BD Alaris 8002TIG03 Directions For Use Manual

BD Alaris 8002TIG03 Directions For Use Manual

Syringe pump with plus software mk4
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Alaris™ Syringe Pump
(with Plus Software) MK4
Models: 8002TIG03, 8003TIG03, 8002TIG03-G, 8003TIG03-G
s
Directions For Use
en

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Summary of Contents for BD Alaris 8002TIG03

  • Page 1 Alaris™ Syringe Pump Directions For Use (with Plus Software) MK4 Models: 8002TIG03, 8003TIG03, 8002TIG03-G, 8003TIG03-G...
  • Page 2: Table Of Contents

    Alaris™ Syringe Pumps Contents Page Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Intended Purpose .
  • Page 3 Alaris™ Syringe Pumps Dosing Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24 Set VTBI over Time .
  • Page 4 Alaris™ Syringe Pumps IrDA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .50 RS232 / Nurse call Connection Data .
  • Page 5: Introduction

    The Alaris Syringe Pump should only be operated by a clinician competent in use of automated syringe pumps and post-placement management of intravenous catheters . BD cannot guarantee the continued system accuracy with other manufacturer’s syringes as identified in the ‘Recognised Syringes’ table. Manufacturers may change syringe specification significant to system accuracy without prior notification.
  • Page 6: About This Manual

    It is important to ensure that you only refer to the most recent version of the Directions for Use and Technical Service Manual for your BD products. These documents are referenced on bd.com. Paper copies of the Directions For Use can be obtained free of charge by contacting your local BD representative.
  • Page 7: Creating A Data Set

    Alaris™ Syringe Pumps Creating a Data Set Creating a Data Set To create a data set for the Pump, first the hospital will need to develop, review, approve and upload a data set according to the following process . Refer to the Alaris Editor help file for further details and operating precautions . 1 .
  • Page 8: Features Of The Pump

    Alaris™ Syringe Pumps Features of the Pump Features of the Pump ON/OFF High visibility Release lever Display Alarm Indicator for MDI Pressure transducer PURGE/BOLUS MUTE PRESSURE OPTION Finger Grips Extension set hook HOLD Shelf for chevron Syringe Clamp Positive Plunger keys and softkeys Grippers Rating Plate (see Symbol Definitions for an...
  • Page 9: Controls And Indicators

    Alaris™ Syringe Pumps Controls and Indicators Controls and Indicators Controls: Symbol Description ON/OFF button - Press once to switch the Pump on . Press and hold down for 3 seconds to switch the Pump off . Note: Logs are maintained for power down events including when the pump is powered down or unexpected power loss .
  • Page 10: Symbol Definitions

    Alaris™ Syringe Pumps Symbol Definitions Symbol Definitions Labelling Symbols: Symbol Description Consult accompanying documents Potential Equalisation (PE) Connector RS232/Nurse call Connector Defibrillation-proof type CF applied part (Degree of protection against electrical shock) Protected against direct sprays of water up to 15° from vertical and protected against solid objects greater than IP32 2 .5mm .
  • Page 11: Main Display Features

    Alaris™ Syringe Pumps Main Display Features Main Display Features Alaris CC Syringe Pump and Alaris CC Guardrails Syringe Pump Display Syringe type fitted / Pressure Pump Profile / Drug name Information Status Volume Infused Infusion Rate Volume VTBI Option Infused Option Alaris GH Syringe Pump and Alaris GH Guardrails Syringe Pump Display Syringe type fitted /...
  • Page 12: Operating Precautions

    Alaris™ Syringe Pumps Operating Precautions Operating Precautions Disposable Syringes and Extension Sets • The Pump has been calibrated for use with single-use disposable syringes . To best 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 .
  • Page 13: Operating Pressure

    BD . Any use of Alaris Syringe Pumps which have been altered or modified otherwise than in strict application of directions provided by BD, is at your sole risk, and BD does not provide any warranty for or endorsement on any Alaris Syringe Pump that has been so modified or altered .
  • Page 14: Electromagnetic Compatibility & Interference

    MRI devices . Therefore, the Pump is not considered an MRI compatible Pump as such . If use of the Pump within an MRI environment is unavoidable, then BD highly recommends securing the Pump at a safe distance from the magnetic field outside the identified ‘Controlled Access Area’...
  • Page 15: Getting Started

    Alaris™ Syringe Pumps Getting Started Getting Started Initial Set-up Before operating the Pump read this Directions For Use manual carefully. 1 . Check that the Pump is complete, undamaged and that the voltage rating specified on the label is compatible with your AC power supply .
  • Page 16: Pole Clamp Installation

    Alaris™ Syringe Pumps Getting Started 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 Recessed area...
  • Page 17: Securing The Syringe With Optional Lock Box

    Alaris™ Syringe Pumps Securing the Syringe with Optional Lock box Securing the Syringe with Optional Lock box Lock box operation The optional lock box is a available in two configurations: • Rate Unlocked lock box - is designed to allow the user to •...
  • Page 18: Syringe Loading

    Alaris™ Syringe Pumps Syringe Loading Syringe Loading Prepare Syringe and Administration Set To decrease potential start-up delays, delivery inaccuracies and delayed generation of occlusion alarms each time a new syringe is loaded: • Use smallest syringe size possible, for example, if infusing 9 ml of fluid, use a 10 ml syringe . •...
  • Page 19: Loading And Confirming A Syringe

    Alaris™ Syringe Pumps Syringe Loading Loading and Confirming a Syringe Warning: To securely load and confirm a syringe carefully follow the steps below. An incorrect loading of a syringe may result in misidentification of the syringe type and size. If then confirmed, this may lead to significant inaccuracy of the infusion rate and may also affect Pump performance.
  • Page 20 . BD recommends limiting the number of configured syringe types and sizes available for selection on the Pump using the Alaris Editor.
  • Page 21: Starting The Pump

    Alaris™ Syringe Pumps Starting the Pump Starting the Pump When operating the Pump, the User should position themselves at a distance of 0.5 metres from the display. 1 . Connect the Pump to an AC power supply using the AC power cable . 2 .
  • Page 22 Alaris™ Syringe Pumps Starting the Pump 8 . Load the syringe according to the procedure in this manual . 9 . Insert the pressure disc into the pressure transducer . Pressure Transducer - Detects if an extension set with a pressure disc is fitted.
  • Page 23: Basic Features

    Alaris™ Syringe Pumps Basic Features Basic Features Bolus Infusion Bolus Administering a controlled volume of fluid or drug at an increased rate for diagnostic or therapeutic 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 .
  • Page 24: Purge

    Alaris™ Syringe Pumps Basic Features Purge 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 button when the Pump is not infusing .
  • Page 25: Dosing Summary

    Alaris™ Syringe Pumps Basic Features Dosing Summary To review currently selected dosing information: 1 . Press the button to first access the options menu . 2 . Select DOSING SUMMARY . 3 . Review the information and then press the QUIT softkey . Set VTBI over Time This option allows a VTBI and delivery time to be specified .
  • Page 26: Add Drug

    Alaris™ Syringe Pumps Basic Features Add Drug This option allows the user to add a drug whilst the Pump is running a ml/h infusion . Note: This option will not be available when operating the Alaris CC Syringe Pump or the Alaris CC Guardrails Syringe Pump in semi dedicated mode and using an extension set without pressure disc .
  • Page 27: Pressure Features

    Alaris™ Syringe Pumps Pressure Features Pressure Features Auto Set Pressure (If enabled)* If the Auto Set Pressure Option is enabled then the Pump automatically adjusts the pressure occlusion limit . After 15 minutes of infusion the Pump automatically adjusts the occlusion pressure limit to XX mmHg above the average infusion pressure, taken from the average of the last five minutes of infusion .
  • Page 28: Alarms And Warnings

    Alaris™ Syringe Pumps Alarms and Warnings 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 2 minutes, then check the display for an alarm message . Press CANCEL to cancel the alarm message .
  • Page 29 Alaris™ Syringe Pumps Alarms and Warnings Display Alarm Description and Troubleshooting Guide Priority TITRATION NOT Medium The infusion rate has been changed, but has not been confirmed after five seconds of no CONFIRMED activity the User will be notified by an auditory cue . The infusion has not been confirmed and two minutes has expired without any operation, a medium priority alarm will be button to silence the alarm, then press the CANCEL softkey to generated .
  • Page 30: 3Rd Edition Alarms

    Alaris™ Syringe Pumps Alarms and Warnings 3rd Edition Alarms Display Alarm Description and Troubleshooting Guide Priority Error Code and Message High The alarm system has detected an internal malfunction . Note the malfunction code . Remove Pump from service for examination by Qualified Service Personnel . DRIVE DISENGAGED High The drive system has been disengaged during operation .
  • Page 31 Alaris™ Syringe Pumps Alarms and Warnings Display Alarm Description and Troubleshooting Guide Priority ADD DRUG NOT COMPLETE The ADD DRUG operation has not been completed after five seconds the User will be notified by an auditory cue . After two minutes have expired and the ADD DRUG operation has not been completed, a low priority alarm is generated .
  • Page 32: Prompts

    Alaris™ Syringe Pumps Prompts Prompts Prompts are indicated by an audible alarm and message, they cannot be silenced and do not have a visual indicator . Display Icon Description and Troubleshooting Guide DOSE WOULD EXCEED* The dose rate has been set to a value which exceeds a Guardrails Soft Alert . Check infusion setting, to continue with infusion at set rate confirm OVERRIDE LIMIT by pressing the YES softkey .
  • Page 33: Configured Options

    Alaris™ Syringe Pumps Configured Options Configured Options This section comprises of a list of options which are configurable . Some can be entered via the Pump configurations (available in Technician Mode) and others through the Alaris Editor Software . Access codes should only be entered by Qualified Service Personnel. Use Alaris Editor to configure general options, drug library and units enabled for each profile and to configure Syringe Brands and Models to be enabled .
  • Page 34: Alaris Editor Software Profile Configuration

    Alaris™ Syringe Pumps Configured Options General Options 1 . Select GENERAL OPTIONS from the Configured Options menu using the keys and press the OK softkey . 2 . Select the option required to enable/disable or adjust and press the MODIFY softkey . 3 .
  • Page 35 Alaris™ Syringe Pumps Configured Options General Syringe Pump Configurations Back Off An automatic feature which is activated following an occlusion . The Pump action reverses and pumps backwards to release the pressure which has built up in the infusion system, this minimises the post occlusion bolus .
  • Page 36: Dosing Only Units

    Alaris™ Syringe Pumps Configured Options Dosing Only Units The following dose rate units can be configured for use in Dosing Only mode . Checking the All checkbox will select all of the listed units . Default Default Default Default Type Unit Unit Unit...
  • Page 37: Alaris Editor Software Profile Drug Library

    Alaris™ Syringe Pumps Configured Options Alaris Editor Software Profile Drug library The following drug parameters are only configurable via the Alaris Editor Software, see Alaris Editor Directions For Use for details on how to configure Profile Drug Library, and are used when the Pump is operated with a drug name selected . Concentration Units The unit for concentration parameters Concentration Limits...
  • Page 38: Specifications

    -0 .1% ± 5% * - Using BD Plastipak 50ml syringe at 5ml/h under normal conditions (95% confidence / 95% of pumps) . Critical Volume The bolus which can occur in the event of a single internal fault condition with a 50 ml syringe is : Maximum Overinfusion - 0 .87ml Purge Specifications The purge rate is limited to the maximum rate for the syringe and can be set as part of the configuration .
  • Page 39 Alaris™ Syringe Pumps Specifications 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 10% of syringe volume, whichever is smaller . End Of Infusion (EOI) Alarm 0 .1% - 5% of syringe volume Maximum Pumping Pressure Limit...
  • Page 40 Alaris™ Syringe Pumps Specifications Dimensions 335 mm (w) x 121 mm (h) x 200 mm (d) . 310 mm (w) x 121 mm (h) x 200 mm (d) . Weight 2 .4 kg (excluding power cable) . Protection against fluid ingress IP32 - Protected against direct sprays of water up to 15°...
  • Page 41: Recognised Syringes

    Subject to the above, BD branded luer lock syringes can be confirmed as BD Plastipak syringes due to there being no significant variance in dimensions.
  • Page 42: Associated Products

    Alaris™ Syringe Pumps Associated Products Associated Products The Alaris Gateway Workstation Product SKU 80203UNS0y-xx Supply Voltage 115-230VAC, ~50-60Hz Electrical Rating 460VA (Maximum) Protection Against Electrical Shock Class 1 Classification Continuous Operation Supply to Pump 115-230V, ~50-60Hz, 60VA The Alaris DS Docking Station Product SKU 80283UNS00-xx Supply Voltage...
  • Page 43: Compatible Extension Sets

    MFX2213 Priming Volume: 0 .8ml • New sets are continuously being developed for our customers. Please contact your local BD representative for availability. • 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.
  • Page 44: Tpn Sets

    Polyethylene Syringe Extension Set (100 cm) . Priming Volume: 1ml • New sets are continuously being developed for our customers. Please contact your local BD representative for availability. • 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.
  • Page 45: Light Protected Sets

    MFX2210 Priming Volume: 1 .6ml • New sets are continuously being developed for our customers. Please contact your local BD representative for availability. • 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.
  • Page 46: Patient Controlled Analgesia (Pca) Sets

    PVC Syringe Extension Set (105 cm) . Priming Volume: 7 .2ml • New sets are continuously being developed for our customers. Please contact your local BD representative for availability. • 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.
  • Page 47: Maintenance

    Alaris Syringe Pump, and in conjunction with Alaris Syringe Pump software, controls battery use, charge and temperature . Any use of battery packs that are not manufactured by BD in the Alaris Syringe Pump is at your sole risk, and BD does not provide any warranty for or endorsement on any battery packs that are not manufactured by BD .
  • Page 48: Cleaning And Storage

    . If you wish to discard electrical and electronic equipment, please contact your BD 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 .
  • Page 49: Occlusion Pressure Limits

    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 G30402M extension set with occlusion sensing disc .
  • Page 50: Without A Pressure Extension Set Fitted, G40020B - Standard Disposable Extension Set

    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 .
  • Page 51: Irda, Rs232 And Nurse Call Specification

    Alaris™ Syringe Pumps IrDA, RS232 and Nurse call Specification IrDA, RS232 and Nurse call Specification IrDA / RS232 / Nurse call Feature The IrDA or RS232 / Nurse call is a feature on the Pump that allows connection to a PC or another Alaris Syringe Pump . This allows data to be transferred between the Pump and a PC or another Alaris Syringe Pump, (e .g .
  • Page 52: Rs232 / Nurse Call Connection Data

    Alaris™ Syringe Pumps IrDA, RS232 and Nurse call Specification RS232 / Nurse call Connection Data RS232 / Nurse call Specification - Connector D Type - 9 Pin TXD/RXD EIA RS232-C Standard TXD Output Voltage Range Minimum: -5V (mark), +5V (space) Typical: -7V (mark), +7V (space) with 3kΩ...
  • Page 53: Trumpet Curves And Start-Up Curves

    Observation Window (mins) Maximum Error Minimum Error Linear Mean = -4 .0% Start-up Trend . BD Plastipak 50 ml @ 1 .0 ml/h Trumpet Curve . BD Plastipak 50 ml @ 1 .0 ml/h Time (mins) Observation Window (mins) Maximum Error Minimum Error Linear Mean = -1 .8%...
  • Page 54: Alaris Gh Syringe Pump And Alaris Gh Guardrails Syringe Pump

    Observation Window (mins) Maximum Error Minimum Error Linear Mean = -2 .5% Start-up Trend . BD Plastipak 50 ml @ 1 .0 ml/h Trumpet Curve . BD Plastipak 50 ml @ 1 .0 ml/h Time (mins) Observation Window (mins) Maximum Error Minimum Error Linear Mean = -1 .8%...
  • Page 55: Products And Spare Parts

    The Technical Service Manual (1000SM00024) is now available in electronic format on the World Wide Web at :- bd .com/int-alaris-technical A username and password are required to access our manuals . Please contact a local customer services representative to obtain login details .
  • Page 56: Document History

    Alaris™ Syringe Pumps Document History Document History Issue Date Software Version Description June 2017 4 .3 .6 August 2017 4 .3 .9 December 2017 4 .3 .9 Initial release March 2018 4 .3 .9 Additional information with regards to Syringe loading June 2018 4 .3 .9 Specifications...
  • Page 57: Contact Us

    Alaris™ Syringe Pumps Contact Us Contact Us For full contact information please refer to bd .com . Customer Service Information Country Telephone email Australia Freephone: 1 800 833 372 au-customerservice@carefusion .com België +32(0)53 720 556 info .benelux@bd .com Canada +1 800 387 8309 CanadaCapital@carefusion .com .
  • Page 58 Trademarks are the property of their respective owners. © 2018 BD. BD, the BD Logo and all other trademarks are property of Becton, Dickinson and Company. This document contains proprietary information of Becton, Dickinson and Company or one of its...

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