PATIENT USER GUIDE
PATIENT USER GUIDE CANÈ S.p.A. Medical Technology Via Cuorgnè 42/a 10098 Rivoli (T O) Italy Tel.+39 011 9574872 - Fax +39 011 9598880 www.canespa.it - mailbox@canespa.
Manual code: MAN 01/06/USA/p CRONO Five 11/10 Date of publication: 10/08 Firmware version: P2I.02.
TABLE OF CONTENTS SECTION 1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page Note . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page Information-Technical assistance . . . . . . . . . . . . . . . . . . . . . . .
SECTION 6 Device activation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 33 SECTION 7 Key-pad lock out . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 34 Table of key-pad functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page 35 SECTION 8 Programming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page Programming of flow rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SECTION 12 General cautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page User guide update . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .page Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SECTION 1 INTRODUCTION CAUTION: US Federal law restricts this device for sale by or on order of a physician. The instructions included in this manual are intended only for the ambula tory drug infusion pump CRONO Five and are addressed to the pump user. The pump is provided with key-pad lock-out in order to avoid accidental or non authorised variations of the selected parameters. The information as to lock or unlock the key-pad are exclusively addressed to the physician.
SECTION 1 The pump must be used: • under strict medical control, • using proper procedure and suitable measure to the patient that could suffer serious consequences (injury or death) following involuntary misuse and/or device failure with consequently interruption of the drug administration. Do not prime any kind of tubing when connected to a patient, as this could result in over-delivery of medication and air embolism.
SECTION 1 Service representative to verify if the pump is operational. Do not use a pump that is damaged. Liquid on the outside of the pump should be wiped off immediately with a soft cloth. Please observe that any liquid penetrating the pump can cause serious damage to the pumps’ electronic circuits. Epidural drug infusions delivering drugs dif ferent from the ones specifically indicated for those kinds of administrations can cause serious lesions or death. CANÈ S.p.A.
SECTION 1 NOTE The manufacturer only takes the responsibility for the safety and reliability of this pump, provided that it is used in accordance with the current instructions for use and only in case any repairs and changes to the device are made exclusively by the manufacturer. INTENDED USE The ambulatory infusion pump of drug Crono Five has been designed to be used in the pain treatment for subcutaneous, intravenous and epidural infusions. The pump is not designed for life sustaining treatments.
SECTION 2 DESCRIPTION OF THE PUMP CRONO Five is a new , innovative PCA pump that is very appreciated by health care professionals and patients due to its small size and technical features. CRONO Five is an ambulatory infusion pump especially suited for control led drug administration on patients in hospital or undergoing a therapy at home. The pump is suitable for subcutaneous, intravenous and epidural infusions allowing 4 different administration modalities: 1. Continuous 2.
SECTION 2 INFUSION SYSTEM The pump administers shots of 5 microliters (µl or mcl) for any given flow rate. The time interval between shots decrease proportionally to increases in programmed flow rates. TECHNICAL FEATURES Pump size 77 x 47 x 29 mm. Weight 115 g (battery included). Battery CR 123A 3V Lithium battery (battery life: about 6 months). Syringe Dedicated 10 and 20 ml capacity with luer-lock connector. Administration volumes From 1 ml to 20 ml with increments of 1 ml.
SECTION 2 Number of boluses doses per hour - from 1 to 12 boluses. - this function can be deactivated by programming 0. Flow accuracy +/-2% (observation period 40 minutes). Max. occlusion pressure 2.2 bar +/-0.8. Time to an occlusion alarm Please, see ANNEX 2. Post-occlusion bolus About 0.4 ml (details are supplied on ANNEX 3). Electric circuit Electric circuit managed by a micro controller equipped with a dedicated software.
SECTION 2 FACTORY SETTINGS The following factory settings are programmed at the delivery of the pump: Key-pad lock-out level L0 Syringe 20 ml Flow rate 1000 mcl/h Bolus dose 0.2 ml Interval between bolus doses 1h Number of bolus doses in 1 hour 1 Clinician Bolus 0.00 ml Number of infusions 0 16 MAN 01/06/USA/p CRONO FIVE 11.
SECTION 3 STANDARD EQUIPMENT SUPPLIED 1. Ambulatory infusion pump. 2. Pump case. 3. Elastic belt. 4. Collar strap. 5. Fabric holder. 6. 2 batteries (one already inserted in the pump). 7. Battery tool. 8. User guide. 2 3 1 5 8 6 4 7 17 MAN 01/06/USA/p CRONO FIVE 11.
SECTION 3 OPTIONAL ACCESSORIES Heightwise leatherette case similar to a cellular phone holder . Detail belt clip Detail opening Color: black Size: 14 x 5,5 x 4 cm Weight: about 36 g Article code: CM/15 18 MAN 01/06/USA/p CRONO FIVE 11.
SECTION 3 Lengthwise leatherette case similar to a glasses case. Detail of belt loop Color: black Size: 13 x 5,5 x 4 cm Weight:: About 50 g. Article code: CM/14 19 MAN 01/06/USA/p CRONO FIVE 11.
SECTION 3 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 . 10 20 ml How to use elastic belt with pump and fabric holder . 20 MAN 01/06/USA/p CRONO FIVE 11.
SECTION 4 PUMP OVERVIEW Syringe fin hook Display Collar strap locking rings Button d Pusher Button - Button + Battery compartment Serial number Short instructions CE mark 21 MAN 01/06/USA/p CRONO FIVE 11.
SECTION 4 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 pro gress as well as giving warnings and alarm messages. Symbol "10 ml" : indicates the device has been set to use 10 ml (CRN 10) syringe setting. Symbol "20 ml" : indicates the device has been set to use 20 ml (CRN 10) syringe setting. 10 20 10 20 “Low battery” symbol: appears when the battery charge is low (see page 65).
SECTION 4 MAIN SCREEN INDICATIONS Pump OFF 10 Prime function 10 Prime execution 20 20 10 20 Flow rate 10 20 Time left to end of infusion (hours) 10 Time left to end of infusion (mins.
SECTION 4 Occlusion Feed/reversal motion of the pump pusher 10 20 10 20 10 End of infusion 20 10 Low battery Battery discharged Volume delivered (ml) as basal flow rate 20 10 20 10 20 Volume delivered (ml) as bolus doses 10 Number of bolus doses already delivered Volume delivered (ml) as clinician bolus Total volume delivered (ml) (basal flow rate + bolus doses + clinician bolus) 10 10 ml syringe selected 20 ml syringe selected 20 20 10 20 10 20 10 20 10 20 The above screens are give
SECTION 4 KEY-PAD The key-pad has 3 buttons for pro gramming and for the operation of the pump. The buttons are time-controlled: keep buttons pressed for a few seconds to activate commands. CAUTION Press the buttons with your fingertips only, do not use sharp or poin ted objects. • Buttons activation is confirmed by a ticking sound, except when inserting the battery. • Command execution is confirmed by a brief acoustic signal.
SECTION 5 SYRINGES The ambulatory infusion pump CRONO Five uses dedicated 1020 ml syringes. Piston Rod Piston The 10-20 ml syringes are: • • • • Sterile. Single use only. Pyrogen-free. To be used only if packaging is not damaged. Syringe structure Needle’s cap Luer-Lock cap Needle LUER LOCK CAP The luer lock cap should be used to protect a filled syringe from con tamination if the syringe isn't used immediately after filling. Luer-Lock cap 26 MAN 01/06/USA/p CRONO FIVE 11.
SECTION 5 FILTRAJET Filter can be used to: Luer Lock cap - female insert • Prevent bacterial infections. Luer Lock Male blue fitting • Eliminate air in the syringe and in the infusion set. • Trap any fragments of glass or plastic to secure a safe and proper drug administration. Tubing set @ 1 x 2.3 PVC - NO DOP Filter 0.2 micron Luer Lock Female transparent fitting Luer Lock cap - Male insert 27 MAN 01/06/USA/p CRONO FIVE 11.
SECTION 5 INFUSION SET • For information about infusion sets, please see the instruction supplied with the products. • Epidural drug infusions must be delivered using infusion sets specifically suitable for such purpose. PREPARATION FOR INFUSION Before the pump and other disposa bles are prepared to be used, make sure that you take the following pre cautions to avoid any contamination: 1. Wash your hands; 2. Prepare a clean working area. min h OFF d NO CRO ET ml 0.
SECTION 5 SYRINGE PREPARATION 1. Attach the supplied needle to the syringe with a clockwise rotation; 2. Draw up the liquid slowly to avoid disconnection between the rubber piston and the piston rod and make sure the volume corresponds exactly to the prescription; 3. Attach luer-lock cap then unscrew the piston rod of the syringe counter-clock wise with a fairly swift movement; 1 2 3 29 MAN 01/06/USA/p CRONO FIVE 11.
SECTION 5 CONNECTING THE SYRINGE TO THE PUMP Connect the dedicated syringe, CRN 10-20, to the pump with a 90° rotation: a click is confirming that the syringe is correctly attached to the pump. Top view WARNING It is important to draw up the intended quantity as accurate as possible, independently if it is a full syringe of 10 ml or 20 ml or a partial volume 1-9 ml or 1-19 ml. 1. By excess volumes, it will be very dif ficult to attach the syringe to the pump without aspirating the excess volume. 2.
SECTION 5 SAFETY SYSTEM TO AVOID FREE-FLOW "Free flow" means an uncontrolled release of the infusion solution from the syringe caused by gra vity. 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 10-20 ml syringe, allowing a secure connection to be made with the syrin ge piston.
SECTION 5 4. Attach the syringe to the pump with a 90° rotation and continue the movement until the syringe clicks into its correct position. 5. Attach the butterfly needle cone onto the syringe 4 5 32 MAN 01/06/USA/p CRONO FIVE 11.
SECTION 6 DEVICE ACTIVATION When you insert the battery the pump starts a sequence of activation during which: 10 1.The pump will carry out a self-test with brief acoustic signals and all symbols will appear on the screen. 2. Select the syringe size options. 3.The pump’s mechanical pusher will place itself in the correct starting position and at the end of this self-adjusting, OFF will appear on the screen. 20 10 20 10 20 10 20 NOTE • The pump is supplied with a battery already inserted.
SECTION 7 KEY PAD LOCK OUT The pump is provided with a key-pad lock-out in order to avoid non authorised or accidental variations of the selected parameters. The CRONO Five pump has 2 lock levels: • L 0: permits complete access to all settings and operating functions. • L 1: permits restricted control of operating functions. Before proceeding to the pump settings make sure that the lock level selected is L 0. CAUTIONS • The key pad lock-out is retained even when the battery is removed.
SECTION 7 TABLE OF KEY-PAD FUNCTIONS The following table lists the accessible functions at any key-pad lock-out level (L 0 or L 1) both when the pump is in OFF and ON condition.
SECTION 8 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 program ming sequence. The first programming option displayed on the screen is flow rate. The flow rate can be changed with the button or the button as long as the presently programmed flow rate is flashing. The second depressing of the button will display the second programming option bolus dose volume.
SECTION 8 OFF 10 20 d Flow rate 10 20 d Bolus dose volume 10 20 d Minimum time interval between bolus doses 10 20 d Number of bolus doses per hour 10 20 d Partial volume 10 20 The following screen displays are examples of programmed values as they appear on the screen. 37 MAN 01/06/USA/p CRONO FIVE 11.
SECTION 8 PROGRAMMING OF FLOW RATE The flow rate can be programmed from 5 mcl/h to 5000 mcl/h as follows: • From 5 mcl/h to 1000 mcl/h with increments of 5 mcl/h. • From 1000 mcl/h to 5000 mcl/h with increments of 10 mcl/h. Programming procedure: 1. When the button is depressed for about 1 second with the pump in OFF condition, the presently programmed flow rate will be displayed and flashing 2 . By depressing the button the value will increase; by depressing the button the value will decrease.
SECTION 8 PROGRAMMING OF BOLUS DOSE The bolus dose can be programmed from 0.01 ml to 2.00 ml with increments of 0.01 ml. The bolus dose is accessed by the second depressing of the button in the pump programming sequence (see page 37). Programming procedure: 1. When the button is depressed for a second time, a "d" is displayed and the presently programmed bolus dose is flashing. 2. By depressing the button the value will increase; by depressing the button the value will decrease.
SECTION 8 MINIMUM TIME INTERVAL BETWEEN BOLUS DOSES The minimum time interval between bolus doses can be programmed from 5 minutes to 24 hours as follows: • From 5 minutes to 1 hour with increments of 5 minutes. • From 1 hour to 24 hours with increments of 15 minutes. This function limits the patient to access the programmed bolus dose before a certain time has elapsed from the latest administered bolus dose.
SECTION 8 NOTE • "t" appears only before the programmed interval time when the interval time is less than 10 hours. • You can accelerate (scrolling) the display of new values by depressing the or the button continuously (in increments of 10 or 30 minutes depending on the range). 10 20 10 20 • Programmed interval time is automatically stored. • By programming " no,Lt", the minimum time between bolus doses is eliminated. 10 20 41 MAN 01/06/USA/p CRONO FIVE 11.
SECTION 8 PROGRAMMING OF BOLUS DOSES PER HOUR The number of bolus doses per hour can be programmed between 1 and 12 boluses per hour. This function limits the patient to access more boluses per hour than programmed. The number of bolus doses per hour is accessed by the fourth depressing of the button in the pump programming sequence (see page 37). Programming procedure: 1.
SECTION 8 play is showing "n 1", will eliminate the bolus dose per hour function and the display will show "n 0", which means that no boluses can be administered. • By depressing the button when the display is showing n 12, will eliminate the bolus number per hour restriction and the display will show no,Ln, which means that there is no longer any restriction how many boluses that can be administered by the patient. 10 20 10 20 43 MAN 01/06/USA/p CRONO FIVE 11.
SECTION 8 PROGRAMMING OF PARTIAL VOLUME Partial volume is used when less than 20 ml is drawn up in the syringe for a specific treatment or for a specific patient, for example children who needs less than the adult dose. Partial volume can be programmed between 1 ml and 20 ml with increments of 1 ml. Partial volume is accessed by the fifth depressing of the button in the pump program ming sequence (see page 37).
SECTION 8 NOTE WARNINGS • Partial volume is automatically stored for the • Do not perform this openext delivery, unless reprogrammed. ration with an infusion set attached to the syrin• At the end of a partial infusion the pusher ge. moves automatically back to the programmed partial volume position. • It is not possible to reprogram the partial volume • By depressing the button and button during an ongoing infusimultaneously, the movement of the pusher sion.
SECTION 9 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 the start position for a new, full or partial volume, infusion 10 20 or • remaining infusion time in hours and (minutes) when the pump is restarted during an ongoing infusion 10 20 NOTE The remaining time to the end of the infusion is displayed in days until less than one day remains, in hours until less
SECTION 9 PRIMING WARNINGS The priming function is used for filling the infusion set with drug from the syringe. A total of • Do not prime the infusion 1.5 ml, in steps of 0.5 ml, can be primed using set when attached to the the priming function. patient. • The infusion set should Priming can only take place when the pusher be attached to the syrinis in the starting position for a new, full or parge before priming starts tial volume infusion.
SECTION 9 b. To skip priming Depress the button; the pump will start the infusion and the display will show the remai ning infusion time. 10 20 c. To start priming Depress the button: the pump will deliver 0,5 ml and the display will show a P followed by the volume in ml that has been primed. After the first priming of 0.5 ml, the display will show Pr again and the procedure can be repeated two more times up to 1,5 ml has been primed. There is no time limit to finish the priming procedure.
SECTION 9 PUMP IN ON (RUNNING) The remaining infusion time is displayed in days hours and minutes when the pump is in ON (running). The letter d flashes when the remaining infu sion time is displayed in days. 10 20 The letter h flashes when the remaining infu sion time is displayed in hours. 10 The “apostrophe” symbol flashes when the remaining infusion time is displayed in minu tes.
SECTION 9 BOLUS DOSE The bolus dose is used by the patient to administer an additional dose of medication as needed. If the bolus dose is programmed to 0 ml, no bolus dose can be administered. Delivering a bolus dose Bolus doses can only be delivered when the pump is in ON (running). 1. Depress the button and the pump will emit an acoustic signal, which indica tes that the pump starts to deliver the programmed bolus dose.
SECTION 9 BOLUS DOSE LIMITATIONS • Time interval between bolus doses (t limitation) • Number of bolus doses per hours (n limitation) Bolus doses cannot be delivered before the time (t) has expired or when the number of programmed boluses per hour (n) has already been administered. The pump will always choose the program med (t) or (n) that administer the lowest amount of bolus doses in ml.
SECTION 9 CLINICIAN BOLUS The access to the clinical bolus function is reserved to physicians or para medic staff. 52 MAN 01/06/USA/p CRONO FIVE 11.
SECTION 9 OCCLUSION OF INFUSION SET 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 display will show the symbol for occlusion and the pump will emit an acoustic signal every 10 seconds. Drug administration is interrupted as long as the occlusion remains.
SECTION 9 END OF INFUSION Ten and five minutes before the end of infu sion, the pump will emit an intermittent acou stic signal lasting two seconds per signal. At the end of infusion, the pump will emit a acoustic signal and END will be displayed. By depressing the and the buttons simultaneously, the acoustic message will be silenced and the pusher will move back to the starting position.
SECTION 9 REVERSALS OF THE PUMP PUSHER Reversal of pusher before the end of infusion. It is possible to interrupt an infusion in pro gress and reverse the pusher to its starting position: • Depress the and the buttons simultaneously to switch off the pump. • Depress the and the buttons simul taneously, End will be displayed for about 10 seconds and the pump will start to reverse the pusher.
SECTION 9 the and the buttons simultaneously; OFF will be displayed; End and OFF will alternate on the screen. By depressing the button, the pump will resume the reversal of the pusher. • If pump reversal is requested when the pusher already is in the starting position for an infusion, the pump will emit an acoustic signal and Err will be displayed.
SECTION 9 SWITCHING OFF THE PUMP Depress the and buttons simultaneously. The display will show OFF. 10 20 If the pump is switched OFF while an infusion is ongoing the device will emit a sequence of 5 short sounds every 5 seconds and OFF will flash on the display . To silence the acoustic alarm press down the button for 5 seconds. Such a condition will be repeated any time the device is switched of f w hile an infusion is in progress. 57 MAN 01/06/USA/p CRONO FIVE 11.
SECTION 10 DISPLAYING PROGRAMMED PARAMETERS To display programmed parameters/values the pump must be running ( ON). The screen will show either remaining delivery time or F0,00 if the flow rate is programmed to 0. 10 20 Display procedure: 1.Depress the button for about 1 second and the programmed flow rate will be displayed 2. If no button is depressed for 5 seconds, the pump will revert to remaining delivery time or F0,00. 3.
SECTION 10 Remaining delivery time 10 20 + Flow rate 10 20 + Bolus dose 10 20 + Minimum time interval between bolus doses 10 20 + 10 Number of bolus doses per hour 20 + 10 Partial volume 20 + 10 Clinician bolus 20 The screens above are examples of what can be displayed. 59 MAN 01/06/USA/p CRONO FIVE 11.
SECTION 10 DISPLAYING DELIVERED VOLUMES This display procedure will show the delivered volume in ml since the start of the infusion for the different delivery options. The pump has to be running (ON) and the screen will either show the remaining delivery time or F0,00. Display procedure: 1. Depress the button for about 1 second and the programmed flow rate will be displayed. 2. If no button is depressed for 5 seconds, the pump will revert to remaining delivery time or F0,00. 3.
SECTION 10 Remaining delivery time ˜ 20 Volume delivered as flow rate during the infusion in progress. ˜ Volume delivered as bolus doses during the infusion in progress. ˜ Number of bolus doses already delive red. ˜ Volume delivered as clinician boluses during the infusion in progress. Total volume delivered (flow rate + bolus doses + clinician bolus doses). 20 20 20 ˜ 20 ˜ 20 The screens above show examples of what can be displayed. 61 MAN 01/06/USA/p CRONO FIVE 11.
SECTION 10 CLEARING THE NUMBER OF BOLUS DOSES DELIVERED The number of bolus doses delivered can be set to zero at any time, provided that the lock level is L0. Clearing procedure: 1. Depress the and the buttons simultaneously for about 4 seconds with the pump in OFF and the number of bolus doses delivered will start flashing on the screen. 2. Depress the button within 5 seconds, the pump will emit an acoustic signal and the number of the bolus doses delivered will be set to zero and OFF will be displayed.
SECTION 10 DISPLAYING THE NUMBER OF COMPLETE INFUSIONS The pump has to be in OFF to be able to dis play the number of complete infusions performed by the pump. Depress the button for about 5 seconds and the number of complete infusions will be displayed. 10 20 20 Clearing the number of complete infusions performed by the pump. Clearing procedure: 1. The pump has to be in OFF and lock level L0. 2. Depress the button for about 5 seconds and the number of complete infusions will be displayed. 10 20 20 3.
SECTION 10 5. If the clearing sequence is correctly performed, the message 0000 will appear on the screen for about 3 seconds followed by the sound of the buzzer. If not, or if no buttons are depressed for more than 7 seconds, the message UNDO will appear on the screen (operation not performed correctly). 6. OFF will be displayed at the end of zero setting.
SECTION 11 LOW BATTERY ALERT The LOW BA TTERY symbol will be conti nuously displayed when the battery level is low. The battery should be changed as soon as the ongoing infusion is completed. If the battery is completely discharged, BA TTERY DISCHARGED, the symbol batt will be displayed and the pump will emit a short acoustic signal. The pump will stop and the infusion cannot be completed without changing bat tery.
SECTION 11 BATTERY INSTALLATION OR REPLACEMENT 10 20 PID PID CR CRO ONNO O PID PID 1. Open the battery compartment using the blue key-ring device that is included with the pump. CRONO CRONO CRONO CRONO PID PID PID PID CR CRO ONNO O PID PID CR CRO ONNO O PID PID 2. Pull out the cover. CRONO CRONO Use only lithium 3 Volt 123 A batteries. Make sure the pump is in OFF condition (OFF will be displayed), then replace the battery.
SECTION 11 WARNINGS If it is dif ficult to remove the battery using the ribbon strap, do not use any other object to remove the battery but try the following proce- • Do not use rechargeable batteries. dure: • The use of batteries of a different type could • Hold the pump and the battery compartresult in device malfuncment firmly in your right hand. tions. • Tap your right hand on the palm of your left • Battery life will vary hand until the battery falls out.
SECTION 12 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 CAN È or CANÈ's local representative.
SECTION 12 MAINTENANCE Should the device be damaged, the pump has to be checked by CAN È or CANÈ's local representative. CANÈ S.p.A. recommends an annual check up on all Crono Five pumps with the aim of evaluating the correct function and accuracy. Such check ups must be carried out only by CAN È S.p.A. or an authorized distributors.
SECTION 12 USER INFORMATION The pump can only be repaired by CAN È S.p.A. and the pump has the refore to be sent to CAN È's local representative in the country in which the pump has been sold for further transportation to CAN È S.p.A. Do not send any pumps for repair before you contact your local repre sentative: - UNITED STATES: INTRA PUMP INFUSION SYSTEMS 920 Minters Chapel Road, Suite 200 Grapevine, Texas 76051 Tel: 866-211-7867 Fax: 630-845-2768 Email: info@intrapump.com MANUFACTURER: CANÈ S.p.A.
SECTION 13 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 S.p.A. will without charge for labour or parts, repair or replace the defective parts upon the terms and conditions set out below. CANÈ S.p.A.
SECTION 13 5. 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. CANÈ S.p.A. is not responsible towards the purchaser or third parties for any damage deriving from the use of the pump after 4 (FOUR) years from the date of purchase. 6. Once the warranty period has expired, CANÈ S.p.A.
SECTION 14 ALARM MESSAGES CODE 10 20 10 INFUSIONS DESCRIPTION/ACOUSTIC SIGNAL ACTION Unfeasable operation --------------- Incorrect reset Continuous acoustic signal 10 20 10 20 10 20 10 20 10 20 10 20 10 20 Irregularity in the security system Continuous acoustic signal Irregularity in the motor circuit Acoustic signal repeated every 10 seconds Mechanical block during “End” phase caused by foreign matter obstructing the pusher’s reversal 7 beeps followed by another 7 beeps after 1 and 2 minut
SECTION 14 CODE 10 20 10 20 10 20 10 INFUSIONS DESCRIPTION ACTION Active limitation of bolus doses number (not possible Refer to user guide at page 51 to deliver bolus doses) Bolus dose not available Refer to user guide (value set for bolus dose is 0) at page 50 Active limitation of interval between bolus doses (not possible to deliver bolus doses) Refer to user guide at page 51 Keypad locked Unlock the keypad 20 Alarm messages are accompanied by audible signals.
SECTION 14 SHORT INSTRUCTIONS INSERTING BATTERY PHASE BUTTONS SCREEN PUMP ACTIVATION • The screen will show all symbols. 10 20 / • Syringe size selection. • Pusher self-adjust. 10 10 20 20 10 20 10 • Pump switches OFF. BUTTONS and 20 REVERSING OF THE PUMP PISTON NUMBER OF INFUSIONS DELIVERED • Reversing of the pump piston to the start position. SCREEN 10 10 10 20 20 20 depress simultaneously • Reading the number of infusions delivered.
SECTION 14 BUTTONS SETTINGS SCREEN Operations feasible only with key-pad unlocked. 10 • Setting flow rate 10 • Setting bolus dose 10 • Setting bolus time limitations 10 20 20 1st depressing 20 PUMP OFF 2nd depressing 20 3rd depressing • Setting boluses number limitations 10 20 4th depressing • Setting partial volume 10 20 5th depressing / • Decrease/Increase above parameters.
SECTION 14 PUMP ON BUTTONS SCREEN INFUSIONS • Bolus dose delivery. and 10 20 • Bolus interruption (if in execution). depress simultaneously BUTTONS PUMP ON 1st depressing 2nd depressing • Administered flow rate in ml since start of infusion. • Administered patient bolus in ml since start of infusion. • Administered number of bolus.
SECTION 14 PUMP ON BUTTONS and PUMP OFF • Pump switches OFF. 10 20 depress simultaneously BUTTONS END OF INFUSION SCREEN END OF INFUSION SCREEN • End of infusion. and depress simultaneously • Piston automatic reversing. • Automatic switch OFF. 78 MAN 01/06/USA/p CRONO FIVE 11.
SECTION 15 PUMP ICON TABLE Pump serial number SN Drip-proof instrument It can withstand occasional liquid dripping or splashing.It must not be immersed in liquid. CE Mark 0476 Electromedical equipment BF type Warning: see instructions for use Dispose of used electric and electronic devices in an environmentally safe manner, using the appropriate containers and according to any regulations that may apply. 79 MAN 01/06/USA/p CRONO FIVE 11.
SECTION 15 SYRINGE BLISTER PACKAGE ICON TABLE CE mark 0123 Recyclable Do not re-use 2 Expiration date Sterilised by Ethylene oxide STERILE EO Polypropylene PP Lot number LOT 80 MAN 01/06/USA/p CRONO FIVE 11.
SECTION 16 STATEMENT OF CONFORMITY 0476 CANÈ S.p.A. is a registered company with its headquarters in V ia Cuorgnè, 42/a 10098 Rivoli (TO) Italy. CANÈ S.p.A. is the manufacturer of the portable, electrically-operated ambulatory infusion pump Crono Five. Serial number Manufacturing date CANÈ S.p.A. declares that this product conforms to the safety provisions as set out in Annex II, risk class IIb, following the directive 93/42/EEC dated 14 June 1993 as certification N. MED-9813 issued by Notified Body 0476.
SECTION 16 NOTE 82 MAN 01/06/USA/p CRONO FIVE 11.
SECTION 17 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. Bolus A bolus dose is an additional quantity of drug that can be released under certain defined conditions. Basal flow rate The basal flow rate is the quantity of drug delivered by the pump in a time unit.
SECTION 17 Luer-lock connector A luer-lock connector is a special threaded fitting used to connect the infu sion set to the syringe. Occlusion pressure An alarm beeps when occlusion pressure is reached. Pyrogen free It means that the syringe does not contain pyrogenic substances, which cause fever as the ones released, for instance, by leucocytes or produced by bacteria. 84 MAN 01/06/USA/p CRONO FIVE 11.
ANNEX 1 ACCURACY TEST The tests have been carried out in compliance with the standard IEC 606012-24 - Medical electrical equipment – Part 2-24: Particular requirements for the safety of infusion and controllers. The following graphics show the accuracy of the pump during the administration. 1.1 - Start-up flow rate • Programmed flow rate: 1000 mcl/h 85 MAN 01/06/USA/p CRONO FIVE 11.
1.2 - Flow rate error (trumpet curve) • Programmed flow rate: 1000 mcl/h • Average error: +/- 2% Accuracy may deviate from the information in this user guide depending on which type of extension set, tubing and access devices are used for the administration of a medication. 86 MAN 01/06/USA/p CRONO FIVE 11.
ANNEX 2 TIME TO AN OCCLUSION ALARM SIGNAL There is a certain interval time between when an occlusion occurs and the time it takes for the pressure in the administration line to trigger the occlu sion alarm signal. The table below is showing the time to an occlusion alarm with different flow rates in combination with an infusion set with 27G need le, 80 cm lenght with very stif f lining.
ANNEX 3 POST-OCCLUSION BOLUS When the occlusion alarm signal is triggered, the pump has built up a cer tain overpressure in the administration line(s), which has to be eliminated to avoid an accidental post occlusion bolus that could result in serious injury or death to the patient. The size of a post-occlusion bolus for Crono Five in combination with an infusion set with 27G needle, 80 cm lenght with very stiff lining is about 0.4 ml.
ANNEX 4 ELECTROMAGNETIC COMPATIBILITY The tests have been carried out in compliance with the standard IEC 606012-24 - Medical electrical equipment - Part 2-24: Particular requirement for the safety of infusion pump and controllers. 4.1 – Emission tests The test has been executed with the antenna in horizontal and vertical polarization. 4.1.1 TEST Radiated Emission Coupling port Enclosure Range frequency 30 - 1000 MHz 4.1.
4.3 - Radiated immunity The A test has been executed with horizontal and vertical field polarization. The B test has been executed with horizontal and vertical field polarization, with steps of equal frequency to 1% of the fundamental one. 4.3.1 TEST Coupling port Frequency range Test level A - Radiated immunity Enclosure 26-80 MHz 10 V/m 80% AM 1kHz B - Radiated immunity Enclosure 80-1000 MHz 10 V/m 80% AM 1kHz 4.3.
