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NEW MODEL

CRONO 50 SCAmbulatory infusion pump

USER GUIDE FOR THE PATIENT

Manual code: MAN 01/EN/00 P CRONO 50 SCPublication date: 05/14

CANè S.p.A. Medical TechnologyVia Cuorgnè 42/a 10098 Rivoli (TO) Italy

Tel.+39 011 9574872 - Fax +39 011 9598880www.canespa.it - [email protected]

3

4MAN 01/EN/00 P CRONO 50 SC 05/14

SECTION 1Symbols and conventions................................................. page 8

SECTION 2Introduction ....................................................................... page 9Warnings .......................................................................... page 10Information – Support ....................................................... page 10

SECTION 3Intended use ..................................................................... page 11Pump description .............................................................. page 13Infusion system................................................................. page 13Technical features............................................................. page 14Factory settings ............................................................... page 16

SECTION 4Supplied standard equipment ........................................... page 17

SECTION 5Pump parts ....................................................................... page 18

SECTION 6LED................................................................................... page 19Control buttons ................................................................. page 19

SECTION 7Liquid Crystal Display (LCD) ............................................ page 20

SECTION 8Low battery alert ............................................................... page 22Replacing the battery........................................................ page 22

CONTENTS

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SECTION 9Errors and faults ............................................................... page 25Infusion set occlusion ....................................................... page 27Post-occlusion bolus......................................................... page 27Pump initialisation............................................................. page 28

SECTION 10Quick reference ................................................................ page 29

SECTION 11Pump settings sequence .................................................. page 33Setting the flow rate .......................................................... page 34Setting the bolus dose volume ......................................... page 35Setting the minimum interval between bolus doses ......... page 36Setting the maximum number of bolus doses deliverablein an hour.......................................................................... page 37Setting the partial volume ................................................. page 38Switching on the pump ..................................................... page 40Priming the infusion set tube ............................................ page 41The pump in use ............................................................... page 43Bolus dose ........................................................................ page 44Restrictions on the administration of bolus doses ............ page 45End of the infusion ............................................................ page 46Withdrawing the pusher .................................................... page 47Switching off the pump ..................................................... page 48Displaying the settings...................................................... page 49Displaying the volumes administered ............................... page 50Resetting the number of bolus doses administered to zero .. page 51

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SECTION 12Reservoir parts ................................................................. page 52Luer-Lock cap functions ................................................... page 53Infusion set ....................................................................... page 53Filtrajet .............................................................................. page 53Preparing the reservoir and connecting to the pump ....... page 54Connecting the reservoir to the pump .............................. page 55Infusion sites..................................................................... page 57Preparing for the infusion ................................................. page 57

SECTION 13How to use the supplied standard equipment .................. page 58Fastening the collar strap to the pump ............................. page 58

SECTION 14GENERAL WARNINGS .................................................... page 60User guide updates .......................................................... page 61Maintenance ..................................................................... page 61Storage ............................................................................. page 61Disposal ............................................................................ page 62Expected pump life ........................................................... page 62Support ............................................................................ page 62Guarantee ........................................................................ page 63EC Declaration of Conformity ........................................... page 65

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APPENDICESAppendix 1........................................................................ page 67Appendix 2........................................................................ page 69Appendix 3........................................................................ page 71Appendix 4........................................................................ page 75Appendix 5........................................................................ page 78Appendix 6........................................................................ page 80Appendix 7........................................................................ page 81Appendix 8........................................................................ page 83

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To assist you in using the manual, the following symbols and conventions have been used:

Triangle containing an exclamation markThis “WARNING” icon indicates something that must always be taken into consideration for the safe use of the pump.

NotepadThis icon indicates a “NOTE” containing additional information or useful tips about the use of the pump.

Flashing symbolThe graphic symbol shown in the manual above the image of the pump display, indicates that the number or the character below is flashing.

SYMBOLS AND CONVENTIONS

SECTION 1

This manual is divided into 5 parts:

Part 1 (red): sections 1 to 9, general information, technical specifications and warnings.

Part 2 (blue): sections 10 and 11, which describes the device functions.

Part 3 (orange): section 12, which describes the reservoir, the preparation and insertion of the reservoir into the pump, the infusion sites and preparation for an infusion.

Part 4 (purple): sections 13 and 14, giving general warnings and a descrip-tion of the supplied standard equipment, as well as discussing maintenance, disposal and support. It also details the guarantee and the EC declaration of conformity.

Part 5 (grey): appendices page 67 to page 84.

9MAN 01/EN/00 P CRONO 50 SC 05/14

INTRODUCTIONThank you for choosing the CRONO 50 SC ambulatory infusion pump.

The instructions provided are only applicable to the CRONO 50 SC ambulato-ry infusion pump. They are intended for use by the medical and paramedical personnel who need to initially set up the pump.

If any of the information is not clear, or in case of any doubts or questions, please contact the CANè S.p.A. Customer Support Service.

Incorrect use of the pump, or failure to follow the instructions and warnings provided in this manual could cause serious injury.

The instructions provided in this manual are essential for the safe and correct use of the pump. Users are advised to read the whole manual before using the device and to keep it in a safe place for future reference.

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 specifi-cations described in this manual at any time and without notice.

SECTION 2

10MAN 01/EN/00 P CRONO 50 SC 05/14

NOTES• In order to ensure this manual is complete and accurate as possible, pleasereport any errors or omissions to the following e-mail address: [email protected].

• CANè S.p.A. reserves the right to modify and/or update this manual at any time and without notice.

SECTION 2

INFORMATION

For further information on the CRONO 50 SC pump, contact:

Servizio Assistenza Clienti (Customer Support Service)CANè S.p.A. Medical TechnologyVia Cuorgnè, 42/a 10098 Rivoli (Torino) - ItalyTel. +39.011.9574872Fax +39.011.9598880www.canespa.it e-mail: [email protected]

Service available Monday to Friday from 8.30 to 17.00.

This pump should not be used by patients who are unable to follow and understand the instructions supplied herein or perform basic operations and regular maintenance of the pump.

WARNING: CONTRAINDICATIONS

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SECTION 3

The CRONO 50 SC ambulatory infusion pump has been designed for treating chronic and post-operative pain, and for subcutaneous infusions in general.

The CRONO 50 SC pump must not be used for life support therapy.

CANè S.p.A. disclaims any liability for the administration of drugs by other methods and for different therapies.

The manufacturer accepts liability for the safety and correct operation of the device, provided that it is used in accordance with the instructions herein and that all required repairs and/or modifications are carried out by the manufac-turer.

The use of incorrect settings and/or incomplete understanding of the opera-tional functions and of the alarms could cause serious harm to the patient.

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.

The device must be used:- under the guidance of a doctor;- following appropriate procedures and adequate measures when dealing. With patients who could suffer serious consequences (injury or death) in the event of accidental operation and/or breakdowns which cause interruptions to the drug administration.

NOTE

WARNINGS

INTENDED USE

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SECTION 3

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 kinks, closed clamps or other occlusions in the line, and expel any air bub-bles.

The level of precision and time required to detect an occlusion may differ from the values indicated in this User guide according to the infusion line elements.

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.

To avoid any potential risks of over infusion due to gravity, do not posi-tion the pump higher than the infusion site.

This situation may cause severe harm to the patient.

If you have any doubts about the functioning of the pump and/or an error or fault occurs, stop using the device and contact the Customer Support Servi-ce.

CANè S.p.A. does not provide a replacement pump during the time required to carry out repairs; this service will be provided by your medical facility or your local distributor.

Any liquid on the pump casing must be removed immediately with absorbent paper.

It is important to establish a procedure and/or alternative to pumped infusion, in case the pump malfunctions. A second pump or an alternative method are a possible solution.

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 ex-pired and follow the instructions for its correct disposal.

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SECTION 3

CRONO 50 SC is an innovative new PCA pump that has been very well received by both patients and health professionals because of its technical characteristics and compact size. CRONO 50 SC is an ambulatory infusion pump for controlled administration of drugs in hospitalised patients or those undergoing home treatment.

The pump is indicated for subcutaneous use and allows for 4 administration methods:1. Continuous2. Bolus on request (PCA)3. Clinical bolus (managed by the doctor)4. Combined (continuous + bolus on request + clinical bolus)

The following diagram illustrates the different combinations of administration method.The pump is equipped with a settings lock to prevent incorrect or unauthorised administration.

The liquid crystal display shows practical information to the doctor and patient about the settings, operation and diagnostics of the pump.

PUMP DESCRIPTION

INFUSION SYSTEMThe pump administers 20 µl doses at intervals which depend on the flow rate chosen. If the scheduled flow rate increases, the time interval between doses decreases proportionally.

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SECTION 3

TECHNICAL FEATURESPump dimensions 84 x 55 x 42 mm (3.31 x 2.17 x 1.65 in).

Weight 139 g (4.47 oz.) (including battery).

Battery 3 Volt Lithium battery, mod. 123 A (battery life approximately 6 months).

Single-use reservoir Special 50 ml reservoir with “Luer-Lock” uni-versal safety fitting

Administration doses Selectable, from 1 ml to 50 ml in 1 ml incre-ments.

Priming function Only available at the start of the infusion. The maximum volume that can be delivered is

1.5 ml.

Flow rates Selectable From 0.05 to 35 ml/h in the following modes: - from 0.05 to 10 ml/h in 0,01 ml/h increments; - from 10 to 35 ml/h in 0.05 ml/h increments. It is possible to disable this function by setting 0 ml/h.

Bolus dose Selectable, from 0.10 ml to 10 ml in 0.02 ml in-crements. It is possible to disable this function by setting 0 ml.

Clinical bolus Selectable, from 0.10 ml to 10 ml in 0.02 ml in-crements. It is possible to disable this function by setting 0 ml.

Minimum interval between Selectable, from 5 min to 24 hours in thebolus doses following modes: - from 5 minutes to 1 hour in 5 minute increments; - from 1 hour to 24 hours in 15 minute increments. It is possible to disable this function by setting no,Lt.

Bolus doses deliverable From 0 to 12 bolus doses. The function may be in one hour disabled by setting no,Ln.

15MAN 01/EN/00 P CRONO 50 SC 05/14

Flow rate precision +/- 3%

Maximum occlusione 1.8 bar +/- 0.8 (PL1)pressure 2.2 bar +/-1 (PL2) 3.2 bar +/- 1.2 (PL3)

Time needed to signal See APPENDIX 4.an occlusion

Bolus dose released Approx. 0.8 ml (PL1) - 1.1 ml (PL2) - 1.3 ml (PL3) (details are given in APPENDIX 4).

Electronic circuit Electronic circuit managed by twin microcon-trollers with dedicated software.

Memory The settings are automatically entered in a flash memory which is retained even if the device is left without a battery.

Display Liquid crystal display (dimensions 1.1 x 2.8 cm).

Motor Coreless DC motor. The microcontroller con-trols the rotation speed using an infrared encoder.

Safety circuits They check that the device is functioning correctly, intervening in the event of any fault with acoustic signals and messages on the display.

Anti-free-flow system This prevents a flow not subject to control by the instrument but caused by the effects of gra-vity from occurring within the administration set.

Operating conditions +10°C / +45 °C 30% / 75% RH 700 hPa / 1060 hPa

Storage conditions -10°C / +60 °C 10% / 100% RH 500 hPa / 1060 hPa

SECTION 3

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FACTORY SETTINGSThe pump is supplied with the following default settings:

Settings lock level L 0

Flow rate 0.80 ml/h Bolus dose 0.2 ml

Interval between the bolus doses 1 h

Number of bolus doses in one hour 1

Clinical bolus 0.00 ml

Number of infusions 0

Maximum occlusion pressure selected PL2 (2.2 bar +/-1)

SECTION 3

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SECTION 4

SUPPLIED STANDARD EQUIPMENT1. CRONO 50 SC ambulatory infusion pump.2. Infusion pump 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, 1 of which is already inside the pump (Code: CR/123A).7. 2 User manuals (doctor and patient).8. Battery-cover opening tool (Code: CA/02).

1

2

3 4

5

6

7

8

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SECTION 5

PUMP PARTS

LED

Serial number

Anti-slip grooves

DisplaySeating for the reservoir wings

Battery compartment cover

CE marking Quick reference

Pusher

Buttons

Support cord attachment

eyelets

19MAN 01/EN/00 P CRONO 50 SC 05/14

SECTION 6

CONTROL BUTTONSThere are 3 control buttons.

The buttons have a built-in safety delay: in order for the command to be exe-cuted, they must be kept pressed for several seconds. Press the buttons using your fingertips only; do not use sharp objects.

The buttons make a clicking sound when pressed.

A short acoustic signal confirms the execution of a command.

The buttons have different functions depending on the condition the pump is in when they are pressed:

- OFF

- StoP (infusion paused)

- ON

WARNING

The red LED on the right of the display lights up when:

1 - the battery is inserted during the pump verification checks, see page 28;

2 - when an error occurs. For further information, see pages 25-26.

LED

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SECTION 7

LIQUID CRYSTAL DISPLAY (LCD)The liquid crystal display shows text messages and icons to provide practical information on the settings, operations performed and any error conditions.

Arrowicon

Padlockicon

Battery levelindicator

Drop icon

Four main digits

Two secondary digits

Four main digits of the displayDisplay the main information on the values set, error conditions, etc.

"Clock" icon:Only displayed when you are using the reserved functions section, while setting the clock.

Clock icon

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Two secondary digits of the displayDisplays one of the following items:• the volume of the reservoir;• information on the parameter displayed by the

four main digits;• unit of measurement of parameter displayed.

"Low Battery" icon:Displayed when the battery is very low (see rela-ted section on page 22).

“Drop” icon:Steady: separates integers from decimal digits.Flashing: hour/minute separator.

“Arrow” icon:• a downward arrow indicates that the pump is

being programmed;

• a right arrow indicates that the parameter displayed is expressed in ml/h.

“Minutes” indicator: • flashes when the remaining delivery time is

expressed in minutes (time left is less than 60 minutes);

• displayed when the interval between two bolus doses is shown in minutes.

"Padlock” icon:Indicates that the settings are locked (L1); i.e. they can be viewed but cannot be changed.

SECTION 7

ml/hPROG

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LOW BATTERY ALERTThe "LOW BATTERY" icon appears steady on the display when the battery is nearly drained.

If the alert persists for several consecutive infusions, the "BATTERY DISCHARGED" message is displayed, accom-panied by intermittent acoustic signals repeated approxi-mately every 10 seconds.When this occurs, the pump can no longer be used and the battery must be replaced.

• You are advised to replace the battery after the “LOW BATTERY” icon is displayed.

• The battery must not be replaced:- during an infusion;- with the infusion set connected to the patient.

WARNINGS

SECTION 8

REPLACING THE BATTERYUse 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 special tool supplied or a paper clip;

2. pull back the cover;

3. use the small ribbon strap (under the battery) to facilitate removal of the battery;

4. remove the discharged battery and discard it properly, using the appro-priate containers.

23MAN 01/EN/00 P CRONO 50 SC 05/14

5. wait 10 seconds before inserting the new battery in the correct position and ensuring that the ribbon strap lies under the battery;

6. close the cover of the battery compartment.

SECTION 8

CRONO PIDCRONO PID

CRONO PID

CRONO PI

D

24MAN 01/EN/00 P CRONO 50 SC 05/14

SECTION 8

• The cover is supplied with a gasket which must remain in position as indicated in the illustration.

• After you have inserted the battery, the pump runs a self-check during which it will emit brief acoustic signals and display all of the icons and indicators.

• During battery replacement, the pump retains the current settings in its me-mory.

• Ensure that the battery compartment cover is properly closed.

Gasket

NOTES

WARNINGS

If the battery cannot be removed by pulling the ribbon strap, do not lever it out with anything but proceed as follows:

• hold the pump and the compartment cover firmly in your right hand;

• strike the palm of your left hand with your right hand to jolt the battery out.

• Do not use rechargeable batteries.

• Using other types of battery than lithium CR 123A batteries could cause the pump to malfunction.

• Battery life can be influenced by the age of the battery, the temperature and how it is stored.

• 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.

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DISPLAY ACOUSTIC SIGNAL

ERROR DESCRIPTION

CORRECTIVE ACTION

Short and continuous acoustic signal. Operation not allowed. ---

Continuous acoustic signal and flashing

LED.

Critical problem in the safety system. Press the button

Intermittent acoustic signal

repeated approximately every 10 secs.

Motor circuit fault. Press the button



Pusher mechanically blocked while

withdrawing (possibly caused by a foreign object preventing its

withdrawal).

Eliminate the cause and initialise the pump

(see page 28).



Advancement system blocked. Press the button



Motor fault. Initialise the device (see page 28).

Intermittent acou-stic signal repeated approximately every 10 seconds (possi-bly accompanied by

flashing LED).

Communication error between the twin microcontrollers.

Press the button

ERRORS AND FAULTS

SECTION 9

26MAN 01/EN/00 P CRONO 50 SC 05/14

DISPLAY ACOUSTIC SIGNAL

ERROR DESCRIPTION

CORRECTIVE ACTION



When a battery is inserted and at the start of every infusion, the device runs a check algorithm on the parameters stored in its memory. If an error is

found, the factory default settings are restored, the

motor stops and an error is shown on the display.

Initialise the device (see page 28) and reset the infusion

settings.



Fault in the safety circuit driving the pump motor. If an error is found, the

pump locks and the error is indicated.

Initialise the device (see page 28).



Fault in the advancement system.




Mechanical block due to an occlusion condition in

the infusion line.


Acoustic signal when the button is

pressed.

Limit to number of bolus doses administered in one hour (it is not possible to administer bolus doses).

This function is not available

(see page 45).


pressed.

The bolus dose is set to 0 ml.

This function is not available

(see page 44).


pressed.

Limit to time interval between 2 bolus doses

(it is not possible toadminister bolus doses).

This function is not available.

(see page 45).

SECTION 9

27MAN 01/EN/00 P CRONO 50 SC 05/14

The displayed error messages (from Er,2 to Er,11 and OCCL) are accompa-nied by an acoustic signal and the system stops.

• Error messages Er,2 and Er,7 are accompanied by the flashing red LED.• The settings prescribed by the doctor must be noted down on pages 83 and 84.

WARNINGS

NOTE

POST-OCCLUSION BOLUSAn occlusion alarm is signalled when the pump detects excessive back pressure on the infusion line. This back pressure must be removed without releasing a post-occlusion bolus, which could cause serious injury to the patient.The volume of a CRONO 50 SC post-occlusion bolus, considering only the pump-reservoir assembly, is about 0.8 ml (PL1) - 1.1 ml (PL2) - 1.3 ml (PL3).

SECTION 9

INFUSION SET OCCLUSION

In these circumstances, the pump stops the infusion: the display indicates that there is an occlusion, accompanied by a short acoustic signal. The pump then emits acoustic signals every 10 seconds.

• Look for the cause of the occlusion all along the infusion line and at the point where the line is connected to the patient.• To avoid or reduce the incidence of occlusions, you are advised to use an infusion set with anti-kink tubes.

NOTES

The pump is designed to recognise when the drug administration is interrupted by external causes, such as kinking of the infusion set tube resulting in occlusion.

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.

28MAN 01/EN/00 P CRONO 50 SC 05/14

• The volume of the bolus released after an occlusion condition can vary, depending on the infusion set and all the other infusion line components.• Another element that could affect the volume of the released bolus after an occlusion condition is the presence of any air in the system.• After the occlusion alarm is signalled, take appropriate measures to avoid the administration of a post-occlusion bolus, such as, for example, disconnecting the infusion set from the patient.

WARNINGS

PUMP INITIALISATION

1. Runs a self-check, emitting a series of short acoustic si-gnals and displaying all the indicators and icons.

2. Performs mechanical positioning of the pusher, moving it to the start infusion position, after which the display shows OFF.

• The pump is supplied with a new battery already inside the pump.

• To initialise the device after an error, remove the battery and reinsert it after 10/15 seconds. If the error persists after the corrective action or the initiali-sation of the device, contact the CANè S.p.A. Technical Support Service.

• For instructions on how to install the battery, see page 24.

• You are advised to initialize the pump if it has been left unused for a long period (more than 1-2 months) and the battery has not been removed.

• If after installing the battery (initialisation of the pump) the display does not show the above messages, remove the battery and reinstall it.

SECTION 9

NOTES

When the battery is inserted, the pump runs the initialisation sequence, du-ring which it:

29MAN 01/EN/00 P CRONO 50 SC 05/14

QUICK REFERENCEButtons have a built-in safety delay: in order for the command to be executed, they must be kept pressed for several seconds.

These quick reference instructions do not offer an alternative to reading the information provided in this manual. They only give a basic and rapid summary of the pump functions.

WARNING

SECTION 10

/

BUTTONS INITIALISATION DISPLAY

• Show all display segments

• Automatic positioning of the pusher

• Automatic switching off of the instrumentAC

TIVA

TIO

N

at start of infusion

BUTTONS NUMBER OF INFUSIONS PERFORMED/RESET OF BOLUS DOSES DISPLAY

• Read number of infusions performed

• Confirm reset of the number of bolus doses to zero

PROG

PUM

P SE

T TO

OFF

/Sto

P

press for 7seconds

andpress

at the same time

• Request reset of the number of bolus dosesadministered to zero (only L0)

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BUTTONS SETTINGS DISPLAY

Operations only possible with the settings lock unlocked

• Setting the flow rate

• Setting the bolus dose volume

• Setting the minimum interval between bolus doses

• Setting the number of bolus doses in an hour

• Setting the partial volume

• Change the value of the preceding settings

PUM

P SE

T TO

OFF

SECTION 10

/

1st press

2nd press

3rd press

4th press

5th press

BUTTONS SWITCHING ON / PRIMING DISPLAY

Priming function only available at the start of a new

• Access to the priming phase

• Perform priming (0.5 ml repeatable 3 times)

• Exit the priming phase: start of infusion

• Interrupt priming (if in progress)

• Automatic switching off of the instrument

PUM

P SE

T TO

OFF

infusion

andpress

at the same time

andpress

at the same time

PROG

PROG

PROG

PROG

PROGml/h

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SECTION 10

BUTTONS INFUSION DISPLAY

• Administration of bolus dose

• Interrupt bolus dose (if in progress)

PUM

P SE

T TO

ON

andpress

at the same time

BUTTONS DISPLAYING THE VOLUMES ADMINISTERED DISPLAY

• Occlusion pressure level

• Volume administered in the form of base flow during

• Volume administered in the form of bolus doses during

• Number of bolus doses administered during

• Volume administered in the form of clinical bolus during

• Total volume administered

PUM

P SE

T TO

ON

the infusion

(flow + bolus doses + clinical bolus doses)

the infusion

the infusion

BUTTONS DISPLAYING THE SETTINGS DISPLAY

• Flow rate

• Bolus dose volume

• Interval between the bolus doses

• Number of bolus doses in one hour

• Partial volume

• Clinical bolus

PUM

P SE

T TO

ON

1st press

2nd press

3rd press

4th press

5th press

1st press

2nd press

3rd press

4th press

5th press

6th press

the infusion

6th press

ml/h

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SECTION 10

BUTTONS END OF INFUSION DISPLAY

• End of the infusion.

• Withdrawal of the pusher.

• Automatic switching off of the instrument.

BUTTONS SWITCHING OFF THE PUMP DISPLAY

Silencing the buzzer and flashing display

andpress

at the same time

andpress

at the same time

PUM

P SE

T TO

ON

END

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PUMP SETTINGS SEQUENCETo change the settings the pump must:• be in the OFF state;• have the settings lock off (i.e. set to L0).

NOTEWhen the settings lock is on (L1), if any attempts are made to change the parameter then the display will show the flashing padlock icon and will emit a few short acoustic signals.

SECTION 11

To access the settings, press the button for approx 1 second: the display shows the setting phase for the flow rate. You can change the parameter settings while the display is flashing by using the and buttons.

Press again. The display shows the setting phase for the bolus dose volume. You can change the parameter settings while the display is flashing by using the and buttons.

Press again. The display shows the setting phase for the minimum inter-val between bolus doses. You can change the parameter settings while the display is flashing by using the and buttons.

Press again. The display shows the setting phase for the maximum number of bolus doses per hour. You can change the parameter settings while the display is flashing by using the and buttons.

Press again. The display shows the setting phase for the partial volume. You can change the parameter settings while the display is flashing by using the and buttons.The partial volume can be set only if the pusher is at the infusion start position.

34MAN 01/EN/00 P CRONO 50 SC 05/14

SECTION 11

SETTING THE FLOW RATE

Proceed as follows:1. While the type of reservoir selected is flashing, press the

button and hold it for a few seconds: the flow rate value flashes on the display;

2. Press the button to increase the value; press the button to decrease it. Each change is indicated by an

acoustic signal.

3. If no button is pressed for 20 seconds, the settings session is terminated and the OFF or StoP message is displayed;

4. Press the button before the OFF or StoP indication is displayed (while the flow rate value is still flashing) to continue to the setting of the next parameter: SETTING THE BOLUS DOSE VOLUME.

The flow rate can be set from 0.05 ml/h to 35.00 ml/h as follows:• From 0.05 ml/h to 10.00 ml/h in 0.01 ml/h increments.• From 10.00 ml/h to 35.00 ml/h in 0.05 ml/h increments.

PROGml/h

NOTES• The flow rate can be quickly changed by continuously pressing either the

or button.

• The flow rate setting is automatically stored in the pump’s memory.

• The flow rate function can be disabled by setting the value F 0,00 ml/h.

PROGml/h

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SETTING THE BOLUS DOSE VOLUME

Proceed as follows:

1. While the selected flow rate flashes, press : the display shows the flashing bolus dose volume indication.


acoustic signal.

3. If no button is pressed for 20 seconds, the settings session is terminated and the OFF or StoP message is displayed;

4. Press the button before the OFF or StoP indication is displayed (while the dose value is still flashing) to continue to the setting of the next parameter: SETTING THE MINIMUM INTERVAL BETWEEN BOLUS DOSES.

The bolus dose volume can be set from 0.10 ml to 10.00 ml in 0.02 ml increments.

SECTION 11

• The bolus dose can be quickly changed by continuously pressing either the or button.

• The bolus dose setting is automatically stored in the pump’s memory.

• The bolus dose function can be disabled by setting the value d 0,00.

NOTES

PROG

PROG

36MAN 01/EN/00 P CRONO 50 SC 05/14

SECTION 11

SETTING THE MINIMUM INTERVAL BETWEEN BOLUS DOSES

Proceed as follows:

1. While the bolus dose volume flashes, press : the bolus dose interval flashes on the display.


acoustic signal.

3. If no button is pressed for 20 seconds, the settings session is terminated and the OFF or StoP message is displayed.

4. Press the button before the OFF or StoP indication is displayed (while the interval value is still flashing) to continue to the setting of the next parameter: SETTING THE MAXIMUM NUMBER OF BOLUS DOSES DELIVERABLE IN ONE HOUR.

The minimum interval between bolus doses can be set to a value between 5 minutes and 24 hours, in the following modes:

• 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

37MAN 01/EN/00 P CRONO 50 SC 05/14

SETTING THE MAXIMUM NUMBER OF BOLUS DOSES DELIVERABLE IN ONE HOUR

Proceed as follows:

1. While the interval between bolus doses flashes, press : the number of bolus doses deliverable in one hour flashes on the display.


acoustic signal.

3. If no button is pressed for 20 seconds, the settings session is terminated and the OFF or StoP message is displayed.

SECTION 11

The maximum number of bolus doses in one hour can be set from 1 to 12.

This applies a numerical limit to the bolus dose function.

• If the setting for the interval between bolus doses is expressed in minutes, the “Minutes” indicator will flash on the display.

• The bolus dose interval setting is automatically stored in the pump memory.

• Press the button while the display shows t 5' to switch 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.

NOTES

PROG

4. Press the button before the OFF or StoP indication is displayed (while the number of doses is still flashing) to continue to the setting of the next parameter: SETTING THE PARTIAL VOLUME (setting that is only available before the start of an infusion, either complete or partial).

PROG

PROG

38MAN 01/EN/00 P CRONO 50 SC 05/14

SETTING THE PARTIAL VOLUME

SECTION 11

The partial volume function is used when the therapy does not require an infusion at the maximum dose level available with the pump, equal to 50 ml.The partial volume can be set from 1 cc to 50 cc in increments of 1 cc.The partial volume function can only be set before starting a new infusion, either a complete one (50 ml) or a partial one.

• The number of bolus doses in one hour setting is automatically stored in the pump memory.

• If you press the button, with the display showing nd 1 the display changes to nd 0. This state indicates that bolus doses cannot be administered to the patient.

• If you press the button, with the display showing nd 12 the display changes to no,Ln. This state disables the number of bolus doses in one hour function, so that there are no limits to the number of bolus doses that can be administered to the patient in an hour.

NOTES

Proceed as follows:

1. While the number of bolus doses deliverable in one hour flashes, press : 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 increase the value; press the button to decrease it. Each change is indicated by an acoustic signal.

PROG

PROG

39MAN 01/EN/00 P CRONO 50 SC 05/14

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 set partial volume value.

• The partial volume setting can be interrupted by pressing the and buttons simultaneously: 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 is not stored and the previous one remains active.If, however, the pusher is withdrawing, the display alternates between OFF and P,cc. The only possible operation is to continue the withdrawal of the pusher, by pressing the button. The pusher withdraws to the position corresponding to the partial volume setting.

• When the device is set to StoP it is not possible to change the partial volume, and the pump displays Err.

SECTION 11

3. Once all settings are completed, if no button is pressed for 20 seconds the display will show P,cc.

4. The pump moves the pusher to the position which corresponds to the set volume: during this operation, an intermittent acoustic signal is emitted while the pusher is advancing and the actual volume corresponding to the pusher position is shown in real time.

5. When the pusher is in the correct position the display shows OFF: the partial volume set is visualized on the secondary display.

40MAN 01/EN/00 P CRONO 50 SC 05/14

WARNINGS

SECTION 11

SWITCHING ON THE PUMP

• 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 bat-tery is removed.

• If the battery is removed when the pump is set to OFF, the partial volume remains in the memory and the pusher is not withdrawn when the battery is replaced.

• 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 when the battery is replaced.

From the OFF state, press the button. The pump will emit a short acoustic signal and display:

• Pr (priming function); the display shows Pr. There are three options: (see page 41): a. Postpone the priming. b. Cancel the priming. c. Perform the priming.

Before starting an infusion:

• Inspect the infusion line to ensure that no kinks, closed clamps or other occlusions are present along the line;

• Expel any air bubbles.

WARNINGS

41MAN 01/EN/00 P CRONO 50 SC 05/14

SECTION 11

PRIMING THE INFUSION SET TUBEThe purpose of the priming function is to fill the infusion set 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. Turn on the device by pressing the button.

2. The display shows Pr. There are three options:

a. Postpone the priming. b. Cancel the priming. c. Perform the priming.

a. Postpone the primingWait for 10 seconds, the pump will turn off automatically.b. Cancel the primingPress the button: the pump begins the infusion and the display shows the time remaining until the end of the infu-sion.c. Perform the primingPress and hold the button to deliver the priming volume; releasing the button interrupts the priming function and the display shows Pr flashing and the number of ml delivered.The display shows Pr again. In this way it is again possible to postpone, cancel or continue performing the priming fun-ction. The procedure can be repeated until a total of 1.5 ml has been delivered.At the end of this stage the pump returns to the OFF state, showing a flashing Pr on the secondary display. Press the

button before OFF is displayed, and the pump begins the infusion.

42MAN 01/EN/00 P CRONO 50 SC 05/14

• If no button is pressed for 10 seconds after the priming indication is display-ed, the display shows the OFF indication.

• The volume delivered during priming is not added to the value indicating the amount administered during infusion.

• Every time the pump has delivered 0.5 ml of drug, it emits an acoustic signal and pauses for about one second.

• Continue with the priming until the drug flows out of the infusion set.

NOTES

SECTION 12

• Do not prime the infusion set with the infusion line connected to the patient.

• The priming function must only be performed with the reservoir connected to the infusion set and before inserting the needle into the infusion site.

• Before beginning an infusion, check that no air bubbles are present in the fluid infusion line and expel any bubbles found. Alternatively, use a vented filter.

WARNINGS

43MAN 01/EN/00 P CRONO 50 SC 05/14

THE PUMP IN USE

When the time is expressed in days, a flashing letter d is shown on the display.

When the time is expressed in hours, a flashing letter h is shown on the display.

When the time is expressed in hours and minutes, the flashing “Drop” symbol is shown on the display.

When the time is expressed in minutes, the "Minutes" indi-cator flashes on the display.

If a flow rate of 0 ml/h has been set, the display shows F 0,00 with the letter F flashing. In this event the drug can only be administered by means of a bolus dose and/or clinical bolus request.

SECTION 12

NOTE

After the priming phase, press the button to access the start of the infusion. When the pump is ON, the display shows the delivery time expressed in days or hours or minutes.

During the infusion, the time indicated on the display counts down day by day, then hour by hour and, below 100h, minute by minute.

44MAN 01/EN/00 P CRONO 50 SC 05/14

Procedure for administering a bolus dose:

1. Press the button: the pump emits an acoustic signal and starts the administration of the bolus dose and 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. The pump pauses for about 2 seconds every 0.1 ml of drug administered before resuming administration, and continues in this way until the set dose has been completed;

2. at the end of the bolus dose administration, the pump emits an acoustic signal and the display shows the time left to the end of the infusion (or F0,00 if a flow rate of 0 ml/h is set).

• The bolus dose administration can be interrupted at any time by pressing the and buttons simultaneously.

•If the bolus dose volume is set to 0 ml, the bolus dose cannot be administered: when the button is pressed, the display will show the indication Er,d.

BOLUS DOSE

SECTION 11

NOTES

The bolus is a supplementary dose of the drug that the patient can request when it is needed. Bolus doses can only be administered while the pump is in action.

45MAN 01/EN/00 P CRONO 50 SC 05/14

RESTRICTIONS ON THE ADMINISTRATION OF BOLUS DOSES

During the limitation period, when a bolus dose is requested, the display will show the indication Er,t (limit to interval between bolus doses is active) or Er,n (limit to number of bolus doses in one hour is active).

SECTION 11

The bolus dose limitation parameters are as follows:

• The interval between bolus doses (time limit)• The number of bolus doses in an hour (numerical limit)

Bolus doses cannot be administered during the limitation period specified by the function.

The bolus function limitation period is determined by the more restrictive of the values set for the minimum interval between two bolus doses and the number of bolus doses in one hour.

46MAN 01/EN/00 P CRONO 50 SC 05/14

SECTION 11

END OF THE INFUSIONTen minutes before the end of the infusion, the device emits an intermittent acoustic signal for 2 seconds. This signal is repeated twice 5 minutes before the end of the infusion.

At the end of the infusion an intermittent acoustic signal is emitted and the display shows End (see page 48).

47MAN 01/EN/00 P CRONO 50 SC 05/14

WITHDRAWING THE PUSHER

• Turn off the pump by pressing the and buttons simultaneously.

• Press the and the 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 cancel the withdrawal request by pressing the and

buttons together.

2. Withdrawal of the pusher at the end of the infusion

Ten minutes before the end of the infusion, the device emits an intermittent acoustic signal that lasts for 2 seconds. This signal is repeated twice, 5 minutes before the end of the infusion.At the end of the infusion an intermittent acoustic signal is emitted and the display shows End.To silence the acoustic signal and withdraw the pusher to the infusion start position it is necessary to press the and buttons together.

3. Pusher in motionWhile the pusher is in a continuous withdrawal motion, the display shows the “pusher continuous withdrawal” indication.

SECTION 11

1. Withdrawal of the pusher before the end of the infusionThis function allows the interruption of an active infusion, withdrawing the pusher to the infusion start position.

To withdraw the pusher, proceed as follows:

48MAN 01/EN/00 P CRONO 50 SC 05/14

NOTES

Do not remove the reservoir until the pusher has been withdrawn to the infu-sion start position.

WARNING

SECTION 11

• The function to withdraw the pusher at the end of the infusion can be interrupted by pressing the and buttons together.

The display then alternates between End and OFF. While in this state, only the button is active. Press it to resume the withdrawal of the pusher.

• The pusher withdrawal time for a volume of 50 cc is about 10 minutes, and is proportionately less for lower volumes.

SWITCHING OFF THE PUMP

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. To switch off the acoustic signals, press the button. This acoustic signal will be repeated every time the device is switched off during an infusion.

Turn the instrument off by pressing the and buttons simultaneously.

49MAN 01/EN/00 P CRONO 50 SC 05/14

DISPLAYING THE SETTINGSThis function displays the pump settings. To display the parameters the pump must be on (the display shows the delivery time or F 0,00).

Proceed as follows:

1. Press the button for about 3 seconds: the display shows the flow rate set in (ml/h);

2. If no button is pressed for approximately 5 seconds, the display will once again show the delivery time or F 0,00;

3. Press or press and hold the button to show the fol-lowing settings in sequence:

• bolus dose volume (ml),

• interval between bolus doses,

• number of bolus doses in one hour,

• partial volume (ml),

• clinical bolus volume (ml).

The settings lock level has no effect on displaying the parameters set.NOTE

SECTION 11

ml/h

50MAN 01/EN/00 P CRONO 50 SC 05/14

DISPLAYING THE VOLUMES ADMINISTEREDDisplaying the volumes delivered provides information on the volumes of drug administered during the current infu-sion.To display the volumes delivered the pump must be on (the display shows the delivery time or F 0,00);

Proceed as follows:

1. Press the button for about 2 seconds: the display shows the programmed occlusion pressure level;

2. Press the button for about 2 seconds: the display shows the volume (in ml) of drug delivered in the form of a flow;

3. If no button is pressed for approximately 2 seconds, the display will once again show the delivery time or F 0,00;

4. Press or press and hold the button to show the fol-lowing settings in sequence:

• volume of dose volume delivered (ml),

• number of bolus doses delivered,

• volume of clinical bolus delivered (ml),

• total volume delivered (ml).

SECTION 11

51MAN 01/EN/00 P CRONO 50 SC 05/14

RESETTING THE NUMBER OF BOLUS DOSES ADMINISTERED TO ZERO

Proceed as follows:

1. With the pump set to OFF or StoP simultaneously press and hold for approximately 4 seconds the and but-tons.

The number of bolus doses administered flashes on the di-splay;

2. Press the button within 7 seconds: the device emits an acoustic signal and the number of bolus doses admini-stered is reset to zero.

3. When the reset has been completed the display shows OFF.

When the settings access is locked, any attempt to access the operation to reset the number of bolus doses administered will cause the device to emit an acoustic signal and display the indication L1.

WARNING

The number of bolus doses administered may be reset to zero at any time, provided the settings lock level is L0.

SECTION 11

• The settings lock level has no effect on displaying the volumes or the number of boluses administered.

• The values for the volumes delivered are updated constantly during infusion.

• The values for volumes administered and number of bolus doses are reset to zero automatically at the start of a new infusion.

NOTES

PROG

52MAN 01/EN/00 P CRONO 50 SC 05/14

SECTION 12

For safety reasons, it is advisable to use original CRN® Crono® reservoirs.

The use of any other type of reservoir could damage the pump and harm the patient.

CANè S.p.A. disclaims any liability if the device is used with a non-original reservoir different from those recommended.

WARNING

The CRONO 50 SC pump uses a dedicated 50 ml CRN® CRONO® reservoir.

The reservoirs are: single-use, non-pyrogenic, usable only if the packaging is undamaged.

RESERVOIR PARTS

Reservoir body Plunger

Stem

Needle

Needle cover

Luer-Lock cap

53MAN 01/EN/00 P CRONO 50 SC 05/14

LUER-LOCK CAP FUNCTIONS• After the reservoir has been filled, the cap faci-litates unscrewing of the stem from the plunger, thus avoiding spillage of the drug;

• it facilitates the correct connection between the pump pusher and the rubber plunger of the reser-voir;

• it protects the drug inside the reservoir if it is not used immediately;

SECTION 12

For information on infusion sets, see the instructions provided with the pro-ducts.

INFUSION SET

FILTRAJETFor a safe infusion it is advisable 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 connectorFemale

1 x 2.3 set tube DOP-free PVC

0.2 micron filter

Luer-Lock connector Blue, male

Capsule

54MAN 01/EN/00 P CRONO 50 SC 05/14

PREPARING THE RESERVOIR1. Screw the needle onto the reservoir in a clockwise direction and remove the needle cover2. Fill the reservoir, aspirating the liquid slowly and checking that the quantity of drug does not exceed its capacity or any partial volume you may have set3. Screw the Luer-Lock cap (a) onto the reservoir and then unscrew the stem, rotating it counter-clockwise (b) with a fairly rapid movement;4. Insert the reservoir into the pump; the rubber plunger will fit onto the pusher. Rotate it clockwise through 90° and a click will confirm it is properly engaged;5. Attach the infusion set connector to the reservoir.

PREPARING THE RESERVOIR AND CONNECTING TO THE PUMP

SECTION 12

1

a

b

2 3 4 5

55MAN 01/EN/00 P CRONO 50 SC 05/14

Connect the special CRN reservoir to the pump and secure it by rotating it 90° clockwise until it clicks.

Front view of the pump

CONNECTING THE RESERVOIR TO THE PUMP

SECTION 12

1

2

2 431

56MAN 01/EN/00 P CRONO 50 SC 05/14

1 - Before filling the reservoirUnscrew and screw back the plunger stem to facilitate its unscrewing after filling the reser-voir.

2 - Filling the reservoirThe liquid must be aspirated slowly.Do not fill the reservoir beyond the maximum level allowed (50 ml).The stem must be unscrewed with a fairly ra-pid movement.

3 - Connecting the reservoir to the pumpTo avoid any leakage of the drug while the reservoir is being inserted into the pump you can use the infusion set as an alternative to the Luer-Lock cap indicated on page 53.

While connecting the reservoir to the pump, hold it as shown in the figure.

When connecting the two components, avoid exerting any pressure on the reservoir walls, because this could cause liquid to leak past the plunger rings.

When filling the reservoir and connecting it to the pump, a small liquid leakage might occur between the first and second rings on the rub-ber plunger: this does not jeopardise either the correct operation of the reservoir or the delivery of the liquid.

WARNING

SECTION 12

1

2

57MAN 01/EN/00 P CRONO 50 SC 05/14

Before preparing for the infusion, it is advi-sable to observe the following precautions:

1. wash hands;

2. prepare a clean working environment.

OFF

MICROJ

ET CRO

NO

0.2 ml

d

h

min

PREPARING FOR THE INFUSION

WARNING

INFUSION SITESThe infusion sites depend on the administration route and the type of set used.

SECTION 12

Always work in aseptic conditions, to reduce the risk of infection to a minimum.

WARNING

The choice of infusion site may depend on the type of drug being infused and is the responsibility of the doctor prescribing the pump.

To avoid any potential risks of over infusion due to gravity, do not posi-tion the pump higher than the infusion site.

58MAN 01/EN/00 P CRONO 50 SC 05/14

HOW TO USE THE SUPPLIED STANDARD EQUIPMENT

PUMP WORN AROUND THE NECKThe pump worn with a collar strap and a fabric case.

The following figures give an indication on how to use the standard accesso-ries supplied with the pump.

FASTENING THE COLLAR STRAP TO THE PUMP

SECTION 13

2

3

1

59MAN 01/EN/00 P CRONO 50 SC 05/14

PUMP WORN AT THE WAISTThe pump worn with an elastic belt and a fabric case.

SECTION 13

60MAN 01/EN/00 P CRONO 50 SC 05/14

GENERAL WARNINGS

The device can be damaged by liquid ingress, hence it must not be kept on while in the bath or while showering, etc. If the device accidentally gets wet (for example due to drug drops or nocturnal enuresis), ensure it is checked by the CANè S.p.A. Service Centre.

The device must be kept away from:- sources of heat (radiators, stoves, heaters);- direct sunlight;- strong electro-magnetic fields (magnets, loudspeakers, mobile devices), details are given in APPENDIX 5.- ionizing radiation;- ultrasound devices;- MRI devices.

The device does not need sterilising.

Do not freeze the CRN reservoir with the drug inside it.

The device must not be placed in a refrigerator or freezer.

The device must not be placed in an oven or microwave.

Reservoirs, infusion sets, needles, filters and all consumables must be dispo-sed of in an appropriate way, using specially designed containers.

If you do not observe the above warnings, the device could malfun-ction, with potentially serious consequences for the user.

SECTION 14

61MAN 01/EN/00 P CRONO 50 SC 05/14

STORAGE

The technical features of the device make it extremely simple to maintain.

If the device is damaged, it is advisable 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.

• Do not immerse the pump in detergent solutions or water.• Avoid liquid ingress in the pump. If the device gets wet, dry it immediately with absorbent paper.• Do not clean the pump with acetone, solvents or abrasive detergents. • Do not sterilise the pump.

If the device is not used for periods over one or two months, it is advisable to remove the battery and store the pump in its case in a dry place at room temperature.

USER GUIDE UPDATESThe version and the date of publication of this User Guide are shown on every page. When a year has passed between the publication date (shown on page 3) and the use of the product, the doctor should contact CANè S.p.A. to de-termine if a more recent version of the manual has been published.

MAINTENANCE

GENERAL WARNINGS

SECTION 14

62MAN 01/EN/00 P CRONO 50 SC 05/14

EXPECTED PUMP LIFE

DISPOSAL

The pump is expected to last for 4 (four) years from its purchase date. For safety reasons the use of the pump must be discontinued after this period.

At the end of the expected pump life, contact CANè S.p.A. Customer Support Service to obtain the necessary instructions for the disposal of the device.

Reservoirs, infusion sets, needles, filters and all consumables must be dispo-sed of in an appropriate way, using specially designed containers.

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 (Torino) - Italy Tel. +39.011.9574872 Fax +39.011.9598880 • CANè S.p.A. Online www.canespa.it - E-mail: [email protected]


SECTION 14

63MAN 01/EN/00 P CRONO 50 SC 05/14

CANè S.p.A. guarantees that the product is free from any material or ma-nufacturing defects for a period of 2 (TWO) YEARS from the original date of purchase.

If any material or manufacturing defects are identified during the validity pe-riod of the guarantee, CANè S.p.A. will repair or substitute the defective com-ponents according to the terms and conditions herein, without any charge for labour or parts; the client shall bear the costs for the dispatch of 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 modifica-tions 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 cover any costs and/or defects arising from mo-difications or adaptations made to the product without prior written authorisa-tion by CANè S.p.A.CANè S.p.A. disclaims any liability either to the purchaser or to third parties for damage to persons or property as a result of improper operation or non-intended use of the device or due to non-compliance with the instructions provided in the User guide. The purchaser undertakes to relieve 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.

GUARANTEE

SECTION 14

64MAN 01/EN/00 P CRONO 50 SC 05/14

4. The following is not covered by the guarantee:• periodic maintenance interventions;• damage due 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 client in person;• accidental and unintentional events, such as liquid ingress and falls;• natural events and malicious or negligent actions;• 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 this period, CANè S.p.A. has no further obligations to perform repairs. CANè S.p.A. disclaims any liability either to the purchaser or to third parties for damage to persons or property as a result of the use of the device after 4 (four) years from the date of purchase.

6. After the guarantee period has expired, support will be provided by CANè S.p.A. with the customer bearing the associated costs for replacement parts, labour and transport applicable at the moment of the request.

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 pe-riod 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 dispatch of the device.

SECTION 14

65MAN 01/EN/00 P CRONO 50 SC 05/14

EC DECLARATION OF CONFORMITY

0476The CANè S.p.A. company, with headquarters in Via Cuorgnè, 42/a 10098 Rivoli (Torino) - Italy, manufacturer of the medical electrical equipment CRONO 50 SC ambulatory infusion pump with reservoir.

Serial number

declares that the device is compliant with the essential requirements of Annex I to Directive 93/42/EC, amended by Directive 2007/47/EC, as per certificate MED 9813 issued by Notified Body No 0476 in accordan-ce with Annex II to said Directive, and is marketed in compliance with the applicable laws of the individual European Member States.

SECTION 14

Rivoli, 26/02/2014 The Chairman

66MAN 01/EN/00 P CRONO 50 SC 05/14

APPENDICES

67MAN 01/EN/00 P CRONO 50 SC 05/14

SYMBOLS PRINTED ON THE PUMP

Pump serial number

IP protection rating1st digit (4) = protection against solid objects larger than 1 mm.

2nd digit (2) = protection against water droplets deflected up to 15º.

CE marking

Medical electrical equipmentType CF

Warning: read instructions before use

Sorted waste collection forelectrical 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."

SN

0476

The symbol of the crossed out waste bin on the product and its packaging indi-cates 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 orga-nised and managed by the manufacturer. Users wishing to dispose of this device must therefore contact the manufacturer (or the appropriate local distributor) and follow the system devised to allow for the separate disposal of devices at the end of their life. A proper waste sorting system for the devices destined for recycling, treatment and environmentally compatible disposal helps reduce the potential-ly negative impact on the environment and health, and facilitates the re-use or recycling of the materials the device is made of. The illegal disposal of a product is punished by administrative penalties as provided in the applicable regulations.

Note: The symbol displayed on the product label is, for obvious size-related re-asons, reduced and simplified with respect to the specifications in the reference standard CENELEC EN50419.

APPENDIX 1

IP 42

68MAN 01/EN/00 P CRONO 50 SC 05/14

SYMBOLS PRINTED ON THE RESERVOIR BLISTER PACK

0123

i Read the instructions

CE marking

Recyclable

2PYROGEN

STERILE EO

PP

REF

LOT

NEEDLE

Single-use only

Non-pyrogenic

Keep dry

Keep away from sunlight

Expiry date

Sterilised with ethylene oxide

Polypropylene

Batch code

Reference number

Needle size

APPENDIX 1

69MAN 01/EN/00 P CRONO 50 SC 05/14

APPENDIX 2

OPTIONAL ACCESSORIES AVAILABLE ON REQUEST1. Vertical leatherette case, similar to a mobile phone case.

Detail of belt clip

Detail of opening system with hole to accommodate the infusion set

Colours available:

Dimensions: 16 x 5.5 x 4 cm

Weight: Approx 60 g

Item code: CM/17/A

70MAN 01/EN/00 P CRONO 50 SC 05/14

2. Horizontal leatherette case, similar to a spectacle case.

Detail of belt clip

APPENDIX 2

Colori disponibili:

Dimensioni: 16 x 5,5 x 4 cm

Peso: Circa 50 g.

Codice articolo: CM/22/A

71MAN 01/EN/00 P CRONO 50 SC 05/14

PRECISION TESTTests have been conducted according to standard IEC 60601-2-24, Medical electrical equipment, Part 2: Particular requirements for the safety of infusion pumps and controllers. The following graphs show the precision of the pump during drug administration.

1.1 – Start-up flow rate• Flow rate setting: 0.2 ml/h.

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1.2 - Flow rate error (trumpet curve)• Flow rate setting: 0.2 ml/h.

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 admi-nistration line of the drug.

Legend:Ep(max.) = maximal percentage variations.Ep(min.) = minimal percentage variations.A(mean.) = mean percentage variations.

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APPENDIX 3

2.1 - Start-up flow rateFlow rate setting: 1 ml/h.

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2.2 - Flow rate error (trumpet curve)Flow rate setting: 1 ml/h.

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 admi-nistration line of the drug.

Legend:Ep(max.) = maximal percentage variations.Ep(min.) = minimal percentage variations.A(mean.) = mean percentage variations.

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PRESSURE LEVELS (PL)

WARNING

LEVEL PRESSUREPL1 1.8 bar +/- 0.8PL2 2.2 bar +/- 1PL3 3.2 bar +/- 1.2

NOTE

The CRONO 50 SC 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).

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.

Pressure level summary table.

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TIME NEEDED TO SIGNAL AN OCCLUSIONThe 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. The values given here show the time needed solely by the pump-reservoir assembly to signal the occlusion.

WARNINGS

APPENDIX 4

• The time needed to signal an occlusion is dependant on the flow rate: the lower the flow rate, the longer will be the time needed.• 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 dimen-sions, 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.

PL1Flow rate Time needed to signal an occlusion0.2 ml/h About 3 hours and 45 minutes1 ml/h About 45 minutes35 ml/h About 1 minute and 20 seconds

PL2Flow rate Time needed to signal an occlusion0.2 ml/h About 5 hours and 20 minutes1 ml/h About 1 hour and 10 minutes35 ml/h About 2 minutes

PL3Flow rate Time needed to signal an occlusion0.2 ml/h About 8 hours1 ml/h About 1 hour and 20 minutes35 ml/h About 2 minutes and 10 seconds

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POST-OCCLUSION BOLUSWhen 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 post-occlusion bolus, considering solely the pump-reservoir assembly, is about 0.8 ml (PL1) - 1.1 ml (PL2) - 1.3 ml (PL3).

• The volume of the bolus dose released after an occlusion condition can in-crease 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 appropriate measures to avoid the administration of a post-occlusion bolus to the patient.

• Patients who might suffer severe harm from the accidental release of a post-occlusion bolus must receive adequate instructions and/or training from medical or paramedical personnel on how to proceed in such a situation.

WARNINGS

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ELECTROMAGNETIC COMPATIBILITY

APPENDIX 5

Guidance and manufacturer's declaration – electromagnetic emissions

CRONO 50 SC is designed to operate in the electromagnetic environment specified below. The client or user of the CRONO 50 SC must ensure that it is operated in such an envi-ronment.

Emission test Compliance Electromagnetic environment – guidance

RF emissionsCISPR 11 Group 1

CRONO 50 SC uses RF energy only for its in-ternal 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.

RF emissionsCISPR 11 Class B

CRONO 50 SC is designed for use in all envi-ronments, including domestic environments and those environments directly linked to the low vol-tage mains supplying residential buildings.

Harmonic emissionsIEC 61000-3-2

Not applicable

Voltage fluctuation/flicker emissions IEC 61000-3-3

Not applicable

The electromagnetic 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 safety – Collateral standard: Electromagnetic compatibility – Requirements and tests.

Guidance and manufacturer's declaration – electromagnetic immunity


Immunity test IEC 60601 test level

Level of compliance

Electromagnetic environment – guidance

IEC 61000-4-2 electrostatic discharge

(ESD)

15 kV in air8 kV bycontact

15 kV in air8 kV bycontact

The flooring material must be wood, con-crete or ceramic. If the floor is covered in a synthetic material, the relative humidity must be at least 30%.

Electromagne-tic fields

400 A/m50 and 60 Hz

400 A/m50 and 60

Hz

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APPENDIX 5

Guidance and manufacturer's declaration – electromagnetic immunity


Immunity test IEC 60601 test level Level of

complianceElectromagnetic

environment – guidance

Radiatedimmunity

80-2500 MHz 10 V/m AM 80% 1 KHz 10 V/m

20-80 MHz 10 V/mAM 80% 1 KHz 10 V/m

Interference may occur in the vicinity of devices marked with the following symbol:

Recommended separation distance between mobile and portableradio-communication devices and CRONO 50 SC

CRONO 50 SC is designed to operate in an electromagnetic environment in which radiated RF disturbances are under control. The client or user of the CRONO 50 SC can help prevent electromagnetic interference by ensuring a minimum distance between mobile and portable communication devices using RF (transmitters) and the CRONO 50 SC as recommended below, relative to the maximum output power of the radio-communication devices.

Maximum specified output power of transmitter (W)

Separation distance at the transmitter frequency (m)

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

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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 con-cerning 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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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 safety – Collateral standard: Safety requirements for medical electrical systems.

• IEC EN 60601-1-2/A1:2006-10. Medical electrical equipment, Part 1: General requirements for safety – 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 safety – 4. Collateral standard: Programmable electrical medical systems.

• IEC EN 60601-1-4/A1: 2000-06. Medical electrical equipment, Part 1: Ge-neral requirements for safety – Collateral standard: Programmable electrical medical systems.

• IEC EN 60601-1-8:2009-11. Medical electrical equipment, Part 1: General requirements for safety – Collateral standard: Alarm systems - General requi-rements, tests and guidance for alarm systems in medical electrical equipment and medical electrical 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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• 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).

• CEI 62-108: 2000-05. Guidance for 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.

• CEI 62-122: 2002-07. Guidance for the acceptance testing and periodic checks on the safety and/or performance of medical devices powered by a specific power source.

• CEI 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 amendments.

• IEC EN 62304:2006-10. Medical device software – Software life cycle pro-cesses.

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APPENDIX 8

INFORMATION

For further information on the CRONO 50 SC pump, contact:

Servizio Assistenza Clienti (Customer Support Service)CANè S.p.A. Medical TechnologyVia Cuorgnè, 42/a 10098 Rivoli (Torino) - ItalyTel. +39.011.9574872Fax +39.011.9598880www.canespa.it E-mail: [email protected]


NOTES

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