CRONO TWIN - Pompe infusionali
Contents
1. Priming administration 3 00 ml available Y 05 imp e Switching on the pump uf iu U yn Alt Alt il e Delivery time or flow rate setting I i Li PROG dit dle dil dle Decreasing Increasing flow rate delivery time L L G i F PROG e Switch between programmed flow rate infusion G G Ines duration display only if F is selected e During the infusion the two secondary display t digits will show the remaining volume to be Se infused Programmed delivery time un Bu t Als Alie Al Ali e StoP condition un C E Pp e Silence acoustic signal and flashing display yn 5 E Oo P MAN 01 EN 00 CRONO TWIN 05 12 SECTION 9 Alte Alte sh Alh OFF StoP condition End of infusion acoustic setting 12 pressure Programmed partial volume 2 pressure Ale sili shi Ali OFF StoP condition yg F F 5 o e End of the infusion Automatic repositioning of the pushers to the starting position e Automatic switch off 32 MAN 01 EN 00 CRONO TWIN 05 12 SECTION 10 PUMP INITIALISATION When you insert the battery the pump runs the initialisation sequence during which it 1 Runs an auto diagnosis emitting a series of short beeps and displaying all the indicators and icons on the display 2 Displays OFF at the end of the preceding operation e The pump is supplied pre loaded with a battery e For instructions on how to install the battery see page 21 e You are advised to initialis2. CRONO TWIN Ambulatory infusion pump USER MANUAL C J CANE CANE S p A Medical Technology Via Cuorgne 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 00 CRONO TWIN Publication date 05 12 CONTENTS SECTION 1 Symbols and COnventions iii Page 8 SECTION 2 INFOGUGHOM cronaca at en Page 9 WARNING PRECAUTIONS FOR USE Page 10 IRINA ar Page 10 SECTION 3 Miended USE sesionin a yea eecdanteaseueeanseciest Page 11 PUMPASSCIPIO Isao ssi Page 13 Technical characteristics Page 14 SECTION 4 Supplied standard equipment Page 16 SECTION 5 PUMP Pallare Page 17 Control OOS cisco eee eee iaia Page 18 Liquid Crystal Display LCD Page 19 Low battery CIN cir cutin cea pionrwesnegaceradeudabeatenvonentesnanectantenaet Page 21 Battery TO plaCeMEeNt p icone doo ai Page 21 SECTION 6 SCHINGS 0Ck caa Page 24 SECTION 7 Errors and anomalies Page 25 Infusion set occlusion see ccacnsncsnsvecitnccpencctoand omcredoadancesebesacst Page 28 Post occlusion DOWNS sirccntoscun sothiecteccetdesecboceectectttarcsacnende Page 28 SECTION 8 FACcIor SeIINgs i ine Page 29 MAN 01 EN 00 CRONO TWIN 05 12 SECTION 9 Quick reference siriani Page 30 SECTION 10 Pump IRIS load rai Page 33 Pump settings
3. 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 holding wings of the infusion set with the other hand and inserting the needle vertically WARNING Ay Do not administer immunoglobulins intravenously if they are accidently 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 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 Repeat the above instructions for the second infusion site 56 MAN 01 EN 00 CRONO TWIN 05 12 SECTION 12 HOW TO USE THE SUPPLIED STANDARD EQUIPMENT The following figures give an indication of how to use the standard equipment supplied with the pump PUMP CARRIED AROUND THE NECK The pump worn with a supporting cord and a fabric pouch PUMP ATTACHED AT THE WAIST The pump worn with an elastic belt and a fabric pouch MAN 01 EN 00 CRONO TWIN 05 12 SECTION 13 GENERAL WARNINGS A The device can be damaged by water so it must not be
4. CRONO TWIN 1 ml h 150 ee Ep ax Epi min mie AL ieai fi O fa e 0 D oa q 10 O 0 Cc O _ A Observation interval mins The degree of precision can be different from the information in this manual according to the type of accessories and extension tubes used in the administration line of the drug 69 MAN 01 EN 00 CRONO TWIN 05 12 OCCLUSION SIGNALLING TIME The time needed to signal an occlusion is the interval between when the occlusion occurs and the detection of the occlusion by the pump This value depends on the flow rate because the lower the flow rate the longer the pump will take to detect the occlusion The values given here consider the time needed jointly by the pump and the reservoir to signal the occlusion Flowrate Occlusion signalling time 0 2 ml h About 22 hours 1 ml h About 3 hours 40 ml h About 5 minutes WARNINGS Ay e The time needed to signal an occlusion is dependant on the flow rate be cause the lower the flow rate the longer will be the time needed by the pump to ascertain the presence of an occlusion condition 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 dimen sions or in an elastic material or when the line from the pump is connected to other devices e For pat
5. SECTION 11 die om di Fi 2 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 Ay Always carry out the infusion in antiseptic conditions to reduce the risk of infection to the minimum 54 MAN 01 EN 00 CRONO TWIN 05 12 SECTION 11 The images refer to the Neria infusion set from Unomedical a company in the Convatec group 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 reservoirs 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 Ay 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 drug can come into contact with the protecting adhesive paper Remove the protective adhesive paper MAN 01 EN 00 CRONO TWIN 05 12 SECTION 11
6. SETTINGS IN OFF CONDITION When the device is set to OFF the following parameters can be set 1 End of infusion acoustic signal programmable also in StoP condition 2 Partial volume The parameters can only be selected if the pump has its settings unlocked LO To access the pump settings sequence while the device is in the OFF state you need to press the QP P button You can change the setting while the display is flashing using the and buttons NOTES LD e The settings of the end of acoustic signal the flow rate or the delivery time and the partial volume is only possible when the keyboard is unlocked L0 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 e The partial does volume can only be programmed at the start of a new infusion MAN 01 EN 00 CRONO TWIN 05 12 SECTION 10 1 END OF INFUSION ACOUSTIC SIGNAL 1 In the OFF or StoP state by pressing the button the pump enters the mode for selecting the end of infusion alarm Al Ale Ald 2 When the oFF or on icon flashes the selection can be a n m T IL _w made using the and a buttons Selecting OFF disables the end of infusion signal Mk ik selecting on activates the end of infusion signal i which will sound 5 mins and 10 mins before the end of the infusion ROS PROG 3 Do not press any bu
7. unlocked Number of infusions 0 In flow rate mode the pump is supplied with the following settings Flow rate 4 ml h End of infusion acoustic signal AL on active Volume 40 ml in 2 x 20 ml syringes Lock level set LO unlocked Number of infusions 0 29 MAN 01 EN 00 CRONO TWIN 05 12 SECTION 9 QUICK REFERENCE The buttons have a built in safety timer 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 Show the type of programme set flow rate delivery time Access the flow rate delivery time selection only possible with LO access level e Change the flow rate delivery time setting Automatic positioning of the pushers at the start of the infusion e Automatic switch off e OFF condition sile ile alle sil all Activate de activate end infusion acoustic signal la on AL n F F PROG 12 pressure Ali Ali e Partial volume programming ik YO F 2 pressure CC r PROG Pump set to OFF un uF F Change the value of the preceding settings 30 MAN 01 EN 00 CRONO TWIN 05 12 SECTION 9 e Partial volume programming Decrease increase partial volume Positioning the pushers for the partial volume e Automatic switch OFF e OFF condition e Priming function
8. 10 ml h in 0 1 ml h increments e 10 ml h to 100 ml h in 1 ml h increments 3 ml 2 5 5 bar 2 5 9 microlitres See APPENDIX 4 About 1 0 ml MAN 01 EN 00 CRONO TWIN 05 12 Electronic circuit Settings memory Display Motor Settings lock Twin microcontrollers Safety circuits Protection rating Pump operating conditions Pump storage conditions MAN 01 EN 00 CRONO TWIN 05 12 SECTION 3 Managed by twin microcontrollers with dedicated software 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 dimensions 1 1 x 2 8 cm 0 43 x 1 0 in Coreless DC Motor The microcontroller controls the rotation speed using an infrared encoder Two configurable levels Guarantee a more reliable system These check that the device is functioning correctly intervening in the event of any anomaly with sounds and messages on the display IP 4X 10 C 45 C 30 75 RH 700 hPa 1060 hPa 10 C 60 C 10 85 RH 900 hPa 1060 hPa 15 SECTION 4 SUPPLIED STANDARD EQUIPMENT 1 CRONO TWIN ambulatory infusion pump with reservoir 2 Ambulatory infusion pump carry case Code VAL 01R 3 Elastic belt Code CM 01 4 Leatherette pouch Code CM 30 5 Pouch support cord Code CM 18 6 2 Batteries one of which is already inserted in the pump Code CR 123A
9. 5 SECTION 13 GENERAL WARNINGS Page 58 Manual ACCS si nea Page 59 WI AUC TIANA Case rire Page 59 STORAGE rici aa Page 59 Boa ce N E E A E Page 60 Expected PUMP ING nina Page 60 UPO ic Page 60 ENE ini ari Page 61 Declaration Of COnformity Page 63 AP PERAN lle eee ee ne Page 65 APPENA ro Page 67 APPENA it Page 68 PAS Fi sa iii Page 70 Appendix Licei Page 71 APPENdIX banana Page 72 APPENOR fauno arie Page 74 Appendix rca Page 77 MAN 01 EN 00 CRONO TWIN 05 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 the safe use of the pump Notepad This icon indicates a NOTE containing additional information or useful tips about the use of the pump Flashing symbol The graphic symbol s shown in the manual above the pictures of the pump display indicates that the information below it is flashing This manual is divided into 4 parts Part 1 red sections 1 to 7 general information technical specifications and warnings Part 2 blue sections 8 to 10 which describe the functions of the CRONO TWIN device Part 3 orange section 11 which describe the reservoir the preparation and insertion of the reservoir into the pump the infusion sites and the preparation for
10. 959 8880 Internet www canespa it e mail service canespa it 10 MAN 01 EN 00 CRONO TWIN 05 12 SECTION 3 INTENDED USE The CRONO TWIN ambulatory infusion pump is designed for the subcutaneous infusion of immunoglobulins and drugs in general The administration of drugs by other means relieves CANE S p A of all liability NOTE The manufacturer holds itself liable for the safety 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 functionality and of the alarms could cause serious harm to the patient i 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 the medical or paramedical personnel the above list is supplied for example purposes only and is not exhaustive The device must be used Under medical supervision Adopting appropriate procedures and adequate mea
11. in the non occluded line NOTES The cause of the occlusion should be looked for along the path of the drug within the infusion set and at the point at which the set is inserted in the patient 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 CRONO TWIN post occlusion bolus considering only the combined volume of the pump and the reservoir is about 1 3 ml per reservoir WARNINGS Ay 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 TWIN 05 12 SECTION 8 FACTORY SETTINGS The pump is supplied in time mode with the following default settings Delivery time 10 h End of infusion acoustic signal AL on active Volume 40 ml in 2 x 20 ml syringes Lock level set LO
12. kept on while in the bath or the shower etc If the device accidentally gets wet for example by drops of the drug or overnight bedwetting you must ensure it is checked by CANE S p A Customer Support Service The device must be kept away from Sources of heat radiators gas rings stoves etc Direct sunlight Strong electro magnetic fields magnets loudspeakers mobile devices details are given in APPENDIX 6 lonising 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 oven Reservoirs infusion sets needles filters and all consumable materials must be disposed of in an appropriate way using the appropriate containers If you do not observe the above warnings the device could malfunction with potentially serious consequences for the user 58 MAN 01 EN 00 CRONO TWIN 05 12 SECTION 13 MANUAL UPDATES The version and the date of publication of this User Manual are given on every page When a year has passed between the publication date given on page 3 and the use of the product the doctor should contact CANE S p A to determine if a more recent version of the manual has been published MAINTENANCE The technical characteristics of the device make it extremely simple to maintain If the de
13. once more you can enter the programming phase indicate by the downwards arrow 4 By pressing the Or button you can reset the number of partial infusions while pressing the P once more you can see the total number of infusions tC Total Counter 5 By pressing the button once again you can see the firmware version of the pump 6 If you do not press anything for 7 seconds or press the button once more the display will switch to read OFF 48 MAN 01 EN 00 CRONO TWIN 05 12 SECTION 11 RESERVOIR PARTS The CRONO TWIN pump uses dedicated 20 ml reservoirs model CRN CRONO Syringe The reservoirs are single use non pyrogenic and only to be used if the packaging is intact E ri na ii mu 4 LFF syl finalan loula Piston rod Plunger m Reservoir body Luer Lock cap Needle cover Needle WARNINGS A e For safety reasons you are recommended to use the original CRN Crono Reservoir e The use of any other type of reservoir could damage the pump and harm the patient e CANE S p A disclaims all liability 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 it facilitates the unscrewing of the piston rod avoiding spillage of the drug e It facilitates the correct connection between the pump pushers and the rubber piston of the reservorr e It protects the drug inside the res
14. set in OFF no end of infusion acoustic signals are emitted during the infusion NOTE D The withdrawal time for a 40 cc syringe is about 6 minutes and is proportionately less for lower volumes 44 MAN 01 EN 00 CRONO TWIN 05 12 SECTION 10 WITHDRAWING THE PUSHERS 1 Stopping an active infusion before the end This function allows you to interrupt an active infusion withdrawing the pushers to the start position of the infusion To carry out a withdrawal proceed as follows e Turn off the pump by pressing simultaneously on the and buttons e Press the and buttons together the display shows End for 10 seconds and then begins to withdraw the pushers e During the 10 seconds that the display shows End you can cancel the withdrawal request by pressing the and buttons together 2 Withdrawal of the pushers at the end of the infusion At the end of the infusion the display shows the message End and the infusor will emit a continuous sound for a few seconds The pushers will remain stationary at the end infusion position for around 10 seconds after which they will begin to withdraw until they reach the start infusion position After a few seconds the pushers start withdrawing until they reach the start position of the infusion When the withdrawal is complete the display shows OFF and the pump is ready for a further infusion Pushers in motion While the pushers are in a continuous withdrawal motion the display shows th
15. the standards e IEC 60601 2 24 1998 Medical electrical equipment Part 2 Particular requirements for the safety of infusion pumps and controllers e IEC 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 The CRONO TWIN is designed to operate in the electro magnetic environment specified below The customer or user of the CRONO TWIN must ensure that it is operated in such an environment Emission test Conformity Electromagnetic environment guide The CRONO TWIN uses RF energy only for its internal operation As a consequence its RF RF Emissions CISPR11 emissions are very low and would thus not be expected to cause any interference to electronic devices in the vicinity RF Emissions CISPR11 The CRONO TWIN is designed for use in all IEC 61000 3 2 harmonic environments including domestic environments Sissons 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 The CRONO TWIN is designed to operate in the electro magnetic environment specified below The customer or user of the CRONO TWIN must ensure that it is operated in su
16. 7 User Manual 16 MAN 01 EN 00 CRONO TWIN 05 12 SECTION 5 PUMP PARTS Display Buttons Attachment for the reservoir wings Pushers Anti slip grooves Battery compartment Serial no Quick reference CE marking MAN 01 EN 00 CRONO TWIN 05 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 states the pump is in when they are pressed OFF StoP ON The functions of the buttons in the various different states mentioned above are described in the quick reference instructions on pages 30 32 and in Section 10 18 MAN 01 EN 00 CRONO TWIN 05 12 SECTION 5 LIQUID CRYSTAL DISPLAY LCD The liquid crystal display uses text messages and icons to display useful information about the settings the operation being performed and any error situations Four principal digits Drop icon p Arrow icon Lock Two secondary digits indicator Low battery indicator Four principal digits of the display Display principal information related to the values of the settings error information etc Two secon
17. Postpone the priming b Skip the priming c Carry out the priming a Postpone the priming Wait 10 seconds the pump will turn off automatically b Skip the priming Press the button the pump starts the infusion and the display shows the time remaining until the end of the infusion or the current flow rate MAN 01 EN 00 CRONO TWIN 05 12 SECTION 10 c Carry out the priming Press and hold the button the pump delivers the priming dose until you release the button and the display 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 again The maximum volume that can be delivered is 1 ml and the procedure can be repeated for up to a total of 3 0 ml 1 5 ml per infusion set Proceed until the infusion set is completely full and a few drops of the drug leak out of it There are no time limits to the priming operation NOTES e If after the priming indication is displayed the buttons are not pressed again for 10 seconds the display shows OFF The priming function can be interrupted by releasing the button The display shows Pr again and you again have the choice of postponing cancelling or performing the priming function as described above 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
18. Technology Via Cuorgne 42 a 10098 Rivoli Turin Italy Tel 39 011 9574872 Fax 39 011 959 8880 e CANE S p A On Line Internet www canespa it E mail service canespa it 60 MAN 01 EN 00 CRONO TWIN 05 12 SECTION 13 GUARANTEE With this guarantee CANE S p A guarantees the product from any material or manufacturing defects for a period of 2 TWO YEARS from the original date of purchase If in the course of this guarantee period any material or manufacturing defects are identified CANE S p A will repair or substitute the defective components according to the terms and conditions herein without any charge for labour or parts the Customer is responsible for the costs of sending the pump to the CANE S p A Customer Support Service CANE S p A reserves the right to vary the characteristics or model of its devices without being under any obligation to make corresponding modifications to devices already manufactured and sold Conditions 1 The guarantee is valid only if the defect is reported within the period of the guarantee 2 This guarantee does not extend to any costs and or defects following modifications or adaptations made to the product without prior written authorisation by CANE S p A CANE S p A disclaims all liability either to the purchaser or to third parties for damage that occurs to persons or things as a result of improper operation of the device for uses of the device for which it was no
19. an infusion Part 4 purple sections 12 and 13 giving general warnings and a description of the supplied standard equipment as well as discussing maintenance disposal and support It also details the guarantee and the declaration of conformity Pages 65 to 77 MAN 01 EN 00 CRONO TWIN 05 12 SECTION 2 INTRODUCTION Thank you for choosing the CRONO TWIN ambulatory infusion pump This manual has been prepared to enable you to make the best use of the CRONO TWIN 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 the failure to follow the instructions and warnings provided in this manual could cause serious injury The instructions provided relate exclusively to the ambulatory infusion pump model CRONO TWIN They 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 accidenta
20. by a beep 3 Do not press any button for 5 seconds and the setting phase will end the display will show P cc 4 The pump moves the pushers to the position which corresponds to the set volume giving an intermittent beep while it does so and displaying in real time the actual volume corresponding to the pushers position 5 When the pushers is in the correct position the display shows OFF e The partial volume setting is automatically stored in the pump s memory e At the end of the infusion the pushers returns to the position corresponding to the partial volume setting MAN 01 EN 00 CRONO TWIN 05 12 SECTION 10 Each time an infusion is started or restarted the display shows the current partial volume setting e The partial volume setting can be interrupted by pressing the and buttons the pump switches off the display shows StoP and the pushers if they were moving forward remain where they were when the interruption occurred The partial volume setting is not stored and the previous value remains in force However if the pushers were withdrawing the display toggles between StoP and P cc The only possible operation is to continue the withdrawal of the pushers by pressing the d button The pushers withdraw to the position of the partial volume setting WARNINGS Ay e This operation must not be carried out with the infusion set connected to the patient e A partial volume cannot be se
21. ch an environment IEC 60601 Level of 3 Immunity test Electromagnetic environment guide test level compliance IEC 61000 4 2 15 kV in electro static 15kVinair8 _ The flooring must be wood concrete or air 8 kV on discharge kV on contact ceramic If the floor is covered in a synthetic contact l ui ESD material the relative humidity must be at Electro 400 A m 50 400 A m 50 least 30 magnetic fields and 60 Hz and 60 Hz 72 MAN 01 EN 00 CRONO TWIN 05 12 Guide and declaration by the manufacturer electro magnetic immunity The CRONO TWIN is designed to operate in the electro magnetic environment specified below The customer or user of the CRONO TW N 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 immunit Y 20 80 MHz 10V m AM 80 1 KHz Co Recommended separation distance between mobile and portable radiocommunication devices and the CRONO TWIN The CRONO TWIN is designed to operate in an electro magnetic environment in which radiated RF disturbances are under control The customer or operator of the CRONO TWIN can help prevent electro magnetic interference by ensuring a minimum distance between mobile and portable communication devices using RF transmitters and t
22. dary digits of the display Display e The volume of the reservoir e Information related to the setting being displayed in the four principal digits H z e The unit of measurement of the setting being displayed 19 MAN 01 EN 00 CRONO TWIN 05 12 SECTION 5 Low Battery indicator Displayed when the battery is nearly spent see related section on page 21 Drop icon Steady the decimal point indicator Flashing the hour and minute separator Arrow icon e A downward arrow indicates that the pump is being programmed e A right arrow indicates that the setting shown is expressed in ml h PROG Minute indicator Flashes when the remaining duration of an infusion 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 20 MAN 01 EN 00 CRONO TWIN 05 12 SECTION 5 LOW BATTERY ALERT 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 In these circumstances the pump can no longer be used and the battery must be replaced WARNINGS Ay e You are advised to replace the battery after the LOW BATTERY alert is displayed e The batt
23. de was selected when the battery was inserted 2 Flow rate if flow mode was selected when the battery was inserted 1 SETTING THE DELIVERY TIME This function is only available if the t function infusion duration is selected when inserting the battery The delivery time can be set from 30 minutes to 400 hours as follows From 30 minutes to 2 hours in increments of 5 minutes From 2 hours to 24 hours in increments of 15 minutes From 24 hours to 400 hours in increments of 2 minutes Procedure __ i 1 Press the button to programme the parameter ri SETTING THE DELIVERY TIME Ea LI OG Alli Ald All 2 Press the button to decrease the value and the button to increase it 3 Do not press any button for 5 seconds and the setting phase will end The flashing displayed value becomes fixed and then the remaining infusion duration is displayed NOTES ia e Ifyou keep pressing either the or the buttons it is possible to change the infusion duration quickly 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 the device will beep several times e The partial volume can only be programmed at the start of a new infusion 42 MAN 01 EN 00 CRONO TWIN 05 12 2 SETTING THE FLOW RATE This function is only available if the F function flow rate is selected when inserting the battery The flow rate can be set f
24. dical 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 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 Protection ratings provided by enclosures IP Code 15 MAN 01 EN 00 CRONO TWIN 05 12 e IEC 62 108 2000 05 Guide to the maintenance of infusion pumps and control systems e IEC EN 62353 2008 11 Medical Electrical E
25. e pushers continuous withdrawal indicator MAN 01 EN 00 CRONO TWIN 05 12 Al Al Ale Ald 45 SECTION 10 NOTE LD Pusher withdrawal at the end of infusion can be interrupted by pressing the and amp buttons together The display then toggles between End and OFF At this point the only active button is the button When you press it the pump recommences the withdrawal of the pushers WARNING A Do not remove the reservoir until the pushers reach the infusion start position SWITCHING OFF THE PUMP To switch off the pump during an infusion press the Alh Alh Alh Alh and the buttons together the display will show StoP 39 L hai n Da 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 46 MAN 01 EN 00 CRONO TWIN 05 12 SECTION 10 DISPLAYING THE SETTINGS This function displays the currently programmed settings of the pump 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 acoustic alarm only if the pump is in StoP If the settings are displayed when the settings lock is set to L1 settings l
26. e the pump if it is left unused for a long period more than 1 2 months and the battery is not removed e If after the insertion of the battery initialisation of the pump the display does not indicate the above mentioned information you should remove and re insert the battery 33 MAN 01 EN 00 CRONO TWIN 05 12 SECTION 10 PUMP SETTINGS SEQUENCE Upon inserting the batteries you can choose the way in which the pump is programmed 1 by flow rate expressed in ml h F or 2 in time expressed in hours and minutes t Procedure 1 Remove and re insert the battery 2 The display shows all the symbols 3 At the same time the device carries out an auto diagnosis during which it emits a beeping sound 4 The display will then show the programming mode F flow rate or t time pressing the button makes the symbol flash you can move from one option to the other using the or buttons 5 Not pressing these buttons for 4 seconds will cause the device to memorise the mode that has been selected 6 The pump then mechanically positions the pushers for the start of the infusion and the display reads OFF NOTE Setting the programming mode is only possible with LO access WARNING Ay Choosing whether to programme the pump by flow rate or by time is the responsibility of the doctor who will decide on the most suitable method 34 MAN 01 EN 00 CRONO TWIN 05 12 SECTION 10
27. epeated every 10 secs approx MAN 01 EN 00 CRONO TWIN 05 12 Operation not allowed Critical problem in the safety system Anomaly in the motor circuit Mechanism of the pushers blocked while withdrawing could be caused by a foreign body preventing its movement Anomaly in the pushers mechanism Anomaly in motor Communication error between the two microcontrollers Press the CD button Press the button Eliminate the cause and initialise the pump Press the button Initialise the pump Press the e 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 Initialise the pump is replaced by the default value the pump motor is locked and the error is indicated both on the display and audibly A check is performed to ensure that the safety circuit which drives the pump motor is working Initialise the pump correctly If an error is found the pump locks and the error is indicated Beep repeated every 10 secs approx Beep repeated every 10 secs approx Beep repeated every Anomaly in the pusher 10 secs approx mechanism Initialise the pump I Eliminate the cause Beep repeated ever NO MO and press the E PS y because of an occlusion p 10 secs approx eee eon ine button See
28. ervoir in case it is not used immediately MAN 01 EN 00 CRONO TWIN 05 12 SECTION 11 INFUSION SET You are recommended to use an infusion set with the following characteristics e Internal volume of reduced tube ideal 0 1 ml maximum 0 62 ml e Tube length not more than 90 cm e Anti kink tubing INFUSION SET PARTS SY val Adhesive Female Luer Lock connector y x Pr z PT Ad 4 Wy we A 3 lt a x PLSD A an snes a A Ay ene ri y lt VI es gt P Py 7 4 SS f 7 A 4 4 a lod as Fd a tte Ses HS A DAS vd i fa are _ m e a 3 Ves d z 7 Needle e Needle cover NOTE ID The images show the Neria infusion set from Unomedical a company of the Convatec group 50 MAN 01 EN 00 CRONO TWIN 05 12 SECTION 11 PREPARATION OF THE RESERVOIRS AND INSERTION INTO THE PUMP 1 Screw the needles onto the reservoirs in a clockwise direction and remove the needles cover 2 Fill the reservoirs aspirating the liquid slowly and checking that the quantity of the drug does not exceed its capacity or any partial volume you may have set 3 Screw the Luer Lock caps a to the reservoirs and then unscrew the piston rods turning it anticlockwise b with a reasonably rapid movement 4 Insert the reservoirs into the pump the pushers will be inserted into the pushers Rotate its clockwise through 90 and its will click and e
29. ery must not be replaced during an infusion with the infusion set connected to the patient e Use 3 Volt Lithium batteries model CR 123 A BATTERY REPLACEMENT To replace the battery ensure that the pump is switched off the display shows OFF or StoP and then proceed as follows 1 Open the cover of the battery compartment sliding it off as shown in figure 1 on page 22 2 Remove the battery positive end first tilting it as shown in figure 2 on page 22 3 Insert the new battery taking care to ensure that it is the right way up and poles match up 4 Close the cover 21 MAN 01 EN 00 CRONO TWIN 05 12 22 SECTION 5 MAN 01 EN 00 CRONO TWIN 05 12 SECTION 5 e After you have inserted the battery the pump runs an auto diagnosis during which it will emit brief audio signals and display all of the icons and indicators e During the battery replacement the pump retains the current settings in its memory e When you have finished changing the battery check that the compartment is properly closed WARNINGS Ay e Do not use rechargeable batteries e Using other types of battery than lithium CR 123 batteries could cause the pump to malfunction e The battery life can be influenced by the age of the battery and the temperature and circumstances of its use and storage e Ensure you always have a replacement battery available for use e If the pump is left inactive for long periods 1 2 mon
30. he CRONO TWIN 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 T3 MAN 01 EN 00 CRONO TWIN 05 12 REFERENCE DIRECTIVES e Directive 93 42 EEC of the Council Medical devices e Legislative Decree No 46 24 February 1997 Implementation of Directive 93 42 EEC concerning medical devices e Directive 2007 47 EC of the European Parliament and of the Council Amending directives 90 385 EEC of the Council on the approximation of the laws of the Member States relating to active implantable medical devices 93 42 EEC of the Council concerning medical devices and 98 8 EC concerning the placing of biocidal products on the market e Legislative Decree No 37 25 January 2010 Implementation of directive 2007 47 EC 74 MAN 01 EN 00 CRONO TWIN 05 12 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 Me
31. ients 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 imme diate corrective action required 70 MAN 01 EN 00 CRONO TWIN 05 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 TWIN post occlusion bolus considering only the combined volume of a single pump and the reservoir is about 1 3 ml WARNINGS A e 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 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 71 MAN 01 EN 00 CRONO TWIN 05 12 ELECTRO MAGNETIC COMPATIBILITY The electro magnetic compatibility tests were performed in compliance with
32. in the reference standard CENELEC EN50419 MAN 01 EN 00 CRONO TWIN 05 12 ICONS USED ON THE RESERVOIR BLISTER PACK 17 Ze A Keep away from sunlight gt Expiry date STERILE Sterilised with ethylene oxide Polypropylene LOT Batch code REF Reference No NEEDLE Needle size 66 MAN 01 EN 00 CRONO TWIN 05 12 rN gt ro re DA IJ07 A LJL LL NA A we p yA 3 N l X gt Mi de ES a OPTIONAL ACCESSORIES AVAILABLE ON REQUEST N Vertical leatherette pouch similar to a mobile phone pouch Rear view Front view Ma Ring for supporting cord Beltloop Display and controls window Detail of opening with aperture for infusion set Colour black Dimensions 154 x 87 x 40 mm A Weight about 62 g i Item code CM 26 NI MAN 01 EN 00 CRONO TWIN 05 12 68 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 drug administration 1 1 Start up flow e Flow rate setting 1 ml h CRONO TWIN 1 mi h E D 4 es 3 LL ot 120 240 360 480 600 720 1080 1200 1320 Elapsed time min MAN 01 EN 00 CRONO TWIN 05 12 APPENDIX 3 TRUMPET CURVE 1 2 Flow rate error trumpet curve e Flow rate setting 1 ml h
33. l 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 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 TWIN 05 12 ki e CANE S p A reserves the right to modify and 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 INFORMATION For further information on the CRONO TWIN pump contact Customer Support Service CANE S p A Medical Technology Via Cuorgn 42 a 10098 Rivoli Turin Italy Tel 39 011 957 4872 Fax 39 011
34. ngage with the pushers 5 Insert the cones of the infusion set over the reservoirs d a peer tt ni b a Li Aia a i z fi A ID MAN 01 EN 00 CRONO TWIN 05 12 SECTION 11 INSERTION OF THE RESERVOIRS INTO THE PUMP Insert the dedicated CRN reservoirs into the pump and engage its by rotating its 90 clockwise a click confirms it has engaged Front view MAN 01 EN 00 CRONO TWIN 05 12 WARNING 1 Before filling the reservoir Unscrew and screw back the piston rod to facilitate its unscrewing after you have filled the reservorr 2 Filling the reservoir The liquid must be aspirated slowly Do not fill the reservoir more than the maximum level allowed of 20 ml The piston rod must be unscrewed with a reasonably rapid movement 3 Inserting the reservoir into the pump To avoid any leakage of the drug 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 49 When making the connection avoid exerting excessive 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 drug MAN 01 EN 00 CRONO TWIN 05 12
35. ock on with the display showing the lock indicator the settings do not flash and cannot be modified The procedure is as follows Alh Ali 1 Press the button for approximately one second the display shows the selection of the acoustic alarm at end of infusion 2 Pressing the button again shows the preprogrammed partial volume m 3 If no button is pressed for approximately 5 seconds the 39 LI F F display returns to OFF or StoP Alh Ah Alh Ali VISUALIZING PARAMETERS WHEN THE PUMP IS IN THE ON CONDITION This function allows checking the current flow setting of the pump To show the current flow setting the pump must be in ON If the pump is in flow mode pressing the button will cause the display to alternate between showing the infusion duration and the flow setting shown with the right arrow flashing to indicate that the value is in ml h 47 MAN 01 EN 00 CRONO TWIN 05 12 SECTION 10 RESETTING THE NUMBER OF PARTIAL INFUSIONS The device contains two infusion counters one which is partial and can be reset and another which shows the total number To reset the number of partial infusions proceed as follows 1 Press the button for about 5 seconds until the display shows the number of partial infusions 2 Without releasing the button press the button and the PC Partial Counter will appear on the display with the number of partial infusions shown in flashing numbers 3 By pressing the button
36. on Class Type BF A N Warning read instructions before use Waste separation of electric and electronic equipment Pursuant to article 13 of Legislative Decree 151 of 25 July 2005 Implementation of the Directives 2002 95 EC 2002 96 EC and e 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 follow the system which has been devised to allow for the sorted materials disposal of devices at the end of their useful lives A proper sorted collection for devices destined for recycling treating 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
37. page 28 26 MAN 01 EN 00 CRONO TWIN 05 12 SECTION 7 WARNING A Following the display of error message Er 8 and the successive initialisation the system reverts to the factory settings see page 29 if this happens the pump settings prescribed by the doctor should be re entered NOTES iS e The displayed error messages from Er 2 to Er 11 and OCCL are accompanied by a beep and the system stops e Toinitialise the device remove the battery and reinsert it after 10 15 seconds If the error is detected again after the corrective action or initialisation of the device contact the Technical Support Service 27 MAN 01 EN 00 CRONO TWIN 05 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 button An occlusion will normally only affect one of the two infusion lines the occluded line is easy to identify by looking at the syringes in the occluded line the piston will be compressed and the support rings will be more visible and more marked than those
38. quipment recurrent test and test after repair of medical electrical equipment e IEC 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 IEC 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 76 MAN 01 EN 00 CRONO TWIN 05 12 INFORMATION For further information on the CRONO TWIN pump contact Customer Support Service CANE S p A Medical Technology Via Cuorgne 42 a 10098 Rivoli Turin Italy Tel 39 011 9574872 Fax 39 011 959 8880 Internet www canespa it E mail service canespa it NOTES TI MAN 01 EN 00 CRONO TWIN 05 12 78 MAN 01 EN 00 CRONO TWIN 05 12
39. re 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 people who assist and or live with the pump user know how the pump works and are aware of 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 TWIN 05 12 SECTION 3 PUMP DESCRIPTION CRONO TWIN is an ambulatory infusion pump which uses single use reservoirs for the controlled subcutaneous administration of immunoglobulins CRONO TWIN uses specific 20 ml syringes called reservoirs Its smaller size and reduced weight make CRONO TWIN ideal for home use thus giving the patient the freedom to engage in everyday activities during the therapy The main technical feature of the pump is that it uses two 20 ml reservoirs thereby allowing 40 ml of a given drug to be administered at the same time and in equal amounts at two different infusion sites The pusher mechanism acts directly on the pistons of the reservoir allowing the pump to administer the drug accura
40. rom 0 1 ml h to 100 ml h as follows From 0 1 ml h to 1 00 ml h in increments of 0 01 ml h From 1 00 ml h to 10 ml h in increments of 0 1 ml h From 10 ml h to 100 ml h in increments of 1 ml h Procedure 1 Press the button to programme the parameter SETTING THE FLOW RATE 2 Press the button to decrease the value and the button to increase it 3 Do not press any button for 5 seconds and the setting phase will end The flashing displayed value becomes fixed and then the remaining infusion duration or flow rate is displayed NOTES SECTION 10 Al Al Al e If you keep pressing either the or the button it is possible to change the flow rate quickly 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 the device will beep several times MAN 01 EN 00 CRONO TWIN 05 12 43 SECTION 10 END OF THE 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 signal is given and the display shows End only if AL is on After a few seconds the pushers start withdrawing until they reache 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
41. sequence Page 34 Settings in OFF condition sccesesecccasencuremssasrccnedeasagueds sane Page 35 End of infusion acoustic signal Page 36 Setting the partial voIUME i Page 37 Switching on the PUMB rire ici Page 39 Priming the infusion Set tuDE n Page 39 The pump in ON COndition ccccceccseeeeeeeeeeeeeeeeeeaees Page 41 Settings in ON CONdiOl selilcalant Page 42 Setting the delivery time i Page 42 Setting the TOW TALC vs cceesicarsorassceucersacceewoncesesbiccaniincwasecsenicces Page 43 End ofthe RUS iaia Page 44 Withdrawing the pushersS Page 45 Switching off the pump i Page 46 Displaying the settiNgs iii Page 47 Visualizing parameters when the pump is in the ON condition Page 47 Resetting the number of partial infusions Page 48 SECTION 11 FRO SCION DI ail Page 49 Luer Lock Cap functions ii Page 49 PADUA S ION SOU rete A EERE ies Page 50 MUSON SE DAS ni Page 50 Preparation of the reservoirs and insertion into the pump Page 51 Insertion of the reservoirs into the pump Page 52 ISS CA RE E tweety Page 54 Preparing for the infusion Page 54 6 MAN 01 EN 00 CRONO TWIN 05 12 SECTION 12 How to use the supplied standard equipment Page
42. set and 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 40 MAN 01 EN 00 CRONO TWIN 05 12 SECTION 10 THE PUMP IN ON CONDITION When the pump is in ON the display shows the duration of the infusion in three different ways e when the delivery time is equal or greater than 100 hours the display shows a flashing letter h and the time will fall hour by hour e when the delivery time is less than 100 hours the display will show the infusion duration in hours and minutes separated by the flashing drop icon the time will count down minute by minute e if the delivery time is less than one hour the time is shown in minutes and the flashing minutes to go symbol is displayed If the pump is programmed according to flow rate by pressing the button you can move from a display of the delivery time to a display of the programmed flow rate with a flashing right arrow and showing the ml h unit of measure and back again WARNINGS Ay Before starting an infusion e Inspect the fluid path to ensure there are no folds clamps or other occlusions in the line e Expel any air bubbles 41 MAN 01 EN 00 CRONO TWIN 05 12 SECTION 10 SETTINGS IN ON CONDITION In the ON condition it is possible to set the following parameters 1 Delivery time if time mo
43. sures 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 MAN 01 EN 00 CRONO TWIN 05 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 fluid path to ensure there are no folds clamps or other occlusions in the line and expel any air bubbles The level of precision and amount of time needed to detect an occlusion could differ from 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 procedu
44. t intended and for the non observance of the instructions provided in the instruction manual The purchaser undertakes to indemnify CANE S p A from any claims by third parties with respect to the above 3 This guarantee is not valid if the model number and serial number of the product have been modified erased removed or have in any way made illegible 61 MAN 01 EN 00 CRONO TWIN 05 12 SECTION 13 4 The following are excluded from the guarantee e Periodic maintenance e Damage consequent to improper use including but not limited to Incorrect power supply Use of the product for purposes other than those for which it is designed Repairs performed by unauthorised personnel or by the Customer e Accidental and unintentional events such as liquid spills and falls e Natural events and malicious or negligent acts e The standard equipment supplied with the pump 5 CANE S p A undertakes to perform repairs on the device for a period of not more than 4 four years from the date of purchase After that period CANE S p A has no further obligations to make repairs La CANE S p A disclaims all liability either to the purchaser or to third parties for damage that occurs to persons or things as a result of the use of the device after 4 four years from the date of purchase 6 After the guarantee period is expired support will be provided by CANE S p A with the customer bearing the subsequent costs of replaced parts labo
45. t 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 memory and the pushers is not withdrawn e If the battery is removed when the pump is set to ON the pushers returns to the infusion start position to recalibrate itself and is then repositioned at the stored partial volume 38 MAN 01 EN 00 CRONO TWIN 05 12 SECTION 10 SWITCHING ON THE PUMP From the OFF state press the button The pump will give a brief beep and display e Pr priming function the display shows Pr There are three options a Postpone the priming b Skip the priming c Carry out the priming e Having carried out the priming or if the pump is turned on to resume the infusion from the StoP state the display will show the infusion duration PRIMING THE INFUSION SET TUBE The priming function lets you fill the infusion set tube with the drug contained in the reservoir The volume available for priming is 3 0 ml 1 5 ml per infusion set which may be dispensed in 1 ml fractions The priming function is enabled when you switch on the device and the pushers are 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 button 2 The display shows Pr There are three options a
46. tely One of the pump s standout features is the ability to choose between time or flow rate programming modes For a better absorption of the drug the pump administers 9 ul shots per infusion site at intervals which depend on the duration of the infusion or the flow rate chosen If the infusion duration is reduced or the programmed flow rate is increased the time interval between the shots decreases proportionally CRONO TWIN has a liquid crystal display LCD which provides the doctor and the patient with information about the settings operations and diagnostics of the pump T3 MAN 01 EN 00 CRONO TWIN 05 12 SECTION 3 TECHNICAL CHARACTERISTICS Pump dimensions Weight Battery Dedicated single use reservoir Partial volume Time mode Flow rate mode Volume of priming available Flow rate precision Occlusion pressure Shot volume Occlusion signaling time Post occlusion bolus 14 81 x 82 x 33 mm 3 18 x 3 23 x 1 31 in 158 g 5 57 oz including battery Lithium CR 123A 3V battery life of about 100 infusions with a 20 ml capacity and a Luer Lock universal security attachment May be selected from 1 to 40 ml in 1 ml increments Can be programmed from e 30 minutes to 2 hours in 5 minute increments e2 hours to 24 hours in 15 minute increments e 24 hours to 400 hours in 2 hour increments Can be programmed from e 0 1 ml h to 1 00 ml h in 0 01 ml h increments e1 00 ml h to
47. ths or more you are advised to remove the battery 23 MAN 01 EN 00 CRONO TWIN 05 12 SECTION 6 SETTINGS LOCK The CRONO TWIN 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 control all of the operational functions L1 locked in this configuration you can use the control buttons to control the operational functions but cannot modify any of the settings When the pump is set to L1 the display shows the lock indicator amp Before attempting to modify any of the settings ensure that the selected access level of the pump is LO indicator not displayed WARNINGS A e This settings access level remains in 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 and the lock indicator on the display to flash 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 TWIN 05 12 ERRORS AND ANOMALIES SECTION 7 ACOUSTIC ERROR CORRECTIVE ibiza SIGNAL DESCRIPTION ACTION Brief beep Continuous acoustic signal Beep repeated every 10 secs approx Beep repeated every 10 secs approx Beep repeated every 10 secs approx Beep repeated every 10 secs approx Beep r
48. tton for 5 seconds and the setting phase will end The displayed value stops flashing and then the OFF or StoP indication is displayed 4 By pressing the button before the OFF or StoP button Alle Ni appears while the OFF or On indication is flashing you move CC v to the next parameter SETTING THE PARTIAL VOLUME 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 e In the StoP condition after the setting for the acoustic alarm at end of infusion the display shows the current partial volume setting but does not allow it to be changed Instead Err is shown on the display if the button is pressed 36 MAN 01 EN 00 CRONO TWIN 05 12 SECTION 10 2 SETTING THE PARTIAL VOLUME The partial volume function is used when the therapy requires an infusion with a dose of less than 40 ml The partial volume can be set from 1 cc to 40 cc in increments of 1 cc You can set this parameter by pressing the button again after programming the end of infusion acoustic signal The partial volume function can only be set before the start of a new infusion either partial or complete 40 ml Proceed as follows 1 The display shows a flashing value for the volume preceded by cc which indicates the unit of volume 1cc 1ml 2 Press the button to decrease the value and the button to increase it Each change is indicated
49. ur and transport in effect 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 62 MAN 01 EN 00 CRONO TWIN 05 12 SECTION 14 DECLARATION OF CONFORMITY CE 04 6 CANE S p A with its registered offices in Via Cuorgn 42 a 10098 Rivoli Turin Italy manufacturer of the CRONO TWIN electro medical ambulatory infusion drug pump via reservoir Serial No declares that the device conforms to the essential requirements of Appendix of Directive 93 42 EEC modified by Directive 2007 47 EEC as per certificate MED 9813 provided by the Notifying Body No 0476 according to Appendix Il of the same Directive and is released to the market in compliance with the corresponding laws of the individual European member states Rivoli 08 03 2012 The Chairman Ami Cau 63 MAN 01 EN 00 CRONO TWIN 05 12 APPENDICES ICONS USED ON THE PUMP IP protection rating P 4X 1 figure protection against entrance of solids 4 protection from solid objects larger than 1 mm 2 figure protection against entrance of liquids X no protection CE marking Electro medical device Electrical classificati
50. vice 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 Ay 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 Ifthe device is not used for 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 59 MAN 01 EN 00 CRONO TWIN 05 12 SECTION 13 DISPOSAL At the end of the expected life of the pump contact the CANE 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 the appropriate containers 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 SUPPORT The device must only be repaired by CANE S p A s Customer Support Service Before sending the device you are advised to contact Customer Support Service CANE S p A Medical
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