Alaris®GW Volumetric Pump
Contents
1. Disposal Information on Disposal for Users of Waste Electrical amp Electronic Equipment This amp symbol on the product and or accompanying documents means that used electrical and electronic products should not be mixed with household 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 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 1000DF00107 Issue 3 26 36 Class Equipment 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 EN 60601 1 Typical earth leakage current 40pA Dielectric Strength Proof strength test 1 7kV dc live and neutral to earth for 10s Per2. Storing the pump If the pump is to be stored for an extended 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 See the Technical Service Manual for further information regarding the charging of the RTC Battery BT1 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 t 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 t The plug of the flow sensor must not be immersed in water as damage will occur
3. The pump is on hold Press C9 to return to infusion or press to return to set up The pump has been left unattended for 2mins Attend to pump and infusion has not started Automatic set check Allow test to complete before operating the pump further 1000DF00107 Issue 3 20 36 Flow Sensor Operation Optional cause the pump to alarm if a significant deviation from the infusion rate occurs The flow sensor will also be able to t The flow sensor automatically monitors the infusion flow rate through the drip chamber The flow sensor will detect empty containers For this reason we recommend use of a flow sensor wherever possible Model 180 Flow Sensor S Handles Pull back handles 7 Flow sensor interface 1 Plug the flow sensor into the flow sensor interface located on the top rear part of the pump 2 Attach the Model 180 Flow Sensor 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 1000DF00107 Issue 3 21 36 Compatible Infusion Sets The pump uses standard single use disposable Infusion sets with Luer lock connectors The user is responsible for verifying the suitabili
4. e Associated Products onis reir set scope t eph IY oaP ESO F e ae S erai eed UP Pe EIN o Rob aee ae es e RUP PIRE UPS Pd ede e Pena bea LPS S sass 24 e Maintenance RP 25 e Cleaning and Storage siseissscccccssesssicesesscscesssessevsacescsdesssvasteosssnsscesseucssoosestas usscsssteansccssessceusseassoesassucoes 26 e Disposal eee 26 e ESTIS S DIE 27 e IrDA RS232 and Nurse call Specification esee eene eere ee eren eee toe et en osten se ense tetas etna ue 29 e Trumpet Curves amp Start up Curves 4 eere eee e esee esee e seen sesta sae tns set ens sets eset osse tasse esos esos seno 30 e Technical Descripti ERE 31 e Products and Spare Parts oncssiccisesccescocsssnecsssonssvessevsvocdsesvasscoceesuensvoensescnodssvacsssensesenssesscesessnsesessnetensess 32 e ETT de ura c P 33 e Document History b 33 e jLLn 34 e lp e M Mr 35 1000DF00107 Issue 3 1 36 Introduction The Alaris GW Volumetric Pump herein after referred to as Pump is a small lightweight volumetric infusion pump that provides accurate and reliable infusions over a range of rates The ideal pump for general care and critical care Intended Use The pump is designed to meet the infusion requirements within the operating environment specified in this Directions For Use DFU
5. including general wards critical and intensive care neonatal outpatients clinics operating rooms and accident and emergency rooms The pump can be used in the Intravenous and epidural routes of delivery of fluids and medications including but not limited to hydration total parenteral nutrition antibiotics blood blood products analgesics anaesthetics and chemotherapy The Asena brand name has been recently changed to the Alaris brand name This change in brand name has no effect on the intended use or functionality of the product Recommended disposable products for use with this product may refer to either the Asena brand name or Alaris brand name and both types are suitable for use with this infusion pump 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 Quick Start Guide 1 Half fill the drip chamber 2 Press amp to switch pump on 3 Openin line clamp 4 Prime FILL set Press once Whilst FILL is displayed press again and hold to clear all visible air from the line 5 Enterrate using 6 Press once to confirm and scroll to VTBI 7 Enter VTBl using or
6. 999 ml h with new fully charged cells with no loss of infusion accuracy measured with 95 percentage population 95 confidence interval Battery Charging 95 charge lt 24 hours all conditions Alarm Conditions SYSTEM ERROR AIR IN LINE BATTERY DEPLETED DOWNSTREAM OCCLUSION Critical Volume UPSTREAM OCCLUSION INCORRECT Infusion SET DOOR OPEN The maximum volume infused following a single fault condition is 1 0ml KVO Infusion Rate Up to a max of 5ml h or the infusion rate if programmed less than the set KVO rate Occlusion Pressure User Selectable Occlusion Alarm Pressure at 125ml h 250mmHg low 350mmHg normal 500mmHg high Fuse Type 2XT 125 mA slow blowing 100 120 VAC nominal 2XT63 mA slow blowing 220 240 VAC nominal Air Sensor Integral Ultrasonic Sensor Air in line detector Configurable 50ul 100ul 250pl 500pl Total Time Setting Up to 99 hours and 59 mins Memory Retention The electronic memory of the pump will be retained for more than 6 months when not powered up 27 36 Specifications continued Minimum Occlusion Alarm Pressure 100mmHg Maximum Occlusion Alarm Pressure 1000mmHg Bolus volume generated at 25 0 ml h when the minimum occlusion alarm threshold is reached 0 3ml Bolus volume generated at 25 0 ml h when the maximum occlusion alarm threshold is reached 0 6ml Maximum time for activation of occlusion alarm Maximum time to alarm a
7. Options To set the user options the pump must be on oL d or in set up mode and the relevant user selectable options are available See also Configurable Options section in this DFU Setting the Occlusion Pressure Level 2 Seconds Press button and hold for 2 seconds and will be displayed Select HI nor or Lo using the G2 keys to set the occlusion pressure level to High Normal or Low Press button to return to Hold or set up mode or next option Setting a VTBI Time Infusion 2 Seconds x2 Dependent on User Select Mode Options Press button and hold for 2 seconds or press button twice and L ac is displayed Select On or OFF using the keys to turn the VTBI time infusion setting on or off Press button to return to Hold or set up mode or next option Setting the Alarm Volume s 2 Seconds Dependent on User Select Mode Options Alarm Volume 1 Low 7 High 1 Press button and hold for 2 seconds or press button until is displayed Select an alarm volume between 1 and 7 using the G2 keys Press button to Haid or set up mode or next option Setting to Micro Mode 2 Seconds Dependent on User Select Mode Options Press button and hold for 2 seconds or press button until 2 2 is displayed Select On or OFF using the keys to turn micro mode on or off Press button once to return to Hold or set up mode an audible
8. after the pump is switched on or after the door has been opened the test takes a maximum of 20 seconds to complete If the pump fails to detect that the Cardinal Health Infusion set has been loaded correctly then the pump will alarm and display bAd SEt refer to Alarms and Warnings section of this DFU 1000DF00107 Issue 3 10 36 Starting the Infusion with a Flow Sensor Check The pump is switched on e The Infusion set has been primed refer to Priming the Infusion Set section of this DFU e The in line clamp is open e The flow sensor is connected refer to Flow Sensor Operation section of this DFU e indicates a drop is detected by the flow sensor during infusion Standard Mode Enter infusion rate ae Volume to be infused BY opr coe n OR Set VTBI to OFF Qp Orr D Volume infused Clear or Accept start infusion ED YD site Enter infusion rate using the W keys Press button once to scroll to VTBI Enter VTBI using the amp keys or switch VTBI off by pressing the amp 2 button until OFF is displayed Press button to scroll back or to clear VI if required Press button to start infusing Micro Mode Enter infusion rate qe p c 0 DO Volume to be infused qup ec OR Set VTBI to OFF Apure o Volume infused Clear or Accept starts infusion B QP 20 Enter infusion rate using the G2 C keys Press button once to scroll to VTBI Enter
9. 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 measures 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 Electromagnetic Compatibility and Interference 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 b
10. hr is illuminated the pump displays the rate or infusion time 1000DF00107 Issue 3 4 36 Symbol Definitions Labelling Symbols Symbol Attention Consult accompanying document Potential Equalisation PE Connector RS232 Nursecall Connector Type CF applied part Degree of protection against electrical shock Protected against vertically falling drops of water Alternating Current Device complies with the requirements of the EC Directive 93 42 EEC Registered with the CE Mark Date of Manufacture Manufacturer Connector for Flow Sensor Important Information Not for Municipal Waste Le Infusion indicator Infusing at a normal ig ri E Infusion indicator Infusing in MICRO mode 4 j Infusion indicator Displays fluid drops detected by the flow sensor when infusing at a esse normal rate a ee Infusion indicator Displays fluid drops detected by the flow sensor when infusing in MICRO fe la mode 1000DF00107 Issue 3 5 36 Operating Precautions 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 in accordance with the Directions for Use 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
11. inserted close the pump door and resume infusion Ensure flow sensor is attached to the primary Infusion set Restart the infusion with the flow sensor connected disconnected as required Connect flow sensor or set a VTBI and re start the infusion Ensure fluid in the drip chamber is not above the fill line Remove pressure in the infusion set to prevent a post occlusion bolus to the patient Remove the cause of the blockage Restart the infusion Remove the Infusion set and load the correct or new set see Compatible Infusion sets Clear air from set Refer to Clearing Air In Line section Release clamp and restart Reload set with pump at least 30cm from the Y site Warnings alert the user but may not stop the infusion and are indicated by an audible sound a message on the display or both 1 Check the display for a warning message Press to silence the sound 2 Rectify the cause of the warning or proceed with caution Bolus is being administered Release button to return to infusion once correct bolus has been administered Finished pre set volume to be infused Pump will infuse at the keep vein open rate until the button is pressed Refer to KVO Rate section of this DFU The pump is priming the Infusion set Ensure all air has been primed out of the Infusion set ILL before starting the infusion Low Battery Connect pump to an AC power source At least 30 mins before bAt alarm
12. latch to open the tubing cover door 2 Release the flow stop mechanism by pushing the lever arm up and to the right 3 Insert the infusion set from left to right into the slot provided following the flow direction label Make sure that the infusion set is pressed firmly past the constriction points and into the slots on either side of the casing Avoiding any slack close the door 4 Re engage the flow stop mechanism by pushing the lever left and down 5 Close the tubing cover door Use the recesses in the cover door to press the door firmly to ensure the latch is correctly applied Open in line clamp on the Infusion set 6 Observe fluid chamber and check for no fluid flow 1000DF00107 Issue 3 9 36 Getting Started Continued Power On Off To power up the pump Gls To power down the pump Af O U x 1 Press the button once and release 2 Check Hold for 3 A high pitch sounder is activated for 3 seconds during seconds this time the main speaker beeps once upon power up ios alas 1 Press and hold All display segments and all indicators are lit The pump will display OFF3 OFF2 OFF1 ifan error occurs during self test the pump will alarm 2 df the button is released during the countdown the After this self test the pump will display last rate setting entered or pump will not power down and it will return to its previous zero depending on the configuration sta
13. over the infusion rate range 1 to 999 ml h Solution Type De ionized amp Degassed Water Nominal 0 68 0 36 over 24 hours of continuous use Temperature 23 2 C Nominal 3 5 1 08 15 C Fluid Head Height 0 3 0 1 m Nominal 0 9 0 62 38 C Back Pressure 0 10 mmHg 3 All are as normal conditions with the following additions Set Rate 1 to 999 ml h Solution Type All fluids Temperature 15 to 38 C Fluid Head Height 0 1 0 m 1000DF00107 Issue 3 28 36 IrDA RS232 and Nursecall Specification RS232 IrDA Feature Nurse call Feature The RS232 IrDA feature is a standard feature on Alaris The nurse call interface is for connection to a suitable GW Volumetric Pump It allows the pump to be monitored monitoring device in order to provide remote indication of remotely via a suitable central monitoring or computer the pump entering an alarm condition system It also enables the internal event log of the pump to be downloaded for technical support purposes The nurse call interface provides a remote backup to the internal audible alarm It should not be relied upon to replace monitoring of the internal RS232 Nurse call Connection Data Typical Connection Data alarm Refer to the Technical Service Manual for further 1 Nurse call Relay Normally Closed NC C information regarding the RS232 interface Since 2 Transmit Data TXD Output it is possible to control the pump using the RS232 3 R
14. section of tubing 1 Press to place the infusion on HOLD 2 Ensure the in line clamp is closed 3 Open the pump door release the flow stop mechanism and move the Infusion set approximately 15cm along 4 See Loading the Infusion Set 5 Close the door press to restart the infusion KVO Keep Vein Open Rate At the end of infusion the pump will continue to infuse at a very low rate refer to Specifications section of this DFU KVO is used to keep the patients vein open in order to prevent blood clots and catheter occlusions If the KVO rate is greater than the set infusion parameters then the pump will continue to infuse at the set infusion rate If the KVO rate has been configured to OFF the pump will stop infusing and generate an alarm 14 36 Basic Features continued Changing the Infusion Set Press to put the pump ON HOLD Close in line clamp and ensure the IV 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 protocol Place new Infusion set into pump see Loading the Infusion Set Squeeze the drip chamber approximately half full or up to fill line if the drip chamber is marked with fluid Prime the set manually Restart infusion see Getting Started Oo OF Mr es s It is recommended that Infusion sets are changed in accordance with th
15. 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 affected 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 Alaris GW 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 Mounting the Pump The fluid height in the container must not be more than 1 metre above the patients heart Do not mount the pump in a vertical position with the AC power inlet pointing upwards as this could affect electrical safety in the event of a fluid spill over the pump Operating Pressure The pumping pressure alarm system is not designed to provide protection against or detection of IV complications which can occur Latex Content The Alaris GW Volumetric Pump does not contain any latex Alarm Conditions Sever
16. sounder will confirm the status Make sure that the TIME indicator is lit if set to on Make sure that the MICRO indicator is lit if set to on The TIME increases decreases in rate dependant units e g 10ml 899 9ml h is 6mins therefore 0 06 is displayed 1000DF00107 Issue 3 17 36 Configurable Options Sheet u Description technical service manual Range The default settings are configurable as displayed in brackets in the table below Each of the configurable options has a code which must only be altered by a qualified service engineer with reference to the TSM for this product Technical Service Manual reference 1000SM00006 Setting Enable VTBI time infusions Maximum priming volume On OFF OFF 1 to 40 ml 40ml Clear infusion parameters to zero on power up On OFF OFF Maximum VTBI in MICRO Mode 0 1 to 999 ml 999ml Bolus rate 1 to 999ml h 400ml h Maximum bolus volume OFF 1 to 99ml 5ml Keep vein open rate OFF 1 0 to 5 0 ml h 5 0ml h Air in line alarm volume single bubble 50 100 250 500uL 100ul Enable secondary infusion capability On OFF OFF Default occlusion pressure on power up Alarm volume level Lo 250mmHg Nor 350mmHg HI 500mmHg 1 7 HI 4 Enable Micro mode On OFF OFF Maximum infusion rate 1 999 ml h 999ml h Enable ASCII mode for c
17. 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 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 t
18. 51 00 Fax 31 33 455 51 01 www cardinalhealth com nl tech benelux cardinal com NO Cardinal Health Solbraveien 10 A 1383 ASKER Norge Tel 47 66 98 76 00 Fax 47 66 98 76 01 www cardinalhealth com no 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 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 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 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 SA Technical Support cardinal com Document History Revision CO Number 1 6317 2 6881 3 7935 Date 24 11 05 May 06 14 03 08 1000DF00107 Issue 3 33 36 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
19. 5mm 1 Align the rotating cam on the rear of the pump with the rectangular bar on the Docking Station Workstation or the equipment rail 2 Push the pump firmly onto the rectangular bar or equipment rail Ensure that the pump clicks securely into position onto the rail or bar 3 To release push the release lever and pull the pump forwards It is recommended that infusion bags be located on a hanger directly above the pump with which they are being used This minimises the potential for confusion of Infusion sets when multiple volumetric pumps are used Alaris DS Docking Station Asena IDS Docking Station amp Alaris Gateway Workstation 1000DF00107 Issue 3 8 36 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 Use of non specified Infusion sets may impair the operation of the pump and the accuracy of the infusion For Alaris GW Volumetric Pump Infusion sets refer to Infusion Sets section of the DFU Position the IV fluid container to avoid spillage onto the pump Ensure that the tubing is inserted completely into the pumping channel avoiding any slack When using 273 003 Infusion sets ensure a separation of at least 30cm is maintained between the pump and the upper Y site 1 Close the in line clamp on the Infusion set Press the door
20. Alaris GW Volumetric Pump Directions For Use English CardinalHealth Page e luippeifqgmee 2 e About This Manual ee 2 o Quick Start G lde oeroecer recs co e a ev eov CR eu Co vae ae ao Ue uae Ue vua eV UR Cae ve sena ere eo REPE CeO age E NE EEKE E VEL TES P DES 2 e Features of the Alaris GW Volumetric Pump eee eee eere eene nostros enses senos ease sn setas etna soo 3 e Controls amp Indicators issccsciccesicscesnscscssccsscecdsecsssnssacsstussssscsccasaucocescesbecsoascuussesseuecosussentecessuosceoussscaseessce 4 e Ed lisrinti i 5 o Operating Precautions n 6 e Getting Started e Y 8 e Starting th min 11 e Secondary Piggyback Infusions eee eee eee eese e eee en sensn ats sonata essen seas etas to sess ense setas enan 13 e Basic Features ERR 14 e Configured imrs 18 e LEID 19 e jn 20 e Flow ECCEDINSI T CPI 21 o Compatible Infusion Sets 1 eee Lees eese reser eene eese enne ene strae tn stesse toss toss teas sens etse ts sess esos e toss tease 22
21. D button Press to start the infusion or to put the infusion on hold CLEAR SILENCE button Press to silence alarm for 1 minute The alarm will resound after this time Resets numeric values to zero PRIME BOLUS button Primes the Infusion set Administers bolus during the infusion PRIMARY SECONDARY button Switches the pump between Primary and Secondary infusion modes If enabled ENTER button Scrolls between rate time VTBI and total volume infused VI Enters values for selected infusion configuration parameters Confirms the rate during an infusion titration CHEVRON keys Increases or decreases the infusion rate TIME limit and VTBI Press and hold to increase the selection speed Used to adjust user selectable options Indicators when illuminated Symbol AC POWER indicator The pump is connected to an AC power supply RATE The pump is displaying the infusion rate in millilitres per hour ml h VTBI The pump is displaying the Volume To Be Infused VTBI in millilitres ml The pump is displaying the Volume Infused VI in millilitres ml TI M E The pump is displaying the infusion time in hours mins M C RO The pump is operating in the MICRO Mode When not illuminated the pump is in the STANDARD Mode S EC The pump is operating in the SECONDARY Mode When not illuminated the pump is in the PRIMARY Mode l h Millilitres hour When ml is illuminated the pump displays the rate VTBI or m r VI When the
22. Fax 56 8621 6384 4025 DE Cardinal Health Pascalstr 2 52499 Baesweiler Deutschland Tel 49 2401 6040 Fax 49 2401 604 121 www cardinalhealth com de DK Cardinal Health Postboks 29 2820 Gentofte Danmark TIf 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 Espana Tel 34 902 555 660 Fax 34 902 555 661 www cardinalhealth com es 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 1 39 11 48 34 www cardinalhealth com fr FR Assistance Technique cardinal com GB Cardinal Health The Crescent Jays Close Basingstoke Hampshire RG22 4BS United Kingdom Tel 44 0800 917 8776 Fax 44 1256 330860 www cardinalhealth com alaris UK Technical Support cardinal com 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 AlarisCE 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 assistenza tecnica cardinal com NL Cardinal Health Kantorenpand Hoefse Wing Printerweg 11 3821 AP Amersfoort Nederland Tel 31 33 455
23. If 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 For further information regarding the replacement of the internal fuses refer to the technical service manual by a qualified service engineer u If the fuses continue to blow an electrical fault may have occurred and have the pump and power supply checked out Battery Operation The internal rechargeable battery allows continued operation when the AC power is unavailable for example during patient transfer or AC power failure The infusion time on battery is rate dependant see Specifications section of the DFU 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 automatically charged during AC operation and whenever the pump is connected to the AC power supply and the AC power indicator is illuminated The battery is maintenance free sealed Nickel Metal Hydride 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 ba
24. 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 e 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 e A fire hazard may exist if the pump is used in the presence of high oxygen concentrations Dangerous Voltage An electrical shock hazard exists if the pump s casing is opened or removed Refer all servicing to qualified service personnel Electrostatic discharge ESD precautions are required when connecting RS232 Nurse Call 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 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 1000DF00107 Issue 3 7 36 Getting Started 1 Before operating the pump read this Directions For Use DFU manual carefully Initial Set Up 1 Check that the pump is complete und
25. 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 SmartSite 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 SmartSite Needle Free Valve port and aspirate miniscule air bubbles 3 Replace according to set change interval see above or 100 activations which ever occurs first For infusions of blood blood products or lipid emulsions replace every 24 hours NOTE During use of Smartsite 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 representative The Center for Disease Control Intravenous Nurses Society USA and other organizations publish guidelines useful in developing facility guidelines Consult facility protocols N 1000DF00107 Issue 3 15 36 Basic Features continued Clearing Air In Line 1 Press button to silence the air in line alarm and put the pump on hold 2 Close the in line clamp 3 Open the door to view the air bubble NOTE Air in line alarms can be activated by both single bubbles and bubbl
26. VTBI using the keys or switch VTBI off by pressing the amp 2 button until OFF is displayed Press button to scroll back or to clear VI if required Press button to start infusing 1000DF00107 Issue 3 Volume infused Clear or Accept start infusion Desa Enter VTBI using the V C keys Press button once to scroll to TIME Enter TIME using the O C keys Press button to scroll back or f to clear VI if required Press button to start infusing Micro Mode with VTBI Time Infusion on Enter volume to be infused Sy 20 Volume infused Clear or Accept starts infusion aE CB GS 6280 Enter VTBI using the W keys Press button once to scroll to TIME Enter TIME using the O C keys Press button to scroll back or to clear VI if required Press button to start infusing 11 36 Starting the Infusion without a Flow Sensor Check The pump is switched on The in line clamp is open Standard Mode Enter infusion rate Volume to be infused ip Volume infused Clear or Accept start infusion B GP 002 Enter infusion rate using the W keys Press button once to scroll to VTBI Enter VTBI using the keys Press button to scroll back or to clear VI if required Press button to start infusing Micro Mode Enter infusion rate Sy segs D Volume to be infused Papae Volume infused Clear or Accept starts i
27. Vein Open rate KVO rate During primary secondary infusion of 2 drugs into a single lumen line it is essential to ensure drug fluid compatibility by consulting a drug compatibility chart or local pharmacist prior to infusion The secondary set connects to the upper Y connection on the primary Infusion set To set the Secondary Infusion the pump must be on Hold or not running Secondary infusion rates above 270ml h may cause simultaneous flow from secondary and primary fluid sources Typical Secondary infusions IV Pole SecondaryFluidContainer Extension Hook Usually a smaller container e g Normally included with the secondary Infusion 50ml 100ml 200ml or 250ml set Primary Infusion set must hang lower to allow the secondary infusion to run and primary infusion to restart on completion of the secondary In line Clamp Primary Fluid Container e g roller clamp Primary Infusion set e g 273 003 with an upper Y injection site In line Clamp e g Roberts clamp Check Valve Prevents secondary infusions from flowing back up the primary Infusion set instead of to the patient Secondary Infusion Set gt e g 72213 Usually shorter tubing to reach the Y site on the primary Infusion set Primary Infusion Set If using a flow sensor it must be on the primary Infusion set 1000DF00107 Issue 3 13 36 Basic Features Rate Titration Press To Confirm zog
28. al 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 Using Collapsable bags Glass Bottles amp Semi Rigid containers It is recommended that the air vent be opened on the Alaris GW 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 Collapsable bags Steps for Semi rigid containers Follow steps 1 to 3 as shown for the semi rigid containers however do not os open vent as in step 4 but prime the 3 l 4 set as per step 5 Ensure the bag outlet j Spike the Fildnp a HA Y Open the air vent ux container chamber to to allow pressure is fully pierced before filling the drip ys fill line equalisation ready chamber for infusion 5 1 Prime the set by P opening closing the Close the roller clamp roller clamp 1000DF00107 Issue 3 6 36 Operating Precautions Continued Operating Environment e When using any infusion pump in conjunction with other pumps or devices requiring vascular access
29. amaged and that the voltage rating specified on the label is compatible with your AC power supply 2 Items supplied are Alaris GW Volumetric Pump UserSupport CD Directions For Use AC Power Cable as requested Protective Packaging 3 Connect the pump to the AC power supply for at least 2V2 hours to ensure that the internal battery is charged verify that the O8 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 15 and 40 mm Recessed 1 Pull the folded pole clamp towards you and unscrew the clamp to leave enough room for the size of the pole 2 Place pump around pole and tighten screw until the clamp is secured to the pole Never mount the pump such that the Infusion stand becomes top heavy or unstable Ensure pole clamp is folded away and stored within recessed area at the rear of the pump before connecting to a Docking Station Workstation or when not in use The rotating cam can be fitted to the rectangular bar on the Docking Station Workstation or equipment rails measuring 10mm by 2
30. check valve before the Y Injection site e g 273 003 2 A secondary infusion set e g 72213 75213 C20128 and C20350 Primary fluid container must hang lower approx 20cm lower than the secondary fluid container to allow the secondary infusion to run Primary infusion will restart on completion of the secondary infusion 1 Set the primary infusion but do not start refer to Starting the Infusion section of this DFU If pump is running press button to put pump on hold 2 Prime Secondary Infusion set following the instructions supplied 3 Close the in line clamp on the secondary set 4 Connect secondary Infusion set into upper Y injection site of the primary Infusion set 5 Lower primary fluid container using extension hook supplied with the secondary Infusion set 6 Press P button and SEE will be displayed Rate Volume OR VTBI Time 7 Enter required rate using the keys 7 Enter VTBI using the keys 8 Press button to scroll to VTBI 8 Press button to scroll to TIME 9 Enter VTBI using the keys 9 Enter TIME using W keys 10 Openthe in line clamp on the secondary set 11 Press C button to scroll further or press button to start the secondary infusion Ensure the SEC Secondary indicator is lit The infusion rate will automatically revert to the primary infusion rate when the secondary infusion is complete On completion of the primary infusion the pump will continue at Keep
31. 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 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 INTERVAL ROUTINE MAINTENANCE PROCEDURE As per hospital policy Thoroughly clean external surfaces of the pump before and after prolonged period of storage 12 Monthly Inspect AC power supply plug and cable for damage Refer to TSM for Inspect the pump casing and pumping mechanism identification of parts Perform functional tests as outlined in the Technical Service Manual 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 Mains Fuses If 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 the AC mains plug if fitted
32. e O D The rate can be increased or decreased without interrupting the infusion If the new rate selected is not confirmed the pump will revert to the current rate and no change in the infusion rate will occur u Panel Lock The Panel Lock feature minimises the risk of unintentional changes to the infusion settings whilst infusing y mec Loc Gn Loc or If Panel Lockis enabled then Loc displays for all non operational button presses Panel Lock prevents button operation with the exception of Scrolling between infusion parameters using the button Muting the alarm using the button Pausing resuming the infusion using the button Hold Mode pp Heta HaL Press 9 to pause the infusion Press 9 again to resume the infusion A call back alarm will activate if the pump is left on Hoc d for more than 2 minutes 1000DF00107 Issue 3 Bolus Infusions To administer a bolus infusion Hold Down PD be L gt pp oen 4 1 Press button once and bal will be displayed 2 Press and Hold button while bol is still displayed release button after administering the desired bolus volume Bolus volume given will be added to the total volume infused VI and subtracted from the volume to be infused VTBI Optimising the Pumps Performance Pump performance may be optimised by moving a new section of the infusion set in the pumping mechanism every 24 hours To insert a new
33. e 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 to put 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 t When changing the Infusion set or the fluid container use aseptic technique according to hospital protocol 1 2 3 4 3 t 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 is not intact or protector caps are unattached If SmartSite Needle Free Valve is accessed by a needle in an emergency the valve will be damaged causing leakage Replace SmartSite Needle Free Valve immediately SmartSite
34. eceived Data RXD Input interface at some distance from the pump and 4 Power Input DSR hence remote from the patient responsibility for the control of the pump is vested in the software 5 Ground GND run on the computer control system 6 Notused The assessment for the suitability of any software 7 Power Input CTS used in the clinical environment to control or 8 Nurse call Relay Normally open NC O receive data from the pump lies with the user of the equipment This software should include 9 Nurse call Relay Common NC COM detection of the disconnection or other failure of the RS232 cable The protocol is detailed in 5 4 RAD TRO NES the Technical Service Manual and is for general information only Any connected analogue and digital components are required to meet IEC EN60950 for data processing and IEC EN60601 for medical devices Anyone connecting additional devices to the 2 S Z 6 signal input or output is a system configurator COM and responsible for meeting the requirements of the system standard IEC EN60601 1 1 1000DF00107 Issue 3 29 36 Trumpet amp 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 flo
35. ecommended that Infusion sets are changed in accordance with the Directions for Use Luer Lock Connector with back check valve Carefully read the Directions For Use supplied with the Infusion set prior to IB Back Check Valve Bum Please note these drawings are not to scale 1000DF00107 Issue 3 23 36 Associated Products The Asena IDS Docking Station The Alaris DS Docking Station The Alaris Gateway Workstation A MoN E NN E EN Bf 1 198 24 36 1000DF00107 Issue 3 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
36. ed as a result of a single fault failure During the power on self test sequence the pump automatically performs system integrity checks and will alarm and display Err should any of these tests fail Refer to Power On Off section of this DFU Air in Line Two ultrasonic transducers continuously check for the presence of air in the Infusion set throughout the infusion This air in line feature operates in two modes Single Bubble Detection The pump will alarm and display ir GEEL whenever a single air bubble greater than the air in line volume alarm limit is detected The alarm limit can be configured to 50 100 250 or 500 uL See also Configurable Options section of this DFU Air in Line Accumulation This accumulation feature monitors the volume of air that passes through the Infusion set by accumulating the volume of individual bubbles over a 15 minute window This feature is particularly useful with infusions for patients that are highly sensitive to air i e infants paediatrics or when infusing products that create significant volumes of small air bubbles t Although an individual bubble may not exceed the pre programmed threshold the additive volume of bubbles in a 15 minute volume may be sufficient to initiate an air in line alarm indicated by an Air OCCL message Downstream Occlusion Pressure The pump includes a pressure sensor to monitor the downstream Infusion pressure When the IV pressure exceeds the alarm p
37. es accumulated over time See page 25 for full description If the size of the air bubble is considered to be CLINICALLY INSIGNIFICANT CLINICALLY SIGNIFICANT 4 Release the flow stop mechanism by pushing the lever arm up 4 Disconnect the Infusion set from the patient and ensure the IV and to the right access to the patient is isolated Close the door Flow Stop Mechanism Lever Arm Open the in line clamp Press the button once and FILL will be displayed FL Press and hold the button while FILL is still displayed until there is no visible air in the IV line according to hospital protocol 9 Close the in line clamp 10 Attach the Infusion set to the patient 11 Open the in line clamp and restore the IV access to the patient Air Bubble 5 Move the tubing along to the right towards the patient to ensure the air bubble is outside of the pumping segment 12 Press the button to resume the infusion Air Bubble 6 Close the door 7 Open the in line clamp 8 Press the button to resume the infusion Use aseptic technique according to hospital protocol Infusion sets without an in line anti siphon valve must be clamped before disconnecting from the patient and the prime F LL procedure will not be necessary to remove the air in line as the air can be removed by gravity 1000DF00107 Issue 3 16 36 Basic Features User Selectable
38. formance strength test 500V dc live and neutral to earth Proof Strength Test The proof strength test is applied at the factory It is not recommended that the proof strength test is reapplied if the pump is tested again during service Classification Continuous Portable Equipment type 4 AC Power Supply 100 120 VAC 50 60Hz 10VA nominal 220 240 VAC 50 60Hz 10VA nominal Protection against fluid ingress IPX1 Proteted against vertically falling drops of water Dimensions 137mm w x 140mm h x 105mm d Weight approx 1 5kg excluding power cable Environmental Specifications 15 C 38 C 20 C 50 C 20 90 10 95 Atmospheric 700hPa 1060 hPa 500hPa 1060hPa Pressure Priming the Infusion set Prime Priming Volume 0 40mI Starting the Infusion Set up aaa __ eae 1 0 99 9ml h 1 999ml h VTBI 0 1 99 9ml 1 9999ml 100 999m VI 0 0 99 9ml 0 9999m 100 9999ml Administering a Bolus 1 999ml h 0 99ml Parameter Bolus Rate Bolus Volume Max Bolus Volume after release of hard occlusion Non condensing Measured in 0 1ml increments Measured in 1ml increments 1000DF00107 Issue 3 BATTERY SPECIFICATIONS Rechargeable NiMH Nickel Metal Hydride Automatically charges when the pump is connected to AC power Battery Life gt 6 hours 25 ml h 4 hours 125 ml h gt 2 hours
39. if using a Flow sensor the VTBI can be switched off by scrolling until GFF is displayed 8 Press to confirm and scroll to VI 9 If necessary press to clear VI 10 Connect Infusion set to the patient access device 11 Press to start infusion 1000DF00107 Issue 3 2 36 Features of the Alaris GW Volumetric Pump Display Indicators Flow Stop Mechanism When activated the mechanism will stop fluid flow Air Sensor Bevel Releases the flow stop mechanism lever arm when the door is closed Release Lever For Rotating cam Rotating Cam To lock onto the rectangular bars Mains Fuses Mains Inlet Potential Equalisation PE connector SEC Door Latch Press outer latch to open the pump door Infra Red Communications port IrDA 1000DF00107 Issue 3 AN a e Tubing Guide Guide to assist in the loading of the Infusion set 3 36 a Main Display Displays the infusion rate VTBI VI and time remaining for VTBI Time infusions Display will flash when pump is operating on battery Keypad Flow Direction Label Pressure Sensor RS232 Nurse call Connector Flow Sensor Interface Folded Pole Clamp Controls and Indicators Controls Symbol ON OFF button Press once to switch the pump ON Press and hold down for approximately 3 seconds to switch the pump OFF RUN HOL
40. included within the Technical Service Manual The Technical Service Manual 1000SM0006 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 1000EL00349 Internal Battery Pack 1001FAOPT91 AC Power Lead UK 1001FAOPT92 AC Power Lead European 1000DF00107 Issue 3 32 36 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 cardinalhealth com au techservice au cardinal com BE Cardinal Health Otto De Mentockplein 19 1853 Strombeek Bever Belgium Tel 32 2 267 38 99 Fax 32 2 267 99 21 www cardinalhealth com be tech benelux 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
41. iner 15 Changing the IV Infusion Set 15 Cleaning and Storage 26 Collapsable bags 6 Contents 1 Controls and Indicators 4 Disposal 26 Docking Station 32 Docking Station Installation 8 Document History 33 Earth Conductor 7 Electromagnetic Compatibility 7 Equipment Rail Installation 8 Features 3 Flow Rate Curves See Trumpet amp Flow Rate Curves Flow sensor 21 Getting Started 8 9 15 Hazards 7 Introduction 2 IrDA 29 Latex Content 6 Loading the IV infusion Set 9 1000DF00107 Issue 3 Nursecall 5 Nurse Call 7 Operating Precautions 6 7 Pole clamp 8 Pressure 27 Prime 15 Quick Start Guide 2 Replacing the Mains Fuses 25 Routine Maintenance Procedures 25 RS232 7 29 32 Semi Rigid containers 6 Service Contacts 33 set change interval 15 SmartSite Needle Free System Instructions 15 Specifications 27 Syringe 2 Test 25 Test Routines 25 Trumpet amp Flow Rate Curves 30 Warranty 34 Workstation 32 35 36 Page Intentionally Left Blank 1000DF00107 Issue 3 36 36 CardinalHealth Alaris Guardrails SmartSite and Asena are registered trademarks of Cardinal Health Inc or one of its subsidiaries All other trademarks are the property of their respective owners 2000 2008 Cardinal Health Inc or one of its subsidiaries All rights reserved 1000DF00107 Issue 3 This document contains proprietary information of Cardinal Health Inc or one of its subsidiaries and its receipt o
42. lve IB Back Check Valve 1000DF00107 Issue 3 22 36 Carefully read the Directions For Use supplied with the Infusion set prior to use Please note these drawings are not to scale Compatible Infusion Sets continued The pump uses standard single use disposable Infusion sets with Luer lock connectors The user is responsible for verifying the suitability of a product used if it is not recommended by Cardinal Health Filter Sets 273 009 1 2um filter set with anti siphon valve with 15um filter in drip chamber 230 cm 273 010 1 2um filter set 1 Y site and anti siphon valve with 15um filter in drip chamber 253 cm i gt Burette Sets 273 103 Burette set with 1 Y site and anti siphon valve 220 cm Opaque Sets 273 011 Opaque PVC infusion set with anti siphon valve and pump segment with 15um filter in drip chamber 235 cm l Secondary Sets 72213 Secondary Piggyback set with 18G needle and hanger approx 84 cm oo Open Gi o Filter Extension Sets C20128 Extension set with 1 2um filter and one Y site Rotating male luer lock approx 51 cm 3 i C20350 Extension set with 0 2um filter and one Y site Rotating male luer lock approx 51 cm Low Sorbing Polyethylene Lined pF Valve Component Key o Anti siphon Valve It is r
43. nfusion Ges Enter infusion rate using the G2 C keys Press button once to scroll to VTBI Enter VTBI using the keys Press button to scroll back or to clear VI if required Press button to start infusing 1000DF00107 Issue 3 The Infusion set has been primed refer to Priming the Infusion Set section of this DFU Sindicates infusion without a flow sensor being used Standard Mode with VTBI Time Infusion on Enter volume to be infused Volume infused Clear or Accept start infusion c Ge x ep qon 6d Enter VTBI using the W keys Press button once to scroll to TIME Enter TIME using the O C keys Press button to scroll back or f to clear VI if required Press button to start infusing Micro Mode with VTBI Time Infusion on Enter volume to be infused Sy 204 Volume infused Clear or Accept starts infusion gt G p 600 Enter VTBI using the W keys Press button once to scroll to TIME Enter TIME using the O keys Press button to scroll back or to clear VI if required Press button to start infusing Secondary Piggyback Infusions Secondary or piggyback Infusion mode is only available if configured refer to Configurable Options section of this DFU Secondary Infusion mode is used to administer an intermittent fluid drug solution e g 4 hourly antibiotic infusion using 1 A primary infusion set with an in line
44. o 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 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 1000DF00107 Issue 3 34 36 About This Manual 2 Air vent 6 Alaris DS Docking Station 32 Alaris Gateway Workstation 32 Alarm 4 19 Associated Products 24 Battery 4 19 Battery Operation 25 Changing the Fluid Conta
45. ommunications On OFF OFF Enable Odd parity for communications On OFF OFF Set Pump address for communications 1 250 1 Flow Sensor Connection Mode AUTO On Set up of current time and date 00 00 to 23 59 01 01 00 to 31 12 99 Language selection IrDA Communications Selection EnGL FrAn dEut ItAL ESPA SE nEd On OFF Nurse Call Activation High Enabled On OFF Drops per ml of fluid 1 to 200 Silent Mode On OFF User select mode options Pressure limit Enabled Alarm volume Enabled Timed infusions Enabled Micro infusions Enabled On OFF On OFF On OFF Flow sensor sensitivity level On OFF Nor Hi EnGL English FrAn French dEut German ItAL Italian ESPA Spanish SE Swedish nEd Dutch Serial Number Software Version Configured by Date Approved by Date 1000DF00107 Issue 3 18 36 Alarms stop the infusion and are indicated by a combination of an audible sound and a message on the display 1 Check the display for an alarm message and review table below for cause and action Press to silence the sound Exceptions are Err amp bfE 2 When the cause of the alarm has been rectified press the button to resume the infusion AIR IN LINE UPSTREAM OCCLUSION INTERNAL BATTERY DEPLETED DOOR OPEN Door was opened during an infu
46. r 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 ud Cardinal Health 1180 Rolle Switzerland www cardinalhealth com alaris
47. raph at 1 0ml h Initial Period Trumpet Graph at 25 0ml h Initial Period 273 001 Infusion Set 273 001 Infusion Set Flow Rate 96 I Flow Rate 96 48 o 5 10 15 20 25 30 35 Observation Window Minutes Minimum Rate Error W Maximum Rate Error A Overall Mean Error 2 596 Observation Window Minutes Minimum Rate Error g Maximum Rate Error A amp Overall Mean Error 1 196 Trumpet Graph at 1 0ml h After 24 Hours Trumpet Graph at 25 0ml h After 24 Hours 273 001 Infusion Set 80 i 273 001 Infusion Set 70 I 6o so 10 40 30 g a 5 I cx g j TS g o 9 c 3 20 c wr 9 30 9 5 Le 40 u M 1 ES xs 15 i 0 5 10 15 20 25 30 35 H H a 5 zh 26 EA E Observation Window Minutes Minimum Rate Error Maximum Rate Error A Overall Mean Error 4 296 Observation Window Minutes Minimum Rate Error Maximum Rate Error A Overall Mean Error 1 196 Note The typical flow rate and trumpet curves Infusion set 273 001 1000DF00107 Issue 3 30 36 Technical Description The following details outline the basic safety checks designed into the pump to minimise the possibility of under or over infusions Power on Self Tests The pump is single fault tolerant which means the pump will either stop and alarm or continue to infuse uninterrupt
48. ressure limit as a result of for example kinked IV tubing or blocked cannula the pump will alarm and display Hi PrES To compensate for the variability in Infusion set tubing the pump performs a relative baseline pressure measurement The pump takes a reference pressure from the IV line when the infusion commences and alarms at a preset limit above the baseline pressure The pressure alarm limits are 250 350 and 500 mmHg above the baseline pressure corresponding to the low normal or high pressure limits To avoid excessively large pressures the pump is capped at 1000 mmHg Upstream Occlusion Pressure To detect upstream occlusions resulting from for example closed clamps or occluded drip chamber filters the pump continuously monitors the upstream IV tubing pressure Upon detection of an occlusion the pump will alarm and display fir CCL The pump uses the ultrasonic transducers of the air sensor to monitor for upstream occlusions and is therefore unable to differentiate an upstream occlusion from an air bubble Pump Based Free Flow Protection The pump is equipped with a flow stop mechanism that is designed to occlude the IV tubing when the pump door is open and the tubing remains properly loaded in the pump Raising the flow stop mechanism lever arm and pushing it to the right activates this mechanism Once activated the user inserts the IV tubing into the tubing guide channel When the pump door is closed the bevel integrated into
49. sion SYSTEM FAULT FLOW ERROR No drops have been detected during an infusion empty container Excessive increase or decrease of fluid flow detected by flow sensor Flow sensor attached to secondary Infusion set FLOW SENSOR CONNECTION ERROR Flow sensor connected disconnected during an infusion Flow sensor is not connected and the primary VTBI is OFF Too much fluid in drip chamber DOWNSTREAM OCCLUSION A blockage has occurred downstream INCORRECT INFUSION SET set incorrectly loaded or set worn Excessive amount of air in line Infusion started with upstream tubing clamped 273 003 set loaded with upper Y site too close to pump 1000DF00107 Issue 3 19 36 See Clearing Air In Line Disconnect the Infusion set from IV access device and use the prime function see Priming the Infusion set Remove the occlusion air and restart the infusion by pressing the button To silence the alarm connect the pump to AC power Restart operation on AC power to charge the internal battery Close the door and restart the infusion Switch pump off Remove pump from service and have the pump inspected by a qualified service engineer Clamp the tubing to stop fluid flow Ensure that the Infusion set tubing is properly loaded in the pumping channel following the flow direction label Ensure that ample fluid is in the fluid container Check for blockage occlusion in Infusion set After the tubing is properly
50. t 1 0ml h is 45min High Pressure Maximum time to alarm at 1 0ml h is 30min Low Pressure Maximum time to alarm at 25ml h is 5 30min High Pressure Maximum time to alarm at 25ml h is 2 10min Low Pressure Maximum time to alarm at 999ml h is 3 secs High Pressure Maximum time to alarm at 999ml h is 2 secs Low Pressure System Accuracy Rate Accuracy 596 at 25 ml h under nominal conditions tested to IEC60601 2 24 9596 confidence interval 8096 population t For all conditions the rate accuracy should be adjusted accordingly Bolus Volume Accuracy 1096 5ml under nominal conditions tested to IEC60601 2 24 Under all conditions the bolus volume accuracy should be de rated as for rate accuracy Occlusion Pressure Accuracy 150 mmHg under nominal conditions 250 mmHg under all conditions Air in Line Accuracy 2096 or 0 025ml under nominal conditions Notes 4 Tested using Distilled water 2096 lipid 5096 glucose 0 996 Normal Saline and 596 B 1 All accuracy specifications are with a 9596 confidence interval 9596 population Aleohol sol tions unless stated otherwise ui 5 Whichever is the greater of the air in line limit set 2 Nominal conditions are defined as 9 Set Rate 125 ml h 25 ml h for rate accuracy 6 For all conditions the rate accuracy should be adjusted by the following Disposable Type 273 001 percentages Needle 18 gauge x 40 mm 10
51. te If the pump alarms segments indicators do not light up correctly or 2 audible sounds are not heard then the pump must be powered down immediately and a qualified service engineer contacted If transportation to an engineer is necessary it is recommended to use the original protective packaging Priming the Infusion Set When using Infusion sets without an anti siphon valve e g 273 004 273 007 and 273 008 the set can be primed without using the pump 1 Ensure the pump is switched on and in line clamp is open 2 Load the Infusion set see Loading the Infusion Set Priming Hold Down FILL gt 3 Press button once FILL will be displayed 4 Press and Hold button while FILL is still displayed prime the Infusion set until there is no visible air in the IV line according to hospital protocol 5 Attach the set to the patient or other Infusion set 6 Start the infusion see starting the infusion Use the prime function to fill the Infusion sets before starting an infusion Never connect the Infusion set to the patient during the priming process The prime FILL volume delivered will not be subtracted from the VTBI or added to the total volume infused Automatic Set Detection The pump automatically tests that a compatible Cardinal Health Infusion set has been loaded correctly refer to Compatible Infusion sets section of this DFU The test will occur at the start of the first infusion
52. the door releases the lever arm such that it will automatically occlude the tubing when the door is re opened Refer to Features of the Alaris GW Volumetric Pump The tubing can be removed from the tubing guide channel by repeating the activation of the lever arm Once the lever arm is re activated and the door is opened the flow stop mechanism no longer occludes flow in the tubing Anti Bolus Function The anti bolus function is designed to reduce the bolus that may occur upon the release of an occlusion following a downstream occlusion alarm Detection of a downstream occlusion is indicated by a 4 P E5 alarm The pump returns the Infusion set line pressure to neutral within 15 seconds by pumping backwards briefly and measuring the Infusion set line pressure through the in line pressure detection system This feature can prevent the fluid bolus to the patient that can occur upon the release of an occlusion which may be caused by a downstream clamp 1000DF00107 Issue 3 31 36 Products and Spare Parts Alaris Infusion System Range of products in the Alaris Infusion System product family are 1 are also available without an RS232 option fitted contact local customer services representative to obtain part number details For Docking Stations 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
53. ttery 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 1000DF00107 Issue 3 25 36 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 Brand Concentration inr A Before cleaning always switch off and disconnect a ag ZEHN an Virkon 196 w v from the AC power supply Do not allow liquid to Do not use the following disinfectant types enter the casing and avoid excess fluid build up on g ypes the pump NaDcc such as PRESEPT Hypochlorites such as CHLORASOL Do not use aggressive cleaning agents as these may Aldehydes such as CIDEX damage the exterior surface of the pump Cationic Surfactants such as Benzalkonium Chloride Do not steam autoclave ethylene oxide sterilise or lodine such as Betadine immerse this pump in any fluid Concentrated Isopropyl alcohol based cleaners will degrade plastic parts
54. ty of a product used if it is not recommended by Cardinal Health Standard Sets 273 001 Infusion set with 15um filter in drip chamber anti siphon valve 220 cm 273 002 Infusion set with 15um filter in drip chamber 1 Y site and anti siphon valve 220 cm gt 273 003 Infusion set with 15um filter in drip chamber 2 Y sites back check valve and anti siphon valve 220 cm es 000 77 Infusion set with 15um filter in drip chamber roller clamp and luer back check valve 210 cm Suitable for gravity infusion 273 004 lt a Blood Sets 273 007 Blood set with 1 upper Y site in line drip chamber with 200um filter and luer back check valve 285 cm Suitable for gravity infusion Blood set with 1 upper and 1 lower Y site back check valve in line drip chamber with 200um filter and luer back check valve 285 cm Suitable for gravity infusion DA A Blood set with 2 spikes 1 upper and 1 lower Y site with anti siphon valve and in line drip chamber with 200um filter 225 cm d 273 008 273 080 2 m Valve Component Key n Anti siphon Valve It is recommended that Infusion sets are changed in accordance with the Directions for Use Luer Lock Connector with back check va
55. w when infusion commences start up curves 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 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 IEC60601 2 24 standard Start up Graph at 25 0ml h Initial Period 273 001 Infusion Set Start up Graph at 1 0ml h Initial Period 273 001 Infusion Set Flow Rate ml h S s S B ox m Ss gt Flow Rate ml h 8 8 B Time minutes Time minutes Trumpet G
56. y 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 This pump is a CISPR 11 Group 1 Class B 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 For further information on electromagnetic compatibility please consult Technical Service Manual 1000SM00006 available from the web www cardinalhealth com alaris Earth Conductor The laris GW Volumetric Pump is a Class device therefore must be earthed when connected to an AC power supply 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
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