Crono PAR 50 Ambulatory infusion pump USER GUIDE
Canè S.p.A. Medical Technology Via Cuorgnè 42/a 10098 Rivoli (TO) Italy Tel.+39 011 9574872 - Fax +39 011 9598880 www.canespa.it - mailbox@canespa.
CONTENTS SECTION 1 Symbols and conventions................................................. Page 8 SECTION 2 Introduction........................................................................ WARNING: PRECAUTIONS FOR USE............................ Information........................................................................ Page 9 Page 10 Page 10 SECTION 3 Intended use...................................................................... Pump description.........................................
SECTION 8 Pump initialisation............................................................. CONTENTS Selecting the pump mode.................................................. Page 30 Page 30 SECTION 9 Selected pump mode: FrEE.............................................. Factory settings................................................................. Page 32 Page 32 SECTION 10 Quick reference FrEE........................................................
SECTION 13 Quick reference Auto........................................................ SECTION 14 Pump settings sequence................................................... Setting the time................................................................. Setting the bolus dose volume.......................................... Setting the interval between bolus doses.......................... Setting the first flow rate (F1)............................................
SECTION 16 How to use the supplied standard equipment................... Fastening the pump collar strap........................................ Page 86 Page 86 SECTION 17 GENERAL WARNINGS..................................................... Manual updates................................................................. Maintenance...................................................................... Storage.............................................................................. Disposal............
SECTION 1 SYMBOLS AND CONVENTIONS To assist you in using the manual, the following symbols and conventions have been used: Triangle containing an exclamation mark This “Warning” icon indicates something that must always be taken into consideration for the safe use of the pump. Notepad This icon indicates a “Note” containing additional information or useful tips about the use of the pump.
SECTION 2 INTRODUCTION Thank you for choosing the CRONO PAR 50 ambulatory infusion pump. If any of the information is not clear, or if you have any doubts or questions, please contact the Customer Support Service of CANè S.p.A. Incorrect use of the pump, or failure to follow the instructions and warnings provided in this manual could cause serious injury. The instructions provided relate exclusively to the ambulatory infusion pump, model CRONO PAR 50.
SECTION 2 The pump does not need to be installed, tested and/or activated. Canè S.p.A. reserves the right to modify the hardware and software specifications described in this manual at any time and without notice. NOTES • In order to make this manual as complete and accurate as possible, please report any errors or omissions to the following e-mail address: service@canespa.it. • Canè S.p.A. reserves the right to modify and/or update this manual at any time and without notice.
SECTION 3 INTENDED USE The CRONO PAR 50 ambulatory infusion pump is designed for the subcutaneous infusion of apomorphine in the treatment of Parkinson’s disease. Canè S.p.A. disclaims all responsibility for the administration of drugs by other methods and for different therapies.
SECTION 3 The device must be used: - under medical supervision, - with appropriate procedures and adequate measures when dealing with patients who could suffer serious consequences (injury or death) in the event of accidents and/or breakdowns which cause an interruption of the administration of the drug. Do not prime the infusion line when it is connected to the patient, because this could cause an overdose of the drug.
SECTION 3 PUMP DESCRIPTION CRONO PAR 50 is an ambulatory infusion pump which uses single-use reservoirs for the controlled subcutaneous administration of drugs containing apomorphine as the active ingredient, in the treatment of Parkinson’s disease. CRONO PAR 50 uses specific 50 ml syringes called reservoirs. Its smaller size and reduced weight make CRONO PAR 50 ideal for home use, thus giving the patient the freedom to engage in everyday activities during the treatment.
SECTION 3 TECHNICAL CHARACTERISTICS Pump dimensions Weight Battery Single-use reservoir Volumes that can be administered Flow rates in FrEE mode (F1, F2, F3) Selectable flow rates in FrEE mode Flow rates in Auto mode (F1, F2, F3) Selectable flow rates in Auto mode Bolus dose volume Interval between bolus doses 3.31 x 2.17 x 1.65 in (84 x 55 x 42 mm). 4.47 oz. (139 g), including battery. Lithium CR 123A 3V (battery life of about 100 infusions).
SECTION 3 Flow rate precision Occlusion pressure Time needed to signal an occlusion Post-occlusion bolus Electronic circuit Settings memory Display Motor Settings lock Safety circuit Ingress protection rating Pump operating conditions Pump storage conditions +/-3%. 3 selectable values; for further information see APPENDICES 4-6. The pump is set to PL2 (2.2 bar +/-1). See Appendix 4. About 1.2 ml (in PL2 mode). Managed by twin microcontrollers with dedicated software.
SECTION 4 SUPPLIED STANDARD EQUIPMENT 1. Ambulatory infusion pump with reservoir CRONO PAR 50. 2. Infuser carry-case (Code: VAL/04). 3. Elastic belt (Code: CM/01). 4. Collar strap (Code: CM/18D). 5. Fabric case (Code: CM/06). 6. 2 batteries (one of which is already inserted in the pump) (Code: CR/123A). 7. 1 User Guide. 8. Battery-cover opening tool (Code: CA/02).
SECTION 5 PUMP PARTS Attachment for the reservoir wings Support cord attachment eyelets LED Display Buttons Pusher Anti-slip grooves Battery compartment Serial no.
SECTION 5 LED The red LED on the right of the display activates in the following circumstances: 1 - when the battery is inserted during the pump verification checks, see page 30; 2 - when an error has occurred. For further information, see page 26-27. CONTROL BUTTONS There are 3 control buttons. The buttons have a built-in safety delay: you must keep them pressed for several seconds before the command takes effect. Use only your fingertips; do not use sharp objects.
SECTION 5 LIQUID CRYSTAL DISPLAY (LCD) The liquid crystal display uses text messages and icons to display practical information about the settings, the operation being performed and any error situations. Clock symbol Four main digits Drop icon Arrow icon Two secondary digits Lock indicator Battery level indicator Four main digits of the display Display principal information related to the values of the settings, error information, etc.
SECTION 5 “Clock” symbol: Only displayed when Auto is selected (see related section on page 53-76). When the clock symbol is visible, the 2 secondary digits below it indicate the current hour of the 24-hour treatment period (in OFF or StoP) or the set flow (in ON). “Low Battery” indicator: Displayed when the battery is nearly spent (see related section on page 21). “Drop” icon: Steady: it separates integers from decimal numbers. Flashing: the hour and minute separator.
SECTION 5 LOW BATTERY ALERT The appearance of the “LOW BATTERY” alert (not flashing) on the display indicates that the battery is nearly spent. If the alert remains displayed for several consecutive infusions, the “SPENT BATTERY” message is displayed, accompanied by a beep repeated about every 10 seconds. In these circumstances the pump can no longer be used and the battery must be replaced. WARNINGS • You are advised to replace the battery after the “LOW BATTERY” alert is displayed.
SECTION 5 5. wait 10 seconds before inserting the new battery checking that it is in the correct position and that the ribbon strap is under the battery; 6. after you have inserted the battery, close the cover.
SECTION 5 In the event that it is not possible to remove the battery using the ribbon strap, do not use an object to lever out the battery, but proceed as follows: • hold the pump and the compartment cover firmly in your one hand; • strike the palm of your other hand with the pump, to jolt the battery from the compartment. NOTES • After you have inserted the battery, the pump runs a self-diagnosis test during which it will emit brief audio signals and display all of the icons and indicators.
SECTION 5 • The time remains in the memory for about 36 hours even when there are no batteries in the device. After 36 hours have elapsed, when the battery is inserted the display will show dashes on the main digits, and the following must be set: hours, minutes, day, month and year by or buttons. pressing the PROG button it is possible to By subsequently pressing the display the two flashing dashes on the right of the drop, representing the minutes.
SECTION 6 SETTINGS LOCK The CRONO PAR 50 pump has 2 access configurations: - L0 (unlocked): in this configuration you can use the control buttons to access all of the settings and parameters, and control all of the operational functions; - L1 (locked): in this configuration you can use the control buttons to control the operational functions, except for the time. When the pump is set to L1 the display shows the lock indicator ( indicator displayed).
SECTION 7 ERRORS AND ANOMALIES DISPLAY AUDIBLE SIGNAL ERROR DESCRIPTION CORRECTIVE ACTION Brief continuous audible signal. Operation not allowed. --- Beep repeated every 10 sec approximately. Possible hardware anomaly of the clock (only Auto mode). button; Press the see warnings on page 28. Continuous acoustic signal and flashing LED. Critical problem in the safety system. Press the button Beep repeated every 10 sec approximately. Anomaly in the motor circuit.
SECTION 7 DISPLAY AUDIBLE SIGNAL ERROR DESCRIPTION CORRECTIVE ACTION When a battery is inserted and at the start of every infusion, the device runs a control algorithm on Initialise the device the parameters stored in Beep repeated every (see page 30) and the memory. If an error is 10 sec approximately. set the prescribed found, the manufacturer infusion parameters. default settings are restored, the motor stops and an error is shown on the display.
SECTION 7 NOTE The displayed error messages (from Er,1 to Er,11 and OCCL) are accompanied by an acoustic signal and the system stops.
SECTION 7 INFUSION SET OCCLUSION The pump is designed to recognise when the administration of a drug has been interrupted by external means, such as, for example, the kinking of the infusion set tube and the consequent occlusion. In these circumstances, the pump stops the infusion: the display indicates that there is an occlusion, accompanied by a brief beep. The pump then continues beeping every 10 seconds.
SECTION 8 PUMP INITIALISATION When you insert the battery, the pump runs the initialisation sequence, during which it: 1. runs a self-diagnosis test, emitting a series of brief acoustic signals, flashing the red LED and displaying all the indicators and icons on the screen; 2. displays OFF at the end of the preceding operation. NOTES • The pump is supplied with a new battery already inside the pump. • To initialise the device, remove the battery and reinsert it after 10/15 seconds.
SECTION 8 To be able to select the mode of the pump, it must: • be set to OFF (at the beginning of a full or partial infusion); • have the settings lock set to L0, ("lock" indicator off). Procedure: 1 - press the button for about 10 seconds, until the display subsequently shows the number of bolus doses administered during the last infusion, the number of completed infusions and finally the SEt message; 2 - when the message SEt is displayed, release the .
FrEE SECTION 9 Selected pump mode: FrEE FACTORY SETTINGS The pump is supplied with the following default settings: 32 Dose 0.20 ml Interval between doses no,Lt Flow rate 1 0.
FrEE SECTION 10 QUICK REFERENCE FrEE The buttons have a built-in safety delay: you must keep them pressed for several seconds before the command takes effect. WARNING These quick reference instructions are not an alternative to reading the information in this manual, but give a basic and rapid summary of the pump’s functions.
FrEE SECTION 10 BUTTONS CONFIGURING THE SETTINGS IN THE OFF CONDITION DISPLAY • Pump set to OFF • Set bolus dose volume (from 0.00 to 2.00 ml) PROG • Setting the interval between the bolus doses (from “no,Lt” to 24 hours) PROG PUMP SET TO OFF • Setting the flow rate F1 (0.05 to 5.00) PROG • Setting the flow rate F2 (0.00 to 5.00 - oFF - disabled) PROG • Setting the flow rate F3 (0.00 to 5.
FrEE SECTION 10 BUTTONS SWITCHING ON / PRIMING DISPLAY • Pump set to OFF PUMP SET TO OFF • Priming function • Priming function (1.
FrEE SECTION 10 BUTTONS SETTINGS LOCK DISPLAY PUMP SET TO OFF/StoP • Pump set to OFF or StoP (2 secs.) (5 secs.
FrEE SECTION 11 BUTTONS END OF INFUSION DISPLAY PUMP ON • Pump set to End • Withdrawal of the pusher • Pump set to OFF BUTTONS DISPLAYING DISPLAY • Pump in OFF PUMP SET TO OFF/StoP - L1 • Bolus dose volume • Interval between the bolus doses • Flow rate F1 • Flow rate F2 • Flow rate F3 ml/h ml/h ml/h • Partial volume • Pump in OFF 37 MAN 01/EN/03 CRONO PAR 50 06/13
FrEE SECTION 11 PUMP SETTINGS SEQUENCE WITH THE PUMP SET TO OFF OR StoP To change the settings the pump must: • be set to OFF or StoP; • have the settings lock off (i.e. set to L0). SETTING THE BOLUS DOSE VOLUME The bolus dose volume can be set from 0.00 to 2.00 ml in increments of 0.022 ml. Proceed as follows: button 1. with the pump set to OFF or StoP press the for a few seconds: the display shows the flashing bolus dose volume indication; 2.
FrEE SECTION 11 SETTING the interval between bolus doses The interval between bolus doses can be set to a value between no,Lt (function disabled) and 24 hours, in the following ways: • from 5 minutes to 1 hour in increments of 5 minutes; • from 1 hour to 24 hours in increments of 15 minutes. This applies a temporal limit to the bolus dose function. Proceed as follows: 1. the display shows the flashing value of the bolus dose interval; PROG PROG PROG 2.
FrEE SECTION 11 setting the first flow rate (F1) The flow rate can be set from 0.05 to 5.00 ml/h as follows: • from 0.05 ml/h to 1.00 ml/h in increments of 0.01 ml/h; • from 1.00 ml/h to 3.00 ml/h in increments of 0.02 ml/h; • from 3.00 ml/h to 5.00 ml/h in increments of 0.05 ml/h. Proceed as follows: 1. the display shows the flashing value of the first flow rate; PROG ml/h 2. press the button to increase the value; press the button to decrease it. Each change is indicated by a beep; 3.
FrEE SECTION 11 setting the SECOND and THIRD flow rates (F2 and F3) The flow rate can be set from 0.00 to 5.00 ml/h as follows: • from 0.00 ml/h to 1.00 ml/h in increments of 0.01 ml/h; • from 1.00 ml/h to 3.00 ml/h in increments of 0.02 ml/h; • from 3.00 ml/h to 5.00 ml/h in increments of 0.05 ml/h. The second and third flow rates are set in the same manner as the first.
FrEE SECTION 11 Setting the partial volume The partial volume function is used when the treatment requires an infusion with less than 50 ml. The partial volume can be set from 1 cc to 50 cc in increments of 1 cc. button again. To set this parameter, press the The partial volume function can only be set before starting a new infusion, either a complete one (50 ml) or a partial one. Proceed as follows: 1.
FrEE SECTION 11 NOTES • The partial volume setting is automatically stored in the pump’s memory. • At the end of the infusion, the pusher returns to the position corresponding to the partial volume setting. button: the • The partial volume setting can be interrupted by pressing the pump switches off (the display shows OFF or StoP) and the pusher, if it was moving forward, remains where it was when the interruption occurred. The partial volume setting is not stored and the previous value remains in memory.
FrEE SECTION 11 SWITCHING ON THE PUMP From the OFF condition, press the button and the pump will give a brief beep and display the following in sequence: • Pr (priming function); There are three options: a. postpone the priming; b. cancel the priming; c. perform the priming. • switching on the pump and displaying the set flow; • delivery time and flow value display.
FrEE SECTION 11 PRIMING THE INFUSION LINE The priming function allows for filling the infusion line with the drug contained in the reservoir. The volume available for priming is 1.5 ml. The priming function is enabled when the device is switched on and the pusher is in the infusion start position, regardless of whether the settings lock is on. The priming procedure is as follows: 1. switch on the device as described in the relevant section; 2. the display shows Pr. There are three options: a.
FrEE SECTION 11 c. Perform the priming button to deliver the priming Press and hold down the dose; the priming function can be interrupted by releasing the button. The display shows a flashing letter Pr followed by the number of millilitres delivered. The display then shows Pr again. In this way it is again possible to postpone, cancel or perform the priming function. The procedure can be repeated until a maximum of 1.5 ml has been delivered in total.
FrEE SECTION 11 PUMP SWITCHED ON When the pump is in ON condition, the display shows the delivery time in: • hours with a flashing h; • hours and minutes, with the "drop" icon flashing; • minutes, if the time to go is less than one hour, with the "minutes" indicator flashing. If a flow rate of 0.00 ml/h has been set, the display shows F0,00 with a flashing letter F; In this event the drug can only be administered by means of a bolus dose request.
FrEE SECTION 11 SELECTING THE FLOW RATE This function allows the patients to change the flow during the day based on their demands, choosing among the 3 available flow rates pre-programmed by the doctor.
FrEE SECTION 11 BOLUS DOSE The bolus is a supplementary dose of the drug that the patient can request when it is needed. If the bolus dose volume has been set to 0.00 ml, the bolus dose cannot be administered. Administration of bolus doses Bolus doses can only be administered while the pump is in ON condition. The procedure for the administration of a bolus dose is as follows: 1.
FrEE SECTION 11 RESTRICTIONS ON THE ADMINISTRATION OF BOLUS DOSES If the bolus dose volume is set to 0.00 ml, pressing the button will display the Er,d error message. The administration of bolus doses is limited by the interval between doses (temporal limitation). By setting no,Lt you can disable this limitation. Bolus doses cannot be administered during the interval period observed by the function.
FrEE SECTION 11 WITHDRAWING THE Pusher 1. Withdrawal of the pusher before the end of the infusion This function allows the interruption of an active infusion, withdrawing the pusher to the start position of the infusion. To stop an active infusion, do the following: • switch the pump off by pressing the button; • press the and buttons together: the display shows End for 10 seconds and then begins to withdraw the pusher; • during the 10 seconds that the display shows End you can button.
FrEE SECTION 11 Pusher in motion While the pusher is in a continuous withdrawal motion, the display shows the “pusher continuous withdrawal” indication. NOTE The pusher withdrawal time for a 50 ml volume is approx 6 minutes, and is proportionately less for lower volumes. WARNING Do not remove the reservoir until the pusher has been withdrawn to the infusion start position. SWITCHING OFF THE PUMP To switch off the device, press the button. The display will show StoP.
Auto SECTION 12 Selected pump mode: Auto mode FACTORY SETTINGS The pump is supplied with the following default settings: Dose 0.20 ml Interval between doses no,Lt Flow rate 1 0.50 ml/h (F1) Flow rate 2 0.50 ml/h (F2) Flow rate 3 0.
Auto SECTION 13 QUICK REFERENCE Auto The buttons have a built-in safety delay: you must keep them pressed for several seconds before the command takes effect. WARNING These quick reference instructions are not an alternative to reading the information in this manual, but give a basic and rapid summary of the pump’s functions.
Auto SECTION 13 BUTTONS SETTINGS DISPLAY • Pump set to OFF and L0 • Visualisation of the time (5 sec) • Enabling the setting of the time PROG • Set the minutes PROG • Set bolus dose volume (from 0.00 to 2.00 ml) PUMP SET TO OFF PROG • Setting the interval between the bolus doses (from “no,Lt” to 24 hours) PROG • Setting the flow rate F1 (from 0.05 to 5.00 ml/h) PROG • Set the F2 flow rate (from 0.05 to 5.00 ml/h) PROG • Set the F3 flow rate (from 0.05 to 5.
Auto SECTION 13 BUTTONS SETTING THE PARTIAL VOLUME DISPLAY PUMP SET TO OFF • Setting the partial volume PROG / • Decrease/Increase of partial volume PROG • Positioning pusher to partial volume • Pump set to OFF BUTTONS SWITCHING ON / PRIMING DISPLAY • Pump set to OFF PUMP SET TO ON • Priming function (keep pressed) • Prime function (1.
Auto SECTION 13 BUTTONS StoP DISPLAY PUMP ON • Pump set to StoP • Silence buzzer and stop display flashing SETTINGS LOCK BUTTONS DISPLAY PUMP SET TO OFF/StoP • Pump set to OFF or StoP (2 secs.) • Displaying the number of administered bolus doses (5 secs.
Auto SECTION 14 BUTTONS END OF INFUSION DISPLAY • Pump set to End • Withdrawal of the pusher • Pump set to OFF BUTTONS DISPLAYING DISPLAY • Pump in OFF and L1 • Setting the time see page 61 PUMP SET TO OFF/StoP - L1 • Bolus dose • Time interval between bolus doses • Flow rate F1 • Flow rate F2 • Flow rate F3 ml/h ml/h ml/h • Flow rates over the daily 24-hour period • Displaying the flows over the daily 24-hour period • Partial volume • Pump in OFF 58 MAN 01/EN/03 CRONO PAR 50 06/13
Auto SECTION 14 PUMP SETTINGS SEQUENCE To change the settings the pump must: • be set to OFF or StoP; • have the settings lock off (i.e. set to L0). You can change the setting while the display is flashing by pressing buttons and . Visualising/setting the time button for about 4 To access the settings pres the seconds: the display shows the time. Pushing the - button for about 5 seconds enables the setting of the time (see page 61).
Auto SECTION 14 Assigning the 4 flows over the daily 24-hour period Press the button again to display and set the assignment of the 4 flows over the daily 24-hour period (of which one is the fixed F0 flow, with a rate of 0.00 ml/h). Press the button to scroll the hours (the two digits left of the drop icon) button to select the different flows (second digit and the to the right of the drop icon). Setting the partial volume button again to display and set the partial Press the volume.
Auto SECTION 14 SETTING THE TIME Proceed as follows: 1. with the pump set to either the OFF or StoP conditions, press the button for about 4 seconds: the display shows the time; Pressing the button enables the setting of the time: the hour value begins to flash. PROG button to increase the value; press the 2. press the button to decrease it. Each change in value is indicated by a brief beep; 3. do not press any button for 20 seconds, and the setting phase will end.
Auto SECTION 14 SETTING the bolus dose volume The bolus dose volume can be set from 0.00 to 2.00 ml in increments of 0.022 ml. Proceed as follows: 1. the letter d is shown on the secondary display and the volume of the bolus dose in the primary display. The numeric values are flashing but the d is steady; PROG 2. press the button to increase the value; press the button to decrease it. Each change is indicated by a beep; 3.
Auto SECTION 14 SETTING the interval between bolus doses The interval between bolus doses can be set to a value between no,Lt (function disabled) and 24 hours, in the following ways: • from 5 minutes to 1 hour in increments of 5 minutes; • from 1 hour to 24 hours in increments of 15 minutes. This applies a temporal limit to the bolus dose function. PROG PROG Proceed as follows: 1. the display shows the flashing value of the bolus dose interval; PROG 2.
Auto SECTION 14 setting the first flow rate (F1) The flow rate can be set from 0.05 to 5.00 ml/h as follows: • from 0.05 ml/h to 1.00 ml/h in increments of 0.01 ml/h; • from 1.00 ml/h to 3.00 ml/h in increments of 0.02 ml/h; • from 3.00 ml/h to 5.00 ml/h in increments of 0.05 ml/h. Proceed as follows: 1. the display shows the flashing value of the first flow rate; 2. press the button to increase the value; press the button to decrease it. Each change is indicated by a beep; PROG ml/h 3.
Auto SECTION 14 setting the SECOND and THIRD flow rates (F2 and F3) The second and third flow rates are set in the same manner and within the same limits as the first. After you have set the third flow, press the button before the OFF or StoP indication is displayed (while the F3 hourly flows value is still flashing) to continue to the setting of the next parameter: ASSIGNING the flows over the DAILY 24-hour period. PROG PROG ml/h ml/h PROG NOTES • If you keep pressing either the flow rate quickly.
Auto SECTION 14 ASSIGNING the flows over the daily 24-hour period You can set a different flow rate for every hour of the day, choosing between the four available rates (F0, F1, F2, F3). Proceed as follows: 1. the first two digits of the display show the hour of the day (24-hour clock) while the last two show the selected flow for the corresponding hour of the day. The first three digits are steady, but the last numeric digit, after the F (0, 1, 2 or 3) indicating the flow, is flashing; PROG 2.
Auto SECTION 14 Setting the partial volume The partial volume function is used when the treatment requires an infusion with less than 50 ml. The partial volume can be set from 1 cc to 50 cc in increments of 1 cc. To set button again. this parameter, press the The partial volume function can only be set before starting a new infusion, either a complete one (50 ml) or a partial one. Proceed as follows: 1.
SECTION 14 Auto NOTES • The partial volume setting is automatically stored in the pump’s memory. • At the end of the infusion, the pusher returns to the position corresponding to the partial volume setting. button: the • The partial volume setting can be interrupted by pressing the pump switches off (the display shows OFF or StoP) and the pusher, if it was moving forward, remains where it was when the interruption occurred: the partial volume setting is not stored and the previous value remains in memory.
Auto SECTION 14 SWITCHING ON the pump From the OFF condition, press the will give a brief beep and display: button. The pump • Pr (priming function) There are three options: a. postpone the priming; b. cancel the priming; c. perform the priming. • Switching on the pump • After you have performed the priming, or if you switch the pump on when it is in the StoP condition, the display shows the infusion time in hours or in hours and/or minutes or just minutes.
Auto SECTION 14 PRIMING THE INFUSION LINE The priming function allows for filling the infusion line with the drug contained in the reservoir. The volume available for priming is 1.5 ml. The priming function is enabled when the device is switched on and the pusher is in the infusion start position, regardless of whether the settings lock is on. The priming procedure is as follows: 1. switch on the device as described in the relevant section; 2. the display shows Pr. There are three options: a.
Auto SECTION 14 c. Perform the priming button to deliver the priming Press and hold down the dose; the priming function can be interrupted by releasing the button. The display shows a flashing letter Pr followed by the number of millilitres delivered. The display then shows Pr again. In this way it is again possible to postpone, cancel or perform the priming function. The procedure can be repeated until a maximum of 1.5 ml has been delivered in total.
Auto SECTION 14 PUMP SWITCHED ON During the infusion the time indicated on the display is shown in hours (with a flashing letter h), or in hours and minutes with the flashing drop icon. If the time "to go" is less than one hour, the time is shown in just minutes, and the flashing “Minute” indicator is displayed. button, the display temporarily toggles If you press the between the "time to go" and the programmed flow rate. If you have selected the F0 flow, the display shows F0 and 0,00.
Auto SECTION 14 NOTE The bolus dose delivery can be interrupted at any time by pressing the button. RESTRICTIONS ON THE ADMINISTRATION OF BOLUS DOSES If the bolus dose volume is set to 0.00 ml, pressing the button will display the Er,d error message. The administration of bolus doses is limited by the interval between doses (temporal limitation). By setting no,Lt you can disable this limitation. Bolus doses cannot be administered during the interval period observed by the function.
Auto SECTION 14 WARNINGS • The number of the administered bolus doses is only available until the beginning of a new infusion; switching the pump on for a new infusion automatically resets the value. • The number of bolus doses includes those delivered by pressing the button. WITHDRAWING THE Pusher 1. Withdrawal of the pusher before the end of the infusion This function allows the interruption of an active infusion, withdrawing the pusher to the start position of the infusion.
Auto SECTION 14 NOTES • While the display shows End, the withdrawal function can button. The display shows be cancelled by pressing the StoP. • The withdrawal function can be interrupted by pressing button. The display then alternates between End the and OFF. At this point the only active button is the button. When you press again the pump recommences the withdrawal of the pusher.
Auto SECTION 14 DISPLAYING THE SETTINGS This function displays the programmed pump settings. To display the pump settings, the pump must be set to OFF or StoP. If the settings are displayed when the settings lock is set to L0 (settings lock off) the settings flash, and can be modified.
SECTION 15 RESERVOIR PARTS The CRONO PAR 50 pump uses dedicated 50 ml reservoirs, model CRN® CRONO® Syringe. The reservoirs are: single-use, non-pyrogenic to be used only if the packaging is undamaged. Needle Piston Reservoir body Needle cover Luer-Lock cap Stem Warning For safety reasons, you are recommended to use the original CRN® reservoirs Crono® Réservoir. The use of any other type of reservoir could damage the pump and harm the patient. Canè S.p.A.
SECTION 15 LUER-LOCK CAP FUNCTIONS • After the reservoir has been filled, the cap facilitates the unscrewing of the stem, avoiding spillage of the pharmaceutical; • it facilitates the correct connection between the pump pusher and the rubber piston of the reservoir; • it protects the drugs inside the reservoir in case it is not used immediately.
SECTION 15 INFUSION SET You are recommended to use an infusion set with the following characteristics: • internal volume of reduced tube (ideal 0.1 ml, maximum 0.62 ml); • tube length not more than 90 cm; • anti-kink tubing. INFUSION SET PARTS Female Luer-Lock connector Adhesive Needle Needle cover Tube NOTE The images show the NeriaTM, infusion set from Unomedical, a Convatec Company.
SECTION 15 PREPARING THE RESERVOIR AND CONNECTING TO THE PUMP 1. Screw the needleTHE into the reservoir in a clockwise direction and remove the PREPARING RESERVOIR needle cover; 2. fill the reservoir, aspirating the liquid slowly and checking that the quantity of the drug does not exceed its capacity or any partial volume you may have set; 3. screw the Luer-Lock cap to the reservoir (a) and then unscrew the stem, rotating it counter-clockwise (b) with a fairly rapid movement; 4.
SECTION 15 CONNECTION OF THE RESERVOIR TO THE PUMP Insert the dedicated CRN reservoir into the pump and engage it by rotating it 90° clockwise; a click confirms it has engaged.
SECTION 15 Warning 1 - Before filling the reservoir Unscrew and screw back the piston rod to facilitate its unscrewing after you have filled the reservoir. 2 - Filling the reservoir The liquid must be aspirated slowly. Do not fill the reservoir more than the maximum level allowed of 50 ml. The rod must be unscrewed with a fairly rapid movement.
SECTION 15 INFUSION SITES The images below show the recommended infusion sites. You are recommended to change the injection site after every infusion to avoid skin irritations. FRONT BACK PREPARING FOR THE INFUSION Before preparing for the infusion, you are recommended to adopt the following precautions: 1. wash your hands; min h d 0.2 ml OFF JET MICRO CRONO 2. prepare a clean working environment. WARNINGS • Always work in antiseptic conditions, to reduce the risk of infection to the minimum.
SECTION 15 The images refer to the NeriaTM infusion set from Unomedical, a Convatec Company. Disinfect the infusion site following the instructions of the relevant medical personnel. Ensure that the area of the infusion site is dry before inserting the subcutaneous needle. Connect the infusion set to the reservoir. Hold the infusion set by the wings. Prime the infusion line manually or use the priming function of the pump (Auto). Ensure there are no air bubbles in the infusion line.
SECTION 15 Remove the needle cover, extracting it with care, before inserting the needle. WARNING Be careful not to touch the NeriaTM needle when you remove the protection. It is important to lift a fold of skin, to reduce the risk of positioning the needle in a muscle. Pinch the skin with your fingers at the chosen infusion site before inserting the needle, which you do by taking the protective wings of the infusion set with the other hand and inserting the needle vertically.
SECTION 16 HOW TO USE THE SUPPLIED STANDARD EQUIPMENT The following figures give an indication of how to use the standard accessories supplied with the pump. PUMP CARRIED AROUND THE NECK The pump worn with a collar strap and a fabric case.
SECTION 16 WEARING THE PUMP AT THE WAIST The pump worn with an elastic belt and a fabric case.
SECTION 17 GENERAL WARNINGS The device can be damaged by liquid, so it must not be kept on while in the bath or the shower, etc. If the device is accidentally made wet, (for example, with drops of the drug, or by bedwetting), you must ensure it is checked by the Canè S.p.A. Service Centre.
SECTION 17 MANUAL UPDATES The version and the date of publication of this User Guide are given on every page. When a year has passed between the publication date (given on page 3) and the use of the product, the doctor should contact Canè S.p.A. to determine if a more recent version of the manual has been published. MAINTENANCE The technical characteristics of the device make it extremely simple to maintain. If the device is damaged, you are recommended to have it checked by the Canè S.p.A.
SECTION 17 DISPOSAL At the end of the expected life of the pump, contact Canè S.p.A. Customer Support Service which will provide you with necessary instructions about the disposal of the device. Reservoirs, infusion sets, needles, filters and all consumables must be disposed of in an appropriate way, using containers designed for this purpose. EXPECTED PUMP LIFE The pump is expected to last for 4 (four) years from its purchase date. For safety reasons you should not continue to use it after this period.
SECTION 17 GUARANTEE Canè S.p.A. guarantees that the product is free from any material or manufacturing defects for a period of 2 (TWO) YEARS from the original date of purchase. If, in the course of this guarantee period, any material or manufacturing defects are identified, Canè S.p.A. will repair or substitute the defective components according to the terms and conditions herein, without any charge for labour or parts; the client is responsible for the costs of sending the pump to the Canè S.p.A.
SECTION 17 4. The following are excluded from the guarantee: • periodic maintenance • damage consequent to improper use, including but not limited to: - incorrect power supply; - use of the product for purposes other than those for which it is designed; - repairs performed by unauthorised personnel or by the Customer; • accidental and unintentional events, such as liquid spills and falls; • natural events and malicious or negligent acts; • the standard equipment supplied with the pump. 5. Canè S.p.A.
SECTION 17 DECLARATION OF CONFORMITY 0476 The company Canè S.p.A., with headquarters in Via Cuorgnè, 42/a 10098 Rivoli (Turin) - Italy, manufacturer of the medical device CRONO PAR 50 ambulatory infusion pump with reservoir for drug administration, Serial no. declares that the device conforms to the essential requirements of Appendix I of Directive 93/42/CE, modified by Directive 2007/47/CE, as per certificate MED 9813 provided by the Notifying Body no.
APPENDICES 94 MAN 01/EN/03 CRONO PAR 50 06/13
APPENDIX 1 ICONS USED ON THE PUMP SN IP 42 Serial no. of the pump IP protection rating 1st digit (4) = protection from solid objects larger than 1 mm. nd 2 digit (2) = protection from water droplets sprayed at an angle up to 15º degrees. CE marking 0476 Electro-medical device Type BF Warning: read instructions before use Sorted waste collection for electrical and electronic devices In accordance with article 13 of Legislative Decree no.
APPENDIX 1 ICONS USED ON THE Reservoir BLISTER PACK i 0123 Read the instructions CE marking Recyclable 2 Use only once PYROGEN Non-pyrogenic Keep dry Keep away from sunlight Expiry date STERILE EO Sterilised with ethylene oxide PP Polypropylene LOT Batch code REF Reference no.
APPENDIX 2 OPTIONAL ACCESSORIES AVAILABLE ON REQUEST 1. Vertical leatherette case, similar to a mobile phone case. Detail of belt clip Detail of opening system with aperture for infusion set Colours: Dimensions: 16 x 5.
APPENDIX 2 2. Horizontal leatherette case, similar to a spectacle case. Detail of belt clip Colours: Dimensions: 16 x 5.
APPENDIX 3 3. Adjustable elastic belt with buckle.
APPENDIX 3 PRECISION TEST (TRUMPET CURVE) The tests have been performed according to IEC 60601-2-24, Electro-medical devices, Part 2: Particular requirements for the safety of infusion pumps and controllers. The following graphs show the precision of the pump during the administration of the drug. Flow rate [ml/h] 1.1 – Start-up flow • Flow rate setting: 1 ml/h.
APPENDIX 3 TRUMPET CURVE Flow rate error percentage 1.2 - Flow rate error (trumpet curve) • Flow rate setting: 1 ml/h. Observation interval (min) The actual degree of precision may differ from that indicated in this manual, depending on the type of accessories and extension tubes used in the administration line of the drug. Legend: Ep(max.) = maximal percentage variations. Ep(min.) = minimal percentage variations. A(mean.) = mean percentage variations.
APPENDIX 4 PRESSURE LEVELS (PL) The CRONO PAR 50 pump allows the medical/paramedical and clinical engineering personnel, as well as the distributor, to set the occlusion pressure level (PL). The device is provided with the occlusion pressure level set to PL2 (2.2 bar +/-1). This level may be insufficient for the demands of the patient and/or for the technical specifications of the infusion line (e.g.
APPENDIX 5 TIME NEEDED TO SIGNAL AN OCCLUSION APPENDIX 2 The time needed to signal an occlusion is the interval between the beginning of the occlusion condition and the recognition of the condition by the pump. This value depends on the flow rate, because the lower the flow rate, the longer will be the time needed by the pump to recognise the occlusion condition. The values given here consider the time needed jointly by the pump and the reservoir to signal the occlusion. Flow rate 0.
APPENDIX 6 POST-OCCLUSION BOLUS When the occlusion alarm sounds, the pump has detected an excessive back pressure in the infusion line. This back pressure must be removed in order to avoid releasing a post-occlusion bolus, which might cause serious harm to the patient. The volume of a CRONO PAR 50 post-occlusion bolus, considering only the combined volume of the pump and the reservoir, is: • about 1.0 ml (PL1); • about 1.2 ml (PL2); • about 1.5 ml (PL3).
APPENDIX 7 ELECTRO-MAGNETIC COMPATIBILITY The electro-magnetic compatibility tests were performed in compliance with the standards: • IEC 60601-2-24:2012, Medical electrical equipment, Part 2: Particular requirements for the safety of infusion pumps and controllers; • IEC EN 60601-1-2 Ed. 2, Medical electrical equipment, Part 1: General requirements for basic safety and essential performance – collateral standard: Electromagnetic compatibility – Requirements and tests.
APPENDIX 7 Guide and declaration by the manufacturer - electro-magnetic immunity CRONO PAR 50 is designed to operate in the electromagnetic environment specified below. The client or user of the CRONO PAR 50 must ensure that it is operated in such an environment.
APPENDIX 8 REFERENCE DIRECTIVES • Council Directive 93/42/EEC: Medical devices. • Legislative Decree no. 46, 24th February 1997. Implementation of Council Directive 93/42/EEC concerning medical devices.
APPENDIX 8 TECHNICAL STANDARDS • IEC EN 60601-1:2007-05. Medical electrical equipment, Part 1: general requirements for basic safety and essential performance. • IEC EN 60601-1/EC:2010-05. Medical electrical equipment, Part 1: general requirements for basic safety and essential performance. • IEC EN 60601-1-1:2003-06. Medical electrical equipment, Part 1: general requirements for basic safety and essential performance – collateral standard: Safety requirements for electromedical systems.
APPENDIX 8 • IEC EN 60601-2-24:2012-10. Medical electrical equipment, Part 2: particular requirements for the safety of infusion pumps and controllers. • IEC EN 60529: 1997-06. Degrees of protection provided by enclosures (IP Code). • IEC 62-108: 2000-05. User Guide to the maintenance of infusion pumps and control systems. • IEC EN 62353:2008-11. Medical electrical equipment - recurrent checks and tests after repair of medical electrical equipment. • IEC 62-122: 2002-07.
APPENDIX 9 SETTINGS 110 MAN 01/EN/03 CRONO PAR 50 06/13
APPENDIX 10 ACCESSING RESERVED SECTION You can access additional reserved functions of the pump, such as: resetting the number of partial infusions, displaying the number of total infusions, displaying the firmware version of the pump, setting the occlusion pressure threshold, setting the date and time.
APPENDIX 10 5 - Press the button again to display the flashing occlusion pressure level: you can select one of the three available levels (PL1, PL2, PL3) by pressing buttons or . button once more, it is possible to 6 - By pressing the set the current time by changing the two flashing digits on the left of the drop icon. button it is possible to By subsequently pressing the set the two flashing digits on the right of the drop icon, that represent the minutes.
APPENDIX 11 INFORMATION For further information on the CRONO PAR 50 pump, contact: Servizio Assistenza Clienti (Customer Support Service) Canè S.p.A. Medical Technology Via Cuorgnè, 42/a 10098 Rivoli (Turin) - Italy Tel. +39.011.9574872 Fax +39.011.9598880 Internet: www.canespa.it E-mail: service@canespa.it Service available Monday to Friday from 8.30 to 17.00.
MAN 01/EN/03 CRONO PAR 50 06/13
