PROFESSIONAL MEDICAL PRODUC TS

SLEEP APNEA SCREEN METER

RS01 (GIMA 33676)

CONTEC MEDICAL SYSTEMS CO., LTD
No 112 Qinhuang West Street,
Economic & Technical Development Zone,
Qinhuangdao, Hebei Province, 066004,
PEOPLE’S REPUBLIC OF CHINA 0123
Made in China
M33676-EN-Rev.5-06.25

Prolinx GmbH Brehmstr. 56, 1060hPa 95%

55°C
40239 Duesseldorf Germany %

-40°C 500hPa 0%
Gima S.p.A.
Via Marconi, 1 - 20060 Gessate (MI) Italy
gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com IP22
User Notice
Dear Users, thank you very much for purchasing the Sleep apnea screen meter.
This Manual is written and compiled in accordance with the council directive MDD93/42/EEC for medical devices
and harmonized standards. In case of modifications and software upgrades, the information contained in this
document is subject to change without notice.
It is a medical device, which can be used repeatedly.
The User Manual contains use and technical descriptions.The Manual describes, in accordance with the device’s
features and requirements, main structure, functions, specifications, correct methods for transportation, assembly,
usage, operation, repair, maintenance and storage, etc. as well as the safety procedures to protect both the user
and device. Refer to the respective chapters for details.
Please read the User Manual carefully before using this device. The User Manual which describes the operating
procedures should be followed strictly. Failure to follow the User Manual may cause measuring abnormality, device
damage and human injury. The manufacturer is NOT responsible for the safety, reliability and performance issues
and any monitoring abnormality, human injury and device damage due to users' negligence of the ope ration
instructions. The manufacturer’s warranty service does not cover such faults.
Owing to the forthcoming renovation, the specific products you received may not be totally in accordance with the
description of this User Manual. We would sincerely regret for that.
Our company has the final interpretation to this manual. The content of this manual is subject to change without
prior notice.
Warnings
Remind that it may cause serious consequences to tester, user or environment.
 Explosive hazard—DO NOT use the device in environment with inflammable gas such as anesthetic.
 DO NOT use the device while examining by MRI or CT, as the induced current may cause burn.
 Do not take the information displayed on the device as the sole basis for clinical diagnosis. The device is
only used as an auxiliary means in diagnosis. And it must be used in conjunction with doctor’s advice,
clinical manifestations and symptoms.
 The maintenance to the device or replacement of the battery can only be performed by qualified service
personnel specified by manufacturer, dangers (such as over-temperature, fire or explosion) may occur
when replacing the battery by the personnel not fully trained. Users are not permitted to maintain or refit
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 the device by themselves.
 Uncomfortable or painful feeling may appear if using the blood oxygen probe ceaselessly, especially for the
microcirculation disturbance users. It is not recommended that the sensor is used on the same finger for
more than 6 hours.
 For some special users who need a more careful inspection on the test site, please don’t place the device
on the edema or tender tissue.
 Please do not stare at the red and infrared light emitter (the infrared light is invisible) after turning on the
device, including the maintenance staff, as it may be harmful to the eyes.
 Each part of the device is firmly fixed,if accidental falling leads to the small parts such as a button to fall
off,avoid swallowing of these parts,it may cause suffocation.
 The device contains silicone, PVC, TPU, TPE and ABS materials, whose biocompatibility has been tested
in accordance with the requirements in ISO 10993-1, and it has passed the recommended biocompatibility
test. The person who is allergic to silicone, PVC, TPU, TPE or ABS can not use this device.
 Do not wrap the nasal oxygen tube, SpO2 probe or USB cable around neck to avoid an accident.
 Be careful to avoid tying or wrapping senor, tube, wire and cable to the patient, avoiding accidents to the
patient.
 The disposal of scrap device, its accessories and packaging should follow the local laws and regulations,
to avoid polluting to the local environment. The equipment and packaging materials must be placed in the
region where the children are out of reaching.
 The device can not be used with the equipment not specified in the Manual. Only the accessories
appointed or recommended by the manufacturer can be used, otherwise it may cause injury to the tester
and operator or damage to the device.
 The SpO2 probe is only suitable for using with the device. The device can only use the SpO2 probe
described in the Manual, so the operator has the responsibility to check the compatibility between the
device and the SpO2 probe before using, incompatible accessories may cause device performance
degradation, device damage or patient injury.
 Do not reprocess the accompanying SpO2 probe.
 Check the device before use to make sure that there is no visible damage that may affect user’s safety and
device performance. When there is obvious damage, please replace the damaged parts before use.
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 When the message “Sensor Off” or “Sensor Fault” appears on the screen, it indicates that the SpO2 probe
is disconnected or line fault occurs. Check the connection of the SpO2 probe and whether there is damage
for the probe, if necessary, please replace the probe to avoid risks. The probe fault will not result in a
safety hazard.
 Functional testers can not be used to assess the accuracy of the SpO2 probe and Pulse Oximeter.
 Some functional testers or patient simulators can be used to verify whether the device works normally, for
example, INDEX-2LFE Simulator (software version: 3.00), please refer to the Manual for the detailed
operation steps.
 Some functional testers or patient simulators can measure the accuracy of the device copied calibration
curve, but they can not be used to evaluate the device accuracy.
 When using the device, please keep it away from the equipment which can generate strong electric field or
strong magnetic field. Using the device in an inappropriate environment may cause interference to the
surrounding radio equipment or affect its working.
 When storing the device, keep it away from children, pets and insects to avoid affecting its performance.
 Do not place the device in places exposed to direct sunlight, high temperature, humidity, dust, cotton wool
or easy to splash water, to avoid affecting its performance.
 The measured accuracy will be affected by the interference of electrosurgical equipment.
 When several products are used on the same patient simultaneously, danger may occur which is arisen
from the overlap of leakage current.
 CO poisoning will appear excessive estimation, so it is not recommended to use the device.
 This device is not intended for treatment.
 The intended operator of the device may be a patient.
 Avoid maintaining the device during using.
 The device can not be used during charging.
 Do not damage the wristband,in order to avoid affecting the use;or the wristband is not fastened,causing
the instrument to fall and damage in the process of use.
 Shock，coma patients should be under the guidance of the hospital and professional nursing staff can be
used.

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 Contents
1 Overview .....................................................................................................................................................................1
1.1Features .......................................................................................................................................................1
1.2Applied range ...............................................................................................................................................1
1.3Environment requirements ...........................................................................................................................2
1.4Precautions ..................................................................................................................................................2
2 Principle ......................................................................................................................................................................5
3 Functions ....................................................................................................................................................................6
4 Appearance and structure ..........................................................................................................................................7
4.1Appearance ..................................................................................................................................................7
4.2Interface introduction ...................................................................................................................................8
4.3Structure, accessories and software description ...................................................................................... 10
5 Operating .................................................................................................................................................................. 11
5.1 Operation and use of the instrument ........................................................................................................ 11
6 Maintain, Transport and Storage ............................................................................................................................. 25
6.1Cleaning and disinfection .......................................................................................................................... 25
6.2Maintenance .............................................................................................................................................. 26
6.3Transport and Storage .............................................................................................................................. 26
7 Troubleshooting ....................................................................................................................................................... 27
8 Symbols ................................................................................................................................................................... 28
9 Specification ............................................................................................................................................................ 30
Appendix 1: EMC ........................................................................................................................................................ 32

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1 Overview
The oxygen saturation is the percentage of HbO2 in the total Hb in the blood, so-called the O2 concentration in the
blood, it is an important physiological parameter for the respiratory and circulatory system. A number of diseases
related to respiratory system may cause the decrease of SpO2 in the blood, furthermore, some other causes such
as the malfunction of human body's self-adjustment, damages during surgery, and the injuries caused by some
medical checkup would also lead to the difficulty of oxygen supply in human body, and the corresponding
symptoms would appear as a consequence, such as vertigo, impotence, vomit etc. Serious symptoms might bring
danger to human's life. Therefore, prompt information of patients' SpO2 is of great help for the doctor to discover
the potential danger, and is of great importance in the clinical medical field.
Insert the finger when measuring, the device will directly display the SpO2 value measured, it has a higher
accuracy and repeatability.
The device is intended to provide sleep test for patients with sleep apnea - hypopnea syndrome, a basis for
whether a comprehensive sleep examination is necessary, and a reference to the effectiveness of treatment for
patients who are receiving treatment, it can be used in family, community medical institution and hospital.
Humanized ON / OFF design: manual and automatic ON / OFF. The patient can adopt manual power-on to record
or auto power-on in accordance with the sleep time estimated to record, to reduce patient’s psychological burden
and test easily. After setting auto power-on, the device will save the cases automatically.
Adopt a large capacity SD card to store many cases, upload case by USB to PC or computer for saving directly. By
the PC software, personal information can be edited to save the case for a long time, the case collected can be
analyzed to help doctor to diagnose quickly, which meets the requirements of respiration department, sleep center
and internal medicine, etc. in hospital.
The patient can also invite expert to diagnose remotely via network, which is convenient for patient to have a
physical examination at home.
1.1 Features
A.LCD display.
B.Easy to operate.
C.Wrist design, small in volume and light in weight.
1.2 Applied range
be applicable for monitoring sleep respiration and SpO2.

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1.3 Environment requirements
Storage Environment
a) Temperature: -40 ℃ ~ + 55 ℃
b) Relative humidity: ≤ 95%
c) Atmospheric pressure: 500 hPa ~ 1060 hPa
Operating Environment
a) Temperature: 10 ℃~ 40 ℃
b) Relative Humidity: ≤ 75%
c) Atmospheric pressure: 700 hPa ~ 1060 hPa
1.4 Precautions
1.4.1 Attention
Point out conditions or practices that may cause damage to the device or other properties.
 Before using the device, make sure that it locates in normal working state and operating environment.
 In order to get a more accurate measurement, it should be used in a quiet and comfortable environment.
 When the equipment from the cold or hot environment to normal room temperature, please do not use it
immediately,wait four hours at least is recommended.
 If the device is splashed or coagulated by water, please stop operating.
 DO NOT operate the device with sharp things.
 The device is suitable for children and adult.
 The device may not be suitable for all users, if you can't get a satisfactory result, please stop using it.
 Data averaging and signal processing have a delay in the upgrade of SpO2 data values. When the data
update period is less than 30 seconds, the time for obtaining dynamic average values will increase, which
is arisen from signal degradation, low perfusion or other interference, it depends on the PR value.
 The device has 5-year service life, date of manufacture: see the label.
 The device does not provide over-limit alarm function for SpO2 and PR, so it is inapplicable for using in the
place where need such function.
 The maximum temperature at the SpO2 probe -tissue interface should be less than 41℃ which is
measured by the temperature tester.
 During measuring, when abnormal conditions appear on the screen, please pull out your finger and

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 reinsert it to measure again.
 If some unknown error appears during measuring,the product can be connected to the adapter through the

date line,long press “ ”button about 10 seconds for reset and then shut down to terminate the operation of the

product.

 Do not contort or drag the wire of the device.

 The plethysmographic waveform is not normalized, as a signal inadequacy indicator, when it is not smooth
and stable, the accuracy of the measured value may degrade. When it tends to be smooth and stable, the
measured value read is the optimal and the waveform at this time is also the most standard.
 The device can not be used during charging.
 If necessary, please visit our official website to get the information about SpO2 probe that can be used with
this device.
 If the device or component is intended for single-use, then the repeated use of these parts will pose risks
on the parameters and technical parameters of the equipment known to the manufacturer.
 If necessary, our company can provide some information (such as circuit diagrams, component lists,
illustrations, etc.), so that the qualified technical personnel of the user can repair the device components
designated by our company.
 Operators cancontact our company to obtain the modified Bland and Altman plot.
 The measured results will be influenced by the external colouring agent (such as nail polish, colouring
agent or color skin care products, etc.), so don't use them on the test site.
 Do not fix the SpO2 sensor with adhesive or else it may result in venous pulsation and inaccurate measure
of SpO2 and pulse rate.
 As to the fingers which are too cold or too thin or whose fingernail is too long, it may affect the measured
results, so please insert the thicker finger such as thumb or middle finger deeply enough into the probe
when measuring.
 The finger should be placed correctly (see picture 5.15), otherwise,the measurement may be inaccurate.
 The light between the photoelectric receiving tube and the light-emitting tube of the device must pass

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 through the subject’s arteriole. Make sure the optical path is free from any optical obstacles like rubberized
fabric, to avoid inaccurate results.
 Excessive ambient light may affect the measured results, such as surgical light (especially xenon light
sources), bilirubin lamp, fluorescent lamp, infrared heater and direct sunlight, etc. In order to prevent
interference from ambient light, make sure to place the sensor properly and cover the sensor with opaque
material.
 requent movement (active or passive) of the subject or severe activity can affect the measured accuracy.
 The SpO2 probe should not be placed on a limb with the blood pressure cuff, arterial ductus or intraluminal
tube.
 The measured value may be inaccurate during defibrillation and in a short period after defibrillation, as it
has not defibrillation function.
 The device has been calibrated before leaving factory.
 The device is calibrated to display functional oxygen saturation.
 The equipment connected with the Oximeter interface should comply with the requirements of IEC
60601-1.
 Please select medical power adapter to charge it, when connecting the special adapter with the socket,
make sure there is no shelter near the socket and it is easy to plug and unplug, otherwise the power will
not be cut off in time when necessary, causes damage.
 The actual product may be slightly different from the picture in the manual ,please refer to the actual
product.
 The expected service life of the attached parts or accessories of the equipment is two year.See the
packaging label for the production date.
 The shelf life shall prevail if the accessory or part has a shelf life that is shorter than its intended service life.
 The device should be operated by medical personnel via professional training,or non-medical personnel
who have been guided.
 This device has the function of prompting, users can check on this function according to chapter 5.1.2 as a
reference.
 The device has the function of limits prompting, when the measured data is beyond the highest or lowest
limit, the device would start prompting automatically on the premise of the prompting function is on.

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 The device has the function of prompting, this function can either be paused, or closed (default setting) for
good. This function could be turned on through menu operation if you need. Please check the chapter
5.1.2 as a reference.
 Please check the package before use.Do not use if the package is damaged.
 Please refer to the body for other matters needing attention.
1.4.2Clinical restriction
A. As the measure is taken on the basis of arteriole pulse, substantial pulsating blood flow of subject is required.
For a subject with weak pulse due to shock, Raynaud’s syndrome, low ambient/body temperature, major bleeding,
or use of vascular contracting drug, the SpO2 waveform (PLETH) will decrease. In this case, the measurement will
be more sensitive to interference.
B. The measurement will be influenced by intravascular staining agents (such as indocyanine green or methylene
blue), skin pigmentation.
C. The measured value may be normal seemingly for the tester who has anemia or dysfunctional hemoglobin(such
as carboxyhaemoglobin (COHb), methaemoglobin (MetHb) and sulfhaemoglobin (SuHb)), but the tester may
appear hypoxia, it is recommended to perform further assessment according the clinical situations and symptoms.
D. Pulse oxygen only has a reference meaning for anemia and toxic hypoxia, as some severe anemia patients still
show better pulse oxygen measured valued.
E. Contraindication:
a. The person who is allergic to silicone, PVC, TPU TPE or ABS.
b. The damaged skin tissue.
c. During cardiopulmonary resuscitation.
d. When the patient is hypovolemic.
e. For assessing the adequacy of ventilatory support.
f. For detecting worsening lung function in patients on a high concentration of oxygen.

2 Principle
The product makes a preliminary judgment on whether the user has sleep apnea - hypopnea syndrome and the
severity of the disease by recording and analyzing the changes of respiration and SpO2 during a sleep.

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3 Functions
A.It can collect the signals of nasal airflow,oxygen saturation and pulse in real time,and display the waveform and
data in real time.
B.Multi case storage function
C.Card reading function
D.Storage function of case database
E.PC software case data and analysis results display function
F.Report output function
G.Continuous recording time
H.Real-time clock
I.Timing recording function
J.PR sound and prompt tone function
K.Charging function
L.Quantity of electricity indication

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4 Appearance and structure
4.1 Appearance

The device is consisted of main unit, nasal oxygen cannula, SpO2 probe, power adapter（optional）, USB data line and
PC software.No detachable parts for main unit itself, applied parts: the nasal oxygen cannula and SpO2 probe, they
are detachable parts.

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4.2 Interface introduction

Figure4.1 Measurement interface

Figure 4.2 Record interface

(1)SpO2 value display

8
 Sign: %SpO2
Description: it displays SpO2 value after inserting the finger into the SpO2 probe.
(2)Pulse rate value display
Sign: PRbpm
Description: it displays PR value after inserting the finger into the SpO2 probe.

(3)Bar graph display

Sign:
Description: it displays the pulse beat after inserting the finger into the SpO2 probe.
(4 )Nasal airflow waveform
Sign: flow
Description: real-time display of nasal airflow waveform
(5)SpO2 plethysmogram waveform display
Sign: SpO2
Description: real-time display of PLETH waveform
(6) Pulse sound indication

Sign:

Description: : ON, : OFF

(7) Prompt (over-limit of SpO2 or PR value) sound indication

Sign:

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 Description: : ON, : OFF

(8)Battery capacity indication

Sign: 、 、 、

Description: it indicates low battery when flickers.

(9)Real-time clock display
Sign: 08:55
Description: it displays real-time clock
(10)Lower limit of SpO2 prompt
Sign: 85
Description: the current lower limit value is “85”.
(11)Record indication
Sign: REC
Description: flickers under record state
(12)Recorded time display
Sign: 00:00:01
Description: the time that the device has recorded, format: hour:minute:second
(13)Prompt functions for finger out, sensor off, sensor fault
It will give corresponding prompts when SpO2 measurement is abnormal:
“Finger out”: no finger detected;
“Sensor off”: no SpO2 probe detected;
“Sensor fault”: the probe is damaged.
4.3Structure, accessories and software description
A. Main unit,nasal oxygen cannula,SpO2 probe,power adapter (optional),USB data line,PC software
B.Accessories:Two Luer male adapter,One User Manual
Please check the device and accessories according to the list to avoid that the device can not work normally.

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C.Software description
PC software name: ResMonPlus PC software model: No
PC software version: V3.0
Naming rule for version: VX.Y. Z. B
X,Y: major enhancive software upgrade
Z: minor enhancive software upgrade
B: improvement software upgrade
Obtain PC software version from “Help” in PC software.
Involved algorithm：
Name: a method for judging respiratory wave of human respiratory monitoring system
Type: mature arithmetic
Purpose: be used for preliminary breathing screening in patients with sleep-disordered breathing.
Clinical function: the algorithm analyzes the breathing digital signal of patients with sleep-disordered breathing to
form an effective and clear respiratory waveform.

5 Operating
5.1 Operation and use of the instrument
5.1.1 Button operation
ON / OFF / Awake button
Power on: the green indicator is light after long pressing “ ”, then it enters to the measurement interface after
displaying the time.
Power off: under non-record state, long pressing “ ”to power off.
under record state, it is disable to power off,you need to stop recording before you operate.
Screen awaking: under record state, if there is no button operation within 60 seconds, it will automatically enter
power-saving state. Short press “ ” to awake the LCD to display.
Menu / Confirm button
Under measurement interface, long press “M” button to enter the main menu, then short press “M” button in main
menu to browse the menu, long press it to enter the next menu or set the menu option selected.

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5.1.2 Menu operation
1.Main menu
Under the measurement interface, long press “M” button to enter the main menu, as shown in Figure 5.1

Figure 5.1 Main menu

Table 5.1

No. Function Description

1 Prompt Select it to enter its setting menu
2 System Setup Select it to enter its setting menu
3 Schedule Poweron Select it to enter its setting menu
4 Record Select it to enter its setting menu
5 DEMO Select it to enter DEMO interface
6 Clock Select it to enter its setting menu
7 Exit Select it to return to measurement interface
2. Prompt setting

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The prompt setting menu is shown as Figure 5.2

Figure 5.2 Prompt setting menu

When the “prompt” is “ON”, the device will give a sound prompt when over-limit or low battery appears. When
“Pulse Sound” is “ON”, it can give a pulse sound prompt.

Table 5.2
No. Function Description
1 SpO2 HI (%) Setting range: 1 ~ 100, default: 99 (unit: %)
2 SpO2 LO (%) Setting range: 0 ~ 99, default: 85 (unit: %)
3 PR HI (bpm) Setting range: 1 ~ 254, default: 150 (unit: bpm)
4 PR LO (bpm) Setting range: 0 ~ 253, default: 50 (unit: bpm)
5 Prompt Sound “ON” / “OFF”, default: “OFF”
6 Pulse Sound “ON” / “OFF”, default: “OFF”
7 Exit Select it to return to previous menu.

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3. System menu
1) The system menu is shown as Figure 5.3:

Figure 5.3 System menu

Table 5.3

No. Function Description

1 Hard.ver Hardware version number, which can not be set by user.
2 Soft.RV Release software version number, which can not be set by user.
3 Soft.FV Full software version number, which can not be set by user.
4 Time format 24-hour format, which can not be set by user.
5 Language setup Select it to enter language setting interface
6 Delete Data Delete data stored by the device
7 Exit Select it to return to previous menu.

2) The language setting menu is shown as Figure 5.4

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 Figure 5.4 Language setting menu

Table 5.4
No. Function Description
1 English Set language to English and return to the main menu displayed in English.
2 Chinese Set language to Chinese and return to the main menu displayed in Chinese.
3 Exit Select it to return to previous menu.
4.Auto Record
Auto Record setting menu is shown as Figure 5.5:

Figure 5.5 Auto Record menu

Table 5.5

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 No. Function Description
1 Set Month Setting range: 1 ~ 12
2 Set Day Setting range: 1 ~ 31
3 Set Hour Setting range: 0 ~ 23
4 Set Minute Setting range: 0 ~ 59
5 Record Length(h) Setting range: 1~10, default: 8, unit: hour
6 Auto Record? “NO”/“YES”, YES: confirm, No: cancel
7 Exit Select it to return to previous menu, “YES”: exit this interface, the settings take effect.
Attention: “Auto poweron” can not be set during recording.
Attention: when it reaches the set time and under “OFF” state, the device will turn on and record automatically.
5. Record setting
1) When “Record” is “OFF”, select it to enter record setting menu shown as Figure 5.6. The prompt
information “You will start to record! Are you sure?” displays on the interface, select “Exit” after setting to
“Yes” to enter the record interface, under record interface, record sign is “REC ●”, it indicates that it is
recording when “●” flickers, recorded time displays on the interface shown as Figure 5.7. Select “Exit” after
setting to “No” to enter the interface which will not record.

Figure 5.6 Record setting menu

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 Figure 5.7 Recorded time interface
Attention:
If the interface prompts “TF card is full” during recording, it indicates that the remaining capacity of the built-in SD
card is insufficient, then the user can not record, the user need to transfer previous cases via computer.
Manual poweroff can not be performed during recording, please exit the record mode firstly, then power off.
Advice:
 Regularly back up the recorded cases by computer to prevent the loss of case due to damage to the
built-in SD card.
 Do not store any file except the cases.
Attention:
The device interface prompt “TF card error”when the card is damaged.
2) When “Record” is “ON”, select it to enter the stop recording menu shown as Figure 5.8. The prompt
information “You will stop recording? Are you sure?” appears on the interface, select “Exit” after setting to
“Yes” to exit the stop recording interface to enter the measurement interface; select “Exit” after setting to
“No” to enter the interface which will continue recording.

3)

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 Figure 5.8 Stop recording menu
6．Time setting
The time setting menu is shown as Figure 5.9:

Figure 5.9 Time setup menu

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 Table 5.6

No. Function Description

1 Set Year Setting range: 10 ~ 99, represents 2010 ~ 2099
2 Set Month Setting range: 1 ~ 12
3 Set Day Setting range: 1 ~ 31
4 Set Hour Setting range: 0 ~ 23
5 Set Minute Setting range: 0 ~ 59
6 Are you sure? “No” / “Yes”, “Yes”: confirm, “No”: cancel
Select it to return to previous menu, select “Exit” after setting to “Yes”, an effective time
7 Exit
interface appears.

Attention: the time can not be set during recording.

5.1.3Connection of application parts
1．Nasal airflow monitoring
Unpack the packaging of nasal oxygen cannula, unscrew the screw cap following Figure 5.10, then insert the
Nasal oxygen cannula into its jack and tighten it. Insert the oxygen breathing apparatus into the nostril, wind the
oxygen-dividing connecting tube from ear to the lower jaw. Turn on the device after adjusting the locating ring to a
comfortable state, after a few seconds, check the respiration state after stable waveform appears. Wearing mode
of nasal oxygen cannula is shown as Figure 5.11, and the overall wearing mode is shown as Figure 5.12.

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 Figure 5.10Connection of nasal oxygen cannula

Figure 5.11 Wearing mode of nasal oxygen cannula

20
 Figure 5.12 Sketch map of overall wearing
Attention:
 Wear the nasal oxygen cannula according to the regulations, or it will affect the collection effect.
 If the non-screwing nasal oxygen cannula is used, then use the Luer male plug to connect.
 The nasal oxygen cannula is disposable, repeated use may cause infection.
 Refer to the packaging of nasal oxygen cannula for its use.

2. Monitoring of SpO2 and PR

The device equips with the two SpO2 probes as table 5.7
Table 5.7

No. Name Quantity Length (cm) Whether shielding

1 Digital fingerstall SpO2 probe 1 35 No

2 Disposable non-woven adult probe 2 35 No

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 Figure 5.13 Digital fingerstall SpO2 probe Figure 5.14 Disposable non-woven adult probe

Figure 5.15 Wearing mode of probe

Insert the SpO2 probe into USB interface, the wearing way is shown in Figure5.15.
(1) Connect the probe with the device.
(2) Insert the finger into the probe.
(3) Under the measurement interface, read the related data directly from the LCD.
Attention:
When inserting the finger, the light emitting from the sensor must be directly irradiated to the side of the fingernail.
5.1.4 Auto poweron function
After setting the time of auto poweron, turn off the device, when it reaches the time set, it will turn on and record
automatically. After “Record Timeslice” time, it will turn off automatically (refer to 5.1.2).

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5.1.5Automatic sync clock and USB data upload
Long press “ ” to turn on the device to enter to the main interface, insert one end of the USB data line into USB
interface as Figure5.16, the other end to the USB interface of PC as Figure 5.17, the connection mode from the
device to PC is shown as Figure5.18. If connection is built at the initial interface of the PC software, the device will
automatically synchronize with the PC. After synchronization, it will enter card read state. If fails to build
connection at the initial interface, clock can not be synchronized. After entering this mode, a new disk will appear
in the computer.After a new drive letter appears in computer, double-click it to open it to find the data recorded,
which can be copied from the device and saved to any disk in my computer. Open the file recorded by the PC
software to analyze the patient’s sleep information.Note that the drive letter recognized by the device when
connected to the computer is write -protected to prevent malware from implanting viruses
(power on - insert the USB data line - open my computer - open the device drive letter - copy the data file
generated to PC hard disk to avoid data missing).

Figure 5.16 Sketch map for connection between Sleep apnea screen meter and USB data line

23
 Figure 5.17 Sketch map for connection between PC and USB data line

Figure 5.18 Sketch map for connection between device and computer
1. USB data line 2. Sleep apnea screen meter 3. PC
Attention:
 The data can not be uploaded until stop recording.
 If “Device drive letter” can not be recognized, unplug the USB data line and insert it again.

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5.1.6 Delete data

Figure 5.19 Delete date interface

As shown in the figure,when the data stored in the device needs to be deleted,the system settings interface in the
menu is entered.Select the “Delete Data” option,When the “delete all data?”Select “Yes”.The date in the device is
then completely delete.
5.1.7 Charging
Connect one end of the power adapter to power socket, the other end to the device by the data line.
Charging indicator: it is orange when the battery is being charged, and it is green after fully charged.
Attention:
 To ensure enough operation time, please fully charge the battery before measuring.
 Please charge the device under “OFF” state.
6 Maintain, Transport and Storage
6.1Cleaning and disinfection
Do not immerse it into liquid.Use 75% alcohol to wipe the device enclosure and the nail pad, and use liquid soap or
isopropanol to wipe the watchband for disinfection nature dry or clean it with clean and soft cloth. Do not spray any
liquid on the device directly, and avoid liquid penetrating into the device.
Attention:
 Please turn off the device before cleaning.

25
 Do not use strong solvent as acetone.
 Do not use abrasive materials as steel wire or silver polishing agent.
 The water used to clean the device should be below 60 ℃.
 Do not allow any liquid to enter the device, and do not immerse any part of the device into any liquid.
 Do not leave any cleaning solution on the surface of the device.
6.2 Maintenance
A.This device is a sophisticated electronic device, please handle with care. Maintain this device according to the
measures listed below, which will prolong this device life.
B.Check the main unit and all accessories periodically to make sure that there is no visible damage that may affect
patient’s safety and monitoring performance. It is recommended that the device should be inspected weekly at
least. When there is obvious damage, stop using it.
C. Please clean and disinfect the device before/after using it according to the User Manual (6.1).
D.Please charge the battery in time when low battery appears.
E.Recharge the battery soon after over-discharge. The device should be recharged every three months when it is
not used for a long time. It can extend the battery life following this guidance.
F.This product does not need to be calibrated during maintenance.
G.The accuracy of the device is controlled by the equipment, which can not be adjusted by user. If the result is
distrustful, please use other methods to verify immediately or contact local distributor or manufacturer to get help.
6.3 Transport and Storage
A.The packed device can be transported by ordinary conveyance or according to transport contract. During
transportation, avoid strong shock, vibration and splashing with rain or snow, and it can not be transported mixed
with toxic, harmful, corrosive material.
B.The packed device should be stored in room with no corrosive gases and good ventilation.
Attention:
 If the instrument is not used for a long time,it should be kept in the packaging box after cleaning and
disinfection,and placed in a room with no corrosive gas and good ventilation.

26
 7 Troubleshooting
Trouble Possible Reason Solution
1.The finger is not properly inserted. 1.Please insert the finger properly
2.The finger is shaking or the patient is and measure again.
The values can not be moving. 2.Let the patient keep calm.
displayed normally or stably. 3.The device is not used in environment 3.Please use the device in normal
required by the manual. environment.
4.The device works abnormally. 4.Please contact the after-sales.
1.Connection problem. 1. Connect correctly.
The display of nasal airflow
2.Wearing mode problem. 2. Wear in correct mode.
is unstable.
3.The patient is moving. 3. Let the patient keep calm.
The device can not be 1.Low battery or the battery is drained away. 1.Please charge the battery.
turned on. 2.The device works abnormally. 2.Please contact the after-sales.
1.The device enters into the energy saving
1.Normal.
The display disappears mode.
2.Please charge the battery.
suddenly. 2.Low battery.
3.Please contact the after-sales.
3.The device works abnormally.
1.Connect the USB data line
PC can not identify SD card 1. Poor connection of USB interface.
repeatedly.
drive letter. 2.SD card is damaged.
2.Contact local service center.

The device can not be used 1.The battery is not charged fully. 1.Please charge the battery.
for full time after charge. 2.The device works abnormally. 2.Please contact the after-sales.

The battery can not be fully

charged even after 10-hour The device works abnormally. Please contact the after-sales.
charging time.

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8 Symbols
Your device may not contain all the following symbols.

Symbol Meanings Symbol Meanings

%SpO2 Oxygen saturation (unit: %) PRbpm Pulse rate (unit: bpm)

Sound prompt: OFF Fully charged

Sound prompt: ON Two grid of power

Pulse sound: OFF One grid of power

Pulse sound: ON Low battery

Caution: read instructions (warnings)

REC ● Record mark
carefully

Type BF applied part No prompt system

Serial number Manufacturer

Recyclable Use-by date

IP22 Covering Protection rate WEEE disposal

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 Date of manufacture USB

P/N Material code Product code

Not made with natural rubber latex Lot number

European Representative
For indoor use only
in the European community

Temperature limit Class II applied

Atmospheric pressure limit Follow instructions for use

Fragile, handle with care. Humidity limit

Sensor Off The probe is disconnected. This side up.

Sensor Fault Probe failure Keep in a cool, dry place

Medical Device compliant

Finger Out The finger is not inserted.
with Directive 93/42/EEC

Stacking limit by number Medical device

Authorized representative in the European

Unique device identifier
community

29
9 Specification
SpO2 [see note 1]
Display range 0% ~ 99%
Measured range 0% ~ 100%
70%~100%: ±2%;
Accuracy [see note 2]
0%~69%: unspecified
Resolution 1%
PR
Display range 30 bpm ~ 250 bpm
Measured range 30 bpm ~ 250 bpm
±2 bpm during the pulse rate range of 30 bpm ~ 99 bpm and ±2% during the pulse
Accuracy[see note3]
rate range of 100 bpm ~ 250 bpm.
Resolution 1 bpm
Nasal airflow
Measured range 0 bpm～40bpm
Accuracy ±2 bpm
Resolution 1 bpm
Light interference Under normal and ambient light conditions, the SpO2 deviation ≤ 1%
Pulse intensity Continuous bar graph display, the higher display indicates the stronger pulse.
Optical sensor [see note 4]
Red light Wavelength: about 660 nm, optical output power: < 6.65 mW
Infrared light Wavelength: about 905 nm, optical output power: < 6.75 mW
Recording function The continuous recording time of fully charged battery shall not be less then 12

30
 hours.(During normal data storage)
Safety class Internally powered equipment, type BF applied part
International Protection IP22
Working voltage DC3.6 V—4.2 V
Working current ≤100 mA
A rechargeable lithium battery (3.7V) .The red wire on the battery denotes anode,
Power supply
the black wire on the battery denotes cathode.
Battery life Charge and discharge: no less than 500 times.
Output voltage: DC 5V
Adapter specification
Output current: 1000 mA
Dimension and Weight
Dimension 69 mm(L) × 50 mm(W)×17.3 mm(H)
Weight About 100 g (including a lithium battery)
Compatibility Group I,Type B
The degree of safety of
application in the presence Not usable in the presence of flammable gas.
of flammable gas
The mode of operation continuous operation
Display color LCD

Note 1: the claims of SpO2 accuracy shall be supported by clinical study measurements taken over the full range.
By artificial inducing, get the stable oxygen level to the range of 70 % to 100 % SpO2, compare the SpO2 values
collected by the secondary standard pulse oximeter equipment and the tested equipment at the same time, to form
paired data, which are used for the accuracy analysis.(It is applicable for the probes equipped)
There are 12 healthy volunteers (male: 6. female: 6; age: 18~45; skin color: black: 2, light: 8, white: 2) data in the

31
clinical report.
Note 2: Because pulse oximeter equipment measurements are statistically distributed, only about two-thirds of
pulse oximeter equipment measurements can be expected to fall within ±Arms of the value measured by a
CO-OXIMETER.
Note 3:PR accuracy has been verified using signals from the patient simulator .The difference between the
measured PR and the set value of the patient simulator is used to calculate the RMS to indicate the accuracy of
the PR.
Note 4: optical sensors as the light-emitting components, will affect other medical devices applied the wavelength
range. The information may be useful for the clinicians who carry out the optical treatment.For example,
photodynamic therapy operated by clinician.
Appendix 1: EMC
This equipmen is suitable for professional healthcare facility environments and home healthcare environments
Attention :
 The device is subject to special EMC precautions and it must be assemblied and used in accordance with
these guidelines.
 The electromagnetic field can affect the device performance, so other equipment used near the device must
meet the corresponding EMC requirements. Mobile phones, X-rays or MRI devices are possible interference
source, as they can emit high-intensity electromagnetic radiation.
 The use of ACCESSORIES and cables other than those specified, with the exception of cables sold by the
MANUFACTURER of the ME EQUIPMENT or ME SYSTEM as replacement parts for internal components, may
result in increased EMISSIONS or decreased IMMUNITY of the ME EQUIPMENT or ME SYSTEM. Including
but not limited to power cord.
 Devices or systems should not be used adjacent to or stacked with other equipment and that if adjacent or
stacked use is necessary, it should be observed to verify normal operation in the configuration in which it will be
used.
 Devices or systems may still be interfered by other equipment, even if other equipment meets the
requirements of the corresponding national standard.
 Accessories must be used to ensure compliance with interference radiation and immunity stands
 Don’t near active HF SURGICAL EQUIPMENT and the RF shielded room of an ME SYSTEM for magnetic

32
 resonance imaging, where the intensity of EM DISTURBANCES is high.
Note：
 This equipment needs special precautions regarding EMC and needs to be assemblied and put into service
according to the EMC information provided below.
 The basic performance:. SpO2 measured range: 70% ~ 100%, absolute error: ±2%; PR measured range: 30
bpm ~ 250 bpm, accuracy:±2 bpm during the pulse rate range of 30 bpm ~ 99 bpm and ±2% during the pulse
rate range of 100 bpm ~ 250 bpm.Nasal airflow measured range: 0 bpm～40bpm，accuracy:±2 bpm;
 When the device is disturbed, the data measured may fluctuate, please measure repeatedly or in another
environment to ensure its accuracy.
 Other devices may affect this device even though they meet the requirements of CISPR.

Product configuration
Serial number name Cable length
1 SpO2 probe 0.35m
2 USB cable 1m

Table 1
Guidance and Declaration - Electromagnetic Emissions
Emissions test Compliance
Conducted and radiated RF
Group 1
EMISSIONS CISPR 11
Conducted and radiated RF
Class B
EMISSIONS CISPR 11
Harmonic distortion IEC 61000-3-2 Class A
Voltage fluctuations
Complies
and flicker IEC 61000-3-3

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 Table 2
Guidance and Declaration - Electromagnetic Immunity
IEC 60601
Immunity Test Compliance level
Test level
Electrostatic discharge (ESD) ±8 kV contact ±8 kV contact
IEC 61000-4-2 ±15 kV air ±15 kV air
Electrical fast ±2 kV for power
transient/burst supply lines ±2 kV for power supply lines
IEC 61000-4-4 ±1 kV for input/ output lines
Surge ±1 kV line(s) to line(s) ±1 kV line(s) to line(s)
IEC 61000-4-5: ±2 kV line(s) to earth ±2 kV line(s) to earth
0 % UT; 0 % UT;
0,5 .cycle .At0°,45°,90°,135°,180°,225°, 0,5 .cycle .At0°,45°,90°,135°,180
Voltage dips and 270°and315°. °,225°,270°and315°.
Voltage interruptions 0 % UT; 1 cycle and 0 % UT; 1 cycle and
IEC 61000-4-11 70 % UT ; 25/30 70 % UT ; 25/30
cycles ;Single phase:at 0°. cycles ;Single phase:at 0°.
0 % UT ; 250/300 cycle 0 % UT ; 250/300 cycle
Power frequency
30 A/m 30 A/m
(50/60Hz) magnetic field
50Hz/60Hz 50Hz/60Hz
IEC 61000-4-8
3V 3V
0,15MHz - 80 MHz 0,15MHz - 80 MHz
Conduced RF 6 V in ISM and amateur radio bands 6 V in ISM and amateur radio
IEC61000-4-6 between bands between
0,15MHz to 80 MHz 0,15MHz to 80 MHz
80%AM at 1kHz 80%AM at 1kHz

34
 10V/m 10V/m
Radiated RF
80 MHz-2,7GHz 80 MHz-2,7GHz
IEC61000-4-3
80%AM at 1kHz 80%AM at 1kHz
NOTE UT is the a.c.mains voltage prior to application of the test level

Table 3
Guidance and manufacturer’s declaration - electromagnetic Immunity
Test IEC60601-1-2 Complian
Band
Frequency Service Modulation Test level ce level
(MHz)
(MHz) (V/m) (V/m)
Pulse
385 380 –390 TETRA 400 modulation b) 18 27 27
Hz
Radiated RF FM c)
GMRS 460,
IEC61000-4-3 450 430-470 ± 5 kHz deviation 28 28
FRS 460
(Test specifications 1 kHz sine
for ENCLOSURE 710 Pulse 9
PORT IMMUNITY to LTE Band 13, 9
745 704 – 787 modulation b)217
RF wireless 17
780 Hz
communications
equipment) 810 GSM 800/900,
870 TETRA 800, Pulse 28
28
800 – 960 iDEN 820, modulation b)18
930 CDMA 850, Hz
LTE Band 5
1720 1700 – GSM 1800; Pulse 28 28
1845 1990 CDMA 1900; modulation b)217

35
 GSM 1900; Hz
DECT;
1970
LTE Band 1, 3,
4, 25; UMTS
Bluetooth,
WLAN, Pulse
2400 –
2450 802.11 b/g/n, modulation b)217 28 28
2570
RFID 2450, Hz
LTE Band 7
5240 Pulse
5100 – WLAN 802.11
5500 modulation b)217 9 9
5800 a/n
5785 Hz

Disposal: The product must not be disposed of along with other domestic waste. The users must dispose of this equipment by
bringing it to a specific recycling point for electric and electronic equipment

GIMA WARRANTY TERMS

The Gima 12-month standard B2B warranty applies

36