IVAC®598 Volumetric Pump
Contents
1. to 70 C Humidity 30 to 75 0 to 100 non condensing Atmospheric 700hPa 1060 hPa 500hPa 1060hPa Pressure System Accuracy 5 with a 1 96 standard deviation under specified conditions Note Accuracy specified under the following conditions Head height 30 76 2cm Test solution distilled water Environmental ambient temperature Back pressure 20 gauge needle Infusion Set Model 59073 59073 has been superseded by G59073 which is identical to the previous infusion set Temperature Starting the Infusion Set up Infusion Rate 1 999ml h in steps of 1ml h 0 OFF 1 9999ml in 1ml increments VTBI VI Total KVO rate 0 9999ml 5 ml h or current set rate if less than 5 ml h in primary operation 1000DF00161 Issue 1 BATTERY SPECIFICATIONS Rechargeable Sealed Lead Acid Automatically charges when the pump is connected to AC power Battery Life 6 hours 125ml h Battery Charging 24 hours Alarm Conditions Alarm conditions cause the pump to display specific alarm messages sound an audible alarm and except for the low battery and KVO mode alerts cease operation Alarm and display messages include FLO door hold bat batt OCCL RELOAD Air and Err See the ALARMS AND DISPLAY MESSAGES section of this DFU for message descriptions Memory Retention At 25 C the electronic memory of the pump will be retained for at least 6 months when not powered up2. Alarm and Display Messages If the pump sounds an alarm note the alarm message and press the RUN HOLD switch to place the pump on hold and silence the alarm Use the following guide to eliminate the cause of the alarm After correcting the condition press the RUN HOLD switch again to restart the infusion Displays Flashing Message with Audible Alarm Upstream Occlusion Check the tubing clamp and container for probable causes and correct Repeated alarms may indicate pump mechanism requires cleaning Refer to the CLEANING section of this DFU FLO Too few or no drops The flow sensor has detected no or insufficient flow Check tubing clamp EU container and flow sensor for probable causes and correct Drip chamber problem Abnormal drops detected Drip chamber fogged or overfilled Shake drip Flow sensor disconnected while pump in operation chamber to clear sidewalls reduce fluid level in drip chamber Plug flow sensor into connector on rear of instrument Possible faulty flow sensor E03 Too many drops Flow detected in excess of the set rate Flow detected while the pump is on hold or in the start up mode Check that the set tubing is completely installed in the mechanism that the mechanism pinches off the tubing and that the drip chamber is not swinging excessively or overfilled ome pee pos Check for kinked tubing clogged filter Repeated alarms may indicate pump posu ES requires cleaning Refer to the CLEANING section of
3. No Filter Length 260cm a RM cce cem Reg fosa oll 2 fu X0 oS ee 2 2 e a J enm T P 4 d as f ae G59073 G59093 G59173E G59273E No Filter 15 Micron Filter 1 SmartSite Needle Free Valve Port 2 SmartSite Needle Free Valve Ports Length 260cm d a nee a nia SO a Aae G59293E 2 SmartSite Needle Free Valve Ports No Filter Length 260cm Length 260cm c r R S G59593 15 Micron Filter Length 270cm No Filter Length 260cm No Filter Length 260cm oe pe Mo a e rRe pame P ar av G59693E G59793E 1 SmartSite Needle Free Valve Port 15 Micron Filter Length 255cm 2 SmartSite Needle Free Valve Ports 15 Micron Filter Length 255cm zd 4 mem E e nt gt q 1 lt j B a e an 5 G59903 G59394 G59016 15 Micron Filter 15 Micron Filter 15 Micron Filter Length 250cm Length 270cm Length 275cm c xd s i 2 o e i NE Lu ar Eu e a ROGER NN fme aan 4 G59953 G59643 G59103E 15 Micron Filter Low Sorbing Infusion Set Length 260cm 15 Micron Filter Opaque white PVC Infusion Set Length 250cm 2 SmartSite Needle Free Valve Ports
4. amp Flow Rate Curves 19 20 Warranty 23 24 24 CardinalHealth Alaris SmartSite and IVAC are registered trademarks of Cardinal Health Inc or one of its subsidiaries All other trademarks belong to their respective owners 2007 Cardinal Health Inc or one of its subsidiaries All rights reserved 1000DF00161 Issue 1 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 subsidiaries is strictly forbidden e Cardinal Health 1180 Rolle Switzerland www cardinal com uk alaris
5. nominal 6 to 8 psi Lightweight and portable with self contained rechargeable battery Automatic flow shutoff with activation of audible and visible alarms Audible and visible low battery alert about one hour before battery alarm Optional flow sensor Model 192 Optional remote computer monitoring capability 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 operating rooms and accident and emergency rooms This pump is suitable for use by appropriately trained clinicians or nurses This pump can be used for Intravenous modes supporting fluid therapy drug therapy blood transfusions and parenteral nutrition About this Manual The user must be thoroughly familiar with the 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 the pump These settings and values are for illustrative use only The complete range of settings and values are detailed in the specifications section 1000DF00161 Issue 1 2 24 Features of the IVAC 598 Volumetric Pump Main Display Display Indicators a Door Keyboard D CAM Follower PET AEN AC power il CAM Follower Indicator Assembly Latch a M Model 598 Air In
6. 46 8 544 43 200 Fax 46 8 544 43 225 22 24 US Cardinal Health 10221 Wateridge Circle San Diego CA 92121 USA Tel 1 800 854 7128 Fax 1 858 458 6179 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 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 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 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 wit
7. DERE SA PNE VEES USE 18 e Trumpet and Flow Rate Curves ccccccccc cece cece cece ee seen 19 e Products and Spare Parts oosvssua s ee ki e a veu P EE PECPPETPN NU OER a class NEAR EVE wes 21 e Service Contacts ioa p EUR CURATUR UNT os eR IUG UE SUN EVER SIE TURA RUN ER REUS I Oe A10 SUR RUN USE Ro Le RR 22 e Warranty oe yov iia aie es ew EVE OVV ETUPEREC w 9 Gib wre wi CLIP VRPEOKVER EE RNC IE CVV P SUVS 23 e il de DT T E 24 1000DF00161 Issue 1 1 24 Introduction The IVAC 598 Volumetric Pump hereinafter referred to as Pump is a small lightweight volumetric infusion pump that provides accurate and reliable infusions over a range of rates The IVAC 598 Volumetric Pump automatically regulates the infusion rate of intravenous solutions The microprocessor based pump uses a linear peristaltic volume displacement mechanism to regulate fluid flow at the desired rate The pump s many features include Easy setup and operation Advisory prompts to assist in setup and operation Quick start mode Diagnostic alarm messages to simplify operation and troubleshooting Easy viewing of rate and volume to be infused VTBI settings Wide range of infusion rates 1 to 999 ml h in 1 ml h increments Volumetric rate entry Volume to be infused capability with automatic switchover to the keep vein open KVO rate Integral ultrasonic air in line detection Detection of upstream downstream occlusions e Low occlusion pressures
8. Line Volumetric Pump NN 4 Sensor FE Cd PE Connector Test Connector Cover AC Power rg Connector 4 O x Lj us Flow Sensor Connector Fuse Holders 1000DF00161 Issue 1 3 24 Controls and Indicators Controls Symbol ON OFF switch Press once to switch the pump ON Press and hold down for approximately 3 seconds to switch the pump OFF RUN E RUN HOLD switch Starts and stops pump infusions Silences cancels alarms VOLUME TO BE INFUSED switch Sets value of Volume To Be Infused VTBI CLEAR VOLUME switch Resets volume infused value to zero READ VOLUME switch Displays volume infused value CHEVRON switches Double chevrons single chevrons for faster slower increase or decrease of infusion rate and volume values Indicators Symbol rf AC POWER indicator When illuminated the pump is connected to an AC power supply and the battery is being charged VTBI The value displayed is the Volume To Be Infused The pump is infusing at the Keep Vein Open KVO rate of 5ml h or current rate whichever is less The value displayed is the volume infused RATE The value displayed is the current infusion rate pm Millilitres The value displayed is the VTBI or volume infused value Millilitres hour The value displayed is the infusion rate Infusion indicator Three horizontal bars in the left hand display position flash sequentially when the pump is infusing 1 Ji m I
9. audible alarms Users must perform regular checks to ensure that the infusion is progressing correctly and no alarms are operating Electromagnetic Compatibility and 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 e In some 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 e This pump isa CISPR 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 electromag
10. this DFU pri nan Set adapter improperly loaded into air detector Reload adapter into air detector Press firmly until flush pr DAD Air detector senses air in tubing Ensure air detector is clean Reload set adapter into air detector Press firmly until LI S flush AIR ra Set adapter improperly loaded into air detector Air detector senses air in tubing or set adapter Remove air according to hospital protocol Ensure air detector is clean dislodged from air detector pooR Door opened during infusion or upon entering run Check set for proper installation Close door and re start pump mode BATT Battery has insufficient charge to operate pump Plug power cord into an AC outlet Pump will be operable immediately Two minutes have elapsed since pump was placed Press RUN HOLD switch once to silence alarm and again to restart pump If switch on hold or into start up mode or a switch may be is stuck contact qualified service personnel stuck If the pump is in start up mode and on battery power it will automatically power off if left in this alarm for 3 minutes nn Pump is in KVO mode Set the VTBI value to a non zero value KVOLILI or less two beeps ERR Possible pump malfunction Cycle power off then on If problem persists do not use pump Contact qualified R service personnel followed by a letter or number Pump mechanism requires cleaning Refer to the CLEANING section of this DFU Momentary P
11. 1 Burette 150ml Length 270cm apo ants EN wa Blood Transfusion sets I o c EH ee N o j T h i E cp a n G59024 G59393E 200 Micron Filter 2 SmartSite Needle Free Valve Ports Length 295cm 200 Micron Filter Length 270cm ccn S ee ec P a tS B D uf P 8 Coe G59980 G59895 200 Micron Filter 200 Micron Filter Length 250cm Length 255cm i o S amp r j gt n O N i 2 X G59893E 1 SmartSite Needle Free Valve Port 200 Micron Filter Length 255cm A gt Ip py ca e 7783 G59894 200 Micron Filter Length 255cm cnp gt ros a Bie a eer It is recommended that infusion sets are changed according to the instructions in the Changing the Infusion Set section Carefully read the Directions For Use supplied with the infusion set prior to use Please note these drawings are not to scale 1000DF00161 Issue 1 18 24 Trumpet and Flow Rate Curves In this pump as with all infusion systems the action of the pumping mechanism and variations cause short term fluctuations in rate accuracy The following curves show typical performance of the system in two ways 1 the accuracy of fluid delivery over various time periods is measured trumpet curves and 2 the delay in onset of fluid flow when infusion commences start up curves Trumpet curves are named for their characteristic shape The
12. Air Sensor Integral Ultrasonic Sensor Maximum time for activation of occlusion alarm Time to alarm at 1ml h is nominally 35 minutes Time to alarm at 100ml h is nominally 0 31 minutes Air in Line Accuracy 100 ul 50 ul Maximum Occlusion Alarm Pressure 11 psi 569 mmHg Nominal 6 to 8 psi Post Occlusion Bolus Bolus volume generated at 1 ml h when the occlusion alarm threshold is reached 0 5 ml Bolus volume generated at 100 ml h when the occlusion alarm threshold is reached 0 5 ml Critical Volume 25 ml at 999 ml h is maximum incremental volume which can occur in case of single point failure 15 24 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 components 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 of service for examination by a qualified service engineer All preventative and corrective maintenance and all such activities shall be performed at a compliant wo
13. IVAC 598 Volumetric Pump Directions For Use English CardinalHealth Page e riseeeliisii pcm 2 e About this Manual scs s err vet Ru ORE en EI RR E Fe EXE RU EP E NOEPETAT E NE RA UA VEEYS 2 e Features of the IVAC 598 Volumetric Pump eeeeeeeeee eene nnn 3 e Controls and Indicators oot vv ora der EE ee Lex eU PTUS ES ERUTO UU VS KO RR amie S Ip 4 e Symbol Definitions cee cece cece reece reece hehehe hh nnn 5 e Operating Precautions ccc ccc ccc cence eee enhn nnn 6 e Getting Started eoe oscura tV EUR ERERTAR UNI TN EET dee PRA TEE RRSDCIR A EPA TENE NM Ve 8 Loadingan Infusion Set i eoe eee yero e E e ER OPUS EXER U CI EE nie FSK Ee RP were MS es eR RI Rc 9 e Starting the Inf slOni zc sva Een ehe ERG TCR NE EAT AT CN IS eROIDUN M PV T DOE C Te ae ENT E 10 e Basic FeatUres cicios oss QURARRRRERRENUA TN VARIAR RESUME UNE TEN UON VER ISI RUNS ERREUR GRAM 11 e Alarm and Display Messages cesses heh hh hn 12 o Flow Sensor Operation Optional eeeeeeeee eere nnn 14 e Specifications ves phone Senes xime pU CH eei nse eran ei e e SIS Re u s x IRURE Wii ime M MEC Des Res is aU US 15 e LIETACIEDISEEEETTERIDIIIQOQILSLOOLS 1 2002102 07 DLL 16 e Cleaning and Storage ccc ccc c cece eee c renee cence eee e eee nese hh nn 17 Oo PICDDII e C 17 e Infusion Sets 5 ooreis e E UE ERE RP ENEU V EUN SES E DNCUS PRA sees mes
14. 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 1000DF00161 Issue 1 16 24 Cleaning and Storage Cleaning the pump 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 Before cleaning always switch off and disconnect n Brand Concentration from the AC power supply Do not allow liquid to enter Hibiscrub 20 v v the casing and avoid excess fuig build up on the pump Virkon 196 w v Do not use aggressive cleaning agents as these may Do not use the following disinfectant types damage the exterior surface of the pump NaDcc such as PRESEPT Do not steam autoclave ethylene oxide sterilise or Hypochlorites such as CHLORASOL immerse this pump in any fluid Aldehydes such as CIDEX Cationic Surfactants such as Benzalkonium Chloride lodine such as Betadine Concentrated Isopropyl alcohol based cleaners will degrade plastic parts Storing the pump If the pump is to be stored for an extended period it should be first cleaned and the internal batt
15. aris Gateway Workstation For Docking Station and Workstation contact local customer services representative to obtain configurations availability and part numbers Spare Parts A comprehensive list of spare parts for this pump is included within the Technical Service Manual The Technical Service Manual 1000SM00016 is available in electronic format on the World Wide Web at www cardinal com uk alaris A username and password are required to access our manuals Please contact a local customer services representative to obtain login details 303910 FUSE 1 5A 250V NORM BLO 129471 BATT PACK 80 90 SER AC Power Lead UK AC Power Lead European 1000DF00161 Issue 1 21 24 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 AU Cardinal Health 8 167 Prospect Highway Seven Hills NSW 2147 Australia Tel 61 2 9838 0255 Fax 61 2 9674 4444 Fax 61 2 9624 9030 BE Cardinal Health Otto De Mentockplein 19 1853 Strombeek Bever Belgium Tel 32 2 267 38 99 Fax 32 2 267 99 21 CA Cardinal Health 235 Shields Court Markham Ontario L3R 8V2 Canada Tel 1 905 752 3333 Fax 1 905 752 3343 CN Cardinal Health Shanghai Representative Office Suite 9B Century Ba Shi Building 398 Huai Hai Rd M Shanghai 200020 China Te
16. ate and ml hr indicators will light The display will show rate alternating with the rate value 4 Use the chevron switches A Y and V to set or change the infusion rate 5 Toread the total infused volume press and hold the READ VOL switch To clear the total infused volume press and hold the CLEAR VOL switch until the display reads 0000 four zeros 6 Press VOL TO BE INF if required The VTBI and ml indicators will light The display will alternate between VTBI and the current VTBI value When operating the pump without a flow sensor a VTBI must be entered This value is independent of any volume already infused If the VTBI is at 0000 and the RUN HOLD switch is pressed the prompt VTBI will be displayed When operating the pump with a flow sensor and a VTBI is not desired press the Y switch until OFF is displayed Use the chevron switches A N Y and V to set VTBI 8 Connect the infusion set to the patient access device 9 Press RUN HOLD to start infusion The run indicator will appear when the pump mechanism begins to operate Changing the infusion rate 1 Press the RUN HOLD switch to place the pump on hold 2 Adjust rate by using the chevron switches 3 Restart the pump by pressing the RUN HOLD keys Clearing total volume infused 1 Press the RUN HOLD switch to place the pump on hold 2 Press and hold CLEAR VOL for 2 seconds until display shows 0000 3 Restart the pump by pressing the RUN HOLD keys Changin
17. er 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 Document History Revision CO Number Date 1 7330 August 2007 1000DF00161 Issue 1 23 24 Air in line Accumulated air 12 single bubble 12 Air vent 6 Battery 15 Battery Operation 16 Blood infusion sets See Infusion sets Blood Changing the Fluid Container 11 Changing the Infusion Set 11 Cleaning and Storage 17 Collapsable bags 6 Contents 1 Controls and Indicators 4 Disposal 17 Document History 23 Earth Conductor 7 Electromagnetic Compatibility 7 Features 3 Flow Rate Curves See Trumpet amp Flow Rate Curves Getting Started 1 8 10 11 Hazards 7 Infusion sets Blood 18 Standard 18 Introduction 2 1000DF00161 Issue 1 KVO 11 Latex Content 7 Loading an Infusion Set 9 Operating Precautions 6 7 Pressure 15 Prime 10 11 Replacing the Mains Fuses 16 Routine Maintenance Procedures 16 Semi Rigid containers 6 Service Contacts 22 Set change interval 11 SmartSite Needle Free System Instructions 11 Specifications 15 Standard infusion sets See Infusion sets Standard Starting the Infusion 10 Test 16 Test Routines 16 Trumpet
18. ery 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 Cleaning and storing the infusion set The infusion set is a disposable single use item and should be discarded after use according to hospital protocol Cleaning the Flow Sensor Before the transfer of the flow sensor to a new infusion set and periodically during use clean the flow sensor by wiping over with a lint free cloth lightly dampened with warm water and a standard disinfectant detergent solution Ensure the connector does not get wet Dry flow sensor before use To aid cleaning of flow sensors which have been heavily soiled contaminated or if the handle operation is not free moving then the flow sensor may be immersed and soaked in clean soapy water see M the inside of the spring mechanism can be cleaned by activating it whilst submerged in the water After cleaning the sensor should be allowed to dry fully prior to use The plug of the flow sensor must not be immersed in water as damage will occur 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 household was
19. f the AC power indicator light does not illuminate remove the pump from service It is recommended that the AC power fuses are only replaced by a qualified service engineer The fuses in the pump should only be replaced by a qualified service engineer For further information regarding the replacement of fuses refer to the Technical Service Manual If the fuses continue to blow an electrical fault may have occurred and the pump and power supply should be 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 a minimum of 6 hours of operation at 125ml h infusion rate When connected to the AC power supply for 24 hours whether the pump is in use or not a battery pack will be fully charged The battery is maintenance free sealed Lead Acid 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 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 replaces the battery For further information regarding the replacement of batteries refer to the Technical Service Manual
20. ffected and should be monitored closely Uncontrolled flow may result if the infusion set is not properly isolated from the patient i e closing a tap in the set or activating an in line clamp roller clamp The infusion set may be fitted with an in line clamp which can be used to occlude tubing in case it is required to stop fluid flow The IVAC 598 Volumetric Pump is a positive pressure pump which should use infusion sets fitted with luer lock fittings or equivalent locking connectors To infuse from a burette close the roller clamp above the burette and open the clamp on the vent on top of the burette Discard infusion set if the packaging is not intact or the protector cap is detached Ensure sets are not kinked as this may occlude the tubing Using Collapsible bags Glass Bottles amp Semi Rigid containers It is recommended that the air vent be opened on the IVAC 598 Volumetric Pump set if using glass bottles or semi rigid containers to reduce the partial vacuum formed as the fluid is infused from the container This action will ensure the pump can maintain volumetric accuracy whilst the container empties The action of opening the air vent for semi rigid containers should take place after the spiking of the container and priming of the drip chamber Steps for the Collapsible bags Steps for Semi rigid containers Follow steps 1 to 3 as shown for the semi rigid containers however do not open vent as i
21. g the Volume To Be Infused 1 Press the RUN HOLD switch to place the pump on hold 2 Press the VOL TO BE INF switch 3 Set new volume by pressing the chevron switches OFF can also be selected when a flow sensor is in use see Notes below 4 Restart the pump by pressing the RUN HOLD switch Notes 1 Without a flow sensor in use a VTBI value must be entered otherwise the pump displays VTBI when the pump is restarted 2 With a flow sensor in use a VTBI value isn t required and OFF can be selected if required 1000DF00161 Issue 1 10 24 KVO Keep Vein Open Rate When using a flow sensor and the solution container empties the pump will alarm and FLO will be displayed When not using a flow sensor and the pump has counted down to zero from the preset volume to be infused value it automatically switches to a 5 ml h KVO rate or current rate whichever is less lights the KVO indicator and produces two audible beeps every 5 seconds 1 To exit the KVO mode press the RUN HOLD switch to place the pump on hold 2 Press the VTBI switch Set the VTBI to a value greater than zero 3 Press RUN HOLD to continue pump operation Changing the Infusion Set Press RUN HOLD switch to place the pump on hold Close in line clamp and ensure the access to the patient is isolated Disconnect the infusion set from the patient Open pump door and remove infusion set from the pump and discard the set and fluid container according to hospital protoc
22. h 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 Health 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 oth
23. il Il i I TTE E iil nin D II Ii I Il ii Il Il WII z 98 E 08 4 2 a LL 0 6 8 0 6 LL 04 04 02 02 0 T ji T T T T 0 T T T T T T 0 20 40 60 80 100 120 0 20 40 60 80 100 120 Time minutes Time minutes Trumpet Graph at 1 0ml h Initial Period Trumpet Graph at 1 0ml h 24 Hour 30 30 204 20 z 5 104 E 10 4 m g g ui E H v g o s 2 S o M 2 E LL 10 4 404 204 20 30 T T T T T T T 30 2 6 10 14 18 22 26 30 2 6 10 14 18 22 26 30 Observation Window Minutes Observation Window Minutes Minimum Rate Error Maximum Rate Error Overall Mean Error Minimum Rate Error Maximum Rate Error Overall Mean Error Start up Graph at 100ml h Initial Period Start up Graph at 100ml h 24 hour 80 70 E z 64 o ki E s z g 2 ni 40 z 2 30 us 20 10 04 T T T T T T 0 20 40 60 80 100 120 0 20 40 60 80 100 120 Time minutes Time minutes 1000DF00161 Issue 1 19 24 Trumpet amp Flow Rate Curves continued Flow Rate Error 96 Flow Rate ml h Flow Rate Error 96 Trumpet Graph at 100ml h Initial Period 381 3 T T T T 6 10 14 18 22 26 30 Observation Window Minutes Maximum Rate Error Overall Mean Error Minimum Rate Error Start up Graph at 999ml h Initial Period 0 8 4 0 6 04 0 2 T T T T T 0 20 40 60 80 100 120 Time minutes Trumpet Graph at 999
24. l 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 ES Cardinal Health Avenida Valdeparra 27 28108 Alcobendas Madrid Espana Tel 34 91 657 20 31 Fax 34 91 657 20 42 FR Cardinal Health Immeuble Antares Technoparc 2 rue Charles Edouard Jeanneret 78300 POISSY France T l 33 1 30 06 74 60 Fax 33 1 39 11 48 34 GB Cardinal Health The Crescent Jays Close Basingstoke Hampshire RG22 4BS United Kingdom Tel 44 0800 917 8776 Fax 44 1256 330860 HU Cardinal Health D brentei t r 1 H 1013 Budapest Magyarorsz g Tel 36 14 88 0232 Tel 36 14 88 0233 Fax 36 12 01 5987 1000DF00161 Issue 1 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 NL Cardinal Health Kantorenpand Hoefse Wing Printerweg 11 3821 AP Amersfoort Nederland Tel 31 33 455 51 00 Fax 31 33 455 51 01 NO Cardinal Health Solbr veien 10 A 1383 ASKER Norge Tel 47 66 98 76 00 Fax 47 66 98 76 01 NZ Cardinal Health 14b George Bourke Drive Mt Wellington Auckland PO Box 14234 Panmure Auckland Tel 09 270 2420 Freephone 0508 422734 Fax 09 270 6285 SE Cardinal Health Hammarbacken 4B 191 46 Sollentuna Sverige Tel
25. ml h Initial Period T T T T 2 6 10 14 18 22 26 30 Observation Window Minutes Maximum Rate Error Overall Mean Error Minimum Rate Error Trumpet Graph at 100ml h 24 Hour S 5 a ui o 5 Sy c z 2 x 4 8 12 16 T T T T T T T 2 6 10 14 18 22 26 30 Observation Window Minutes Minimum Rate Error Maximum Rate Error Overall Mean Error Start up Graph at 999ml h 24 hour 14 rin en AeA APN peel Aa ANRC eR gh RP 08 4 064 E E 2 SG 044 z 2 ui 02 0 T T r T T T T 0 20 40 60 80 100 120 Time minutes Trumpet Graph at 999ml h 24 Hour 10 8 6 S a4 8 i 2 g c 0 o 2 4 is 4 6 8 10 T T T T T T T 2 6 10 14 18 22 26 30 Observation Window Minutes Minimum Rate Error Maximum Rate Error Overall Mean Error Note The typical flow rate and trumpet curves are achieved using a recommended infusion set 1000DF00161 Issue 1 20 24 Products and Spare Parts Alaris Infusion System Range of products in the Alaris Infusion System product family are 80013UN01 Alaris GS Syringe Pump 80023UNO01 Alaris GH Syringe Pump 80023UN01 G Alaris GH Syringe Pump with Guardrails Safety Software 80083UN00 xx Alaris DS Docking Station 80033UND1 G Alaris CC Syringe Pump with Guardrails Safety Software 80203UNSOx xx Al
26. mount the pump such that the infusion stand becomes top heavy or 1000DF00161 Issue 1 8 24 Getting Started Continued Loading an Infusion Set Ensure the appropriate infusion set for the fluid drug to be infused has been selected Follow the instructions supplied with the individual infusion set Only use IVAC 598 Volumetric Pump infusion sets Refer to Infusion Sets section of the DFU Position the fluid container to avoid spillage onto the pump Ensure that the tubing is inserted completely into the top set retainer through to the tubing guide avoiding any slack Top set retainer 1 Prime the IV infusion set slowly and close the roller clamp 2 Open the door 3 Load the primed IV infusion set Open the latch Load the upper tubing segment into the top set retainer Insert lower tubing segment into the Air In Line Sensor Close the latch ensuring the set is enclosed 4 Close the door x Latch 5 Open the roller clamp Ensure no fluid flows i p p Infusion Set Q shown open Air In Line Sensor 1000DF00161 Issue 1 9 24 Getting Started Continued Starting the Infusion 1 PRIME AND LOAD THE SET Refer to Loading an Infusion Set 1 Ensure the pump is connected to an AC power supply also operates from battery 2 Connect flow sensor if required See Flow Sensor Operation 3 Press the ON OFF switch to power on the pump The pump will power up and the r
27. n step 4 but prime the 3 ue 4 set as per step 5 Ensure the bag outlet 4 Spike the Fill drip sg Open the air vent II container chamber to to allow pressure is fully pierced before filling the drip AN fill line equalisation ready chamber for infusion 5 Prime the set by 1 opening closing the Close the roller clamp roller clamp 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 fluid channels of such pumps Typical examples of those pumps are used during dialysis bypass or cardiac assist applications The pump is suitable for use in all establishments other than domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes 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 The pumping pressure alarm system is not designed to provide protection against or detection of extravasation or tissuing complications which can occur 1000DF00161 Issue 1 6 24 Operating Precautions Continued Poo Alarm Conditions d Alarm Conditions e Several alarm conditions detected by this pump will stop the infusion and generate visual and
28. netic radiation which is within the levels specified by IEC EN60601 2 24 and IEC EN60601 1 2 If the pump interacts with other equipment measures should be taken to minimise the effects for instance by repositioning or relocation Earth Conductor e The IVAC 598 Volumetric Pump is a Class device therefore must be earthed when connected to an AC power supply e This pump also has an internal power source e When connected to an external power source a three wire Live Neutral Earth supply must be used If the integrity of the external protective conductor on the AC power cable has been compromised the pump should be disconnected from the AC power source and operated utilising the internal battery An explosion 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 p Dangerous Voltage An electrical shock hazard exists if the pump s casing is opened or removed Refer all servicing to qualified service personnel If this 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 e If this pum
29. nfusion indicator with Flow Sensor in use Upper two horizontal bars convert to a square when a la l drop is detected by the flow sensor in the drip chamber Flashing Display When the pump is operating on battery power the Display flashes on off 1000DF00161 Issue 1 4 24 Symbol Definitions Labelling Symbols Symbol Attention Consult accompanying document Potential Equalisation PE Connector Type CF applied part Degree of protection against electrical shock Protected against vertically falling drops of water Device complies with the requirements of the EC Directive 93 42 EEC Registered with the CE Mark Date of Manufacture Manufacturer Important Information Not for Municipal Waste Fuse rating 1000DF00161 Issue 1 5 24 Operating Precautions Lou Sin Sets ed To ensure correct and accurate operation only use Cardinal Health single use infusion sets described in this Directions For Use It is recommended that infusion sets are changed according to the instructions in the Changing the Infusion Set section Carefully read the Directions For Use supplied with the infusion set prior to use Use of non specified infusion sets may impair the operation of the pump and the accuracy of the infusion When combining several apparatus and or instruments with infusion sets and other tubing for example via a 3 way tap or multiple infusion the performance of the pump may be a
30. nsor wherever possible IVAC Flow Sensor Model 192 7 Handles Pull back handles VTBI VOL 1 Plug the flow sensor into the flow sensor interface located on the top rear part of the pump 2 Attach the IVAC Flow Sensor Model 192 to the drip chamber of the infusion set by pulling back the handles Refer to the illustration above 3 Proceed with load priming and set up instructions as described in section Getting Started NOTE Ensure drip chamber is half full and upright Always attach the flow sensor before you start an infusion Avoid using the flow sensor in direct sunlight Always ensure lens is clean 1000DF00161 Issue 1 14 24 Electrical Protection Class Type CF Electrical Mechanical Safety Complies with IEC EN60601 1 and IEC EN60601 2 24 Electro Magnetic Compatibility EMC Complies with IEC EN60601 1 2 and IEC EN60601 2 24 Electrical Safety IEC EN60601 1 Earth Leakage Current Normal Condition Maximum 100pA rms ungrounded at 220V rms Classification Continuous mode of operation Portable Equipment AC Power Supply 220 to 240V AC 50 60 Hz 0 07A 3 wire grounded system Fuse Type 2XT63 mA 250V Dimensions 133mm w x 193mm h x 184mm d Weight approx 2 7kg excluding power cable Protection against fluid ingress IPX1 Protected against vertically falling drops of water Environmental Specifications 1 f410 C to 40 C to 40 C 4o cto 70 C
31. ol Prepare the new infusion set load infusion set into pump and close the door see Loading the Infusion Set Restart infusion see Getting Started OP ow NS When changing the infusion set or the fluid container use aseptic technique according to hospital protocol It is recommended that infusion sets are changed in accordance with the Directions For Use Carefully read the Directions For Use supplied with the infusion set prior to use The set change interval is 24 hours Changing the Fluid Container Press RUN HOLD switch to place the pump on hold Remove bag spike on infusion set from empty used container Discard empty used container according to hospital protocol Insert spike into new container Squeeze the drip chamber approximately half full or up to fill line if the drip chamber is marked with fluid Restart infusion see Getting Started wk Wn gt When changing the infusion set or the fluid container use aseptic technique according to hospital protocol It is recommended that infusion sets are changed in accordance with the Directions For Use Carefully read the Directions For Use supplied with the infusion set prior to use SmartSite Needle Free System Instructions SmartSite Needle Free Valve is designed to permit safe gravity flow and automated flow injection and aspiration of fluids without the use of needles by utilising luer lock and luer slip connectors Precautions Discard if packaging i
32. p behaves abnormally remove from service and contact a qualified service engineer Latex Content e The IVAC 598 Volumetric Pump does not contain any latex 1000DF00161 Issue 1 7 24 Getting Started 1 Before operating the pump read this Directions For Use DFU manual carefully Initial Set Up 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 598 Volumetric Pump Directions For Use CD ACPower Cable as requested Protective Packaging 3 Connect the pump to the AC power supply for at least 6 hours to ensure that the internal battery is charged verify that the AC Mains indicator is lit The pump will automatically operate from its internal battery if the pump is switched on without being connected to the 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 Pole Clamp Installation A pole clamp is fitted to the rear of the pump and will provide secure fixing to vertical I V poles of a diameter between 12 and 26 mm Pole Clamp 1 Unscrew the clamp to leave enough room for the size of the pole D 2 Place pump around pole and tighten screw until the clamp is secured to the pole unstable t Never
33. rk place in accordance with the information supplied Cardinal Health Alaris Products 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 INTERVAL ROUTINE MAINTENANCE PROCEDURE As per Hospital policy Thoroughly clean external surfaces of the pump before and after prolonged period of storage At least once per year i Inspect AC power supply plug and cable for damage Refer to TSM for identification of 2 Perform functional tests as outlined in the Technical Service Manual parts Operate the pump on battery power until the battery low alarm then charge the battery to confirm battery operation and charging Inspect mechanism for damage or excessive wear Clean and lubricate the mechanism as outlined in the Technical Service Manual 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 Mains 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 may have blown First check the power supply fuse in the AC mains plug if fitted I
34. s not intact or protector caps are unattached If Needle Free Valve is accessed by a needle in an emergency the valve will be damaged causing leakage Replace Needle Free Valve immediately Needle Free Valve contraindicated for blunt cannula system DO NOT leave slip luer syringes unattended DIRECTIONS Use Aseptic Technique 1 Prior to every access swab top of Needle Free Valve port with 70 Isopropyl alcohol 1 2 seconds and allow to dry approximately 30 seconds NOTE Dry time is dependent on temperature humidity ventilation of the area 2 Prime valve port If applicable attach syringe to Needle Free Valve port and aspirate minuscule air bubbles 7 3 Replace every 72 hours for stand alone valves However if the valve is part of the set then the set change interval is as per the complete set or 100 activations which ever occurs first For infusions of blood blood products or lipid emulsions replace infusion set every 24 hours NOTE During use of Needle Free Valve port fluid may be observed between the housing and blue piston This fluid does not enter the fluid path and requires no action For product questions or needle free valve educational materials contact your Cardinal Health Alaris Products representative The Center for Disease Control Intravenous Nurses Society USA and other organizations publish guidelines useful in developing facility guidelines Consult facility protocols aii 1000DF00161 Issue 1 11 24
35. te 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 environmental factors into consideration To ensure no risk or hazard remove the internal rechargeable battery and the Nickel Metal Hydride 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 1000DF00161 Issue 1 17 24 The IVAC 598 Volumetric Pump uses standard single use disposable infusion sets The user is responsible for verifying the suitability of a product used if it is not recommended by Cardinal Health G59033E 2 SmartSite Needle Free Valve Ports 15 Micron Filter amp 0 2 Micron In Line Filter Length 265cm Standard infusion sets G59123E 2 SmartSite Needle Free Valve Ports 15 Micron Filter amp 1 2 Micron In Line Filter Length 260cm G59021 No Filter Length 267cm G59027E 3 SmartSite Needle Free Valve Ports
36. ump has automatically shut off due to low battery Plug the power cord into an AC outlet The pump will be operable after several display that charge seconds disappears shortly after power up 1000DF00161 Issue 1 12 24 Alarm and Display Messages Alternating Messages BAT Low battery battery has about 1 hour or less of Plug the power cord into an AC outlet f useable charge remaining alternating with rate display pump continues to run nn Pump has been placed on hold This is not an alarm Press RUN HOLD switch once to restart infusion HOLD condition alternating with rate value RATE Pump is in rate setting mode This is not an alarm Press RUN HOLD or VOL TO BE INF switch to advance to VTBI setting mode condition alternating with rate value TBI Pump is in VTBI setting mode This is not an alarm Press RUN HOLD switch once to start infusion vio i condition alternating with VTBI value Prompts T VTBI value is at zero Set the VTBI value to a non zero value or operate the pump with a flow sensor n and set VTBI to OFF I 1000DF00161 Issue 1 13 24 Flow Sensor Operation Optional if a significant deviation from the infusion rate occurs The flow sensor will also be able to detect empty containers For 1 The flow sensor automatically detects drops falling in the drip chamber The flow sensor will cause the pump to alarm this reason we recommend use of a flow se
37. y 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 the 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 and the degree of inter vascular integration the clinical effect cannot be determined from the trumpet curves alone The start up curves represent continuous flow versus operating time for two hours 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 Start up Graph at 1 0ml h Initial Period Start up Graph at 1 0ml h 24 hour 2 2 184 18 164 16 144 144 2 Hil Bi ILL E TIE l FORUM M QAUM WIL JUI TOOL NIE JL n R i MA ANN A AM JUL MA AMT E u E oH i i WIN INI
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