Cane Crono User guide

Crono PAR 50
Ambulatory infusion pump
USER GUIDE
Canè S.p.A. Medical Technology
Via Cuorgnè 42/a 10098 Rivoli (TO) Italy
Tel.+39 011 9574872 - Fax +39 011 9598880
www.canespa.it - mailbox@canespa.it
Manual code: MAN 01/EN/03 CRONO PAR 50
Publication date: 06/13
3
CONTENTS
SECTION 1
Symbols and conventions................................................. Page 8
SECTION 2
Introduction........................................................................ Page 9
WARNING: PRECAUTIONS FOR USE............................ Page 10
Information........................................................................ Page 10
SECTION 3
Intended use...................................................................... Page 11
Pump description............................................................... Page 13
Technical characteristics................................................... Page 14
SECTION 4
Supplied standard equipment............................................ Page 16
SECTION 5
Pump parts........................................................................ LED................................................................................... Control buttons.................................................................. Liquid Crystal Display (LCD)............................................. Low battery alert................................................................ Battery replacement.......................................................... Page 17
Page 18
Page 18
Page 19
Page 21
Page 21
SECTION 6
Settings lock...................................................................... Page 25
SECTION 7
Errors and anomalies........................................................ Page 26
Infusion set occlusion........................................................ Page 29
Post-occlusion bolus......................................................... Page 29
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MAN 01/EN/03 CRONO PAR 50 06/13
SECTION 8
Pump initialisation............................................................. Page 30
CONTENTS
Selecting the pump mode.................................................. Page 30
SECTION 9
Selected pump mode: FrEE.............................................. Page 32
Factory settings................................................................. Page 32
SECTION 10
Quick reference FrEE........................................................ Page 33
SECTION 11
Pump settings sequence with the pump set to OFF or StoP.... Setting the bolus dose volume.......................................... Setting the interval between bolus doses.......................... Setting the first flow rate (F1)............................................ Setting the second and third flow rates (F2 and F3)......... Setting the partial volume.................................................. Switching on the pump...................................................... Priming the infusion line.................................................... Pump switched on............................................................. Selecting the flow rate....................................................... Bolus dose......................................................................... Restrictions on the administration of bolus doses............. Displaying the number of administered bolus doses
during an infusion and the number of infusions................. Withdrawing the pusher..................................................... Switching off the pump ..................................................... Page 38
Page 38
Page 39
Page 40
Page 41
Page 42
Page 44
Page 45
Page 47
Page 48
Page 49
Page 50
Page 50
Page 51
Page 52
SECTION 12
Selected pump mode: Auto.............................................. Page 53
Factory settings................................................................. Page 53
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MAN 01/EN/03 CRONO PAR 50 06/13
SECTION 13
Quick reference Auto........................................................ Page 54
SECTION 14
Pump settings sequence................................................... Setting the time................................................................. Setting the bolus dose volume.......................................... Setting the interval between bolus doses.......................... Setting the first flow rate (F1)............................................ Setting the second and third flow rates (F2 and F3)......... Assigning the flows over the daily 24-hour period............. Setting the partial volume.................................................. Switching on the pump...................................................... Priming the infusion line.................................................... Pump switched on............................................................. Bolus dose......................................................................... Restrictions on the administration of bolus doses............. Displaying the number of administered bolus doses during
an infusion and the number of infusions............................ Withdrawing the pusher..................................................... Switching off the pump...................................................... Displaying the settings...................................................... SECTION 15
Reservoir parts.................................................................. Luer-Lock cap functions.................................................... Infusion set........................................................................ Infusion set parts............................................................... Filtrajet............................................................................... Preparing the reservoir and connecting to the pump........ Connection of the reservoir to the pump........................... Infusion sites..................................................................... Preparing for the infusion.................................................. Page 59
Page 61
Page 62
Page 63
Page 64
Page 65
Page 66
Page 67
Page 69
Page 70
Page 72
Page 72
Page 73
Page 73
Page 74
Page 75
Page 76
Page 77
Page 78
Page 79
Page 79
Page 79
Page 80
Page 81
Page 83
Page 83
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MAN 01/EN/03 CRONO PAR 50 06/13
SECTION 16
How to use the supplied standard equipment................... Page 86
Fastening the pump collar strap........................................ Page 86
SECTION 17
GENERAL WARNINGS..................................................... Manual updates................................................................. Maintenance...................................................................... Storage.............................................................................. Disposal............................................................................. Expected pump life............................................................ Support ............................................................................. Guarantee ........................................................................ Declaration of conformity................................................... Page 88
Page 89
Page 89
Page 89
Page 90
Page 90
Page 90
Page 91
Page 93
APPENDICES
Appendix 1........................................................................ Appendix 2........................................................................ Appendix 3........................................................................ Appendix 4........................................................................ Appendix 5........................................................................ Appendix 6........................................................................ Appendix 7........................................................................ Appendix 8........................................................................ Appendix 9........................................................................ Appendix 10...................................................................... Appendix 11....................................................................... Page 95
Page 97
Page 99
Page 102
Page 103
Page 104
Page 105
Page 107
Page 110
Page 111
Page 113
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MAN 01/EN/03 CRONO PAR 50 06/13
SECTION 1
SYMBOLS AND CONVENTIONS
To assist you in using the manual, the following symbols and conventions have been used:
Triangle containing an exclamation mark
This “Warning” icon indicates something that must always be taken
into consideration for the safe use of the pump.
Notepad
This icon indicates a “Note” containing additional information or useful
tips about the use of the pump.
Flashing symbol
The graphic symbol
shown in the manual above the pictures of the pump
display, indicates that the number or the character below it is flashing.
This manual is divided into 6 parts:
Part 1 (red): sections 1 to 8, general information, technical specifications and
warnings.
Part 2 (blue): sections 9 to 11, describing the working of the pump when FrEE
mode has been selected.
Part 3 (green): sections 12 to 14, describing the working of the pump when
Auto mode has been selected.
Part 4 (orange): section 15, which describes the reservoir, the preparation and
connection of the reservoir to the pump, the infusion sites and the preparation
for an infusion.
Part 5 (purple): sections 16 and 17, giving general warnings and a description
of the supplied standard equipment, as well as discussing maintenance, disposal and support. It also details the guarantee and the declaration of conformity.
Part 6 (grey): appendices page 95 to page 114.
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MAN 01/EN/03 CRONO PAR 50 06/13
SECTION 2
INTRODUCTION
Thank you for choosing the CRONO PAR 50 ambulatory infusion pump.
If any of the information is not clear, or if you have any doubts or questions,
please contact the Customer Support Service of CANè S.p.A.
Incorrect use of the pump, or failure to follow the instructions and warnings
provided in this manual could cause serious injury.
The instructions provided relate exclusively to the ambulatory infusion pump,
model CRONO PAR 50. They are intended for use by the medical and paramedical personnel who need to set up the pump initially and subsequently
by patients who are capable of managing their treatment autonomously, or
persons who are caring for patients.
The pump offers two different programming modes:
- one called FrEE, that allows the patient to freely select, during the day, one
of the 3 available flow rates pre-programmed by the doctor;
- one called Auto, that administers different flows pre-programmed by the
doctor, automatically switching among them over the daily 24 hours.
The pump has a settings lock system (see page 25) which stops the settings
from being modified by accident: the purpose of the settings lock function is
to prevent accidental changes to the settings.
The CRONO PAR 50 pump allows the medical/paramedical and clinical engineering personnel, as well as the distributor, to set, if needed, the occlusion
pressure level (PL).
Information on the selection of the pressure level (PL) is available in APPENDIX 10 “ACCESSING RESERVED SECTION”, together with instructions for
resetting the infusion counter and programming the time and date; it is possible
to remove this information from the manual (see page 111 and 112), as this
information should not be disclosed to the patient.
The instructions provided in this manual are essential for the safe and correct
use of the pump. You are advised to read the whole manual before starting to
use the device and to refer the manual for future reference.
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MAN 01/EN/03 CRONO PAR 50 06/13
SECTION 2
The pump does not need to be installed, tested and/or activated.
Canè S.p.A. reserves the right to modify the hardware and software specifications described in this manual at any time and without notice.
NOTES
• In order to make this manual as complete and accurate as possible,
please report any errors or omissions to the following e-mail address:
service@canespa.it.
• Canè S.p.A. reserves the right to modify and/or update this manual at any
time and without notice.
WARNING: PRECAUTIONS FOR USE
This pump should not be used autonomously by patients who are not
able to follow and understand the instructions supplied in this manual
or able to perform the basic operations and the regular maintenance of
the pump.
INFORMATION
For further information on the CRONO PAR 50 pump, contact:
Servizio Assistenza Clienti (Customer Support Service)
Canè S.p.A. Medical Technology
Via Cuorgnè, 42/a
10098 Rivoli (Turin) - Italy
Tel. +39.011.9574872
Fax +39.011.9598880
Internet: www.canespa.it e-mail: service@canespa.it
Service available Monday to Friday from 8.30 to 17.00.
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SECTION 3
INTENDED USE
The CRONO PAR 50 ambulatory infusion pump is designed for the subcutaneous infusion of apomorphine in the treatment of Parkinson’s disease.
Canè S.p.A. disclaims all responsibility for the administration of drugs by
other methods and for different therapies.
NOTE
The manufacturer holds itself responsible for the safety of patients and the
correct functioning of the device provided that it is used in accordance with
these instructions, and that any required repairs and/or modifications are carried out exclusively by the said manufacturer.
WARNINGS
The use of incorrect settings and/or incomplete understanding of the operational functions and of the alarms could cause serious harm to the patient.
The clock (hours and minutes) must be correctly set when the pump is in Auto
mode, as the administration of the different flows is directly correlated to the
daily 24 hours.
You are recommended to check the time displayed before every infusion.
It is further recommended to reset the clock at the beginning and end of Daylight
Saving Time (Summer Time) and when changing time zone.
Before using the pump, evaluate whether its use is appropriate for the need
and for the patient, paying close attention to the following aspects:
- the technical specifications of the pump;
- the infusion sets which will be used;
- whether you will be using multiple tube sets and clamps in the infusion line;
- The cognitive and psycho-physical condition of the patient.
With respect to the clinical procedural aspects, which are the responsibility
of medical or paramedical personnel, the above list is supplied for example
purposes only and is not exhaustive.
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MAN 01/EN/03 CRONO PAR 50 06/13
SECTION 3
The device must be used:
- under medical supervision,
-with appropriate procedures and adequate measures when dealing with
patients who could suffer serious consequences (injury or death) in the event
of accidents and/or breakdowns which cause an interruption of the administration of the drug.
Do not prime the infusion line when it is connected to the patient, because
this could cause an overdose of the drug.
Before beginning an infusion, inspect the infusion line to ensure there are no
folds, clamps or other occlusions in the line, and expel any air bubbles.
The level of precision and the amount of time needed to detect an occlusion
could differ from the values indicated in this User Guide for the elements
composing the infusion line.
If you have any suspicion that the pump has been in any way damaged, for
example by liquid penetration or having been dropped, contact the Customer
Support Service to check that the pump is functioning correctly. Do not use a
damaged pump.
If you have any doubts about the functioning of the pump and/or an error or
anomaly occurs, stop using the device and contact the Customer Support
Service.
Canè S.p.A. does not supply a replacement service for the pump during
the period needed for any repairs; such a service should be supplied by the
relevant medical structure or the local distributor.
Any liquid on the pump casing must be removed immediately with paper
towels.
It is important to establish a procedure and/or alternative to pumped infusion,
in case the pump malfunctions. Possible solutions could either be to have a
secondary pump or to have an alternative system.
It is recommended that the individuals who assist and/or live with the pump
user know how the pump works and the information in this User Guide.
It is important to stop using the device after the indicated service life has expired and follow the instructions for its correct disposal.
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SECTION 3
PUMP DESCRIPTION
CRONO PAR 50 is an ambulatory infusion pump which uses single-use
reservoirs for the controlled subcutaneous administration of drugs containing
apomorphine as the active ingredient, in the treatment of Parkinson’s disease.
CRONO PAR 50 uses specific 50 ml syringes called reservoirs.
Its smaller size and reduced weight make CRONO PAR 50 ideal for home use,
thus giving the patient the freedom to engage in everyday activities during the
treatment.
The technical characteristics of the pump are:
- the possibility of selecting two different modes of operation of the device, one
of which has base-level functions - FrEE - while the other has more advanced
functions for patients with greater therapeutic demands - Auto;
-a clock which allows administering different flow rates over a daily 24-hour
period;
-twin microcontrollers making the device safer and more reliable;
The pusher mechanism acts directly on the piston of the reservoir, allowing
the pump to administer the drug accurately.
For a better absorption of the drug, the pump administers 20 µl shots at intervals which depend on the flow rate chosen. If the programmed flow rate is
increased, the time interval between the shots decreases proportionally.
CRONO PAR 50 has a liquid crystal display (LCD) which shows practical
information to the doctor and patient about the settings, operations and
diagnostics of the pump.
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SECTION 3
TECHNICAL CHARACTERISTICS
Pump dimensions
Weight
Battery
Single-use reservoir
Volumes that can be
administered
Flow rates in FrEE mode
(F1, F2, F3)
Selectable flow rates in
FrEE mode
Flow rates in Auto mode
(F1, F2, F3)
Selectable flow rates in
Auto mode
Bolus dose volume
Interval between bolus doses
3.31 x 2.17 x 1.65 in (84 x 55 x 42 mm).
4.47 oz. (139 g), including battery.
Lithium CR 123A 3V
(battery life of about 100 infusions).
With a 50 ml capacity and a “Luer-Lock”
universal security attachment.
Selectable, from 1 to 50 ml in 1 ml
increments.
Programmable from:
• 0.05 ml/h to 1.00 ml/h in 0.01 ml/h
increments
• 1.00 ml/h to 3.00 ml/h in 0.02 ml/h
increments;
• 3.00 ml/h to 5,00 ml/h in 0.05 ml/h
increments;
• F2 and F3 may also be programmed
to 0.00 ml/h or to oFF (flow rate display
disabled).
3, all programmable.
Programmable from:
• 0.05 ml/h to 1.00 ml/h in 0.01 ml/h
increments;
• 1.00 ml/h to 3.00 ml/h in 0.02 ml/h
increments;
• 3.00 ml/h to 5.00 ml/h in 0.05 ml/h
increments;
4, of which 3 are programmable and 1
is fixed at 0 ml/h.
Programmable from 0.00 to 2.00 ml in
0.020 ml increments.
Programmable from:
• 5 minutes to 1 hour in 5 minute increments;
• 1 hour to 24 hours in 15 minutes increments.
It is possible to disable this function by
setting no,Lt (see page 50 and 73).
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SECTION 3
Flow rate precision
Occlusion pressure
Time needed to signal an
occlusion
Post-occlusion bolus
Electronic circuit
Settings memory
Display
Motor
Settings lock
Safety circuit
Ingress protection rating
Pump operating conditions
Pump storage conditions
+/-3%.
3 selectable values; for further information see APPENDICES 4-6. The
pump is set to PL2 (2.2 bar +/-1).
See Appendix 4.
About 1.2 ml (in PL2 mode).
Managed by twin microcontrollers
with dedicated software.
All settings are automatically entered in a flash memory which is retained even if the device is left without
a battery.
Liquid crystal display (LCD)
(dimensions 0.43 x 1.1 in 1.1 x 2.8
cm;).
Coreless DC motor.
The microcontroller controls the
rotation speed using an infrared
encoder.
Two selectable levels.
Checks that the device is functioning correctly, intervening in the
event of any anomaly with acoustic signals and messages on the
display.
IP 42
+10°C / +45°C.
30% / 75% RH.
700 hPa / 1060 hPa.
-10°C / +60°C.
10% / 85% RH.
500 hPa / 1060 hPa.
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SECTION 4
SUPPLIED STANDARD EQUIPMENT
1. Ambulatory infusion pump with reservoir CRONO PAR 50.
2. Infuser carry-case (Code: VAL/04).
3. Elastic belt (Code: CM/01).
4. Collar strap (Code: CM/18D).
5. Fabric case (Code: CM/06).
6. 2 batteries (one of which is already inserted in the pump) (Code: CR/123A).
7. 1 User Guide.
8. Battery-cover opening tool (Code: CA/02).
2
7
3
6
5
8
4
1
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SECTION 5
PUMP PARTS
Attachment for the reservoir wings
Support cord
attachment
eyelets
LED
Display
Buttons
Pusher
Anti-slip
grooves
Battery
compartment
Serial no.
Quick reference
CE marking
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MAN 01/EN/03 CRONO PAR 50 06/13
SECTION 5
LED
The red LED on the right of the display activates in the following circumstances:
1 - when the battery is inserted during the pump verification checks, see page 30;
2 - when an error has occurred. For further information, see page 26-27.
CONTROL BUTTONS
There are 3 control buttons.
The buttons have a built-in safety delay: you must keep them pressed for
several seconds before the command takes effect. Use only your fingertips;
do not use sharp objects.
The buttons make a clicking sound when pressed.
A brief beep confirms that a command is being executed.
WARNING
The buttons have different functions depending on the condition the pump
is in when they are pressed:
- OFF
- StoP
- ON
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SECTION 5
LIQUID CRYSTAL DISPLAY (LCD)
The liquid crystal display uses text messages and icons to display practical
information about the settings, the operation being performed and any error
situations.
Clock
symbol
Four main digits
Drop icon
Arrow icon
Two secondary digits
Lock indicator
Battery level
indicator
Four main digits of the display
Display principal information related to the values
of the settings, error information, etc.
Two secondary digits of the display
Display one of the following details:
• the size (volume) of the reservoir;
• the time (if the Auto mode has been selected);
• information related to the setting being displayed
in the four main digits;
• The unit of measurement of the setting being displayed.
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MAN 01/EN/03 CRONO PAR 50 06/13
SECTION 5
“Clock” symbol:
Only displayed when Auto is selected (see
related section on page 53-76). When the clock
symbol is visible, the 2 secondary digits below it
indicate the current hour of the 24-hour treatment
period (in OFF or StoP) or the set flow (in ON).
“Low Battery” indicator:
Displayed when the battery is nearly spent
(see related section on page 21).
“Drop” icon:
Steady: it separates integers from decimal
numbers.
Flashing: the hour and minute separator.
“Arrow” icon:
•a
downward arrow indicates that the pump is
being programmed;
• A right arrow indicates that the setting shown
is expressed in ml/h.
ml/h
PROG
“Minute” indicator:
• fl ashes when the remaining delivery time is
expressed in minutes (time left is less than 60
minutes);
•d
isplayed (steady) when the interval between
two bolus doses is expressed in minutes.
“Lock” indicator:
Indicates that the settings are locked (L1); i.e.
they can be viewed but cannot be changed
(except the time).
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SECTION 5
LOW BATTERY ALERT
The appearance of the “LOW BATTERY” alert (not flashing)
on the display indicates that the battery is nearly spent.
If the alert remains displayed for several consecutive infusions, the “SPENT BATTERY” message is displayed, accompanied by a beep repeated about every 10 seconds.
In these circumstances the pump can no longer be used
and the battery must be replaced.
WARNINGS
• You are advised to replace the battery after the “LOW BATTERY” alert is
displayed.
• The battery must not be replaced:
- during an infusion;
- with the infusion set connected to the patient.
BATTERY REPLACEMENT
Use a 3 Volt Lithium battery, model CR 123A.
To replace the battery, ensure that the pump is switched off (the display shows
OFF or StoP), and then proceed as follows:
1.open the cover of the battery compartment with the appropriate tool supplied, or by using a paper clip;
2. pull back the cover;
3.use the small ribbon strap (which lies under the battery) to facilitate removal of the battery;
4.remove the discharged battery and discard it properly, using the appropriate containers.
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SECTION 5
5. wait 10 seconds before inserting the new battery checking that it is in the
correct position and that the ribbon strap is under the battery;
6. after you have inserted the battery, close the cover.
CRONO
CRONO
PID
PID
CR
CRO
ONNO
O PI
PID
D
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SECTION 5
In the event that it is not possible to remove the battery using the ribbon strap,
do not use an object to lever out the battery, but proceed as follows:
• hold the pump and the compartment cover firmly in your one hand;
• strike the palm of your other hand with the pump, to jolt the battery from the
compartment.
NOTES
• After you have inserted the battery, the pump runs a self-diagnosis test during which it will emit brief audio signals and display all of the icons and indicators.
• During the battery replacement, the pump retains the current settings in its
memory.
• Ensure that the battery compartment cover is closed correctly.
• The cover is supplied with a gasket which must remain in
position as indicated in the illustration.
Gasket
WARNINGS
• Do not use rechargeable batteries.
•Using other types of battery than lithium CR 123A batteries could cause the
pump to malfunction.
•The battery life can be influenced by the age of the battery and the temperature
and circumstances of its use and storage.
• Ensure you always have a replacement battery available for use.
• If the pump is left inactive for long periods (1-2 months or more), you are
advised to remove the battery.
MAN 01/EN/03 CRONO PAR 50 06/13
23
SECTION 5
•The time remains in the memory for about 36 hours even
when there are no batteries in the device. After 36 hours
have elapsed, when the battery is inserted the display
will show dashes on the main digits, and the following
must be set: hours, minutes, day, month and year by
or
buttons.
pressing the
PROG
button it is possible to
By subsequently pressing the
display the two flashing dashes on the right of the drop,
representing the minutes.
PROG
PROG
button once more, it is possible to
By pressing the
set the date with the two flashing dashes displayed on
the left, which represent the day.
PROG
PROG
By pressing the
button once more, it is possible to
display the two flashing dashes on the right, which represent the month.
PROG
PROG
By pressing the
button once more, it is possible to display the two digits and flashing dashes, which represent
the year.
PROG
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SECTION 6
SETTINGS LOCK
The CRONO PAR 50 pump has 2 access configurations:
- L0 (unlocked): in this configuration you can use the control buttons to access
all of the settings and parameters, and control all of the operational functions;
- L1 (locked): in this configuration you can use the control buttons to control
the operational functions, except for the time. When the pump is set to L1 the
display shows the lock indicator ( indicator displayed).
Before attempting to modify any of the settings, ensure that the selected access
level of the pump is L0 ( indicator not displayed).
To lock or unlock the settings, do the following:
button for about 6
1. with the pump set to either OFF or StoP, press the
seconds: the display shows the number of bolus doses administered during the
last infusion, followed by the number of infusions that have been completed;
button, also press the
2. without releasing the
either L0 or L1, with 0 or 1 flashing;
button: the display shows
3. you can now select whether to lock or unlock the settings by pressing either
or
.
WARNINGS
• This settings access level (L0 and L1) remains in memory even if the battery
is removed.
• When the settings access is L1 (locked), any attempt to access the locked
options will cause the pump to beep intermittently and display the "lock"
indicator.
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SECTION 7
ERRORS AND ANOMALIES
DISPLAY
AUDIBLE
SIGNAL
ERROR
DESCRIPTION
CORRECTIVE
ACTION
Brief continuous
audible signal.
Operation not allowed.
---
Beep repeated every
10 sec approximately.
Possible hardware
anomaly of the clock
(only Auto mode).
button;
Press the
see warnings on page
28.
Continuous acoustic
signal and flashing
LED.
Critical problem in the
safety system.
Press the
button
Beep repeated
every 10 sec
approximately.
Anomaly in the motor
circuit.
Press the
button
Beep repeated
every 10 sec
approximately.
Mechanism of the
pusher blocked while
withdrawing (could be
caused by a foreign
body preventing its
movement).
Beep repeated
every 10 sec
approximately.
Pusher system
blocked.
Press the
Beep repeated
every 10 sec
approximately.
Motor anomaly.
Initialise the device
(see page 30).
Intermittent acoustic
signal repeated
approximately every
10 seconds (possibly
accompanied by
flashing LED).
Communication error
between the two
microcontrollers.
Eliminate the cause
and initialise the pump
(see page 30).
Press the
button
button
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MAN 01/EN/03 CRONO PAR 50 06/13
SECTION 7
DISPLAY
AUDIBLE
SIGNAL
ERROR
DESCRIPTION
CORRECTIVE
ACTION
When a battery is inserted
and at the start of every
infusion, the device runs
a control algorithm on
Initialise the device
the parameters stored in
Beep repeated every
(see page 30) and
the memory. If an error is
10 sec approximately.
set the prescribed
found, the manufacturer
infusion parameters.
default settings are
restored, the motor stops
and an error is shown on
the display.
Anomaly in the safety
circuit which drives the
Beep repeated every
pump motor. If an error is
10 sec approximately.
found, the pump locks and
the error is indicated.
Initialise the device
(see page 30).
Beep repeated every
10 sec approximately.
Initialise the device
(see page 30).
Anomaly in the pusher
system.
Mechanism blocked
Beep repeated every
because of an occlusion in
10 sec approximately.
the infusion line.
Eliminate the cause
and press the
button
(see page 29).
The bolus dose has been
set to 0.00 ml.
This function is not
available.
(see pages 50 and
73).
The bolus dose cannot be
administered because the
Beep when you press
dose interval imposed by
button.
the
the function has not been
completed.
This function is not
available.
(see pages 50 and
73).
Beep when you press
the
button.
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MAN 01/EN/03 CRONO PAR 50 06/13
SECTION 7
NOTE
The displayed error messages (from Er,1 to Er,11 and OCCL) are accompanied by an acoustic signal and the system stops.
WARNINGS
• Following the display of error message Er,1 in the:
button, the pump recom- ON condition (Auto version) after you press the
mences the delivery of the drug, but only using the lowest of the programmed
flow rates;
button, the pump will be set back to
- OFF condition, after you press the
OFF;
button, the pump will be
- Battery insertion condition, after you press the
initialised (as described on page 30).
• The display will show the clock icon and the flashing dashes on the two
secondary digits until the time is reset.
• It is necessary to reset the hours and minutes by accessing the settings as
described in the “PUMP SETTINGS SEQUENCE” section on pages 38 and 59.
• If at the time when Er,1 is signalled the hourly flow value is set to F0, the
pump will NOT administer the drug until it is switched off and on again.
• If the time is not reset, every time the pump starts or resumes an infusion,
it will signal Er,1 and administer the drug for the whole delivery time at the
minimum flow among the 3 set values.
• In the event that it is not possible to reset the time from the settings menu of
the pump, contact the Canè S.p.A. Technical Support Service.
• Error messages Er,2 and Er,7 are accompanied by the flashing red LED.
• Following the display of error message Er,8 and the successive initialisation,
the system re-imposes the factory settings in FrEE mode (see pages 32 and
53): in this event the pump settings prescribed by the doctor should be reentered.
• The settings prescribed by the doctor must be noted on a copy of the patient
settings record sheet on page 110 or the notes sheet on page 113.
28
MAN 01/EN/03 CRONO PAR 50 06/13
SECTION 7
INFUSION SET OCCLUSION
The pump is designed to recognise when the administration
of a drug has been interrupted by external means, such as,
for example, the kinking of the infusion set tube and the
consequent occlusion.
In these circumstances, the pump stops the infusion: the
display indicates that there is an occlusion, accompanied
by a brief beep. The pump then continues beeping every
10 seconds.
While the system is still occluded, the drug is not
administered: to recommence the infusion, press the
button after having removed the cause of the occlusion.
NOTES
• The cause of the occlusion is to be found along the infusion line and at the
point of injection.
• To avoid or reduce the incidence of occlusions, you are advised to use an
infusion set with anti-kinking tubes.
POST-OCCLUSION BOLUS
The occlusion alarm is given when the pump detects excessive back pressure
in the infusion line. This back pressure must be removed without releasing a
post-occlusion bolus, which could cause serious harm to the patient.
The volume of a CRONO PAR 50, post-occlusion bolus, considering only the
combined volume of the pump and the reservoir is about 0.9 ml (in PL2 mode).
WARNINGS
• The volume of the bolus released after an occlusion can vary, depending on
the infusion set and all the other components that comprise the infusion line.
• Another element that could affect the volume of the released bolus after an
occlusion is the presence of any air in the system.
• After the occlusion alarm is given, take any and all measures appropriate
to avoid the administration of a post-occlusion bolus, such as, for example,
disconnecting the infusion set from the patient.
29
MAN 01/EN/03 CRONO PAR 50 06/13
SECTION 8
PUMP INITIALISATION
When you insert the battery, the pump runs the initialisation sequence, during
which it:
1. runs a self-diagnosis test, emitting a series of brief acoustic signals, flashing the red LED and displaying all the
indicators and icons on the screen;
2. displays OFF at the end of the preceding operation.
NOTES
• The pump is supplied with a new battery already inside the pump.
• To initialise the device, remove the battery and reinsert it after 10/15 seconds. If the error is detected again after the corrective action or initialisation of
the device, contact the Canè S.p.A. Technical Support Service.
• For instructions on how to install the battery, see page 21.
•You are recommended to initialise the pump if it is left unused for a long
period (more than 1 - 2 months) and the battery is not removed.
•If, after the insertion of the battery (initialisation of the pump) the display
does not indicate the above-mentioned information, you are recommended
to remove and re-insert the battery.
SELECTING THE PUMP MODE
The CRONO PAR 50 pump offers, in a single body, two programming modes
called FrEE and Auto, to satisfy different therapeutic needs.
FrEE is a mode with basic functions that allows the patient to freely select,
during the day, one of the 3 available flow rates pre-programmed by the doctor,
the bolus dose and the drug volume contained in the reservoir.
Auto is a mode with advanced functions which allows you to program different
flow rates over the daily 24-hour period, as well as other functions described
below.
30
MAN 01/EN/03 CRONO PAR 50 06/13
SECTION 8
To be able to select the mode of the pump, it must:
• be set to OFF (at the beginning of a full or partial infusion);
• have the settings lock set to L0, ("lock" indicator off).
Procedure:
1 - press the
button for about 10 seconds, until the
display subsequently shows the number of bolus doses
administered during the last infusion, the number of completed infusions and finally the SEt message;
2 - when the message SEt is displayed, release the
. The display shows Auto or
button and press the
FrEE flashing message and the arrow points to PROG
demonstrating that the pump is ready to be programmed;
3 - press the
button to switch from Auto to FrEE, or
button to switch from FrEE to Auto;
press the
PROG
4 - if you have set FrEE go to the next page. If you have
set Auto go to page 53.
PROG
WARNINGS
• Always verify that the clock is correctly set when switching pump mode
from FrEE to Auto.
• When the device is set to StoP it is not possible to change the pump mode,
and the pump displays Err.
31
MAN 01/EN/03 CRONO PAR 50 06/13
FrEE
SECTION 9
Selected pump mode: FrEE
FACTORY SETTINGS
The pump is supplied with the following default settings:
32
Dose
0.20 ml
Interval between doses
no,Lt
Flow rate 1
0.50 ml/h (F1)
Flow rate 2
oFF (F2)
Flow rate 3
oFF (F3)
Volume
50 cc
Number of administered bolus doses
0
Number of infusions
0
Access level (settings lock)
L0
Occlusion pressure
PL2 (2,2 bar +/-1)
MAN 01/EN/03 CRONO PAR 50 06/13
FrEE
SECTION 10
QUICK REFERENCE FrEE
The buttons have a built-in safety delay: you must keep them pressed for
several seconds before the command takes effect.
WARNING
These quick reference instructions are not an alternative to reading the information in this manual, but give a basic and rapid summary of the pump’s functions.
BUTTONS
SELECTING THE PUMP MODE
DISPLAY
• Pump set to OFF
(keep pressed)
• Number of bolus doses administered during the last infusion
(after 2 seconds)
PUMP SET TO OFF
• Displaying the number of infusions (after 6 seconds)
• Pump mode selection (after 10 seconds)
• Accessing the pump mode selection
/
• Selecting the pump mode (FrEE/Auto)
PROG
• Pump set to OFF
33
MAN 01/EN/03 CRONO PAR 50 06/13
FrEE
SECTION 10
BUTTONS
CONFIGURING THE SETTINGS IN THE OFF CONDITION
DISPLAY
• Pump set to OFF
• Set bolus dose volume (from 0.00 to 2.00 ml)
PROG
• Setting the interval between the bolus doses
(from “no,Lt” to 24 hours)
PROG
PUMP SET TO OFF
• Setting the flow rate F1 (0.05 to 5.00)
PROG
• Setting the flow rate F2 (0.00 to 5.00 - oFF - disabled)
PROG
• Setting the flow rate F3 (0.00 to 5.00 - oFF - disabled)
PROG
• Setting the partial volume (from 1 to 50 ml)
(see table SETTING THE PARTIAL VOLUME)
ml/h
ml/h
ml/h
PROG
• Pump set to OFF
/
BUTTONS
• Decrease/increase stored value
SETTING THE PARTIAL VOLUME
DISPLAY
PUMP SET TO OFF
• Setting the partial volume
PROG
/
• Decrease/Increase of partial volume
PROG
• Positioning pusher to partial volume
• Pump set to OFF
34
MAN 01/EN/03 CRONO PAR 50 06/13
FrEE
SECTION 10
BUTTONS
SWITCHING ON / PRIMING
DISPLAY
• Pump set to OFF
PUMP SET TO OFF
• Priming function
• Priming function (1.5ml available)
(keep pressed)
• Pump in OFF
(prime delivered, prime function still available see pages 45/46)
• Switching on the pump
• Start of infusion
• Selecting the flow rate
PROG
BUTTONS
ADMINISTRATION OF BOLUS DOSE
ml/h
DISPLAY
PUMP ON
• Pump set to ON
• Administration of bolus dose
• Pump set to ON
BUTTONS
SWITCHING OFF/StoP
DISPLAY
PUMP ON
• Delivery time
• Pump set to StoP
• Silence buzzer and stop display flashing
35
MAN 01/EN/03 CRONO PAR 50 06/13
FrEE
SECTION 10
BUTTONS
SETTINGS LOCK
DISPLAY
PUMP SET TO OFF/StoP
• Pump set to OFF or StoP
(2 secs.)
(5 secs.)
press and hold
• Displaying the number of administered
bolus doses
• The number of completed infusions is
displayed
• Access settings lock
PROG
/
PROG
• Settings lock selection/deselection
• Pump set to OFF or StoP
BUTTONS
WITHDRAWAL OF THE Pusher BEFORE THE END
OF THE INFUSION
DISPLAY
PUMP ON
• Pump set to StoP
+
• Pump set to End
• Withdrawal of the pusher
• Pump set to OFF
36
MAN 01/EN/03 CRONO PAR 50 06/13
FrEE
SECTION 11
BUTTONS
END OF INFUSION
DISPLAY
PUMP ON
• Pump set to End
• Withdrawal of the pusher
• Pump set to OFF
BUTTONS
DISPLAYING
DISPLAY
• Pump in OFF
PUMP SET TO OFF/StoP - L1
• Bolus dose volume
• Interval between the bolus doses
• Flow rate F1
• Flow rate F2
• Flow rate F3
ml/h
ml/h
ml/h
• Partial volume
• Pump in OFF
37
MAN 01/EN/03 CRONO PAR 50 06/13
FrEE
SECTION 11
PUMP SETTINGS SEQUENCE WITH THE PUMP SET TO OFF OR StoP
To change the settings the pump must:
• be set to OFF or StoP;
• have the settings lock off (i.e. set to L0).
SETTING THE BOLUS DOSE VOLUME
The bolus dose volume can be set from 0.00 to 2.00 ml in increments of 0.022 ml.
Proceed as follows:
button
1. with the pump set to OFF or StoP press the
for a few seconds: the display shows the flashing bolus
dose volume indication;
2. to change the value, within 20 seconds press the
button to increase it. Each
button to decrease it, or the
change is indicated by a beep;
3. if you do not press any button for 20 seconds, the settings
session is terminated and the message OFF or StoP is
displayed;
button before the OFF or StoP is displayed
4. press the
(while the bolus dose volume is still flashing) to continue
to the setting of the next parameter: SETTING the
interval between bolus doses.
PROG
PROG
NOTES
• If you keep either the
or
button pressed, it is possible to quickly
change the bolus dose volume.
• The bolus dose setting is automatically stored in the pump’s memory.
• If you press the
button when the display indicates d0,02, the value changes to d0,00: this setting disables the bolus dose function.
• If the settings lock is set to L1 (the display is showing the "lock" indicator),
when you press the
button, the pump displays the current settings, which
cannot be changed.
Warning
If the bolus dose volume is set to 0.00 ml, pressing the
infusion will display the Er,d error message.
38
button during the
MAN 01/EN/03 CRONO PAR 50 06/13
FrEE
SECTION 11
SETTING the interval between bolus doses
The interval between bolus doses can be set to a value
between no,Lt (function disabled) and 24 hours, in the
following ways:
• from 5 minutes to 1 hour in increments of 5 minutes;
• from 1 hour to 24 hours in increments of 15 minutes.
This applies a temporal limit to the bolus dose function.
Proceed as follows:
1. the display shows the flashing value of the bolus dose
interval;
PROG
PROG
PROG
2. press the
button to increase the value; press the
button to decrease it. Each change is indicated by a beep;
3. if you do not press any button for 20 seconds, the settings
session is terminated and the message OFF or StoP is
displayed;
4. press the
button before the OFF or StoP indication
is displayed (while the bolus dose interval is still flashing)
to continue to the setting of the next parameter: setting
the first flow rate (F1).
PROG
ml/h
NOTES
• If you keep either the
or
button pressed, it is possible to quickly change
the interval between the bolus doses.
• The bolus dose interval setting is automatically stored in the pump's memory.
• Press the
button with the display showing it 5’, the display changes to
no,Lt: this setting disables the function that regulates the interval between
bolus doses, and thus disables any time restrictions on the administration of
bolus doses.
39
MAN 01/EN/03 CRONO PAR 50 06/13
FrEE
SECTION 11
setting the first flow rate (F1)
The flow rate can be set from 0.05 to 5.00 ml/h as follows:
• from 0.05 ml/h to 1.00 ml/h in increments of 0.01 ml/h;
• from 1.00 ml/h to 3.00 ml/h in increments of 0.02 ml/h;
• from 3.00 ml/h to 5.00 ml/h in increments of 0.05 ml/h.
Proceed as follows:
1. the display shows the flashing value of the first flow rate;
PROG
ml/h
2. press the
button to increase the value; press the
button to decrease it. Each change is indicated by a beep;
3. if you do not press any button for 20 seconds, the settings
session is terminated and the message OFF or StoP is
displayed;
button before the OFF or StoP indication
4. press the
is displayed (while the F1 flow rate value is still flashing) to
continue to the setting of the next parameter: setting the
SECOND flow rate (F2).
PROG
ml/h
NOTES
• If you keep either the
flow rate quickly.
or
button pressed, it is possible to change the
• Every flow rate setting is automatically stored in the pump’s memory.
40
MAN 01/EN/03 CRONO PAR 50 06/13
FrEE
SECTION 11
setting the SECOND and THIRD flow rates (F2 and F3)
The flow rate can be set from 0.00 to 5.00 ml/h as follows:
• from 0.00 ml/h to 1.00 ml/h in increments of 0.01 ml/h;
• from 1.00 ml/h to 3.00 ml/h in increments of 0.02 ml/h;
• from 3.00 ml/h to 5.00 ml/h in increments of 0.05 ml/h.
The second and third flow rates are set in the same manner
as the first.
After you have set the third flow, press the
button before
the OFF or StoP indication is displayed (while the F3 hourly
flows value is still flashing) to continue to the setting of the
next parameter: PARTIAL VOLUME.
PROG
PROG
ml/h
ml/h
PROG
NOTES
• If you keep either the
or
button pressed, it is possible
to change the flow rate quickly.
• If the flow rate is programmed to 0.00 ml/h, the device
will not administer the drug via flow, but only through the
administration of bolus doses.
• it is also possible to set the oFF condition for flows F2 and/
or F3, so that the flows will not be displayed, and therefore
will not be selectable, when the pump is ON.
PROG
ml/h
PROG
41
MAN 01/EN/03 CRONO PAR 50 06/13
FrEE
SECTION 11
Setting the partial volume
The partial volume function is used when the treatment
requires an infusion with less than 50 ml.
The partial volume can be set from 1 cc to 50 cc in
increments of 1 cc.
button again.
To set this parameter, press the
The partial volume function can only be set before starting a
new infusion, either a complete one (50 ml) or a partial one.
Proceed as follows:
1. the display shows a flashing value for the volume,
preceded by cc , which indicates the unit of volume (1 cc
= 1 ml);
PROG
2. press the
button to decrease the value, and the
button to increase it. Each change is indicated by a beep;
PROG
3. do not press any button for 20 seconds and the setting
phase will end. The display will show P,cc. Press the
button while P,cc is shown to cancel the partial volume
setting. The display shows the OFF indication;
4. the pump moves the pusher to the position which
corresponds to the set volume: an intermittent acoustic
signal is emitted while it does so, and the pump displays - in
real time - the actual volume corresponding to the pusher
position;
5. when the pusher is in the correct position, the display
shows OFF. The selected partial volume value will be shown
on the secondary display.
42
MAN 01/EN/03 CRONO PAR 50 06/13
FrEE
SECTION 11
NOTES
• The partial volume setting is automatically stored in the pump’s memory.
• At the end of the infusion, the pusher returns to the position corresponding
to the partial volume setting.
button: the
• The partial volume setting can be interrupted by pressing the
pump switches off (the display shows OFF or StoP) and the pusher, if it was
moving forward, remains where it was when the interruption occurred. The
partial volume setting is not stored and the previous value remains in memory.
If, however, the pusher was in the process of being withdrawn, the display
shows OFF and P,cc alternately. The only possible operation is to continue
button. The pusher withdraws
the withdrawal of the pusher, by pressing the
to the position of the partial volume settings.
• When the device is set to StoP it is not possible to change the partial volume,
and the pump displays Err.
WARNINGS
•This operation must not be carried out with the infusion set connected to
the patient.
• A partial volume cannot be set while an infusion is in progress.
•The partial volume setting remains in the pump’s memory even if the battery is removed.
•If the battery is removed when the pump is set to OFF, the partial volume
remains in memory and the pusher is not withdrawn.
• If the battery is removed when the pump is set to ON, the pusher returns
to the infusion start position for recalibration, and then repositions itself at
the stored partial volume.
43
MAN 01/EN/03 CRONO PAR 50 06/13
FrEE
SECTION 11
SWITCHING ON THE PUMP
From the OFF condition, press the
button and the pump
will give a brief beep and display the following in sequence:
• Pr (priming function);
There are three options:
a. postpone the priming;
b. cancel the priming;
c. perform the priming.
• switching on the pump and displaying the set flow;
• delivery time and flow value display.
WARNINGS
Before starting an infusion:
• check that the reservoir is correctly connected;
• inspect the infusion line to ensure there are no folds, clamps or other
occlusions in the line;
• expel any air bubbles.
44
MAN 01/EN/03 CRONO PAR 50 06/13
FrEE
SECTION 11
PRIMING THE INFUSION LINE
The priming function allows for filling the infusion line with the drug contained
in the reservoir.
The volume available for priming is 1.5 ml.
The priming function is enabled when the device is switched on and the pusher
is in the infusion start position, regardless of whether the settings lock is on.
The priming procedure is as follows:
1. switch on the device as described in the relevant section;
2. the display shows Pr. There are three options:
a. postpone the priming;
b. cancel the priming;
c. perform the priming.
a. Postpone the priming
Press the
and
buttons together: the pump switches
off and the display shows OFF. Or wait 10 seconds and the
pump switches itself off automatically.
b. Cancel the priming
button; the pump begins the infusion and the
Press the
display shows the time remaining until the end of the infusion.
45
MAN 01/EN/03 CRONO PAR 50 06/13
FrEE
SECTION 11
c. Perform the priming
button to deliver the priming
Press and hold down the
dose; the priming function can be interrupted by releasing
the button. The display shows a flashing letter Pr followed
by the number of millilitres delivered. The display then
shows Pr again. In this way it is again possible to postpone,
cancel or perform the priming function. The procedure can
be repeated until a maximum of 1.5 ml has been delivered
in total.
At the end of this phase, if the infusion is not started by
button, the pump returns to OFF.
pressing the
NOTES
• Every time the pump administers 0.5 ml of drug, it emits an audible signal
and pauses for about one second.
• Continue with the priming until the drug arrives at the end of the infusion set.
• If, after the priming indication is displayed, the buttons are not pressed
again for 10 seconds, the display shows OFF.
WARNINGS
• Do not prime the infusion set with the tube connected to the patient.
• The priming function must only be performed with the reservoir attached to
the infusion set and before inserting the needle into the infusion site.
• Before beginning an infusion, check that there are no air bubbles in the infusion line, expelling any that are found. Alternatively, use a vented filter.
• While the displays flashes Pr it is not possible to select the programming
mode (FrEE/Auto) or change the partial volume.
46
MAN 01/EN/03 CRONO PAR 50 06/13
FrEE
SECTION 11
PUMP SWITCHED ON
When the pump is in ON condition, the display shows the
delivery time in:
• hours with a flashing h;
• hours and minutes, with the "drop" icon flashing;
• minutes, if the time to go is less than one hour, with the
"minutes" indicator flashing.
If a flow rate of 0.00 ml/h has been set, the display shows
F0,00 with a flashing letter F; In this event the drug can only
be administered by means of a bolus dose request.
ml/h
NOTE
If the device is switched off during an infusion and the display shows StoP,
press the
button to restart the infusion.
47
MAN 01/EN/03 CRONO PAR 50 06/13
FrEE
SECTION 11
SELECTING THE FLOW RATE
This function allows the patients to change the flow during the day based on
their demands, choosing among the 3 available flow rates pre-programmed
by the doctor.
Procedure:
1 - with the pump on, press the
button;
2 - the display shows the currently set flow rate flashing with
the arrow indicating the programming mode;
PROG
3 - press the
button again, and the display shows the
other available flow values;
PROG
ml/h
ml/h
4 - after selecting the desired flow, do not press the
button again, and after a few seconds the value is saved in
the memory and the pump will proceed with the infusion at
the newly selected flow rate;
5 - during this selection the
and
buttons are disabled.
NOTES
• If F2 and/or F3 are set to 0.00, the pump allows the selection of these flow
values as an alternative to F1, with no administering being performed as the
flow is equal to 0; selecting a 0 flow can be convenient to intentionally interrupt
the administration for a set period, for instance during the night.
• If F2 and F3 are set to oFF, the pump allows the display and use of the F1
flow only.
WARNING
The preset flow selection function is available even when the settings lock is
on; to disable this option, it is necessary to set the F2 and F3 flows to oFF in
order to disable them, forcing the pump to use a unique flow rate.
48
MAN 01/EN/03 CRONO PAR 50 06/13
FrEE
SECTION 11
BOLUS DOSE
The bolus is a supplementary dose of the drug that the patient can request
when it is needed.
If the bolus dose volume has been set to 0.00 ml, the bolus dose cannot be
administered.
Administration of bolus doses
Bolus doses can only be administered while the pump is in ON condition.
The procedure for the administration of a bolus dose is as follows:
1. press the
button: the pump gives a beep and
commences to administer the bolus dose, during which a
flashing letter d is shown on the secondary display, while
the volume of the bolus dose being administered is shown
on the main display. During the bolus dose administration,
the pump beeps and pauses for about 1 seconds for every
0.11 ml of drug administered;
2. at the end of the bolus dose administration, the pump
beeps and the display shows the time remaining of the
original infusion, or, if the setting is for a flow rate of 0.00
ml/h, it shows F0,00.
ml/h
NOTES
• The bolus dose administration can be interrupted by pressing the
• If the bolus dose volume is set to 0.00 ml, pressing the
the Er,d error message.
button.
button will display
49
MAN 01/EN/03 CRONO PAR 50 06/13
FrEE
SECTION 11
RESTRICTIONS ON THE ADMINISTRATION OF BOLUS DOSES
If the bolus dose volume is set to 0.00 ml, pressing the
button will display the Er,d error message.
The administration of bolus doses is limited by the interval
between doses (temporal limitation).
By setting no,Lt you can disable this limitation.
Bolus doses cannot be administered during the interval
period observed by the function.
During the limitation period, if you request a bolus dose,
the display shows Er,t (temporal limitation between active
bolus doses).
Displaying the number of administered bolus doses
during an infusion and the NUMBER OF INFUSIONS
1 - To check the number of bolus doses administered by
the patient during an infusion while the pump is in OFF or
button for a few seconds and
StoP, press and hold the
the value will be displayed.
2 - To check the number of infusions delivered by the device
button for
while it is OFF or StoP, press and hold the
about 8 seconds.
WARNINGS
• The number of the administered bolus doses is only available until the beginning of a new infusion; switching the pump on for a new infusion automatically
resets the value.
• The number of bolus doses includes those interrupted by pressing the
button.
50
MAN 01/EN/03 CRONO PAR 50 06/13
FrEE
SECTION 11
WITHDRAWING THE Pusher
1. Withdrawal of the pusher before the end of the infusion
This function allows the interruption of an active infusion, withdrawing the
pusher to the start position of the infusion.
To stop an active infusion, do the following:
• switch the pump off by pressing the
button;
• press the
and
buttons together: the display shows
End for 10 seconds and then begins to withdraw the pusher;
• during the 10 seconds that the display shows End you can
button.
cancel the withdrawal request by pressing the
2. Withdrawal of the pusher at the end of the infusion
Ten minutes before the end of the infusion, the device gives
an intermittent beep for 2 seconds. This signal is repeated
twice at 5 minutes from the end of the infusion.
At the end of the infusion an audible signal is given and the
display shows End.
After a few seconds, the pusher starts withdrawing until it
reaches the start position of the infusion.
NOTES
• While the display shows End, the withdrawal function can
be cancelled by pressing the
button. The display shows
StoP.
• The withdrawal function can be interrupted by pressing
button. The display then alternates between End
the
and OFF. At this point the only active button is the
button. When you press again the pump recommences the
withdrawal of the pusher.
51
MAN 01/EN/03 CRONO PAR 50 06/13
FrEE
SECTION 11
Pusher in motion
While the pusher is in a continuous withdrawal motion, the
display shows the “pusher continuous withdrawal” indication.
NOTE
The pusher withdrawal time for a 50 ml volume is approx 6 minutes, and is
proportionately less for lower volumes.
WARNING
Do not remove the reservoir until the pusher has been withdrawn to the infusion
start position.
SWITCHING OFF THE PUMP
To switch off the device, press the
button. The display
will show StoP. If the pump is switched off during an infusion, the device will emit a series of 10 short beeps every
10 seconds, and the display will flash the StoP message.
button.
To suppress the audible signals, press the
52
MAN 01/EN/03 CRONO PAR 50 06/13
Auto
SECTION 12
Selected pump mode: Auto mode
FACTORY SETTINGS
The pump is supplied with the following default settings:
Dose
0.20 ml
Interval between doses
no,Lt
Flow rate 10.50 ml/h (F1)
Flow rate 20.50 ml/h (F2)
Flow rate 30.50 ml/h (F3)
Flow rate over 24-hour period
F2
Volume 50 cc
Number of administered bolus doses
0
Number of infusions
0
Access level (settings lock)
L0
53
MAN 01/EN/03 CRONO PAR 50 06/13
Auto
SECTION 13
QUICK REFERENCE Auto
The buttons have a built-in safety delay: you must keep them pressed for
several seconds before the command takes effect.
WARNING
These quick reference instructions are not an alternative to reading the information in this manual, but give a basic and rapid summary of the pump’s functions.
BUTTONS
SELECTING THE PUMP MODE
DISPLAY
• Pump set to OFF
(keep
pressed)
• Displaying the number of administered bolus doses
(after 2 seconds)
PUMP SET TO OFF
• Displaying the number of infusions
(after 6 seconds)
• Pump mode selection
(after 10 seconds)
• Accessing the pump mode selection
/
• Selecting the pump mode (FrEE/Auto)
PROG
• Pump set to OFF
54
MAN 01/EN/03 CRONO PAR 50 06/13
Auto
SECTION 13
BUTTONS
SETTINGS
DISPLAY
• Pump set to OFF and L0
• Visualisation of the time
(5 sec)
• Enabling the setting of the time
PROG
• Set the minutes
PROG
• Set bolus dose volume (from 0.00 to 2.00 ml)
PUMP SET TO OFF
PROG
• Setting the interval between the bolus doses
(from “no,Lt” to 24 hours)
PROG
• Setting the flow rate F1 (from 0.05 to 5.00 ml/h)
PROG
• Set the F2 flow rate (from 0.05 to 5.00 ml/h)
PROG
• Set the F3 flow rate (from 0.05 to 5.00 ml/h)
PROG
and
ml/h
ml/h
ml/h
• Assigning the flows over the daily 24-hour period
PROG
• Setting the partial volume (from 1 to 50 ml)
(see table SETTING THE PARTIAL VOLUME)
PROG
• Pump set to OFF (after 20 seconds)
/
• Decrease/increase stored value
55
MAN 01/EN/03 CRONO PAR 50 06/13
Auto
SECTION 13
BUTTONS
SETTING THE PARTIAL VOLUME
DISPLAY
PUMP SET TO OFF
• Setting the partial volume
PROG
/
• Decrease/Increase of partial volume
PROG
• Positioning pusher to partial volume
• Pump set to OFF
BUTTONS
SWITCHING ON / PRIMING
DISPLAY
• Pump set to OFF
PUMP SET TO ON
• Priming function
(keep
pressed)
• Prime function (1.5ml available)
Pump in OFF
(prime delivered, function still available see pages 70/71)
• Switching on the pump
• Start of infusion
• Temporary switching between infusion/flow
BUTTONS
ADMINISTRATION OF BOLUS DOSE
ml/h
DISPLAY
PUMP ON
• Pump set to ON
• Administration of bolus dose
• Pump set to ON
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MAN 01/EN/03 CRONO PAR 50 06/13
Auto
SECTION 13
BUTTONS
StoP
DISPLAY
PUMP ON
• Pump set to StoP
• Silence buzzer and stop display flashing
SETTINGS LOCK
BUTTONS
DISPLAY
PUMP SET TO OFF/StoP
• Pump set to OFF or StoP
(2 secs.)
• Displaying the number of administered
bolus doses
(5 secs.)
• The number of completed infusions is
displayed
press and hold
• Access settings lock
PROG
/
PROG
• Settings lock selection/deselection
• Pump set to OFF or StoP
BUTTONS
WITHDRAWAL OF THE Pusher BEFORE THE END
OF THE INFUSION
DISPLAY
PUMP ON
• Pump set to StoP
+
• Pump set to End
• Withdrawal of the pusher
• Pump set to OFF
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MAN 01/EN/03 CRONO PAR 50 06/13
Auto
SECTION 14
BUTTONS
END OF INFUSION
DISPLAY
• Pump set to End
• Withdrawal of the pusher
• Pump set to OFF
BUTTONS
DISPLAYING
DISPLAY
• Pump in OFF and L1
• Setting the time
see page 61
PUMP SET TO OFF/StoP - L1
• Bolus dose
• Time interval between bolus doses
• Flow rate F1
• Flow rate F2
• Flow rate F3
ml/h
ml/h
ml/h
• Flow rates over the daily 24-hour period
• Displaying the flows over the daily 24-hour period
• Partial volume
• Pump in OFF
58
MAN 01/EN/03 CRONO PAR 50 06/13
Auto
SECTION 14
PUMP SETTINGS SEQUENCE
To change the settings the pump must:
• be set to OFF or StoP;
• have the settings lock off (i.e. set to L0).
You can change the setting while the display is flashing by pressing buttons
and
.
Visualising/setting the time
button for about 4
To access the settings pres the
seconds: the display shows the time.
Pushing the - button for about 5 seconds enables the setting
of the time (see page 61).
Setting the minutes
Press the
button again, and the display shows and allows
setting the minutes (see page 61).
Setting the bolus dose volume
Press the
button, and the display shows and allows
setting of the bolus dose volume (see page 62).
Setting the interval between bolus doses
Press the
button again, and the display shows and
allows setting the interval between the bolus doses (see
page 63).
Setting the first flow rate (F1)
Press the
button again, and the display shows and allows
setting the first flow rate (see page 64).
Setting the second flow rate (F2)
button again, and the display shows and allows
Press the
setting the second flow rate (see page 65).
Setting the third flow rate (F3)
button again, and the display shows and allows
Press the
setting the third flow rate (see page 65).
PROG
PROG
PROG
PROG
PROG
PROG
PROG
ml/h
ml/h
ml/h
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MAN 01/EN/03 CRONO PAR 50 06/13
Auto
SECTION 14
Assigning the 4 flows over the daily 24-hour period
Press the
button again to display and set the assignment
of the 4 flows over the daily 24-hour period (of which one
is the fixed F0 flow, with a rate of 0.00 ml/h). Press the
button to scroll the hours (the two digits left of the drop icon)
button to select the different flows (second digit
and the
to the right of the drop icon).
Setting the partial volume
button again to display and set the partial
Press the
volume. The partial volume can be set only if the pusher
is at the infusion start position and the pump is set to
OFF.
PROG
PROG
NOTES
• If the settings lock is on (set to L1 with the display showing the lock icon ),
and you press the
button, the device only allows to modify the hours and
minutes but not the other parameters, which can, however, be displayed in
button (see page 78).
sequence by pressing the
button is pressed when the time is displayed the pump passes
• If the
directly to the bolus dose setting.
• Do not press any button for 20 seconds, and the setting phase will end. The
flashing displayed value becomes fixed and then the OFF or StoP indication
is displayed.
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MAN 01/EN/03 CRONO PAR 50 06/13
Auto
SECTION 14
SETTING THE TIME
Proceed as follows:
1. with the pump set to either the OFF or StoP conditions,
press the
button for about 4 seconds: the display shows
the time;
Pressing the
button enables the setting of the time: the
hour value begins to flash.
PROG
button to increase the value; press the
2. press the
button to decrease it. Each change in value is indicated by
a brief beep;
3. do not press any button for 20 seconds, and the setting
phase will end. The flashing displayed value becomes fixed
and then the OFF or StoP indication is displayed;
4. press the
button before the OFF or StoP is displayed
(while the hour value is still flashing) to continue to the setting
of the minutes;
PROG
button to increase the minutes; press the
5. press the
button to decrease them. Each change in value is indicated
by a brief beep;
6. do not press any button for 20 seconds, and the setting
phase will end. The flashing displayed value becomes fixed
and then the OFF or StoP indication is displayed.
7. press the
button before the OFF or StoP indication is
displayed (while the minutes are still flashing) to continue to
the setting of the next parameter: SETTING THE BOLUS
DOSE VOLUME.
PROG
NOTE
If you keep pressing either the
change the hours and minutes.
or the
button, it is possible to quickly
61
MAN 01/EN/03 CRONO PAR 50 06/13
Auto
SECTION 14
SETTING the bolus dose volume
The bolus dose volume can be set from 0.00 to 2.00 ml in increments of 0.022
ml.
Proceed as follows:
1. the letter d is shown on the secondary display and
the volume of the bolus dose in the primary display. The
numeric values are flashing but the d is steady;
PROG
2. press the
button to increase the value; press the
button to decrease it. Each change is indicated by a beep;
3. if you do not press any button for 20 seconds, the settings
session is terminated and the message OFF or StoP is
displayed;
4. press the
button before the OFF or StoP indication
is displayed (while the bolus dose volume is still flashing)
to continue to the setting of the next parameter: SETTING
the interval between bolus doses.
PROG
NOTES
• If you keep pressing either the
or
buttons, it is possible to quickly
change the bolus dose volume.
• The bolus dose setting is automatically stored in the pump’s memory.
• If you press the
button when the display indicates d0,02, the value changes to d0,00: this setting disables the bolus dose function.
Warning
If the bolus dose volume is set to 0.00 ml, pressing the
infusion will display the Er, d error message.
button during the
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MAN 01/EN/03 CRONO PAR 50 06/13
Auto
SECTION 14
SETTING the interval between bolus doses
The interval between bolus doses can be set to a value
between no,Lt (function disabled) and 24 hours, in the
following ways:
• from 5 minutes to 1 hour in increments of 5 minutes;
• from 1 hour to 24 hours in increments of 15 minutes.
This applies a temporal limit to the bolus dose function.
PROG
PROG
Proceed as follows:
1. the display shows the flashing value of the bolus dose
interval;
PROG
2. press the
button to increase the value; press the
button to decrease it. Each change is indicated by a beep;
3. if you do not press any button for 20 seconds, the settings
session is terminated and the message OFF or StoP is
displayed;
4. press the
button before the OFF or StoP indication
is displayed (while the bolus dose interval is still flashing)
to continue to the setting of the next parameter: setting
the first flow rate (F1).
PROG
ml/h
NOTES
• If you keep pressing either the
or
buttons, it is possible to quickly
change the interval between the bolus doses.
• The bolus dose interval setting is automatically stored in the pump's memory.
• Press the
button with the display showing it 5’, the display changes to
no,Lt: this setting disables the function that regulates the interval between
bolus doses, and thus disables any time restrictions on the administration of
bolus doses.
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MAN 01/EN/03 CRONO PAR 50 06/13
Auto
SECTION 14
setting the first flow rate (F1)
The flow rate can be set from 0.05 to 5.00 ml/h as follows:
• from 0.05 ml/h to 1.00 ml/h in increments of 0.01 ml/h;
• from 1.00 ml/h to 3.00 ml/h in increments of 0.02 ml/h;
• from 3.00 ml/h to 5.00 ml/h in increments of 0.05 ml/h.
Proceed as follows:
1. the display shows the flashing value of the first flow rate;
2. press the
button to increase the value; press the
button to decrease it. Each change is indicated by a beep;
PROG
ml/h
3. if you do not press any button for 20 seconds, the settings
session is terminated and the message OFF or StoP is
displayed;
button before the OFF or StoP indication
4. press the
is displayed (while the F1 flow rate value is still flashing) to
continue to the setting of the next parameter: setting the
SECOND flow rate (F2).
PROG
ml/h
NOTES
• If you keep pressing either the
the flow rate quickly.
or
buttons, it is possible to change
• Every flow rate setting is automatically stored in the pump’s memory.
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MAN 01/EN/03 CRONO PAR 50 06/13
Auto
SECTION 14
setting the SECOND and THIRD flow rates (F2 and F3)
The second and third flow rates are set in the same manner
and within the same limits as the first.
After you have set the third flow, press the
button before
the OFF or StoP indication is displayed (while the F3 hourly
flows value is still flashing) to continue to the setting of the
next parameter: ASSIGNING the flows over the
DAILY 24-hour period.
PROG
PROG
ml/h
ml/h
PROG
NOTES
• If you keep pressing either the
flow rate quickly.
or
buttons, it is possible to change the
• The flow (F0) the value of which is 0.00 ml/h. This flow can be selected only
when assigning the flows over the daily 24-hour period.
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MAN 01/EN/03 CRONO PAR 50 06/13
Auto
SECTION 14
ASSIGNING the flows over the daily 24-hour period
You can set a different flow rate for every hour of the day, choosing between
the four available rates (F0, F1, F2, F3).
Proceed as follows:
1. the first two digits of the display show the hour of the day
(24-hour clock) while the last two show the selected flow
for the corresponding hour of the day. The first three digits
are steady, but the last numeric digit, after the F (0, 1, 2 or
3) indicating the flow, is flashing;
PROG
2. press the
button to select the hour of the day;
then press the
button to select the required flow
corresponding to the selected hour of the day. Each change
is indicated by a beep. Press the
button again to change
the display to the next hour: press the
button to select
the required flow. Proceed in the same way to set the flows
for each successive hour;
3. do not press any button for 20 seconds, and the setting
phase will end. The flashing displayed value becomes fixed
and then the OFF or StoP indication is displayed;
4. press the
button before the OFF or StoP indication
is displayed (while the hourly flow value is still flashing) to
continue to the setting of the next parameter: Setting
the partial volume.
PROG
NOTE
If you set the F0 flow rate for any hour, during that hour no drug will be
administered, as the flow rate will be 0.00 ml/h: the display shows the remaining
button will temporarily display F0
time of the infusion, and pressing the
with the value of 0.00 ml/h.
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Auto
SECTION 14
Setting the partial volume
The partial volume function is used when the treatment requires an infusion
with less than 50 ml.
The partial volume can be set from 1 cc to 50 cc in increments of 1 cc. To set
button again.
this parameter, press the
The partial volume function can only be set before starting a new infusion,
either a complete one (50 ml) or a partial one.
Proceed as follows:
1. the display shows a flashing value for the volume,
preceded by cc , which indicates the unit of volume (1 cc
= 1 ml);
PROG
2. press the
button to decrease the value, and the
button to increase it. Each change is indicated by a beep;
PROG
3. do not press any button for 20 seconds and the setting
phase will end; the display will show P,cc;
4. the pump moves the pusher to the position which
corresponds to the set volume: an intermittent acoustic
signal is emitted while it does so, and the pump displays - in
real time - the actual volume corresponding to the pusher
position;
5. when the pusher is in the correct position the display
shows OFF.
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SECTION 14
Auto
NOTES
• The partial volume setting is automatically stored in the pump’s memory.
• At the end of the infusion, the pusher returns to the position corresponding
to the partial volume setting.
button: the
• The partial volume setting can be interrupted by pressing the
pump switches off (the display shows OFF or StoP) and the pusher, if it was
moving forward, remains where it was when the interruption occurred: the
partial volume setting is not stored and the previous value remains in memory.
However, if the pusher was withdrawing: the display toggles between OFF and
P,cc. The only possible operation is to continue the withdrawal of the pusher,
button. The pusher withdraws to the position of the partial
by pressing the
volume settings.
• When the device is set to StoP it is not possible to change the partial volume,
and the pump displays Err.
WARNINGS
• This operation must not be carried out with the infusion set connected to
the patient.
• A partial volume cannot be set while an infusion is in progress.
• The partial volume setting remains in the pump’s memory even if the battery is removed.
• If the battery is removed when the pump is set to OFF, the partial volume
remains in memory and the pusher is not withdrawn.
• If the battery is removed when the device is in the ON, the pusher returns
to the infusion start position after a reset and then repositions itself according to the memorised partial volume.
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MAN 01/EN/03 CRONO PAR 50 06/13
Auto
SECTION 14
SWITCHING ON the pump
From the OFF condition, press the
will give a brief beep and display:
button. The pump
• Pr (priming function)
There are three options:
a. postpone the priming;
b. cancel the priming;
c. perform the priming.
• Switching on the pump
• After you have performed the priming, or if you switch the
pump on when it is in the StoP condition, the display shows
the infusion time in hours or in hours and/or minutes or just
minutes.
button again, and the display shows the
Press the
corresponding hourly flow value.
ml/h
NOTE
During the infusion the time shown on the display is counted down:
• hour by hour if the time shown on the display is expressed in hours, with a
flashing letter h;
• minute by minute if the time shown on the display is expressed in hours
and minutes or just minutes.
WARNINGS
Before starting an infusion:
• check that the reservoir is correctly connected;
• Inspect the infusion line to ensure there are no folds, clamps or other
occlusions in the line;
• expel any air bubbles;
• in case different hourly flows are used, check that the time is correctly set.
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Auto
SECTION 14
PRIMING THE INFUSION LINE
The priming function allows for filling the infusion line with
the drug contained in the reservoir.
The volume available for priming is 1.5 ml.
The priming function is enabled when the device is
switched on and the pusher is in the infusion start position,
regardless of whether the settings lock is on.
The priming procedure is as follows:
1. switch on the device as described in the relevant section;
2. the display shows Pr. There are three options:
a. postpone the priming;
b. cancel the priming;
c. perform the priming.
a. Postpone the priming
Press the
and
buttons together: the pump switches
off and the display shows OFF. Or wait 10 seconds and the
pump switches itself off automatically.
b. Cancel the priming
button; the pump starts the infusion and the
Press the
display shows the time remaining until the end of the infusion, as well as the current flow rate.
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Auto
SECTION 14
c. Perform the priming
button to deliver the priming
Press and hold down the
dose; the priming function can be interrupted by releasing
the button. The display shows a flashing letter Pr followed
by the number of millilitres delivered. The display then
shows Pr again. In this way it is again possible to postpone,
cancel or perform the priming function. The procedure can
be repeated until a maximum of 1.5 ml has been delivered
in total.
At the end of this phase, if the infusion is not started by
button, the pump returns to OFF.
pressing the
NOTES
• Every time the pump administers 0.5 ml of drug, it emits an audible signal
and pauses for about one second.
• Continue with the priming until the drug arrives at the end of the infusion set.
There are no time limits to the priming operation.
• If, after the priming indication is displayed, the buttons are not pressed
again for 10 seconds, the display shows OFF.
WARNINGS
• Do not prime the infusion set with the tube connected to the patient.
• The priming function must only be performed with the reservoir attached to
the infusion set and before inserting the needle into the infusion site.
• Before beginning an infusion, check that there are no air bubbles in the infusion line, expelling any that are found. Alternatively, use a vented filter.
• While the displays flashes Pr it is not possible to select the programming
mode (FrEE/Auto) or change the partial volume.
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MAN 01/EN/03 CRONO PAR 50 06/13
Auto
SECTION 14
PUMP SWITCHED ON
During the infusion the time indicated on the display is shown
in hours (with a flashing letter h), or in hours and minutes
with the flashing drop icon. If the time "to go" is less than
one hour, the time is shown in just minutes, and the flashing
“Minute” indicator is displayed.
button, the display temporarily toggles
If you press the
between the "time to go" and the programmed flow rate.
If you have selected the F0 flow, the display shows F0 and
0,00. In this event the drug can only be administered by
means of a bolus dose request.
ml/h
ml/h
BOLUS DOSE
The bolus is a supplementary dose of the drug that the patient can request
when it is needed. If the bolus dose volume has been set to 0.00 ml, the bolus
dose cannot be administered.
Administration of bolus dose
Bolus doses can only be administered while the pump is in ON condition.
The procedure for their administration is as follows:
button; the pump gives a beep and
1. Press the
commences to administer the bolus dose, during which a
flashing letter d is shown on the secondary display, while
the volume of the bolus dose being administered is shown
on the main display. During the bolus dose administration,
the pump beeps and pauses for about 1 seconds for every
0.11 ml of drug administered.
2. At the end of the bolus dose administration, the pump
beeps and the display shows the time remaining of the
original infusion, or, if the setting is for a flow rate of 0.00
ml/h, it shows F0,00.
ml/h
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MAN 01/EN/03 CRONO PAR 50 06/13
Auto
SECTION 14
NOTE
The bolus dose delivery can be interrupted at any time by pressing the
button.
RESTRICTIONS ON THE ADMINISTRATION OF BOLUS DOSES
If the bolus dose volume is set to 0.00 ml, pressing the
button will display the Er,d error message.
The administration of bolus doses is limited by the interval
between doses (temporal limitation).
By setting no,Lt you can disable this limitation.
Bolus doses cannot be administered during the interval
period observed by the function.
During the limitation period, if you request a bolus dose,
the display shows Er,t (temporal limitation between active
bolus doses).
NOTE
If all the hourly flows are set to F0, the display shows F0,00
with a flashing F. Pressing the
button temporarily displays
F0 with 0.00 ml/h.
ml/h
ml/h
Displaying the number of administered bolus doses
during an infusion and the NUMBER OF INFUSIONS
1 - To check the number of bolus doses administered by the
patient during an infusion while the pump is OFF or StoP,
button for a few seconds and the
press and hold the
value will be displayed (nd = number of doses).
2 - To check the number of infusions delivered by the device
(PC = partial counter) while it is OFF or StoP, press and
button for about 8 seconds.
hold the
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MAN 01/EN/03 CRONO PAR 50 06/13
Auto
SECTION 14
WARNINGS
• The number of the administered bolus doses is only available until the beginning of a new infusion; switching the pump on for a new infusion automatically
resets the value.
• The number of bolus doses includes those delivered by pressing the
button.
WITHDRAWING THE Pusher
1. Withdrawal of the pusher before the end of the infusion
This function allows the interruption of an active infusion, withdrawing the
pusher to the start position of the infusion.
To stop an active infusion, do the following:
• switch the pump off by pressing the
button;
• press the
and
buttons together: the display shows
End for 10 seconds and then begins to withdraw the pusher;
• during the 10 seconds that the display shows End you can
button.
cancel the withdrawal request by pressing the
2. Withdrawal of the pusher at the end of the infusion
Ten minutes before the end of the infusion, the device gives
an intermittent beep for 2 seconds. This signal is repeated
twice at 5 minutes from the end of the infusion.
At the end of the infusion an intermittent beep is given and
the display shows End.
After a few seconds, the pusher starts withdrawing until it
reaches the start position of the infusion.
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MAN 01/EN/03 CRONO PAR 50 06/13
Auto
SECTION 14
NOTES
• While the display shows End, the withdrawal function can
button. The display shows
be cancelled by pressing the
StoP.
• The withdrawal function can be interrupted by pressing
button. The display then alternates between End
the
and OFF. At this point the only active button is the
button. When you press again the pump recommences the
withdrawal of the pusher.
Pusher in motion
While the pusher is in a continuous withdrawal motion, the
display shows the “pusher continuous withdrawal” indication.
NOTE
The pusher withdrawal time for a 50 ml volume is approx 6 minutes, and is
proportionately less for lower volumes.
WARNING
Do not remove the reservoir until the pusher has been withdrawn to the infusion
start position.
SWITCHING OFF THE PUMP
To switch off the device, press the
button. The display
will show StoP. If the pump is switched off during an infusion, the device will emit a series of 10 short beeps every
10 seconds, and the display will flash the StoP message.
button.
To suppress the audible signals, press the
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MAN 01/EN/03 CRONO PAR 50 06/13
Auto
SECTION 14
DISPLAYING THE SETTINGS
This function displays the programmed pump settings.
To display the pump settings, the pump must be set to OFF
or StoP.
If the settings are displayed when the settings lock is set to
L0 (settings lock off) the settings flash, and can be modified.
If the setting are displayed when the settings lock is set to
L1 (settings lock on, with the display showing the "lock"
indicator), the parameters do not flash and are not modifiable
(with the exception of the time - see page 61).
Proceed as follows:
1. press the
button for about 4 seconds: the display shows the time;
2. do not press any button for about 20 seconds, and the display will go back
to OFF or StoP;
button again to show the other settings in sequence: hours,
3. press the
minutes, bolus dose volume, interval between bolus doses, flow rates,
flows over the daily 24-hour period and partial volume.
NOTES
• When the settings lock is on (L1), you can, if needed, change the time settings using the following procedure:
button for about 1 second: the display shows the flashing hour
1. press the
and minute settings;
button. The hour value begins to flash and you can change
2. press the
the hour and minute settings. This function can be used, for example, if you
transfer to a different time zone.
• To display the flows assigned over the daily 24-hour period, press the
button.
76
MAN 01/EN/03 CRONO PAR 50 06/13
SECTION 15
RESERVOIR PARTS
The CRONO PAR 50 pump uses dedicated 50 ml reservoirs, model CRN®
CRONO® Syringe.
The reservoirs are: single-use, non-pyrogenic to be used only if the packaging is undamaged.
Needle
Piston
Reservoir body
Needle cover
Luer-Lock cap
Stem
Warning
For safety reasons, you are recommended to use the original CRN® reservoirs Crono® Réservoir.
The use of any other type of reservoir could damage the pump and harm the
patient.
Canè S.p.A. disclaims all responsibility if the device is used with a non-original reservoir different from that recommended.
77
MAN 01/EN/03 CRONO PAR 50 06/13
SECTION 15
LUER-LOCK CAP FUNCTIONS
•After the reservoir has been filled, the cap
facilitates the unscrewing of the stem, avoiding spillage of the pharmaceutical;
•it facilitates the correct connection between
the pump pusher and the rubber piston of the
reservoir;
•it protects the drugs inside the reservoir in
case it is not used immediately.
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MAN 01/EN/03 CRONO PAR 50 06/13
SECTION 15
INFUSION SET
You are recommended to use an infusion set with the following characteristics:
• internal volume of reduced tube (ideal 0.1 ml, maximum 0.62 ml);
• tube length not more than 90 cm;
• anti-kink tubing.
INFUSION SET PARTS
Female Luer-Lock connector
Adhesive
Needle
Needle cover
Tube
NOTE
The images show the NeriaTM, infusion set from Unomedical, a Convatec
Company.
FILTRAJET
For a safe infusion you are recommended to use a filter in order to:
• prevent bacterial infections;
• eliminate air from the reservoir and the infusion set;
• capture micro-particles such as those from glass or plastic.
Luer-Lock cap
Male
Luer-Lock connector
Female
0.2 micron filter
Tube set @ 1 x 2.3
PVC-NO DOP
Capsule
Luer-Lock connector
Blue, male
79
MAN 01/EN/03 CRONO PAR 50 06/13
SECTION 15
PREPARING THE RESERVOIR AND CONNECTING TO THE PUMP
1. Screw
the needleTHE
into the
reservoir in a clockwise direction and remove the
PREPARING
RESERVOIR
needle cover;
2. fill the reservoir, aspirating the liquid slowly and checking that the quantity
of the drug does not exceed its capacity or any partial volume you may have
set;
3. screw the Luer-Lock cap to the reservoir (a) and then unscrew the stem,
rotating it counter-clockwise (b) with a fairly rapid movement;
4. connect the reservoir to the pump; the rubber piston will be inserted into
the pusher. Rotate it clockwise through 90° and it will click and engage with
the pusher;
5. insert the cone of the infusion set over the reservoir.
a
b.
1
2
3
4
5
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MAN 01/EN/03 CRONO PAR 50 06/13
SECTION 15
CONNECTION OF THE RESERVOIR TO THE PUMP
Insert the dedicated CRN reservoir into the pump and engage it by rotating it
90° clockwise; a click confirms it has engaged.
1
2
Front view of the pump
1
2
3
4
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SECTION 15
Warning
1 - Before filling the reservoir
Unscrew and screw back the piston rod to facilitate its unscrewing after you have filled the
reservoir.
2 - Filling the reservoir
The liquid must be aspirated slowly.
Do not fill the reservoir more than the maximum level allowed of 50 ml.
The rod must be unscrewed with a fairly rapid
movement.
3 - Connection of the reservoir to the pump
To avoid any leakage of the drug while the
reservoir is being connected to the pump, you
can use the infusion set, as an alternative to
the Luer- Lock cap indicated on page 78.
While connecting the reservoir to the pump,
hold them as shown in the figure.
When making the connection, avoid exerting
any pressure on the reservoir walls, because
this could cause liquid to leak past the piston
rings.
While filling the reservoir and connecting it to
the pump, a small leakage might occur between the first and second rings on the rubber
piston. This does not compromise either the
correct working of the reservoir or the delivery
of the drug.
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SECTION 15
INFUSION SITES
The images below show the recommended infusion sites.
You are recommended to change the injection site after every infusion to
avoid skin irritations.
FRONT
BACK
PREPARING FOR THE INFUSION
Before preparing for the infusion, you are recommended to adopt the following precautions:
1. wash your hands;
min
h
d
0.2
ml
OFF
JET
MICRO
CRONO
2. prepare a clean working environment.
WARNINGS
•Always work in antiseptic conditions, to reduce the risk of infection to the
minimum.
•Warning, apomorphine stains clothing and objects.
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MAN 01/EN/03 CRONO PAR 50 06/13
SECTION 15
The images refer to the NeriaTM infusion set
from Unomedical, a Convatec Company.
Disinfect the infusion site following the
instructions of the relevant medical personnel.
Ensure that the area of the infusion site is dry
before inserting the subcutaneous needle.
Connect the infusion set to the reservoir.
Hold the infusion set by the wings. Prime the
infusion line manually or use the priming function of the pump (Auto). Ensure there are
no air bubbles in the infusion line.
WARNING
When you are priming the infusion line and
are preparing to insert the needle below the
skin, hold the set with the needle pointing
downwards to ensure that none of the drugs
can come into contact with the protecting
adhesive paper.
Remove the protective adhesive paper.
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MAN 01/EN/03 CRONO PAR 50 06/13
SECTION 15
Remove the needle cover, extracting it with
care, before inserting the needle.
WARNING
Be careful not to touch the NeriaTM needle
when you remove the protection.
It is important to lift a fold of skin, to reduce
the risk of positioning the needle in a muscle.
Pinch the skin with your fingers at the chosen infusion site before inserting the needle,
which you do by taking the protective wings
of the infusion set with the other hand and
inserting the needle vertically.
Press firmly on the adhesive to fix it to the skin.
Check the infusion site frequently to ensure
that the needle remains in the correct position.
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SECTION 16
HOW TO USE THE SUPPLIED STANDARD EQUIPMENT
The following figures give an indication of how to use the standard accessories supplied with the pump.
PUMP CARRIED AROUND THE NECK
The pump worn with a collar strap and a fabric case.
FASTENING THE PUMP COLLAR STRAP
1
2
3
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MAN 01/EN/03 CRONO PAR 50 06/13
SECTION 16
WEARING THE PUMP AT THE WAIST
The pump worn with an elastic belt and a fabric case.
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SECTION 17
GENERAL WARNINGS
The device can be damaged by liquid, so it must not be kept on while in the
bath or the shower, etc. If the device is accidentally made wet, (for example,
with drops of the drug, or by bedwetting), you must ensure it is checked by
the Canè S.p.A. Service Centre.
The device must be kept away from:
- sources of heat (radiators, gas rings, stoves);
- the direct rays of the sun;
- strong electromagnetic fields (magnets, loudspeakers, mobile devices), de-
tails are supplied in APPENDIX 6;
- ionizing radiation;
- ultrasound devices;
- MRI devices.
The device does not need sterilising.
Do not freeze the CRN reservoir with the drug still in it.
The device must not be placed in a fridge or freezer.
The device must not be placed in an oven or microwave.
Reservoirs, infusion sets, needles, filters and all consumables must be disposed of in an appropriate way, using containers designed for this purpose.
If you do not observe the above warnings, the device could malfunction, with potentially serious consequences for the user.
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SECTION 17
MANUAL UPDATES
The version and the date of publication of this User Guide are given on every
page. When a year has passed between the publication date (given on page
3) and the use of the product, the doctor should contact Canè S.p.A. to determine if a more recent version of the manual has been published.
MAINTENANCE
The technical characteristics of the device make it extremely simple to maintain.
If the device is damaged, you are recommended to have it checked by the
Canè S.p.A. Customer Support Service before re-using it.
The external surfaces can be cleaned with a lightly dampened soft cloth,
using a mild detergent or disinfectant.
GENERAL WARNINGS
• Do not immerse the pump in detergent solutions or water.
• Avoid getting liquids inside the pump. If the device gets wet, immediately try
to dry it with absorbent paper.
• Do not clean the pump with acetone, solvents or abrasive detergents.
• Do not sterilise the pump.
STORAGE
If the device is not used for a period of more than one or two months, you are
recommended to remove the battery and put the pump away in its case in a
dry place at room temperature.
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SECTION 17
DISPOSAL
At the end of the expected life of the pump, contact Canè S.p.A. Customer
Support Service which will provide you with necessary instructions about the
disposal of the device.
Reservoirs, infusion sets, needles, filters and all consumables must be disposed of in an appropriate way, using containers designed for this purpose.
EXPECTED PUMP LIFE
The pump is expected to last for 4 (four) years from its purchase date. For
safety reasons you should not continue to use it after this period.
SUPPORT
The device must only be repaired by Canè S.p.A. Customer Support
Service. You are recommended, before sending the device, to contact:
• Servizio Assistenza Clienti (Customer Support Service)
Canè S.p.A. Medical Technology
Via Cuorgnè, 42/a
10098 Rivoli (Turin) - Italy
Tel. +39.011.9574872
Fax +39.011.9598880
• Canè S.p.A. Online
Internet: www.canespa.it - E-mail: service@canespa.it
Service available Monday to Friday from 8.30 to 17.00.
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SECTION 17
GUARANTEE
Canè S.p.A. guarantees that the product is free from any material or manufacturing defects for a period of 2 (TWO) YEARS from the original date of
purchase.
If, in the course of this guarantee period, any material or manufacturing defects are identified, Canè S.p.A. will repair or substitute the defective components according to the terms and conditions herein, without any charge for
labour or parts; the client is responsible for the costs of sending the pump to
the Canè S.p.A. Customer Support Service.
Canè S.p.A. reserves the right to change the characteristics or model of its
devices, without being under any obligation to make corresponding modifications to devices already manufactured and sold.
Conditions:
1. The guarantee is valid only if the defect is reported within the period of the
guarantee.
2. This guarantee does not extend to any costs and/or defects following modifications or adaptations made to the product, without prior written authorisation by Canè S.p.A.
Canè S.p.A. disclaims all responsibility either to the purchaser or to third
parties for damage that occurs to persons or things as a result of improper
operation of the device, for uses of the device for which it was not designed
and for the non-observance of the instructions provided in the User Guide.
The purchaser undertakes to indemnify Canè S.p.A. from any claims by third
parties with respect to the above.
3. This guarantee is not valid if the model or serial number of the product have
been modified, erased, removed or have in any way been made illegible.
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SECTION 17
4. The following are excluded from the guarantee:
• periodic maintenance
• damage consequent to improper use, including but not limited to:
- incorrect power supply;
- use of the product for purposes other than those for which it is designed;
- repairs performed by unauthorised personnel or by the Customer;
• accidental and unintentional events, such as liquid spills and falls;
• natural events and malicious or negligent acts;
• the standard equipment supplied with the pump.
5. Canè S.p.A. undertakes to perform repairs on the device for a period of
not more than 4 (four) years from the date of purchase.
After that period, Canè S.p.A. has no further obligations to make repairs.
Canè S.p.A. disclaims all responsibility either to the purchaser or to third
parties for damage that occurs to persons or things as a result of the use of
the device after 4 (four) years from the date of purchase.
6. After the guarantee period is expired, support will be provided by Canè
S.p.A. with the customer bearing the subsequent costs of replaced parts,
labour and transport in effect at the time.
7. The company disclaims any liability with respect to the patient and/or third
parties for any health problems and/or inconvenience resulting from the period when the device is being repaired.
8. The company disclaims any liability with respect to the patient and/or third
parties for any problems and/or delays associated with the shipping of the
device.
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SECTION 17
DECLARATION OF CONFORMITY
0476
The company Canè S.p.A., with headquarters in Via Cuorgnè, 42/a
10098 Rivoli (Turin) - Italy, manufacturer of the medical device CRONO
PAR 50 ambulatory infusion pump with reservoir for drug administration,
Serial no.
declares that the device conforms to the essential requirements of Appendix I of Directive 93/42/CE, modified by Directive 2007/47/CE, as
per certificate MED 9813 provided by the Notifying Body no. 0476 according to Appendix II of the same Directive, and is released to the
market in compliance with the corresponding laws of the individual European member states.
Rivoli, 12/07/2012
The Chairman
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MAN 01/EN/03 CRONO PAR 50 06/13
APPENDICES
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MAN 01/EN/03 CRONO PAR 50 06/13
APPENDIX 1
ICONS USED ON THE PUMP
SN
IP 42
Serial no. of the pump
IP protection rating
1st digit (4) = protection from solid objects larger than 1 mm.
nd
2 digit (2) = protection from water droplets sprayed at an angle up to 15º degrees.
CE marking
0476
Electro-medical device
Type BF
Warning: read instructions before use
Sorted waste collection for
electrical and electronic devices
In accordance with article 13 of Legislative Decree no. 151 of 25
July 2005 “Implementation of Directives 2002/95/EC, 2002/96/EC
and 2003/108/EC concerning the restriction of the use of certain
hazardous substances in electrical and electronic equipment,
as well as the disposal of waste.”
The symbol of the crossed out waste bin on the product and its packaging indicates that at the end of its useful life, the product must be disposed of separately
from other waste. Sorted waste disposal of products at the end of their life is organised and managed by the manufacturer. Users wishing to dispose of this device
must therefore contact the manufacturer (or the appropriate local distributor) and
use the system which has been devised to allow for the separate disposal of devices at the end of their life. A proper differentiated collection system for devices
destined for recycling, treatment and environmentally compatible disposal helps
reduce the potentially negative impacts on the environment and health, and facilitates the re-use or recycling of the materials from which the device is constructed.
The illegal disposal of a product is punishable according to the laws currently in
force.
Note: The symbol displayed on the product label is, for obvious reasons of space,
reduced and simplified with respect to the specifications in the reference standard
CENELEC EN50419.
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MAN 01/EN/03 CRONO PAR 50 06/13
APPENDIX 1
ICONS USED ON THE Reservoir BLISTER PACK
i
0123
Read the instructions
CE marking
Recyclable
2
Use only once
PYROGEN
Non-pyrogenic
Keep dry
Keep away from sunlight
Expiry date
STERILE EO
Sterilised with ethylene oxide
PP
Polypropylene
LOT
Batch code
REF
Reference no.
NEEDLE
Needle size
96
MAN 01/EN/03 CRONO PAR 50 06/13
APPENDIX 2
OPTIONAL ACCESSORIES AVAILABLE ON REQUEST
1. Vertical leatherette case, similar to a mobile phone case.
Detail of
belt clip
Detail of opening system
with aperture for infusion set
Colours:
Dimensions: 16 x 5.5 x 4 cm
Weight: about 60 g
Item code: CM/17/A
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MAN 01/EN/03 CRONO PAR 50 06/13
APPENDIX 2
2. Horizontal leatherette case, similar to a spectacle case.
Detail of belt clip
Colours:
Dimensions: 16 x 5.5 x 4 cm
Weight: about 50 g
Item code: CM/22/A
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MAN 01/EN/03 CRONO PAR 50 06/13
APPENDIX 3
3. Adjustable elastic belt with buckle.
1
2
3
Colour: black
Dimensions: 110 cm
Weight: about 50 g
Item code: CM/31
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MAN 01/EN/03 CRONO PAR 50 06/13
APPENDIX 3
PRECISION TEST (TRUMPET CURVE)
The tests have been performed according to IEC 60601-2-24, Electro-medical devices, Part 2: Particular requirements for the safety of infusion pumps
and controllers. The following graphs show the precision of the pump during
the administration of the drug.
Flow rate [ml/h]
1.1 – Start-up flow
• Flow rate setting: 1 ml/h.
Elapsed time [min]
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MAN 01/EN/03 CRONO PAR 50 06/13
APPENDIX 3
TRUMPET CURVE
Flow rate error percentage
1.2 - Flow rate error (trumpet curve)
• Flow rate setting: 1 ml/h.
Observation interval (min)
The actual degree of precision may differ from that indicated in this manual,
depending on the type of accessories and extension tubes used in the administration line of the drug.
Legend:
Ep(max.) = maximal percentage variations.
Ep(min.) = minimal percentage variations.
A(mean.) = mean percentage variations.
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MAN 01/EN/03 CRONO PAR 50 06/13
APPENDIX 4
PRESSURE LEVELS (PL)
The CRONO PAR 50 pump allows the medical/paramedical and clinical engineering personnel, as well as the distributor, to set the occlusion pressure
level (PL).
The device is provided with the occlusion pressure level set to PL2 (2.2 bar
+/-1).
This level may be insufficient for the demands of the patient and/or for the
technical specifications of the infusion line (e.g. the device signals constant
occlusion conditions), or it may be too high (infusion line not designed for the
set pressure value). In this case the pressure can be decreased by setting
PL1 (1.8 bar +/- 0,8) or increased by setting PL3 (3.2 bar +/-1,2).
NOTE
Pressure level summary table.
LEVEL
PL1
PL2
PL3
PRESSURE
1.8 bar +/- 0.8.
2.2 bar +/- 1
3.2 bar +/- 1.2.
WARNINGS
• Information on the selection of the pressure level (PL) is available in APPENDIX 10 “ACCESSING RESERVED SECTION”, and must not be provided
to the patient.
• Changing the occlusion pressure will vary the time needed to signal an occlusion and the post-occlusion bolus volume, as indicated in the enclosed tables.
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APPENDIX 5
TIME NEEDED TO SIGNAL AN OCCLUSION
APPENDIX 2
The time needed to signal an occlusion is the interval between the beginning
of the occlusion condition and the recognition of the condition by the pump.
This value depends on the flow rate, because the lower the flow rate, the longer will be the time needed by the pump to recognise the occlusion condition.
The values given here consider the time needed jointly by the pump and the
reservoir to signal the occlusion.
Flow rate
0.2 ml/h
1 ml/h
5 ml/h
PL1
Time needed to signal an occlusion
About 5 h 15 min
About 50 minutes
About 10 minutes
Flow rate
0.2 ml/h
1 ml/h
5 ml/h
PL2
Time needed to signal an occlusion
About 6 h 50 min
About 1 h 15 min
About 15 minutes
Flow rate
0.2 ml/h
1 ml/h
5 ml/h
PL3
Time needed to signal an occlusion
About 7 h 45 min
About 1 h 30 min
About 20 minutes
WARNINGS
• The time needed to signal an occlusion is dependant on the flow rate, because the lower the flow rate, the longer will be the time needed by the pump
to activate the occlusion alarm.
• The time needed to signal the occlusion can increase if there is air in the
line, if you are using catheters, filters and extension tubes of other dimensions, or in an elastic material, or when the line from the pump is connected
to other devices.
• For patients who could suffer severe harm if there is an interruption in the
administration of the drug by the pump, arrangements must be made for them
to be under the strict supervision of a doctor who can take any immediate
corrective action required.
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APPENDIX 6
POST-OCCLUSION BOLUS
When the occlusion alarm sounds, the pump has detected an excessive back
pressure in the infusion line. This back pressure must be removed in order to
avoid releasing a post-occlusion bolus, which might cause serious harm to
the patient. The volume of a CRONO PAR 50 post-occlusion bolus, considering only the combined volume of the pump and the reservoir, is:
• about 1.0 ml (PL1);
• about 1.2 ml (PL2);
• about 1.5 ml (PL3).
WARNINGS
• The volume of the bolus dose released post occlusion can increase if there
is air in the line, if you are using catheters, filters and extension tubes of other
dimensions or of a softer material, or when the line from the pump is connected
to other devices.
• After the occlusion alarm sounds, take any and all measures appropriate to
avoid the administration of a post-occlusion bolus to the patient.
• Patients who might suffer severe harm from the accidental release of a postocclusion bolus must receive adequate instructions and/or training from medical
or paramedical personnel on how to proceed in such a situation.
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APPENDIX 7
ELECTRO-MAGNETIC COMPATIBILITY
The electro-magnetic compatibility tests were performed in compliance with the
standards:
• IEC 60601-2-24:2012, Medical electrical equipment, Part 2: Particular requirements
for the safety of infusion pumps and controllers;
• IEC EN 60601-1-2 Ed. 2, Medical electrical equipment, Part 1: General requirements
for basic safety and essential performance – collateral standard: Electromagnetic
compatibility – Requirements and tests.
Guide and declaration by the manufacturer - electro-magnetic emissions
CRONO PAR 50 is designed to operate in the electromagnetic environment specified below.
The client or user of the CRONO PAR 50 must ensure that it is operated in such an environment.
Emission test
Compliance
Electro-magnetic environment - guide
CISPR 11 RF emissions
Group 1
CRONO PAR 50 uses RF energy only for its
internal operation. As a consequence, its RF
emissions are very low and would thus not be
expected to cause any interference to electronic
devices in the vicinity.
Emissions in
RF CISPR 11
Class B
Harmonic emissions
IEC 61000-3-2
N/A
IEC 61000-3-3 emissions
in the event of voltage
fluctuations or flicker
N/A
CRONO PAR 50 is designed for use in all environments, including domestic environments and
those environments directly linked to the low voltage mains supplying residential buildings.
Guide and declaration by the manufacturer - electro-magnetic immunity
CRONO PAR 50 is designed to operate in the electromagnetic environment specified below.
The client or user of the CRONO PAR 50 must ensure that it is operated in such an environment.
Immunity test
IEC 60601
test level
Level of
compliance
IEC 61000-4-2
electro-static
discharge
(ESD)
15 kV in air, 8
kV on contact
15 kV in
air, 8 kV on
contact
Electro-magne400 A/m
tic fields
50 and 60 Hz
400 A/m
50 and 60
Hz
Electromagnetic environment - guide
The flooring must be wood, concrete
or ceramic. If the floor is covered in a
synthetic material, the relative humidity
must be at least 30%.
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APPENDIX 7
Guide and declaration by the manufacturer - electro-magnetic immunity
CRONO PAR 50 is designed to operate in the electromagnetic environment specified below. The client or user of the CRONO PAR 50 must ensure that it is operated in such an
environment.
Immunity
test
IEC 60601 test level
Level of
compliance
80-2500 MHz 10V/m
AM 80% 1 KHz
10V/m
20-80 MHz 10V/m
AM 80% 1 KHz
10V/m
Radiated
immunity
Electromagnetic environment guide
Interference could occur in the vicinity of devices marked with the following symbol:
Recommended separation distance between mobile and portable radio
communication devices and the CRONO PAR 50
CRONO PAR 50 is designed to operate in an electromagnetic environment in which radiated RF disturbances are under control. The client or user of the CRONO PAR 50 can help
prevent electromagnetic interference by ensuring a minimum distance between mobile and
portable communication devices using RF (transmitters) and the CRONO PAR 50 as recommended below, relative to the maximum output power of the radio-communication devices.
Maximum specified
output power of
transmitter (W)
150 kHz to 80 MHz
80 MHz to 800 MHz
0.01
1.2
0.12
0.1
3.8
0.38
1
12
1.2
10
38
3.8
100
120
12
Separation distance at the transmitter frequency (m)
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MAN 01/EN/03 CRONO PAR 50 06/13
APPENDIX 8
REFERENCE DIRECTIVES
• Council Directive 93/42/EEC: Medical devices.
• Legislative Decree no. 46, 24th February 1997. Implementation of Council
Directive 93/42/EEC concerning medical devices.
• Directive 2007/47/EC of the European Parliament and of the Council:
Amending Council Directive 90/385/EEC on the approximation of the laws of
the Member States relating to active implantable medical devices, Council
Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market.
• Legislative Decree No. 37, 25 January 2010. Implementation of Directive
2007/47/EC.
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MAN 01/EN/03 CRONO PAR 50 06/13
APPENDIX 8
TECHNICAL STANDARDS
• IEC EN 60601-1:2007-05. Medical electrical equipment, Part 1: general
requirements for basic safety and essential performance.
• IEC EN 60601-1/EC:2010-05. Medical electrical equipment, Part 1: general
requirements for basic safety and essential performance.
• IEC EN 60601-1-1:2003-06. Medical electrical equipment, Part 1: general
requirements for basic safety and essential performance – collateral standard:
Safety requirements for electromedical systems.
• IEC EN 60601-1-2/A1:2006-10. Medical electrical equipment, Part 1: general
requirements for basic safety and essential performance – collateral standard:
Electromagnetic compatibility – Requirements and tests.
• IEC EN 60601-1-2:2010-01. Medical electrical equipment, Part 1: general
requirements for basic safety and essential performance - collateral standard:
Electromagnetic compatibility – Requirements and tests.
• IEC EN 60601-1-4:1997-08. Medical electrical equipment, Part 1: general
requirements for basic safety and essential performance – 4. Collateral standard: Programmable electromedical systems.
• IEC EN 60601-1-4/A1: 2000-06. Medical electrical equipment, Part 1: general
requirements for basic safety and essential performance – collateral standard:
Programmable electromedical systems.
• IEC EN 60601-1-8:2009-11. Medical electrical equipment, Part 1: general
requirements for basic safety and essential performance – collateral standard:
Alarm systems - General requirements, tests and guidance for alarm systems
in medical electrical equipment and electromedical systems.
• IEC EN 60601-1-11:2011-07. Medical electrical equipment, Part 1: General
requirements for basic safety and essential performance - Collateral Standard:
Requirements for medical electrical equipment and medical electrical systems
used in the home healthcare environment.
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MAN 01/EN/03 CRONO PAR 50 06/13
APPENDIX 8
• IEC EN 60601-2-24:2012-10. Medical electrical equipment, Part 2: particular
requirements for the safety of infusion pumps and controllers.
• IEC EN 60529: 1997-06. Degrees of protection provided by enclosures (IP
Code).
• IEC 62-108: 2000-05. User Guide to the maintenance of infusion pumps and
control systems.
• IEC EN 62353:2008-11. Medical electrical equipment - recurrent checks and
tests after repair of medical electrical equipment.
• IEC 62-122: 2002-07. User Guide to acceptance testing and periodic maintenance of the safety and/or performance of medical devices powered by a
specific power source.
• IEC 62-143: 2007-05. Table of correspondence between articles (clauses) in
publication IEC 60601-1:2006 and those of its 1988 edition, and its subsequent
modifications.
• IEC EN 62304:2006-10. Medical device software – Software life cycle processes.
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MAN 01/EN/03 CRONO PAR 50 06/13
APPENDIX 9
SETTINGS
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APPENDIX 10
ACCESSING RESERVED SECTION
You can access additional reserved functions of the
pump, such as: resetting the number of partial infusions,
displaying the number of total infusions, displaying the
firmware version of the pump, setting the occlusion
pressure threshold, setting the date and time.
Procedure:
button for about 7
1 - with the device OFF, press the
seconds, until the display shows first the number of bolus
doses administered (nd) during the last infusion, followed
by the number of partial infusions (PC) delivered;
2 - press the
button (without releasing the
button),
and the number of infusions starts to flash. Release both
button again. In this phase the
buttons and press the
arrow indicating PROG is displayed and you can choose
one of the following:
a) reset the partial infusion counter to zero by pressing
the
or
button, or,
b) continue programming or displaying by pressing the
button, as follows.
PROG
button again and the display will show
3 - Press the
the total number of infusions.
4 - Press the
button again and the display will show
the firmware version (release).
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APPENDIX 10
5 - Press the
button again to display the flashing occlusion pressure level: you can select one of the three
available levels (PL1, PL2, PL3) by pressing buttons
or
.
button once more, it is possible to
6 - By pressing the
set the current time by changing the two flashing digits
on the left of the drop icon.
button it is possible to
By subsequently pressing the
set the two flashing digits on the right of the drop icon,
that represent the minutes.
PROG
PROG
PROG
You can select the desired hours and minutes values by
or
.
pressing the buttons
button once more, it is possible to
7 - By pressing the
set the date by changing the two flashing digits displayed
on the left, which represent the day.
PROG
button it is possible
By subsequently pressing the
to set the two flashing digits on the right, that represent
the month.
PROG
button it is possible to
By subsequently pressing the
set the four flashing digits that represent the year.
PROG
You can select the desired day, month and year by presor
.
sing the buttons
8 - If you do not press any button for 20 seconds, the
selected year (or any other previous parameter) will
become steady, the pump exits the reserved functions
mode and the display shows OFF/StoP.
NOTE
If you keep pressing either the
or the
quickly change the hours and minutes.
button, it is possible to
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APPENDIX 11
INFORMATION
For further information on the CRONO PAR 50 pump, contact:
Servizio Assistenza Clienti (Customer Support Service)
Canè S.p.A. Medical Technology
Via Cuorgnè, 42/a
10098 Rivoli (Turin) - Italy
Tel. +39.011.9574872
Fax +39.011.9598880
Internet: www.canespa.it E-mail: service@canespa.it
Service available Monday to Friday from 8.30 to 17.00.
NOTES
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114
MAN 01/EN/03 CRONO PAR 50 06/13