CRONO 30
Contents
1. ee Page 66 Appendix GE EE EE NE Page 68 APPENdIX EE Page 72 PP ere Page 73 APPENAXNO EEE Page 74 niece qe Page 76 MEAN S censeam ERUNT MEINEN MEMMIUS Page 79 MAN 01 EN 03 CRONO 30 06 14 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 A into consideration for safe use of the pump Notepad This icon indicates a NOTES containing additional information or useful tips about the use of the pump Flashing symbol The graphic symbol shown in the manual above the pictures of the pump display indicates that the information below it is flashing This manual is divided into 5 parts Part 1 red sections 1 to 7 general information technical specifications and warnings Part 2 blue sections 8 to 10 describe the functions of the CRONO 30 device Part 3 orange section 11 which describes the reservoir the preparation and insertion of the reservoir into the pump the infusion sites and the preparation for an infusion Part 4 purple sections 12 and 13 giving general warnings and a description of the accessories supplied as well as discussing maintenance disposal and support It also details the guarantee and the declaration of conformity pages 65 to 802. Page 37 Setting the partial volume eeeeseeseees Page 38 Setting the delivery time i Page 40 Switching on the pump i Page 41 The pump in NN Page 41 Priming the infusion line Page 42 Switching off the PUMP EE nia Page 43 Withdrawing the pusher essere Page 44 Displaying the settings eeeeeeeeeees ee Page 46 Resetting the number of infusion counter Page 47 SECTION 11 REeScIVOIFPalsw iuris De Urn dh Page 48 Luer lock cap functions i Page 48 BE ASTON EE eau da uua Page 49 infusion Ad Page 49 mill RN m Page 49 Identifying the filter components Page 49 Preparation of the reservoir and connection to the pump Page 50 Connection of the reservoir to the pump Page 51 ignit Tea NE ee Page 53 Preparing for the infusion Page 53 10 MAN 01 EN 03 CRONO 30 06 14 SECTION 12 How to use the accessories supplied Page 56 SECTION 13 GENERAL WARNINGS p Page 57 Maintenance iii Page 58 lle P Page 58 PEPSI Page 58 Expected pump life Page 58 M hr Page 59 Guarantee EEE Page 60 Declaration of GONO Page 62 APPSTOK Tee Page 64 PENN
3. The displayed error messages from Er2 to Er 11 and OCCL are accompanied by a beep and the system stops e To initialize the device remove the battery and reinsert it after 10 15 sec If the error is detected again after the corrective action or initialisation of the device contact the CANE S p A Technical Support Service 31 MAN 01 EN 03 CRONO 30 06 14 SECTION 7 INFUSION SET OCCLUSION The pump is designed to recognize when the administration of a drug has been interrupted by external means such as for example the kinking of the infusion set tube and consequent occlusion An occlusion can be resolved in two ways 1 automatically by the pump which attempts to continue t L E L every two minutes 2 if the pump s automatic attempts do not work you must intervene and remove whatever was causing the occlusion Then re start the infusion manually by pressing the button NOTES E e The cause of the occlusion is to be found along the infusion line and at the point of injection e To avoid or reduce the incidence of occlusions you are advised to use an infusion set with anti kinking tubes POST OCCLUSION BOLUS The occlusion alarm is given when the pump detects excessive back pressure in the infusion line This back pressure must be removed without accidentally releasing a post occlusion bolus which could cause serious harm to the patient The volume of a post occlusion bolus of the CRONO 30 considering the
4. enable disable the end of infusion acoustic signal Level 2 does not allow you to select infusion time partial volume complete forced retraction of the pusher enable disable the end of infusion acoustic signal CONTENTS SECTION 1 Symbols and COnventions iii Page 12 SECTION 2 IRTOCRCION X S a Page 13 WARNING PRECAUTIONS FOR USE Page 14 Further information Page 14 SECTION 3 Meedia Page 15 PU SIN Page 17 INTUSION SYSICA rin Page 17 Technical characteriSstiCS Page 18 SECTION 4 Equipment supplied ciano Page 20 SECTION 5 PUMO DAN age eE ini Page 21 Control buttons cine ri Page 22 LED EE air Page 22 Liquid crystal display LCD Page 23 Low battery indicator ii Page 25 Battery replacement iii Page 26 SECTION 6 Se IS TOCK EEE Page 28 SECTION 7 Errors and anomalies tti Page 29 Infusion set occlusion Page 32 merimosellendsei Page 32 MAN 01 EN 03 CRONO 30 06 14 SECTION 8 Factory SelUNGS eissii ananena REE EE a aE Page 33 SECTION 9 Quick reference rrrrnrrnrnnnrnnrrvnrnnnrnnnnnsenvnnnenrnureesrnnnenrnuve Page 34 SECTION 10 PUTE TN Page 36 Pump settings sequence with the pump in OFF or StoP condition Page 37 Setting of end of infusion acoustic signal
5. O 10 15 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 drugs 71 MAN 01 EN 03 CRONO 30 06 14 TIME NEEDED TO SIGNAL AN OCCLUSION 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 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 Delivery time Time needed to signal an occlusion Approx 5 minutes Approx 30 minutes Approx 2 hours and 30 minutes WARNINGS A e The time needed to signal an occlusion is dependant on the flow rate because the lower the flow rate the longer the time needed by the pump to activate the occlusion alarm e The time needed to signal the occlusion can increase if there is air in the line if you are using catheters filters and extension tubes of other dimensions or in an elastic material or when the line from the pump is connected to other devices For patients who could suffer severe harm if there is an interruption in the administration of the drug by the pump arrangements must be made for them to be under the strict supervision of a
6. c Perform the priming e Having carried out the priming or if the pump is turned on to resume the infusion from the StoP condition the display will show the delivery time THE PUMP IN ON CONDITION When the pump is in action the display shows the delivery time counting down at 1 minute intervals to the end of the infusion WARNINGS Before starting an infusion Inspect the infusion line to ensure there are no folds clamps or other occlusions in the line Expel any air bubbles 41 MAN 01 EN 03 CRONO 30 06 14 SECTION 10 PRIMING THE INFUSION LINE The priming function allows filling the infusion set tube with the drugs contained in the reservoir The volume available for priming is 1 5 ml The priming function is enabled when the device is switched on and the pusher is in the infusion start position regardless of whether the settings lock is on The priming procedure is as follows 1 Turn on the device by pressing the amp button 2 The display shows Pr There are three options a Postpone the priming b Skip the priming c Perform the priming a Postpone the priming Wait 10 seconds the pump will turn OFF automatically b Skip the priming Press the button the pump begins the infusion and the display shows the time remaining until the end of the infusion c Perform the priming Press and hold down the button the pump delivers the priming dose until you release the button
7. collateral standard Electro magnetic compatibility Requirements and tests IEC EN 60601 1 4 1997 08 Medical electrical equipment Part 1 general requirements for basic safety and essential performance 4 Collateral standard Programmable medical electrical systems IEC EN 60601 1 4 A1 2000 06 Medical electrical equipment Part 1 general requirements for basic safety and essential performance collateral standard Programmable medical electrical systems IEC EN 60601 1 8 2009 11 Medical electrical equipment Part 1 general requirements for basic safety and essential performance collateral standard Alarm systems General requirements tests and guidance for alarm systems in medical electrical equipment and medical electrical systems IEC EN 60601 2 24 1999 07 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 TI MAN 01 EN 03 CRONO 30 06 14 e CEI 62 108 2000 05 Guide to the maintenance of infusion pumps and control systems e IEC EN 62353 2008 11 Medical Electrical Equipment recurrent checks and test after repair of medical electrical equipment e CEI 62 122 2002 07 Guide to acceptance testing and periodic maintenance of the safety and or performance of medical devices powered by a specific power source e CEI 62 143 2007 05 Table of correspondence between arti
8. infusion of drugs for ferrochelation therapy CANE S p A disclaims all responsibility for the administration of drugs by other methods NOTE The manufacturer holds itself responsible for the safety of patients and the correct functioning of the device provided that it is used in accordance with these instructions and that any required repairs and or modifications are carried out exclusively by the said manufacturer WARNINGS A The use of incorrect settings and or incomplete understanding of the operational functions and of the alarms could cause serious harm to the patient Before using the pump evaluate whether its use is appropriate for the need and for the patient paying close attention to the following aspects The technical specifications of the pump The infusion sets which will be used Whether you will be using multiple tube sets and clamps in the infusion line The cognitive and psycho physical condition of the patient With respect to the clinical procedural aspects which are the responsibility of medical or paramedical personnel the above list is supplied for example purposes only and is not exhaustive The device must be used Under the control of a doctor Adopting 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
9. removal of the battery 4 Remove the discharged battery and discard it properly 5 Insert the new battery checking that it is in the correct position and that the ribbon strap is under the battery 6 After having installed the battery close the cover NOTES E 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 e Hold the pump and the compartment cover firmly in one hand e Strike the palm of your other hand with the pump to jolt the battery from the compartment The cover is supplied with a gasket which must remain in position as indicated in the illustration Gasket 26 MAN 01 EN 03 CRONO 30 06 14 SECTION 5 x 27 MAN 01 EN 03 CRONO 30 06 14 SECTION 6 SETTING LOCK The CRONO 30 pump has 3 access configurations LO 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 switching on priming and switching off but cannot modify any of the settings the delivery time enabling disabling the end of infusion acoustic signal when the pump is set to L1 the display shows the lock indicator L2 locked in this configuration the keyboard allows the control of operating function
10. 12 MAN 01 EN 03 CRONO 30 06 14 SECTION 2 INTRODUCTION Thank you for having chosen the ambulatory infusion pump model CRONO 30 This manual has been prepared to enable you to make the best use of the CRONO 30 pump supplying information on the settings safe use and maintenance of the device If any of the information is not clear or if you have any doubts or questions please contact the Customer Support Service of CANE 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 herein are exclusively with respect to the ambulatory infusion pump model CRONO 30 and are intended for use by the medical and paramedical personnel who need to set up the pump initially and subsequently by patients who are capable of managing their therapy autonomously or persons who are caring for patients The pump has a settings locking system see Page 28 which stops the settings from being modified by accident The information relating to the locking unlocking of the settings lock is supplied at the back of this manual on a plastic card The purpose of the settings lock is to avoid accidental or unauthorised modification of the selected parameters If it is considered inappropriate that the patient should be aware of how to unlock the settings lock the doctor and or other person who is assisting the patient should not supply this informat
11. 15 MAN 01 EN 03 CRONO 30 06 14 SECTION 3 Do not prime the infusion line when it is connected to the patient because this could cause an overdose of the drug Before beginning an infusion inspect the infusion line to ensure there are no folds clamps or other occlusions in the line and expel any air bubbles The precision and the time needed to indicate an occlusion could vary with respect to the values indicated in this manual depending on the type of catheter the infusion set and all the elements which comprise the infusion line If you have any suspicion that the pump has been in any way damaged for example by fluid penetration or having been dropped contact the Customer Support Service to check that the pump is functioning correctly Do not use a damaged pump If you have any doubts about the functioning of the pump or an error or anomaly occurs stop using the device and contact the Customer Support Service CANE S p A does not supply a replacement service for the pump during the period needed for any repairs such service should be supplied by the relevant medical structure or the local distributor Any liquid on the pump casing must be removed immediately with absorbent paper It is important to establish a procedure and or alternative to pumped infusion in case the pump malfunctions A valid alternative could be to have both a second pump and an alternative backup system It is recommended that the individual
12. between shots is approx 4 sec whereas with a delivery time of 10 00 h and a 30 ml reservoir the interval between shots is approx 40 seconds 17 MAN 01 EN 03 CRONO 30 06 14 SECTION 3 Pump dimensions Weight TECHNICAL CHARACTERISTICS 80 x 47 x 30 mm 3 14 x 1 85 x 1 18 in 125 g 4 40 oz including battery Lithium CR 123A 3V battery life approx Battery 200 infusions Single use reservoirs Dedicated with a 30 ml capacity and a Luer Lock universal safety attachment Partial volume Delivery time From 1 to 30 ml in steps of 1 ml Programmable from 1 h to 99 hin steps of 15 min Available priming volume 1 5 ml 2 Flow rate precision Occlusion pressure Shot volume 4 5 bar 2 0 33 microlitres shot quantity administered for every rotation of the motor Occlusion signalling time Post occlusion bolus Settings memory See Appendix 4 Approx 1 2 ml All settings are automatically stored in a flash memory which is retained even if the device is left without a battery Display Liquid crystal display LCD 1 1 x 2 8 cm 0 43 x 1 0 in 18 MAN 01 EN 03 CRONO 30 06 14 Motor Settings lock Electronic circuit with twin microcontrollers Safety circuits Ingress protection rating Pump operating conditions Pump storage conditions MAN 01 EN 03 CRONO 30 06 14 SECTION 3 Coreless DC motor the rotation of which is contr
13. concrete discharge ESD contact KV on contact or ceramic If the floor is covered in a synthetic material the relative M T 400 A m 400 A m humidity must be at least 30 agnetic flelds I 50 and 60 Hz 50 and 60 Hz MAN 01 EN 03 CRONO 30 06 14 Guide and declaration by the manufacturer electro magnetic immunity CRONO 30 is designed to operate in the electro magnetic environment specified below The customer or user of the CRONO 30 must ensure that it is operated in such an environment Immunity IEC 60601 test level Level of Electromagnetic test compliance environment guide Interference could occur in the vicinity of devices marked with the following symbol 80 2500 MHz 10V m AM 80 1 KHz Radiated immunity 20 80 MHz 10V m AM 80 1 KHz Recommended separation distance between mobile and portable radiocommunication devices and the CRONO 30 CRONO 30 is designed to operate in an electro magnetic environment in which radiated RF disturbances are under control The customer or user of the CRONO 30 can help prevent electro magnetic interference by ensuring a minimum distance between mobile and portable communication devices using RF transmitters and the CRONO 30 as recommended below relative to the maximum output power of the radio communication devices Maximum specified Separation distance at the transmitter frequency m output power of icd d 75 MAN 01 EN 03 CRONO 30 06 14 REFERENCE DIRECTIVES
14. obligation to repair CANE S p A declines any responsibility towards purchasers or third parties for damages which may occur during the use of the device after 4 four years from the purchase date 6 After the warranty expires assistance shall be provided by CANE S p A which charges for the replaced components manpower and transportation in force at the time 7 The company declines all responsibility towards the patient and or third parties for any health problems and or difficulties arising during any period in which the device is returned to CANE for technical assistance 8 The company declines all responsibility towards the patient and or third parties for any difficulties or delays regarding the shipment of the device 61 MAN 01 EN 03 CRONO 30 06 14 62 SECTION 14 DECLARATION OF CONFORMITY CE 04 6 The Company CANE S p A with headquarters in Via Cuorgn 42 a 10098 Rivoli Turin Italy manufacturer of the medical device CRONO 30 ambulatory infusion pump with r servoir for drug administration a Serial no declares that the device complies with all the fundamental requirements specified in Appendix I of Directive 93 42 EC amended by Directive 2007 47 EC as per 9813 medical certificate issued by Notified Body No 0476 according to Appendix Il of the Directive itself This device is put on the market in accordance with the laws applied by the individual European states Rivoli 03 08 2012 The Chai
15. 11 RESERVOIR PARTS The CRONO 30 pump uses model CRN CRONO Syringe 30 ml dedicated reservoirs The reservoirs are single use non pyrogenic and only to be used if the packaging is undamaged crn LATEN FREE SL B os RUN luu HELL Piston rod Piston Reservoir body Luer Lock cap PE Needle cover Needle WARNNGS AA For safety reasons you are recommended to use original CRN Crono reservolrs e The use of any other type of reservoir could damage the pump and harm the patient CANE S p A disclaims all responsibility if the device is used with a non original reservoir different from that recommended LUER LOCK CAP FUNCTIONS e After the reservoir has been filled the cap facilitates the unscrewing of the stem avoiding spillage of the drugs t facilitates the correct connection between the pump pusher and the rubber piston of the reservoir e It protects the drugs inside the reservoir in case it is not used immediately 48 MAN 01 EN 03 CRONO 30 06 14 SECTION 11 INFUSION SET You are recommended to use an infusion set with the following characteristics e Low internal volume of tube ideally 0 1 ml maximum 0 62 ml e Tube length not more than 90 cm e Anti kink tubing INFUSION SET PARTS m f P Adhesive Female Luer Lock connector NOTE L k The images show the Neria infusion set from Unomedical a Convatec Company FILTER For a sa
16. CRONO 30 Ambulatory Infusion Pump USER GUIDE MEDIGAL TEGHNOLOGY CANE S p A Medical Technology Via Cuorgn 42 a 10098 Rivoli TO Italy Tel 39 011 9574872 Fax 39 011 9598880 www canespa it mailbox canespa it Manual code MAN 01 EN 03 CRONO 30 Publication date 06 14 CRONO 30 Key pad lock out instructions NOTICE Confidential Information only to the physician The pump has a key pad lock out function in order to avoid non authorised or accidental va riations of the selected parameters if it is opportune that the patient not be able to change the pump settings it is advised that this information not be divulged to the him her The device is supplied with the key pad lock out level O KEY PAD LOCK OUT Three different levels may be set 0 1 2 The levels are useful to avoid undesired operation and they actually lock out the key pad Level 0 means no restriction Level 1 does not allow you to select infusion time enable disable the end of infusion acoustic signal Level 2 does not allow you to select infusion time partial volume complete forced retraction of the pusher enable disable the end of infusion acoustic signal KEY PAD LOCK OUT SETTING In order to set the level key pad lock out you need to follow the procedure below Pump in OFF condition Display OFF Press the button for about 5 seconds the device will utter the sound ticking of pressed push but
17. DIX 3 PRECISION TEST 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 drugs 1 1 Start up flow e Programmed delivery time 1 h e Volume administered 29cc corresponding to a flow of 29 ml h pum z TS Elapsed time min 68 MAN 01 EN 03 CRONO 30 06 14 APPENDIX 3 TRUMPET CURVE 1 2 Flow rate error trumpet curve e Programmed delivery time 1 h e Volume administered 29cc corresponding to a flow of 29 ml h o 4 o i i od aq C co i vo a 4 6 8 12 14 16 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 drugs 69 MAN 01 EN 03 CRONO 30 06 14 y APPENDIX 3 PRECISION TEST 2 1 Start up flow e Programmed delivery time 10 h e Volume administered 29cc corresponding to a flow of 2 9 ml h gt E E LL Elapsed time min 70 MAN 01 EN 03 CRONO 30 06 14 APPENDIX 3 TRUMPET CURVE 2 2 Flow rate error trumpet curve e Programmed delivery time 10 h e Volume administered 29cc corresponding to a flow of 2 9ml h o o is O ES Qo CO D o d v
18. E Marking C 0476 pa A R CANE gi MAN 01 EN 03 CRONO 30 06 14 SECTION 5 CONTROL BUTTONS a There are 3 control buttons d ON 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 The buttons make a clicking sound when pressed A brief beep confirms that a command is being executed WARNING The buttons have different functions according to which of the following conditions the pump is in when they are pressed OFF StoP ON The functions of the buttons in the various different conditions mentioned above are described in the quick reference instructions on Pages 34 and 35 and in Section 10 LED The red LED to the right of the display is switched on in the following circumstances 1 When the battery is inserted during the pump verification checks see Page 36 2 When an error has occurred see Pages 29 30 22 MAN 01 EN 03 CRONO 30 06 14 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 Four main digits Arrow icon Lock Two secondary digits cator Battery condition Drop icon indicator Four main digits of the display Display prin
19. ED 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 58 MAN 01 EN 03 CRONO 30 06 14 SECTION 13 SUPPORT The device must only be repaired by the CANE S p A Customer Support Service You are recommended before sending the device to contact Servizio Assistenza Clienti Customer Support Service CANE S p A Medical Technology Via Cuorgne 42 a 10098 Rivoli Turin Italy Tel 39 011 957 4872 Fax 39 011 959 8880 CANE S p A Online Internet www canespa it E mail service canespa it MAN 01 EN 03 CRONO 30 06 14 59 SECTION 13 GUARANTEE With this warranty CANE S p A guarantees the product from any faults in materials or manufacturing faults for the duration of 2 two years starting from the original purchase date Should faults in materials or manufacturing faults be found during this warranty period CANE S p A shall repair or replace the faulty components under the terms and conditions stated below without any charge for the costs of manpower or spare parts the cost of sending the device to the CANE S p A Customer Support shall remain on the Customer s account CANE S p A reserves the right to vary the characteristics or the model of its devices with no obligation to make changes to already manufactured and sold devices Conditions 1 The warranty shall only apply if the fault is claimed w
20. EM z 1 a When the withdrawal is complete the display shows OFF and the pump is ready for a further infusion Lay c3 co i Pusher in motion While the pusher is in the process of being withdrawn the display shows the pusher continuous withdrawal indication TT 1 8 44 MAN 01 EN 03 CRONO 30 06 14 SECTION 10 e The function to withdraw the pusher can be interrupted by pressing the and buttons together The display then alternates between End and OFF At this point only the button is active When pressed again the pump recommences the withdrawal of the pusher e The duration of the withdrawal of the pusher is approximately 6 minutes for a volume of 30 cc the duration is proportionally shorter for smaller volumes WARNING A Do not remove the reservoir until the pusher has been withdrawn to the infusion start position 45 MAN 01 EN 03 CRONO 30 06 14 SECTION 10 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 LO settings lock off the settings flash and can be modified If the settings are displayed when the settings lock is set to L1 or L2 settings lock on with the display showing the lock indicator the settings do not flash and cannot be modified Proceed as follows 1 Press the button for approx 1 second the disp
21. L AU Partial dose volume programming also availlable in L1 Decrease Increase the preceding parameter values Number of infusions PC Partial Counter press for 4 seconds Switching on the pump e Priming phase e Start of infusion MAN 01 EN 03 CRONO 30 06 14 SECTION 9 Pr Priming max 1 5 ml n ng E Pr and press e Switching off the pump 30 E E E contemporaneously keep pressed e Delivery time 30 THE Al Wy AV Setting of infusion time keypad unlocked L i e from 1 h to 99 h in steps of 15 minutes Decrease increase time 9 9 e Switching off the pump MW S AM A press contemporaneously 26 5 t C P and Interruption of an active infusion withdrawing the pusher press s f contemporaneously to the start position of the infusion e End of the infusion e Automatic repositioning of the pusher to the starting position e Automatic switch off MAN 01 EN 03 CRONO 30 06 14 SECTION 10 PUMP INITIALISATION When you insert the battery the pump runs the initialization sequence during which it 1 Runs a self diagnosis test emitting a series of brief beeps flashing the red LED and displaying all the indicators and icons on the screen 2 At the end of the self diagnosis test the pusher is withdrawn if the battery was removed after an error or with the pump in ON 3 When the pusher has been fully withdrawn the display shows OFF N
22. OTES E e The pump is supplied with a new battery already inside the pump For instructions on how to install the battery see Page 26 You are recommended to initialize the pump if it is left unused for a long period more than 1 2 months and the battery is not removed WARNING Ay The setting of the pump is the responsibility of the doctor who will choose the parameter values best suited to the therapy required for the patient 36 MAN 01 EN 03 CRONO 30 06 14 PUMP SETTINGS SEQUENCE WITH THE PUMP IN OFF or StoP SECTION 10 CONDITION To change the settings the pump must e be in the OFF or StoP condition e have the settings lock off i e set to LO SETTING OF END OF INFUSION ACOUSTIC SIGNAL 1 While the display is showing the type of reservoir selected press the button the pump enters the mode for selecting the end of infusion acoustic signal When the value flashes select a new value using the and buttons Selecting OFF disables the end of infusion sound Selecting on activates the end of infusion acoustic signal which will sound 5 min and 10 min before the end of the infusion Do not press any button for 10 seconds and the setting phase will end The flashing displayed value becomes fixed and then OFF or StoP is displayed Press the button before OFF is displayed while the value of the end of infusion sound is still flashing to pass to the setting of the successive parameter SET
23. TING THE PARTIAL VOLUME Al ML NU oF ML Ay ami PROG pato AL AL NOTES E e Setting the reservoir type the end of infusion sound and the partial dose volume is only possible when the settings are unlocked LO e When the settings lock is on L1 if any attempts are made to change the parameter then the display will show the flashing lock symbol and beep several times MAN 01 EN 03 CRONO 30 06 14 37 SECTION 10 SETTING THE PARTIAL VOLUME The partial volume function is used when the therapy requires an infusion with less than 30 ml The partial volume can be set from 1 cc to 30 cc in 1 cc increments Access the setting of this parameter by pressing the button again while the parameter value is still flashing The partial volume can be set only before the start of a new complete or partial infusion Proceed as follows 1 38 The display shows a flashing value for the volume preceded by cc which indicates the unit of volume 1 cc 1 ml Press the button to decrease the value and the button to increase it Each change Is indicated by a beep Do not press any button for 10 seconds and the setting phase will end The display will show P cc The pusher is automatically positioned at the configured partial volume value An intermittent beep is emitted while it does so and the pump displays in real time the actual volume corresponding to the pusher positi
24. The display then shows a flashing letter Pr in the secondary digits followed by the number of ml delivered When the button is released the display shows Pr The procedure can be repeated up to a maximum release of 1 5 ml Proceed until the infusion set is completely full and a few drops of the drugs leak out of it 42 MAN 01 EN 03 CRONO 30 06 14 SECTION 10 NOTES E e f you keep the button pressed the pump delivers the priming dose giving an acoustic signal every consecutive delivery of 0 5 ml i e 0 5 1 0 1 5 ml If after the priming indication is displayed the buttons are not pressed again for 10 seconds the display shows OFF e The priming function can be interrupted by releasing the button The display shows Pr again and you again have the choice of postponing skipping to start the infusion or performing the priming function as described above WARNINGS A e Do not prime the infusion set with the tube connected to the patient e The priming function must only be performed with the reservoir attached to the infusion set before inserting the needle into the infusion site e Before beginning an infusion check that there are no air bubbles in the infusion line expelling any that are found Alternatively use a vented filter SWITCHING OFF THE PUMP To switch off the pump during an infusion press the and NL NM ML NM the buttons simultaneously the display will show StoP If the pump is
25. able materials must be disposed of in an appropriate way using containers designed for the purpose If you do not observe the above warnings the device could malfunction with potentially serious consequences for the user of MAN 01 EN 03 CRONO 30 06 14 SECTION 13 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 CANE S p A Customer Support Service before re using it The external surfaces can be cleaned with a lightly dampened soft cloth using a mild detergent or disinfectant GENERAL WARNINGS A e Do not immerse the pump in detergent solutions or water e Avoid getting liquids inside the pump If the device gets wet immediately try to dry it with absorbent paper e Do not clean the pump with acetone solvents or abrasive detergents e Do not sterilise the pump STORAGE If the device is not used for any period more than one or two months you are recommended to remove the battery and put the pump away in its case in a dry place at room temperature DISPOSAL At the end of the expected life of the pump contact the CAN S p A Customer Support Service which will provide you with instructions about the disposal of the device Reservoirs infusion sets needles filters and all consumable materials must be disposed of in an appropriate way using containers designed for the purpose EXPECT
26. al electrical equipment Part 1 General requirements for basic safety and essential performance collateral standard Electro magnetic compatibility Requirements and tests Guide and declaration by the manufacturer electro magnetic emissions CRONO 30 is designed to operate in the electro magnetic environment specified below The customer or user of the CRONO 30 must ensure that it is operated in such an environment Emissiontes Compliance Electromagnetic environment guide CRONO 30 uses RF energy only for its internal operation As a consequence its RF emissions CISPR 11 RF emissions are very low and would thus not be expected to cause any interference to electronic devices in the vicinity CISPR 11 RF emissions CRONO 30 is designed for use in all IEC 61000 3 2 harmonic environments including domestic environments libio and those environments directly linked to the low IEC 61000 3 3 emissions voltage mains supplying residential buildings in the event of voltage fluctuations or flicker Guide and declaration by the manufacturer electro magnetic immunity CRONO 30 is designed to operate in the electro magnetic environment specified below The customer or user of the CRONO 30 must ensure that it is operated in such an environment IEC 60601 Level of Electromagnetic Immunity test test level compliance environment guide IEC 61000 4 2 15 kV in 15 kV in air 8 l Mae air 8 KV on The flooring must be of wood
27. cipal information related to the values of the settings error information etc Two secondary digits of the display Display alternately e The volume remaining in the reservoir e Information related to the setting being displayed H H in the four main digits e The unit of measurement of the setting being displayed 23 MAN 01 EN 03 CRONO 30 06 14 SECTION 5 Low battery indicator Displayed when the battery is low see related section on Page 25 Drop icon Flashing the hour and minute separator Arrow icon The arrow indicates that the pump is being programmed LL PROG Minute indicator Flashes when the remaining delivery time Is expressed in minutes time left is less than 60 minutes Lock indicator Indicates that the settings are locked L1 i e they can be viewed but cannot be changed ED dq 24 MAN 01 EN 03 CRONO 30 06 14 SECTION 5 LOW BATTERY INDICATOR The appearance of the LOW BATTERY alert not flashing on the display indicates that the battery is low If the alert remains displayed for several consecutive infusions the SPENT BATTERY message is displayed accompanied by a beep repeated approximately every 10 seconds n H t In these circumstances the pump can no longer be used and the battery must be replaced am During battery replacement when in the OFF or StoP conditions the pump retains the current settings and the position of the pusher in i
28. cles clauses in the publication IEC 60601 1 2006 and those of the 1988 edition of the same and its subsequent modifications EC EN 62304 2006 10 Medical device software Software life cycle processes 18 MAN 01 EN 03 CRONO 30 06 14 FURTHER INFORMATION For further information about the CRONO 30 pump contact Servizio Assistenza Clienti Customer Support Service CANE S p A Medical Technology Via Cuorgne 42 a 10098 Rivoli Torino Italy Tel 39 011 957 4872 Fax 39 011 959 8880 Internet www canespa it E mail service canespa it NOTES 79 MAN 01 EN 03 CRONO 30 06 14 80 MAN 01 EN 03 CRONO 30 06 14
29. doctor who can take any immediate corrective action required 72 MAN 01 EN 03 CRONO 30 06 14 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 30 post occlusion bolus considering only the combined volume of the pump and a single reservoir is approx 1 2 ml WARNINGS The volume of the bolus dose released post occlusion can increase if there is air in the line if you are using catheters filters and extension tubes of other dimensions or of a softer material or when the line from the pump is connected to other devices After the occlusion alarm sounds take any and all measures appropriate to avoid the administration of a post occlusion bolus to the patient e Patients who might suffer severe harm from the accidental release of a post occlusion bolus must receive adequate instructions and or training from medical or paramedical personnel on how to proceed in such a situation 73 MAN 01 EN 03 CRONO 30 06 14 ELECTRO MAGNETIC COMPATIBILITY The electro magnetic compatibility tests were performed in compliance with the standards EC 60601 2 24 2012 Medical electrical equipment Part 2 Particular requirements for the safety of infusion pumps and controllers EC EN 60601 1 2 Ed 2 Medic
30. e Council Directive 93 42 EEC Medical devices Legislative Decree no 46 24th February 1997 Implementation of Council Directive 93 42 EEC concerning medical devices Directive 2007 47 EC of the European Parliament and of the Council Amending Council Directive 90 385 EEC on the approximation of the laws of the Member States relating to active implantable medical devices Council Directive 93 42 EEC concerning medical devices and Directive 98 8 EC concerning the placing of biocidal products on the market Legislative Decree No 37 25 January 2010 Implementation of Directive 2007 47 EC 16 MAN 01 EN 03 CRONO 30 06 14 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 electro medical systems IEC EN 60601 1 2 A1 2006 10 Medical electrical equipment Part 1 general requirements for basic safety and essential performance collateral standard Electro magnetic compatibility Requirements and tests IEC EN 60601 1 2 2010 01 Medical electrical equipment Part 1 general requirements for basic safety and essential performance
31. fe infusion the use of filters is advised to e Prevent possible infections due to bacteria e Remove air from inside the syringe and the infusion set e Retain micro particles such as glass and plastic fragments IDENTIFYING THE FILTER COMPONENTS Male Luer Lock cap 0 2 micron filter Female Luer Lock cap Female Luer Lock cap Tube set 1 x 2 3 Blue Male Luer Lock PVC NO DOP connector MAN 01 EN 03 CRONO 30 06 14 SECTION 11 PREPARATION OF THE RESERVOIR AND CONNECTION TO THE PUMP 1 Screw the needle onto the r servoir in a clockwise direction and remove the needle cover 2 Fill the r servoir aspirating the liquid slowly and checking that the quantity of the drug does not exceed its capacity or any partial dose volume you may have set 3 Remove the needle used to fill the syringe and insert the cone of the infu sion set over r servoir 4 Unscrew the stem turning it anticlockwise with a reasonably rapid movement 5 Insert the syringe into the pump Rotate through 90 and it will click and engage with the pusher n uU 10 5 1 i N e NO 6 6 Ng in MAN 01 EN 03 CRONO 30 06 14 SECTION 11 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 Front view MAN 01 EN 03 CRONO 30 06 14 SECTION 11 WARNING Ay e Be
32. fore filling the reservoir Unscrew and screw back the piston rod to facilitate its unscrewing after you have filled the reservoir ee CC TF varex ener E e Filling the reservoir The liquid must be aspirated slowly Do not fill the reservoir more than the maximum level allowed The rod must be unscrewed with a fairly rapid movement e Inserting the reservoir into the pump To avoid any leakage of the drugs while the reservoir is being inserted into the pump you can use the infusion set as an alternative to the Luer Lock cap indicated on Page 50 When making the connection avoid exerting any pressure on the reservoir walls because this could cause liquid to leak past the piston rings While filling the reservoir and inserting it into the pump a small leakage might occur between the first and second rings on the rubber piston This does not compromise either the correct working of the reservoir or the delivery of the drugs 52 MAN 01 EN 03 CRONO 30 06 14 SECTION 11 INFUSION SITES The figures below indicate the recommended infusion sites You are recommended to change the injection site after every infusion to avoid skin irritations m PREPARING FOR THE INFUSION Before preparing for the infusion you are recommended to adopt the following precautions 1 Wash your hands 2 Prepare a clean working environment WARNING Always work in antiseptic conditions to reduce the risk of infectio
33. ially negative impacts on the environment and health and facilitates the re use or recycling of the materials from which the device is constructed The illegal disposal of a product is punishable according to the laws currently in force Note The symbol displayed on the product label is for obvious reasons of space reduced and simplified with respect to the specifications in the reference standard CENELEC EN50419 MAN 01 EN 03 CRONO 30 06 14 APPENDIX 1 ICONS USED ON THE RESERVOIR BLISTER PACK Read the instructions C 01 23 CE marking Recyclable E Use only once OO da Non pyrogenic jo Keep dry Keep away from sunlight el ZS Expiry date STERILE Sterilized with ethylene oxide Polypropylene LOT Batch code REF Reference no NEEDLE Needle size 65 MIL MAN 01 EN 03 CRONO 30 06 14 OPTIONAL ACCESSORIES AVAILABLE ON REQUEST 1 Vertical leatherette case similar to a mobile phone case Detail of belt clip T Detail of opening system Bl with aperture for infusion set Item code CM 15 Colour black Dimensions CM 15 approx 16 x 5 5 x 4 cm Weight CM 15 approx 60 g 66 MAN 01 EN 03 CRONO 30 06 14 APPENDIX 2 2 Horizontal leatherette case similar to a spectacle case MAN 01 EN 03 CRONO 30 06 14 Detail of belt clip Item code CM 22 Colour black Dimensions CM 22 16 x 5 5x 4 cm Weight CM 22 Approx 50 g 67 y APPEN
34. ion The instructions in this manual are essential for the safe and correct use of the pump You are recommended to read the whole manual before starting to use the device and to keep the manual handy for future reference The pump does not need to be installed tested or activated CANE S p A reserves the right to modify the hardware and software specifications described in this manual at any time and without notice 13 MAN 01 EN 03 CRONO 30 06 14 SECTION 2 NOTES E CANE S p A reserves the right to modify or update this manual at any time and without notice e 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 WARNING PRECAUTIONS FOR USE A This pump is not recommended for independent use by patients who are unable to follow and understand the instructions supplied in this manual or unable to perform the basic operations and the regular maintenance of the pump FURTHER INFORMATION For further information about the CRONO 30 pump contact Servizio Assistenza Clienti Customer Support Service CAN S p A Medical Technology Via Cuorgn 42 a 10098 Rivoli Turin Italy Tel 39 011 957 4872 Fax 39 011 959 8880 Internet www canespa it E mail service canespa it 14 MAN 01 EN 03 CRONO 30 06 14 SECTION 3 INTENDED USE The CRONO 30 ambulatory infusion pump is designed for the subcutaneous
35. ithin the terms of the warranty 2 This warranty does not cover the costs and or any faults due to modifications or adaptations made to the product without prior written authorization issued by CANE S p A CANE S p A declines any responsibility towards purchasers or third parties which may concern people or objects due to improper use of the device not intended use and due to non compliance with the regulations reported in the instruction manual The buyer undertakes to exempt CANE S p A from any claim made by third parties concerning the above 3 This warranty is void if the model indication or the serial number indicated on the product have been modified deleted removed or in any case made illegible 4 The following is excluded from the warranty e Periodic maintenance interventions e Damage due to improper use including but not limited to incorrect electrical power supply use of the product for purposes other those it is intended for repair interventions performed by unauthorized personnel or by the Customer 60 MAN 01 EN 03 CRONO 30 06 14 SECTION 13 Unforeseeable and accidental events such as falls and infiltration of liquids Natural events and malicious or culpable actions The accessories provided with the pump 5 CANE S p A undertakes for a period not exceeding 4 four years from the purchase date to perform repairs to the device After this period CANE S p A is exempt from the
36. lay will show the menu for selecting the end of infusion acoustic signal ML AU 2 Press the 8 button again and the display will show the selected partial volume in L2 only the visualization is possible 3 Do not press any button for 5 seconds and the setting phase will end The display will show OFF or StoP 46 MAN 01 EN 03 CRONO 30 06 14 SECTION 10 RESETTING THE NUMBER OF INFUSION COUNTER The device contains two infusion counters one which is a partial count of infusions and can be reset and another which shows the total number of infusions effected To reset the number of infusion counter proceed as follows 1 Press the button for approx 4 seconds until the display Pi t 3 shows the counter of infusions PC Partial Counter or LE M MU ME V 2 Without releasing the button press the button y i 4 the partial counter of infusions begins to flash Ar LI My Al MW SU 3 Press the button once more to invoke the programming mode the down arrow is displayed 4 Press either the CJ or the 4 buttons to set the or partial counter of infusions to zero Alternatively press the button to display the total count of infusions effected tC Total Counter 5 Press the 8 button again to display the firmware release rE Release 6 If you do not press anything for approx 10 seconds or press the button again the display changes to OFF 47 MAN 01 EN 03 CRONO 30 06 14 SECTION
37. n to the minimum 53 MAN 01 EN 03 CRONO 30 06 14 SECTION 11 The images refer to the Neria 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 Ensure there are no air bubbles in the infusion line WARNING N When you are priming the infusion line and are preparing to insert the needle below the skin hold the set with the needle pointing downwards to ensure that none of the drugs can come into contact with the protecting adhesive paper Remove the protective adhesive paper 54 MAN 01 EN 03 CRONO 30 06 14 SECTION 11 Remove the needle cover extracting it with care before inserting the needle WARNING AN Be careful not to touch the Neria 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 Press firmly on the adhesive to fix it to the skin Check the infusio
38. n site frequently to ensure that the needle remains in the correct position 55 MAN 01 EN 03 CRONO 30 06 14 SECTION 12 HOW TO USE THE ACCESSORIES SUPPLIED The following figures give an indication of how to use the standard accessories supplied with the pump WEARING THE PUMP AROUND THE NECK The pump worn with the collar strap and a fabric case WEARING THE PUMP AT THE WAIST The pump worn with an elastic belt and a fabric case PUMP WORN ON THE ARM Pump carried using an elastic armband accessory available upon request 56 MAN 01 EN 03 CRONO 30 06 14 SECTION 13 GENERAL WARNINGS A The device can be damaged by liquids so it must not be kept on while in the bath or the shower etc If the device is accidentally made wet for example drops of the drug or overnight bedwetting you must ensure it is checked by the CAN S p A Customer Support Service The device must be kept away from Sources of heat radiators gas rings stoves etc The direct rays of the sun Strong electro magnetic fields magnets loudspeakers mobile devices details are supplied in Appendix 6 lonizing radiation Ultrasound devices MRI devices The device does not need sterilising Do not freeze the CRN reservoir with the drug still in it The device must not be placed in a fridge or freezer The device must not be placed in an oven or microwave Reservoirs infusion sets needles filters and all consum
39. olled by an infrared system Two configurable levels Ensures a more reliable and safer infusion system These check that the device is functioning correctly intervening in the event of any anomaly with sounds and messages on the display IP 42 10 C 45 C 30 75 RH 700 hPa 1060 hPa 10 C 60 C 10 85 RH 500 hPa 1060 hPa 19 SECTION 4 EQUIPMENT SUPPLIED 1 CRONO 30 ambulatory infusion pump 2 Infuser carry case Code VAL 01R 3 Elastic belt Code CM 01 4 Fabric pouch Code CM 02 5 Collar strap Code CM 18D 6 2 Batteries one of which is already inserted in the pump Code CR 123A 7 Battery cover opening tool 8 User Manual MANUA LE D USO d CANE i Illy ii 4 Pompa portatile di farmaci per la terapia ferrochelante o e o lt o ac O 20 MAN 01 EN 03 CRONO 30 06 14 SECTION 5 PUMP PARTS Attachment for the reservoir wings CILL 7 Tadi dl Display Supporting eyelets PROG i of the supporting cC cord 7 ta x Buttons f Anti slip grooves Pusher Battery compartment B2 CRONO 30 SN Serial no UTILIZZARE ESCLUSIVAMENTE SIRINGHE CRN 30 PER USO SOTTOCUTANEO E SECONDO PRESCRIZIONE MEDICA L AZIONE SUI PULSANTI DEVE DURARE ALAN ee CE ON ACCESO B em TOTI Quick reference P OFF SETTAGGE be O ors idm IENTO CONSULTARE ATTENTAMENTE IL C
40. on When the pusher is in the correct position the display changes to OFF Al AU MAN 01 EN 03 CRONO 30 06 14 SECTION 10 NOTES E e The partial volume setting is automatically stored in the pump s memory e At the end of the infusion the pusher returns to the position corresponding to the partial volume setting e The partial volume setting can be interrupted by pressing the and buttons simultaneously ifthe pusher is still advancing the pump switches off the display shows StoP and the pusher remains where it was when the infusion was interrupted the partial volume setting is not stored and the previous value remains in memory if however the pusher was in the process of being withdrawn the display alternates between OFF and P cc The only possible operation is to continue the withdrawal of the pusher by pressing the button The pusher withdraws to the position of the partial volume setting e The partial volume can only be programmed at the start of a new infusion WARNINGS N This operation must not be carried out with the infusion set connected to the patient A partial volume cannot be set while an infusion is in progress e The partial volume setting remains in the pump s memory even if the battery is removed e fthe battery is removed when the pump is set to OFF StoP the partial volume remains in the memory and the pusher is not withdrawn e If the battery is removed when the
41. pump is set to ON the pusher returns to the infusion start position for recalibration and then repositions itself at the stored partial dose volume 39 MAN 01 EN 03 CRONO 30 06 14 SECTION 10 SETTING THE DELIVERY TIME The delivery time can be set from 1 h to 99 h in increments of 15 minutes Procedure 1 Push the button to switch on the pump 2 The pump enters the prime function 3 Push the the infusion begins 4 Push the button to program the delivery time the time shown on the display begins to flash 5 While the time is flashing it is possible to decrease the value with the button and increase it using the button Holding either of the buttons down causes the time to change more rapidly If no button is pressed for 10 seconds the display stops flashing NOTES E e The delivery time is automatically stored by the pump e Holding either of the buttons down causes the delivery time to change more rapidly e f either of the keypad lock levels L1 or L2 is active each time an attempt is made to change the parameter the padlock symbol flashes and the bumps emits a series of acoustic signals 40 MAN 01 EN 03 CRONO 30 06 14 SECTION 10 SWITCHING ON THE PUMP From the OFF condition press the button The pump will give a brief beep and display e Pr priming function the display shows Pr There are three options see Page 42 a Postpone the priming b Cancel the priming
42. pump syringe set only is approximately 1 2 ml WARNINGS A e The volume of the bolus released after an occlusion can vary depending on the type of catheter the infusion set and all the other components that comprise the infusion line e Another element that could affect the volume of the released bolus after an occlusion is the presence of any air in the system After the occlusion alarm is given disconnect the infusion set from the patient to avoid a post occlusion bolus being administered to the patient 32 MAN 01 EN 03 CRONO 30 06 14 SECTION 8 FACTORY SETTINGS The pump is supplied with the following default settings Reservoir 30 ml End of infusion acoustic signal AL on active Lock level set LO unlocked Delivery time 10 h Number of infusions 0 33 MAN 01 EN 03 CRONO 30 06 14 SECTION 9 QUICK REFERENCE The buttons have a built in safety delay you must keep them pressed for several seconds before the command takes effect 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 Self diagnosis test Automatic positioning of the pusher e Automatic switch off Programming conditions Pump switched off Beginning of a new infusion Settings lock unlocked AU ML NU AR Selection of end of acoustic signal a an this parameter can always be programmed RL Y RL Y PROG PROG A
43. rman e E a MAN 01 EN 03 CRONO 30 06 14 APPENDIGES ICONS USED ON THE PUMP IP protection rating D 42 1 digit 4 protection from solid objects larger than 1 mm 2 digit 2 protection from water droplets sprayed at an angle up to 15 degrees from the vertical CE marking Electro medical device Electrical classification Class I Type BF AN Warning read instructions before use Separated waste collection of electrical and electronic equipment In accordance with article 13 of Legislative Decree 151 of 25 July 2005 no 151 Implementation of Directives 2002 95 EC ae 2002 96 EC and 2003 108 EC concerning the restriction of the use of certain hazardous substances in electrical and electronic equipment as well as the disposal of waste The symbol of the crossed out waste bin on the product and its packaging indicates that at the end of its useful life the product must be disposed of separately from other waste Sorted waste disposal of products at the end of their useful life is organised and managed by the manufacturer Users wishing to dispose of this device must therefore contact the manufacturer or the appropriate local distributor and use the system which has been devised to allow for the separate disposal of devices at the end of their useful lives A proper differentiated collection system for devices destined for recycling treatment and environmentally compatible disposal helps reduce the potent
44. s on off prime but not the setting of parameters delivery time the partial volume pusher withdrawal enabling disabling the end of infusion acoustic signal When L2 is selected the display shows the padlock symbol amp Before attempting to modify any of the settings ensure that the selected access level of the pump is LO OFF amp symbol WARNINGS A e This access level for the functions remains in the memory even if the battery is removed e When the settings access is L1 locked any attempt to access the locked options will cause the pump to beep intermittently and display the lock indicator e The information relating to the locking unlocking of the settings lock is supplied at the back of this manual on a plastic card and is only for use by a doctor 28 MAN 01 EN 03 CRONO 30 06 14 SECTION 7 ERRORS AND ANOMALIES AUDIBLE ERROR CORRECTIVE Brief beep Operation not allowed ENSEM Continuous tone and Critical problem in the flashing LED safety system V Press the button Beep repeated every Anomaly in the motor 10 sec approx circuit Press the amp button Mechanism of the pusher blocked while Beep repeated every withdrawing could be Eliminate the cause 10 sec approx caused by a foreign and initialize the pump body preventing its movement Beep repeated every Pusher mechanism 10 sec approx blocked Press the amp button Beep repeated every 10 sec appro
45. s who assist and or live with the pump user know how the pump works and the information in this user manual It is important to stop using the device after the indicated service life has expired and follow the instructions for its correct disposal 16 MAN 01 EN 03 CRONO 30 06 14 SECTION 3 PUMP DESCRIPTION CRONO 30 is an ambulatory infusion pump for controlled subcutaneous administration of drugs CRONO 30 is a union of high technology and innovative design Its reduced dimensions and weight make it ideal for home use giving the patient the freedom to engage in everyday activities during the therapy CRONO 30 uses 30 ml dedicated reservoirs To improve the absorption of the drugs CRONO 30 administers 33 ul per shot The pusher mechanism which operates directly on the rubber piston of the reservoir enables the pump to combine high delivery pressure with excellent precision while administering the drugs An innovative infusion control system allows the pump to automatically restart and finish an infusion after an occlusion has been removed CRONO 30 is provided with a liquid crystal display LCD which shows practical information to the doctor and patient about the settings operations and diagnostics of the pump INFUSION SYSTEM The pump administers microdoses shots of 33 ul at intervals which depend on the configured delivery time For example if the delivery time is 1 00 h with a 30 ml reservoir the interval
46. switched off during an infusion the device will emit a series of 10 short beeps every 10 seconds and the display will flash the StoP message To interrupt the audible signals press the button These indications will be repeated each time the pump is switched off during an infusion 43 MAN 01 EN 03 CRONO 30 06 14 SECTION 10 WITHDRAWING THE PUSHER 1 Stopping an infusion before the end 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 AL ML SU WE e Turn off the pump by pressing the and buttons E 4 t Dn m simultaneously e Press the and buttons simultaneously the display shows End for 10 seconds and then begins to withdraw the pusher e During the 10 seconds that the display shows End the withdrawal request may be cancelled by pressing the and buttons together 2 Withdrawal of the pusher at the end of the infusion If AL is active ten minutes before the end of the infusion the device emits an intermittent acoustic signal for 2 seconds The same signal is repeated twice 5 minutes before the end of the infusion and at the end of the infusion a continuous acoustic signal is emitted and the the display shows the End message The pusher remains stationary at the end infusion position for around 10 seconds after which it begins to withdraw until it reaches the start infusion position
47. ton The display will read the number of delivered infusions Without releasing the button press the button as well The display will read the flashing indication of the level previously set Acting on and buttons you may increase or decrease the value of the key pad lock out level The key pad lock out level is stored even after removing the battery CAN S p A Medical Technology Via Cuorgn 42 a 10098 Rivoli TO Italy Tel 39 011 9574872 Fax 39 011 9598880 www canespa it mailbox canespa it WARNING The pump has a function of key pad lock out in order to avoid non authorised or accidental variations of the selected parameters if it is opportune that the patient not be able to change the pump settings it is advised that this information not be divulged to the him her The device is supplied with the key pad lock out level O The information concerning the operation of key pad lock out and key pad unlock is provided separately from the current user guide and is only for the physician Whenever the key pad is on lock out condition any attempt to modify the protected parameters make the display visualise the padlock indicator A accompanied by an intermittent acoustic si gnal Three different levels may be set 0 1 2 The levels are useful to avoid undesired operation and they ac tually lock out the key pad Level 0 means no restriction Level 1 does not allow you to select infusion time
48. ts memory If the battery needs to be changed during an infusion the pump must be in the StoP condition If the battery is removed with the pump in the ON condition the pump is automatically re initialized i e the pusher is withdrawn and repositioned to start an infusion displaying OFF on the display WARNINGS e Do not use rechargeable batteries Using other types of battery than lithium CR 123 A batteries could cause the pump to malfunction The battery life can be influenced by the age of the battery and the temperature and circumstances of its use and storage Ensure you always have a replacement battery available for use e If the pump is left inactive for long periods 1 2 months or more you are advised to remove the battery NOTES Jo e 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 e When you have finished changing the battery check that the compartment is properly closed 25 MAN 01 EN 03 CRONO 30 06 14 SECTION 5 BATTERY REPLACEMENT Use a 3 Volt Lithium battery model 123 A To replace the battery ensure that the pump is switched off the display showing OFF or StoP and then proceed as follows 1 Open the battery compartment using the PID battery tool for this purpose 2 Pull out the cover 3 Use the small ribbon strap which lies under the battery to facilitate the
49. x Motor anomaly Initialize the pump Beep repeated every 10 sec Communication error approx possibly between the two Press the 4 button accompanied by microcontrollers flashing LED 29 MAN 01 EN 03 CRONO 30 06 14 SECTION 7 AUDIBLE ERROR CORRECTIVE DISPLAY SIGNAL DESCRIPTION ACTION When a battery is inserted and at the start of every infusion the pump performs a check of the Beep repeated every settings in the memory If uu eh 10 sec approx an error is found the value Initialize the pump l in error is replaced by the default value the pump motor is locked and the error is indicated both on the display and audibly Anomaly in the safety circuit which drives the pump motor If an erroris Initialize the pump found the pump locks and the error is indicated Beep repeated every 10 sec approx Beep repeated every Anomaly in the pusher 10 sec approx mechanism Initialize the pump Eliminate the cause Beep repeated eve ven and press the PEER ry because of an occlusion in P 10 sec approx l a button the infusion line See Page 32 30 MAN 01 EN 03 CRONO 30 06 14 SECTION 7 WARNINGS A e Following the display of error message Er 8 and the successive initialisation the system reverts to the factory settings see Page 33 in this event the pump settings prescribed by the doctor should be re entered e Error messages Er 2 and Er 7 are accompanied by the flashing red LED NOTES E
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