Alaris® GH Syringe Pump
Contents
1. RS232 Nurse Call Connection Data Nurse call Specification Connector TXD RXD TXD Output Voltage Range RXD Input Voltage Range RXD Input Thresholds RXD Input Resistance Enable Isolation Socket Pump Baud Rate Start Bits Data Bits Parity Stop Bits Nurse Call Relay Contacts Typical Connection Data D Type 9 Pin EIA RS232 C Standard Minimum 5V mark 4 5V space Typical 7V mark 7V space with 3kO load to ground 30V 30V max Low 0 6V minimum High 3 0V maximum 3kQ minimum Active Low 7V to 12V Active High 7V to 12V powers up the isolated RS232 circuitry Inactive Floating open circuit allows isolated RS232 circuitry to power down 1 5kV dc or ac peak 38 4 kBaud 1 Start Bit 8 Data Bits No Parity 1 stop bit Pins 1 8 9 30V dc 1A rating 1 Nurse call Relay Normally Closed NC C 2 Transmit Data TXD Output 3 Received Data RXD Input 4 Power Input DSR 5 Ground GND 6 Not used 7 Power Input CTS 8 Nurse call Relay Normally open NC O 9 Nurse call Relay Common NC COM GND DSR RXD TXD NCC 5 4 9 7 6 NC NCO CTS COM 1000DF00002 Iss 2 27 32 Trumpet Curves amp Start up Curves In this pump as with all infusion systems the action of the pumping mechanism and variations in individual syringes cause short term fluctuations in rate accuracy The following curves show typical performance of the system in2. The following graphs show the typical values for time to alarm and bolus volume that can be expected in the event of an occlusion when the BD Plastipak 50 ml syringe is selected with a G40020B standard extension set 2 00 2 00 Time to alarm 1 0 ml h Time to alarm 5 0 ml h typical typical y y t E E E Occlusion Level Occlusion Level em Bolus Volume without back off 2 00 Bolus Volume with back off ml Occlusion Level Occlusion Level Tests at low alarm levels may alarm immediately the force at these levels is commonly less than the friction in the syringe with no additional fluid pressure The result is that the pressure relating to the low forces will be less than the nominal quoted occlusion pressure Bolus volume following occlusion will be minimised by the back off feature if enabled The back off will reduce the line pressure by removing the volume stored in the occluded line and deducting this volume from the volume infused 1000DF00002 Iss 2 26 32 IrDA RS232 and Nurse Call Specification IrDA RS232 Nurse Call Feature The RS232 Nurse call feature is an optional feature on Alaris Syringe Pumps It allows the pump to be monitored remotely and or controlled via a suitable central monitoring or computer system When the pump is started by a command from the serial interface communication must take place over the serial interface a communication must take place
3. 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 Tel 56 8621 63844603 Tel 56 8621 63844493 Fax 56 8621 6384 4025 Document History Revision CO Number 1 6056 2 6881 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 Date October 05 May 06 1000DF00002 Iss 2 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 9
4. 4 Confirm correct size and brand of syringe 5 A Ensure extension set is attached to syringe but disconnected from patient If the PURGE SYRINGE option has been enabled then the prompt to purge screen is displayed and the set can be purged as required 6 INFUSION RATE Change rate if necessary using the amp SC keys 7 PURGE Press the button followed by the PURGE softkey 8 Connect extension set to the patient access device 9 Press the button to start the infusion 1000DF00002 Iss 2 2 32 Features of the Alaris GH Syringe Pump ON OFF Release lever for High visibility RUN Display MDI Alarm Indicator PURGE BOLUS MUTE PRESSURE OPTION Finger Grips Extension HOLD Shelf for chevron Syringe Clamp Positive Plunger set hook keys and softkeys Grippers Rating Plate see Symbol Definitions for an explanation of the symbols used Release lever for Rotating Cam Rotating Cam to lock on to horizontal rectangular bars IR Communications port Carrying Potential Folded Pole RS232 Extension set Handle Equalisation Clamp Connector hook PE connector optional 1000DF00002 Iss 2 3 32 Controls amp Indicators Controls ON OFF button Press once to switch the pump ON Press and hold down for 3 seconds to switch the pump OFF RUN button Press to start the infusion The green LED will flash during infusion HOLD button Press to put the infusion on hold
5. Battery life is typically 4h from fully charged 5 0ml h amp 20 C under normal conditions Charging takes 2 2 hours from discharge to 90 charge Memory Retention The electronic memory of the pump will be retained for more than 6 months when not powered up Fuse Type 2xT 1 25A slow blowing AC Power Supply 115 230VAC 50 60Hz 20VA nominal Dimensions 310 mm w x 121 mm h x 200 mm d Weight 2 7 kg excluding power cable Protection against fluid ingress IPX1 Protected against vertically falling drops of water Alarm Conditions Drive Disengaged Occlusion Check Syringe Battery Low Battery Empty Near End Of Infusion End of Infusion VTBI Done AC Power Fail Internal Malfunction Attention Nurse Callback Titration not confirmed Environmental Specifications Operating Temperature 5 C 40 C Operating Relative Humidity 20 90 Operating Atmospheric Pressure 700hPa 1060hPa Transport amp Strorage Temperature 30 C 50 C Transport amp Strorage Relative Humidity 10 95 Transport amp Strorage Atmospheric Pressure 500hPa 1060hPa Electrical Mechanical Safety Complies with IEC EN60601 1 and IEC EN60601 2 24 EMC Complies with IEC EN60601 1 2 and IEC EN60601 2 24 20 32 Compatible Syringes The pump is calibrated and labelled for use with single use disposable Luer lock syringes Only use the size and type of syringe specified on the pump display The full l
6. occlusion even if the bolus delivery is incomplete If the volume to be infused VTBI is reached during a bolus the VTBI complete alarm will sound Press amp to silence the alarm or CANCEL to acknowledge the alarm See VTBI section for more details on VTBI operation Manual Bolus The Manual Bolus is delivered by moving the plunger drive mechanism forward while the pump is infusing This method of delivering a bolus is not recommended as best clinical practice The syringe must be confirmed and the plunger mechanism has to move from an engaged position to disengage and then re engage position A minimum travel of 1mm leadscrew pitch must be detected to register 1000DF00002 Iss 2 13 32 Basic Features Continued Pressure Level To check and adjust the pressure level press the button A bar graph will be displayed showing the pressure alarm level and the current pressure level Press the ADY keys to increase or decrease the alarm level The new level will be indicated on the display Press OK to exit the screen wn The interpretation of pressure readings and occlusion alarms are the responsibility of the clinician depending on the specific application Rate Titration If Rate Titration is enabled the rate can be adjusted while infusing 1 Select the new rate using the ASC keys The message START TO CONFIRM gt will flash on screen and pump continues to infuse at the original rate 2 Press the
7. PURGE softkey until fluid flows and the purging of the syringe extension line is complete Release the softkey The volume used during purging will be displayed 7 CONNECT TO PATIENT Connect the extension set to the patient access device 8 START Press to commence operation INFUSING will be displayed The AMBER STOP light will be replaced by the flashing GREEN START light to indicate that the pump is in operation 9 STOP Press to halt the operation ON HOLD will be displayed The amber light will replace the green light 1000DF00002 Iss 2 12 32 Basic Features The C9 button allows the delivery of a limited volume of fluid in order to purge the extension set prior to being connected to a patient or after changing a syringe 1 Press the C button when the pump is not infusing Ensure that the extension set is not connected to the patient N Press and hold the PURGE softkey until fluid flows and the purging of the IV infusion set is complete The volume used during purging will be displayed but it is not added to the volume infused w When purging is complete release the PURGE softkey Press the QUIT softkey to exit back to the main display The pump will not purge if the rate lock has been enabled During PURGE the pressure limit alarms are temporarily increased to their maximum level 4 Bolus Infusion Bolus Administering a controlled volume of fluid or drug at an increased rate for diagnostic or therapeuti
8. Sets the Near End Of Infusion warning time as time left to End Of Infusion Sets the End Of Infusion point When enabled the pump will switch to running at the KVO rate when EOI is reached Sets the Keep Vein Open KVO rate at which the pump will operate if KVO at EOI is enabled When enabled the motor will reverse to relieve line pressure when an occlusion occurs When disabled the infusion information is cleared on power up When enabled the rate can be locked to prevent unwanted changes of the set infusion rate When enabled the button beeps are muted When enabled the AC Power Failure Alarm will sound if the AC power is disconnected When enabled the rate can be changed whilst the pump is infusing Enables disables the Pressure Icon on the main display Sets the maximum pressure value Sets the default occlusion alarm level Sets the maximum value for infusion rate Sets the purge rate Sets the maximum permissible purge volume Prompt to purge syringe after confirmation Enables disables the bolus feature Sets the default bolus rate Sets the maximum value for bolus rate Sets the maximum permissible bolus volume Volume infused will be increased if plunger is manually moved in and syringe remains confirmed Adjusts the time for the pump to sound the call back alarm Rate will be set to zero when VTBI has been set up with stop as the end rate Enables disables the event log Enables disables the Battery Icon on the
9. Usethe keys to adjust the character displayed pressing NEXT to access the next position 3 When the correct name is displayed press OK to return to the Configured Options menu Enable Syringes This option is used to pre configure the type and size of syringe permitted for use on the pump Select all possible syringes which may be used and disable any that should not be used 1 Select ENABLE SYRINGES from the Configured Options menu using the keys and press the OK softkey Use the amp keys to scroll through the list of syringes pressing MODIFY to enable disable a syringe brand and individual models within the brand N w When all modifications are complete press OK to return to the Configured Options menu Tate UE This option is used to set the language of messages shown on the pump display 1 Select LANGUAGE from the Configured Options menu using the S keys and press the OK softkey 2 Use the amp amp keys to select the language 3 When the desired language has been selected press SELECT softkey to return to the Configured Options menu Contrast This option is used to set the contrast on the pump display 1 Select CONTRAST from the Configured Options menu using the keys and press the OK softkey 2 Use the amp amp Y keys to select a contrast ratio value The contrast of the display will change when scrolling through the numbers 3 When the desired value has been reached press the OK softkey to
10. button to confirm the new infusion rate and start infusing at the new rate If Rate Titration is disabled the rate can only be adjusted whilst on hold 1 Press the button to put the pump on hold 2 Select the new rate using the ASC keys 3 Press the button to start infusing at the new rate Volume to be Infused VTBI This option allows a specific volume to be infused to be set Rate at the end of this VTBI can also be set selecting from stop KVO or continuous infusion at the set rate 1 Press the VTBI softkey to select the volume to be infused option 2 Enter the volume to be infused using the amp 3 keys and press the OK softkey 3 Select the rate at the end of the VTBI using the amp keys to scroll through the on screen choices The default is stop 4 Press the OK softkey to enter the rate and exit the VTBI menu Clear Volume This option enables the volume infused to be cleared 1 Press the VOLUME softkey to display the CLEAR VOLUME option 2 Press the YES softkey to clear the volume Press the NO softkey to retain the volume Selecting YES resets the volume infused in the 24H LOG option Rate Lock If Rate Lock is enabled when the infusion rate has been set and the infusion started or following a bolus infusion the rate lock prompt will appear on the main display To select the rate lock function press the YES softkey Press the NO softkey if the rate lock is not required When rate lock is enabled the foll
11. pump Do not use aggressive cleaning agents as these may damage the exterior surface of the pump Do not steam autoclave ethylene oxide sterilise or immerse this pump in any fluid Disposal Information on Disposal for Users of Waste Electrical amp Electronic Equipment This 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 1000DF00002 Iss 2 25 32 Occlusion Pressure Limits Time to alarm following occlusion is achieved in less than 30 minutes at rates of 1 ml h and higher by the appropriate selection of occlusion levels
12. return to the Configured Options menu 1000DF00002 Iss 2 18 32 Alaris GH Syringe Pump Configured Options Record General Options Enter the pump specific information for your records on a copy of this page Option E Max infusion rate Max bolus rate Max bolus rate 1200ml h 10ml h 1200ml h 5 0ml 5 0ml 0 5ml 0 1ml 25 0ml Disabled tmbedDmbed mm omm 0 Disabled EmbedDmbed FevewTLOGDSPLA Disabled Enabled Enabled Deablea Enabled EmbedDmbed For software versions 1 9 x amp 2 3 x and above Range 1 9 x amp Disabled Disabled Disabled 5mins 1 096 Enabled 1 0ml h Enabled Enabled Disabled Disabled Enabled Disabled Enabled L10 Seting O Enabled Disabled b Enabled Disabled PY Enabled Disabled PY 0 1 5 of syringe volume PY Enabled Disabled peu 0Im h 25ml h EE Enabled Disabled NEN Enabled Disabled b Enabled Disabled Po Enabled Disabled PY Enabled Disabled Pe Enabled Disabled Enabled Disabled LO L10 50mmHg 1000mmHg LO L10 50mmHg 1000mmHg 1 0ml h 1200ml h 100ml h 500ml h 1200ml h 200ml h 2 0ml Disabled Enabled Enabled Disabled Enabled Disabled 500ml h 10ml h 1200ml h N bo iw x lt ty 2 a t co o lt m Syringes Enabled Drug Names Hospital Name Serial No Software Version Approved by Configured by Date Date 1000DF00002 Iss 2 19 32 Infusion Specifica
13. the OK softkey The display shows the hourly volume infused The volume infused shown in brackets is the total volume infused since the volume was last cleared See example below 07 48 08 00 4 34ml 4 34ml 08 00 09 00 2 10ml 6 44ml 09 00 10 00 2 10ml 8 54ml VOLUME CLEARED 3 Press the QUIT softkey to exit the log Event Log This option allows the event log to be reviewed It can be enabled disabled 1 Press the button to access the options menu 2 Select the EVENT LOG option using the keys and press the OK softkey 3 Scroll through the log using the keys Press the QUIT softkey to exit the log Drug Name This option enables the selection of a drug from the drug names set up in configuration 1 Press the button to access the options menu 2 Select DRUG NAME Note Selecting CLEAR DRUG NAME will clear the drug name 3 Press the OK softkey to confirm the drug name or press the QUIT softkey to exit the option 1000DF00002 Iss 2 15 32 Alarms and Warnings Alarms are indicated by a combination of an audible alarm flashing alarm indicator and a descriptive message in the display 1 First press the button to silence the alarm for a maximum of 2 minutes then check the display for an alarm message Press CANCEL to cancel the alarm message 2 If the infusion has stopped rectify the cause of the alarm then press the button to resume the infusion Display DRIVE DISENGAGED OCCLUSION CHECK SYRI
14. 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 The Alaris GH Syringe Pump is compatible with a wide range of standard single use disposable Luer lock syringes It accepts syringe sizes from 5 ml to 50 ml See the Compatible Syringes section for a full list of compatible syringes Simple to set up and easy to operate Large graphics format display e Medical Device Interface MDI a unique mounting mechanism Rate Range from 0 1 to 1200ml h Event logging records operation of pump Advanced Communications and Nurse call interfaces Configurable drug names About This Manual The user must be thoroughly familiar with the Alaris GH Syringe Pump described in this manual prior to use All illustrations used in this manual show typical settings and values which may be used in setting up the functions of the pump These settings and values are for illustrative use only Where stated a minimum infusion rate refers to a nominal rate of 1 0ml h and an intermediate infusion rate refers to a nominal rate of 5 0ml h The complete range of infusion rates settings and values are shown in the Specifications section Quick Start Guide 1 Press the button to turn the pump on 2 CLEAR SETUP NO retains previous data YES clears previous data 3 Load syringe
15. 00002 Iss 2 L Labelling Symbols 5 Language 9 18 Loading a Syringe 11 M Maintenance 24 25 Mount 7 10 N Nurse Call 8 17 27 Oo Occlusion 20 26 Operating Precautions 7 8 P Plunger 3 11 Pole Clamp 3 10 Pressure 6 20 26 Purge 3 4 13 20 Q Quick Start Guide 2 See also Starting the Pump R Rate Lock 14 REPAIRING LOGS 12 RS232 3 5 8 27 29 S Screen Icons 6 Service Contacts 30 Spare Parts 29 Specifications 20 Start up Curves 28 Starting the Pump 12 Storage 25 Syringes 2 18 19 21 See also Loading a Syringe T Technical Service Manual 17 27 29 Test 24 Titration 14 20 Trumpet Curves 28 V Volume Infused 6 20 Volume to be Infused See VTBI VTBI 6 13 14 15 16 20 Ww Warnings 16 Warranty 31 Weight 20 Workstation 10 29 32 32 CardinalHealth Alaris Asena Guardrails and IVAC are registered trademarks of Cardinal Health Inc or one of its subsidiaries All other trademarks belong to their respective owners 2000 2006 Cardinal Health Inc or one of its subsidiaries All rights reserved 1000DF00002 Issue 2 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 author
16. 8 76 00 Fax 47 66 98 76 01 NZ Cardinal Health 14 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 46 8 544 43 200 Fax 46 8 544 43 225 30 32 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 d
17. Alaris GH Syringe Pump Directions For Use English r e ur r Uy jz CardinalHealth Page e MEP OGUICEION peser 2 e About This Manual mee 2 e QUICK Start CI Ee EE 2 e Features of the Alaris GH Syringe Pump cese eene eere eere serene ense n setas tense tn sense en se tne sense ease 3 e Controls amp INGICAtONS e T 4 o Symbol DERMITIONS wiisciscccisecticsscecscacesesctssscsccssses sonassosssoesacusscssesousseadsccacisdessesdcsssscassdenssessadssodisseesaeases 5 e Main Display Features assisti 6 e Operating Precautions 7 e GetING Started A E O E 9 e BASIC FOAtures lm Mn 13 e Alarms ANd Warnings ssisssscscscssesscessscsacsessseessccecossecsssecsevoussesseasnseasecscesuaseesseuscesecdecesousssensausacsbsssusseusses 16 e erppEesbrtleee T M 17 o SPECIFICATIONS mee 20 e IO UuDmulaunprq 21 o CE IIEl Cou eere Tta ce 21 e Compatible Extension Sets csssccsssscssssscssssccssssccsssccssssscssssccssssscsssscsessscssssssssssssssssssssssssssscsessscoess 22 e Maintenance AR 24 e Occlusion Pressure Limits eee e cresce eee e esee seen eene nets aetas eto
18. NGE BATTERY LOW BATTERY EMPTY NEAR END OF INFUSION END OF INFUSION TITRATION NOT CONFIRMED VTBI DONE AC POWER FAIL Error Code and Message ATTENTION with 3 Beeps Alarm Indicator Colour AMBER RED Description and Troubleshooting Guide The drive system has been disengaged during operation Check the finger grips and the position of the syringe Excessive pressure measured at the syringe plunger exceeding the alarm limit Identify and remove the cause of the blockage in the drive syringe or administration system before restarting the infusion Incorrect size of syringe has been fitted the syringe has not been positioned correctly or has been disturbed during operation Check the syringe location and the position Battery charge low with 30 minutes operation remaining Battery indicator will flash and after 30 minutes a continuous audible alarm will indicate that the battery is exhausted Reconnect to the AC power supply to continue operation and charge the internal battery The internal battery is exhausted Connect the pump to the AC power supply The pump is nearing the end of the infusion This value can be configured The pump has reached the end of the infusion A pre set volume will remain in the syringe to minimise the risk of the infusion of air bubbles into the set This value can be configured The infusion rate has been changed but has not been confirmed and 2 minutes has expired without any o
19. The amber LED will be lit while on MUTE button Press to silence alarm for 2 minutes configurable Press and hold until 3 beeps are heard for 15 minutes silence PURGE BOLUS button Press to access PURGE or BOLUS soft keys Press and hold down soft key to operate PURGE the extension set during set up Pump is on hold Extension set is not connected to the patient e Volume Infused VI is not added BOLUS fluid or drug delivered at an accelerated rate e Pumpis infusing Extension set is connected to the patient e Vlis added OPTION button Press to access optional features see Basic Features PRESSURE button Use this button to display the pumping pressure and alarm CHEVRON keys Double or single for faster slower increase or decrease of values shown on display BLANK SOFTKEYS Use in conjunction with the prompts shown on the display Indicators BATTERY indicator When illuminated the pump is running on the internal battery When flashing the battery power is low with less than 30 minutes of use remaining AC POWER indicator When illuminated the pump is connected to an AC power supply and the battery is being charged 1000DF00002 Iss 2 4 32 Symbol Definitions Labelling Symbols Attention Consult accompanying documents Potential Equalisation PE Connector RS232 Nurse call Connector Optional Defibrillation proof type CF applied part Degree of protection against electrical shoc
20. c purposes The pump should always be infusing and always attached to the patient Drugs given by an IV bolus could achieve immediate and high drug concentration levels Bolus can be used at the start of an infusion or during an infusion The bolus feature can be configured to a BOLUS Disabled b BOLUS Enabled _ i Hands On only ii Hands On and Hands Free BOLUS Disabled If configured to Disabled pressing the button will have no effect and the pump will continue to infuse at the set rate AHands On bolus and Hands Free bolus cannot be administered if the RATE LOCK is active During BOLUS the pressure limit alarm is temporarily increased to the maximum level BOLUS Enabled Hands On In Hands on Bolus press and hold the flashing BOLUS soft key to deliver the required bolus The bolus rate can be adjusted The bolus volume is limited in the configuration 1 During infusion press the button once to display the bolus screen 2 Use the amp amp keys to adjust the bolus rate if required 3 Todeliver the bolus press and hold the BOLUS softkey During the bolus the volume being infused is displayed When the desired bolus volume has been delivered or the bolus volume limit is reached release the softkey The bolus volume is added to the total volume infused BOLUS Enabled Hands On and Hands Free The Hands Free Bolus is delivered with a single press of the flashing BOLUS soft key On intial use th
21. d in the extension set and retained in the syringe at the end of infusion as this dead space will not be infused Place the pump on a stable horizontal surface or secure as described above Prepare load and prime the single use disposable syringe and extension set using standard aseptic techniques 1 Squeeze the finger grips together on the plunger holder and slide the mechanism to the right Pull the syringe clamp forward and down To ensure the syringe is loaded correctly place the barrel flange in the space between the syringe clamp and the syringe flange clamp This is correct if the syringe remains in position before the syringe clamp is closed Insert the syringe ensuring that the barrel flange is located in the slots on the syringe flange clamp Lift the syringe clamp until it locks against the syringe barrel Squeeze the finger grips on the plunger holder and slide the mechanism to the left until it reaches the plunger end Release the finger grips Ensure that the plunger grippers are securing the plunger in place and the finger grip returns to its original position CHE ND Secure the extension set using the extension set hook at the rear of the pump This provides protection against accidental dislodging of the syringe from the pump Ensure that both plunger grippers are fully locked onto the plunger flange and the upper finger grip has returned to its original position Plunger Plunger Flange Grippers Plunger P
22. e bolus rate and bolus volume are at default values and can be changed On subsequent uses the bolus rate and bolus volume will remain as per previously set and can be changed as required Following CLEAR SETUP the default bolus rate is determined via the configuration and the default bolus volume is 0 1ml 1 During infusion press the C button to display the Hands Free bolus selection screen 2 Press the YES softkey to go to Hands Free selection bolus screen press the HANDS ON softkey for Hands On bolus see section above 3 Use the DY keys to set the bolus volume dose required If necessary press the RATE softkey to adjust the bolus delivery rate 150 300 600 900 1200ml h Note Rate may be restricted by the syringe size and the CAP BOLUS RATE 4 Press the flashing BOLUS softkey once to begin the delivery of the preset bolus The display will show the bolus being delivered the bolus counting down and revert to main infusion display upon completion of the bolus 5 To terminate a bolus being delivered press STOP softkey This will stop the bolus and continue infusing at the set rate Press the button to stop the bolus delivery and place the pump on hold 6 If the bolus volume reaches the set bolus volume limit the bolus will stop and the pump will revert to infuse at the set infusion rate and continue infusing If the Hands Free bolus option is active then this feature will be cancelled following any interruption in delivery e g
23. efects in material and workmanship under normal use and service for a period of one 1 year from the date of delivery by Cardinal Health to the original purchaser If any product requires repair during the applicable warranty period the purchaser should communicate directly with its local Cardinal Health service centre to determine the appropriate service facility Except as provided otherwise in this warranty repair or replacement will be carried out at Cardinal Health s expense The product requiring service should be returned promptly properly packaged and postage prepaid by purchaser Loss or damage in return shipment to Cardinal Health shall be at purchaser s risk In no event shall Cardinal Health be liable for any incidental indirect or consequential damages in connection with the purchase or use of any Cardinal Health product This warranty shall apply solely to the original purchaser This warranty shall not apply to any subsequent owner or holder of the product Furthermore this warranty shall not apply to and Cardinal Health shall not be responsible for any loss or damage arising in connection with the purchase or use of any Cardinal Health product which has been A repaired by anyone other than an authorised Cardinal 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 rem
24. every 15 seconds or the pump will alarm display communications failure and stop infusing This failure protects against failure of the communications including the removal of the RS232 cable 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 alarm Refer to the Technical Service Manual for further information regarding the RS232 interface Since it is possible to control the syringe pump using the RS232 interface at some distance from the pump and hence remote from the patient responsibility for the control of the pump is vested in the software run on the computer control system The assessment forthe suitability of any software used in the clinical environment to control or receive data from the pump lies with the user of the equipment This software should include detection of the disconnection or other failure of the RS232 cable The protocol is detailed in the Technical Service Manual and is for general information only Any connected analogueand digital components are required to meet IEC EN60950 for data processing and IEC EN60601 for medical devices Anyone connecting additional devices to the signal input or output is a system configurator and responsible for meeting the requirements of the system standard IEC EN60601 1 1 Baud Rate 38 4 kBaud Start Bits 1 Start Bit Data Bits 8 Data Bits Parity No Parity Stop Bits 1 stop bit
25. facturers can cause variations in accuracy and trumpet curves as compared to those represented Additional curves for compatible syringes are available upon written request For applications where flow uniformity is a concern rates of 1 0 ml h or above are recommended Start up Trend BD Plastipak 50ml e 0 1ml h Trumpet Curve BD Plastipak 50ml 0 1ml h E on A I iu W I VE g 5 104 A te ke amp 0 06 5 EN 20 0 04 0 02 E 0 00 40 0 02 d 0 10 20 30 40 50 60 70 80 90 100 410 120 M 46 i ne s a 28 Time mins Observation Window mins H Maximum Error Minimum Error A linearMean 10 2 startup Trend BD Plastipak 50 ml 1 0 ml h Trumpet Curve BD Plastipak 50 ml 1 0 ml h os E 10 TT Rm RH N PE 2 ACA 4 5 8 E 5 2 Gd 0 6 u 10 04 15 0 2 00 20 0 10 20 30 40 50 60 70 80 90 100 110 120 E 5 10 15 20 25 30 35 Time mins Observation Window mins Maximum Error Minimum Error Linear Mean 1 8 15 H Trumpet Curve BD Plastipak 50 ml 5 0 ml h 100 Start up Trend BD Plastipak 50 ml 5 0 ml h 9 0 10 80 5 70 d 0 fie 4 Sr 50 a z I g 40 v e 5 30 E 20 10 10 00 15 0 10 20 30 40 50 60 70 80 90 100 110 120 9 5 10 15 20 25 30 35 Time mins Observation Window mins Maximum Error Minimum Error t LinearMean 0 2 1000DF00002 Iss 2 28 32 Pr
26. ist of permitted syringe models is dependent on the software version of the pump 5ml leue ee eres eese Astrazeneca BBraunPerfusor o v BOPerfusor oo BDPreise Codan v Codan Perfusion Fresenius Injectomat_ v INpo 0 v Rpjectt The Rapiject 50ml syringe is a specialised syringe with a large diameter barrel To provide protection against accidental dislodging always ensure the infusion line is secured using the infusion set hook see Loading a Syringe section ETYCO Healthcare KENDALL MONOJECT Y v aa Hx pu ecu ESCAS Associated Products The Alaris DS The Asena IDS The Alaris Gateway Workstation Docking Station Docking Station SAY 1000DF00002 Iss 2 21 32 Compatible Extension Sets The pump uses standard single use disposable extension sets and syringes with Luer lock connectors The user is responsible for verifying the suitability of a product used if it is not recommended by Cardinal Health Standard Sets G40015 G40020B G402EP Standard PVC Syringe Extension Set 150 cm Priming Volume 2 6ml Standard PVC Syringe Extension Set 200 cm Priming Volume 1 5ml Extension set luer lock connectors Ki
27. ization of Cardinal Health Inc or one of its subsidiaries is strictly forbidden Cardinal Health 1180 Rolle Switzerland www cardinalhealth co uk alaris
28. k Device complies with the requirements of the EC Directive 93 42 EEC Registered with the CE Mark Date of Manufacture Manufacturer Not for Municipal Waste Important information Fuse Rating 1000DF00002 Iss 2 5 32 Main Display Features Pump S type fitted Status rug name F a8 0 8 0 Oen E pe Avus EEE VTBI Pressure Information VOLUME Om 00 00 VOLUME Infusion Volume Volume Infused Rate Infused Option Screen Icons symbol Description B HO TIME REMAINING DISPLAY icon Indicates time before syringe will require replacing BATTERY icon Indicates battery charge level to highlight when the battery will require recharging 1000DF00002 Iss 2 6 32 Operating Precautions Disposable Syringes and Extension Sets This Alaris GH Syringe Pump has been calibrated for use with single use disposable syringes To ensure correct and accurate operation only use 3 piece Luer Lock versions of the syringe make specified on the pump or described in this manual Use of non specified syringes or extension sets may impair the operation of the pump and the accuracy of the infusion Uncontrolled flow or syphoning may result if the syringe is located incorrectly in the pump or if it is removed from the pump before the extension set is properly isolated from the patient Isolation may include closing a tap in the patient line or activating a flo
29. k 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 Alaris GH Syringe Pump User Support CD Directions For Use AC Power Cable as requested Protective Packaging 3 Connect the pump to the AC power supply for at least 2 hours to ensure that the internal battery is charged verify that the OE is lit Language Selection 1 Oninitial start up the pump will display the Select Language screen 2 Select the required language from the list displayed using the ASC keys 3 Press the OK softkey to confirm your selection The pump will automatically operate from its internal battery if the pump is switched on without being connected to the AC power supply Should the pump fail to perform correctly replace in its original protective packaging where possible and contact a qualified service engineer for investigation 1000DF00002 Iss 2 9 32 Getting Started continued Do not mount the pump with the AC power inlet or the syringe pointing upwards This could affect the electrical safety in the event of a fluid spill or lead to the infusion of air which may be in the syringe Pole Clamp Installation The pole clamp is 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 area 1 Pullthe folded pole clamp towards you and unscrew the clam
30. lunger Holder Syringe Barrel Barrel Flange Syringe Clamp Syringe Flange Clamp 1000DF00002 Iss 2 11 32 Getting Started Continued 1 Connect the pump to an AC power supply using the AC power cable Press the button e The pump will run a short self test Ensure that two beeps are activated during this test e Check the display test pattern and ensure that no rows are missing e Check that the displayed time and date are correct Note A warning REPAIRING LOGS may be displayed if event log information was not completely stored at the previous power down This is for information only the pump will continue to power up as normal 2 CLEAR SETUP Answering NO will retain all previous rate and volume settings YES will automatically reset the rate and volume settings to zero 3 LOAD SYRINGE Load the syringe according to the procedure in this manual 5 CONFIRM SYRINGE Check that the syringe type and size being used matches the display If required the make of syringe can be changed by pressing the TYPE button Press CONFIRM when the correct type and size are shown If the PURGE SYRINGE option has been enabled then the prompt to purge screen is displayed and the set can be purged as required 5 INFUSION RATE Check the rate shown if old patient data has been retained and change the rate if necessary using the keys 6 PURGE if required Press the C amp button and then press and hold the
31. main display Sets the alarm volume of the pump at high medium or low Backlight dims between hours 21 00 and 06 00 1000DF00002 Iss 2 17 32 Configured Options Continued Drug Set up This option is used to set up a list of drug names Select DRUG LIBRARY from the menu using the amp SC X keys and press the OK softkey Select the required drug and press the OK softkey In order to use a drug it must be enabled Press the YES softkey to enable the selected drug PWN gt To add or change a drug name use the amp amp keys to scroll through the alphabet pressing NEXT to select a letter and move on to the next position On completion press the OK softkey yi When the set up is complete turn the pump OFF then return the pump into operation as required Alternatively select the next configuration option from the menu Clock Set 1 Select CLOCK SET from the Configured Options menu using the amp C keys and press the OK softkey 2 Use the amp amp Y keys to adjust the date displayed pressing the NEXT softkey to access the next field 3 When the correct time and date are displayed press the OK softkey to return to the Configured Options menu Hospital Name This option allows the user to programme in the name of the hospital ward or department This will appear during the power up display sequence 1 Select HOSPITAL NAME from the Configured Options menu using the amp amp Y keys and press the OK softkey 2
32. ment large motors portable radios cellular telephones etc and is designed to remain safe when unreasonable levels of interference are encountered e This pumpis a 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 electromagnetic radiation which is within the levels specified by IEC EN60601 1 2 and IEC EN60601 2 24 If the pump interacts with other equipment measures should be taken to minimise the effects for instance by repositioning or relocation e nsome circumstances the pump may be affected by an electrostatic discharge through air at levels close to or above 15kv or by radio frequency radiation close to or above 10v m If the pump is affected by lt this external interference the pump will remain in a safe mode the pump will duly stop the infusion and ca EE alert the user by generating a combination of visual and audible alarms Should any encountered alarm condition persist even after user intervention it is recommended to replace that particular pump and quarantine the pump for the attention of appropriately trained technical personnel Consult Technical Service Manual for further information e Anexplosion hazard exists if the pump is used in the presence of flammable anaesthetics Exercise ca
33. ml v2 3 x amp above or v1 9 x 1min 24h VTBI Complete Rate Stop KVO 0 1ml h to 2 5ml h set rate if lower than KVO or continue at set rate Near End Of Infusion Alarm 1min 15min to end of infusion or 1096 of syringe volume whichever is smaller End Of Infusion EOI Alarm 0 196 596 of syringe volume Electrical Classification Class product Continuous Mode Operation Transportable Maximum Pumping Pressure Limit Highest alarm level 1000mmHg nominal at L 10 Occlusion Accuracy 96 of full scale L 0 L 3 L 5 L 10 approx approx approx approx 50 mmHg 300 mmHg 500 mmHg 1000 mmHg Using most common 50ml syringes under normal conditions 9596 confidence 9596 of pumps 1000DF00002 Iss 2 System Accuracy Volumetric Mean 296 nominal Derating Temperature 0 5 5 40 C High Rates 2 0 rates gt syringe volume h eg 50ml h in a 50ml syringe Important System accuracy is 2 typical by volume as measured using the trumpet curve test method defined in IEC EN60601 2 24 at rates of 1 0ml h 23 C and above when the pump is used with the recommended syringes Differences in factors such as size and plunger force in compatible syringes can cause variations in accuracy and trumpet curves See also trumpet curves section in this manual Battery Specifications Rechargeable sealed NiMH Automatically charges when the pump is connected to AC power
34. nk resistant DEHP free PVC yellow striped tubing Bore 1mm Length 200cm Priming volume 1 6ml Light Protected Sets G40215 G40320 Low Sorbing Sets G40615 G40620 G40720 Amber PVC Syringe Extension Set 150 cm Priming Volume 1 2ml White PVC Syringe Extension Set 200 cm Priming Volume 3 6ml Polyethylene Syringe Extension Set 150 cm Priming Volume 1 5ml Polyethylene Syringe Extension Set 200 cm Priming Volume 1 6ml Polyethylene Lined Syringe Extension Set with clamp 200 cm Priming Volume 1 5ml It is recommended that extension sets are changed in accordance with the Directions for Use Carefully read the Directions For Use supplied with the extension set prior to use Please note these drawings are not to scale 1000DF00002 Iss 2 22 32 Compatible Extension Sets Continued The pump uses standard single use disposable extension sets and syringes with Luer lock connectors The user is responsible for verifying the suitability of a product used if it is not recommended by Cardinal Health Patient Controlled Analgesia PCA Sets 30822 PVC Syringe Extension Set with clamp 152 cm Priming Volume 0 5ml PVC Y Syringe Extension Set with back check valve and 2 clamps 178 cm Priming Volume 1 5ml m ICEF PVC Syringe Extension Set with back check valve Y Site and clamp 32 cm Priming Volume 1 2ml PVC Y Syringe Extension Set with anti siphon valve back check
35. oducts and Spare Parts Alaris Infusion System Range of products in the Alaris Infusion System product family are 80053UN01 Alaris PK Syringe Pump 1 are also available without an RS232 option fitted contact local customer services representative to obtain part number details 2 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 included within the Technical Service Manual The Technical Service Manual 1000SM00001 is now available in electronic format on the World Wide Web at www cardinalhealth co uk alaris A username and password are required to access our manuals Please contact local customer services representative to obtain login details 1000SP01122 Internal Battery Pack 1000DF00002 Iss 2 29 32 Service Contacts For service contact your local Affiliate Office or Distributor AE Cardinal Health PO Box 5527 Dubai United Arab Emirates Tel 971 4 28 22 842 Fax 971 4 28 22 914 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
36. oved 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 1000DF00002 Iss 2 31 32 Symbols 24 Hour Log 15 A About This Manual 2 Alaris DS Docking Station 10 29 Alaris Gateway Workstation 10 29 Alarms 16 Associated Products 21 Battery 16 17 20 29 See also Battery Operation Battery Operation 24 Bolus 3 4 13 20 C Cleaning 25 Clock Set 18 Concentration 25 Contrast 18 Controls CHEVRON 4 HOLD 3 4 12 MUTE 3 4 ON OFF 3 4 OPTION 3 4 PRESSURE 3 4 PURGE BOLUS 3 4 RUN 3 4 SOFTKEYS 4 D Display 3 6 16 Disposal 25 Docking Station 10 29 Dosing 15 Drug Name 15 Drug Set up 18 Equipment Rail 10 Event Log 15 Extension Sets 7 22 23 F Fuses 24 G General Options 17 19 H Hands Free 13 Hands On 13 Hospital Name 18 19 l Indicators AC POWER 4 BATTERY 4 Installation 10 Introduction 2 IrDA 27 1000DF
37. owing are unavailable Changing the infusion rate titration Bolus purge Switching the pump off VTBI over time infusions To disable the rate lock if selected 1 Press the button to access the options menu 2 Select the UNLOCK RATE option using the keys and press the OK softkey To enable the rate lock if not selected 1 Press the C button to access the options menu 2 Select RATE LOCK and press the OK softkey 1000DF00002 Iss 2 14 32 Basic Features Continued Set VTBI over Time This option allows a specific VTBI and delivery time to be set The rate necessary to deliver the required volume within the specified time is calculated and displayed 1 Stop the infusion Press the button to access the options menu Select the SET VTBI OVER TIME option using the amp Y keys and press the OK softkey Adjust the volume to be infused using the amp V keys When the desired volume has been reached press the OK softkey Enter the time over which the volume is to be infused The infusion rate will automatically be calculated Press the OK softkey to enter the value AowNM un Select the rate at VTBI end from the list using the amp amp Y keys and press the OK softkey The default is STOP 24 Hour Log This option allows the 24 hour log of volume infused to be reviewed 1 Press the button to access the options menu 2 Select the 24H LOG option using the amp amp keys and press
38. p 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 Ensure the pole clamp is folded away and stored within the recessed area at the rear of the pump before connecting to a Docking Station Workstation or when not in use Never mount the pump such that the IV infusion stand becomes top heavy or unstable Docking Station Workstation or Equipment Rail Installation Rectangular bar Release lever push to release Rotating cam The rotating cam can be fitted to the rectangular bar on the Docking Station Workstation or the equipment rail measuring 10 by 25 mm 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 Hold the pump horizontally push the pump firmly onto the rectangular bar or equipment rail Ensure that the pump clicks securely into position onto the bar 3 Torelease push the release lever and pull the pump forwards Alaris DS Docking Station Asena IDS Docking Station and Alaris Gateway Workstation 1000DF00002 Iss 2 10 32 Getting Started continued Loading a Syringe Only use a syringe of the type stated on the pump or in this manual Using an incorrect syringe could adversely affect the accuracy of the infusion and the performance of the pump When initially loading the syringe allow for the volume of fluid containe
39. peration Press the button to silence the alarm then press the CANCEL softkey to clear this message and silence the alarm Check infusion rate and confirm by pressing the button or press the button to revert to the previous rate Press the button to start infusion This alarm only occurs if rate titration is enabled The pre set Volume To Be Infused is complete AC Power has been disconnected and the pump is operating on battery power if this occurs when the pump is infusing the message INFUSION CONTINUES will be displayed Reconnect AC power supply or press the QD button to silence the alarm and continue with battery operation The alarm will automatically cancel if the AC power supply is reconnected The alarm system has detected an internal malfunction Note the malfunction code Remove pump from service for examination by a qualified service engineer Three beeps will sound if the pump has been left ON for more than 2 minutes referred to as CALLBACK in the log without starting the operation Press the button to silence the alarm for a further 2 minutes Alternatively press and hold down the button and wait for 3 beeps in succession this will put the warning alarm on standby for 15 minutes Alarms indicated AC POWER FAIL NEAR END OF INFUSION VTBI DONE KVO or CONTINUE ATTENTION TITRATION NOT CONFIRMED BATTERY LOW All others Configurable option 1000DF00002 Iss 2 16 32 Configured Options This menu comp
40. pplied by Cardinal Health Refer to the Technical Service Manual for the access code for technical service features Interval Routine Maintenance Procedure As per Hospital Policy Thoroughly clean external surfaces of the pump before and after prolonged period of storage Atleast once per year 1 Inspect AC power supply plug and cable for damage Refer to TSM for 2 Perform functional tests as outlined in the Technical Service Manual identification of parts f 3 Operate the pump on battery power until the battery low alarm then charge the battery to confirm battery operation and charging Please refer to Technical Service Manual for calibration procedures The units of measurement used in the calibration procedure are standard SI The International System of Units units Replacing the AC Fuses If the pump continually illuminates the battery symbol and the AC power indicator light does not illuminate when the pump is connected to the AC power supply and switched ON either the power supply fuse in the AC plug if fitted or the internal fuses have blown First check the power supply fuse in the AC mains plug if fitted If the AC power indicator light does not illuminate remove the pump from service It is recommended that only a qualified service engineer replaces the AC fuses For further information regarding the replacement of internal AC fuses refer to the Technical Service Manual If the fuses continue to blow suspec
41. re to locate the pump away from any such hazardous sources T ITI Dangerous Voltage An electrical shock hazard exists if the pump s casing is opened or removed Refer all servicing to qualified service personnel 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 in the installation or its arrangement is in doubt the pump should be operated from the battery Do not open the RS232 Nurse Call protective covering when not in use Electrostatic discharge ESD precautions are required when connecting RS232 Nurse Call Touching the pins of the kod 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 MZ otherwise suspected to have been damaged remove it from service for inspection by a qualified service engineer When transporting or storing the pump use original packaging where possible and adhere to temperature humidity and pressure ranges stated in the Specifications section and on the outer packaging Latex Content The Alaris GH Syringe Pump does not contain any Latex 1000DF00002 Iss 2 8 32 Getting Started Initial Set up Before operating the pump read this Directions For Use manual carefully 1 Chec
42. rises a list of options which are configurable by the user 1 Turn the pump OFF 2 Whilst holding down the button turn the pump ON 3 Themain display will show 000 Enter the access code for Configured Options using the keys pressing NEXT to move through the digits A full list of access codes can be found in the Technical Service Manual 4 When the complete code shows on screen press OK to enter The Configured Options menu will be displayed General Options Je po NURSE CALL FITTED NURSE CALL INVERT RS232 SELECTED NEOI WARNING EOI POINT KVO AT EOI KVO RATE BACK OFF AUTO SAVE RATE LOCK QUIET MODE AC FAIL RATE TITRATION PRESSURE DISPLAY CAP PRESSURE PRESSURE DEFAULT CAP RATE PURGE RATE PURGE VOLUME LIMIT PURGE SYRINGE BOLUS DEFAULT BOLUS CAP BOLUS RATE BOLUS VOL LIMIT MANUAL BOLUS CALL BACK TIME VTBI CLEAR RATE EVENT LOG DISPLAY BATTERY ICON AUDIO VOLUME AUTO NIGHT MODE Select GENERAL OPTIONS from the menu using the amp amp keys and press the OK softkey Select the option you wish to enable disable or adjust and press the MODIFY softkey When all the desired modifications have been carried out press the QUIT softkey Either select the next configuration option from the menu or turn the pump OFF returning it to operation as required Enables Nurse Call hardware option When enabled the nurse call output is inverted Sets the pump s communications to use RS232 hardware option
43. s tasas tense toss sos ease oar SEST aS 26 o IrDA RS232 and Nurse call Specification eene eee e eee eee eee eee o eee en esee en esee ao se esset aae s esas 27 e Trumpet Curves amp Start up Curves 4 crees eee e eee eee ee essen netto assess set eo sesta sse ena set eo sse ts sse eoe seno 28 e Products and eror Tid un Ce 29 e Service CONTACTS c M 30 e Document History ec M 30 e rEn 31 e Ihr 3 A AEE E E c ERUIT ANDIUS 32 1000DF00002 Iss 2 1 32 Introduction The Alaris GH Syringe Pump herein after referred to as pump is a fully featured syringe pump suitable for critical care and general infusion applications Intended Use The pump is designed to meet the infusion requirements within the operating environment specified in this Directions For Use DFU including general wards critical and intensive care neonatal operating rooms and accident and emergency rooms This pump is suitable for use by appropriately trained clinicians or nurses The syringe pump is suitable to deliver fluids and medications via intravenous routes Supporting fluid therapy blood transfusions and parenteral feeding 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
44. t an electrical fault and have the pump and power supply checked out by a qualified service engineer Battery Operation The internal rechargeable battery allows continued operation when the AC power is unavailable for example during patient transfer or AC power failure A fully charged battery will provide over 4 hours of operation at typical infusion rates From the battery low alarm it will take about 27 hours to 90 charge when reconnected to the AC power supply whether the pump is in use or not 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 battery For further information regarding the replacement of batteries refer to the Technical Service Manual Test Routines The test routines are designed to allow confirmation of many of the pump functions defaults and calibrations without requiring internal inspection They do not represent a full calibration check See the Technical Service Manual for a complete list of the test procedures access codes and calibration procedures 1000DF00002 Iss 2 24 32 Maintenance contin
45. tablishments 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 Operating Pressure This is a positive pressure pump designed to achieve very accurate fluid administration by automatically compensating for resistance encountered in the infusion system The pumping pressure alarm system is not designed to provide protection against or detection of IV complications which can occur P uum e Alarm Conditions Several alarm conditions detected by this pump will stop the infusion and generate visual and audible alarms Users must perform regular checks to ensure that the infusion is progressing correctly and no alarms are operating 1000DF00002 Iss 2 7 32 Operating Precautions continued Electromagnetic Compatibility amp 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 equip
46. tions Maximum infusion rate can be set as part of the configuration 0 1ml h 150ml h 5ml syringes 0 1ml h 300ml h 10ml syringes 0 1ml h 600ml h 20ml syringes 0 1ml h 900ml h 30ml syringes 0 1ml h 1200ml h 50ml syringes The Volume Infused range is 0 0ml 9990ml Bolus Specifications Maximum Bolus rates can be set as part of the configuration Bolus rates are user adjustable in increments of 10ml h 10 ml h 150ml h 10 ml h 300ml h 10 ml h 600ml h 10 ml h 900ml h 30ml syringes 10 ml h 1200ml h 50ml syringes The bolus volume limit can be set as part of the configuration Minimum 0 5ml 0 1ml v2 3 x amp above or v1 9 x Maximum 25 0ml Increments of 0 1ml default 5 0ml During BOLUS the pressure limit alarms are temporarily increased to their maximum level Critical Volume The bolus which can occur in the event of a single internal fault condition with a 50 ml syringe is 5ml syringes 10ml syringes 20ml syringes Maximum Overinfusion 0 5ml Purge Specifications The purge rate is limited to the maximum rate for the syringe and can be set as part of the configuration 100ml h 500ml h The purge volume range is 0 5ml 5ml During PURGE the pressure limit alarms are temporarily increased to their maximum level Keep Vein Open KVO Rate 0 1 ml h 2 5ml h End Of Syringe Rate Stop KVO 0 1ml h to 2 5ml h or set rate if lower than KVO Volume To Be Infused VTBI 0 1ml 100ml 0 1ml 1000
47. two ways 1 the delay in onset of fluid flow when infusion commences start up curves and 2 the accuracy of fluid delivery over various time periods is measured trumpet curves The start up curves represent continuous flow versus operating time from the start of the infusion They exhibit the delay in onset of delivery due to mechanical compliance and provide a visual representation of uniformity Trumpet curves are derived from the second hour of this data Tests performed per IEC EN60601 2 24 standard Trumpet curves are named for their characteristic shape They display discrete data averaged over particular time periods or observation windows not continuous data versus operating time Over long observation windows short term fluctuations have little effect on accuracy as represented by the flat part of the curve As the observation window is reduced short term fluctuations have greater effects as represented by the mouth of 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 therefore the clinical effect cannot be determined from the trumpet curves alone Start up and trumpet curves may not be indicative of operation under negative pressure Differences in factors such as size and plunger force in compatible syringes produced by other manu
48. ued Cleaning and Storage Before the transfer of the pump to a new patient and periodically during the use clean the pump by wiping over with a lint free cloth lightly dampened with warm water and a standard disinfectant detergent solution Recommended cleaners are Brand Concentration Hibiscrub 20 v v Virkon 1 w v Do not use the following disinfectant types Disinfectants which are known to be corrosive to metals must not be used which include NaDcc such as Presept Hypochlorites such as Chlorasol Aldehydes such as Cidex Cationic Surfactants such as Benzalkonium Chloride Use of lodine such as Betadine will cause surface discoloration Concentrated Isopropyl alcohol based cleaners will degrade plastic parts The syringe and extension sets are disposable single use items and should be discarded after use according to their manufacturers instructions If the pump is to be stored for an 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 Before cleaning always switch OFF and disconnect from the AC power supply Never allow liquid to enter the casing and avoid excess fluid build up on the
49. valve and 2 clamps 183 cm Priming Volume 1 8ml E AA NM a PVC Syringe Extension Set with anti siphon valve and clamp 156 cm Priming Volume 0 6ml It is recommended that extension sets are changed in accordance with the Directions for Use Carefully read the Directions For Use supplied with the extension set prior to use Please note these drawings are not to scale 1000DF00002 Iss 2 23 32 Maintenance Routine Maintenance Procedures To ensure that this pump remains in good operating condition it is important to keep it clean and carry out the routine maintenance procedures described below All servicing should only be performed by a qualified service engineer with reference to the Technical Service Manual TSM Circuit diagrams and 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 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 su
50. w stop clamp Secure the extension set to the pump using the extension set hook at the rear of the pump This provides protection against accidental dislodging of the syringe from the pump When combining several apparatus and or instruments with extension sets and other tubing for example via a 3 way tap the performance of the pump may be impacted and should be monitored closely e 1 0m e Mounting the Pump The pump must be mounted within 1 0m above or below the patient s heart The most accurate pressure monitoring in the extension set is achieved when the pump is positioned close to the patients heart level Do not mount the pump in a vertical position with the syringe pointing upwards as this could lead to an infusion of air which may be in the syringe To protect against the introduction of air the user should regularly monitor the progress of the infusion syringe extension line and patient connections and follow the priming procedure specified herein Operating Environment When using any infusion pump in conjunction with other pumps or devices requiring vascular access extra care is advised Adverse delivery of medication or fluids can be caused by the substantial variation in pressures created within the local vascular system by such pumps Typical examples of those pumps are used during dialysis bypass or cardiac assist applications This pump is suitable for use in Hospital and clinical environments other than domestic es
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