Fresenius Pilote A2 - Frank`s Hospital Workshop
Contents
1. Electronic control anomaly Keyboard anomaly 1 ml deviation volume to be infused Date of maintenance reached FAr b Message A Technical malfunction alarm indicators Er Error message technical malfunction alarm indicators Press STOP to resume the device normal operation Er A Error message technical malfunction alarm indicators N Er AN Error message technical malfunction alarm indicators Er Error message technical malfunction alarm indicators trL message only displayed when the device is turned on Press CONFIRM to continue Warning check the device as soon as possible Note in case of malfunction alarm note the error message and stop the device by pressing the OFF key 5 10 seconds can be necessary If the alarm persists when the device is switched on again without use on patient contact the qualified technicians in your establishment or our After Sales Department The sound level can be set by rotating the shutter placed underneath the device ra NU PIL A2 TD IS 1342 rev 3 09 12 03 Performances Flow rates The values given in the table below correspond to device configuration Syringes 50 60 ml 20 ml from 0 1 to 120 0 from 50 0 to 275 0 Infusion flow rate ml h from 0 1 to 200 0 Bolus rate ml h from 50 0 to 500 0 Prime rate ml h 500 0 275 0 0 1 ml h increments Volume limit Volume limit ml from 1 to 99 92. Operations for use Installation The syringe pump can be used on mains 4 battery or external supply Particular attention should be paid to the stability of the device before it is put into use 1 Connect the power supply cord to the mains source and to the syringe pump The mains power indicator lights up Note connect device to mains as often as possible to recharge battery Syringe installation 1 Connect the extension set to the syringe according to proper practices 2 Place syringe in its cradle the flanges correctly in the provided slot 3 Turn the syringe barrel clasp into the closed position and move the syringe drive forward the syringe plunger head Syringe barrel clasp N elje Syringe flanges cradle Syringe plunger head 4 Press the ON key to turn ON the Pilot Note if C L is displayed preventive maintenance should be considered Press s to continue Programming infusion capacity brand and type semi rasna 1 Syringe brand selection syringe list given as an example 2 agre e g ADRENALIN Cr c5 lt continuous nd press Drug name selection according to device configuration P Ar 2 Prime the line 3 Connect infusion set to patient and check general installation O se e g flow rate 5 2 ml h 4 Flowrate setting ml h 5 Starting the infusion e lt Important flow rate may be programmed during infusi
3. qualified technician The qualified technicians in your establishment or our After Sales Service should be informed if the device is dropped or if any of malfunction occurs In this case the device must not be used For further information concerning the pump servicing or its use please contact our After Sales Service or our Customer service If the device has to be returned to our After Sales Department proceed to its cleaning and desinfection Then pack it very carefully if possible in its original packaging before sending it Fresenius Vial is not liable for loss or damage to the device during transport to our After Sales Department Regular inspections In order to check that the device is functioning optimally regular inspections are recommended every 12 months A regular control check consists of various inspection operations listed in the Technical manual These control checks must be performed by an experienced technician and are not covered by any contract or agreement provided by Fresenius Vial Note the pump must be checked serviced and repaired only by Fresenius Vial or by a qualified technician Failure to comply with these maintenance procedures can damage the device and lead to a functional failure NU PIL A2 TD IS 1342 rev 3 09 12 03 Quick check procedure Pilot A2 This protocol allows a quick check of the pump functionality Serial number ID N Date does
4. Use a cloth soaked in DETERGENT DISINFECTANT previously diluted with water if required to destroy micro organisms Avoid abrasive scrubbing which could scratch the casing Do not rinse or wipe surfaces Do not use TRICHLOROETHYLENE DICHLOROETHYLENE AMMONIA AMMONIUM CHLORIDE CHLORINE and AROMATIC HYDROCARBON ETHYLENE DICHLORIDE METHYLENE CHLORIDE CETONE These aggressive agents could damage the plastic parts and cause device malfunction m Take care also with ALCOHOL BASED SPRAYS 20 40 alcohol They lead to tarnishing of and small cracks in the plastic and do not provide the necessary cleaning prior to disinfection Using disinfecting applies by SPRAYS may be done in accordance with the manufacturer recommendations from a distance of 30 cm of the device avoid the accumulation of the product in liquid form Please contact the appropriate service handling suitable cleaning and disinfection products in your establishment for further details Storage The device should be stored in a dry cool place In case of prolonged storage the battery should be disconnected via the battery access flap situated underneath the device This should be done by a qualified technician u Storage temperature 10 C 60 C m Permissive relative humidity maxi 85 no condensation 10 Servicing To ensure normal performance of the device it is recommended to replace the internal battery each 3 years This should be done by a
5. Vh efault value in m none B from 50 to maxi o o m 1 name of drug PAc G drug name entry o 15 names programmable 4r e g O to accede to the o ADRENALIN or free th hanes nase next name or to Note confirm the 15 name to change the name A c leave F Ar amp configuration m disconnection detection PAr J mains disconnected o SELE O detection m no detection no 5E i m Date f 4 and d day PAr 0 date and time selection Oo time h n selection O O O fox 5 year h hour a I minute 8 NU PIL A2 TD IS 1342 rev 3 09 12 03 Operating precautions The symbol visible on the condensed instruction guide of the device recommends this Operator Guide should be completely read in accordance with the EN 60 601 1 Standard Fresenius Vial will not be liable for any damages or claims medical or otherwise of any nature whatsoever whether direct or consequential caused by improper use of this device Special attention must be paid to the stability of the Pilot Use the device in horizontal position on a table or with the I V pole accessories We recommend you partially or completely recharge the battery when you receive the device or in the case of prolonged storage so as to prevent all risk of premature discharge The device must not be used in the presence of inflammable anaesthetic agents due to the risk of explosion It should always be used away from all risk areas The
6. of guarantee Fresenius Vial guarantee that this product is free from defects in materials and workmanship excluding batteries and accessories for a period of one year from the date of invoice If you comply to benefit from the materials and workmanship guarantee from our After Sales Service or an agent authorised by Fresenius Vial the following conditions must be respected m The device must have been used according to the instructions in this Operator s Guide m The device must not have been damaged when in storage at the time of repair or show signs of improper handling m The device must not have been altered or repaired by non qualified personnel m The serial number ID N must not have been altered changed or erased In case of non respect of these conditions Fresenius Vial will prepare an estimate for repair covering the parts and labour reguired Where return and repair of a device is necessary please contact Fresenius Vial Customer or After Sales Department 14 NU PIL A2 TD IS 1342 rev 3 09 12 03 Notes NU PIL A2 TD IS 1342 rev 3 09 12 03 15 Useful addresses All requests for information or documentation technical files tubing sets catalogue or brochures must be sent to CUSTOMER SERVICE AFTER SALES SERVICE Fresenius Vial Le Grand Chemin F 38590 BREZINS France Tel 33 0 4 76 67 10 10 Fax 33 0 4 76 67 11 34 Consult our Web site www fresenius vial fr This Op
7. syringe driver line as near to the start of the catheter as possible in order to minimise the dead space and consequently the impact of any change in flow rate on the feeder line Do not use this assembly k Preferred assembly I i I i y JE s Per gy ma iji VAA Non reflux valve _ NI Wye Opening the pump or the battery cover must only be carried out by the qualified personnel in your establishment and taking all the necessary technical precautions Non respect of these procedures is dangerous to the personnel and may damage the syringe pump We recommend you follow the maintenance procedures defined in the technical maintenance manual To obtain a copy of the technical maintenance manual please contact our After Sales Department or our Commercial Department specifying the identification number of the device Maintenance Cleaning and disinfection The Pilot is part of the patient s immediate environment It is advisable to clean and disinfect the device s external surfaces on a daily basis in order to protect patient and staff Disconnect the device from its mains supply before starting to clean m Do not place in an AUTOCLAVE nor IMMERSE the device Do not let liquids enter the device s casing m If the device is placed in a high contamination risk unit it is advisable to leave it in the room during aerial disinfection after having disinfected it with a moist cloth m
8. 50 60 Hz 110 V on request Installation with 2 POWER FIX 2 1 POWER LINK 1 ROLLING STAND 180 cat 073070 NU PIL A2 TD IS 1342 rev 3 09 12 03 Power Link cat 073430 To connect a POWER FIX 2 to a POWER FIX 2 or 4 together ek IDEA s sr a Disposable SE 2400Y 2 channel Sterile catheter extension set in PVC FAN M w dah JU w Injectomat Line PVC 150 cm Extension line for infusion 1B San Injectomat Line PE 200 orange Opaque extension line for infusion of light sensitive drugs or for drugs not compatible with PVC C S I SE 1500 AR 1 channel Sterile catheter extension set in PVC with Y connector equipped with one way valve Ue i ID o SE 1600 AR AS 1 channel Sterile catheter extension set in PVC with anti siphon valve and Y connector eguipped with one way valve Cte lij O Note that the expiry date is written on the packaging set can be used for 5 years from the manufacturing date also written on the peel open pouch All sets are designed and controlled by Fresenius in order to guarantee the performances and the safety features of our pumps The manufacturing is done by Fresenius CE0123 CE0459 or by its qualified subcontractors CE0123 CE0318 for and on behalf of Fresenius in exclusive distribution The CE certificates are available on request 13 Conditions
9. OPERATOR S GUIDE Syringe pump PILOT A2 Introduction The Pilot A2 has been designed and manufactured with the greatest care It introduces a new concept of control with easy reading of alarms and safety features The configuration flexibility of the Pilot A2 provides overall improvement in the working conditions of medical teams thus increasing patient safety A choice of easily accessible configurations ensures optimum use of functions according to the needs of each department The use of this material requires great care The user must be able to handle the instrument properly and must know how to fully operate Please read the operator s guide carefully before putting the device into use A company of Fresenius Kabi Table of contents Operations for USE ee nana 2 Internal safety features e ee 3 PetlOrMmANCES is alinei Preje ista 5 Technical characteristics ee ee 6 CONPIQUIATION S isss saae sni nn nun nu ile 8 Operating precautions e nana 9 Maintenance nana renen 10 External power SOUFCE anannnennennea 12 Operation with the internal battery 12 Accessori85S asan nnnnannnnnnnannnnnna ennen 13 Disposable lt 22icsccc8 ch cece ine kn ki ida ni 13 Conditions of guarantee nee 14 Useful addresses a ere 16 V Fresenius Vial Infusion Technology
10. Recharging the battery To recharge battery just connect the Pilot to a mains power supply Recharging of the battery is visualised by the mains indicator GL Battery life indicator While the pump is running on battery battery life may be displayed Battery life displayed takes care of the current flow rate g bAt 4h58 autonomy in h min Note use charging mode for a complete battery life indicator when device is turned off Charging mode It includes total duration of charging battery when device is not used 1 Remove syringe and press CHAr continuous press 2 Charging mode activation G Note to leave the charging mode press d continuous press NU PIL A2 TD IS 1342 rev 3 09 12 03 Accessories Fresenius Vial recommends the use of Pilot range accessories Transfix cat 073416 Composed of transport handle cat 073419 and the multi purpose clamp cat 073418 this system enables rapid fixation to a horizontal rail or vertical support decreases loss of space and provides perfect stability Transport Handle cat 073419 Multi purpose clamp cat 073418 RS 232 cord Cat 073413 9m 9f Cat 073414 9m 25 Battery supply cable cat 073415 Power Fix 2 cat 073428 Power Fix 4 cat 073429 1 power cord only to connect 2 or 4 Pilot to mains Power Fix 2 and 4 includes mounting clamps for I V pole CE marking complies with EN 60 601 1 230 V
11. ameters mode press then simultaneously g o Pdr appears on display Press aj within 2 seconds to confirm start of configuration Note press 2 to cancel modification at any time Press to leave configuration mode at any time Configuration mode Confirm Choice Configuration available on start up Display Press to select sce m last selection in ml hr PAc I flow rate memorizing Oo a nen fox m default value 00 0 ml hr noe i m automatic confirmation PAr 2 syringe selection type oJ a SELI Pod m manual scrolling m for 50 ml syringe types PAr 3 max flow rate selectable oe elas max flow rate O 0 0 od for 20 ml syringe types 50cc 9 PAc 4 selectable syringes Oo 1st syringe brand 50 ml capacity ox m selectable SEL O O not selectable syringe list given as an example selection for all syringe list ROGE riming compulsor PA 5 confirming compulsory O P 9 p y Puri prime after syringe confirming m priming not compulsory m KVO rate no KVO rate PAr 1 KVO rate 7 m empty syringe mode PAc A empty syringe mode i m no empty syringe mode m from 1 to 9999 hours of Beate continuous use 1230 ex 1230h from 1 to 9999 O O m drug name selection PA b frequency of maintenance PA C drug name m No selection m syringe flanges detection S 8 8 8 6 8 PA d syringe flanges no detection last selection in ml h 8 8 8 8 Q Q PA F bolus rate memorizing default value i
12. d higher than the injection site please pay attention to correctly secure the syringe and manipulate the syringe only when the extension set is clamped or disconnected from patient side High depression may create syringe siphoning In this situation you must check the integrity if the syringe used possible leakage and if necessary insert anti siphon valves Pressure variation may generate flow discontinuity mainly noticeable at low flow rates and depending of the infusion system characteristics such as friction force stickiness compliance of syringes and mechanical back lash Anti siphon valves will also eliminate any risk of free flow during syringe changes An air leakage in a syringe with a line not equipped with an anti siphon valve may generate an uncontrolled flow delivery Do not use in conjunction with positive pressure infusion devices that could generate back pressure higher than 2 000 Hpa susceptible to damage infusion disposable and the device Fresenius Vial recommends the use of one way valves or positive pressure infusion devices for multi line infusions If there is no one way valve on a gravity infusion line during a multi line infusion this will make it impossible to detect occlusions on the patient side and could result in accumulation of the drug being infused in the gravity line which could later be infused in an uncontrolled manner when the occlusion is released Place the connection between the feeder line and the
13. erator s Guide may contain inaccuracies or typographical errors Modifications may thus be made and will be included in later editions As standards and equipment change from time to time the features shown and described in this document must be confirmed by our departments This Operator s Guide may not be reproduced in whole or in part without the written consent of Fresenius Vial Fresenius Vial si ge social Le Grand Chemin F 38590 BREZINS FRANCE Fresenius v Fresenius Vial Kabi Infusion Technology
14. has Department NAM sivina iii 1 Check the state of the device absence of impact marks and noises turn upside down the device presence of all labels as well as their legibility 2 Press ON power supply lead not connected the indicator illuminates 3 Check the condition of the power lead and connect the device to the mains source the mains AE indicator illuminates YES O NO O 4 Install a syringe Auto control mode press simultaneously on S and 9 keys r C L t if Indicator light test 1 Press 9 to start the test 2 Check the presence of all luminous indicators and press o YES O NO O 3 Select OKAY comply ra no comply or Et 1 return by pressing O V and confirm o Cc r L t e Alarms test 1 Press aj to start the test ALAR appears on display 2 The DISENGAGED MECHANISM and ANTI SIPHON indicators flash Disengage pusher block constant indicators light up The confirm signal flashes press 3 The SYRINGE BARREL CLASP and HIGH flash Position the syringe barrel clasp on upper position constant indicator and HIGH light up The confirm signal flashes press 4 The flashing display indicates CZ Turn the syringe barrel clasp into the closed position and check the detected capacity by the device The confirm signal flashes press 5 The SYRINGE BARREL CLASP and La flash Remove the syringe and position the syringe barrel clasp on lower position YES O NO O constant indicator a
15. ime versus infusion flow rate These values are representative of syringes used during trials with an Pilot A2 and serve as an indication only of the pump s overall performance Threshold values Flowrate lower middle ee upper eee Syringe 1 ml h 40 60 120 50 60 ml 5 ml h 8 12 20 120 ml h 25 35 50 Syringe used B D Plastipak Luer Lok B D Plastipak and Luer Lok are registered trademarks of Becton Dickinson Bolus volume on occlusion release Threshold value lower middle ee upper 000 50 60 ml syringe lt 0 2 ml lt 0 4 ml lt 0 8 ml 20 ml syringe lt 0 2 ml lt 0 4 ml lt 0 8 ml Note wait until the Alarm occlusion flashing indicators turns on indicating the bolus has been reduced Technical characteristics Mains supply Mains supply Maxi consumption Maxi power consumption Internal protective fuse 230 V 50 60 Hz 110V on request 100mA 23 VA T 100 mA 250V IEC 127 External supply External supply 9 Battery Characteristics Autonomy Battery recharging Compliance 12 to 15 Volts Continuous voltage Power gt 15 Watts 6 V 1 1 1 3 Ah Sealed lead rechargeable min 7 h av at 5 ml hr Partial 70 of capacity 8 hours Total 100 of capacity 16 hours Compliance with EN 60 601 1 and EN 60 601 2 24 CE0454 IP34 CE 0459 marking in compliance with EEC 93 42 Medical Device Directive Protection against ingre
16. irm gt 15 seconds no syringe selection gt 1 min Pressing an unauthorised key Programmed end of pause Message ex Battery alarm prealarm indicators izi e Battery alarm alarm indicators Note memorisation of programmed parameters 10 min Connect device to mains bAt messsage displayed Press g to acknoledge this warning lt H Prealarm end of infusion indicators Note to use Empty syringe mode press CONFIRM key s lt H Alarm end of infusion indicators Note to use Empty syringe mode press CONFIRM key lt H Prealarm end of infusion indicators Prealarm flashing ml indicators Alarm KVO ml indicators 6 Flashing alarm P occlusion indicators lt H Alarm syringe barrel clasp indicators e lt Alarm plunger head position indicators e lt j Alarm disengaged mechanism indicators Flashing confirm indicator Flashing confirm signal flashing capacity and brand syringe indicators Audible signal only Alternating displays of flow rate value and 5 GP Checks Malfunction alarm Error message Er G i Error messages r 0 14 20 24 30 34 40 44 50 38 Error message r 88 Error messages E 32 52 120 Be Preventive maintenance warning Infusion Stop YES YES YES YES YES NO Silence alarm g YES YES YES NO YES Activation Device cannot check the infusion Motor rotation control anomaly
17. maximum variance of the Syringe Syringe Pump combination The test protocol used to obtain these results is described in the EN 60 601 2 24 For further information please refer to this publication This graph is therefore representative of syringes used during trials and serve as an indication only of the pump s overall performance Please contact our After Sales Department for the others curves 10 10 10 10 Flew rate 1 ml hr Flew rate 5 ml hr Flew rate 20 mi hr Pilet real time eutput frem start up Flew rate setting maximum allewable maximum allewable maximum allewable max variance max mim min variance 3 k flewrate mi hr BhowKLOL NORA wHhdowsornwan minimum allewable minimum allewable minimum allewable variance frem neminal flewrate dk amp bsosnwrn 3 5 variance frem neminal flewrate variance frem neminal flewrate a 2 5 11 18 31 2 11 18 31 2 5 11 19 31 20 48 se se 100 128 ebservatien windews mn ebservatien windews mn ebservatien windews mn time mn Syringes used B D Plastipak 50 ml Luer Lok NU PIL A2 TD IS 1342 rev 3 09 12 03 me oe Configuration Fresenius Vial recommends the presence of its qualified personnel or of a member of the Technical Department of your establishment to help you implement the configuration procedures you wish to choose Moving to configuration of the various par
18. ml 0 1 ml increment from 100 to 999 ml 1 ml increment KVO rate Keep Vein Open 1 ml h or flow rate originally selected if this is less than 1 ml h Accuracy Flow rate accuracy 3 with pre programmed syringes Device accuracy 1 Syringe accuracy 2 Pause duration From 1 minute to 9 hours 59 minutes 1 min increments Syringe type list The Pilot A2 recognises the size of the installed syringe The last syringe brand used is proposed when the device is turned on Brands and types 50 60 ml 20 ml B D PLASTIPAK El FRESENIUS INJECTOMAT E BRAUN OMNIFIX E E BRAUN PERFUSOR E a PIC INDOLOR a TERUMO E E Different syringe lists are available For further information please contact our Customer Service Fresenius Vial cannot accept any responsibility for errors in flow due to modifications of the specifications of the syringes introduced by the manufacturer NU PIL A2 TD IS 1342 rev 3 09 12 03 Display of the name of the drug According to configuration PA It is possible to display periodically during infusion the name of the drug used 15 names of drugs may be programmed by configuration F Ar amp Pressure limit Pilot A2 proposes a choice of 3 occlusion alarm thresholds Syringes 50 60 ml 20 ml Threshold value lower 300 600 mmHg middle ee 500 1000 upper eee 900 1700 Values given for B D Plastipak Luer Lok syringes Note 1 bar 750 mmHg 1000 hPa Occlusion alarm response t
19. nd L H light up The confirm signal flashes press 6 Select GAY or Ctr 2 return by pressing O O and confirm o C C L t 3 Pusher block advance test 1 Press 9 start the test 2 Install a 50 or 20 ml syringe filled at 7 cc 3 Select syringe O O and start the test aj run appears on displays The end of the test is signalled by message te and 5 ze volume infused for 50 and 20 ml syringe check the advance of syringe plunger 5 cc 0 5 cc 4 Select OKAY no or Cte Z return by pressing O O and confirm o 5 After the validation of SKA the message Ere indicates the end of the auto control test 6 Press od to restart device on normal mode YES O NO O Visa All control result comply YES O NO O NU PIL A2 TD IS 1342 rev 3 09 12 03 11 12 15 V power source A socket positioned on the rear panel makes it possible to use a 12 15 V 15 W supply in rescue vehicles Operation from the external power can be recognised by the mains indicator E The battery automatically recharges 12 Operation with the internal battery The Pilot contains an internal battery which automatically takes over when the mains supply is disconnected and ensures normal function with no loss of the programmed data When mains is disconnected the bAt message is displayed and a warning signal is turned on Press g to acknowledge this warning Operation from the battery can be recognised by the battery indicator ii
20. ol feature activates an alarm at 1 ml over infusion or 20 rate deviation After Sales Department should always be notified of any abnormal function where no specific cause can be found whichever is shortest Note the battery automatically takes over when the mains supply is disconnected Prealarms and alarms With visual and audible signal Checks Battery Mains Infusion Volume limit Pressure Syringe installed Others alarms Infusion Silence alarm Stop w Prealarm NO YES Alarm YES YES 2 min Disconnection NO YES End of infusion prealarm NO YES End of infusion alarm YES YES Empty syringe YES YES Prealarm NO YES Alarm KVO rate YES 2 min Occlusion alarm YES YES 2 min Syringe barrel clasp YES YES 2 min Syringe flanges insertion Plunger head position YES YES Anti siphon systems Disengaged mechanism YES YES Unconfirmed program or NO flow rate 00 0 ml hr No syringe selection YES YES Key disabled NO NO Programmed end of YES NO pause NU PIL A2 TD IS 1342 rev 3 09 12 03 Activation low battery discharged battery mains disconnected 5 minutes before end of infusion alarm or 10 of total syringe capacity Syringe empty theory Total syringe empty 5 minutes before the volume limit alarm or 10 of syringe capacity Volume limit reached Programmed limit reached Syringe incorrectly positioned Syringe incorrectly positioned Drive systems not engaged No conf
21. on and must be confirmed within 15 seconds following the change Proceed as described above to change the syringe Infused volume Consulting the infused volume g MA P CE con continuous press Erasing the infused volume Volume limit Programming a volume limit ml od 2 3 ITT 9 double press gt g double press Erasing programmed volume limit ge g g gt continuous press Programmed volume limit recall Bolus function Administering a bolus ml 8 bot 9 continuous press Changing bolus rate ml h 0 continuous press STOP and Pause Stop sound warning after one roy minute To resume infusion e Pause duration selection from 1 min to 9 hrs 59 min 225860 Le press 20 Ending Pause and resuming infusion Occlusion alarm threshold setting 3 occlusion pressure limits available Selection is adjusted manually by a safety located on the rear of the syringe drive gt Upper limit D ee ee dp Lower limit Middle limit eco OFF To turn off the Pilot 2 O press for more than 2 seconds NU PIL A2 TD IS 1342 rev 3 09 12 03 Internal safety features The Pilot device have a continuous inspection system which functions as soon as the pump is in use Nevertheless the qualified personnel in your establishment or our In case of single fault condition an alarm is activated within the limit of 5 rate deviation In addition a secondary contr
22. r Sales Department Only use Luer Lock three part syringes from the list of pre programmed brands If a syringe is used which does not correspond to the syringe list on the device the specified precision level cannot be guaranteed Use only sterile catheter extensions which can resist pressures of up to 2000 HPa The use of unscrewable extension lines or syringes may result in spillage if infusions are carried out at high flow rates and or high pressure Infusion line set up must be done in accordance with local standard operating procedures and good clinical practice Fresenius Vial recommends the use of the Luer Lock type infusion lines proposed in page 13 NU PIL A2 TD IS 1342 rev 3 09 12 03 Standard precaution should be taken to prevent contamination or injuries while discarding the associate disposable e g syringes extension sets needles etc The device is designed to infuse any medical substance that can be injected The physiological effects of medicine can be influenced by the characteristics of the device and disposable syringe Check that they are compatible with prescriptions the characteristics of trumpet curves and occlusion alarm setting times in relation to the programmed flow rate While in use negative pressure variation may occur in the syringe by the relative height from the device to the injection site or by combined infusion devices such as blood pump alternative clamp etc When the device is place
23. recommended temperature for normal use of the device is between 10 and 40 C The device may only be connected to the mains with the power cord supplied by the manufacturer Check that the supply voltage corresponds with the value indicated on the label placed underneath the device Fuses should be replaced by equivalent parts Refer to the part list of the technical manual for full specification Do not exceed the permitted voltage whether the supply is from the mains an external source or via the different external connections DC adapter should not be used Only external battery like vehicle battery can be attached to drive the pump from external power Fresenius Vial recommend the used of the external power source cable for Pilot To preserve the environment remove the battery from the device prior to destruction or at the end of the device life and as during normal maintenance replacement return it to a competent recycling organisation Proceed in the same way for the device itself electronic boards plastics Avoid short circuit and excessive temperature This device can be disturbed by a large electromagnetic fields external electrical influences and electrostatic discharges above the limits stipulated by EN 60 601 1 2 and EN 60 601 2 24 It can also be disturbed by pressure or pressure variations mechanical shocks heat ignition sources etc If you wish to use the device in special conditions please contact our Afte
24. ss of liquid Protection against leakage current Type CF equipment Protection against electrical shocks Class Il equipment Device materials Casing Drive Syringe barrel clasp Polycarbonate Polyester alloy shock resistant Programming keyboard Polyester labels Dimensions Height Width Depth Weight Weight 120 x 330 x 155 mm approx 2 2 Kg Indicators lights Mains power operation Battery power operation Confirm signal Infusion in progress Prealarm Alarm KVO Programmed volume limit or infused volume Flow rate On hold duration Display Syringe list available example Occlusion Syringe barrel clasp Syringe flanges insertion Plunger head position anti siphon system Disengaged mechanism End of infusion Battery alarm Technical malfunction KVO mi a sli lt a constant yellow constant green flashing green flashing green flashing orange flashing red flashing red constant or flashing green constant or flashing green constant or flashing green 3 green digits tens units 1 orange digit decimals Capacity ml constant or flashing green brand and type constant or flashing green flashing red flashing red flashing red flashing red flashing orange flashing red constant red NU PIL A2 TD IS 1342 rev 3 09 12 03 Trumpet curves Trumpet curves demonstrate the evolution of the minimum and
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