Alaris IVAC PCAM - Frank`s Hospital Workshop
Contents
1. RESP ALARM PUMP PRINTER 25 PIN PIN 9 TXD1 PIN 3 RX PIN 4 PWR1 PIN 5 CTS PINS GND PIN7 GND PIN 8 CTS1 mms PIN 20 DTR GND PWR1 TXD2 RXD2 AIM IN 5 4 3 2 NC NC CTS1 TXD1 1000DF00135 Iss 5 28 32 Trumpet Curves amp Start up Curves In this pump as with all infusion systems the action of the pumping mechanism and variations in individual syringes cause short term fluctuations in rate accuracy The following curves show typical performance of the system in two ways 1 the delay in onset of fluid flow when infusion commences start up curves and 2 the accuracy of fluid delivery over various time periods is measured trumpet curves The start up curves represent continuous flow versus operating time from the start of the infusion They exhibit the delay in onset of delivery due to mechanical compliance and provide a visual representation of uniformity Trumpet curves are derived from the second hour of this data Tests performed per IEC EN60601 2 24 standard Trumpet curves are named for their characteristic shape They display discrete data averaged over particular time periods or observation windows not continuous data versus operating time Over long observation windows short term fluctuations have little effect on accuracy as represented by the flat part of the curve As the observation window is reduced short term fluctuations have greater effects as represented by the mouth of the2. chirp alarm during use on battery near end NO no chirp alarm 8 Continuous infusions YES Continuous infusions option in protocols NO Continuous infusions are not available 9 Loading doses YES Loading dose option appears in protocols To activate this option NEW PATIENT is confirmed The protocol also includes the loading dose Start the PCA NO Loading doses are not available 10 Max dose limits YES Dose limit option appears in protocols NO Dose limits are not available 11 Variable dose rates YES Allows the dose rate to be varied when modifying the protocol Dose rate can be either STAT rate 100ml h max or the dose can be delivered over a period of time from 1 to 60 minutes NO Each dose will be delivered at the STAT rate and there is no option to change when modifying the protocol Use buttons to set pump identity between 000 and 127 for use with remote communications 13 Comms enabled YES RS232 Communications enabled ERN or RN 14 Nurse call YES Nurse call connector enabled e il 15 Nurse call inverted YES Nurse call inverted enabled i NN 1000DF00135 Iss 5 17 32 Configured Options Continued General Options continued 16 Continuous Print YES Allows printing of events as they happen NO Continuous printing disabled 17 Default Syringe Use buttons to select the default syringe brand 18 Lock syringe type YES Syringe type locked to default s
3. 5 13 32 Basic Features Continued Event Log Record of events since NEW PATIENT selected Including protocol selection and changes patient demands etc The event log will also record all alarms All events are recorded against date clock and total drug infused 1 To access the Event Log press the W button four times 01 11 97 EVENT LOG TOTAL COVER CLOSED 50ml BD Plastipak 2 Toreturn to the previous screen press the BACK softkey PCAM START GOOD DEMAND BAD DEMAND 3 To return to the Protocol Summary press the W button again A printer fitted with a serial interface or cable with parallel to serial converter can be connected to the pump either during normal PCA operation or following use Printing patient history provides a permanent record and can be used for analysis away from the bedside All patient history including protocols and the 24 hour demand pattern and drug dose administered graphs are available for printing When connected to the printer the pump can also be configured to provide line by line continuous printing of all events patient demands etc as they occur at the bedside See General Options IPint Connect Printer then Information printed Protocol Summary Turn LOCK 1 to SET position All protocol information will be printed with patient Press button header Patient History amp button All protocol information demand and drug totals 24 hour graphs and records will be pr
4. Only use the size and type of syringe specified on the pump display The full list of permitted syringe models is dependent on the software version of the pump Syringe Range Syringe Type UNIVERSAL fvace __ v v Pp dB Plastipak Y v v o esraunomifx v v v oo fem MEN v v J ERA sota eee AE BDWelwde v v v o Precise Y o ehamaset j i CI A EE 3 FreseniusInjectomat_ Lei o Monoject 7 Y PO Reo __ v vx J _ SSS ie e SS Ss SS BRAUNPERFUSOR BBrunPerfusor Jq Y cc neue igo ee eee anpor ao d j d Y TYCO Healthcare KENDALL MONOJECT WR lt 1000DF00135 Iss 5 23 32 Compatible Extension Sets The pump uses standard single use disposable extension sets and syringes with Luer lock connectors The user is responsible for verifying the suitability of a product used if it is not recommended by Cardinal Health Standard Sets G40015 Standard PVC Syringe Extension Set 150 cm Priming Volume 2 6ml G40020B Standard PVC Syringe Extension Set 200 cm Priming Volume 1 5ml G402EP Extension set luer lock connectors Kink resistant DEHP free PVC yellow striped tubing Bore 1mm Length 200cm Priming volume 1 6ml Light Protected Sets G40215 Amber Polyethylene Syringe Extension Set 150 cm Priming Volume 1 2ml G40320 White PVC Syringe Extension Set 200 cm Priming
5. or over 1 to 180 minutes delivery period Modify PCA Protocol in SET mode When option to disable MODIFY PROTOCOL has been selected BATTERY OPERATION 6 hours operation from a fully charged battery at 5 0ml h and 20 C under normal conditions BATTERY TYPE AND RECHARGE TIME Rechargeable sealed lead acid type 10 hours from discharge to 80 charge 24 hours from discharge to 100 charge EVENT HISTORY 2000 events rolling memory MEMORY RETENTION All calibration and set up information will be retained in the pump memory for a minimum of 3 years BOLUS VOLUME ACCURACY The following table provides an indication ofthe accuracy with which a bolus infusion will be delivered Test carried out as specified in IEC EN60601 2 24 Max No of Positive Samples 25 Bolus Volume Papes pep pos 22 32 Occlusion Pressure Limits The following tables show the worst case values for line pressure time to alarm and bolus volume that can be expected in the event of an occlusion when the IVAC 50ml syringe and G40020B extension set are selected Rate Maximum Time to Nominal Occlusion Maximum Infusion Maximum Bolus Alarm Level occlusion alarm Alarm Pressure Pressure Volume ml h min sec ml 1 i i Un W N o oj jo ju o hN oljojojojo jol lo Un WIN ul un Du win EN M p M o Compatible Syringes The pump is calibrated and labelled for use with single use disposable Luer lock syringes
6. syringe could adversely affect the accuracy of the infusion and the performance of the pump When initially loading the syringe allow for the volume of fluid contained in the extension set and retained in the syringe at the end of infusion as this dead space will not be infused Place the pump on a stable horizontal surface or secure as described above Prepare load and prime the single use disposable syringe and extension set using standard aseptic techniques 1 Squeeze the finger grips on the plunger holder and slide the mechanism to the left Lift the syringe clamp and rotate clockwise 2 Insert the syringe into the slots on the plunger holder 3 Squeeze the finger grips on the plunger holder and slide the mechanism to the right until the syringe finger flanges locates in the V slot Gently advance the syringe until the finger flanges touch the front of the V slot closest to the syringe clamp This is important to prevent delay at the start of the infusion 4 Rotate the syringe clamp anticlockwise until it locks onto the syringe barrel to secure the syringe 5 Check that the syringe plunger and finger flanges are correctly located in their slots rl mq cel fe Changing a Syringe during an infusion When changing the syringe LOCK 1 should remain in the RUN position except when a change is required to the protocol Press the P3 button to halt the infusion and place the pump on
7. N N N wwe A BRAUN PERFUSOR TC wa C Hospital Name Serial No Software Version Approved by Configured by Date Date 1000DF00135 Iss 5 20 32 Drugs and Protocols Record a1Dq Kq paaoiddy 9 Dg Kq parnbijuo UOIS49 SADMIJOS 4aquinyw DIAS 9poyw O op p p pj SET Fis bi A A ee AA IND EA UC HUN i JOE A A ee parruan ANA e ie e a cdi i ore Jequunu 02030Jd dn jas 1 npJjag 0203014 pupyy 1uaunabdog uonngnsu D3idsoH 11666 U00 bul666 brio yu xeu LUNWIXEIN W66 WO O 6w6 66 Brio asog Buipeo uinuuelw u use u uoo y 6wo 666 y Bro snonunuo WNWIXE N 146 66 U070 6w6 66 Brio 3509 Yd WNWIXEIN W6 66 W0 0 Bw 6 66 Brio soq Yd WUNWIUIN EN i iile EL ia ae uonegus uo Iu B6Ww666 ju orl jur buie ee ju brl Brig winuwixeyy uonenue2uo5 Bnig WUNWIUIN s1912e1eup ZL owen brug s 1u17 Ajajos pub saupu nig 5 bri vay E Br Lu 6W6 66 wy6r sp40224 ANOKA 103 uoipui0jJui 2112ads duind ay 423103 p402ey s 0 030Jd pue s niq 21 32 1000DF00135 Iss 5 Specifications CONCENTRATION RANGE 1ug ml 999ug ml in 1ug ml steps 1 0mg ml 99 9mg ml in 0 1mg ml steps VOLUME MODE Concentration can also be set OFF in which case no mass data is displayed PCA DOSE RANGE Mass Mode O 0ug 99 9ug in 1pg steps 1mg 99 9mg in 0 1mg steps Volume Mode PCA DELIVERY RATE 100ml h max STAT rate for 30ml 50ml and 100ml syrin
8. and the pump to be configured is set to learn mode using the access codes listed in the Technical Service Manual The pump in learn mode will display PASS or FAIL for each information set being received from the teach mode device The pumps must run through at least one complete sequence of the information sets and then switch off first the learn pump and then the teach pump After using this method it is the user s responsibility to check that the configuration has been copied over correctly 1000DF00135 Iss 5 14 32 Basic Features Continued Pre Set PCA Protocols Operation of the pump is greatly simplified by the use of PRE SET PCA protocols When LOCK 1 is turned to the SET position the pump will automatically display pre set PROTOCOL A if NEW PATIENT has been selected or display the previous protocol in use if NEW PATIENT has not been selected With LOCK 1 in the SET position itis possible for the user to modify the pre set protocol using the MODIFY PROTOCOL button and select another pre set protocol using the NEXT PROTOCOL button To modify a Pre Set Protocol PROTOCOL lh Press MODIFY PROTOCOL indicated on the screen un 2 The protocol summary will be displayed Use buttons to PCA Dose Lockout Continuous Loading highlight a field press ALTER to enter that field and buttons to select desired values MAX 50 0ml MODIFY NEXT IN 4h PROTOCOL PROTOCOL 3 When field is correct press CONFIRM or CANCE
9. of service for examination by a qualified service engineer All preventative and corrective maintenance and all such activities shall be performed at a compliant work place in accordance with the information supplied Cardinal Health will not be responsible should any of these actions be performed outside the instructions or information supplied by Cardinal Health Refer to the Technical Service Manual for the access code for technical service features Interval Routine Maintenance Procedure As per Hospital Policy Thoroughly clean external surfaces of the pump before and after prolonged period of storage Atleast once per year 1 Inspect AC power supply plug and cable for damage Refer to TSM for 2 Perform functional tests as outlined in the Technical Service Manual identification of parts 3 Operate the pump on battery power until the battery low alarm then charge the battery to confirm battery operation and charging Please refer to Technical Service Manual for calibration procedures The units of measurement used in the calibration procedure are standard SI The International System of Units units Replacing the AC Fuses If the pump continually illuminates the battery symbol and the AC power indicator light does not illuminate when the pump is connected to the AC power supply and switched ON either the power supply fuse in the AC plug if fitted or the internal fuses have blown First check the power supply fuse in
10. the AC mains plug if fitted If the AC power indicator light does not illuminate remove the pump from service It is recommended that only a qualified service engineer replaces the AC fuses For further information regarding the replacement of internal AC fuses refer to the Technical Service Manual If the fuses continue to blow suspect an electrical fault and have the pump and power supply checked out by a qualified service engineer Battery Operation The internal rechargeable battery allows continued operation when the AC power is unavailable for example during patient transfer or AC power failure A fully charged battery will provide over 6 hours of operation at typical infusion rates From the battery low alarm it will take about 24 hours to fully recharge when reconnected to the AC power supply whether the pump is in use or not The battery is maintenance free sealed lead acid type and requires no routine servicing However to achieve optimum operation ensure that the battery is fully recharged after full discharge before storage and at regular 3 month intervals during storage Cardinal Health recommend verification that the pump operates on battery power once the pump has been removed from the AC power supply refer to Starting the Pump section Charge retention will eventually degrade Where retention is critical the internal battery should be replaced every 3 years It is recommended that only a qualified service engineer
11. www cardinalhealth com alaris ZA Cardinal Health Unit 2 Oude Molen Business Park Oude Molen Road Ndabeni Cape Town 7405 South Africa Tel 27 0 860 597 572 Tel 27 21 510 7562 Fax 27 21 5107567 www cardinalhealth com za ey Cal SA Technical Support cardinal com Document History Revision CO Number 1 6921 2 7751 3 8700 4 8853 5 9116 Date July 06 July 07 July 08 October 08 January 09 1000DF00135 Iss 5 30 32 Spare Parts A comprehensive list of spare parts for this pump is included within the Technical Service Manual The Technical Service Manual 1000SM00017 is now available in electronic format on the World Wide Web at www cardinalhealth com alaris A username and password are required to access our manuals Please contact local customer services representative to obtain login details Cardinal Health Alaris Products Cardinal Health warrants that A Each new infusion instrument pump controller or peripheral instrument is free from defects in material and workmanship under normal use and service for a period of two 2 years from the date of delivery by Cardinal Health to the original purchaser B Each new accessory is free from defects in material and workmanship under normal use and service for a period of ninety 90 days from the date of delivery by Cardinal Health to the original purchaser C Each Mains Cable Battery Flow Sensor ECD and non disposable probe is fre
12. 0 E A mumrrmmsomsc rmt E AR rear A TTT i E E 5 O sa III E 15 E 0 10 20 30 0 10 20 30 Observation Window mins Observation Window mins Trumpet Curve 5 0 ml h Trumpet Curve 5 0 ml h 15 15 10 O A O rtm mmsrmsc rmt 10 THIRD Bc Nb e Bo Mice c c d 3 Oli TTT i hx I er B Meise de A A a TT a nOD A A E EE E er EE dde ed 15 5 0 10 20 30 0 10 20 30 Observation Window mins Observation Window mins Performance with syringes BD Plastipak B Braun Omnifix Monoject Once 2 Performance with syringes IVAC Zeneca Terumo Nipro Fresenius B Braun minute minimum maximum 5 5 0ml h Long term mean accuracy 2 Perfusor amp JMS 2 minute minimum maximum 7 5 5 0ml h Long term is in addition to the trumpet curve percentage error mean accuracy 2 is in addition to the trumpet curve percentage error Evaluation over the range 100mmHg to 100mmHg equivalent to water height 1 3m will produce trumpet curves with the limits shown above 1000DF00135 Iss 5 29 32 Service Contacts For service contact your local Affiliate Office or Distributor AE Cardinal Health PO Box 5527 Dubai United Arab Emirates Tel 971 4 28 22 842 Fax 971 4 28 22 914 www cardinalhealth com international distributors alaris AU Cardinal Health 3 167 Prospect Highway PO Box 355 Seven Hills NSW 2147 Australia Tel 61 2 9838 0255 Fax 61 2 9674 4444 www cardin
13. IN 4h STAT OK CONFIRM SYRINGE DEMANDS TOTAL GOOD SYRINGE NAME CHANGE TYPE DRUG INFUSED START TO BEGIN PCA DEMANDS DRUG INFUSED TOTAL o 0 ug GOOD 0 0 0 mi SYRINGE NAME SIZE PROTOCOL 11 32 Basic Features The button allows the delivery of a limited volume of fluid in order to purge the extension set prior to being connected to a patient 1 PURGE can only be operated with the cover opened and LOCK 1 in the RUN position 2 Press the buttons together until fluid flows and priming of the syringe extension set is complete The audible alarm will operate during use of the buttons and the volume used during priming will be shown in the volume infused display PURGING 100ml h 0 0ml The PURGE feature is not activated when the cover is closed Ensure that the extension set is disconnected from the patient before purging the line No alarms are disabled during the operation of the PURGE feature During PURGE the pressure limit alarms are temporarily increased to their maximum level 4 Clinician Over ride The clinician over ride feature can be used in RUN mode to administer an additional bolus dose or continuous background infusion of a limited dose and duration for example during the PCA lock out period The clinician over ride is a special feature which can be configured according to the specific clinical situation Clinician over ride can also be used in SET mode to allow modification of the pre set PCA Pr
14. IVACPCAM Syringe Pump Directions For Use English CardinalHealth Page o Introduction 2 AboutThisManual suini 2 o Features OF CHE edt a e REID 3 o Controls amp INdicators rssruisiinirinionziva 4 e Symbol PIDE OD TEASE TTE TD LI m 5 e Main Display Features 6 e Operating Precautions ccccssscsssscssscsscssscsscscsssssssssssssscscssssssssesssssscsssssscsesssssscssssssscsosssssessoosees 7 e ulcer 9 e AAA PO 12 e A ATTE IIS LLL LICET DIETE 16 e inier 17 e Drugs and Protocol Record 4 e eeeeeeee sese seoneseeee senno se nen nese sense tasto nanne se VE VEDAVA EEEE Niti 21 e SPECIFICATIONS n 22 e Occlusion Pressure Limits 1 crece eese e eee en ee eee eere eere rece eeceerane see e nere senerenee tens renerenesionesenesennecnneo 23 e ISOn ribns 23 e Compatible Extension Sets acsncccssssccsssnsseosssssonsssconsssveesssscsveonssssncessenessesvesssoessunoevecnssesesossenceseensssees 24 e Maintenance RRRRRRRRRRRRRRRRRRRRRRRRRRERRRERREERE ssd tsss vsossvovss sss s vesto sco ss dsssv s 26 e RS232 and N
15. L 1 0 ml 5 mins 2 0ml h 2 0 ml 4 Display will show Protocol A Drug name Drug X Drug conc 1 0mg ml PCA Dose 1 0mg 1 0ml Lockout period 5 mins Occlusion level 4 Continuous Oug h 0 0ml h Loading dose Ong 0 0ml Max limit 50mg 50 0ml Limit duration 4 hours PCA delivery STAT 5 Press OK to return to display Notes A modified protocol has no pre set letter To utilise this function MODIFY PROTOCOL must be enabled in GENERAL OPTIONS To change to another Pre Set Protocol Press NEXT PROTOCOL to display the step through the pre set protocol Pre set protocols are identified as A to J When the desired protocol has been selected it can be used by turning LOCK 1 to the RUN position or can be modified using the MODIFY PROTOCOL To confirm a Protocol Whenever a new protocol is selected modified or LOCK 1 is turned to the SET position the CONFIRM PROTOCOL display will appear Pressing OK automatically records the protocol and any changes in the EVENT LOG history If the calculated rate goes to more than one decimal place the pump displays the rate to one decimal place only however the pump will infuse at a rate equivalent to two decimal places The displayed rate will be rounded down to prevent the user believing an over infusion is taking place For Example If 30ug h was required using a drug preparation of 44ug ml this would equate to a rate of 0 681818ml h The pump will round the calculation to two dec
16. NG DOSE LIMIT DOSE RATE Ong 50 0 mg IN 4h STAT These icons are not displayed when disabled Screen Icons PUMPING PRESSURE icon When enabled this icon is shown on the Display It provides a visual indicator of current pumping pressure and pressure level at which the alarm will operate MAXIMUM DOSE icon When enabled this icon is shown on the Display It provides a visual indication of the amount of drug administered during the limit period as shown to the left of the icon If the dose limit reaches the alarm level the bottle icon will appear full the pump will stop infusing and the message Max Dose Limit is displayed and the icon will flash until the dosing is less than the maximum dose limit Clinician over ride is always available BACK icon Indicates the softkey to press to go back to previous screen 1000DF00135 Iss 5 6 32 Operating Precautions Disposable Syringes and Extension Sets This pump has been calibrated for use with single use disposable syringes To ensure correct and accurate operation only use 3 piece Luer Lock versions of the syringe make specified on the pump or described in this manual Use of non specified syringes or extension sets may impair the operation of the pump and the accuracy of the infusion Uncontrolled flow or syphoning may result if the syringe is located incorrectly in the pump or if it is removed from the pump before the extension set i
17. Pump 4kV dc or ac peak Refer to the Technical Service Manual for further Baud Rate 9600 Baud information regarding the RS232 interface Start Bits 1 Start Bit Since it is possible to control the syringe pump using the RS232 interface at some distance from Data Bits 8 Data Bits the pump and hence remote from the patient Parity Odd Parity responsibility for the control of the pump is A vested in the software run on the computer Stop Bits ee Bit control system Nurse Call Relay Contacts Pins 6 amp 7 The assessment forthe suitability of any software used in the clinical environment to control or receive data from the pump lies with the user IBM PUMP IBM of the equipment This software should include COMPATIBLE COMPATIBLE detection of the disconnection or other failure 9 PIN 25 PIN of the RS232 cable The protocol is detailed in the Technical Service Manual and is for general PIN 3 TXD PIN 2 RXD2 PIN 2 TXD information only PIN 2 RXD PIN 3 TXD2 PIN 3 RXD Any connected analogue and digital components PIN 5 GND PIN 5 GND PIN7 GND are required to meet IEC EN60950 for data PIN 7 RTS PIN 4 RTS processing and IEC EN60601 for medical devices Anyone connecting additional devices to the PIN 8 CTS PIN 5 CTS signal input or output is a system configurator PIN 4 DTR PIN 20 DTR and responsible for meeting the requirements of the system standard IEC EN60601 1 1 PIN 6 DSR FINCAS PUMP PIN 1 ALM1
18. ThispumpisaCISPR 11 Group 1 Class A device and uses RF energy only for its internal function in the normal product offering Therefore its RF emissions are very low and are not likely to cause any interference with the nearby electronic equipment However this pump emits a certain level of electromagnetic radiation which is within the levels specified by IEC EN60601 1 2 and IEC EN60601 2 24 If the pump interacts with other equipment measures should be taken to minimise the effects for instance by repositioning or relocation e nsome circumstances the pump may be affected by an electrostatic discharge through air at levels close to or above 15kV or by radio frequency radiation close to or above 10V m If the pump is affected by this external interference the pump will remain in a safe mode the pump will duly stop the infusion and alert the user by generating a combination of visual and audible alarms Should any encountered alarm condition persist even after user intervention it is recommended to replace that particular pump and quarantine the pump for the attention of appropriately trained technical personnel Consult Technical Service Manual for further information e Anexplosion hazard exists if the pump is used in the presence of flammable anaesthetics Exercise care to locate the pump away from any such hazardous sources e Dangerous Voltage An electrical shock hazard exists if the pump s casing is opened or removed Refe
19. Volume 3 6ml Low Sorbing Sets G40615 Polyethylene Syringe Extension Set 150 cm Priming Volume 1 5ml G40620 Polyethylene Syringe Extension Set 200 cm Priming Volume 2ml G40720 Polyethylene Lined Syringe Extension Set with clamp 200 cm Priming Volume 1 5ml 04105010509 Polyethylene Syringe Extension Set 100 cm Priming Volume 1ml For availability please contact your local Cardinal Health representative because new sets are continuously being developed for our customers It is recommended that extension sets are changed in accordance with the Directions for Use Carefully read the Directions For Use supplied with the extension set prior to use Please note these drawings are not to scale 1000DF00135 Iss 5 24 32 Compatible Extension Sets Continued The pump uses standard single use disposable extension sets and syringes with Luer lock connectors The user is responsible for verifying the suitability of a product used if it is not recommended by Cardinal Health Patient Controlled Analgesia PCA Sets 30822 PVC Syringe Extension Set with clamp 152 cm Priming Volume 0 5ml E 0 E PVC Y Syringe Extension Set with back check valve and 2 clamps 178 cm Priming Volume 1 5ml ee 30842E PVC Syringe Extension Set with back check valve SmartSite Needle Free Valve Port and clamp 30 cm Priming Volume 1 4ml i C3 PVC Y Syringe Extension Set with anti siphon valve back check
20. alhealth com au e Cal techservice au cardinal com BE Cardinal Health Leuvensesteenweg 248 D 1800 Vilvoorde Belgium Tel 32 2 267 38 99 Fax 32 2 267 99 21 www cardinalhealth com be Cal tech belux cardinal com CA Cardinal Health 235 Shields Court Markham Ontario L3R 8V2 Canada Tel 1 905 752 3333 Fax 1 905 752 3343 www cardinalhealth com ca CN Cardinal Health Shanghai Representative Office Suite 9B Century Ba Shi Building 398 Huai Hai Rd M Shanghai 200020 China Tel 56 8621 63844603 Tel 56 8621 63844493 Fax 56 8621 6384 4025 DE Cardinal Health Pascalstr 2 52499 Baesweiler Deutschland Tel 49 2401 604 0 Fax 49 2401 604 121 www cardinalhealth com de DK Cardinal Health Firskovvej 25 B 2800 Lyngby Danmark Tlf 45 70 20 30 74 Fax 45 70 20 30 98 ES Cardinal Health Edificio Veganova Avenida de La Vega n 1 Bloque 1 Planta 1 28108 Alcobendas Madrid Espafia Tel 34 902 555 660 Fax 34 902 555 661 www cardinalhealth com es Cal servicio tecnico cardinal com FR Cardinal Health Immeuble Antares Technoparc 2 rue Charles Edouard Jeanneret 78300 POISSY France T l 33 1 30 06 74 60 Fax 33 13911 48 34 www cardinalhealth com fr e Cal FR Assistance Technique cardinal com GB Cardinal Health The Crescent Jays Close Basingstoke Hampshire RG22 4BS Unit
21. e from defects in material and workmanship under normal use and service for a period of ninety 90 days from the date of delivery by Cardinal Health to the original purchaser D Each new Thermometer is free from defects in material and workmanship under normal use and service for a period of one 1 year from the date of delivery by Cardinal Health to the original purchaser If any product requires repair during the applicable warranty period the purchaser should communicate directly with its local Cardinal Health service centre to determine the appropriate service facility Except as provided otherwise in this warranty repair or replacement will be carried out at Cardinal Health s expense The product requiring service should be returned promptly properly packaged and postage prepaid by purchaser Loss or damage in return shipment to Cardinal Health shall be at purchaser s risk In no event shall Cardinal Health be liable for any incidental indirect or consequential damages in connection with the purchase or use of any Cardinal Health product This warranty shall apply solely to the original purchaser This warranty shall not apply to any subsequent owner or holder of the product Furthermore this warranty shall not apply to and Cardinal Health shall not be responsible for any loss or damage arising in connection with the purchase or use of any Cardinal Health product which has been A repaired by anyone other than an authorised Cardinal H
22. e infusion LOCK 2 Insert key into LOCK 2 and turn key clockwise to open the syringe cover This key lock is located on the left side of the pump BATTERY indicator When illuminated the pump is running on the internal battery When flashing the battery power is low with less than 30 minutes of use remaining AC POWER indicator When illuminated the pump is connected to an AC power supply and the battery is being charged 1000DF00135 Iss 5 4 32 Symbol Definitions Labelling Symbols Attention Consult accompanying documents Potential Equalisation PE Connector RS232 Nurse call Connector Optional Class Il Equipment Type CF applied part Degree of protection against electrical shock IP X 4 Protected against splashing fluid degree of protection against fluid ingress Device complies with the requirements of the EC Directive 93 42 EEC Registered with the CE Mark Date of Manufacture Manufacturer Not for Municipal Waste Important information 1000DF00135 Iss 5 5 32 Main Display Features Main Display Current Protocol Pump Status Volume Infused Time Mass Volume PCA AVAILABLE DEMANDS DRUG INFUSED m ameng PCA Demand I TOTAL 1 0 Hg Pressure Icon da 2900 0 1 mi mf 3 Maximum Dose Icon PROTOCOL 7 Syringe Type Infusion Rate View Protocol Summary Protocol Summary Screen PROTOCOL MORPHINE PCA DOSE LOCKOUT CONTINUOUS 1 0 mg ml 1 0 mg 2 min 0 ug h LOADI
23. ealth service representative B altered in any way so as to affect in Cardinal Health s judgement the stability or reliability of the product or has had the product s serial or lot number altered effaced or removed C subjected to misuse or negligence or accident or D improperly maintained or used in any manner other than in accordance with the written instructions furnished by Cardinal Health This warranty is in lieu of all other warranties express or implied and of all other obligations or liabilities of Cardinal Health and Cardinal Health neither assumes nor authorises any representative or other person to assume for it any other liability in connection with the sale of Cardinal Health products CARDINAL HEALTH DISCLAIMS ALL OTHER WARRANTIES EXPRESS OR IMPLIED INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE 1000DF00135 Iss 5 31 32 A About This Manual 2 Alarms 16 Battery 31 See also Battery Operation Battery Operation 26 Bolus 12 C Cleaning 27 Clinician over ride 9 12 Clock Set 18 Concentration 27 Controls PRESSURE 4 PURGE BOLUS 3 4 D Display 3 6 Disposal 27 DOSE 6 16 19 20 22 Drug Names and Safety Limits 18 19 Drug Set up 19 E Extension Sets 7 24 25 F Fuses 26 G General Options 17 18 20 H HISTORY 3 4 22 Hospital Name 18 20 Indicators AC POWER 4 BATTERY 4 Installation 9 Introduction 2 L Labelling Symbols 5 Language 18 L
24. ective pain service the pump promotes improved pain management more effective use of nursing resources provides patient comfort and can contribute towards a quicker recovery Intended Use The pump is designed to meet the infusion requirements within the operating environment specified in this Directions For Use DFU including general wards critical and intensive care neonatal operating rooms and accident and emergency rooms This pump is suitable for use by appropriately trained clinicians or nurses The pump is suitable to deliver fluids and medications via intravenous and epidural routes Supporting fluid therapy blood transfusions and parenteral feeding The pump is compatible with a wide range of standard single use disposable Luer lock syringes lt accepts syringe sizes from 20 ml to 100 ml See the Compatible Syringes section for a full list of compatible syringes User configured PCA protocols e Comprehensive history Large graphics format display Two key positions providing separation of nursing and programming procedures e 10 pre set hospital PCA protocols Unique electronic hand set with status indicator e Communications and nurse call interfaces About This Manual The user must be thoroughly familiar with the IVAC PCAM Syringe Pump described in this manual prior to use All illustrations used in this manual show typical settings and values which may be used in setting up the functions of t
25. ed Kingdom Tel 44 0800 917 8776 Fax 44 1256 330860 www cardinalhealth com alaris Ds Cal UK Technical Support cardinal com HU Cardinal Health D brentei t r 1 H 1013 Budapest Magyarorszag Tel 36 14 88 0232 Tel 36 14 88 0233 Fax 36 12 01 5987 e CA Alaris CE cardinalhealth com IT Cardinal Health Via Ticino 4 50019 Sesto Fiorentino Firenze Italia T l 39 055 30 33 93 00 Fax 39 055 34 00 24 www cardinalhealth com it CA assistenza tecnica cardinal com NL Cardinal Health De Molen 8 10 3994 DB Houten Nederland Tel 31 30 22897 11 Fax 31 30 225 86 58 www cardinalhealth com nl ey Sl support alaris nl cardinal com NO Cardinal Health Solbr veien 10 A 1383 ASKER Norge Tel 47 66 98 76 00 Fax 47 66 98 76 01 www cardinalhealth com no A Gl technical supportNO cardinal com NZ Cardinal Health 14B George Bourke Drive Mt Wellington 1060 PO Box 14 518 Panmure 1741 Auckland New Zealand Tel 09 270 2420 Freephone 0508 422734 Fax 09 270 6285 www cardinalhealth com nz e Cal techservice nz cardinal com SE Cardinal Health Hammarbacken 4B 191 46 Sollentuna Sverige Tel 46 8 544 43 200 Fax 46 8 544 43 225 www cardinalhealth com se an Cal technical supportSE cardinal com US Cardinal Health 10020 Pacific Mesa Blvd San Diego CA 92121 USA Tel 1 800 854 7128 Fax 1 858 458 6179
26. ed period it should be first cleaned and the internal battery fully charged Store in a clean dry atmosphere at room temperature and if available employ the original packaging for protection Once every 3 months during storage carry out functional tests as described in the Technical Service Manual and ensure that the internal battery is fully charged Before cleaning always switch OFF and disconnect from the AC power supply Never allow liquid to enter the casing and avoid excess fluid build up on the pump Do not use aggressive cleaning agents as these may damage the exterior surface of the pump Do not steam autoclave ethylene oxide sterilise or immerse this pump in any fluid Disposal Information on Disposal for Users of Waste Electrical amp Electronic Equipment This X symbol on the product and or accompanying documents means that used electrical and electronic products should not be mixed with municipal waste If you wish to discard electrical and electronic equipment please contact your Cardinal Health affiliate office or distributor for further information Disposing of this product correctly will help to save valuable resources and prevent any potential negative effects on human health and the environment which could otherwise arise from inappropriate waste handling Information on Disposal in Countries outside the European Union This symbol is only valid in the European Union The product should be disposed of taking e
27. ent history graphs etc However any remaining PCA lockout time will be cleared and a PCA demand will be immediately available The pump will retain the events in a rolling memory Following selection of a new patient it remains possible in technician mode to access previous patient s history still held in memory Patient history can be accessed at any time by pressing the Y button The pump provides a clear rolling 24 hour graphical representation of the PCA demand pattern and the drug administered to the patient The graphs are updated when the history button is pressed and give values for each completed hour and the current hour The cumulative counters on the Drug Infused history screen update in real time 24 Hour Review An hour by hour record of the last 24 hours showing good and total PCA demands along with the total dose and volume per hour This information provides the accurate demand pattern and drug infused values from which the other graphs are derived 1 To access the 24 Hour Review press the Wy button once HOUR cjole TOTAL MASS h VOL h 2 To return to the previous screen press the BACK softkey 13 00 13 59 15 59 16 59 00 17 59 3 To scroll through to the next History screen press the button PCA Demands Provides a record of the last 24 hours good and failed PCA demands The good demands are indicated by the shaded section of the graph and the failed demands by the clear section The latest hou
28. erences in factors such as size and plunger force in compatible syringes can cause variations in accuracy and trumpet curves Also see trumpet curves section Environmental Specifications 10 C 40 C 30 75 700hPa 1060hPa 20 C 50 C 5 95 600hPa 1060hPa Operating Temperature Operating Relative Humidity Operating Atmospheric Pressure Transport amp Storage Temperature Transport amp Storage Relative Humidity Transport amp Storage Atmospheric Pressure 1000DF00135 Iss 5 OPERATION MODE Continuous CRITICAL VOLUME The maximum over infusion which can occur in the event of a single fault condition is 0 8ml for 20ml 30ml and 50ml syringes and 1 5ml for a 100ml syringe ALARM CONDITIONS Pressure Limit exceeded Low Battery Warning Drive Disengaged Battery Exhausted Syringe Almost Empty Cover Open during operation Syringe Empty Hand set Disconnected Max Dose Limit optionally alarmed Internal Malfunction Nurse Attention Call Back PUMPING PRESSURE ALARM LEVEL 375mmHg nominal default alarm level L 4 with 11 user selectable alarm levels L 0 to L 10 Syringes may limit below level 10 Syringe Error The maximum pressure that can be developed by the system at the maximum user selectable alarm level is 1100mmHg CLINICIAN OVER RIDE Bolus or continuous infusion in RUN mode User selectable from 1ug 99 9mg or 0 1ml to 99 9ml volume mode bolus dose administered at the STAT rate 100ml h
29. ess OK when complete 11 MIN PCA DOSE Use buttons to set minimum PCA dose Press OK when complete 12 MAX PCA DOSE Use buttons to set maximum PCA dose Press OK when complete 13 MAX CONTINUOUS Use buttons to set maximum continuous rate Press OK when complete 14 MAX LOADING DOSE Use buttons to set maximum loading dose Press OK when complete 15 MAX DOSE LIMIT Use buttons to set maximum dose limit Press OK when complete 16 MAXCLINICIAN BOLUS Use buttons to set the maximum clinician bolus Press OK when complete 17 NEXT DRUG to display the next drug name and the safety limits The ten pre set drug protocols are identified as 1 to 10 18 Press QUIT to exit and return to configuration menu 19 When set up is complete turn LOCK 1 to OFF position to save selection and to turn pump off 1000DF00135 Iss 5 19 32 Configured Options Record General Options Enter the pump specific information for your records on a copy of this page ICONS ON DISPLAY YES NO BD PLASTIPAK FRESENIOUS INJECT IVAC RAPIJECT BUR PHARMA JECT U IFI DEFAULT SYRINGE BD PRECISE BD PLASTIPAK MONOJECT BRAUN PERFUSOR R R PRONTO JANPOL BD WORLDWIDE ONCE with options kit fitted wesosuwraawm sN Trans avormosss sno Te e esso ME __ esso E o esso 0 v E METI d s 0 IET NO __ esso ME IET YS i esso ME IET YS o OE esso Tes o IET NO E IET oe __ ETIN E N 5 Y A Y V N Y Y Y Y Y
30. figured to flash when a PCA dose is being delivered The indicator on the patient hand set will reflect the configuration of the pump and will provide feed back on all or just good demands and the indicator light can be disabled should the clinical situation require Where appropriate the hand set can be configured so that the patient will not need to refer to the instrument to assess if PCA is being delivered or is available The hand set is provided with a clip for attaching it to bedding or clothing The pump concept is that the patient can be instructed in the use of the hand set as it will carry all the information required by the patient using PCA This design simplifies patient instruction and encourages a smooth transfer to alternative devices used to treat long term chronic pain should this be indicated A latching but non locking connector makes the hand set easy to fit To remove hold the body of the connector and pull away from the pump An alarm warning will operate if the hand set is disconnected from the pump while it is in operation or the hand set is connected to the unit with the PCA button depressed In addition the pump can be operated in continuous or clinician over ride modes without the hand set connected should this be required 1000DF00135 Iss 5 9 32 Getting Started continued Only use a syringe of the type stated on the pump or in this manual Using an incorrect
31. ges and 80ml h for 20ml syringes 0 0ml 99 9ml in 0 1ml steps Option to set duration from 1 to 60 mins in 1 min steps to minimum rate of 0 1ml h and maximum of the STAT rate RATE CONVERSION FACTOR When pump is programmed in Mass units the conversion factor is ml h dose concentration time in minutes 60 LOCKOUT INTERVAL 0 180 minutes in 1 minute steps LOADING DOSE RANGE Mass Mode Oug 999ug in 1ug steps 0 0mg 99 9mg in 0 1mg steps Delivered at STAT rate Volume Mode 0 0ml 99 9ml in 0 1ml steps CONTINUOUS RATE RANGE Mass Mode Oug h 90ug h in 10ug h steps 0 0mg h 999 0mg h in 0 1mg h steps Volume Mode 0 0ml h 35 0ml h in 0 1ml h steps MAX DOSE LIMIT Mass Mode off 1ug 999ug in 1pg steps 1mg 999mg in 1mg steps Volume Mode off 0 1ml to 999ml in 0 1ml steps 1 8 hours duration in 1 hour steps PURGE RATE 100ml h SYSTEM ACCURACY Drive Linearity 1 Bolus 0 05ml Volumetric 2 nominal Volumetric accuracy is 2 typical by volume at the STAT PCA rate and above when the pump is used with the recommended syringes Differences in factors such as size and plunger force in compatible syringes can cause variations in accuracy and trumpet curves Important System accuracy is 2 typical by volume as measured using the trumpet curve test method defined in EN60601 2 24 1998 at rates of 1 0ml h and above when the pump is used with the recommended syringes Diff
32. he pump These settings and values are for illustrative use only Where stated a minimum infusion rate refers to a nominal rate of 1 0ml h and an intermediate infusion rate refers to a nominal rate of 5 0ml h The complete range of infusion rates settings and values are shown in the Specifications section 1000DF00135 Iss 5 2 32 Controls amp Indicators Controls START button Press to start the infusion The green LED will flash during infusion STOP button Press to put the infusion on hold The amber LED will be lit while on hold PURGE button Press and hold both buttons to purge the extension set during set up See Basic Features for further information HISTORY button Press to display PCA demands and drug infused history graphs 24 hour review and event log PRINT button Press to print patient history Note A suitable printer must be connected to the pump PLUS MINUS buttons Use to move cursor and to increase or decrease values shown on main display ARROW buttons Use as softkeys in conjunction with the prompts shown on the display LOCK 1 Insert key into LOCK 1 keyswitch and turn key to switch between OFF SET and RUN positions OFF Turns the power off SET Use to select or modify protocols and to access configuration and test routines RUN Use to start the infusion Note Switching from RUN mode to SET mode without first pressing the STOP button automatically stops th
33. hold Open the cover using LOCK 2 Close the extension line to the patient Change the syringe fitting the new syringe as per instructions above Gm gp I Follow steps 7 to 10 of Starting the Pump section on the next page 1000DF00135 Iss 5 10 32 10 NEW PATIENT Getting Started Continued Starting the Pump AC POWER Connect pump to AC power supply using the AC power cable Note the pump will operate on an internal battery when not connected to an AC power source for a limited time Prior to beginning an infusion disconnect the pump from the AC power supply confirm the pump continues to function on battery power Then reconnect the pump to the AC power source SET Insert key into LOCK 1 Turn to SET position Answering NO will retain all previous patient history except for the PCA lockout time remaining which will be reset to PCA AVAILABLE YES will automatically reset the patient history to zero Check time and date is correct and answer YES or NO SELECT MODIFY PROTOCOL Carefully check the protocol displayed If required press MODIFY PROTOCOL to adjust the current protocol or NEXT PROTOCOL to select an alternative pre set protocol RUN Turn LOCK 1 to the RUN position and remove the key from pump CONFIRM PROTOCOL Carefully check that protocol is correct Press OK CONFIRM SYRINGE Check that the syringe type and size being used matches display If required
34. imal places giving an actual infusion rate of 0 68ml h whilst the screen which can only display to one decimal place will show as 0 6ml h 1000DF00135 Iss 5 15 32 Alarms are indicated by a combination of an audible alarm flashing amber STOP light and a descriptive message in the display 1 First press the MUTE softkey to silence the alarm for a maximum of 2 minutes then check the display for an alarm message Press Cs to cancel the alarm message 2 If the infusion has stopped rectify the cause of the alarm then press the button to resume the infusion Message Cause and Troubleshooting Guide DRIVE DISENGAGED PUMP DRIVE DISENGAGED The drive system has been disengaged during operation Use LOCK 2 to unlock and open the cover Check the finger grips and the position of the syringe COVER OPENED COVER OPENED DURING OPERATION The cover has been opened during operation Check cover and LOCK 2 LINE OCCLUSION EXCESSIVE PUMPING PRESSURE Pumping pressure has reached the alarm limit Use LOCK 2 to unlock and open the cover squeeze finger grips on the plunger holder to release the drive mechanism and relieve any excessive pressure in the syringe and patient line Identify and remove the cause of the blockage in the drive syringe or administration system before restarting the infusion SYRINGE ERROR SYRINGE SIZE ERROR FITTED INCORRECTLY Incorrect size of syringe has been fitted the syringe clamp has not been positioned correctly on
35. inted with patient header Event Log Press 1 button until event log is displayed All events will be printed from information on ee buttons to position display at start point screen forward with time date and patient header for events to be printed Press button Event Log at New Patient Press amp button All events will be printed from the patient event log Continuous Mode Enable Continuous printing by selecting YES in General Options 1 Connect printer 2 All events will be printed as they occur Teach Learn Mode By programming the configuration of one pump in the conventional way from the front panel buttons other pumps can have the configuration copied over using the teach and learn modes When set to learn mode the pump will accept information sets from a pre configured pump set to teach mode When set to teach mode the pump sends out via the communications interface a sequence of all the information sets required to configure another pump To fully configure a pump it is necessary to send 22 complete information sets as described in the protocols and the full cycle takes about 22 seconds The two pumps must be connected together using an RS232 Demonstration Cable Both pumps must be of the same version software and revision and set to a common pump comms identification number see General Options The configured pump is set to teach mode
36. ion generated by the radiation therapy equipment such as Linear Accelerator may severely affect functioning of the pump Please consult manufacturer s recommendations for safe distance and other precautionary requirements For further information please contact your local Cardinal Health representative e Magnetic Resonance Imaging MRI The pump contains ferromagnetic materials which are susceptible to interference with magnetic field generated by the MRI devices Therefore the pump is not considered an MRI compatible pump as such If use of the pump within an MRI environment is unavoidable then Cardinal Health highly recommends securing the pump at a safe distance from the magnetic field outside the identified Controlled Access Area in order to evade any magnetic interference to the pump or MRI image distortion This safe distance should be established in accordance with the manufacturers recommendations regarding electromagnetic interference EMI For further information please refer to the product technical service manual TSM Alternatively contact your local Cardinal Health representative for further guidance e Accessories Do not use any non recommended accessory with the pump The pump is tested and compliant with the relevant EMC claims only with the recommended accessories Use of any accessory transducer or cable other than those specified by Cardinal Health may result in increased emissions or decreased pump immunity e
37. larm screen will flash USE LOCK 2 TO OPEN COVER AC POWER FAIL AC POWER SUPPLY DISCONNECTED WARNING AC Power has been disconnected and the pump is operating on battery power Reconnect AC power supply or press Cs to silence the alarm and continue battery operation The display will light up ON BATTERY The alarm will automatically cancel if the AC power supply is reconnected MALFUNCTION INTERNAL MALFUNCTION The alarm system has detected an internal malfunction Note the malfunction code Remove pump from service for examination by a qualified service engineer MAX DOSE EXCEEDED MAX DOSE LIMIT The maximum dose over time limit has been exceeded Infusion is stopped when the alarm occurs roms Press Cs to cancel the alarm The max dose icon will flash until dosing is less than the maximum dose limit Note that this alarm can be disabled under General Options 3 BEEPS NURSE ATTENTION WARNING Alarm without screen prompt Pump left switched ON for more than 2 minutes without starting operation Press La or any of the control buttons to silence the alarm for a further 2 minutes To cancel this alarm for 15 minutes press and hold the 4 button until 3 rapid consecutive beeps are heard 1000DF00135 Iss 5 16 32 Configured Options This menu comprises a list of options which are configurable by the user 1 Whilst holding down the 9 button turn the pump ON 2 The main display will show 000 Enter the access code for Configured O
38. nvironmental factors into consideration To ensure no risk or hazard remove the internal rechargeable battery and the Lithium battery from the control board and dispose of as outlined by the local country regulations All other components can be safely disposed of as per local regulations 1000DF00135 Iss 5 27 32 RS232 and Nurse Call Specification RS232 Nurse Call Feature RS232 Nurse Call Connection Data The RS232 Nurse call feature is a feature on Alaris Syringe Pumps Nurse call Specification It allows the pump to be monitored remotely and or controlled via a suitable central monitoring or computer system Connector DType 9 Pin When the pump is started by a command from the serial interface TXD RXD EIA RS232 C Standard communication must take place over the serial interface A TXD Output Voltage Range Minimum 5V mark 5V communication must take place every 15 seconds or the pump space will alarm display communications failure and stop infusing This failure protects against failure of the communications including the removal of the RS232 cable Typical 7V mark 7V space with 3KQ load to ground RXD Input Voltage Range 15V to 15V max RXD Input Thresholds Low 0 6V minimum High 3 0V The nurse call interface provides a remote maximum backup to the internal audible alarm It should RXD Input Resistance iaa not be relied upon to replace monitoring of the internal alarm Isolation Socket
39. oading a Syringe 10 LOCK 3 4 11 12 14 15 16 17 19 20 M Maintenance 26 27 Mass 6 18 19 21 22 Mount 7 9 N Nurse Call 28 O Occlusion 23 Operating Precautions 7 8 1000DF00135 Iss 5 P Patient hand set 9 PCA 2 6 9 11 12 13 14 15 16 17 19 21 22 25 Pole Clamp 9 Pressure 22 23 PRINT 3 4 20 Protocol 11 13 14 15 17 18 28 Purge 3 4 R RS232 5 8 28 S Screen Icons 6 Service Contacts 30 Spare Parts 31 Specifications 22 Start up Curves 29 Starting the Pump 11 Storage 27 Syringes 2 23 See also Loading a Syringe T Teach Learn Mode 14 Technical Service Manual 17 18 28 31 Test 26 Trumpet Curves 29 V Variable dose rates 17 Volume 6 19 21 22 23 24 25 WwW Warranty 31 32 32 CardinalHealth PCAM Alaris SmartSite and IVAC are registered trademarks of Cardinal Health Inc or one of its subsidiaries All other trademarks belong to their respective owners 2000 2009 Cardinal Health Inc or one of its subsidiaries All rights reserved 1000DF00135 Issue 5 This document contains proprietary information of Cardinal Health Inc or one of its subsidiaries and its receipt or possession does not convey any rights to reproduce its contents or to manufacture or sell any product described Reproduction disclosure or use other than for the intended purpose without specific written authorization of Cardinal Health Inc or one of its subsidia
40. ons to select required values 3 When the field is correct press CONFIRM Press OK to return to the protocol summary One of the ten drugs programmed in the Drug Names and Safety Limits are selectable for each protocol Additionally a default drug with limits set to extremes may be chosen if Generic Drug is enabled in General Options Default drugs are named MASS DRUG and VOL DRUG The names indicate the underlying dose mode Hospital Name This option allows the user to programme in the name of the hospital ward or department This will appear during the power up display sequence and the Display Sleep screen if enabled in General Options 1 Whilst holding down the button turn the pump ON 2 The main display will show 000 Enter the access code for Hospital Name using the buttons pressing NEXT to move through the digits A full list of access codes can be found in the Technical Service Manual 3 When the complete code shows on screen press ENTER The Hospital Name Option will be displayed Use the buttons to adjust the character displayed pressing NEXT to access the next position 5 5 When the correct name is displayed turn LOCK 1 to the the OFF position 1000DF00135 Iss 5 18 32 Configured Options Continued Drug Names and Safety Limits If enabled in General Options a drug can be configured in either Mass or Volume dosing mode If this option is disabled all drugs and protocols are comp
41. otocol when this option has been disabled for normal use 1 Turn LOCK 1 to RUN position and ensure green light is illuminated on the 7 button CLINICIAN ACCESS CODE 2 Press and hold down the b s button for 2 seconds c access cove Poo 3 Use buttons and NEXT softkey to enter three figure pre programmed clinician access code See technical service manual 4 Select BOLUS or CONTINUOUS 5 Use buttons to select the dose delivered when the correct value has been entered press OK 6 Use buttons to select period over which the dose is to be delivered Press OK when correct time has been CLINICIAN ACCESS CODE entered BOLUS OR CONTINUOUS XXXX Oml CLINCIAN DOSE Oml 7 BEGIN BOLUS YES Clinician bolus continuous FOO p infusion will be delivered to the patient NO Quit set up and return to normal operation The delivery of the clinician over ride continuous infusion will automatically halt while a Patient or Clinician over ride bolus is being administrated To cancel clinician over ride during delivery press button and press the YES softkey During BOLUS the pressure limit alarms are temporarily increased to their maximum level 1000DF00135 Iss 5 12 32 Basic Features Continued Each time the pump is switched ON it will ask if this is a new patient Pressing YES will provide opportunity to re set patient history Pressing NO continues with the current protocol and retains all protocol records ev
42. ptions using the buttons pressing NEXT to move through the digits A full list of access codes can be found in the Technical Service Manual 3 When the complete code shows on screen press ENTER The Configured Options menu will be displayed General Options Select GENERAL OPTIONS from the menu using the buttons and press ENTER Select the option you wish to enable disable or adjust and press MODIFY When all the desired modifications have been carried out press QUIT qe op cB a Either select the next configuration option from the menu or turn the pump OFF returning it to operation as required fosti Toessisi 1 ICONS on display YES displays Pumping Pressure and Maximum Dose ICONS NO ICONS disabled 2 Protocols in use PCA pre set protocols to be available Select number from 1 to 10 3 Modify protocol YES allows protocols to be modified in SET mode NO removes modify protocol option in SET mode A B E 4 Handset mode MODE BEEP GOOD ALL ALL HAND SET LIGHT PCAM STOPPED OFF OFF OFF PCA AVAILABLE ON ON ON PCA DELIVERING FLASH ON FLASH PCA LOCK OUT OFF ON ON 5 Delayed call back YES call back alarm can be delayed from 10 mins up to 90 mins NO call back will be cancelled for up to 2 mins or extended to 15 mins To extend call back alarms press and hold the Cs button for 4 seconds 6 Display Sleep YES display goes blank after 2 minutes Pet licet 7 Chirp low alarms YES
43. r all servicing to qualified service personnel e Do not open the RS232 protective covering when not in use Electrostatic discharge ESD precautions are required when connecting RS232 Touching the pins of the connectors may result in ESD protection failure It is recommended that all actions must be taken by appropriately trained personnel e Ifthis pump is dropped subjected to excessive moisture fluid spillage humidity or high temperature or otherwise suspected to have been damaged remove it from service for inspection by a qualified service engineer When transporting or storing the pump use original packaging where possible and adhere to temperature humidity and pressure ranges stated in the Specifications section and on the outer packaging Latex Content e The pump and handset do not contain any Latex 1000DF00135 Iss 5 8 32 Getting Started Initial Set up Before operating the pump read this Directions For Use manual carefully 1 Check that the pump is complete undamaged and that the voltage rating specified on the label is compatible with your AC power supply 2 Items supplied are IVAC PCAM Syringe Pump User Support CD Directions For Use AC Power Cable as requested Protective Packaging 3 Connect the pump to the AC power supply for 24 hours to ensure that the internal battery is fully charged verify that the CE is lit The pump will automatically operate from its internal batte
44. r is shown at the right side of the display This graph provides a clear picture of good and bad PCA demands and pattern of the patients usage Used in conjunction with the PCA Demands graph this display helps to indicate if the PCA protocol needs modification and when to end treatment 1 To access the PCA demand graph press the W button twice DEMANDS 2 To exit the screen press the BACK softkey FAIL GOOD 3 To scroll through to the next History screen press the WW button 10 00 EH 18 Drug Infused Record of the total amount of drug administered to the patient over the last 24 hours The latest hour is shown at the right side of the display This graph provides a clear picture of the actual drug administered including loading dose continuous background infusions clinician over rides and protocol changes The left side of the display shows cumulative dose and time counters with the time mass and volume infused since the patient session started or since the counters were last reset To reset counters press CLEAR and then CONFIRM Used in conjunction with the PCA Demands graph this display helps to indicate relative pattern of the demand pattern and the actual drug administered 1 To access the Drug Infused graph press the l button three times DRUG INFUSED 2 To return to the previous screen press the BACK softkey REN Oug 0 0ml 3 To scroll through to the next History screen press the WW button 1000DF00135 Iss
45. replaces the battery For further information regarding the replacement of batteries refer to the Technical Service Manual Test Routines The test routines are designed to allow confirmation of many of the pump functions defaults and calibrations without requiring internal inspection They do not represent a full calibration check See the Technical Service Manual for a complete list of the test procedures access codes and calibration procedures 1000DF00135 Iss 5 26 32 Maintenance continued Cleaning and Storage Before the transfer of the pump to a new patient and periodically during the use clean the pump by wiping over with a lint free cloth lightly dampened with warm water and a standard disinfectant detergent solution Recommended cleaners are Brand Concentration Hibiscrub 20 v v Virkon 1 w v Do not use the following disinfectant types Disinfectants which are known to be corrosive to metals must not be used which include e NaDcc such as Presept Hypochlorites such as Chlorasol Aldehydes such as Cidex Cationic Surfactants such as Benzalkonium Chloride Use of lodine such as Betadine will cause surface discoloration e Concentrated Isopropyl alcohol based cleaners will degrade plastic parts The syringe and extension sets are disposable single use items and should be discarded after use according to their manufacturers instructions If the pump is to be stored for an extend
46. ries is strictly forbidden Cardinal Health 1180 Rolle Switzerland www cardinalhealth com alaris
47. ry if the pump is switched on without being connected to the AC power supply Prior to use on battery power verify the pump continues to function on battery power once disconnected from the AC power supply Should the pump fail to perform correctly replace in its original protective packaging where possible and contact a qualified service engineer for investigation Do not mount the pump with the AC power inlet or the syringe pointing upwards This could affect the electrical safety in the event of a fluid spill or lead to the infusion of air which may be in the syringe Pole Clamp Installation The pole clamp is supplied fitted to the rear of the pump and will provide secure fixing to standard I V poles of a diameter of up to 40mm The pole clamp can also be fitted in a choice of 4 fixing positions allowing the pump to be mounted to vertical and horizontal poles equipment rails and hospital furniture in a variety of convenient operating orientations The pole clamp may be adjusted for use with horizontal fittings by using the existing fixings screws with the alternative fixing holes in the pole clamp The pole clamp may also be secured to the base of the pump in a choice of four positions Patient Hand Set The patient hand set supplied with the pump is designed to be ambidextrous and suitable for both adult and paediatric use The hand set provides an indicator light which clearly shows when the pump is available and can be con
48. s properly isolated from the patient Isolation may include closing a tap in the extension set or activating a flow stop clamp When combining several apparatus and or instruments with extension sets and other tubing for example via a 3 way tap the performance of the pump may be impacted and should be monitored closely Mounting the Pump Do not mount the pump in a vertical position with the syringe pointing upwards as this could lead to an infusion of air which may be in the syringe To protect against the introduction of air the user should regularly monitor the progress of the infusion syringe extension set and patient connections and follow the priming procedure specified herein Operating Environment When using any infusion pump in conjunction with other pumps or devices requiring vascular access extra care is advised Adverse delivery of medication or fluids can be caused by the substantial variation in pressures created within the local vascular system by such pumps Typical examples of those pumps are used during dialysis bypass or cardiac assist applications This pump is suitable for use in Hospital and clinical environments other than domestic establishments and those directly connected to the public single phase AC mains power supply network that supplies buildings used for domestic purposes However it may be used in domestic establishments under the supervision of Medical professionals with additional necessary appropriate meas
49. the syringe or has been disturbed during operation or plunger is not fitted in plunger slot Use LOCK 2 to unlock and open the cover check syringe size position of syringe clamp syringe and plunger CHECK HANDSET PATIENT HAND SET FAILURE Patient hand set has become faulty or disconnected during operation Check operation and connection of the hand set to the pump Press to continue if operation without the hand set is required BATTERY LOW BATTERY CHARGE LOW WARNING Battery charge low with 30 minutes operation remaining Battery indicator will flash and after 30 minutes a continuous audible alarm will indicate that the battery is exhausted Reconnect to AC power supply to continue operation and charge internal battery BATTERY EXHAUSTED BATTERY EXHAUSTED Internal battery exhausted To silence the alarm switch LOCK 1 to the OFF position and reconnect pump to AC power supply Restart operation on AC power whilst charging the internal battery Switch to the RUN position SYRINGE NEAR EMPTY NEAR END OF SYRINGE WARNING Syringe almost empty with about 6 of its volume remaining Press 5 to silence alarm and continue operation Display will flash SYRINGE NEAR EMPTY The alarm screen will also flash USE LOCK 2 TO OPEN COVER SYRINGE EMPTY SYRINGE EMPTY END OF INFUSION The pump has reached the end of the infusion About 1 of the syringe volume will remain in the syringe helping to prevent the infusion of air bubbles into the PCA set The a
50. the make of syringe can be changed by pressing the CHANGE TYPE softkey Press OK PURGE if required The PURGE buttons can only be used when the cover is open and LOCK 1 is in the RUN position When the purge operation is complete close the cover CONNECT PATIENT Connect the PCA extension set to the patient access device Recheck the protocol START Press the J button to commence pump operation Either PCA AVAILABLE or CONTINUOUS INFUSION will be displayed with the rate demand and drug totals If selected a loading dose will be delivered PROTOCOL Press PROTOCOL softkey at any time to display the protocol summary To return to the main screen press QUIT The pump will automatically operate from its internal battery if the pump is switched on without being connected to the AC power supply Each time the pump is switched ON check that the alarm beeps twice and that all the segments of the display the green and amber lights are illuminated during the self test routine LOCK 1 should not be turned from OFF to SET whilst the syringe extension set is connected to the patient 1000DF00135 Iss 5 00 00 NEW PATIENT 0 00 00 CLEAR PREVIOUS PATIENT INFORMATION YES PROTOCOL SUMMARY PCA Dose Drug x 1 0 mgimi Lockout 5 mins H mim MODIFY PROTOCOL CONFIRM PROTOCOL DRUG NAME PCA DOSE LOCKOUT CONTINUOUS 10 0 mg ml 1 0 mg ugih LOADING DOSE LIMIT DOSE RATE 0 ug 50 0 mg
51. trumpet Knowledge of system accuracy over various observation windows may be of interest when certain drugs are being administered Short term fluctuations in rate accuracy may have clinical impact depending on the half life of the drug being infused therefore the clinical effect cannot be determined from the trumpet curves alone Start up and trumpet curves may not be indicative of operation under negative pressure Differences in factors such as size and plunger force in compatible syringes produced by other manufacturers can cause variations in accuracy and trumpet curves as compared to those represented Additional curves for compatible syringes are available upon written request For applications where flow uniformity is a concern rates of 1 0 ml h or above are recommended Start up Trend BD Plastipak 50ml 1 0ml h Trumpet Curve BD Plastipak 50ml e 1 0ml h 2 0 e 10 E 0 0 E 0 30 60 90 120 0 10 20 30 Time mins Observation Window mins Start up Trend BD Plastipak 50 ml 5 0 ml h Trumpet Curve BD Plastipak 50 ml 5 0 ml h 10 0 15 f 10 norm z y 5 A PITTI TOT COTTO COTTI SI TRE TT TOTTI 5 0 d E VAAN 0 O AA Cie ee eee EVE EEE E Been n mn 40mm MH eene 0 0 7 15 B 0 30 60 90 120 0 10 20 30 Time mins Observation Window mins Trumpet curve values show minimum and maximum percentage rate error at 2 minutes and long term accuracy Trumpet Curve 1 0 ml h Trumpet Curve 1 0 ml h 15 10
52. ures Consult Technical Service Manual appropriately trained technical personnel or Cardinal Health for further information This pump is not intended to be used in the presence of a flammable anaesthetic mixture with air or oxygen or nitrous oxide Operating Pressure This is a positive pressure pump designed to achieve very accurate fluid administration by automatically compensating for resistance encountered in the infusion system The pumping pressure alarm system is not designed to provide protection against or detection of IV complications which can occur Alarm Conditions Several alarm conditions detected by this pump will stop the infusion and generate visual and audible alarms Users must perform regular checks to ensure that the infusion is progressing correctly and no alarms are operating 1000DF00135 Iss 5 7 32 Operating Precautions continued Electromagnetic Compatibility amp Interference e This pump is protected against the effects of external interference including high energy radio frequency emissions magnetic fields and electrostatic discharge for example as generated by electrosurgical and cauterising equipment large motors portable radios cellular telephones etc and is designed to remain safe when unreasonable levels of interference are encountered Therapeutic Radiation Equipment Do not use the pump in the vicinity of any Therapeutic Radiation Equipment Levels of radiat
53. urse call Specification cere e eese e eerte e eene etra ette nennen teas en estes teas esas ete seno 28 e Trumpet Curves amp Start up Curves eee eese eene eee se see scenes ecneee nonne eenes scene senese see neeseneeeseenecoee 29 e Service Contacts AA o q vtok r osssesos vvo st revo os sotu sosvosvss rtud esssS 30 e Document History c eeee cerne eene e eere etes teens etta nese ne neon nese nane ne sees isss vsus ns n conc visovi vesd see toas estos aan 30 e A Part iicsiccccscsssccnssscsccsuesdsensustocsevenvassoncacesssdeestncdesenausvedcosesnssdebsncussenedouuvacsensuactessesdswassessensbescosesess 31 e Lrrn sss o 31 e SA M AI 32 1000DF00135 Iss 5 1 32 Introduction The IVAC PCAM Syringe Pump herein after referred to as pump system allows a patient to maintain a consistent level of pain relief by providing self administration of a clinician prescribed dose of analgesic as and when it is required When the hand set is operated and the demand is within the parameters set by the clinician the pump will automatically administer a precise bolus dose of analgesic For enhanced monitoring and management of post operative acute pain within the hospital the pump provides convenient Patient Controlled Analgesia PCA and detailed information at the bed side about the patients use of PCA Central to an eff
54. uted in dose units of mass On all drug parameter screens except DRUG name press BACK to return to the previous parameter 1 Turn LOCK 1 to SET position while pressing down CJ button 2 Enter the access code using the buttons 3 Select DRUG NAMES AND SAFETY LIMITS from the menu Press ENTER CONFIGURATION OPTIONS 1 DRUG NAMES AND SAFETY LIMITS 2 GENERAL OPTIONS 3 PROTOCOL DEFAULT SET UP 4 CLOCK SET 4 Press MODIFY DRUG to modify the drug summary Use buttons to select desired values When field is correct press OK to store the selection 5 NAME Use buttons to set highlighted letter Press NEXT for next character up to twelve letters Press OK when complete 6 DOSE MODE Use buttons to change dose mode Changing dose mode resets Drug parameters to defaults and also resets Protocols that use this drug To change dose mode press CONFIRM Press OK when complete Note DOSE MODE will not be displayed if Mix Mass amp Volume Modes is disabled in General Options 7 MIN DRUG CONC Use buttons to set minimum concentration For volume mode concentration can be set to OFF the lowest value Press OK when complete 8 MAX DRUG CONC Use buttons to set maximum concentration Press OK when complete If min Drug conc is set to OFF this parameter does not appear 9 MIN LOCKOUT PERIOD Use buttons to set minimum lockout period Press OK when complete 10 MAX LOCKOUT PERIOD Use buttons to set maximum lockout period Pr
55. valve and 2 clamps 183 cm Priming Volume 1 8ml ly gt SCE PVC Syringe Extension Set with anti siphon valve and clamp 156 cm Priming Volume 0 6ml e C3 04102215162 PVC Syringe Extension Set with rotating luer 150 cm Priming Volume 2 9ml 04100010162 PVC Syringe Extension Set 105 cm Priming Volume 7 2ml For availability please contact your local Cardinal Health representative because new sets are continuously being developed for our customers It is recommended that extension sets are changed in accordance with the Directions for Use Carefully read the Directions For Use supplied with the extension set prior to use Please note these drawings are not to scale 1000DF00135 Iss 5 25 32 Maintenance Routine Maintenance Procedures To ensure that this pump remains in good operating condition it is important to keep it clean and carry out the routine maintenance procedures described below All servicing should only be performed by a qualified service engineer with reference to the Technical Service Manual TSM Circuit diagrams and component parts lists and all other servicing information which will assist the qualified service engineer in performing repair of the parts designated as repairable are available upon request from Cardinal Health If the pump is dropped damaged subjected to excessive moisture or high temperature immediately take it out
56. yringe NO Syringe type not locked to default syringe 19 Quiet mode YES Quiet mode enabled NO Quiet mode disabled 20 Generic Drug Enabled YES Allows Protocols to be set up to use a Generic Drug which is preset to maximum safety limits NO Disallows use of Generic Drug 21 Max Dose Limit Alarm YES Alarm is generated when max dose limit is reached 22 Mix Mass amp Vol Modes YES Allow a mix of mass and volume dose mode for drugs and protocols Clock Set 1 Select CLOCK SET from the Configured Options menu and press ENTER 2 Use the buttons to adjust the date and time displayed pressing NEXT to access the next field 3 When the correct time and date are displayed press OK to return to the Configured Options menu The internal clock is the reference against which the pump stores patient history and events Changing the clock will automatically reset the dates against which all new patient history is stored in the pump After changing the clock the pump will force a YES response the next time the NEW PATIENT screen appears This will clear the patient history Therefore patient history should always be recorded and if required printed prior to changing the clock Pre Set Protocol Set Up 1 Select PROTOCOL DEFAULT SET UP from the Configured Options menu and press ENTER 2 Press MODIFY PROTOCOL to display current protocol summary Use the buttons to highlight a field press ALTER to access the field and the butt
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