Cane Crono Guide de l'utilisateur

USER GUIDEAmbulatory infusion pumpCRONO PAR 50

10MAN 01/EN/03 CRONO PAR 50 06/13NOTES• In order to make this manual as complete and accurate as possible, please report any errors or omissions to t

100MAN 01/EN/03 CRONO PAR 50 06/13PRECISION TEST (TRUMPET CURVE)The tests have been performed according to IEC 60601-2-24, Electro-medi-cal devices, P

101MAN 01/EN/03 CRONO PAR 50 06/131.2 - Flow rate error (trumpet curve)• Flow rate setting: 1 ml/h.The actual degree of precision may differ from that

102MAN 01/EN/03 CRONO PAR 50 06/13APPENDIX 4PRESSURE LEVELS (PL)The CRONO PAR 50 pump allows the medical/paramedical and clinical en-gineering personn

103MAN 01/EN/03 CRONO PAR 50 06/13APPENDIX 2TIME NEEDED TO SIGNAL AN OCCLUSIONThe time needed to signal an occlusion is the interval between the begin

104MAN 01/EN/03 CRONO PAR 50 06/13POST-OCCLUSION BOLUSWhen the occlusion alarm sounds, the pump has detected an excessive back pressure in the infusio

105MAN 01/EN/03 CRONO PAR 50 06/13ELECTRO-MAGNETIC COMPATIBILITYAPPENDIX 7Guide and declaration by the manufacturer - electro-magnetic emissionsCRONO

106MAN 01/EN/03 CRONO PAR 50 06/13APPENDIX 7 Guide and declaration by the manufacturer - electro-magnetic immunityCRONO PAR 50 is designed to operate

107MAN 01/EN/03 CRONO PAR 50 06/13REFERENCE DIRECTIVES• Council Directive 93/42/EEC: Medical devices.• Legislative Decree no. 46, 24th February 1997

108MAN 01/EN/03 CRONO PAR 50 06/13TECHNICAL STANDARDS• IEC EN 60601-1:2007-05. Medical electrical equipment, Part 1: general requirements for basic

109MAN 01/EN/03 CRONO PAR 50 06/13• IEC EN 60601-2-24:2012-10. Medical electrical equipment, Part 2: particular requirements for the safety of infusi

11MAN 01/EN/03 CRONO PAR 50 06/13SECTION 3The CRONO PAR 50 ambulatory infusion pump is designed for the subcuta-neous infusion of apomorphine in the t

110MAN 01/EN/03 CRONO PAR 50 06/13APPENDIX 9SETTINGS

111MAN 01/EN/03 CRONO PAR 50 06/13APPENDIX 10ACCESSING RESERVED SECTIONYou can access additional reserved functions of the pump, such as: resetting th

112MAN 01/EN/03 CRONO PAR 50 06/13APPENDIX 105 - Press the button again to display the ashing oc-clusion pressure level: you can select one of the

113MAN 01/EN/03 CRONO PAR 50 06/13APPENDIX 11INFORMATIONFor further information on the CRONO PAR 50 pump, contact:Servizio Assistenza Clienti (Custome

114MAN 01/EN/03 CRONO PAR 50 06/13

12MAN 01/EN/03 CRONO PAR 50 06/13The device must be used:- under medical supervision,- with appropriate procedures and adequate measures when dealing

13MAN 01/EN/03 CRONO PAR 50 06/13SECTION 3CRONO PAR 50 is an ambulatory infusion pump which uses single-use reservoirs for the controlled subcutaneou

14MAN 01/EN/03 CRONO PAR 50 06/13SECTION 3TECHNICAL CHARACTERISTICSPump dimensions 3.31 x 2.17 x 1.65 in (84 x 55 x 42 mm).Weight 4.47 oz. (139 g), in

15MAN 01/EN/03 CRONO PAR 50 06/13Flow rate precision +/-3%.Occlusion pressure 3 selectable values; for further infor-mation see APPENDICES 4-6. The pu

16MAN 01/EN/03 CRONO PAR 50 06/13SECTION 4SUPPLIED STANDARD EQUIPMENT1. Ambulatory infusion pump with reservoir CRONO PAR 50.2. Infuser carry-case (Co

17MAN 01/EN/03 CRONO PAR 50 06/13SECTION 5PUMP PARTSDisplayButtonsAttachment for the reservoir wingsLEDSupport cord attachment eyeletsAnti-slip groove

18MAN 01/EN/03 CRONO PAR 50 06/13SECTION 5CONTROL BUTTONSThere are 3 control buttons.The buttons have a built-in safety delay: you must keep them pres

19MAN 01/EN/03 CRONO PAR 50 06/13SECTION 5LIQUID CRYSTAL DISPLAY (LCD)The liquid crystal display uses text messages and icons to display practical inf

20MAN 01/EN/03 CRONO PAR 50 06/13“Clock” symbol:Only displayed when Auto is selected (see related section on page 53-76). When the clock symbol is vis

21MAN 01/EN/03 CRONO PAR 50 06/13LOW BATTERY ALERTThe appearance of the “LOW BATTERY” alert (not ashing) on the display indicates that the battery is

22MAN 01/EN/03 CRONO PAR 50 06/135. wait 10 seconds before inserting the new battery checking that it is in the correct position and that the ribbon

23MAN 01/EN/03 CRONO PAR 50 06/13SECTION 5• The cover is supplied with a gasket which must remain in position as indicated in the illustration.• After

24MAN 01/EN/03 CRONO PAR 50 06/13SECTION 5PROGPROGPROGPROG• The time remains in the memory for about 36 hours even when there are no batteries in th

25MAN 01/EN/03 CRONO PAR 50 06/13SECTION 6SETTINGS LOCKWARNINGSThe CRONO PAR 50 pump has 2 access congurations:- L0 (unlocked): in this conguration

26MAN 01/EN/03 CRONO PAR 50 06/13DISPLAYAUDIBLE SIGNALERROR DESCRIPTIONCORRECTIVE ACTIONBrief continuous audible signal.Operation not allowed. ---Beep

27MAN 01/EN/03 CRONO PAR 50 06/13DISPLAYAUDIBLE SIGNALERROR DESCRIPTIONCORRECTIVE ACTIONBeep repeated every 10 sec approximately.When a battery is ins

28MAN 01/EN/03 CRONO PAR 50 06/13SECTION 7The displayed error messages (from Er,1 to Er,11 and OCCL) are accompa-nied by an acoustic signal and the sy

29MAN 01/EN/03 CRONO PAR 50 06/13POST-OCCLUSION BOLUSWARNINGSSECTION 7INFUSION SET OCCLUSIONThe pump is designed to recognise when the administration

Manual code: MAN 01/EN/03 CRONO PAR 50Publication date: 06/13CANÈ S.p.A. Medical TechnologyVia Cuorgnè 42/a 10098 Rivoli (TO) Italy Tel.+39 011 957487

30MAN 01/EN/03 CRONO PAR 50 06/13SECTION 8SELECTING THE PUMP MODEPUMP INITIALISATION1. runs a self-diagnosis test, emitting a series of brief acou-st

31MAN 01/EN/03 CRONO PAR 50 06/13To be able to select the mode of the pump, it must:• be set to OFF (at the beginning of a full or partial infusion);•

32MAN 01/EN/03 CRONO PAR 50 06/13FrEESELECTED PUMP MODE: FrEESECTION 9FACTORY SETTINGSThe pump is supplied with the following default settings:Dose 0.

33MAN 01/EN/03 CRONO PAR 50 06/13FrEEFrEEQUICK REFERENCE FrEEThe buttons have a built-in safety delay: you must keep them pressed for several seconds

34MAN 01/EN/03 CRONO PAR 50 06/13FrEEBUTTONS CONFIGURING THE SETTINGS IN THE OFF CONDITION DISPLAYPUMP SET TO OFF• Pump set to OFF• Set bolus dose vol

35MAN 01/EN/03 CRONO PAR 50 06/13FrEEFrEESECTION 10BUTTONS SWITCHING ON / PRIMING DISPLAYPUMP SET TO OFF• Pump set to OFF• Priming function• Priming f

36MAN 01/EN/03 CRONO PAR 50 06/13FrEESECTION 10BUTTONSSETTINGS LOCKDISPLAY• Pump set to OFF or StoP• Displaying the number of administered• The number

37MAN 01/EN/03 CRONO PAR 50 06/13FrEEFrEESECTION 11BUTTONS DISPLAYING DISPLAY• Pump in OFF• Bolus dose volume• Interval between the bolus doses • Flow

38MAN 01/EN/03 CRONO PAR 50 06/13FrEEProceed as follows:1. with the pump set to OFF or StoP press the button for a few seconds: the display shows the

39MAN 01/EN/03 CRONO PAR 50 06/13FrEEFrEESETTING THE INTERVAL BETWEEN BOLUS DOSESThe interval between bolus doses can be set to a value between no,Lt

4MAN 01/EN/03 CRONO PAR 50 06/13SECTION 1Symbols and conventions... Page 8SECTION 2Introduction ...

40MAN 01/EN/03 CRONO PAR 50 06/13FrEESETTING THE FIRST FLOW RATE (F1)The ow rate can be set from 0.05 to 5.00 ml/h as follows:• from 0.05 ml/h to 1.0

41MAN 01/EN/03 CRONO PAR 50 06/13FrEEFrEESETTING THE SECOND AND THIRD FLOW RATES (F2 AND F3)The ow rate can be set from 0.00 to 5.00 ml/h as follows:

42MAN 01/EN/03 CRONO PAR 50 06/13FrEESETTING THE PARTIAL VOLUMEThe partial volume function is used when the treatment requires an infusion with less t

43MAN 01/EN/03 CRONO PAR 50 06/13FrEEFrEENOTESWARNINGS• This operation must not be carried out with the infusion set connected to the patient.• A p

44MAN 01/EN/03 CRONO PAR 50 06/13FrEEBefore starting an infusion:• check that the reservoir is correctly connected;• inspect the infusion line to ensu

45MAN 01/EN/03 CRONO PAR 50 06/13FrEEFrEEPRIMING THE INFUSION LINEThe priming procedure is as follows:1. switch on the device as described in the rele

46MAN 01/EN/03 CRONO PAR 50 06/13FrEEc. Perform the primingPress and hold down the button to deliver the priming dose; the priming function can be in

47MAN 01/EN/03 CRONO PAR 50 06/13FrEEFrEEPUMP SWITCHED ONWhen the pump is in ON condition, the display shows the delivery time in:• hours with a ashi

48MAN 01/EN/03 CRONO PAR 50 06/13FrEESELECTING THE FLOW RATESECTION 11This function allows the patients to change the ow during the day based on thei

49MAN 01/EN/03 CRONO PAR 50 06/13FrEEFrEE1. press the button: the pump gives a beep and commences to administer the bolus dose, during which a ash

5MAN 01/EN/03 CRONO PAR 50 06/13CONTENTSSECTION 8Pump initialisation... Page 30Selecting t

50MAN 01/EN/03 CRONO PAR 50 06/13FrEEDISPLAYING THE NUMBER OF ADMINISTERED BOLUS DOSES DURING AN INFUSION AND THE NUMBER OF INFUSIONS1 - To check the

51MAN 01/EN/03 CRONO PAR 50 06/13FrEEFrEEWITHDRAWING THE PUSHER• switch the pump off by pressing the button;• press the and buttons together: the

52MAN 01/EN/03 CRONO PAR 50 06/13FrEEDo not remove the reservoir until the pusher has been withdrawn to the infusion start position.WARNINGSWITCHING O

53MAN 01/EN/03 CRONO PAR 50 06/13AutoFrEESELECTED PUMP MODE: AUTO MODESECTION 12FACTORY SETTINGSThe pump is supplied with the following default settin

54MAN 01/EN/03 CRONO PAR 50 06/13AutoBUTTONS SELECTING THE PUMP MODE DISPLAY• Pump set to OFF• Displaying the number of administered bolus doses (aft

55MAN 01/EN/03 CRONO PAR 50 06/13AutoBUTTONS SETTINGS DISPLAYPUMP SET TO OFF• Pump set to OFF and L0• Visualisation of the time• Enabling the setting

56MAN 01/EN/03 CRONO PAR 50 06/13AutoSECTION 13BUTTONS SETTING THE PARTIAL VOLUME DISPLAY• Setting the partial volume• Decrease/Increase of partial vo

57MAN 01/EN/03 CRONO PAR 50 06/13AutoBUTTONSSETTINGS LOCKDISPLAY• Pump set to OFF or StoP• Displaying the number of administered• The number of comple

58MAN 01/EN/03 CRONO PAR 50 06/13AutoBUTTONS DISPLAYING DISPLAY• Pump in OFF and L1• Setting the time• Bolus dose• Time interval between bolus doses•

59MAN 01/EN/03 CRONO PAR 50 06/13AutoPUMP SETTINGS SEQUENCESECTION 14To change the settings the pump must:• be set to OFF or StoP;• have the settings

6MAN 01/EN/03 CRONO PAR 50 06/13SECTION 13Quick reference Auto ... Page 54SECTION 14Pump setting

60MAN 01/EN/03 CRONO PAR 50 06/13AutoAssigning the 4 ows over the daily 24-hour periodPress the button again to display and set the assignment of th

61MAN 01/EN/03 CRONO PAR 50 06/13AutoSETTING THE TIMEProceed as follows:1. with the pump set to either the OFF or StoP conditions, press the button f

62MAN 01/EN/03 CRONO PAR 50 06/13AutoSETTING THE BOLUS DOSE VOLUMEProceed as follows:1. the letter d is shown on the secondary display and the volu

63MAN 01/EN/03 CRONO PAR 50 06/13AutoSETTING THE INTERVAL BETWEEN BOLUS DOSESThe interval between bolus doses can be set to a value between no,Lt (f

64MAN 01/EN/03 CRONO PAR 50 06/13AutoSETTING THE FIRST FLOW RATE (F1)Proceed as follows:1. the display shows the ashing value of the rst ow rate;2.

65MAN 01/EN/03 CRONO PAR 50 06/13AutoSETTING THE SECOND AND THIRD FLOW RATES (F2 AND F3)The second and third ow rates are set in the same manner and

66MAN 01/EN/03 CRONO PAR 50 06/13AutoASSIGNING THE FLOWS OVER THE DAILY 24-HOUR PERIODProceed as follows:1. the rst two digits of the display show th

67MAN 01/EN/03 CRONO PAR 50 06/13AutoSETTING THE PARTIAL VOLUMEProceed as follows:1. the display shows a flashing value for the volume, preceded by cc

68MAN 01/EN/03 CRONO PAR 50 06/13AutoNOTESWARNINGSSECTION 14• This operation must not be carried out with the infusion set connected to the patient.•

69MAN 01/EN/03 CRONO PAR 50 06/13AutoSECTION 14SWITCHING ON THE PUMPFrom the OFF condition, press the button. The pump will give a brief beep and di

7MAN 01/EN/03 CRONO PAR 50 06/13SECTION 16How to use the supplied standard equipment ... Page 86Fastening the pump collar strap ...

70MAN 01/EN/03 CRONO PAR 50 06/13AutoPRIMING THE INFUSION LINESECTION 14The priming function allows for lling the infusion line with the drug contain

71MAN 01/EN/03 CRONO PAR 50 06/13AutoSECTION 14• Every time the pump administers 0.5 ml of drug, it emits an audible signal and pauses for about one s

72MAN 01/EN/03 CRONO PAR 50 06/13AutoPUMP SWITCHED ONDuring the infusion the time indicated on the display is shown in hours (with a ashing letter h)

73MAN 01/EN/03 CRONO PAR 50 06/13AutoThe bolus dose delivery can be interrupted at any time by pressing the button. If the bolus dose volume is set

74MAN 01/EN/03 CRONO PAR 50 06/13AutoWITHDRAWING THE PUSHERSECTION 14To stop an active infusion, do the following:• switch the pump off by pressing th

75MAN 01/EN/03 CRONO PAR 50 06/13AutoSECTION 14NOTES• While the display shows End, the withdrawal function can be cancelled by pressing the button. T

76MAN 01/EN/03 CRONO PAR 50 06/13AutoDISPLAYING THE SETTINGSThis function displays the programmed pump settings.To display the pump settings, the pump

77MAN 01/EN/03 CRONO PAR 50 06/13SECTION 15For safety reasons, you are recommended to use the original CRN® reser-voirs Crono® Réservoir.The use of an

78MAN 01/EN/03 CRONO PAR 50 06/13LUER-LOCK CAP FUNCTIONS• After the reservoir has been lled, the cap facilitates the unscrewing of the stem, avoi-d

79MAN 01/EN/03 CRONO PAR 50 06/13FILTRAJETFor a safe infusion you are recommended to use a lter in order to:• prevent bacterial infections;• eliminat

8MAN 01/EN/03 CRONO PAR 50 06/13To assist you in using the manual, the following symbols and conven-tions have been used:Triangle containing an exclam

80MAN 01/EN/03 CRONO PAR 50 06/13PREPARING THE RESERVOIR1. Screw the needle into the reservoir in a clockwise direction and remove the needle cover;2.

81MAN 01/EN/03 CRONO PAR 50 06/13Insert the dedicated CRN reservoir into the pump and engage it by rotating it 90° clockwise; a click conrms it has e

82MAN 01/EN/03 CRONO PAR 50 06/131 - Before lling the reservoirUnscrew and screw back the piston rod to fa-cilitate its unscrewing after you have ll

83MAN 01/EN/03 CRONO PAR 50 06/13Before preparing for the infusion, you are re-commended to adopt the following precau-tions:1. wash your hands;2. pre

84MAN 01/EN/03 CRONO PAR 50 06/13The images refer to the NeriaTM infusion set from Unomedical, a Convatec Company.Disinfect the infusion site followin

85MAN 01/EN/03 CRONO PAR 50 06/13Remove the needle cover, extracting it with care, before inserting the needle.Be careful not to touch the NeriaTM nee

86MAN 01/EN/03 CRONO PAR 50 06/13HOW TO USE THE SUPPLIED STANDARD EQUIPMENTPUMP CARRIED AROUND THE NECKThe pump worn with a collar strap and a fabric

87MAN 01/EN/03 CRONO PAR 50 06/13WEARING THE PUMP AT THE WAISTThe pump worn with an elastic belt and a fabric case.SECTION 16

88MAN 01/EN/03 CRONO PAR 50 06/13GENERAL WARNINGSThe device can be damaged by liquid, so it must not be kept on while in the bath or the shower, etc.

89MAN 01/EN/03 CRONO PAR 50 06/13GENERAL WARNINGSSTORAGEThe technical characteristics of the device make it extremely simple to main-tain.If the devic

9MAN 01/EN/03 CRONO PAR 50 06/13INTRODUCTIONThank you for choosing the CRONO PAR 50 ambulatory infusion pump.If any of the information is not clear, o

90MAN 01/EN/03 CRONO PAR 50 06/13EXPECTED PUMP LIFEDISPOSALThe pump is expected to last for 4 (four) years from its purchase date. For safety reasons

91MAN 01/EN/03 CRONO PAR 50 06/13CANÈ S.p.A. guarantees that the product is free from any material or ma-nufacturing defects for a period of 2 (TWO) Y

92MAN 01/EN/03 CRONO PAR 50 06/134. The following are excluded from the guarantee:• periodic maintenance• damage consequent to improper use, including

93MAN 01/EN/03 CRONO PAR 50 06/13DECLARATION OF CONFORMITY0476The company CANÈ S.p.A., with headquarters in Via Cuorgnè, 42/a 10098 Rivoli (Turin) - I

94MAN 01/EN/03 CRONO PAR 50 06/13APPENDICES

95MAN 01/EN/03 CRONO PAR 50 06/13ICONS USED ON THE PUMPSerial no. of the pumpIP protection rating1st digit (4) = protection from solid objects larger

96MAN 01/EN/03 CRONO PAR 50 06/13ICONS USED ON THE RESERVOIR BLISTER PACK0123iRead the instructionsCE markingRecyclable2PYROGENSTERILEEOPPREFLOTNEEDLE

97MAN 01/EN/03 CRONO PAR 50 06/13APPENDIX 2OPTIONAL ACCESSORIES AVAILABLE ON REQUEST1. Vertical leatherette case, similar to a mobile phone case.Colou

98MAN 01/EN/03 CRONO PAR 50 06/132. Horizontal leatherette case, similar to a spectacle case.Colours:Dimensions: 16 x 5.5 x 4 cmWeight: about 50 gItem

99MAN 01/EN/03 CRONO PAR 50 06/133. Adjustable elastic belt with buckle. 1 2 3Colour: blackDimensions: 110 cmWeight: about 50 gItem code: CM/31APPEND