MAN 01/04 CRONO FE 03/11 InTRODUCTIOn The instructions provided in this manual are intended for both the prescri- bing physician, and for patients who subsequently use the Crono FE pump. The pump is ready to use at delivery and does not require installation or other tests before being used on patients.
InTEnDED USE Crono FE is an ambulatory drug delivery pump designed to deliver subcu- taneous and intravenous pulsatile infusion. InFORMaTIOn – TECHnICal aSSISTanCE...
MAN 01/04 CRONO FE 03/11 DESCRIPTIOn OF THE PUMP Crono FE is a new innovative pulsatile ambulatory infusion pump for con- trolled drug administration on patients in hospital or in ambulatory care. The pump is provided with key-pad lock-out functions in order to avoid un- authorized reprogramming of the drug administration protocol.
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MAN 01/04 CRONO FE 03/11 Interval time between F-boluses Programmable from 5 minutes to 300 minutes in steps of 5 minutes. F-bolus pump mean accuracy +/- 1%. F-bolus system: • mean accuracy +/- 2%. • maximum positive deviation + 13.7%.
MAN 01/04 CRONO FE 03/11 FaCTORY SETTInGS The following factory settings are programmed at the delivery of the pump: Key-pad lock-out level Syringe size 10 ml F-bolus 25 µl F-bolus interval time 90 minutes Number of infusions...
MAN 01/04 CRONO FE 03/11 OPTIOnal aCCESSORIES Optional accessories are available upon request: Upright leather holder similar to a mobile telephone holder. Horizontal leather holder similar to a sunglasses case.
MAN 01/04 CRONO FE 03/11 HOW TO USE THE STanDaRD EqUIPMEnT SUPPlIED The following illustrations show how the pump and its accessories can be set up. How to attach collar strap to the pump and the fabric holder. How to use elastic belt with pump and fabric holder...
MAN 01/04 CRONO FE 03/11 HOW TO WEaR THE PUMP The following pictures show the various ways the pump can be worn. Wearing the pump around the neck Wearing the pump around the neck with a collar strap and a fabric holder.
MAN 01/04 CRONO FE 03/11 PUMP OVERVIEW Collar strap locking rings Syringe fin hook Display Buttons Pusher Battery compartment Serial number Short instructions...
MAN 01/04 CRONO FE 03/11 lIqUID CRYSTal DISPlaY (lCD) This is a screen on the front of the pump where symbols and messages are displayed informing the user about operations in progress as well as giving warnings and alarm messages.
MAN 01/04 CRONO FE 03/11 MaIn SCREEn InDICaTIOn The above screens are given as examples of what can be displayed. Pump off Prime function Prime execution Time left to the end of infusion (hour) Time left to the end of infusion (days)
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MAN 01/04 CRONO FE 03/11 Pump locked Number of delivered infusions Error message (see page 47) Occlusion Feed/reversal motion of the pump pusher End of infusion Low battery Battery discharged Volume delivered (ml) as F-bolus doses...
MAN 01/04 CRONO FE 03/11 KEY-PaD • The key-pad has 3 buttons for programming and for the operation of the pump. • The buttons are time-controlled: keep buttons pressed for a few seconds to activate commands. • Command execution is confirmed by a brief acoustic signal.
MAN 01/04 CRONO FE 03/11 SYRInGES Piston The ambulatory infusion pump Crono FE uses dedicated 10 and 20 ml dedi- cated syringes. The 10 and 20 ml syrin- ges are: • sterile; • single use only; • pyrogen-free; • to be used only if packaging is not damaged.
MAN 01/04 CRONO FE 03/11 SYRInGE PREPaRaTIOn 1. Attach the supplied needle to the syringe with a clockwise rotation. 2. Draw up the infusion solution slowly. Do not exceed the syringe capacity. 3. Attach luer-lock cap and unscrew the piston rod of the syringe counter-clock wise with a fairly swift movement.
In order to prevent this from happening, the tip of the pump pusher has been knurled which part must be inserted inside the rubber piston of the Crono FE syringe allowing a secure connection to be made with the syringe piston. WaRnInGS •...
Put the pump back in the pump case if it is not going to been used for a long period of time (1-2 months) and remove the battery. KEY PaD lOCK OUT The Crono FE pump has 2 lock levels: • L 0: permits complete access to all settings and operating functions.
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MAN 01/04 CRONO FE 03/11 the pump in OFF: the number of complete infusions already delivered will appear on the screen. Without releasing the button and depressing the button as well: L 0 or L1 will appear on the screen with 0 or 1 blinking.
MAN 01/04 CRONO FE 03/11 TablE OF KEY-PaD FUnCTIOnS The following table lists the accessible functions at any key-pad lock-out level (L0 or L1) both when the pump is in OFF and ON condition. Functions and selection Pump switch ON...
MAN 01/04 CRONO FE 03/11 PROGRaMMInG For programming, the pump must be: • In OFF condition • With key-pad lock-out in L0 Depress the button for about 1 second to access the pump programming sequence. The first program- ming option displayed on the screen is the syringe size.
MAN 01/04 CRONO FE 03/11 PROGRaMMInG THE SYRInGE SIZE The syringe size dose can be programmed either to 10 (ml) or to 20 (ml). The syringe size is accessed by the first depressing of button in the pump programming sequence (see page 25).
MAN 01/04 CRONO FE 03/11 PROGRaMMInG OF F-bOlUS DOSE VOlUME The F-bolus dose volume can be programmed from 5 µl to 1000 µl in steps of 5 µl. The F-bolus dose is accessed by the second depres- sing of the button in the pump programming sequence (see page 25).
MAN 01/04 CRONO FE 03/11 InTERVal TIME bETWEEn F-bOlUS DOSES Interval time between F-bolus doses can be program- med from 5 minutes to 300 minutes in steps of 5 minu- tes. Interval time between F-bolus doses is accessed by the third depressing of the...
MAN 01/04 CRONO FE 03/11 nuously (in steps of 10 minutes). If it is not necessary to re-program the present value, just depress the button while the value flashes. PROGRaMMInG OF PaRTIal VOlUME Partial volume is used when less than 10 or 20 ml is drawn up in the syringe for a specific treatment or for a specific patient.
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MAN 01/04 CRONO FE 03/11 programmed partial volume. During the movement of the pusher, there will be an acoustic signal and the volume corresponding to the selected par- tial volume will be displayed on the screen. When the pusher reaches its programmed position,...
MAN 01/04 CRONO FE 03/11 STaRTInG THE PUMP Depress the button when the pump is in OFF and there will be a short acoustic signal and the display will show either: Pr (priming function) provided that the pusher is in...
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MAN 01/04 CRONO FE 03/11 The prime function is available at both lock levels. Priming procedure: Depress the button when the pump is in OFF The display shows Pr. There are three different alternatives to choose from: To postpone priming...
MAN 01/04 CRONO FE 03/11 The display will show Pr and alternative a, options can be selected again. There is no time limit to finish the priming procedure. nOTE The priming volume is not included in the administra- tion volume.
MAN 01/04 CRONO FE 03/11 InFUSIOn SET OCClUSIOn The pump has been designed to recognise when the drug delivery is interrupted by external circumstances such as involuntary kink of the infusion set tubing. In this case the pump stops running the infusion, the dis- play will show the symbol for occlusion and the pump will emit an acoustic signal every minute.
MAN 01/04 CRONO FE 03/11 REVERSalS OF THE PUMP PUSHER Reversal of pusher before the end of infusion It is possible to interrupt an infusion in progress and reverse the pusher to its starting position: Depress the and the buttons simultaneously to switch off the pump.
MAN 01/04 CRONO FE 03/11 PUMP PUSHER MOVEMEnT When the pump pusher reverses with a continuous movement, a symbol depicting movement will be dis- played. nOTE • The reversal of the pusher before the end of infu- sion can be interrupted by depressing the buttons simultaneously;...
MAN 01/04 CRONO FE 03/11 SWITCHInG OFF THE PUMP Depress the buttons simultaneously. The display will show OFF. DISPlaYInG PROGRaMMED PaRaMETERS To display programmed parameters the pump must be running (On). The screen will show pro- grammed F-bolus volume in µl, the interval time bet- ween F-boluses and the partial volume.
MAN 01/04 CRONO FE 03/11 DISPlaYInG DElIVERED VOlUMES This display procedure will show the delivered volume in µl since the start of the infusion. The pump has to be running (On) and the screen will either show the remaining delivery time or the remaining time to the next F-bolus.
MAN 01/04 CRONO FE 03/11 DISPlaYInG THE nUMbER OF COMPlETE InFUSIOnS • The pump has to be in OFF to be able to display the number of complete infusions performed by the pump. • Depress the button for about 7 seconds and the number of complete infusions will be displayed.
MAN 01/04 CRONO FE 03/11 baTTERY REPlaCEMEnT Use only lithium 3 Volt 123 A batteries. Make sure the pump is in OFF condition (OFF will be displayed), then replace the battery. Battery replacement procedure: Open the battery compartment using the keyring device that is included with the pump Pull out the cover.
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MAN 01/04 CRONO FE 03/11 in your right hand. • Tap your right hand on the palm of your left hand until the battery falls out. nOTE When a battery is installed, the pump performs a self-test during which all symbols will be displayed and the pump will emit acoustic signals.
MAN 01/04 CRONO FE 03/11 GEnERal CaUTIOnS The device may be damaged upon contact with any liquid, therefore remo- ve it before taking a bath or shower etc. Should the pump accidentally come into contact with any liquid (drug solution, sweat, bed wetting) the pump has to be checked by CANè...
MAN 01/04 CRONO FE 03/11 CaUTIOnS Do not dip the device into water or detergent solutions. Avoid the risk of liquid penetration inside the instrument. Should the device become wet, absorb the liquid with blotting paper. Do not clean the pump with acetone, solvents or abrasive detergents.
MAN 01/04 CRONO FE 03/11 USER InFORMaTIOn The pump can only be repaired by CANè S.p.A. and the pump has there- fore to be sent to CANè's local representative in the country in which the pump has been sold for further transportation to CANè S.p.A.:...
MAN 01/04 CRONO FE 03/11 ManUFaCTURER’S GUaRanTEE With this consumer guarantee, CANè S.p.A. guarantees that this product is free from defects in materials and workmanship for a period of 2 (TWO) YEARS beginning from the date of purchase. If during this period of guarantee the product proves defective due to improper materials or workmanship, CANè...
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MAN 01/04 CRONO FE 03/11 CANè S.p.A. will aim to carry out repairs to the device over a period not in excess of 4 (FOUR) years, from the date of purchase. After 4 years, CANè S.p.A. will no longer be obliged to make any repairs.
MAN 01/04 CRONO FE 03/11 alaRM MESSaGES Code Description action Unfeasable operation --------------- Uncorrected reset Re-start device Critical condition of the security Press button system Irregularity of the motor circuit Press button Mechanical block during “End” 1. Remove the cause phase caused by foreign matter 2.
MAN 01/04 CRONO FE 03/11 SHORT InSTRUCTIOnS buttons battery Insertion Screen - The screen will show all symbols. - Pusher self-adjust. - Pump switches OFF. buttons Pusher reversal Screen Reversing of the pusher to the start position. depress simultaneously buttons...
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MAN 01/04 CRONO FE 03/11 buttons Settings Screen Operation feasible only with key-pad unlocked. 1st depressing - Syringe size. 2nd depressing - Setting F-bolus. 3rd depressing - Setting interval time between F-bolus. 4th depressing - Setting partial volume. Decrease/Increase above parameter.
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MAN 01/04 CRONO FE 03/11 buttons Screen review option Screen (setting parameters) - Programmed F-bolus volume. 1st depressing - Programmed F-bolus interval time. 2nd depressing - Programmed partial volume. 3rd depressing buttons Screen review option Screen (volume already delivered) - Total administered volume since start 1st depressing of the infusion.
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MAN 01/04 CRONO FE 03/11 buttons Pump On Screen Pump switches OFF...
MAN 01/04 CRONO FE 03/11 PUMP ICOn TablE Pump serial number Drip-proof instrument It can withstand occasional liquid dripping. It must not be immersed in liquid. Electro medical equipment BF type Warning: see instructions for use 0476 CE mark Dispose of used electric and electronic...
MAN 01/04 CRONO FE 03/11 SYRInGE blISTER PaCKaGE ICOn TablE Read the instructions 0123 CE mark Recycle Do not reuse this device Pyrogen free PYROGEN Protection against moisture Do not expose to direct sunlight Expiration date Sterilized with Ethylene oxide...
MAN 01/04 CRONO FE 03/11 GlOSSaRY Alarm An alarm is a condition that warrants the user’s attention, and is critical enough that it requires that the pump be shut down or reset. When an alarm occurs, an alarm beep is sounded and a descriptive mes- sage appears on the display screen.
MAN 01/04 CRONO FE 03/11 STaTEMEnT 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 ambulatory infusion pump with "réservoir" for drug administration Serial number...
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