Resp Lead
In the Resp setting menu, select【Res p Le ad】, and you can select【RA-LA】
or【RA-LL】.
Setting Apnea Alarm Time
In the Resp setting menu, select【Apnea Alm】, and select the apnea time
as required in the options. The monitor ind icates an alar m when a pre- adjusted
time has elapsed since the last detected breath.
The Apnea Alarm Time can be set in the Maintenance Mode with
password, the password can only be got from the manufacturer.
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8.5.2 Setting Resp Waveform
Select Resp waveform area, and then enter the Resp wavefor m setting
menu.
Setting Wave Gain
If Resp wave on the screen is too sma ll or be cut much, yo u shall se lect
【Wave Gain】in the Resp setting menu to change the amp litude of Resp wave.
The options are【0.25×】,【1×】,【2×】and【4×】.
Setting Wave Speed
In the Resp setting menu, select【Wave Spee d】, and select proper sweep
speed in the options.
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Chapter 9 SpO2
9.1 Introduction
The measureme nt of oxygen saturation o f arteria l blood (also known as
pulse oxygen saturation, usually shortened as SpO 2 ) adopts the princip les of
light spectra and volume tracing. The LED emits lights with two specific
wavelengths, which are selective ly absorbed by oxygenated hemoglobin and
deoxyhe moglobin. The optical receptor measures the changes in the light
intensity after the light passes the capillary network and estimates the ratio of
oxygenated hemoglobin and the total hemoglobin.
oxygenated hemoglobin
SpO 2 % = 100%
oxyhemoglobin + deoxyhemoglobin
The SpO 2 sensor measurement wave lengths are nomina lly 660nm for the
Red LED and 905nm for infrared LED
9.2 Safety Information
Use only SpO2 se nsors s pecifie d in this manual. Follow the SpO2
sensor’s instructions for use and adhere to all warnings and cautions.
Whe n a tre nd toward patie nt deoxyge nation is indicate d, blood
samples s hould be analyze d by a laboratory co-oxime te r to complete ly
unde rstand the patient’s conditions.
Do not use the monitor and the SpO2 se nsor during magne tic
resonance imaging (MRI). Induce d curre nt could cause burns.
Prolonge d continuous monitoring may increase the risk of une xpe cte d
changes in skin characte ris tics , s uch as irritation, re dde ning,
blis te ring or burns. Ins pe ct the sens or s ite eve ry two hours and move
the se nsor if the skin quality changes. For neonates, or patie nts wit h
poor pe riphe ral blood circulation or se ns itive skin, ins pe ct the se nsor
site more freque ntly.
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Che ck the SpO2 se nsor and its package for any s ign of damage be fore
use. Do not use the sensor if any damage is detected.
Before use , the ope rator mus t e ns ure the compatibilityies of the
monitor, SpO2 se nsor and exte ns ion cables ; othe rwise, this may lead to
the burning of patie nts ; do not use damage d se ns or or exte ns ion cable .
Do not soak the se nsor into wate r or make it we t, othe rwise it may be
damage d.
Whe n dis pos ing the dis pos able SpO2 probe or use less SpO2 probe ,
ple ase obse rve all local, state, and fe de ral regulations that re late to
the disposal of this products or similar products.
Pulse rate me as ure me nt is base d on the optical de tection of a
pe riphe ral flow pulse and the refore may not dete ct ce rtain
arrhythmias . The pulse oxime te r s hould not be use d as a re place me nt
or substitute for ECG based arrhythmia analysis.
In case it is necessary to add a clip to fix the finge rtip se nsor, the cable
ins tead of the se nsor itse lf s hould be clippe d. Please note that the
cable of sensor should not be pulle d with force.
A function tester cannot be used to assess the accuracy of the SpO2.
The pleth wave is not equal to the intensity of PR signal.
The production divergence and drive current of LED influence the range
of the peak wavelength of the emitted light by the oxygen probe .
The monitor does not provide automatic self-examination alarm
signal and the ope rator has to use SpO2 s imulator for
self-examination.
To validate the PR accuracy, we re fe re nce to the e lectronic pulse
simulator the computation the PR accura cy.
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9.3 Monitoring Procedure
1. Selecting SpO2 Sensor
Depending on the patient category, weight and application site, you can
select the SpO2 sensor as required.
2. Connecting SpO2 Sensor
Plug the SpO 2 sensor cable into the SpO 2 connector on the measureme nt
module.
3. Applying SpO2 Sensor
Clean the application s ite, such as colored na il polish, and apply the sensor
to the patient.
Do not use the SpO2 se nsor on a limb whe re the NIBP cuff is applie d.
This may res ult in inaccurate SpO2 reading due to blocke d blood flow
during cuff inflation.
Do not conduct SpO2 meas ure me nt on the finge r s me are d wit h nail
polish, otherwise unreliable measure me nt results might be produce d.
Whe n us ing finge r se nsor, make s ure the nail faces to the light
window.
9.4 SpO2 Display
9.4.1 Waveform Display
Pleth waveform
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9.4.2 Parameter Display
Signal intensity indicator
SpO2 unit SpO2 value
Pleth bar
Indicator of signal intensity Description
“Weak Signal” The signa l strength is too weak to
“*” measure.
The signal strength is low.
“**” The signal strength is good.
“***” The signal strength is best.
Whe n the “Weak Signal” is indicate d, it means the signal obtaine d by the
SpO2 probe is too bad. User s hould che ck the patie nt’s condition and
move the probe to other appropriate position.
9.5 Setting SpO2
9.5.1 Setting SpO 2 Parameter
Select SpO2 parameter area to enter SpO 2 parameter setting.
Setting NIBP measure me nt on the same limb
When NIBP and SpO 2 are simulta neously measured to the same limb of
patient, the operator shall enter the SpO 2 parameter setting me nu and set
【NIBP Same Side 】to【On】in order to ensure that the SpO 2 alarm status will
keep constant dur ing the NIBP measureme nt until the comp letion of NIBP
measurement. If【NIBP Same Side 】is set to【Off】, the low perfus ion will
result in the SpO 2 measurement inaccuracy during the NIBP measurement and
trigger the physiological alarm of SpO 2 .
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Setting QRS Volume
Select【 QRS Volume 】in the SpO 2 setting menu to change the QRS volume.
The volume can be set to a value between 1 and 6, and also can be silenced.
Setting Average Time
The SpO 2 reading shown on the monitor is the average of data collected
within a specific time. The shorter the averaging time is, the quicker the
monitor responds to the change in the patient‟s oxygen saturation le vel.
Contrarily, the longer the averaging time is, the slower the monitor responds
to the change in the patient‟s oxygen saturation level, but the measure ment
accuracy will be improved. When a critica l patient is monitored, selecting
shorter averaging time will help understanding the patient‟s state.
You can select【Ave rage Time 】 in the SpO 2 setting menu, and select a
proper time as required.
Setting PR Source
To set the PR source, you can select the PR parameter area, then select
【PR Source 】. The options of【SpO2 】, 【HR】and【Auto】are available.
【SpO2】: The monitor takes SpO 2 as the PR source.
【HR】: The monitor takes HR as the PR source.
【Auto】: When the monitor can detect SpO 2 signa l, the monitor will
automatica lly take the SpO 2 as the PR source. If fa iling to detect the SpO 2
signal, the monitor will automatically take HR as the PR source.
9.5.2 Setting SpO 2 Waveform
Setting Wave Speed
Select【Wave Spee d】in the SpO 2 wave setting menu, and select the wave
speed in the options as required.
9.6 Measurement Limitations
If you doubt the SpO 2 measurements, check the patient‟s vital signs first,
then check the monitor and SpO 2 sensor. The following factors may influence
the accuracy of measurements:
——Incorrect sensor application or use;
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——Significant leve ls of dysfunctiona l he moglobins.(such as
carboxyhemoglobin or methemoglobin);
——Intravascular dyes such as indocyanine green or methylene blue;
——Exposure to excessive illumination, such as surgical lamps (especially
ones with a xenon light source), bilirub in lamps, fluo rescent lights,
infrared heating la mps, or direct sunlight (exposure to excessive
illumination can be corrected by covering the sensor with a dark or
opaque material)
——Excessive patient movement;
——Venous pulsations;
——Placeme nt of a sensor on an extremity with a blood pressure cuff,
arterial catheter, or intravascular line.
——Low perfusion;
——Electromagnetic interference, such as MRI device;
——Electrosurgical units.
The monitor can be used during defibrillation, but the readings may be
inaccurate for a short time
Loss of pulse signal can occur in any of the following situation:
——The sensor is too tight;
——There is excessive illumination from light sources such as a surgica l
lamp, a brilirubin lamp, or sunlight;
——A blood pressure cuff is inflated on the same extremity as the one with
a SpO2 sensor attached;
——The patient has hypotens ion, severe vasoconstriction, severe ane mia,
or hypothermia;
——There is arterial occlusion proximal to the sensor.
——The patient is in cardiac arrest or is in shock.
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Chapter 10 Temperature (Temp)
10.1 Introduction
The monitor measures Temperature with Temperature sensors. The type of
the temperature sensors are surface and coelo m. The surface sensor is use to
measuring body surface temperature, such as axilla and forehead skin. The
coelom sensor is use to measuring the rectum temperature.
10.2 Safety Information
Disposable Temp probes must not be re-sterilize d or reused.
Should the Te mp probe become damage d be yond re pair, or for some
re ason its useful life is cons ide re d to be at an e nd, ple ase obse rve all
local, s tate, and fe de ral re gulations that re late to the dis posal of this
products or similar products.
The se lf-tes t of the te mpe rature me as ure me nt is pe rforme d
automatically te rmly during the monitoring. The test proce dure las ts
about 1s and does not affect the normal me as ure me nt of the Te mp
monitoring.
The Te mp se nsors and cables s hould be handle d wit h care . Whe n not
in use, the se ns or and the cable s hould be rounde d into loose ring
shape.
If the ambie nt te mpe rature is ove r 15-35 ℃ , the te mpe rature
measure me nt may be inaccurate .
If Te mp to be me as ure d be yond probe ’s me as uring range , ove r
meas uring range alarm will be dis playe d on the s cree n. Check if probe
is on the corres ponding patie nt body s ite, or change it to othe r s ite on
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the patient.
If “Te mp self-check e rror” is dis playe d on the scree n, it is poss ibly
that s ome thing is wrong with the te mpe rature module , the ope rator
should stop using the module and contact the manufacture r.
The minimum measuring time of TEMP recomme nd to 15min.
The mode of operation of our TEMP is direct mode.
10.3 Monitoring Procedure
1. Selecting Temp probe
Select the correct type and size of probe for your patient.
2. Connecting Temp probe to monitor
Plug the Temp cable into the Temp connector on monitor.
3. Applying the probe to patient
Apply the probe to the patient correctly.
4. Selecting Label
Select an appropriate temperature label.
5. Checking the Alarm Setting
Check that the alar m settings are appropriate for this patient and this type of
Temp measurement.
Make s ure you set alarm limits for the corre ct labe l. The alarm limits you
set are s tore d for that particular labe l only. Changing the labe l may change
the alarm limits .
10.4 Temp Display
Temp Label
Temp unit
Temp value
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Chapter 11 NIBP
11.1 Introduction
The monitor uses the oscillo metric method for measuring NIBP. It is
applicable for adult, pediatr ic and neonatal patients. The method of
oscillometr ic indirectly estimates the systolic and diastolic pressures within
the blood vessels by measur ing the change of the pressure within blood
pressure cuff along with the volume of the arteries and calculates the average
pressure.
The NIBP measurement is suitable for use in the presence of electrosurgery
and during the discharge of a cardiac defibr illator according to IEC
80601-2-30/EN 80601-2-30.
A phys ician must determine the clinical significance of the NIBP
measurement.
11.2 Safety Information
Che ck the patie nt category be fore monitoring. Incorrect settings may
res ult in s ome ris k for patie nt s afe ty. Highe r adult setting is not
suitable for pediatric and neonatal patients .
Do not use the NIBP with pregnant or pre -eclamptic patie nt. Do not
use the NIBP cuff on the arm of a mas tectomy patie nt, we s ugges t
measuring blood pressure on their legs.
Do not me as ure NIBP on patie nts wit h s ickle-cell disease or any
condition where skin damage has occurre d or is expected.
Use clinical judge me nt to decide whe the r to pe rform fre que nt Auto
BP me as ure me nts on patie nts with seve re blood clotting dis orde rs
because of the risk of hematoma in the limb fitted with the cuff.
Use clinical judge me nt to decide whe the r to pe rform Auto BP
measure me nt on the patients of thrombasthe mia.
Do not use the NIBP cuff on a limb with an intrave nous infus ion or
arte rial cathe te r in place. This could cause tiss ue damage around the
catheter when the infus ion is slowed or blocked during cuff inflation.
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If you doubt the NIBP me as ure me nts, che ck the patie nt’s vital s igns
by other device, and then check the monitor.
The continuous cuff press ure due to conne ction tubing kinking may
cause the effect of blood flow inte rfe re nce and res ulting harmf ul
injury to the patient.
Do not use the cuff over a wound, as this can cause furthe r injury.
That press urization of the cuff can te mporarily cause loss of functio n
of simultaneous ly used monitoring equipme nt on the same limb.
Whe n the me as ure me nt res ults are abnormal, ple ase calibrate it as
chapter 11.8 describes.
11.3 Measurement Limitations
NIBP measurements are not possib le with heart rate extremeties of less than
40 bpm or greater than 240 bpm, or if the patient is on a heart- lung machine.
The measurement may be inaccurate or impossible:
——with excessive and continuous patie nt movement s uch as shiver ing or
convulsions;
——if a regular arterial pressure pulse is hard to detect;
——with cardiac arrhythmias;
——with rapid blood pressure changes;
——with severe shock or hypothermia that reduces blood flow to the
peripheries;
——on an edematous extremity.
11.4 Measurement Mode
There are three modes of measuring NIBP:
Manual: measurement on demand.
Auto: continually repeated measurements in the set interval.
STAT: rapid series of measurements over a five minutes period, then the
monitor returns to the previous mode. Use only on supervised patients.
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11.5 Monitoring Procedure
11.5.1 Preparing to Measure NIBP
1. Check the patient category, if you want to change the patient category,
select【M ain me nu】smartkey→【Patie nt M anage.】→【Admit Patie nt】
and select the patient type as required.
To obtain accurate routine resting blood press ure meas ure me nts ,
(including the condition hyperte nsion) follow the below steps:
Keep the patient in a suitable position, including :
1) comfortably seated;
2) legs uncrossed;
3) feet flat on the floor;
4) back and arm supporte d;
5) middle of the cuff at the level of the right atrium of the heart;
Suggest the patie nt to re lax as much as possible and not talk during
the measure me nt procedure,
Suggest that 5 min should elapse before the first reading is taken;
Suggest that ope rator pos ition on the right s ide of the monitor in
normal use.
2. Select the appropriate cuff according to patient category.
——Check the limb circumference of patient.
——Select the appropriate cuff (The applicable limb circumference for cuff is
marked on the cuff). The width of the cuff should be about 40% of the limb
circumference (50% for neonate) or 2/3 of the upper arm‟s length. The
inflatable part of the cuff should be long enough to encirc le 50% ~80% of the
limb.
The accuracy of measure me nt of BP depends on the suitability of the cuff.
3. Confirm the cuff has been entirely deflated.
4. Plug the air pipe plug of cuff into the connector (NIBP) of monitor until
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the plug and socket contact well. (Attention: you shall nip the part of air
pipe plug of cuff close to socket with fingers, before pulling it out.)
5. Tie the cuff to the upper arm or thigh of the patient.
Ensure the mark “Φ” on the cuff lies above the artery, while the air pipe is
under the cuff. Ensure the air pipe outside the cuff does not knot and the white
line on the cuff is within the range “ ”. Else, the cuff shall be
replaced with a proper size.
The monitor is applicable for standard neonatal cuff, pediatr ic cuff and
adult cuff. (including arm cuff and thigh cuff).
While me as uring blood press ure, the patie nt mus t keep calm without
talking.
The cuff tie d on the limb s hall be on the same level as the patie nt’s
he art so as to avoid the reading e rror res ulting from the hydros tatics
effe ct of the blood flow betwee n the heart and cuff. If the cuff pos ition
is highe r than heart leve l, the BP re ading will be lowe r. 0.75mmHg
(0.1kPa) s hould be adde d to the me as ure d value, for each ce ntime te r
highe r; in case the cuff pos ition is lowe r than heart le vel, the BP
re ading will be highe r. 0.75mmHg (0.1kPa) s hould be de ducte d for
each centime te r lower.
The e nvironme ntal or ope rational factors which can affect the
performance of the NIBP module and its BP reading :
1) Avoid compress ion or res triction of press ure tubes. Air mus t pass
unrestricte d through the tubing.
2) The bladde r of the cuff is not folded or twiste d.
3) A wrong cuff size, and a folde d or twis te d bladde r, can cause
inaccurate measure me nts
4) Do not wrap the cuff too tightly around the limb.
6. Connect the cuff with the air- inflating pipe and ensure the pipe
connecting cuff is not knotted or tangled while placing pipe naturally without
any press or force.
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11.5.2 Starting and Stopping Measurements
Use the button or smartkey to start or stop measurements.
11.5.3 Auto Measurement
1. Select NIBP parameter area, and enter NIBP setting menu.
2. Set【Measure Mode】to【Auto】.
3. Set【Inte rval】in the options as required.
4. Start the Auto measurement manua lly for the first time, and then enter the
Auto mode, the first auto measurement will be started within 5min, and then
the monitor will start the measure ment continua lly repeated in the set interva l
after the first measurement.
Prolonge d NIBP meas ure me nts in Auto mode are associate d wit h purport,
ische mia and ne uropathy on the limb tie d to the cuff. Whe n monitoring a
patie nt, examine the extre mities of the limb f re que ntly for normal color,
warmth and se ns itivity. If any abnormality is obse rve d, stop the NIBP
measure me nts.
11.5.4 STAT Measurement
Select / smartkey, or select NIBP parameter area, and select
【 Start/Stop STAT 】 to start or stop the STAT measurement. The
measurement will last 5min.
11.6 NIBP Display
There is no wave form disp layed for NIBP measurement, the NIBP readings
are displa yed in the parameter area. The following figure shows the NIBP
display screen, the display on your monitor may look slightly different.
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2 3
1 1
5 4
1. Pressure unit 1 1
2. Measurement mode
3. Mean arterial blood pressure
4. Diastolic blood pressure
5. Systolic blood pressure
11.7 Setting NIBP
11.7.1 Setting Unit
Select NIBP parameter area, and select【Unit】in the NIBP setting menu, and
The options are【mmHg】or【kPa】.
11.7.2 Setting Initial Cuff Inflation Pressure
Select NIBP parameter area, and select【Inflation】in the NIBP setting
menu,set the initial cuff inflation pressure according to patient type and
requirement.
11.7.3 Setting Assisting Venous Puncture
You can use the NIBP cuff to cause sub- diastolic pressure, and block the
venous blood vessel to assist venous puncture.
1. Select the NIBP parameter area, and e nter the NIBP parameter setting
menu.
2. Select【Ve nipunc. Press】, and set to a proper value.
3. Select【Stat/Stop Assist Venipunc.】to start it.
4. Puncture vein and draw blood sample.
5. Select【Stat/Stop Assis t Ve nipunc.】aga in to deflate the cuff. The cuff
deflates automatically after a set time if you do not deflate it.
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11.7.4 NIBP Resetting
Select NIBP parameter area, and select【Reset】, then the inflation va lue of
blood pressure pump restores to the initia l value. In case the blood pressure
pump doesn‟t work as norma l but without any prompt, the blood pressure
pump can be checked by reset, thus the blood pressure pump in abnorma l
condition due to unexpected reason will automatically restore.
11.8 NIBP Calibration
Maintenance and calibration of NIBP measurement is necessary every year.
If you need to calibrate NIBP, please contact the authorized service personnel.
Calibration tools: 3 way connector, pipe, roundness pump, metal container
(500±25 ml), standard manometer (Calibration already, precis ion over 1 mmHg)
1. Connect mo nitor, manometer, roundness pump and metal conta iner as
follows.
2. Reading of mano meter should be 0 before deflate, if not, cut the connection
until it return to zero.
3. Select【M ainte nance 】→input password→【M ain Menu】→【M ainte nance
】→【Machine Mainte nance 】→【NIBP M ainte nance 】→【Adult】→【
NIBP Calibration】.
4. Turn up pump output pressure to 150 mmHg, the pressure showed by monitor
and consult ma nometer can‟t be over 3 mmHg, if not, setting 【 Press
Calibration】for 150 mmHg, select【Ok】key in right of the menu.
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Chapter 12 Freezing
While monitor ing a patient, you can freeze the waveform on the screen,
and then you can carefully sur vey the condition of the patient during this time
interval through reviewing the frozen waveform.
12.1 Freezing Waveform
Under the non- freezing condition, select【Wave Free ze 】smartkey on lower
monitor screen or press the button on the front monitor panel, then you
can get the waveform enter freezing condition.
All wave form will be frozen without any more refreshing or roll. The data
displayed in the parameter area will normally be refreshed.
The freezing condition will not influence the following functions:
—— Display and refreshing of dynamic short- time graphic trends.
——Display and refreshing of respiration oxygen chart.
——Display and refreshing of the monitoring screen of other sickbeds.
12.2 Reviewing Waveform
When the wavefor ms are frozen, user can review the frozen wave forms
using the following methods:
Select or , or in the Freeze setting, then by turning the trim
knob right or le ft to make the waveform move right or left accordingly.
Meanwhile, a downward arrow and time scale will be showed at the lower
right corner of each waveform. The initial freezing time is recorded as【0s】.
Select or , the time interva l of the waveform moving is 4s.For
example,when the initia l freezing time is recorded as 【0s 】, select , time
scale will gradually changes into【-4s】,【-8s 】,【-12s 】… along with the
waveform moving rightwards.
Select or , the time interva l of the waveform moving is 1s. For
example, when the initial freezing time is recorded as【0s 】, selecting , time
scale will gradually changes into【-1s 】,【-2s 】,【-3s 】… along with the
waveform moving rightwards.
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12.3 Releasing Freezing
When wave forms are frozen, you can select the【De free ze 】smartkey on
lower monitor screen, or press the button on the front monitor pane l to
release the freezing condition.
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Chapter 13 Reviewing
Select【M ain Menu】 smartkey→【Revie w】to enter the review functio n.
Select【 Pat. Information】, 【Tabular Tre nds 】, 【NIBP Revie w】, 【ARR
Review】,【Alm Review】to open the relevant reviewing windows.
13.1 Reviewing Graphic Trends
Select【M ain Me nu】 or 【Tre nd Revie w】s martkey→【Revie w】→
【Tabular Tre nds 】→【Graph. Tre nd】to open the graphic trends review
window which is as follows.
Scale Graphic Trends area
Parameter
selecting
frame Trend
cursor
Parameter
displaying
area
13.1.1 Selecting Review Parameter
You can select reviewing parameters by the following way:
——Select one parameter label in the parameter selecting frame.
——Select【 Tre nd Group】and select the parameter comb ination required
to display from the pull-down menu.
If you want to add a trend group defined by user as required, the following
way is available:
Select 【Tre nd Group Set】in the graphic trends window and enter the
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Trend Group Setup menu. You can define the na me of trend group as required
and add the parameter label requiring displayed .
13.1.2 Selecting Time interval
Select【Time interval 】in the menu whic h is under the graphic trends
window, and then select an appropriate resolution according to your need.
13.1.3 Browsing Graphic Trends
If needing to browse the graphic trends of this parameter in more time
intervals:
——Select or and shift time scale axis leftwards or rightwards to
browse the graphic trends of this parameter in more time intervals.
——Select or and shift time scale axis to the first or last page, you
can browse the graphic trends in the first or the last time interval
——Select or , you can shift the trend cursor. The corresponding time
of current cursor position will displa y above the cursor, and the
parameter va lue will d isplay left to the graphic trends window. The value
will vary with the shift of trend cursor.
——Select or and turn page up or down to browse the graphic
trends with more parameters within this time interval.
13.2 Reviewing Tabular Trends
Select the【Main Me nu】smartkey→【Revie w】→【Tabular Tre nds 】
to open the Tabular Trends review window as follows.
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13.2.1 Selecting Review Parameter
——Select【Sele ct Tre nd Group】 in the menu which is under the tabular
trends window, then select the parameter group in the pull-down menu. If
needing to add trend groups defined by the user, the fo llowing way is
available:
——Select【Tre nd Group Se tup】 in the menu which is under the tabular
trends window to enter the Trend Group Setup menu. You can define the trend
group name by yourse lf based on your need, and then add the parameter label
needing displaying.
13.2.2 Selecting Time interval
Select【 Interval】in the menu which is under the graphic trends window,
select an appropriate resolution according to your need.
13.2.3 Browsing Tabular Trends
Select or and shift t ime scale axis leftwards or rightwards to
browse the trends data of this parameter in the previous or the next page.
Select or and shifting time scale axis to the first or last page, you
can browse the trends data in the first or the last time interval.
Select or and shift time scale axis le ftwards or rightwards to browse
the trends data in the previous or the next time interval.
If needing to browse the trend data of this parameter in more time intervals,
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please select or and turn page up or down to browse the trends
data of more parameters in this time interval.
13.3 Reviewing NIBP Measurement Results
Select【Main Me nu】smartkey→【Revie w】→【NIBP Revie w】, then you
can open NIBP review window as follows.
In the window, there are【Sys 】,【Dia】 ,【PR】and【Time 】. You can
select , , or to browse NIBP measurement results.
At the same time ,you can select other parameters you want to review by
click【Se lect Param】.
13.4 Reviewing Parameter Alarm
When a parameter alarm occurs, the monitor can store all the parameters‟
value at the alarm time and the associated wavefor m during 16 seconds before
or after the alarm. So that you can review the alarm events.
When the alarm system is powered down or experienced a total loss of
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power for a finite duration, the contents of the alarm events will not be lost.
Select【Main Me nu】→【Revie w】→【Alm Revie w】, you can open the
list of parameter alarm events.
Select one of the events and then select 【Wave】to open its parameter
review window as follows.
Once the s tore d alarm e ve nts have reache d full capacity, whe n a
new event occurs , it will replace the data of the oldest event.
The action of a User dis abling the alarm s yste m will not be
entered in the Alarm log.
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13.4.1 Browsing
In the me nu which is under the parameter review window, select or
to shift the waveform left and right.
In the menu which is under the parameter review window, select or
to turn page up or down.
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Chapter 14 Calculations
The calculations aren‟t a result of direct measureme nt of patient data, but
are based on the data entered by the user. This monitor has the function of
drug dose calculation, hemodynamic, nephrid ium, ventilation and oxygenation
calculation.
14.1 Drug Dose Calculation
This calculation of drug concentratio n is ma inly aimed at facilitating the
work of physic ians. It conducts concentratio n calculation on some commonly
used drugs.
14.1.1 Calculation Step
1. Select【Main Me nu】smartkey→【Calculation】→【Drug Calc】. Or Select
【Calculation】smartkey on the screen directly→【Drug Calc】.
2. Select【Drug Name 】, the following categories of drugs can be calculated
by the monitor : AMINOPHYLLINE, DOBUTAMINE, DOPAMINE,
EPINEPHRINE, HEPARIN, ISUPREL, LIDOCAINE, NIPRIDE,
NITROGLYCERIN and PITOCIN. In addition, it provides DRUG_A,
DRUG_B, DRUG_C, DRUG_D and DRUG_E to displace any other drugs
flexibly.
3. Input【Patie nt We ight】, as independent information the weight is only
used in the function of the calculation of drug concentration.
4. After finishing the above operation, in the system, the values that are
given initia lly are only a group of random initia l values and the operator
shall not take this value as the calc ulation standard and a gr oup of values
appropriate to the patient must be reentered according to the physic ians‟
comments.
5. Affirm that the inputting parameter values are correct.
6. Affirm that the calculation results are correct.
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14.1.2 Calculation Unit
Drug A, drug B, drug C, drug D, drug E are not the real na me of drugs, but
only code name of drugs. The five kinds of drugs‟ units are fixed. You can
select the appropriate units according to the phys ic ians' comments. The rules
of unit displaying are as follows:
Drug A, drug B and drug C are fixed to “g” series units: g, mg and mcg.
Drug D is fixed to “unit” series units: unit, k unit and m unit.
Drug E is fixed to “mEq” unit.
When define some kind of drug by yourse lf, yo u should select drug A,
drug B, drug C, drug D, drug E according to the unit series.
Drip speed and volume per drip are invalid for neonatal.
14.1.3 Titration Table
After finis hing the calculation of drug dose calculation, select
【Titration】 in the interface of drug dose calculation to enter the interface of
titration table.
You can rejigger the following options in the titration table:
Reference:You can select from【Dose】,【INF Rate】and【Drip
Rate】.
Dose Type: Select the dose unit according to your need.
Step: You can select from 1~10.
The data in the titration table will have some change after finishing the
above options.
You can also select or and turn page up and down to browse more
data. DOSAGE means dose while SPEED means transfusion speed.
14.2 Hemodynamic Calculation
14.2.1 Calculation Step
1. Select 【 Main Me nu 】 smartkey→ 【 Calculation 】 , then select
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【Hemodynamic】.
2. Input each parameter ‟s value correctly:
a) If you are calculating the current patient, the monitor can get HR,
Height and Weight auto matica lly. And you need to put in the other
parameters‟ value by yourself.
b) If you are not calculating the current patient, you need to input all of
the parameters‟ value by yourself.
3. After you have finis hed the data input, please make sure they are correct.
Then you can press the button 【 Calculation】 to get all the output
parameters‟ value.
4. In the Calculation Step window, you can:
a) Select【Range】, the unit of each parameter disappears, and the unit of
the parameter in red word will be changed into the logical range of
them. The option has been changed into【Unit】, select【Unit】to
redisplay the unit of each parameter.
b) Select【Show Input】to display the corresponding input value of the
current calculation result.
If the re is a s ign of “---” in the output parame te r, it me ans the
parame te r is invalid in this calculation.
If the output parame te r is re d, it means the parame te r is beyond the
logical range.
14.2.2 Input Parameters
Abbreviation Unit Full Name
C.O. L/min cardiac output
CUP mmHg /
HR bpm heart rate
PAWP mmHg pulmonary artery wedge pressure
Art Mean mmHg mean artery pressure
MAP mmHg mean arterial pressure
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Abbreviation Unit Full Name
MPAP mmHg mean pulmonary artery pressure
CVP mmHg central venous pressure
EDV ml end diastolic volume
Height cm height
Weight kg weight
14.2.3 Output Parameters
Abbreviation Unit Full Name
C.I. L/min/m2 cardiac index
BSA m2 body surface area
SV ml stroke volume
2
SI ml/m stroke index
SVR DS/cm5 systemic vascular resistance
SVRI DS·m2 /cm5 systemic vascular resistance index
PVR DS/cm5 pulmonary vascular resistance
PVRI DS·m2 /cm5 pulmonary vascular resistance index
LCW kg·m left cardiac work
LCWI kg·m/m2 left cardiac work index
LVSW g·m left ventricular stroke work
LVSWI g·m/m2 left ventricular stroke work index
RCW kg·m right cardiac work
RCWI kg·m/m2 right cardiac work index
RVSW g·m right ventricular stroke work
RVSWI g·m/m2 right ventricular stroke work index
EF % ejection fraction
14.3 Nephridium Calculation
14.3.1 Calculation Step
1. Select 【 Main Menu 】 smartkey→ 【 Calculation 】 , then select
【Nephridium】.
2. Input each parameter‟s value correctly.
3. After you have finished the data input, please make sure they are correct.
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Then you can press the button【Calculation】to get all the output parameters‟
value.
4. In the Calculation Step window, you can:
a) Select【Range】, the unit of each parameter disappears, and the unit of
the parameter in red word will be changed into the logical range of the m. The
option has been changed into【Unit】, select【Unit】 to redisplay the unit of
each parameter.
b) Select【Show Input】to display the corresponding input va lue of the
current calculation result.
If the re is a s ign of “---” in the output parame te r, it me ans the
parame te r is invalid in this calculation.
If the output para me te r is in re d word, it means the parame te r is
beyond the logical range.
14.3.2 Input Parameters
Abbreviation Unit Full Name
URK mmol/L urine pstassium
URNa mmol/L urinary sodium
Urine ml/24h urine
Posm mOsm/kgH2O plasm osmolality
Uosm mOsm/kgH2O urine osmolality
SerNa mmol/L serum sodium
Cr umol/L creatinine
UCr umol/L urine creatinine
BUN mmol/L blood urea nitrogen
Height cm height
Weight kg weight
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14.3.3 Output Parameters
Abbreviation Unit Full Name
URNaEx mmol/24h urine sodium excretion
URKEx mmol/24h urine potassium excretion
Na/K % sodium potassium ratio
CNa ml/24h clearance of sodium
Clcr ml/min creatinine clearance rate
FENa % fractional excretion of sodium
Cosm ml/min osmolar clearance
CH2O ml/h free water clearance
U/P osm \ urine to plasma osmolality ratio
BUN/Cr mmol/L blood urea nitrogen creatinine ratio
U/Cr \ urine-serum creatinine ratio
14.4 Ventilation Calculation
14.4.1 Calculation Step
1. Select 【 Main Menu 】 smartkey→ 【 Calculation 】 , then select
【Ventilation】.
2. Input each parameter‟s value correctly:
3. After you have finished the data input, please make sure they are correct.
Then you can press the button【Calculation】to get all the output parameters‟
value.
4. In the Calculation Step window, you can:
a) Select 【Unit of Press ure 】 to change the unit of pressure. And its value
will convert and renovate automatically at the same time.
b) Select【Range 】, the unit of each parameter disappears, and the unit of
the parameter in red word will be changed into the logical range of the m. The
option has been changed into【 Unit】, select【Unit】to redispla y the unit of each
parameter.
c) Select【Show Input】to disp lay the corresponding input va lue of the
current calculation result.
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If the re is a s ign of “---” in the output parame te r, it me ans the
parame te r is invalid in this calculation.
If the output parame te r is in re d background, it means the
parame te r is beyond the logical range.
14.4.2 Input Parameters
Abbreviation Unit Full Name
FiO2 % percentage fraction of inspired oxygen
RR rpm respiration rate
PeCO2 mmHg partial pressure of mixed expiratory CO2
PaCO2 mmHg partia l pressure of carbon dioxide in the
arteries
PaO2 mmHg partial pressure of oxygen in the arteries
TV ml tidal volume
RQ \ respiratory quotient
ATMP mmHg atmospheric pressure
14.4.3 Output Parameters
Abbreviation Unit Full Name
PAO2 mmHg partial pressure of oxygen in the alveoli
AaDO2 mmHg alveolar- arterrial oxygen difference
Pa/FiO2 mmHg oxygenation ratio
a/AO2 % arterial to alveolar oxygen ratio
MV L/min minute volume
Vd ml volume of physiological dead space
Vd/Vt % physio logic dead space in percent of tidal
volume
VA L alveolar volume
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14.5 Oxygenation Calculation
14.5.1 Calculation Step
1. Select 【 Main Me nu 】 smartkey→ 【 Calculation 】 , then select
【Oxygenation】.
2. Input each parameter‟s value correctly:
3. After you have finished the data input, please make sure they are correct.
Then you can press the button【Calculation】to get all the output parameters‟
value.
4. In the Calculation Step window, you can:
a) Select 【Unit of Press ure 】【 Unit of Hb】and 【Unit of Oxyge n Conte nt】
to change the unit of pressure. And its va lue will convert and renovate
automatically at the same time.
b) Select【Range】, the unit of each parameter disappears, and the unit of the
parameter in red word will be changed into the logical range of the m. The
option has been changed into【Unit】, select 【Unit】to redisp lay the unit
of each parameter.
c) Select【Show Input】to display the corresponding input value of the
current calculation result.
If the re is a s ign of “---” in the output parame te r, it me ans the
parame te r is invalid in this calculation.
If the output parame te r is in re d background, it means the
parame te r is beyond the logical range.
14.5.2 Input Parameters
Abbreviation Unit Full Name
C.O. L/min cardiac output
FiO2 % percentage fraction of inspired oxygen
PaO2 mmHg partial pressure of oxygen in the arteries
PaCO2 mmHg partia l pressure of carbon dioxide in the
arteries
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SaO2 % arterial oxygen saturation
PvO2 mmHg partial pressure of oxygen in venous blood
SvO2 % venous oxygen saturation
Hb g/L hemoglobin
CaO2 ml/L arterial oxygen content
CvO2 ml/L venous oxygen content
VO2 ml/min oxygen consumption
RQ without respiratory quotient
ATMP mmHg atmospheric pressure
Height cm height
Weight kg weight
14.5.3 Output Parameters
Abbreviation Unit Full Name
BSA m2 body surface area
VO2 calc ml/min oxygen consumption
C(a-v)O2 ml/L arteriovenous oxygen content difference
O2ER % oxygen extraction ratio
DO2 ml/min oxygen transport
PAO2 mmHg partial pressure of oxygen in the alveoli
AaDO2 mmHg alveolar- arterial oxygen difference
CcO2 ml/l capillary oxygen content
Qs/Qt % venous admixture
C.O.calc L/min calculated cardiac output
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Chapter 15 Battery
15.1 Introduction
The monitor can be fitted with rechargeable battery to ensure its
continuous work upon failure of AC Mains power supply. It needs no specia l
ma intenance under the normal condition. When the monitor is connected to
the AC Mains Power, the battery will always be charging irrespective of
whether the monitor is operating or not. In the event of losing AC Mains
power, the monitor will automatically work from the battery without
interruption.
Indicative message under the screen will display battery states:
Indicates that the battery is fully charged.
Indicates that the battery is half charged.
Indicates that the battery is almost depleted and need to be
charged immediately.
Indicates that the battery is being charged.
Indicates that the AC ma ins is connected, and the device is
installed with battery.
Indicates that the AC mains is connected, and the device is not
installed with battery.
The power supply of battery can only functio n for a certain period.
Excessive low voltage of the battery will trigger a technical alar m and the
“Battery Low” message will be disp layed. At this moment, the monitor should
be immediately connected to the AC Mains Source, to charge the battery.
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Re move the batte ries prior to s hipping or if the monitor is not like ly
to be used for an extended period of time.
Disconne ct the AC s upply mains plug whe n the batte ry is fully
charge d.
For long-te rm monitoring, be fore plugging into the AC powe r
supply, the monitor must be installe d with the backup battery.
Use only batteries specified in this manual.
Keep the batteries out of childre n’s reach.
The batte ries s hould be installe d or re place d by se rvice pe rsonne l
specifie d by manufacture r. Re place me nt of batte ries by inade quate ly
traine d personne l could result in a hazard.
15.2 Installing a Battery
The battery compartment is in the back part of the monitor, please refer to
the following steps when installing or charging the batteries.
1. Turn off power of the monitor, and disconnect the power wire and other
connected wires.
2. Open the battery door towards the direction labeled on it.
3. Take out the old battery.
4. Insert the new battery towards the direction labeled.
5. Close the battery door.
15.3 Optimizing Battery Performance
A battery needs at least two optimizing cycles when it is put into use for
the first time. A battery cycle is one comp lete, uninterrupted charge of the
battery, followed by a complete, uninterrupted discharge of the battery. A
battery should be conditioned regularly to maintain its useful life. Condition a
battery once when it is used or stored for two months, or when its run time
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becomes noticeably shorter.
To optimize a battery, follow this procedure:
1. Disconnect the monitor fro m the patient and stop all monitor ing and
measuring procedures.
2. Place the battery requir ing optimizing, into the battery compartme nt of the
monitor.
3. Place the monitor in the charger stand and connect the AC mains. Allow the
battery to be charged uninterruptedly for above 6 hours.
4. Remo ve the AC ma ins and allow the monitor to run from the battery until it
shuts off.
5. Replace the monitor in the charger stand and connect the AC ma ins. Allow
the battery to be charged uninterruptedly for above 6 hours.
6. The optimizing of the battery is over.
15.4 Checking Battery Performance
The perfor mance of a battery ma y deteriorate over time. To check the
performance of a battery, follow this procedure:
1. Disconnect the monitor fro m the patient and stop all monitor ing and
measuring procedures.
2. Place the monitor in the charger stand and connect the AC mains. Allow the
battery to be charged uninterruptedly for above 6 hours.
3. Disconnect AC mains and allow the monitor to run on the battery until it
shuts off.
4. The operating time of a battery reflects its performance directly.
The ope rating time of a batte ry de pe nds on the configuration and
ope ration of the monitor. NIBP me as ure me nt, SpO2me as ure me nt will
deplete the battery faster than other parame te rs ’ measure me nt.
Che ck the pe rformance of the batte ries regularly to see if the re are
any proble ms .
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15.5 Disposing Batteries
Batte ries that are damage d or de ple te d s hould be re place d and dis carde d
prope rly. Dispose of used batteries according to local regulations .
The se rvice life of batte ry de pe nds on the se rvice time and fre que ncy. This
monitor battery can be charge d and discharge d for 300 times generally.
Do not dis asse mble batte ries, or dis pose of the m in fire, or cause the m to
short circuit. They may ignite, explode, or leak, causing personal injury.
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Chapter 16 Maintenance and Cleaning
16.1 Equipment Maintenance
For optimal pe rformance , product se rvice s hould be pe rforme d only by
qualifie d service personne l.
To e ns ure the pe rformance and safe ty of e quipme nt, it must be checke d
once eve ry year. Whe n che cking the e quipme nt, please contact professional
technology engineers.
The service personnel can provide servic ing only when they have passed the
profession trainning, and acquired the work license.
Seasonal Safety Check:
Please clean the plug of power cord at least once a year. Too much dust on
plug may cause the fire.
The fo llowing safety checks should be performed at least once every 12
months by a qualified person who has adequate training, knowledge, and
practical experience to perform these tests.
The data should be recorded in an equip ment log. If the device is not
functioning properly or fa ils any of the fo llowing tests, the device has to be
repaired.
① Inspect the equip ment and accessories for mechanical and functiona l
damage.
② Inspect the safety relevant labels for legibility.
③ Inspect the fuse to verify comp liance with rated current and breaking
characteristics.
④ Verify that the device functions properly a s described in the instructio ns for
use.
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⑤ Test the protection earth resistance according IEC 60601-1:0.1 .
⑥ Test the earth leakage current according IEC 60601- 1: Limit: NC 500μA,
SFC: 1000μA.
⑦ Test the enclosure leakage current according to IEC 60601- 1:Limit: NC
100μA, SFC: 500μA.
⑧ Test the patient leakage current (normal operation) according IEC 60601-1:
Limit: type CF: for a.c.: 10μA, for d.c.: 10μA.
⑨ Test the patient leakage current under single fault condition according I EC
60601-1:
Limit: type CF: for a.c.: 50μA, for d.c.: 50μA.
⑩ Test the patient leakage current Mains vo ltage on app lied part: According
IEC 60601-1:
Limit: type CF: for a.c.: 50uA
No use-serviceable parts inside.
We will make available on re quest compone nt part lis ts, des criptions ,
calibration ins tructions , or othe r information which will ass ist the use r’s
appropriate ly qualifie d technical pe rsonne l to re pair those parts of
equipme nt which are designate d by the manufacture r as repairable.
16.2 Equipment Cleaning
Keep your equipment and accessories free of dust and dirt. To avoid damage
to the equipment, follow these rules:
1. Always dilute according the ma nufacturer ‟s instructio ns or use lowest
possible concentration.
2. Do not immerse part of the equipment in the liquid.
3. Do not pour liquid onto the equipment or accessories.
4. Do not allow liquid to enter the case.
5. Never use abrasive materia ls (such as steel wool or silver polish), or erosive
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cleaners (such as acetone or acetone-based cleaners).
Be s ure to s hut do wn t he s yste m and dis conne ct all powe r cables from the
outlets before cleaning the equipme nt.
If you s pill liquid onto the e quipme nt or accessories, contact us or your
service personne l.
16.3 Cleaning of the Monitor
Common detergent and non-corrosive dis infectant used in hospital can be
applied to clean monitor, however you must be aware that many kinds of
detergents must be diluted prior to utilization, and please use it according to the
instruction of detergent manufacturer.
Avoid the use of alcohols, amino or acetonyl detergent.
The enclosure and screen of monitor shall be free of dust, and they can be
wiped with lint- free soft cloth or sponge soaked in detergent. While cleaning,
be careful not to spill liquid onto the instr ument and keep any liquids out of it.
When wiping the side pane l of monitor, you must be especia lly careful to keep
water out of all kinds of cable and outlet on the panel.
Do not use abrasive material including wire brush or metal brighte ner dur ing
cleaning because this material will damage the panel and monitor screen.
Do not submerge the monitor in liquid.
If cable or plug of accessories accidenta lly gets wet, please rinse it with
distilled water or deionized water and dry it in the environment of temperature
40℃ to 80℃ for at least one hour.
16.4 Cleaning and Disinfection of Accessories
1. ECG cable
The recommended dis infectors include glutaric dia ldehyde solution and 10%
decolourant solution.
a) Please clean cable prior to sterilization.
b) Clean the cable sur face with soft cloth bedewed with some fresh water
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or neutral soapy water.
c) Scrub cable with soft cloth bedewed with some disinfector.
d) Wipe off the dis infector rema ining on cable by soft cloth bedewed
withfresh water.
e) Put cable in a shady and cool environment for airing.
Attention:
Do not sterilize lead wire with high-pressure, radioactive or steam device.
Do not directly submerge lead wire in liquid.
To avoid long- time harm to cable, it is suggested that sterilization to the
product be conducted only whe n necessary according to the regulation of your
hospital.
Do not clean and reuse disposable electrode.
2. SpO2 Sensor
The recommended dis infector inc lude: isopropyl alcohol 70%, 10%
decolourant solutio n can be used for sterilization at lower standard. Don‟t use
und iluted decolourant (5% ~ 5.25% sodium hypochlorite) or other
non-recommended disinfector in order to avoid damage to sensor.
The method of cleaning and sterilization can refer to the corresponding
method of ECG cable.
Attention:
Do not immerse the sensor in water, solvents, or cleaning solutions (the
sensors and connectors are not waterproof).
Do not sterilize by irradiation, steam, or ethylene oxide.
Do not directly submerge sensor in any liquid.
To avoid lo ng- time harm to sensor, it is suggested that sterilizatio n to the
product is conducted only whe n necessary according to the regulation of
your hospital.
3. Temp Sensor
The recommended disinfector: 70% isopropyl alcohol solution, glutaric
dialdehyde solution and 10% decolourant solution.
The method of cleaning and sterilization can refer to the corresponding
method of ECG cable.
Attention:
Do not repeatedly sterilize and use disposal temperature sensor.
To avoid lo ng- time harm to sensor, it is suggested that sterilizatio n to the
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product be conducted only whe n necessary acco rding to the regulation of your
hospital.
Temp sensor can only withstand 80~100℃ temperature for a short time
and the heating temperature is not allowed to surpass 100℃.
4. NIBP Cuff
a) Please regularly clean the product;
b) Remove cuff from connector and pull out airbag from sheath;
c) Submerge clean and soft medical gauze pad or other soft cleaning tools into
fresh water or neutral soapy water, and wring out surplus water fro m the
submerged gauze then wipe airbag and pipe;
d) Wash the cuff sheath in the clean neutral soapy water;
e) After the sheath and airbag intens ive drying, enc lose airbag with cuff sheath
and put into operation.
Attention:
Excessive or frequent cleaning may dama ge airbag, so don‟t clean airbag
unless necessary.
Do not dry airbag and sheath in high temperature.
If higher sterilization level is required, please choose disposal cuff.
One disposal cuff can only be used for one patient.
Carefully keep water and cleaning solution out of the connecting parts of
cuff and monitor.
16.5 Maintenance frequency
1. For operator:
1) Inspection before use. See chapter 3.2.1
2) Maintenance after use. See chapter 16.4
3) Maintenance performed every 3 months:
——Accessory maintenance, See chapter 16.4;
——Main unit check, including: Function key check, plug check and so on.
——Alarm function test, the specific test methods are as follows:
After the monitor is norma lly operated, plug in or plug out the cables (such
as ECG,SpO2) randomly or connect the SpO2 sensor with fingers ,then adjust
the volume from mute to 6 , the volume should become louder and louder;
change alarm le vel fro m low ,middle to high respective ly , the alarm tone and
alarm lamp must change correspondingly too. See chapter 5.
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2. For service person:The following work must be down every 1 year:
1) The performance test of ECG, SpO2, Respiration, NIBP parameter module.
2) Possible calibration of some parameter such as NIBP,see chapter 11.8.
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Chapter 17 Accessories
Use only accessories s pe cifie d in this manual. Us ing othe r accessories
may cause damage to the monitor and we can no longe r e ns ure the
specified measuring accuracy.
Dis posable accessories are designe d for s ingle -patie nt use only.
Reus ing the m may cause a risk of contamination and affect the
measure me nt accuracy.
Che ck the accessories and the ir packages for any s ign o f damage. Do
not use them if any damage is detected.
To avoid los ing the efficacy or co ntamination of the accessory, please
don’t open the disposable or sterile accesssory packages untimely.
If the sterile accesssory package is damage d, please do not use it.
1. ECG
ECG Electrode
Type Patient category PN
Adult 15-100-0008
Disposable
Pediatric/ Neonatal 15-100-0009
ECG Cable
Type Description Standard PN
Snap 5-lead AHA 15-027-0001
Snap 3- lead AHA 15-027-0002
2. SpO2
BLT SpO2 Sensor
Type Patient category PN
Adult 15-100-0013
Adult 15-100-0058
Reusable
Pediatric 15-100-0014
Neonatal 15-100-0015
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3. Temp
Temp probe
Type Applied site PN
Surface 15-100-0027
Reusable
Coelom 15-100-0028
4. NIBP
Disposable cuffs
Limb circumfe rence
Model Patient category PN
(cm)
3-5.5 15-100-0104
4-8 15-100-0105
M5541 Neonatal
6-11 15-100-0106
7-13 15-100-0107
Reusable cuffs
Patient Limb circumfe rence Bladde r width PN
category (cm) (cm)
Adult 25-35 14.4 15-100-0118
Adult (Thigh) 44-53 15-100-0142
Large adult 33-47 15-100-0120
Pediatric 18-26 11 15-100-0121
Neonatal 6-11 15-100-0122
5. Power adapter
Model PN
LXCP52-015 16-100-0099
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Appendix A Product Specifications
A.1 Safety Specifications
According to the MDD 93/42/EEC, the monitor is Type Ⅱ b equipment.
Classified according to the IEC60601-1 is as follows:
Degree of Degree of
Classification of Degree of
protection protection
protection protection Mode of
Parts against against
against electric against electric operation
ingress of hazards of
shock shock
liquid explosion
Mainframe No mark
Secondary I
No mark
display
Temp Module
NIBP Module Type CF IPX1 Not suitable Continuous
ECG Module applied part
NA
defibrillation
SpO 2 Module proof
RESP Module
Note:
I: Class I, internally and externally powered equipment.
CF: Type CF applied part.
NA: Not applicable
Not suitable: Equipment is not suitable for use in the presence of flammable
anesthetic mixture with air or with oxygen or nitrous oxide.
A.2 Environmental Specifications
Operating temperature +5℃ to +40℃
Operating humidity ≤ 85%(non condensing)
Operating atmospheric
700hPa to 1060hPa
pressure
Transportation and
-20℃ to +55℃
storage temperature
Transportation and
≤ 93%(non condensing)
storage humidity
Transportation and 500hPa to 1060hPa
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storage atmospheric
pressure
A.3 Physical Specifications
Parts Weight(kg) Size(W×H×D)(mm) Remark
<2 kg 220mm×180mm×90mm Including screen,
stationary parameter
Mainframe module, a lithium battery,
without accessories.
A.4 Power Specifications
Input voltage 100V-240V AC
Frequency 50Hz/60Hz
Earth leakage current <0.3 mA
Input current 1.5A-0.7A
Standard requirement According to IEC 60601-1 and IEC 60601-1-2
Fuse T 2A/250V, integrated in the power module
A.5 Hardware Specifications
A.5.1 Display
Mainframe display
Type Color TFT LCD
Size(diagonal) 8 inch
Resolution 800×600 pixels
A.5.2 Battery
Type Rechargeable lithium ion battery
Model DVAUS-BLT-002
Size 67mm×56mm×22mm
Weight About 160 g
Quantity 1
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Rated voltage 11.1 VDC
Capability 2200mAh
Operating time When the capacity is 2200mAh, the operating time is over
6h
Charge time from 0% <4h
to 90%
Turn off delay 5 min -30 min after the low battery alarm first occurs.
Indicator of battery
With
capability
A.5.3 Power adapter
Input characteristics
Rated input voltage 100-240 VAC
AC input frequency range 50/60 Hz
Maximum input current 1.5 A
Output characteristics
Rated output voltage 15 V
Output current range 3A
Isolation 2 MOPP(reference 240V)
A.5.4 Mainframe LED
Physiological 1 (Yellow/Red)
/Technical alarm
indicating lamp lamp
Power indicating 1 (Green/Orange)
When powered with AC, it lights green while turn on and
off the monitor.
When powered with battery, it lights orange only while turn
on the monitor.
Battery charging 1 (Orange)
indicating lamp
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A.5.5 Audio indicating
Speaker Gives audible alarm, QRS tone;
Supports Pitch Tone and multi- level volume;
Alarm tones meet the requirement of IEC 60601-1-8.
Alarm pressure 45 dB to 85 dB. Testing place is 1 meter from the tone.
A.5.6 Input device
Keys
1 power button, 4 shortcut keys (NIBP measurement, alarm
Key Numbers
pause, waveform freezing, and return to main screen)
Trim Knob 1
Touch screen
Touch screen input With
Mode ResistanceTouch screen
Size 8”
A.5.7 Connectors
Power 1 DC power inlet, 15V、3A
Wired network 1, standard RJ45 interfaces. 10M/100M, TCP/IP
USB 2, standard USB2.0 socket(for the connections to a mouse,
U Disk and so on)
A.5.8 Data Storage
Trend data Long trend: 168h, minimum resolution is 1min(store
when power goes off)
High resolution trend: 2h, minimum resolution is 5s
Parameter alarm 128 groups of parameter alarm events and associated
event parameter waveform at the alarm moment. Waveform
length is selected among 8s, 16s and 32s.
ARR event 128 groups of ARR event and the associated waveform for
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each waveform. The waveform length is selected among 8s,
16s and 32s.
NIBP measurement 1000 groups
result
Holographic The storage time depends on the stored waveforms and the
waveform quantity of them.
A.5.9 Alarm
Level Low, medium and high
Indication Sound and light indication
Setup Default and custom
Silence All alarms can be silenced
Volume 45~85 dB measured at 1 meter
A.6 Measurement Specifications
A.6.1 ECG
EN 60601-2-27 / IEC 60601-2-27, ANSI/AAMI EC 13:
Standard
2002
3 lead: I, II, III
Lead type
5 lead: I, II, III, aVR, aVL, aVF, V-
Lead standard AHA, IEC
2.5 mm/mV(×0.25), 5 mm/mV(×0.5), 10 mm/mV(×1),
Gain
20 mm/mV(×2), 40 mm/mV(×4), Auto
Diagnostic mode ≥ 89 dB
CMRR Monitor mode ≥ 105 dB
Surgery mode ≥ 105 dB
Diagnostic mode: 0.05 Hz to 150 Hz
Bandwidth (-3d B) Monitor mode: 0.5 Hz to 40 Hz
Surgery mode: 1 Hz to 25Hz
Input impedance ≥ 5.0 MΩ
ECG signal range ± 10.0 mV
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Electrode offset
± 500 mV
potential
Patient leakage current < 10 uA
System noise ≤ 30 μVpp (RTI)
AC filter (50/60 Hz Monitor, Surgery mode: AC filter turns on.
line frequency) Diagnostic, User mode: AC filter turns on or off.
Standardizing signal 1 mV ± 5%
Baseline recovery Monitor mode: ≤ 3 s; Surgery mode: ≤ 1 s
Indication of electrode
Every electrode (exclusive of RL)
separation
Sweep speed 12.5 mm/s, 25 mm/s, 50 mm/s
Breakdown Voltage 4000VAC 50Hz/60Hz. 60S
Protection Anti-interference of electrocautery uint
Anti-protector of defibrillation
Protection against the
effects of defibrillation
<5s after Defibrillation.
and blocking after
defibrillation
Recovery time of
equipment from
ECG waveform will recover to the baseline in 10 s.
electrodes polarization
after defibrillation
With pacer pulse detector, complies with IEC 60601-2-27:
2005, 50.102.12. For the pacer pulse in compliance with
following conditions, pacer mark will be signed on the
Pacer pulse mark screen(≥ 2 mm):
Pacing pulse amplitudes: ±2 mV to ±700mV
Pacing pulse widths: 0.1 ms to 2ms
Rise time: 10 us to 100us
HR
Adult: 10 bpm to 300 bpm
Measurement range
Pediatric and Neonatal: 10 bpm to 350 bpm
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Resolution 1 bpm
Accuracy ±1% or ±1 bpm, whichever is greater
Detecting sensitivity ≥0.20mVpp
(II lead)
Response time of HR <12s
meter to change in HR
Response of HR to
QRS amplitude is Adult: without response
1mVp-p, width is
10ms
0 bpm to 350 bpm, high/low limit can be adjusted per 5
Alarm range
bpm.
ECG/ST/arrhythmia supplemental information as required by AAMI EC11/13
Cut mode: 300W
Electrosurgery
Coag mode: 100W
protection
HR change: ≤10%
(electrocautery uint
Resuming time: ≤10s
protection)
Complies with ANSI/AAMI EC 13:2002, 4.2.9.14
Input circuit current < 0.1uA
Tall T-Wave rejection Minimum recommended 1.2 mV T-Wave amplitude
capability Complies with ANSI/AAMI EC 13:2002, 4.1.2.1 c)
≤ 50 bpm, once every 4 beats;
Heart rate averaging
> 50 bpm, once every 12 beats.
Ventricular bigeminy: 80 bpm
HR meter accuracy
Slow alternating ventricular bigeminy: 60 bpm
and response to
Rapid alternating ventricular bigeminy: 120 bpm
irregular rhythm
Bidirectional systoles: 90 bpm
HR change from 80 bpm to 120 bpm: less than 10s
Response time of HR
HR change from 80 bpm to 40 bpm: less than 10s
meter to change in HR
Complies with ANSI/AAMI EC13-2002: 4.1.2.1 f
Vent Tachycardia 1mVp-p, 206bpm:
Time to alarm for Gain 0.5, Range 4.8s to 5.2s, Average 5.0s;
Tachycardia Gain 1.0 Range 3.6s to 5.2s, Average 4.8s;
Gain 2.0, Range 2.8s to 4.3s, Average 3.8s.
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Vent Tachycardia 2mVp-p, 195bpm:
Gain 0.5, Range 4.8s to6.2s, Average 5.6s;
Gain 1.0, Range 4.6s to 5.2s, Average 5.0s;
Gain 2.0, Range 3.8s to 5.4s, Average 4.6s.
Indicator for ECG Each amplificatory channel has ECG abnormal operation
working abnormally indicating. It complies with EC13 2002, 4.2.9.1.
Pacemaker pulse No rejection of pulses with amplitudes of ±2mV ~ ±700
rejection performance mV and durations of 0.5 ~ 2.0 ms.
A.6.2 Resp
Measurement method Thoracic impedance
Selected from:Ⅰ (RA-LA) or Ⅱ (RA-LL);
Lead
Default: Ⅱ
Excitation frequency Sine wave: 64.8 kHz
Excitation current ≤ 0.3mA
Excitation current < 500 µA RMS max.
Measuring impedance
0.2Ω to 3Ω
range
Baseline impedance 500 Ω to 2000Ω(using defibrillator proof cable with
range resistance of 1kΩ)
Gain ×0.25, ×1,×2,×4
Bandwidth 0.25 Hz to 2.0Hz(-3dB)
Sweep speed 6.25mm/s, 12.5mm/s, 25mm/s
Measurement range 0 rpm to 150 rpm
Resolution 1 rpm
Accuracy ±2 rpm
0 rpm to 150 rpm, high/low limit can be adjusted
Alarm range
continuously.
Delay of apnea alarm 10s, 15s, 20s, 25s, 30s, 35s, 40s, 45s, 50s, 55s, 60s
Blinking display of the data and parameters, text prompts,
Alarm Indication Three levels of alarming: sound-light alarming, alarming
with blinked data and parameters, and that with text
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prompts.
Recovery time after
<10s
defibrillation
A.6.3 NIBP
Standard EN 80601-2-30 / IEC 80601-2-30
Measurement way Automatic oscillometry
Measurement kinds Sys, Dia, Map,PR
Sys 30~270 mmHg
Adult Dia 10~220 mmHg
Map 20~235 mmHg
Sys 30~235 mmHg
Measurement range
Pediatric Dia 10~220 mmHg
(mmHg)
Map 20~225 mmHg
Sys 30~135 mmHg
Neonatal Dia 10~110 mmHg
Map 20~125 mmHg
Cuff pressure range 0 mmHg to 280 mmHg
Resolution 1 mmHg
Pressure accuracy
Static: ±3 mmHg
Clinic: Average error: ±5 mmHg, standard deviation: ≤8 mmHg
Unit mmHg, kPa
The cuff will deflate automatically when power is off
or time of measurement is beyond 120 seconds(90
Cuff auto deflation
seconds for neonate) or the cuff pressure is beyond the
overpressure protection set by software and hardware.
Normally, it is 20s to 45s (depending on HR and moving
interference typically)
Measurement time
Maximal measurement time: 120s(adult / pediatric), 90s
(neonate)
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Adult default: 160 mmHg
Initial inflation
Pediatric default: 130 mmHg
pressure
Neonatal default: 75 mmHg
Double hardware,software overpressure protection
Software overpressure Adult: (297±3) mmHg
protection Pediatric: (147±3) mmHg
Neonatal: (252±3) mmHg
Inflation pressure(should be close to diastolic pressure):
Assistant venipuncture Adult : 20 mmHg to 120 mmHg (normally 80 mmHg);
inflation mode Pediatric: 20 mmHg to 80 mmHg (normally 60mmHg);
Neonatal: 20 mmHg to 50 mmHg (normally 40mmHg).
Intervals for periodic 1min, 2min, 2.5min, 3min, 4min, 10min, 15min, 30min,
measurement time 60min, 90min, 120min,240min, 480min, 720min.
0 mmHg to 300 mmHg, high/low limit can
Sys
be adjusted continuously.
0 mmHg to 300 mmHg, high/low limit can
Alarm range Dia
be adjusted continuously.
0 mmHg to 300 mmHg, high/low limit can
Map
be adjusted continuously.
Blinking display of the data and parameters, text prompts,
Three levels of alarming: sound- light alarming, alarming
Alarm Indication
with blinked data and parameters, and that with text
prompts.
Adult Single, Cycle, STAT
Work mode Pediatric Single, Cycle, STAT
Neonatal: Single, Cycle
PR
PR range 40 bpm to 240 bpm
Resolution 1 bpm
Recovery time after
<10s
defibrillation
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A.6.4 SpO2
BLT SpO2
SpO2
Measurement technic Digital SpO 2 technic
Measurement range 0% to 100%
Resolution 1%
70% to 100%: ±2%
Accuracy
0% to 69%: unspecified
Alarm range 85% to 100%, high/low limit can be adjusted continuously.
Average time Normal:8s, slow: 16s,fast: 4s
Anti-interference Anti-interference of movement
ability Anti-interference of electrocautery unit
Resisting low With powerful ability of resisting low perfusion, PR
perfusion ability amplitude can reach to 0.2% with value of SpO 2 displaying
with (When the SpO2 value becomes higher, the pitch tune
PR modulation tone
will become higher. When the SpO2 value becomes
(Pitch Tone)
lower, the pitch tune will be lower.)
Pulse oximetry sensors contain LEDs that emit red light at
a wavelength of approximately 660 nm and infrared light at
a wavelength of approximately 905 nm.
Sensor The total optical output power of the sensor LEDs is less
than 15 mW.
This information may be useful to clinicians, such as those
performing photodynamic therapy.
PR
Measurement range 20bpm to 250 bpm
Resolution 1 bpm
Average time 8s
Accuracy ±1% or ±1 bpm, whichever is the greater
0bpm~300bpm, high/low limit can be adjusted
Alarm range
continuously.
0 bpm to 300 bpm, high/low limit can be adjusted
PR alarm range
continuously.
Recovery time after <10s
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defibrillation
A.6.5 Temp
Standard ISO80601-2-56
Measurement way Thermal resistance way
Measurement Range 0.0℃~50.0℃ (32℉~122℉)
Rated output range 25.0~45.0℃
At 45.1~50.0℃, ±0.3℃ (including the probe)
Measurement Accuracy At 25.0~45.0℃, ±0.2℃ (including the probe)
At 0.0~24.9℃, ±0.3℃ (including the probe)
Resolution 0.1℃
Temperature unit Centigrade (℃), Fahrenheit (℉)
Updated time Every 1~2 s
Self-test About every 5~10 mins
Temperature probe nominal
2522Ω@25℃
resistance
YSI400 series probes or other compatible probes
Temperature probe type
(accuracy ± 0.1℃)
0.0~50.0 ℃ , with upper and lower limits
Alarm Range
continuously adjustable
Blinking display of the data and parameters, text
prompts, Three levels of alarming: sound- light
Alarm Indication
alarming, alarming with blinked data and
parameters, and that with text prompts.
Recovery time after
<10s
defibrillation
Measurement mode Direct mode
Transient response time <30 s
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Appendix B Factory Defaults
This section lists the most important factory default settings. These settings are
not user-adjustable. However, you can restore the factory default settings of the
monitor if necessary.
The items with ★ can be only displayed in the configuration mode
while others can be displayed in all modes.
B.1 Monitor Defaults
System
Patient messages
Patient messages Factory Defaults
Category Adult
Paced No
Interface Setup
Interface setup Factory defaults
Brightness 3
Alarm
Alarm setup Factory defaults
ALM Volume 2
Min Alm Volume★ 2
Alarm paused time★ 2min
High ALM Volume★ ALM Volume +2
Med ALM Volume★ ALM Volume +2
High Alm Sound interval★ 10s
Med Alm Sound interval★ 15s
Low Alm Sound interval★ 25s
ALM Sound type★ ISO
ECG
ECG setup Adult Pediatric Neonatal
Alarm Switch★ On
Alarm Lev. Medium
Alarm Printing Switch★ Off
Limit Display★ Off
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High limit of HR alarm 120 160 200
(bpm)
Low limit of HR alarm (bpm) 50 75 100
QRS Volume 2
Lead Type 5 Lead
ECG Mode Monitor
Wave Gain 1
Wave Speed 25 mm/s
Primary Lead Select Ⅱ
Leads Off Alarm Lev. ★ Medium
Color Green
ST segment
ST setup Adult Pediatric Neonatal
ST Analysis Switch Off
Alarm Switch On
Alarm Lev. Medium
Alarm Print★ Off
ST-X high alarm limit (mV) +0.2
ST-X low alarm limit (mV) -0.2
Note : X stands for I,II,III,aVR, aVL, aVF, V-.
Arrhythmia
Arrhythmia setup Adult Pediatric Neonatal
ARR Analysis Switch Off
PVCs Alarm Lev. Medium
High Alarm Limit of PVCs 10
ARR ALM Setup Alarm Alarm Lev Alarm Print★
ASYSTOLE On High Off
VENT FIB/TACH On High Off
RUN PVCs On Medium Off
COUPLET On Low Off
BIGEMINY On Low Off
TRIEMINY On Low Off
R ON T On Low Off
VPB On Low Off
TACHY On Medium Off
BRADY On Medium Off
MISSED BEAT On Medium Off
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ST Elevation On Low Off
ST Depression On Low Off
PNP On Medium Off
PNC On Medium Off
NOISE On Low Off
V-TACH On High Off
Frequent PVCs On Low Off
VENT BRADY On Medium Off
EXTREME TACHY On Medium Off
EXTREME BRADY On Medium Off
NON-SUSTAIN VT On Medium Off
VENT RHYTHM On Medium Off
PAUSE On Medium Off
IRREGULAR HR On Low Off
QT Analyze
QT Analyze setup Adult Pediatric Neonatal
QT Analysis Switch Off
QTc Over High Alarm Lev. Medium
DQTc Over High Alarm Lev. Medium
QTc Over High Limit 440
DQTc Over High Limit 40
Resp
Resp setup Adult Pediatric Neonatal
Resp Lead RA-LL
Alarm Switch★ On
Alarm Lev. Medium
Alarm Print★ Off
Limit Display★ Off
High limit of RR (rpm) 30 30 100
Low limit of RR (rpm) 8 8 30
Apnea Time 20s
Apnea Alarm Level High
Wave Gain 2
Wave Speed 12.5 mm/s
Color Azure
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SpO2
SpO2 setup Adult Pediatric Neonatal
Alarm Switch★ On
HI Limit Alarm Lev. Medium
LO Limit Alarm Lev. Medium
Alarm Print★ Off
Limit Display★ Off
High alarm limit of SpO 2 (%) 100 100 95
Low alarm limit of SpO 2 (%) 90 90 85
Desat Limit (%)★ 85 85 85
PI Alarm Switch★ Off
PI Alarm Level Medium
Low alarm limit of PI (%) 0.5 0.5 0.3
QRS Volume 2
NIBP same side On
Average Time 4s
Wave Speed 25 mm/s
Color Yellow
Temp
Temp setup Adult Pediatric Neonatal
Alarm Switch★ On
Alarm Lev. Medium
Alarm Print★ Off
Limit Display★ Off
High alarm limit(℃) 39.0
Low alarm limit(℃) 36.0
Unit ℃
Color Yellow
NIBP
NIBP setup Adult Pediatric Neonatal
Alarm Switch★ On
Alarm Lev. Medium
Alarm Print★ Off
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Limit Display★ Off
ALM Source Sys &Map&Dia
Alarm Limit (mmHg)
High alarm limit of Sys 160 120 90
Low alarm limit of Sys 90 70 40
High alarm limit of Dia 90 70 60
Low alarm limit of Dia 50 40 20
High alarm limit of Map 110 90 70
Low alarm limit of Map 60 50 25
Measure Mode Manual
Unit mmHg
Inflation(mmHg) 160 130 75
Venipuncture Press(mmHg) 80 60 40
Interval 5 min
Color White
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Appendix C Alarm messages
C.1 Monitor Alarm Messages
System
Technical alarm:
Alarm messages Cause Level
Battery low Voltage of battery is too low Medium
ECG
Physiological alarm:
Alarm messages Cause Level
HR high HR measuring value is above the high Medium
alarm limit (User-Selectable
HR low HR measuring value is below the low Medium or High)
alarm limit
ECG signal too weak Can‟t detect the patient‟s ECG signal. High
ST-X high ST-X measuring value is above the Medium
high alarm limit (User-Selectable)
ST-X low ST-X measuring value is below the
low alarm limit
Technical alarm:
Alarm messages Cause Level
RA、LA、LL、V- leads ECG electrode fall off the skin or
off ECG cables fall off the monitor
Medium
ECG leads off Key-leads are disconnected, so it can‟t
measure normal ECG waveform.
Ⅰ、Ⅱ、Ⅲ、V- polarize ECG electrode polarized Low
ECG communicating ECG measurement failure or Medium
error communication failure
ECG noise ECG noise is too much. Low
Resp
Physiological alarm:
Alarm messages Cause Level
RR high RR measuring value is above the high Medium
alarm limit (User can select
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RR low RR measuring value is below the low Medium or High)
alarm limit
Resp apnea No signal for breath in specific
High
interval
SpO2
Physiological alarm:
Alarm messages Cause Level
SpO 2 high SpO 2 measuring value is above the Medium
high alarm limit (User can select
Medium or High)
SpO 2 low SpO 2 measuring value is below the Medium
low alarm limit (User can select
Medium or High)
SpO 2 Desat limit SpO 2 measuring value is too low. High
PR high PR measuring value is above the high
alarm limit Medium
(User can select
PR low PR measuring value is below the low Medium or High)
alarm limit
SpO 2 pulse timeout SpO 2 signal is predominantly invalid
High
and therefore cannot be analyzed
PI low PI measuring value is below the low Medium
alarm limit (User can select
Medium or High)
Technical alarm:
Alarm messages Cause Level
SpO 2 sensor off SpO2 sensor may be disconnected
Medium
from the patient or the monitor
SpO2 communicating SpO 2 measurement failure or
Medium
error communication error
SpO2 low confidence No SpO2 measurement data occurs or
Low
low confidence in 25s
Prompt messages:(displayed in SpO 2 parameter area)
Messages Cause Level
Search pulse SpO 2 module is searching for pulse Prompt message
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User Guide
Temp
Physiological alarm:
Alarm messages Cause Level
〈Temp label〉high 〈Temp label〉 measuring value is
Medium
above high alarm limit
(User can select
〈Temp label〉low 〈Temp label〉measuring value is
Medium or High)
below low alarm limit
Technical alarm:
Alarm messages Cause Level
〈Temp label〉sensor off 〈Temp label〉sensor may be
Medium
disconnected from user or monitor
〈Temp label〉over high range 〈Temp label〉over measuring range
〈Temp label〉below low range 〈Temp label〉below measuring
range Low
TEMP lev.1 self test failure Temp self checking error
TEMP lev.2 self test failure Temp self checking error
Temp communicating error Temp measurement error or
Medium
communication error
NIBP
Physiological alarm:
Alarm messages Cause Level
NIBP Sys high NIBP Sys measuring value is above
high alarm limit
NIBP Sys low NIBP Sys measuring value is below Medium
low alarm limit (User-Selectable
NIBP Dia high NIBP Dia measuring value is above Medium or High)
high alarm limit
NIBP Dia low NIBP Dia measuring value is below
low alarm limit
Medium
NIBP Map high NIBP Map measuring value is above
(User-Selectable
high alarm limit
Medium or High)
NIBP Map low NIBP Map measuring value is below
low alarm limit
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Technical alarm 1(displayed in the indicating area under NIBP MAP):
Alarm messages Cause Level
Loose Cuff 1. Cuff is completely unwrapped.
2. The cuff is not connected.
3. Adult cuff used in neonate mode.
Air Leak Air leak in pneumatics, hose, or cuff.
Air Pressure Error Unable to maintain stable cuff
pressure, e.g. kinked hose.
Weak Signal Very weak patient signal due to a
loosely wrapped cuff. The pulse of
patient is too weak. Low
Range Exceeded Measurement range exceeds module
specification.
Excessive Motion 1.Too many retries due to interference
of motion artifact.
2.Signal is too noisy during
measurement, e.g. patient has severe
tremor.
3.Irregular pulse rate, e.g. arrhythmia.
Overpressure Sensed Cuff pressure exceeds the specified
high safety limit. Could be due to Medium
rapid squeezing or bumping of cuff.
Signal Saturated Large motion artifact that saturates the
BP amplifier ‟s amplitude handing
capability.
Air System Leak Module reports Air Leakage failure
while in the Pneumatic Test mode.
System Failure Module occurs abnormal processor Low
event.
Time Out Measurement took more than 120
seconds in adult, 90 seconds in
neonate mode.
Cuff Type Error Neonate cuff used in adult mode.
Over the measurement range of the
Unspecified accuracy
software design
The device is powered off accidently
Cycle mode abort
during the Cycle mode measurement
Zero Calibrate Failure Zero calibration fails Medium
Calibrate Failure NIBP pressure calibration fails
Overpress Zero Failure Hardware overpress zero fails
Overpress Cal. Failure Hardware over presscalibration fails
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User Guide
Prompt messages(displayed in NIBP parameter area):
Messages Cause Level
NIBP Resetting NIBP measurement module is
resetting
Overpress Testing NIBP is testing Over-Pressure Prompt message
Manometer Testing NIBP is testing Manometer
Air Leakage Testing NIBP is testing Air Leakage
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User Guide
Appendix D Troubleshooting
This chapter conducts categorization based on the failure type of the monitor,
and for troubleshooting, please refer to the failure table and conduct checks according
to the sequence.
The recommended solutions given in this chapter can solve most of the
equipment failures, but may not necessarily cover all possible failures. In case of any
failures not included in this chapter, please contact the after-sale service department of
our Company.
D.1 Common Failure Analysis and Troubleshooting
Phenomenon Possible causes Actions to resolve problems
AC power is not
Check whether the AC power is connected
connected, or battery
correctly, or whether the battery capacity is
capacity is
sufficient.
insufficient
Monitor can be 1. Check whether the power switch and the cable
turned on, but from the indicator to the key board, the cable
LED or battery from key board to the main control unit and the
LED does not Cable failure cable from the power module to the main control
light up unit are properly connected.
2. Check whether the cables and plugs are
damaged.
Power module is
Replace the power module.
damaged
Power module is
Battery cannot Replace the power module.
damaged
be recharged
Battery failure Replace the battery.
1. Check whether the cable from the LCD
display screen to the main-board is properly
Cable failure connected.
Black screen,
2. Check whether cables and connectors are
monitor runs
damaged.
normally
Backlight board is
Replace the backlight board.
damaged
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User Guide
Phenomenon Possible causes Actions to resolve problems
LCD display screen
Replace the LCD display screen.
is damaged
1. Check whether the cable from the key board
Cable failure to the main-board is properly connected.
Keys have no
2. Check whether cables and plugs are damaged.
response
Key board is
Replace the key board.
damaged
1. Check whether the cable from the knob to the
key board and the cable from the key board to
Trim knob has Cable failure the main-board are properly connected.
no response 2. Check whether cables and plugs are damaged.
Trim knob is broken Replace the trim knob coder.
1. Check whether the cable from the SOPB
interface board to the main-board is properly
USB equipment Cable failure.
connected.
can not be used
2. Check whether cables and plugs are damaged.
(peripheral
USB interface board
equipment has Replace the USB interface board.
is damaged
no damage)
Main-board is
Replace the main-board.
damaged
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User Guide
Appendix E Guidance and Manufacturer’s
Declaration of EMC
Use of this equipme nt adjacent to or stacked with other equipment
should be avoided because it could result in improper operation. If s uch
use is necessary, this equipme nt and the other equipment should be
observed to verify that they are operating normally.
Use of accessories, transducers and cables other than those specified or
provided by the manufacturer of this equipme nt could result in increased
electromagnetic emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.
Portable RF communications equipme nt (including pe ripherals such as
antenna cables and external antennas) should be used no closer than 30
cm (12 inches) to any part of the TRUSCOPE TOUCH MINI, including
cables specified by the manufacturer. Otherwise, degradation of the
performance of this equipment could result.
Table 1
declaration - electromagnetic emission
TRUSCOPE TOUCH MINI is intended for use in the electromagnetic environment specified below. The
customer or the user of TRUSCOPE TOUCH MINI should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions Group 1 TRUSCOPE TOUCH MINI uses RF energy only for
CISPR 11 its internal function. Therefore, its RF emissions are
very low and are not likely to cause any interference
in nearby electronic equipment.
RF emissions Class A TRUSCOPE TOUCH MINI is suitable for use in all
CISPR 11 establishments other than domestic and those
Harmonic emissions directly connected to the public low-voltage power
Class A
IEC 61000-3-2 supply network that supplies buildings used for
Voltage fluctuations/ domestic purposes.
Complies
flicker emissions
IEC 61000-3-3
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User Guide
Table 2
declaration - electromagnetic immunity
TRUSCOPE TOUCH MINI is intended for use in the electromagnetic environment specified below. The
customer or the user of TRUSCOPE TOUCH MINI should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment -
guidance
Electrostatic ±8 kV contact ±8 kV contact Floors should be wood, concrete
discharge (ESD) ±2 kV, ±4 kV, ±8 kV, ±15 ±2 kV, ±4 kV, ±8 or ceramic tie. If floors are
IEC 61000-4-2 kV air kV, ±15 kV air covered with synthetic material,
the relative humidity should be at
least 30 %.
Electrical fast ± 2 kV for power supply ± 2 kV for power
Mains power quality should be
transient/burst lines supply lines
that of a typical commercial or
IEC 61000-4-4 ± 1 kV for input/output ± 1 kV for
hospital environment.
lines input/output lines
Surge ± 0.5kV, ± 1 kV line(s) to
± 0.5kV, ± 1 kV
Mains power quality should be
IEC 61000-4-5 lines line(s) to lines
that of a typical commercial or
± 0.5kV, ± 1 kV, ± 2 kV ± 0.5kV, ± 1 kV, ±
hospital environment.
line(s) to earth 2 kV line(s) to
earth
Voltage dips, 0 % UT; 0.5 cycle At 0°, 0 % UT; 0.5 cycle
45°, 90°, 135°, 180°, At 0°, 45°, 90°, Mains power quality should be
short
225°, 270°and 315° 135°, 180°, 225°, that of a typical commercial or
interruptions and 270°and 315° hospital environment. If the user
voltage 0 % UT; 1 cycle and
of the TRUSCOPE TOUCH M INI
variations on 70 % UT; 25/30 cycles 0 % UT; 1 cycle
Single phase: at 0° and requires continued operation
power supply 70 % UT; 25/30 during power mains interruptions,
input lines 0 % UT; 250/300 cycles cycles it is recommended that the
IEC 61000-4-11 Single phase: at 0°
TRUSCOPE TOUCH M INIbe
0 % UT; 250/300 powered from an uninterruptible
cycles power supply or a battery.
Power frequency 30 A/m 30 A/m Power frequency magnetic fields
(50/60 Hz) should be at levels characteristic
magnetic field of a typical location in a typical
IEC 61000-4-8 commercial or hospital
environment.
NOTE: UT is the a.c. mains voltage prior to application of the test level.
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User Guide
Table 3
declaration - electromagnetic immunity
TRUSCOPE TOUCH MINI is intended for use in the electromagnetic environment specified below. The
customer or the user of TRUSCOPE TOUCH MINI should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance
Conducted RF 3V 3V Portable and mobile RF communications equipment
IEC 61000-4-6 0.15 MHz to 80 0.15 MHz to 80 should be used no closer to any part of TRUSCOPE
MHz MHz TOUCH MINI, than the recommended separation
6 V in ISM and 6 V in ISM and distance calculated from the equation applicable to the
between 0.15 MHz between 0.15 frequency of the transmitter.
and 80 MHz MHz and 80 Recommended separation distance
MHz 3.5
Radiated RF 3V/m 3V/m d P 150 KHz to 80 MHz
IEC 61000-4-3 80 MHz to 2.7 V 1
GHz 3.5
d P 80 MHz to 800 MHz
E1
7
d P 80 MHz to 2.7 GHz
E1
where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey, a should
be less than the compliance level in each frequency
range.
Interference may occur in the vicinity of equipment
marked with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a Field strengths from fixed RF transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which
TRUSCOPE TOUCH MINI is used exceeds the applicable RF compliance level above, TRUSCOPE
TOUCH MINI should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as re-orienting or relocating TRUSCOPE TOUCH MINI.
b Over the frequency range 0.15 MHz to 80 MHz, field strengths should be less than 3 V/m.
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User Guide
Table 4
Recommended separation distances between
portable and mobile RF communications equipment and TRUSCOPE TOUCH MINI
TRUSCOPE TOUCH MINI is intended for use in an electromagnetic environment in which radiated
RF disturbances are controlled. The customer or the user of TRUSCOPE TOUCH MINI can help
prevent electromagnetic interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and TRUSCOPE TOUCH MINI, as recommended
below, according to the maximum output power of the communications equipment.
Rated maximum output power S eparation distance according to frequency of transmitter
of transmitter m
W 0.15 MHz to 80 MHz 80 MHz to 800 MHz 80 MHz to 2.7 GHz
d 1.2 P d 1.2 P d 2.3 P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
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User Guide
Table 5
declaration - IMMUNITY to proximity fields from RF wireless communications equipment
TRUSCOPE TOUCH MINI is intended for use in an electromagnetic environment in which RF wir eless
communications equipment are controlled.
Immunity IEC60601 test level Compliance Electromagnetic
test level environment -
Test Modulation Maximum Immunity
guidance
frequency power level
Radiated 385 MHz **Pulse 1.8W 27 V/m 27 V/m
RF Modulation:
IEC 18Hz
61000-4-3 450 MHz *FM+ 5Hz 2W 28 V/m 28 V/m
deviation:
1kHz sine
710 MHz **Pulse 0.2 W 9 V/m 9 V/m
745 MHz Modulation:
780 MHz 217Hz
810 MHz **Pulse 2W 28 V/m 28 V/m
870 MHz Modulation:
930 MHz 18Hz
1720 MHz **Pulse 2W 28 V/m 28 V/m
1845 MHz Modulation:
1970 MHz 217Hz
2450 MHz **Pulse 2W 28 V/m 28 V/m
Modulation:
217Hz
5240 MHz **Pulse 0.2 W 9 V/m 9 V/m
5500 MHz Modulation:
5785 MHz 217Hz
Note * - As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because
while it does not represent actual modulation, it would be worst case.
Note** - The carrier shall be modulated using a 50 % duty cycle square wave signal.
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