BD Alaris Directions For Use Manual

Gateway workstation
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Alaris
Gateway Workstation
v1.3.x
en Directions For Use

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Summary of Contents for BD Alaris

  • Page 1 Alaris Gateway Workstation ™ v1.3.x en Directions For Use...
  • Page 2: Table Of Contents

    Alaris™ Gateway Workstation v1.3.x Contents Page About This Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Conventions Used in this Manual .
  • Page 3 Alaris™ Gateway Workstation v1.3.x Wired Networking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 Auxiliary Interface .
  • Page 4: 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 5: Introduction

    Note: The 3rd Edition Alarms profile and Original Alarms Profile are selectable on the Pumps listed below with the exception of Alaris™ Enteral Plus Syringe Pump MK4 v4 .6 .x and Alaris™ GW 800 Volumetric Pump . Alaris™ Enteral Plus Syringe Pump MK4 v4 .6 .x and Alaris™ GW 800 Volumetric Pump have only 3rd Edition compliant alarms programmed .
  • Page 6 Medium Software (flashing (flashing (flashing Version red) yellow) yellow) Alaris™ GH Syringe Pump (with Plus 8002TIG03 v4 .3 .x Software) MK4 Alaris™ CC Syringe Pump (with Plus 8003TIG03 v4 .3 .x Software) MK4 Alaris™ GH Guardrails™ Syringe 8002TIG03-G v4 .3 .x Pump (with Plus Software) MK4 Alaris™...
  • Page 7 BD Alaris™ neXus CC Syringe Pump CCneXus1 v5 .0 .20 BD Alaris™ neXus CC Syringe Pump CCneXus1-S v5 .0 .20 Alaris™ GW 800 Volumetric Pump and Alaris™ Enteral Plus Syringe Pump only Infusion Pump Model Code Minimum Beacon Nurse Call...
  • Page 8 * xxx, xxxx and xxxxxx denotes the language and country specific model codes ** The display on the Alaris™ GW Volumetric Pump and the Alaris™ GW 800 Volumetric Pump can only show four characters so software version is shown without the letter r *** The medium (yellow) level alarm is not triggered for a Rate Lock alarm for the Alaris™...
  • Page 9 Alaris™ Gateway Workstation v1.3.x Introduction Note: The single and dual channel Alaris™ SE Pump can be connected to the serial interface of the Workstation however can not be fitted onto the MDI tile . Note: All Pumps listed under ‘Legacy Pumps’ activate the Pump Alarm Location Beacon for high, medium, and low priority alarms, where applicable .
  • Page 10: Intended Users

    Conditions for Use The Alaris™ Gateway Workstation is an accessory for a medical device but it is not directly used in patient care, and so has no defined conditions for use . However, it is used to provide mounting, power and communications support to Alaris™...
  • Page 11: Undesirable Side-Effects

    Alaris™ Gateway Workstation v1.3.x Introduction Undesirable Side-Effects The Alaris™ Gateway Workstation has no undesirable side-effects associated with its use when used in accordance with the Directions For Use . Workstation Hardware Options There are two different configuration options for the Workstation . To identify its configuration, refer to the labels on the front and back of the Workstation .
  • Page 12: Workstation Software Options

    There are different software versions that can be ordered for each Primary Workstation . The software version of Workstation can be identified by the labelling on the front . Contact local BD representative for further information about Workstation versions, upgrade options and product availability .
  • Page 13: Workstation Identification

    Alaris™ Gateway Workstation v1.3.x Introduction Workstation Identification The Workstation can be confirmed by viewing the serial number label on the rear of the Workstation and checking the SKU is 80300UNSxx, where xx indicates the connectivity option . The two or three numbers at the end of the SKU identifies the Workstation configuration, see below for all available configurations .
  • Page 14: Controls And Indicators

    Alaris™ Gateway Workstation v1.3.x Controls and Indicators Controls and Indicators Controls Symbol Description ON/OFF Button – Press once to switch the Workstation on . Press and hold for two seconds to switch the Workstation off . In the event that the system needs to be reset, press and hold for at least four seconds, then press again to switch the Workstation on .
  • Page 15: Symbol Definitions

    Alaris™ Gateway Workstation v1.3.x Symbol Definitions Symbol Definitions Labelling Symbols Symbol Description 30V/1A Nurse call Connector RS232 Connector Auxiliary Connector Interface Device, General (Barcode Reader Connector) AC Inlet AC Outlet - Do Not Use This equipment contains an RF transmitter (where fitted)
  • Page 16 Alaris™ Gateway Workstation v1.3.x Symbol Definitions Symbol Description Fragile, handle with care Keep dry Transport and Storage Humidity limitation 106 kPa Transport and Storage Atmospheric pressure limitation 50 kPa +50°C Transport and Storage Temperature limit -20°C 50kg Lifting hazard for Workstation Trolley, do not lift without assistance...
  • Page 17: Features Of The Workstation

    Alaris™ Gateway Workstation v1.3.x Features of the Workstation Features of the Workstation Modular Design The Workstation is a modular design . The Base Module comprises three MDI tiles with modules of two MDI tiles expanding the vertical configuration . Horizontal T-pieces of two, three or four MDI tiles may be added to accommodate Pumps and fluid bag hangers, as required .
  • Page 18 Alaris™ Gateway Workstation v1.3.x Features of the Workstation Configuration 80300UNSxx-235, shown mounted on an Alaris™ Gateway Workstation Trolley: Bag Supports Bag Support Rail Mounting Rail Infusion Line Tidies Mounting Rail Mounting Rail Trolley Note: Qualified Service Personnel are required to assemble the Trolley and to mount the Workstation on the Trolley .
  • Page 19: Infusion Line Tidies (Where Fitted)

    . Alaris™ Gateway Workstation Trolley When the Workstation is mounted to the Alaris™ Gateway Workstation Trolley and is not being transported, the brakes should be engaged .
  • Page 20: Adjustable Height Bag Hangers (Where Fitted)

    Alaris™ Gateway Workstation v1.3.x Features of the Workstation Adjustable Height Bag Hangers (where fitted) The 18 mm diameter adjustable height pole has been designed as a convenient means of securing the fluid bags onto the Workstation . The pole supports a maximum load to 3kg . The pole is held securely by a clamp and a slip catch . This gives additional flexibility when selecting the required height of the fluid bags .
  • Page 21: Ac Power Output To Infusion Pumps

    Pumps and the Workstation. Leakage current values for product is given in the following table. Note that only Pumps that are powered from the MDI tile AC outlet connector need to be included in the calculation. Example: Alaris™ SE Pumps do not need to be included. Product...
  • Page 22: System Notifications

    • Tones compliant with aforementioned standards • Tones that sound similar to alarm tones on legacy Alaris™ Infusion Pumps It is recommended that all Pumps in a single care area be configured with the same alarm tones, where applicable, to avoid User confusion.
  • Page 23: Nurse Call Interface

    Call activates when a Pump communicates an alarm condition to the Workstation via the IrDA interface or RS232 for Alaris™ SE Pump . The communication of such an alarm condition could be interrupted if, for example, the Pump was not correctly attached to the Workstation .
  • Page 24: Pump Alarm Location Beacon (Where Fitted)

    Alaris™ Gateway Workstation v1.3.x Features of the Workstation Pump Alarm Location Beacon (where fitted) The Pump Alarm Location Beacon is mounted on the upper face of the Workstation to assist with identifying the location of any Pumps that have entered an alarm state . When lit, the Pump Alarm Location Beacon colour matches that of the visual status indicator on the Pumps .
  • Page 25 Features of the Workstation Note: The legacy Alaris™ GW Volumetric Pump does not have a visual status indicator but still activates the Pump Alarm Location Beacon for alarms and some warnings . The Alaris™ GW 800 Volumetric Pump does have a visual status indicator, and activates the Pump Alarm Location Beacon for alarm conditions .
  • Page 26: Operating Precautions

    Special instructions for isolation room: Use with the nurse-call feature in order to make alarms visible outside of the room Exclude use of the Alaris™ GW Volumetric Pumps, which are not fully compatible with the Workstation nurse call . BDDF00794 Issue 4...
  • Page 27 .) and has been tested to EN/IEC 60601-1-2 and ETSI EN 301 489-17 (where applicable) . The Workstation is a CISPR II Group 1 Class A device . When Alaris™ Infusion Pumps are attached and operational, the system becomes a CISPR II Group 1 Class A system .
  • Page 28 BD, is at your sole risk, and BD does not provide any warranty for or endorsement on any Alaris™ Gateway Workstation that has been so modified or altered. BD product warranty shall not apply in the event the Alaris™...
  • Page 29 Do not orientate the Workstation with the AC inlet or outlets exposed in the event of a spill. When mounted to the Alaris™ Gateway Workstation Trolley and not in transport the Trolley brakes should be engaged. BDDF00794 Issue 4...
  • Page 30: Operation Of Workstation

    Alaris™ Gateway Workstation v1.3.x Operation of Workstation Operation of Workstation Switching On When operating the Workstation, the User should position themselves at a distance of one metre from the Workstation. After initially switching on the Workstation, any services and applications running on the Workstation may take up to 90 seconds to become fully operational .
  • Page 31: Resetting The Workstation

    Alaris™ Gateway Workstation v1.3.x Operation of Workstation Resetting the Workstation In the unlikely event that the Workstation needs to be reset, press and hold the key for at least four seconds until the ON Status Indicator is extinguished, release the key then press again to switch the Workstation back on .
  • Page 32: Mounting A Pump

    Alaris™ Gateway Workstation v1.3.x Operation of Workstation Mounting a Pump 1 . Ensure the Workstation is connected to the AC power and power up sequence has completed successfully . 2 . Align the rotating cam on the rear of the Pump with the rectangular bar on the Workstation .
  • Page 33: Data Communication Interfaces

    Note: Any Workstation connecting to the device must have the appropriate antivirus and authentication policies to restrict access to the Alaris™ Gateway Workstation web interface . Barcode Reader Interface A barcode reader may be attached to the Workstation . The interface provided by the Workstation supplies power and a serial data connection to the barcode reader .
  • Page 34: Barcode Reader (Optional)

    Alaris™ Gateway Workstation v1.3.x Barcode Reader (optional) Barcode Reader (optional) Overview The barcode reader (where fitted) allows the scanning and recognition of barcodes . Cable Connection Green LED Red LED Laser Aperture The Workstation must be powered down before attaching or disconnecting the barcode reader.
  • Page 35: Data Communications Interface Specifications

    Rating: 30V/1A Description Pin 1: NC_COM Pin 2: NC_NC Pin 3: NC_NO Barcode Reader Interface For use with BD supplied barcode reader only. Workstation Connector Type: Binder 09 0998 00 05 Cable Type: N/A Description Pin 1: +5V Pin 2: TxD...
  • Page 36: Ethernet Interface

    Alaris™ Gateway Workstation v1.3.x Data Communications Interface Specifications Ethernet Interface Connector Type: RJ45 Cable Type: CAT5e Ethernet Cable: Length >1 .5m Isolation: 1 .5kV Data Rate: 10/100Mbps Description Pin 1: TxD+ Pin 2: TxD– Pin 3: RxD+ Pin 4: N/C Pin 5: N/C Pin 6: RxD–...
  • Page 37: Auxiliary Interface

    Alaris™ Gateway Workstation v1.3.x Data Communications Interface Specifications Auxiliary Interface Connector Type: RJ45 Cable Type: CAT5e Ethernet Cable: As required Isolation: 1 .5kV Description Pin 1: Tx+ Pin 2: Tx– Pin 3: Rx+ Pin 4: N/C Pin 5: N/C Pin 6: Rx–...
  • Page 38: Product Specifications

    Alaris™ Gateway Workstation v1.3.x Product Specifications Product Specifications Electrical Protection Against Electrical Shock: Class I Supply Voltage: 115-230V, ~50-60Hz Rating: 460VA (Maximum) Fuses: 2 x T 4H, 250V Consult Qualified Service Personnel for replacement of fuses . AC Outlets: MDI Tile: 115-230V, ~50-60Hz, 60VA Protection against fluid ingress: IP22 - Protected against solid foreign objects of 12 .5 mm diameter and greater, and protected against vertically falling...
  • Page 39: Classification

    Alaris™ Gateway Workstation v1.3.x Product Specifications Classification Continuous Operation Regulatory Compliance Complies with EN/IEC 60601-1 and EN/IEC 60601-1-2 Potential Equalisation Conductor The function of the Potential Equalisation Connector (Conductor) is to provide a direct connection between the Workstation and the potential equalisation busbar of the electrical installation . To use the Potential Equalisation Connector, connect the Potential Equalisation Connector on the Workstation to the potential equalisation busbar of the electrical installation .
  • Page 40: Physical

    Includes Pumps, Syringe Pumps with lockboxes and 1 litre fluid bags on each bag support . Note, all weights • derived from lockbox weight . Refer to the Alaris™ CC/GH Syringe Pump DFU for more information on lockbox . Total VA Rating for two connected Workstations should not exceed 460VA (includes combinations of Pumps •...
  • Page 41: Trolley Compatibility

    • Includes Pumps, Syringe Pumps with lockboxes and 1 litre fluid bags on each bag support . Note, all weights derived from lockbox weight . Refer to the Alaris™ CC/GH Syringe Pump DFU for more information on lockbox . • Total VA Rating for two connected Workstations should not exceed 460VA (includes combinations of Pumps within leakage current limits) .
  • Page 42: Maintenance

    Workstation software, controls battery use, charge and temperature . Any use of battery packs that are not manufactured by BD in the Alaris™ Gateway Workstation 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 43: Cleaning And Storage

    If the Workstation has visible cracks or damage to the case, do not clean and immediately take out of service for examination by Qualified Service Personnel. Do not clean the AC connector and socket. Contact local BD Qualified Service Personnel for further guidance.
  • Page 44: Disposal

    . To discard electrical and electronic equipment, contact local BD affiliate office or distributor for further information . Disposing of this product correctly helps 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 45: Spare Parts

    Alaris™ Gateway Workstation v1.3.x Spare Parts Spare Parts A comprehensive list of spare parts for this Workstation is included within the Technical Service Manual . The Technical Service Manual (BDTM00004) is now available in electronic format on the World Wide Web at: bd .com/int-alaris-technical...
  • Page 46: Document History

    Alaris™ Gateway Workstation v1.3.x Document History Document History Issue Date Software Description Version December 2020 1 .3 .x Updated for latest regulations . December 2020 1 .3 .x Updated for latest regulations . September 2021 1 .3 .x Updated for latest regulations .
  • Page 47: Contact Us

    Alaris™ Gateway Workstation v1.3.x Contact Us Contact Us For full contact information, refer to bd .com . Customer Service Information Country Telephone Email Australia Freephone: 1 800 656 100 bd_anz@bd .com België +32(0)53 720 556 info .benelux@bd .com Canada +1 800 387 8309 CanadaCapital@carefusion .com...
  • Page 48 BD Switzerland Sàrl, Route de Crassier 17, Business Park Terre-Bonne, Batiment A4, 1262 Eysins, Switzerland bd.com BD, the BD Logo, Alaris and Guardrails are trademarks of Becton, Dickinson and Company or its affiliates. © 2022 BD. All rights reserved.

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