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CRONO Super PID

1. ii page 33 Setting of end of infusion acoustic signal page 34 Setting the partial voIUME i page 35 Switching on the PUMP page 37 Priming the infusion line page 37 The pump in ON COFPQONIOLD cnticans cirea ta a drm ote iin cines page 39 Setting the delivery time ii page 39 End TM page 40 Withdrawing the pusher page 40 Switching off the PUMP srsrcirn tiov cales atro eaES etus page 42 Displaying the settings page 42 Resetting the number of infusion counter page 43 SECTION 11 FROSOFVOIFDAFIS ters ed cis Ip MIR EDU HCM TORRE page 44 Luer lock cap functions page 44 BATES IOS OT EE page 45 INUSIORNSCE OAS EE page 45 Preparation of the reservoir and connection to the pump page 46 Connection of the reservoir to the pump page 47 Agit sie EEE page 49 Preparing Tor the InT slOll asucc opui iere donor segete se siece page 49 6 MAN 01 EN 00 CRONO SUPER PID 02 12 SECTION 12 How to use the accessories Supplied Page 52 SECTION 13 Maintenance ues nicae n dni q vida iic qu rae neu dava ERREUR Rd dE Page 54 GENERAL WARNINGS Page 54 202 EEE EE A Page 54 BIE DOS Alig sia ES IUIUS MESI UM MM NU Page 54 Expected pump life Page 54 SUPOT Len Page 55 GTA
2. 21 MAN 01 EN 00 CRONO SUPER PID 02 12 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 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 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 one hand Strike the palm of your other hand with the pump to jolt the battery from the compartment e The cover is supplied with a gasket which must remain in position as indicated in the illustration Gasket 22 MAN 01 EN 00 CRONO SUPER PID 02 12 SECTION 5 23 MAN 01 EN 00 CRONO SUPER PID 02 12 SECTION 6 SETTINGS LOCK The CRONO Super PID pump has 2 access configurations LO unlocked in this configuration you can use the control buttons to access all of the settings and parameters and contro
3. button the pump begins the infusion and the display shows the time remaining until the end of the infusion b Skip the tuto c Perform the priming Press and hold down the button the pump delivers the priming dose until you release the button The display then shows a flashing letter P 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 NOTES 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 e 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 38 MAN 01 EN 00 CRONO SUPER PID 02 12 SECTION 10 WARNINGS Ay 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 Before beginning an infusion check that there are no air bubbles in
4. CRONO Super PID Ambulatory infusion pump NEW MODEL USER GUIDE CJ CANE Da CANE CANE S p A Medical Technology Via Cuorgn 42 a 10098 Rivoli TO Italy Tel 39 011 957 4872 Fax 39 011 959 8880 www canespa it mailbox canespa it Manual code MAN 01 EN 00 CRONO Super PID Publication date 02 12 CONTENTS SECTION 1 Symbols and COnventions iii Page 8 SECTION 2 MON Page 9 WARNING PRECAUTIONS FOR USE Page 10 Tg e TNO BERN IRR RO eee Page 10 SECTION 3 METTET Ene Page 11 TEN Page 13 Technical characteristiCS Page 14 SECTION 4 Equipment supplied in Page 16 SECTION 5 PUMP Palla la na Page 17 Cod iaia Page 18 LED rn inte Page 18 Liquid crystal display LCD Page 19 Low battery indicator 2 Page 21 Battery replacement i Page 22 SECTION 6 SU Ok Page 24 SECTION 7 Errors and anomalies rrranrnnnrnnnnnnnrnnnnnnnnnnnnnnnnnnnnnnnnnnnen Page 25 Infusion set occlusion source rousse eoe E Dim Potente viti bor idecueo Page 28 Post occlusion DONS secuntur rir umunt ense tutti ra iita etes Page 28 MAN 01 EN 00 CRONO SUPER PID 02 12 SECTION 8 Factory SES seen page 29 SECTION 9 Quick reference nenne page 30 SECTION 10 Pump NN page 32 Pump settings sequence with the pump OFF condition page 33 Setting the reservoir type
5. immunity 20 80 MHz 10V m AM 80 1 KHz 9 Recommended separation distance between mobile and portable radiocommunication devices and the CRONO Super PID CRONO Super PID is designed to operate in an electro magnetic environment in which radiated RF disturbances are under control The customer or user of the CRONO Super PID can help prevent electro magnetic interference by ensuring a minimum distance between mobile and portable communication devices using RF transmitters and the CRONO Super PID 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 transmitter W 150 kHZ to 80 MHz 80 MHz to 800 MHz 71 MAN 01 EN 00 CRONO SUPER PID 02 12 REFERENCE DIRECTIVES 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 72 MAN 01 EN 00 CRONO SUPER PID 02 12 TECH
6. General requirements tests and guidance for alarm systems in medical electrical equipment and medical electrical systems 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 13 MAN 01 EN 00 CRONO SUPER PID 02 12 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 articles clauses in the publication IEC 60601 1 2006 and those of the 1988 edition of the same and its subsequent modifications e IEC EN 62304 2006 10 Medical device software Software life cycle processes 14 MAN 01 EN 00 CRONO SUPER PID 02 12 INFORMATION For further information about the CRONO Super PID pump contact Servizio Assistenza Clienti Customer Support Service CANE S p A Medical Technology Via Cuorgn 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 75 MAN 01 EN 00 CRONO SUPER PID 02 12 76 MAN 01
7. Release 6 If you do not press anything for approx 10 seconds or press the P button again the display changes to OFF MAN 01 EN 00 CRONO SUPER PID 02 12 43 SECTION 11 RESERVOIR PARTS The CRONO Super PID pump uses model CRN CRONO Syringe 10 ml and 20 ml dedicated reservoirs The reservoirs are single use non pyrogenic and only to be used if the packaging is undamaged ue F m manam 13 Ly Lr Lu Vuln Piston rod Piston Reservoir body Luer Lock cap Needle cover Needle WARNINGS A e For safety reasons you are recommended to use original CRN Crono reservoirs 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 t protects the drugs inside the reservoir in case it is not used immediately 44 MAN 01 EN 00 CRONO SUPER PID 02 12 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
8. 15 approx 60 g Weight CM 20 approx 32 g 62 MAN 01 EN 00 CRONO SUPER PID 02 12 2 Horizontal leatherette case similar to a spectacle case MAN 01 EN 00 CRONO SUPER PID 02 12 APPENDIX 2 Detail of belt clip Item code CM 22 for use with 10 or 20 ml reservoirs Item code CM 21 only for use with 10 ml reservoirs Colour black Dimensions CM 22 16 x 5 5x 4 cm Dimensions CM 21 12 x 5 5 x 4 cm Weight CM 22 Approx 50 g Weight CM 21 Approx 33 g 63 APPENDIX 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 19cc corresponding to a flow of 19 ml h Tay E D U pas 3 LL 10 15 Elapsed time min 64 MAN 01 EN 00 CRONO SUPER PID 02 12 APPENDIX 3 TRUMPET CURVE 1 2 Flow rate error trumpet curve e Programmed delivery time 1 h e Volume administered 19cc corresponding to a flow of 19 ml h Ep max Ep min w A mcan 10 O 0 2 G O i od Q Le O pus wu o D i 3 LL 6 8 10 12 14 Observation interval min The actual degree of precision may differ from that indicated in this manual depending on the t
9. ERE Page 56 Declaration of CONformity Page 58 Appendix du e Page 60 APPENA A RR Tm Page 62 APPENA role oa Page 64 APPENA EE cueeeeeeceaieett Page 68 APPENOO urine Page 69 FN cari Page 70 use 4 nano Page 72 APPENA Oni EE Page 75 MAN 01 EN 00 CRONO SUPER PID 02 12 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 safe use of the pump A 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 Super PID 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 t
10. 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 potentially 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 00 CRONO SUPER PID 02 12 N N ICONS USED ON THE RESERVOIR BLISTER PACK Read the instructions CE marking Recyclable Use only once Non pyrogenic Keep dry a a a a a a Keep away from sunlight M lt a AN Expiry date STERILE Sterilized with ethylene oxide Polypropylene Batch code Reference no NEEDLE Needle size 61 MAN 01 EN 00 CRONO SUPER PID 02 12 OPTIONAL ACCESSORIES AVAILABLE ON REQUEST 1 Vertical leatherette case similar to a mobile phone case Detail of belt clip N Detail of opening system i with aperture for infusion set Item code CM 15 for use with 10 or 20 ml reservoirs Item code CM 20 only for use with 10 ml reservoirs Colour black Dimensions CM 15 approx 16 x 5 5 x 4 cm Dimensions CM 20 approx 13 x 5 5 x 4 cm Weight CM
11. C 61000 3 2 harmonic environments including domestic environments Sn 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 Super PID is designed to operate in the electro magnetic environment specified below The customer or user of the CRONO Super PID must ensure that it is operated in such an environment IEC 60601 Level of Electromagnetic Immunity test i test level compliance environment guide IEC 61000 4 2 15 kV in electro static air 8 kV on discharge ESD contact 15 kV in air 8 The flooring must be of wood concrete kV on contact or ceramic If the floor is covered in a synthetic material the relative M ic field 400 A m 400 A m humidity must be at least 30 agnetic fields I 50 and 60 Hz 50 and 60 Hz MAN 01 EN 00 CRONO SUPER PID 02 12 Guide and declaration by the manufacturer electro magnetic immunity CRONO Super PID is designed to operate in the electro magnetic environment specified below The customer or user of the CRONO Super PID must ensure that it is operated in such an environment Immunity IEC 60601 test level Level of Electromagnetic test compliance environment guide 80 2500 MHz 10V m AM 80 1 KHz Interference could occur in the vicinity of devices marked with the Radiated following symbol
12. EN 00 CRONO SUPER PID 02 12
13. EN 00 CRONO SUPER PID 02 12 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 eee Battery condition Drop icon indicator Four main digits of the display Display principal information related to the values of the settings error information etc Two secondary digits of the display Display e The volume of the selected reservoir e Information related to the setting being displayed Bg in the four main digits e The unit of measurement of the setting being displayed 19 MAN 01 EN 00 CRONO SUPER PID 02 12 SECTION 5 Low battery indicator Displayed when the battery is low see related section on page 21 Drop icon Flashing the hour and minute separator Arrow icon The arrow indicates that the pump is being programmed paga TEE ia TR 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 A 20 MAN 01 EN 00 CRONO SUPER PID 02 12 SECTION 5 LOW BATTERY INDICATOR The appearance of the LOW BATTERY alert not flashing on the display indicat
14. NICAL 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 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
15. NINGS 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 e 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 doctor who can take any immediate corrective action required 68 MAN 01 EN 00 CRONO SUPER PID 02 12 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 Super PID post occlusion bolus considering only the combined volume of the pump and a single reservoir is approx 1 2 ml WARNINGS A 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 e After the occlusion alarm sounds take any an
16. 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 Super PID considering the 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 28 MAN 01 EN 00 CRONO SUPER PID 02 12 SECTION 8 FACTORY SETTINGS The pump is supplied with the following default settings Reservoir 20 mi End of infusion acoustic signal AL on active Lock level set LO unlocked Delivery time 1h Number of infusions 0 29 MAN 01 EN 00 CRONO SUPER PID 02 12 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 Pro
17. actic shock or thrombo embolic events Always check this before continuing with an infusion Press firmly on the adhesive to fix it to the skin Check the infusion site frequently to ensure that the needle remains in the correct position 51 MAN 01 EN 00 CRONO SUPER PID 02 12 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 52 MAN 01 EN 00 CRONO SUPER PID 02 12 SECTION 13 GENERAL WARNINGS Ay 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 CANE 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 p
18. already manufactured and sold devices Conditions 1 The warranty shall only apply if the fault is claimed within 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 56 MAN 01 EN 00 CRONO SUPER PID 02 12 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 fo
19. d 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 69 MAN 01 EN 00 CRONO SUPER PID 02 12 ELECTRO MAGNETIC COMPATIBILITY The electro magnetic compatibility tests were performed in compliance with the standards EC 60601 2 24 1998 Medical electrical equipment Part 2 Particular requirements for the safety of infusion pumps and controllers EC EN 60601 1 2 Ed 2 Medical 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 Super PID is designed to operate in the electro magnetic environment specified below The customer or user of the CRONO Super PID must ensure that it is operated in such an environment Emissiontes Compliance Electromagnetic environment guide CRONO Super PID uses RF energy only for its internal operation As a consequence its RF CISPR 11 RF emissions 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 Super PID is designed for use in all IE
20. d that the individuals 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 Do not administer immunoglobulins intravenously if they are accidentally administered to a blood vessel or capillary the patient could suffer an anaphylactic shock or thromboembolic events Always check this before continuing with an infusion 12 MAN 01 EN 00 CRONO SUPER PID 02 12 SECTION 3 PUMP DESCRIPTION CRONO Super PID is an ambulatory infusion pump for controlled subcutaneous administration of drugs CRONO Super PID 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 Super PID uses 10 and 20 ml dedicated reservoirs To improve the absorption of the drugs CRONO Super PID administers 22 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 Super PID is provided with a liquid crystal display LCD which shows p
21. e CRONO Super PID ambulatory infusion pump is designed for the subcutaneous infusion of immunoglobulins and drugs in general CANE S p A disclaims all responsibility for the administration of drugs by other methods NOTE 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 Ay 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
22. e display shows OFF and the pump is ready for a further infusion Pusher in motion While the pusher is in the process of being withdrawn the display shows the pusher continuous withdrawal indication NOTE 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 WARNING A Do not remove the reservoir until the pusher has been withdrawn to the infusion start position 41 MAN 01 EN 00 CRONO SUPER PID 02 12 SECTION 10 SWITCHING OFF THE PUMP To switch off the pump during an infusion press the CE and the buttons simultaneously the display will show StoP Alf Ab Mb Alf If the pump is 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 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 set
23. en 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 3 When the pusher has been fully withdrawn the display shows OFF NOTES Wi e The pump is supplied with a new battery already inside the pump For instructions on how to install the battery see page 22 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 e f after the insertion of the battery initialization of the pump the display does not indicate the above mentioned information you are recommended to remove and re insert the battery WARNING A 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 32 MAN 01 EN 00 CRONO SUPER PID 02 12 SECTION 10 PUMP SETTINGS SEQUENGE WITH THE PUMP OFF CONDITION To change the settings the pump must be in the OFF condition e have the settings lock off i e set to LO SETTING THE RESERVOIR TYPE You can select either the 10 or the 20 ml reservoir as follows Select the reservoir type as follows 1 With the device in the OFF condition press the button for a few seconds the display fla
24. es 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 In these circumstances the pump can no longer be used and the battery must be replaced During battery replacement when in the OFF or StoP conditions the pump retains the current settings and the position of the pusher in its 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 A e Do not use rechargeable batteries e 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 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. gramming conditions Pump switched off Beginning of a new infusion Settings lock unlocked T M ca Selection of reservoir type 10 or 20 ml In dl PROG PROG slo Mis Mi Me Mi Selection of end of acoustic signal E z Qi an Lr this parameter can always be programmed T Partial dose volume programming l c u CC T PROG Decrease Increase the preceding parameter values and Interruption of an active infusion withdrawing press contemporaneously the pusher to the start position of the infusion i e Number of infusions PC Partial Counter press for 4 seconds MAN 01 EN 00 CRONO SUPER PID 02 12 SECTION 9 Switching on the pump Priming phase Start of infusion Priming max 1 5 ml keep pressed I and press contemporaneously Switching off the pump Delivery time Programming the delivery time settings lock unlocked from 15 min to 1 h in increments of 5 min 10 ml reservoir from 30 min to 1 h in increments of 5 min 20 ml reservoir Decrease increase time from 1 h to 99 h in increments of 15 min both reservoirs Programmed delivery time 20 30 TT StoP condition an Ck oa p Silence acoustic signal and flashing display e End of the infusion Automatic repositioning of the pusher to the starting position e Automatic switch off MAN 01 EN 00 CRONO SUPER PID 02 12 SECTION 10 PUMP INITIALISATION Wh
26. he declaration of conformity pages 62 to 77 MAN 01 EN 00 CRONO SUPER PID 02 12 SECTION 2 INTRODUCTION Thank you for having chosen the ambulatory infusion pump model CRONO Super PID This manual has been prepared to enable you to make the best use of the CRONO Super PID 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 Super PID 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 24 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
27. ing after you have filled di the reservoir i 2 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 3 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 46 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 48 MAN 01 EN 00 CRONO SUPER PID 02 12 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 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 A Always work in antiseptic conditions to reduce the risk of infection to the minimum 49 MAN 01 EN 00 CRONO SUPER PID 02 12 SECTION 11 The images refer
28. kink tubing INFUSION SET PARTS TRAN cmm Adhesive Female Luer Lock connector Needle Needle cover e NOTE f The images show the Neria infusion set from Unomedical a Convatec Company 45 MAN 01 EN 00 CRONO SUPER PID 02 12 SECTION 11 PREPARATION OF THE RESERVOIR AND CONNECTION TO THE PUMP 1 2 3 Screw the needle into the reservoir in a clockwise direction and remove the needle cover 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 ocrew the Luer Lock cap to the reservoir a and then unscrew the stem rotating it counter clockwise b with a fairly rapid movement Insert the reservoir into the pump the rubber piston will be inserted into the pusher Rotate it clockwise through 90 and it will click and engage with the pusher Insert the cone of the infusion set over the reservoir d bd d MAN 01 EN 00 CRONO SUPER PID 02 12 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 fi Front view MAN 01 EN 00 CRONO SUPER PID 02 12 SECTION 11 WARNING 1 Before filling the reservoir Unscrew and screw back the piston rod to Ha facilitate its unscrew
29. l 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 When the pump is set to L1 the display shows the lock indicator Before attempting to modify any of the settings ensure that the selected access level of the pump is LO OFF 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 24 MAN 01 EN 00 CRONO SUPER PID 02 12 ERRORS AND ANOMALIES SECTION 7 ACOUSTIC ERROR CORRECTIVE DENE SIGNAL DESCRIPTION ACTION Operation not allowed Brief beep Continuous acoustic signal and flashing LED Critical problem in the safety system Beep repeated every 10 sec approx Anomaly in the motor circuit Mechanism of the pusher blocked while withdrawing could be caused by a foreign body preventing its movement Beep repeated every 10 sec approx Pusher mechanism blocked Beep repeated every 10 sec approx Beep repeated every 10 sec approx Motor ano
30. l is given and the display shows End only if AL is on After a few seconds the pusher starts withdrawing until it reaches the start position of the infusion When the withdrawal is complete the display shows OFF and the pump is ready for a further infusion If AL is set in OFF no end of infusion acoustic signals are emitted during the infusion The pusher withdrawal time for a 20 ml volume is approx 6 minutes and is proportionately less for lower volumes 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 40 MAN 01 EN 00 CRONO SUPER PID 02 12 SECTION 10 To stop an active infusion do the following e Turn off the pump by pressing the and buttons 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 At the end of the infusion the display shows the message End and the pump will emit an acoustic signal for a few seconds 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 When the withdrawal is complete th
31. laced in an oven or microwave Reservoirs infusion sets needles filters and all consumable 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 53 MAN 01 EN 00 CRONO SUPER PID 02 12 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 materia
32. ls must be disposed of in an appropriate way using containers designed for the 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 54 MAN 01 EN 00 CRONO SUPER PID 02 12 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 CAN S p A Online Internet www canespa it E mail service Qcanespa it MAN 01 EN 00 CRONO SUPER PID 02 12 55 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
33. maly Beep repeated every 10 sec approx possibly accompanied by flashing LED Communication error between the two microcontrollers MAN 01 EN 00 CRONO SUPER PID 02 12 Press the amp button Press the amp button Eliminate the cause and initialize the pump Press the amp button Initialize the pump Press the button 25 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 settings in the memory If an error is found the value in error is replaced by the default value the pump motor is locked and the error is indicated both on the display and audibly Initialize the pump Beep repeated every 10 sec approx Anomaly in the safety Beep repeated every COUI WNG rives WG Initialize the Ne pump motor If an error is un RESA found the pump locks and pump the error is indicated Beep repeated every Anomaly in the pusher Initialize the 10 sec approx mechanism pump Eliminate the cause and press the e button See page 28 Mechanism blocked because of an occlusion in the infusion line Beep repeated every 10 sec approx 26 MAN 01 EN 00 CRONO SUPER PID 02 12 SECTION 7 WARNINGS A Following the display of error message Er 8 and the successive initialisation the system reverts to the factory settings see page 29 in this event the pump set
34. nd the partial dose volume is only possible when the settings are unlocked LO 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 34 MAN 01 EN 00 CRONO SUPER PID 02 12 SECTION 10 SETTING THE PARTIAL VOLUME The partial volume function is used when the therapy requires an infusion with less than 10 or 20 ml The partial volume can be set to from 1 cc to 10 cc in 1 cc increments 10 ml reservoir or from 1 cc to 20 cc in 1 cc increments 20 ml reservoir 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 10 or 20 ml Proceed as follows AM At 1 The display shows a flashing value for the volume preceded by cc which indicates the unit of volume EE 1 cc 1 ml MH Alb 2 Press the button to decrease the value and the button to increase it Each change is indicated by a beep 3 Do not press any button for 10 seconds and the setting phase will end The display will show P cc 4 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 position 5 When the pusher is in the correct position the di
35. or other person who is assisting the patient should not supply this information 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 and 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 MAN 01 EN 00 CRONO SUPER PID 02 12 CANE S p A reserves the right to modify and or update this manual at any time and without notice 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 Qcanespa 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 INFORMATION For further information about the CRONO Super PID 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 10 MAN 01 EN 00 CRONO SUPER PID 02 12 SECTION 3 INTENDED USE Th
36. ractical information to the doctor and patient about the settings operations and diagnostics of the pump INFUSION SYSTEM The pump administers microdoses shots of 22 ul at intervals which depend on the configured delivery time For example if the delivery time is 1 00 h with a 20 ml reservoir the interval between shots is approx 4 sec whereas with a delivery time of 10 00 h and a 20 ml reservoir the interval between shots is approx 40 seconds 13 MAN 01 EN 00 CRONO SUPER PID 02 12 SECTION 3 Pump dimensions Weight Battery Single use reservoirs Partial volume Delivery time Available priming volume Flow rate precision Occlusion pressure Shot volume Occlusion signalling time Post occlusion bolus 14 TECHNICAL CHARACTERISTICS 76 x 49 x 29 mm 3 00 x 1 94 x 1 15 in 115 g 4 06 oz including battery Lithium CR 123A 3V battery life approx 100 infusions Dedicated with a 10 and 20 ml capacity and a Luer Lock universal safety attachment Selectable from 1 to 10 ml in 1 ml increments 10 ml reservoir Selectable from 1 to 20 ml in 1 ml increments 20 ml reservoir Programmable from e 15 min to 99 h 10 ml reservoir e 30 min to 99 h 20 ml reservoir 1 5 ml 2 6 0 bar 2 0 22 microlitres shot quantity administered for every rotation of the motor See Appendix 4 Approx 1 2 ml MAN 01 EN 00 CRONO SUPER PID 02 12 Settings memory Display Motor Se
37. shes TYPE OF RESERVOIR 2 To select the type of reservoir press the or buttons It is not possible to change the setting of the reservoir type when an infusion is in course 3 Do not press any button for 10 seconds and the setting phase will end The flashing displayed value becomes fixed and then OFF is displayed 4 Press the button before OFF is displayed while the reservoir type is still flashing and you will pass to the setting of the successive parameter END OF INFUSION ACOUSTIC SIGNAL AL MAN 01 EN 00 CRONO SUPER PID 02 12 33 SECTION 10 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 Al Alle Alf 2 When the value flashes select a new value using the Da and 35 buttons Selecting oFF disables the end of infusion sound ET E adi Selecting on activates the end of infusion acoustic signal which will sound 5 min and 10 min before the end of the infusion 3 Do not press any button for 10 seconds and the setting phase will end The flashing displayed value becomes fixed and then OFF is displayed 4 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 SETTING THE PARTIAL VOLUME Setting the reservoir type the end of infusion sound a
38. splay changes to OFF 35 MAN 01 EN 00 CRONO SUPER PID 02 12 SECTION 10 NOTES e 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 The partial volume setting can be interrupted by pressing the and buttons simultaneously ifthe pusheris 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 The partial volume can only be programmed at the start of a new infusion WARNINGS A e 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 If the 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 pump is set to ON the pusher returns to the infusion star
39. t 3 CRONO super PID sn Serial no PER UDO BO TTOCUT AE E ASD PE BENENE vt bta L AZIONE RS PUR SARTI DEVE NART ALCUNE RETTA CN ins OFF BTOP sento RE m CHF SETTAOUR FELL PPO De na 1651 Se DE FLIES Quick reference VOLLOAE PALE jor 2L Unc TT ME is ZEE LEI ON DECHEMENTCUICRE MENTO OPA TF LIECNE Some AMP ATTENTAMENTE 1 MALE OPERATING CE marking Til un Dea A CANE Wa A BIOL TTA lke ____ lt l 4 17 MAN 01 EN 00 CRONO SUPER PID 02 12 SECTION 5 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 The buttons make a ticking 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 30 and 31 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 32 2 When an error has occurred see pages 25 27 18 MAN 01
40. t position for recalibration and then repositions itself at the stored partial volume 36 MAN 01 EN 00 CRONO SUPER PID 02 12 SECTION 10 SWITCHING ON THE PUMP From the OFF condition press the button The pump will give a brief beep and display Pr priming function the display shows Pr There are three options see page 39 a Postpone the priming b Cancel the priming 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 WARNINGS A Before starting an infusion e Inspect the infusion line to ensure there are no folds clamps or other occlusions in the line e Expel any air bubbles 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 37 MAN 01 EN 00 CRONO SUPER PID 02 12 SECTION 10 The priming procedure is as follows 1 Turn on the device by pressing the 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 Press the
41. the drug MAN 01 EN 00 CRONO SUPER PID 02 12 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 and 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 recommende
42. the infusion line expelling any that are found Alternatively use a vented filter 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 SETTING THE DELIVERY TIME The delivery time can be set to any of the following values e from 15 min to 1 h in increments of 5 min 10 ml reservoir e from 30 min to 1 h in increments of 5 min 20 ml reservoir e from 1 h to 99 h in increments of 15 min both reservoirs Procedure 1 Press the button and the pump allows setting the delivery time the time display begins to flash Mb Al All 2 While the display is flashing you can select the time using the button to decrease the displayed value or the tt button to increase it Keep either of these buttons pressed to change the infusion time value more quickly Do not press any button for 10 seconds and the setting phase will end and the infusion time will stop flashing 39 MAN 01 EN 00 CRONO SUPER PID 02 12 SECTION 10 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 END OF INFUSION Ten minutes before the end of the infusion the device gives an intermittent beep lasting 2 seconds This signal is repeated twice at 5 minutes from the end of the infusion At the end of the infusion a continuous signa
43. tings 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 display indicates the type of reservoir selected 2 Press the button for approx 1 second the display will show the menu for selecting the end of infusion acoustic signal 3 Press the button again and the display will show the selected partial volume 4 Do not press any button for 5 seconds and the setting phase will end The display will show OFF or StoP 42 MAN 01 EN 00 CRONO SUPER PID 02 12 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 shows the counter of infusions PC Partial Counter 2 Without releasing the button press the button the partial counter of infusions begins to flash 3 Press the button once more to invoke the programming mode the down arrow is displayed 4 Press either the or the T 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 P button again to display the firmware release rE
44. tings prescribed by the doctor should be re entered Error messages Er 2 and Er 7 are accompanied by the flashing red LED e 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 when the pump is in an error condition or the ON condition 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 27 MAN 01 EN 00 CRONO SUPER PID 02 12 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 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 4 button NOTES L 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
45. 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 A 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 50 MAN 01 EN 00 CRONO SUPER PID 02 12 SECTION 11 Remove the needle cover extracting it with care before inserting the needle WARNING Ay 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 WARNING A Do not administer immunoglobulins intravenously if they are accidentally administered to a blood vessel or capillary the patient could suffer an anaphyl
46. ttings lock Electronic circuit with twin microcontrollers Safety circuits Ingress protection rating Pump operating conditions Pump storage conditions MAN 01 EN 00 CRONO SUPER PID 02 12 SECTION 3 All settings are automatically stored in a flash memory which is retained even if the device is left without a battery Liquid crystal display LCD 1 1 x 2 8 cm 0 43 x 1 0 in Coreless DC motor the rotation of which is controlled 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 15 SECTION 4 EQUIPMENT SUPPLIED 1 CRONO Super PID 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 2 3 16 MAN 01 EN 00 CRONO SUPER PID 02 12 SECTION 5 PUMP PARTS Attachment for the reservoir wings a na E Display Supporting eyelets imn PRO of the supporting cord Buttons Bucher em A R Anti slip grooves Battery compartmen
47. ur years from the purchase date to perform repairs to the device After this period CANE S p A is exempt from the 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 Can 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 of MAN 01 EN 00 CRONO SUPER PID 02 12 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 Super PID ambulatory infusion pump with r servoir for drug administration mm 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 de
48. vice is put on the market in accordance with the laws applied by the individual European states Rivoli 29 12 2011 The Chairman ac i a 58 MAN 01 EN 00 CRONO SUPER PID 02 12 APPENDIGES MAN 01 EN 00 CRONO SUPER PID 02 12 59 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 Type BF A N 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 NENNEN 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
49. ype of accessories and extension tubes used in the administration line of the drugs 65 MAN 01 EN 00 CRONO SUPER PID 02 12 APPENDIX 3 PRECISION TEST 2 1 Start up flow e Programmed delivery time 10 h e Volume administered 19cc corresponding to a flow of 1 9ml h cs E ms 3 LL 120 Elapsed time min 66 MAN 01 EN 00 CRONO SUPER PID 02 12 APPENDIX 3 TRUMPET CURVE 2 2 Flow rate error trumpet curve e Programmed delivery time 10 h e Volume administered 19cc corresponding to a flow of 1 9ml h Oo O t o i od Q i O pus i o D U i z LL 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 67 MAN 01 EN 00 CRONO SUPER PID 02 12 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 4 minutes Approx 1 hour Approx 3 h 30 min WAR

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