10 Working Instruction PDF
10 Working Instruction PDF
USER GUIDE
Crono
USER GUIDE
TABLE OF CONTENTS
SECTION 1
Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 7
Note . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 7
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 7
User assistance information . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 7
SECTION 2
Pump description. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 8
Factory settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 8
Technical features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 9
SECTION 3
Standard equipment supplied . . . . . . . . . . . . . . . . . . . . . . . . . . page 10
Optional accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 11
SECTION 4
How to use standard equipment supplied . . . . . . . . . . . . . . . . . page 12
How to wear the pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 13
SECTION 5
Pump parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 14
Liquid Crystal Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 15
Main screen indications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 16
SECTION 6
Syringe parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 17
Luer Lock Cap functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 17
Infusion set . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 18
Infusion set parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 18
Infusion sites . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 19
Infusion preparation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 19
Syringe preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 20
Connection of the syringe to the pump . . . . . . . . . . . . . . . . . . . . page 21
SECTION 7
Working instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 22
Pump activation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 23
SECTION 8
Programming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 25
5 MAN 01/C/05
TABLE OF CONTENTS
SECTION 9
Switching on the device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 27
Priming the infusion set. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 27
End of infusion. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 28
Storing data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 28
Switch off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 28
Reading the number of infusions . . . . . . . . . . . . . . . . . . . . . . page 28
Re-setting the number of infusion . . . . . . . . . . . . . . . . . . . . . . . . page 29
Reversal of pump piston . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 30
Piston movements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 30
Infusion set occlusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 30
Tamper resistant feature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 31
SECTION 10
Low battery alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 33
Battery replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 33
SECTION 11
Cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 35
Maintenance and cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 36
Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 36
SECTION 12
User Assistance information . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 37
Manufacturer’s guarantee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 37
SECTION 13
Alarm messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 39
Summary of functions and buttons . . . . . . . . . . . . . . . . . . . . . . . page 40
SECTION 14
Pump icon table. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 41
Syringe blister icon table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 42
SECTION 15
A glossary of terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 44
SECTION 16
Index of illustrations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 46
MAN 01/C/05
6
SECTION 1
FOREWORD
CAUTION: US Federal law restricts this device for sale by or on order of
a physician.
This manual is written with the aim of informing the user of this pump. The
instructions and details given here are fundamental for the correct and
safe use of this device.
Please take time to read all the information before using the pump and
moreover keep this guide in a safe place for future reference.
NOTE
The manufacturer only considers itself responsible for the safety and relia-
ble working of this pump, provided that it is used in accordance with the
current instructions for use.
The manufacturer declines all responsibility towards the purchaser and
any third party for any damage to the pump caused by tampering, impro-
per use, modifications and/or reparations by unauthorised personnel.
INTENDED USE
The ambulatory infusion pump Crono has been designed for subcuta-
neous drug infusions. Canè S.r.l. declines all responsibility for the admini-
stration of drugs and solutions and/or methods of drug infusions other than
those described in this manual.
UNITED STATES:
INTRA PUMP INFUSION SYSTEMS
920 Minters Chapel Road, Suite 200
Grapevine, Texas 76051
Tel: 866-211-7867
Fax: 630-845-2768
Email: info@intrapump.com
7 MAN 01/C/05
SECTION 2
PUMP DESCRIPTION
Canè S.r.l. - a company specialized in the production of ambulatory
pumps since 1972 - has developed a new generation of compact pumps:
Crono which is a perfect combination of high technology and innovative
design.
Infusion pumps using normal commercial syringes are bulky and cumber-
some and thus difficult to use in the true sense of "ambulatory". This can
have a negative impact on patient compliance and treatment goals.
FACTORY SETTINGS
The following features were set at the factory but can be re-programmed:
Syringe size 20 ml
Audible signal for end infusion AL.0 (Non active)
Delivery time 10 hours
Key-pad lock level Lo,0 (key-pad unlocked)
Number of infusions 0
MAN 01/C/05
8
TECHNICAL FEATURES
9 MAN 01/C/05
SECTION 3
6 4
5
7
MAN 01/C/05
10
OPTIONAL ACCESSORIES
Fig.2
11 MAN 01/C/05
SECTION 4
Fig.3
How to attach collar strap to the
pump and the fabric holder
10
20 ml
Fig.4
How to use elastic belt with
pump and fabric holder
MAN 01/C/05
12
HOW TO WEAR THE PUMP
The following pictures show the different ways the pump can be worn.
13 MAN 01/C/05
SECTION 5
PUMP PARTS
Fig.7 Syringe fin hook
Display
Collar strap
locking rings
Button + Button
- Button
d
Serial number
Brief
instructions
MAN 01/C/05
14
LIQUID CRYSTAL DISPLAY
This is a screen on the front of the pump displaying symbols which inform
the patient of operations in progress as well as showing warnings and
alarm messages.
10
20
10
“Battery” symbol: appears when the battery is nearly expired (see
20 the related paragraph, page 30)
20 “20 ml” symbol: indicates the device has been programmed to use
20 ml (CRN 20) syringe
15 MAN 01/C/05
SECTION 6
DELIVERY TIME
10
20
10
20
PARTIAL VOLUME
10
20
OFF INDICATION
20 ML SYRINGE SELECTED
10
20
20
ERROR MESSAGE
10
20
OCCLUSION
10
20
20
END OF INFUSION
10
20
LOW BATTERY
10
20
BATTERY DISCHARGED
10
20
20
KEY-PAD UNLOCKED
10
20
10
20
KEY-PAD LOCKED: LEVEL 1
10
20
KEY-PAD LOCK SETTING
MAN 01/C/05
16
SYRINGE PARTS
The Crono pump uses dedicated syringes which are available in two sizes:
• CRN® 10 ml CRONO® Syringe
• CRN® 20 ml CRONO® Syringe
Fig.8
Syringe structure
20ml
Needle
10
Plunger
Needle’s cap
Plunger Rod
Luer-lock cap
with ease.
• To protect the drug in the syringe if infusion is not
imminent.
Luer-Lock cap
17 MAN 01/C/05
INFUSION SET
It is advisable to use infusion sets which have the following specification:
• Tube with internal diameter of limited dimensions (optimum 0.36 mm,
maximum 0.6 mm);
• Length of the tube not exceeding 90 cm;
• Tube with dead space lower than 0.5 ml;
• Anti-kink tube.
Female
Needle
Luer lock
Tube
MAN 01/C/05
18
INFUSION SITES
Fig.11
Infusion sites can be any of the following:
INFUSION PREPARATION
min
h
OFF
d
O
CRON
OJET
ml MICR
0.2
19 MAN 01/C/05
SYRINGE PREPARATION
1.Put the supplied needle on the syringe with a clockwise rotation.
2.Fill up the syringe, aspirating the drug slowly to avoid disconnection be-
tween the rubber plunger and plunger rod. Verify the drug inside does
not exeed 10 or 20 ml capacity.
5.Insert the syringe into the instrument with a 90° rotation, making sure to
detect a “click” which indicates the syringes is locked into the pump.
MAN 01/C/05
20
SYRINGE PREPARATION
Fig.12
1 2 3 4 5
10
20 ml
10
10
20 ml
20 ml
10
10
20 ml
20 ml
min
h
min
OFF
h
d
O OFF
R ON d
TC
JE O
RO R ON
0.2
ml
MIC TC
JE
RO
0.2
ml
MIC
Top view
21 MAN 01/C/05
SECTION 7
WORKING INSTRUCTIONS
• Press the buttons with your finger-tips only, do not use sharp or poin-
ted objects.
min min
h h
OFF
OFF
Fig.14
d O d
ON
CR NO
T
OJE
RO
R TC
l MIC JE
0.2
m
RO
ml MIC
0.2
MAN 01/C/05
22
PUMP ACTIVATION
During the device activation phase it is possible to select the fol-
lowing parameters:
• Syringe size (10 ml or 20 ml)
• End of infusion audible signal (ON or OFF)
The syringe size and the end of infusion signal can only be
selected and/or changed immediately after battery insertion.
Device activation:
2. The pump will carry out a self-test, during which the display 10
10 ml syringe 20 ml syringe
10 10
20 20
+
-
10 10
20 20
10 10
20 20
20
20
20
Fig.15
20 20 ml
20 ml
10
20 ml syringe
10 10 ml
10ml
5
10 ml syringe
MAN 01/C/05
24
SECTION 8
PROGRAMMING
• Delivery time
• Partial volume
25 MAN 01/C/05
PROGRAMMING PARTIAL SYRINGE VOLUME
If the therapy requires the use of a partially filled syringe, the
infusion starting point of the pump piston can be stored into
the pump’s memory.
Proceed as follows:
20
infused.
20
20
stored volume
4. At the end of the infusion the pump piston will return to the
stored position.
10
20
6. Any time the pump is switched on, the screen will display
the cc stored volume.
10
20
MAN 01/C/05
26
SECTION 9
20
• The instrument will emit a brief sound and show the delivery 10
20
Any time you press this button the pump piston moves forward
with increments of 0.45 mm corresponding to 0.2 ml.
WARNING
Make sure the infusion set is not connected to the patient
during priming!
27 MAN 01/C/05
END OF INFUSION
20
END.
The pump piston will automatically return to its starting posi- 10
STORING DATA
Information regarding syringe size, delivery time and number of infusions
already administered will be automatically stored in the memory. Stored
data are not lost even when battery is removed.
SWITCH OFF
20
stered.
MAN 01/C/05
28
RE-SETTING THE NUMBER OF INFUSIONS
As each infusion is finished a record of this is automatically
kept by the pump, even if the battery is removed.
Instructions on how to retrieve this information is on page 28.
1. With the pump switched OFF, press the button until the
10
20
correctly.
20
incorrectly
29 MAN 01/C/05
REVERSAL OF PUMP PISTON
1. Total reversal
It is possible to interrupt the infusion already in progress and
make the pump piston return to its starting position. Proceed in
the following way:
simultaneously.
20
20
20
PISTON MOVEMENTS
When the pump piston has to move either backwards or for-
wards you will read a symbol on the display indicating this.
10
20
20
MAN 01/C/05
30
pump resumes regular delivery, the screen will alternate the occlusion
warning message with the information regarding the delivery time.
First of all, “Lo,0” message on the screen means that the pump
is in normal, unlocked mode. “Lo,1” means that the pump is
locked.
10
20
20
20
31 MAN 01/C/05
9. The pump will resume operation in lock mode.
10
20
20
20
MAN 01/C/05
32
SECTION 10
20
soon as possible.
If the battery is not replaced soon after the screen warning, a
subsequent infusion could be interrupted.
20
BATTERY REPLACEMENT
1. Open the battery compartment using the battery tool or a paper clip.
2. Pull out the cover.
3. Use the small ribbon strap (which lies under the battery) to facilitate the
removal of the battery.
4. Remove the discharged battery and discard it properly.
5. Insert the new battery checking that it is correctly placed in accordance
with polarity and that the ribbon strap is under the battery.
6. After having installed the battery, close the cover.
If the battery cannot be removed by pulling the strap, do not try to lever
with an object or tool. Take the pump firmly in one hand and, as gently as
possible, shake the battery out onto your other hand.
33 MAN 01/C/05
BATTERY REPLACEMENT
Fig.16
PID
PID
CRONO
CRONO
CR
CROONNO
O PI
PIDD
1 2
3 4
5 6
MAN 01/C/05
34
SECTION 11
CAUTIONS
• Use only a lithium 3 Volt CR 123 A battery.
• Batteries other than this type may cause the pump to malfunction.
• Under average operating conditions, each battery should last about 150
infusions. Keep a spare battery in a convenient place.
• If the pump is not used for long periods of time, it highly recommended
to remove the battery from the pump.
• Remove the pump before taking a bath or shower: the pump may be
damaged upon contact with water. Should the pump accidentally come
into contact with any liquid (drug solution, sweat, bed wetting) the
pump must be checked by the manufacturer or a qualified personnel
authorised by the manufacturer.
• If you suspect that liquid has penetrated into the pump (a leakage or
spill), please contact the appropriate person within your specialist health
care team or your authorized distributor for advice.
• Syringes, infusion set, needles, and all material used during the infusion
process must be discarded properly.
35 MAN 01/C/05
MAINTENANCE AND CLEANING
The Crono pump requires no particular maintenance operation, owing to
its technical features.
To clean the instrument, use a soft cloth slightly moistened with a mild
detergent.
In the event the instrument becomes wet, absorb the liquid with blotting-
paper.
STORAGE
If the pump is not going to be used for a long period of time (more than 1
or 2 months), it is advisable to remove the battery, put it inside the device
case and store it in a dry place.
MAN 01/C/05
36
SECTION 12
UNITED STATES:
INTRA PUMP INFUSION SYSTEMS
920 Minters Chapel Road, Suite 200
Grapevine, Texas 76051
Tel: 866-211-7867
Fax: 630-845-2768
Email: info@intrapump.com
MANUFACTURER’S GUARANTEE
With this consumer guarantee, Canè S.r.l. guarantees that this product
is free from defects in materials and workmanship for a period of 2
(TWO) YEARS beginning from the date of purchase.
Canè S.r.l. reserves the right to modify the characteristics or the model
of the pump and accessories without obligation to make similar modifi-
cations to pumps and accessories previously manufactured or sold.
Conditions:
1. This guarantee will be granted only if the defect is brought to the
attention of Canè S.r.l.
2. This guarantee will not be in effect if the pump and accessories have
37 MAN 01/C/05
been damaged as a result of modifications or adjustments made
without prior written consent from Canè S.r.l.
3. This guarantee will not apply if the type or serial number on the product
has been altered, deleted, removed or made illegible.
5. Once the warranty period has expired, Canè S.r.l. will provide the
service debiting the costs of components being replaced, expenses of
labour charges and freight charges.
MAN 01/C/05
38
SECTION 13
ALARM MESSAGE
ALARM MESSAGE DESCRIPTION ACTION
20
+
20
+
20
+
20
OCCLUSION
PRESS
+
10
20
BUTTON
20 (EEPROM)
20 PILOTING CIRCUIT
Please note: if your pump shows Err8, and you subsequently re-start
*
it, the programmed settings will revert to the factory settings (see
page 8). Therefore, whenever this condition takes place, you must re-
program the settings assigned by your doctor or PD nurse.
39 MAN 01/C/05
SUMMARY OF FUNCTIONS AND BUTTONS
The follow brief instructions are by no means an alternative to reading the information supplied in this
manual. The following tables are both a concise and quick reference with regard to pump use and its
buttons.
Time control buttons: the buttons must be pressed for a few seconds if a command is to be carried
out. This ensures that if the patient accidentally touches a button, no commands will be activiated.
BUTTONS PUMP ACTIVATION / SYRINGE SIZES AND END INFUSION SIGNAL SCREEN
The syringe sizes and the end infusion signal can only be selec-
ted and/or changed immediately following the battery insertion.
10
20
- +
• Syringes Size setting (10 / 20 ml)
/
10 10
20 20
20 20
• Piston self-adjust
10
20
20
20
10
20
10
20
depress simultaneously
-
depress simultaneously
20
PUMP ON
+ • Pump switches ON
20
20
20
depress simultaneously
PUMP OFF
20
depress simultaneously
• End of infusion
10
END OF INFUSION
20
20
20
MAN 01/C/05
40
SECTION 14
Drip-proof instrument
It can withstand occasional liquid dripping or splashing.
It must not be immersed in liquid.
Electromedical equipment
BF type
41 MAN 01/C/05
SYRINGE BLISTER PACKAGE ICON TABLE
0123 CE mark
Recycle
Expiration date
PP Polypropylene
REF
Ref number
NEEDLE
Needle dimensions
MAN 01/C/05
42
SECTION 15
A GLOSSARY OF TERMS
Alarm
An alarm is a condition that warrants the user’s attention, and is critical
enough that it requires that the pump be shut down or reset.
When an alarm occurs, an alarm beep is sounded and a descriptive mes-
sage appears on the display screen.
Display screen
The pump’s liquid crystal display screen is located on the front panel of the
pump, providing the information about the functioning of the pump.
Infusion set
An infusion set consists of a length of thin plastic tubing with a luer lock
connector at one end. At the other end, there is a very small needle that is
placed under the skin. The infusion set is connected to the pump and used
to deliver drugs, in fluid form, to the body.
Infusion site
The infusion site is the place on the body where the infusion set needle is
inserted under the skin.
Luer-lock connector
A luer-lock connector is a special threaded fitting used to connect the infu-
sion set to the syringe.
Occlusion
Occlusion means “blockage”. The pump is designed to be able to sense
when delivery of the drug is being blocked for some reason. The pump will
automatically stop delivering drug and sound an alarm to alert you to clear
the occlusion and restart the pump.
43 MAN 01/C/05
Subcutaneous
Subcutaneous means beneath the skin. The infusion set needle is pla-
ced subcutaneously.
Syringe pump
Pump intended for controlled infusion of liquids into the patient by a
syringe, and in which the delivery time is set by the operator.
MAN 01/C/05
44
SECTION 16
INDEX OF ILLUSTRATIONS
45 MAN 01/C/05