Alaris™ Gateway Workstation Directions For Use v1.3...(with Plus Software) MK4 8002TIG03-G v4 .3 .x Yes Yes Yes Yes Yes Alaris CC Guardrails Syringe Pump (with Plus Software) MK4

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Alaris™ Gateway Workstation v1.3.x

Directions For Useen

BDDF00122 Issue 3 1/36


ContentsPage

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Workstation Hardware Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3Workstation Software Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5Workstation Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

About This Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10

Conventions used in this manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10Controls and Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11

Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11

Symbol Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12

Labelling Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12Features of the Workstation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13

Modular Design . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13Infusion Line Tidies (where fitted) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15Alaris Trolley . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .15Adjustable Height Bag Hangers (where fitted) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16Power Input . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16Battery Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .16AC Power Output to Infusion Pumps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17Powering an auxiliary Workstation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17System Notifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18System Fault Indication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19Nurse Call Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19Pump Alarm Location Beacon (where fitted) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20

Operating Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21

Operating Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21Electromagnetic Compatibility and Interference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22Workstation Mounting Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23

Operation of Workstation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24

Switching On . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24Switching Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24Resetting the Workstation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24Fitting an Auxiliary Workstation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25Removing an Auxiliary Workstation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25Mounting a Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26Removing a Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26

Data Communication Interfaces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27

Barcode Reader Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27RS232 Serial Interfaces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27Ethernet Interfaces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27Wireless Ethernet Interface (where fitted) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27Auxiliary Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27

Barcode Reader (optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28



Visual Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28Scanning a Barcode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28

Data Communications Interface Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29

Nurse Call Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29Barcode Reader Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29Serial RS232 Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29Ethernet Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30Wireless Ethernet Interface (where fitted) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30Auxiliary Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30

Product Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31

Electrical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31Environmental . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31Classification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31Regulatory Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31Potential Equalisation Conductor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31Patents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .31Physical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32Trolley Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32

Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33

Routine Maintenance Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33Replacing the AC Fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33Cleaning and Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .34

Spare Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35

Spare Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35Document History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .35

Contact Us . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .36

Customer Service Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .36


Alaris™ Gateway Workstation v1.3.xIntroduction

IntroductionThe Alaris™ Gateway Workstation v1 .3 .x (hereinafter referred to as Workstation) has been designed as a modular system to provide a communications gateway between an Alaris Infusion Pump (hereinafter referred to as Pump) and any Patient Data Management System (PDMS), Patient Monitoring (PM) System, Hospital Information System (HIS) or Clinical Information System (CIS) that requires access to the infusion data retained within the Pump .

Workstation Hardware Options There are three different configuration options for the Workstation . To identify its configuration, refer to the labels on the front and back of the Workstation .

Option 1. Basic or Auxiliary Workstation

REF

80300UNS01-32

SN:

T135070253 17 .04 .2014

This is an entry level Workstation with organization and central AC power supply functionality . It does not support PDMS connectivity . It may be used as an Auxiliary Workstation to increase the number of Pumps needed at the bedside .

Option 2. Primary wired Workstation

REF

80300UNS02-32

SN:

T135070253 17 .04 .2014

This option is designed to accommodate connectivity to third party systems via a hospital wired network infrastructure . A Primary wired Workstation can be coupled with one Auxiliary Workstation to send infusion data for up to 26 Pumps to third party systems .

Option 3. Primary wireless Workstation

REF

80300UNS03-32

SN:

T135070253 17 .04 .2014

This option is designed to accommodate connectivity to third party systems via a hospital wired or wireless network infrastructure . A Primary wireless Workstation can be coupled with one Auxiliary Workstation to send infusion data for up to 23 Pumps to third party systems .



Workstation Software OptionsThere 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 . Please contact local BD representative for further information about Workstation versions, upgrade options and product availability .

Alaris Gateway Workstation

(software versions v1 .2 and v1 .3 .x)

Alaris Gateway Workstation

(software versions 1 .1 .6 and below)

Note: Alaris Gateway Workstation v1 .3 .x is differentiable from other models by the software version listed on the back label .

Alaris®

Gateway Workstation

The Alaris DS Docking Station, although similar in appearance to the Workstation, does not have any connectivity features. The Alaris DS Docking Station can be identified by the number of vertical MDI tiles, as it has an even number compared to the Workstation which has an odd number and that the AC power Cable socket is at the front.

Note: Please make sure to refer to the correct Workstation Directions For Use to familiarise with the specific Workstation version .

Features:

• Central management system for multiple Pumps• Medical Device Interface (MDI) – a unique mounting mechanism providing data communications and AC power to the Pump• Reduced cable clutter with the use of a single AC power inlet• Efficient organisation of multiple infusion lines and configurations• Workstation battery back-up in the event of power supply interruption• High visibility Pump Alarm Location Beacon assists with the location of Pumps in an alarm state, when fitted• Nurse call interface for all Pumps attached to the Workstation MDI Tiles

The Workstation supports optional upgrades to enhance the data communication interfaces and to support software for connections to such client / server systems .

It is recommended the Workstations in a single care area should be of the same software version. Using Workstations of different software versions could lead to inconsistent representation of Pump Alarm Signals on the Workstations.



Intended UseThe Alaris Gateway Workstation v1 .3 .x is intended to be used to provide mounting, power and communications support to the Alaris Infusion Pumps range within the operating environment specified in this Directions For Use (DFU) . In such environments, the Workstation may be exposed to the following range of therapies: fluid therapy, blood transfusions, parenteral feeding, drug therapy, chemotherapy, dialysis and anaesthesia . The Workstation is designed not to directly impact or affect the infusion delivery process .

The Workstation is designed to work with the following Alaris Infusion Pumps:

Pumps with alarms that are compliant with IEC 60601-1-8: 2012 and IEC 60601-2-24:2012

wThe default alarm system is ORIGINAL ALARMS (IEC/EN 60601-1-8 2nd Edition alarms). 3RD EDITION ALARMS (IEC/EN 60601-1-8 3rd Edition alarms) are also installed. To change the Pump alarm system from ORIGINAL ALARMS to 3RD EDITION ALARMS please refer to the Technical Service Manual. Please note that this change should only be performed by Qualified Service Personnel.

Pumps have 2 alarm tones to choose from during configuration:

• ORIGINAL ALARMS: Low, medium and high priority alarm tones that sound like the auditory alarms and warnings from software versions prior to 3 .4 .5

• 3RD EDITION ALARMS: Low, medium and high priority alarm tones in accordance with IEC 60601-1-8: 2012 and IEC 60601-2-24:2012

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 .4 .9 and Alaris GW 800 Volumetric Pump . Alaris Enteral Plus Syringe Pump MK4 v4 .4 .9 and Alaris GW 800 Volumetric Pump have only 3rd Edition compliant alarms programmed .

ORIGINAL ALARMS Alarm Tone Set

Infusion Pump Model Code Minimum Supported Software Version

Beacon Nurse CallHigh (flashing red)

Medium (flashing amber)

Low (solid amber)

High Medium

Alaris GH Syringe Pump (with Plus Software) MK4

8002TIG03 v4 .3 .x Yes Yes Yes Yes Yes

Alaris CC Syringe Pump (with Plus Software) MK4


Alaris GH Guardrails™ Syringe Pump (with Plus Software) MK4

8002TIG03-G v4 .3 .x Yes Yes Yes Yes Yes

Alaris CC Guardrails Syringe Pump (with Plus Software) MK4


Alaris PK Plus Syringe Pump MK4 8005TIG03 v3 .5 .x Yes Yes Yes Yes YesAlaris Enteral Plus Syringe Pump MK4 8007ENT03 v4 .5 .x Yes Yes Yes Yes YesAlaris GP Volumetric Pump (with Plus Software)


Alaris GP Guardrails Volumetric Pump (with Plus Software)


Alaris VP Plus Guardrails Volumetric Pump




3RD EDITION ALARMS Alarm Tone Set




Low (solid amber)

High Medium Low

Alaris GH Syringe Pump (with Plus Software) MK4

8002TIG03 v4 .3 .x Yes Yes Yes Yes Yes Yes

Alaris CC Syringe Pump (with Plus Software) MK4


Alaris GH Guardrails™ Syringe Pump (with Plus Software) MK4

8002TIG03-G v4 .3 .x Yes Yes Yes Yes Yes Yes

Alaris CC Guardrails Syringe Pump (with Plus Software) MK4


Alaris PK Plus Syringe Pump MK4 8005TIG03 v3 .5 .x Yes Yes Yes Yes Yes YesAlaris Enteral Plus Syringe Pump MK4 8007ENT03 v4 .5 .x Yes Yes Yes Yes Yes YesAlaris GP Volumetric Pump (with Plus Software)


Alaris GP Guardrails Volumetric Pump (with Plus Software)


Alaris VP Plus Guardrails Volumetric Pump


Alaris GW 800 Volumetric Pump And Alaris Enteral Plus Syringe Pump only




Low (solid amber)

High Medium Low

Alaris GW 800 Volumetric Pump 800TIG2xxx1* V6r1x

(V61x)**

Yes No No Yes No No

Alaris Enteral Plus Syringe Pump MK4 8007ENT01 v4 .4 .9 N/A N/A N/A N/A N/A N/A

Note: For Pump alarms compliant to IEC 60601-1-8:2012 and IEC 60601-2-24:2012 the 3rd Edition Alarm Profile must be selected on the Pump . For legacy Pump alarms the Original Alarms Profile must be selected on the Pump .

Note: In some instances, legacy Workstation software versions may provide mismatched Pump alarm location beacon behaviour when using Pumps with selectable alarm profiles .



Legacy PumpsNote: Legacy Pumps do not have Low priority alarms .

Note: Information signals are not clearly distinguishable from Pump alarms in legacy Pump versions .


Beacon Nurse CallHigh (red)

Medium (amber)

High Medium

Alaris GS Syringe Pump 80013UN01 v2 .3 .6 Yes Yes Yes Yes

Alaris GH Syringe Pump 80023UN01 v2 .3 .6 Yes Yes Yes YesAlaris CC Syringe Pump 80033UND1 v2 .3 .6 Yes Yes Yes YesAlaris TIVA Syringe Pump 80043UN01 v2 .3 .6 Yes Yes Yes YesAlaris PK Syringe Pump 80053UN01 v3 .2 .16 Yes Yes Yes YesAlaris Enteral Syringe Pump 8002ENT01 v4 .1 .6

v4 .2 .1

Yes Yes Yes Yes

Alaris GH Guardrails™ Syringe Pump 80023UN01-G v3 .1 .4 Yes Yes Yes YesAlaris CC Guardrails Syringe Pump 80033UND1-G v3 .1 .4 Yes Yes Yes YesAlaris GH Syringe Pump (with Plus Software) MK3 8002MED01 v4 .1 .4 Yes Yes Yes YesAlaris CC Syringe Pump (with Plus Software) MK3 8003MED01 v4 .1 .4 Yes Yes Yes YesAlaris GH Guardrails Syringe Pump (with Plus Software) MK3 8002MED01-G v4 .1 .4 Yes Yes Yes YesAlaris CC Guardrails Syringe Pump (with Plus Software) MK3 8003MED01-G v4 .1 .4 Yes Yes Yes YesAlaris GH Syringe Pump (with Plus Software) MK4 8002MED01

8002TIG01

v4 .1 .8 Yes Yes Yes Yes

Alaris CC Syringe Pump (with Plus Software) MK4 8003MED01

8003TIG01


Alaris GH Guardrails Syringe Pump (with Plus Software) MK4 8002MED01-G

8002TIG01-G


Alaris CC Guardrails Syringe Pump (with Plus Software) MK4 8003MED01-G

8003TIG01-G


Alaris GW Volumetric Pump 2504xxxx1* v5r1F (v51F) **

v5r2A (v52A) **

Yes No Yes No

Alaris GP Volumetric Pump 80263UN01 v1 .7 .18 Yes Yes*** Yes YesAlaris GP Guardrails Volumetric Pump 80263UN01-G v1 .9 .2 Yes Yes Yes YesAlaris GP Volumetric Pump (with Plus Software) 9002MED01

9002TIG01

v2 .1 .14

v2 .1 .15

Yes Yes Yes Yes

Alaris GP Guardrails Volumetric Pump (with Plus Software) 9002MED01-G

9002TIG01-G

v2 .1 .14

v2 .1 .15

Yes Yes Yes Yes

Alaris VP Plus Guardrails Volumetric Pump 9003MED01-G

9003TIG01-G


Alaris SE Pump 7131xxxxxx*

7231xxxxxx*

v2 .79

v2 .80

v4 .54

v8 .53

Yes Yes Yes Yes

* 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 will be shown without the letter r*** The medium (amber) level alarm will not be triggered for a Rate Lock alarm for the Alaris GP Volumetric Pump

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 above will activate the Pump Alarm Location Beacon for high, medium, and low priority alarms, where applicable . Refer to each Pump’s Directions for Use for alarm information . The legacy Alaris GW Volumetric Pump and the Alaris GW 800 Volumetric Pump exhibit the following differences in behaviour for the Pump Alarm Location Beacon:

Legacy Alaris GW Volumetric Pump Alaris GW 800 Volumetric Pump

Condition Alarm Location Beacon Behaviour Alarm Location Beacon Behaviour

End of Infusion (KVO enabled) Amber Beacon in KVO Phase None for KVO Phase

End of Infusion (KVO disabled) None Red Beacon

Low Battery Amber Beacon Red Beacon

Attention None Red Beacon

To access and configure the software installed on the Workstation, use a standard Web browser and an Ethernet connection either over a network or by directly linking to the Workstation from a client PC .

The Workstation Web Browser User Interface is validated on Windows Internet Explorer 10 .

The software is provided under and is subject to a licence from BD .



Workstation IdentificationThe 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 .

Available Configurations

80300UNSxx-30 80300UNSxx-32 80300UNSxx-33 80300UNSxx-34 80300UNSxx-035



BDDF00122 Issue 3 10/36

Alaris™ Gateway Workstation v1.3.xAbout This Manual

About This ManualThe user must be thoroughly familiar with the Workstation described in this manual prior to use .

Please refer to the relevant Directions For Use for correct operation of the Pumps .

All illustrations used in this manual show typical settings and values which may be used in setting up the functions of the Workstation . These settings and values are for illustrative use only . The complete range of settings and values are shown in the Specifications section .

The illustrations in this DFU show example configurations and equipment that might not be available to all markets and regions . Please contact the local affiliate office for further information .

Keep this Manual for future reference during the Pump’s operational life.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. An estimated delivery time will be provided when the order is placed.

Conventions used in this manual

BOLD Used for Display names, software commands, controls and indicators referenced in this manual, for example, Battery Indicator, ON/OFF button .

'Single quotes' Used to indicate cross-references made to another section of this manual .

Italics Used to refer to other documents or manuals and also used for emphasis .

Warning A warning is an alert to a potential hazard which could result in serious personal injury and/or product damage if proper procedures are not followed .

Caution A caution is an alert to a potential hazard which could result in minor personal injury and/or product damage if proper procedures are not followed .

Note Notes contain supplementary information or emphasize a point or procedure .

Caution: Wherever this symbol is shown an Important note is found . These notes highlight an aspect of use that is important for the user to be aware of when operating the Pump .

User Accesses the product at the patient to administer treatment and monitors the products use .

Qualified Service Personnel Service and repair the product . Upload and download data to product .

BDDF00122 Issue 3 11/36

Alaris™ Gateway Workstation v1.3.xControls and Indicators

Controls and Indicators

Controls

Symbol Description

a

a

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 .

Note: Logs are maintained for power down events including when the Workstation is powered down or unexpected power loss .

Indicators

Symbol Description

j

j

Battery Indicator - When illuminated the Workstation is operating from internal battery; when flashing the battery power is low and auto power down is imminent .

k

k

AC Power Indicator - When illuminated the Workstation is connected to the AC power supply and the battery is being charged .

A Status Indicator - Provides a visual indication of the internal software activity .

B Status Indicator - Provides a visual indication of communication activity of the network within the Workstation .

d ON Status Indicator - When illuminated the Workstation is powered on .

wSystem Fault Indicator - The Workstation will illuminate this indicator when an internal fault is present and detected or when the Workstation is operating from internal battery .

BDDF00122 Issue 3 12/36

Alaris™ Gateway Workstation v1.3.xSymbol Definitions

Symbol Definitions

Labelling Symbols

Symbol Description

n Nurse call Connector

o RS232 Connector

c Auxiliary Connector

pInterface Device, General

(Barcode Reader Connector)

i Ethernet Network Connector

g AC Inlet

AC Outlet - Do Not Use

h This equipment contains an RF transmitter (where fitted)

W Fuse Rating

Consult accompanying documents

x Potential Equalisation (PE) Connector

IP22 Protection against fingers or other object not greater than 80mm in length and 12mm in diameter . Protection against water droplets deflected up to 15° from vertical . Protected against access to hazardous parts with finger .

r Alternating Current

u Workstation complies with the requirements of Council Directive 93/42/EEC as amended by 2007/47/EC .

T Date of Manufacture

t Manufacturer

U Not for Municipal Waste

D Class 1 Laser Product

Pushing Prohibited - see ‘Operating Precautions’ section for details .

C Warning electrical shock hazard do not tamper .

V Electrostatic discharge (ESD) precautions

m Wired Workstation

l Wireless Workstation

BDDF00122 Issue 3 13/36

Alaris™ Gateway Workstation v1.3.xFeatures of the Workstation

Features of the Workstation

Modular DesignThe Workstation is a modular design . The Base Module comprises 3 MDI tiles with modules of 2 MDI tiles expanding the vertical configuration . Horizontal T-pieces of 2, 3 or 4 MDI tiles may be added to accommodate Pumps and fluid bag hangers, as required . The Workstation can only be modified and assembled by Qualified Service Personnel .

Configuration 80300UNSxx-73:

Pump Mounting Rail

AC supply outlet

Infrared communications port

Warning Light Emitting Diode (LED)

Adjustable Height Pole

Slip Catch

Pump Alarm Location Beacon

(Not fitted on 4 MDI Tile Horizontal Module)

Bag Supports

w

Alaris™ GatewayWorkstation v1.3

IP22B

Covered under Patents: U.S. Pat. 6,593,528; EP 1502612 (DE, CH, FR, GB, ES & IT), CA 2614658. Design Patents: AU144124; DE 49910883; FR 997137; and JP 1117998

Rear View

Auxiliary Interface

Ethernet Interface

Potential Equalisation (PE) Connector

Nurse Call Interface

Standard RS232 Serial Interface

RS232 Serial Interface (optional)


Barcode Reader


AC Power Input

AC Power Output

Base Module (3 MDI Tile Base) Front View

A/B Status IndicatorsBattery

Indicator

AC Power Indicator

ON/OFF

ON Status Indicator

System Fault Indicator

Infusion Line Tidies

Alaris® Gateway Workstation 1.5

MDI Tile

Pole Clamp

BDDF00122 Issue 3 14/36


Configuration 80300UNSxx-235, shown mounted on an Alaris Trolley:

Infusion Line Tidies

Bag Supports

Trolley

Bag Support Rail

Mounting Rail

Mounting Rail

Mounting Rail

Note: Qualified Service Personnel are required to assemble the Trolley and to mount the Workstation on the Trolley .

BDDF00122 Issue 3 15/36


Infusion Line Tidies (where fitted)To assist in the routing of infusion sets and syringe extension sets from the Pumps to the patient, line tidies can be attached to the rear of the Workstation . The infusion line tidies are height adjustable allowing positioning adjacent to both syringe and volumetric Pumps, and may be mounted on the left or right hand side of the Workstation . To use the infusion line tidies:

1 . Loosen the hand wheel and adjust to the desired position .2 . Hand tighten the hand wheel to secure the device .3 . Refit rubber strip .

Note: It is recommended that line tidies be used to organize the infusion lines, this could reduce the risk of tangled infusion lines and tripping the user or patient .

Alaris TrolleyWhen the Workstation is mounted to the Alaris Trolley and is not being transported, the brakes should be engaged .

To operate the Alaris Trolley brakes:

1 . Locate brake mechanism at the end of the wheels .

2 . Press down to engage the brakes . 3 . Pull up to disengage the brakes .Warning: All wheels that have brakes should be set to the same engaged or disengaged state.

Prior to moving the Alaris Trolley all brakes should be disengaged.

Bottom up view, showing 4 locking casters:

New Alaris Trolleys shipped with Workstation of version 1.3.x or higher are equipped with 4 locking casters.

BDDF00122 Issue 3 16/36


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 3 kg . 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 . To operate the clamp:

1 . Grip the handle at the lower end of the pole and carefully loosen the hand wheel .

3b

1

2

4

3

2 . Apply an upward pressure to the pole handle, this will release the locking lever and allow the pole to move freely .

3 . Changing the bag hanger height:

a) To increase the bag hanger height: Continue pushing the pole upward to the required height . Once set, release the upward pressure on the pole, re-engaging the locking lever .

b) To reduce the bag hanger height: Hold the locking lever in the released position and adjust the pole downward to the required height . Release the locking lever and release the upward pressure on the pole, re-engaging the locking lever .

4 . Tighten the hand wheel to securely lock the pole into position .

To reduce the potential risk for nuisance alarms, the fluid bag should be placed at the height recommended in the specific Pump Directions For Use, bag hanger poles should be adjusted to the required height.For Workstation configurations 80300UNSxx-235 and 80300UNSxx-035, use the bag hanger assembly PN 1000SP01414 to secure fluid bags onto the Workstation.

Power InputThe Workstation is powered from the AC supply through a standard IEC AC connector . When connected to the AC supply the AC Power indicator is illuminated . Both the Live and Neutral lines of the main supply are protected using fuses carried in a double fuse holder located on the AC inlet connector .

Warning: When connected to the AC supply, 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, then the Workstation must not be used.

To isolate the Workstation from AC supply remove the AC connector from the source socket. The Workstation should be positioned to allow access for disconnecting the AC connector.

Battery SupplyThe Workstation should normally be operated from the AC power supply . However, in the event of temporary loss of AC power, an internal power supply will provide 60 minutes of communications . AC power to the Pumps will be discontinued .

Warning: AC Power should be re-applied as soon as possible as there will be no AC power supplied to the Pumps while the Workstation is running on the battery.

The Battery indicator illuminates whenever the Workstation is running from the internal battery . When illuminated the Workstation is operating from internal battery; when flashing the battery power is low and auto power down is imminent . The battery is automatically charged whenever the Workstation is connected to the AC supply . As the Workstation is designed to operate from the AC power supply it will only power up when connected to the AC supply .

Caution: In the event of a power loss, the Workstation with fully charged battery will emit an audible tone every 30 seconds for the first 14 minutes to alert operators, accompanied by a visual indicator. This audible tone and visual indicator will escalate to every 15 seconds after 14 minutes until the battery is fully depleted. These tones and indications should not be confused with the continuous alarm and LED notification that is initiated if the Workstation exhibits a fault condition.

If transfer of the Workstation is required, then prior to disconnecting from AC power supply the User must ensure there is sufficient battery power on each of the Pumps.

BDDF00122 Issue 3 17/36


AC Power Output to Infusion PumpsThe Workstation has its own power distribution circuit to supply AC power to the attached Pumps . For safety, power is not applied to the MDI tile IEC connector until the Pump is fully attached to the MDI tile . The AC power indicator on the infusion Pump will illuminate when Pump is powered and charging .

Warning: The MDI tile AC outlet connection is intended only for connection to a Pump. Never attach any other equipment to the outlet connector.

The Workstation minimises the potential for a high peak in-rush currents when AC power is simultaneously applied to the Pumps . When the Workstation is initially switched on, or when re-connected to the AC whilst operating from the internal battery, a small delay in the application of AC power will occur between each MDI tile . This staggers the distribution of AC power to all Pumps and therefore, reduces the peak in-rush current .

Powering an auxiliary WorkstationWorkstations are fitted with an auxiliary AC power outlet connection . However, this should not be used to power a second Workstation . If a second Workstation is required at the bedside, plug the Auxiliary Workstation directly into a wall AC power outlet .

Note: The safe use of the auxiliary AC power outlet requires management of the number of Pumps installed so that the system earth leakage current does not exceed 500uA . For this reason a warning label is placed blocking access to auxiliary AC outlet . This warning label should not be removed .

BDDF00122 Issue 3 18/36


System NotificationsThe Workstation is equipped with both audio and visual notifications to promote user awareness . System Notifications have been segregated into four different categories: Status Notifications, System Fault Indications, Pump Alarms, and Nurse Calls based off their required response and method of user awareness . All System Notifications generated by the Workstation are considered Information Signals . They are not used to indicate an Alarm State but maybe used to replicate an Alarm Signal present on the attached Pumps . The Primary and Secondary Speakers are used to generate the auditory notifications . The purpose of the Primary speaker is to relay the Workstation’s status . Whereas the Secondary speaker indicates a failure within the system . The table below summarizes the behaviour of the auditory speakers .

Audio Generator Approximate Sound Pressure Level @ 1 metre

Primary Speaker ≤ 45 dB(A)

Secondary Speaker ≥ 45 dB(A)

In some user environment the Sound Pressure Level of the Primary and Secondary Speakers could be less than the ambient noise.

A high level summary of the System notifications can be found in the table below . Status Notifications are represented by small LEDs and are the only System Notifications that use the primary speaker . System Fault Indications are represented by the System Fault Indicator and use the secondary speaker . The Pump Alarm Location Beacon and Nurse Call are used to replicate the Pump Alarm Condition, where fitted .

Trigger Visual Indicator Audio Indicator Category DescriptionWorkstation AC Power Disconnect

Battery Indicator and System Fault Indicator

Secondary Speaker Status See ‘Battery Supply’

Alarm Beacon Pump Alarm Location Beacon N/A Pump Alarm See ‘Pump Alarm Location Beacon’ Barcode Reader Barcode LED Primary Speaker Status See ‘Barcode Reader’Docking Pump Warning LED N/A Status See ‘Docking a Pump’ and

‘Removing a Pump’Nurse Call Nurse Call N/A Nurse Call See ‘Nurse Call’Power on On Status Indicator Both Speakers Status See ‘Operation of Workstation’SFI System Fault Indicator Secondary Speaker Fault See ‘System Fault Indication’

Alerts generated by the Workstation should be addressed secondary to any Pump alarms

Workstations of software version 1 .3 .x are compatible with all alarm schemes provided by the Pumps listed in the compatibility matrix found in the ‘Intended Use’ section of this guide . The Workstation will be compatible with the new alarm schemes on Pumps with the latest software versions that are compliant with IEC 60601-1-8:2012 and IEC 60601-2-24:2012 . For more specifics about the available alarms schemes on each specific Pump, please refer to the specific Pump Directions for Use .

Note: The latest Pumps with alarm schemes that are compliant with IEC 60601-1-8:2012 and IEC 60601-2-24:2012 may offer two sets of alarm tones:

• 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. The Hospital/Facility is responsible for selecting and configuring the desired alarm scheme. Legacy Workstations with software versions 1.1.3, 1.1.3 MR, 1.1.5, 1.1.6, 1.2 or 1.5 do not support the new Pump low priority visual alarms scheme defined in IEC 60601-1-8:2012. For newer, compliant Pumps mounted onto these Workstations, it is a possible that there will be a mismatch in the alarm priority or information signal indicated by the Workstation and the alarm priority or information signal indicated by the Pump. Refer to each individual Pump’s Directions for Use for further details on the alarm schemes. In any case, the User should always refer to the alarm on the Pump for the correct priority.

BDDF00122 Issue 3 19/36


System Fault IndicationContinuous monitoring of the power distribution and communications system integrity is performed by the Workstation . In the event that a system fault occurs whilst in use, the System Fault Indicator will be illuminated accompanied by an audible tone . To avoid any possible interruption to the infusion, AC power to the Pumps will be maintained on the MDI tile should a system fault be detected .

In addition to scenarios described above the Workstation also briefly illuminates the System Fault Indicator and activates the audible tone each time the Workstation is switched on .

Trigger Visual Indicator Audio Indicator Description

Communication Failure System Fault Indicator

Secondary Speaker Communication failure of the internal components of the Workstation .

POST failure System Fault Indicator

Secondary Speaker Failure of any of the step defined in the ‘Operation of Workstation’ Section

Caution: If the System Fault Indicator fails to illuminate when the Workstation is switched on, remove the Workstation from service and contact Qualified Service Personnel.

Caution: Should a System Fault occur during use, remove the Workstation from service as soon as possible and contact Qualified Service Personnel.

The Workstation auditory SFI signal is a continuous tone.

Nurse Call InterfaceA nurse call interface is provided which is activated whenever any Pump attached to the Workstation enters an alarm state, and stops when the condition is cleared on the Pump . The Nurse Call Interface may be connected to operate in a normally open or normally closed contact position . Verify the Nurse Call is automatically activated each time the Workstation is switched on .

The Nurse Call interface on the Workstation allows a single connection point to a hospital Nurse Call system . This Nurse 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 .

Caution: If the Nurse Call Interface fails to operate when the Workstation is switched on, suspect a fault with the interface. Remove the Workstation from service and contact Qualified Service Personnel.

Caution: There may be a delay, of approximately ten seconds, between the Pump going into alarm and the Nurse Call Interface activating via the Workstation. There may also be a delay, of approximately ten seconds, between the Pump alarm clearing and the Nurse Call Interface de-activating via the Workstation and the Pump Alarm Location Beacon switching off.

Caution: Where reliability of the nurse call interface is paramount, then connection has to be made from the nurse call system directly to the nurse call interface on the Pump.

BDDF00122 Issue 3 20/36


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 . Alarms of high priority, such as when an infusion is terminated are reflected as flashing Red . Alarms of medium priority, such as Battery Low, are reflected as flashing Amber . Alarms of low priority, such as AC Disconnection, are reflected as solid Amber . The Pump Alarm Location Beacon will indicate the highest level of alarm if there are multiple Pumps in alarm . The Pump Alarm Location Beacon flashes automatically whenever any Pump located on an MDI Tile of the Workstation enters the alarm condition, and stops when the condition is cleared on the Pump . The Pump Alarm Location Beacon automatically illuminates red then amber each time the Workstation is switched on .

The Pump Alarm Location Beacon is provided in order to allow Pumps with active alarms to be easily located; it does not replace the alarm on the Pump which remains the principle indicator that the attention of a clinician is required .

A summary of the Pump Alarm Location Beacon Priority Level Indicators can be found below .

Pump Alarm Priority

Pump Alarm Location Beacon Colour

Pump Alarm Location Beacon Flashing Frequency (3rd Edition Alarms Profile selected)

Pump Alarm Location Beacon Flashing Frequency (Original Alarms Profile selected)

HIGH Priority Red Flashing faster than MEDIUM Priority Flashing faster than MEDIUM Priority

MEDIUM Priority Amber/ Yellow Flashing Flashing faster than LOW Priority

LOW Priority Amber/ Yellow Solid Flashing

Note: In some instances, legacy Workstation software versions may provide mismatched Pump alarm location beacon behaviour when using Pumps with selectable alarm profiles .

Caution: If the Pump Alarm Location Beacon fails to illuminate when the Workstation is switched on, suspect a fault with the beacon. Remove the Workstation from service and contact Qualified Service Personnel.

Caution: There may be a delay, of approximately six seconds, between the Pump going into alarm and the Pump Alarm Location Beacon activating via the Workstation.

Caution: In the event of a communication fault between the Workstation and the Pump, the Workstation Alarm Location Beacon and Pump Alarm Beacon may not be synchronised. In this case, refer to the Pump’s Alarm status, communication faults could result from hardware failures or incorrect configuration of the Pump communication parameters.

The Pump Alarm Location Beacon is selectively populated and cannot be fitted to a 4 MDI Tile Horizontal Module. However the Pumps have their own means to alarm , nurse call is always provided, and it is the hospital’s responsibility to monitor the Pump’s alarms.

Note: The legacy Alaris GW Volumetric Pump does not have a visual status indicator but will still activate the Pump Alarm Location Beacon for alarms and some warnings . The Alaris GW 800 Volumetric Pump does have a visual status indicator, and will activate the Pump Alarm Location Beacon for alarm conditions . The following table summarizes the differences in beacon behaviour for the variants of the Alaris GW Volumetric Pump:

Legacy Alaris GW Volumetric Pump Alaris GW 800 Volumetric Pump

Condition Alarm Location Beacon Behaviour Alarm Location Beacon Behaviour

End of Infusion (KVO enabled) Amber Beacon in KVO Phase None for KVO Phase

End of Infusion (KVO disabled) None Red Beacon

Low Battery Amber Beacon Red Beacon

Attention None Red Beacon

Note: See the ‘Introduction’ section for lists of the Pump Alarm Location Beacon and Nurse Call compatibility between the Pumps and Workstation .

Note: Refer to the individual Pump DFU for alarm priority information .

Note: Alaris GW 800 Volumetric Pump does not have selectable alarm profiles .

BDDF00122 Issue 3 21/36

Alaris™ Gateway Workstation v1.3.xOperating Precautions

Operating PrecautionsOperating Environment• Users of the Workstation should read all instructions in this manual before using this medical device .

• The Workstation is suitable for all establishments, including those directly connected to the public low-voltage power supply network . The Workstation is designed for use in the hospital environment, not a road ambulance or home health care environments .

• When setting up a Workstation, an assessment of any potential hazards associated with the routing of electrical leads and infusion lines should be made . Where appropriate, mitigations identified and implemented .

• The Workstation should only be used with compatible BD products, accessories, infusion bags and disposables .

• While being used for patient therapy, each Workstation should be dedicated to the care of a single patient . Where an auxiliary Workstation is used, this should be dedicated to the same patient as the primary Workstation to which it is connected .

• This Workstation is not intended to be used in the presence of a flammable anaesthetic mixture with air or oxygen or nitrous oxide .

• The Workstation does not support antivirus software . It is the Hospital’s responsibility to ensure that the network is secure .

• 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 .Electromagnetic Compatibility and Interference

M• This Workstation is protected against the effects of external interference, including high energy

radio frequency emissions, magnetic fields and electrostatic discharge (for example, as generated by electrosurgical and cauterising equipment, large motors, portable radios, cellular telephones etc .) and has been tested to IEC/EN60601-1-2 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 .

• This Workstation is a CISPR II Group 1 Class A equipment 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 Workstation emits a certain level of electromagnetic radiation which is within the levels specified by IEC/EN60601-2-24, IEC/EN60601-1-2 and ETSI EN 301 489-17 (where applicable) . If however the Workstation interacts with other equipment, measures should be taken to minimise the effects, for instance by repositioning or relocation .

• Therapeutic Radiation Equipment: Do not use the Workstation in the vicinity of any Therapeutic Radiation Equipment . Levels of radiation generated by the radiation therapy equipment such as a Linear Accelerator, may severely affect functioning of the Workstation . Please consult manufacturer’s recommendations for safe distance and other precautionary requirements . For further information, please contact your local BD representative .

MR• Magnetic Resonance Imaging (MRI): The Workstation contains ferromagnetic materials which are

susceptible to interference with magnetic field generated by the MRI devices . Therefore, the Workstation is considered not to be MRI compatible . If use of the Workstation within an MRI environment is unavoidable, then BD highly recommends securing the Workstation at a safe distance from the magnetic field outside the identified ‘Controlled Access Area’ in order to evade any magnetic interference to the Workstation; or MRI image distortion . This safe distance should be established in accordance with the manufacturers’ recommendations regarding electromagnetic interference (EMI) . For further information, please refer to the product technical service manual (TSM) . Alternatively, contact your local BD representative for further guidance .

• Accessories: Do not use any non-recommended accessory with the Workstation . The Workstation is tested and compliant with the relevant EMC claims only with the recommended accessories . Use of any accessory, transducer or cable other than those specified by BD may result in increased emissions or decreased Workstation immunity .

• The Workstation features an optional radio frequency IEEE 802 .11n Wireless Local Area Network interface (Universal Dual Band Wireless Internet Adapter) . When fitted, the Workstation must emit electromagnetic energy in order to perform its intended function . Nearby electronic equipment may be affected .

• In some circumstances the Workstation may be affected by an electrostatic discharge through air at levels above 15kV; or by radio frequency radiation above 10V/m . If the Workstation is affected by this external interference, it will remain in a safe mode and alerts the user by generating a combination of visual indicators and audible tones . Should any encountered alarm condition persist, even after user intervention, it is recommended to replace that particular Workstation and quarantine for the attention of Qualified Service Personnel .

• Portable and mobile RF communications equipment can affect other, nearby medical electrical equipment .

BDDF00122 Issue 3 22/36


Hazards• The Workstation is heavy and poses a potential lifting hazard . Use caution when unpacking and installing

the Workstation . Use caution when lifting the Docking Station as it is heavy .

• All Pumps mounted on a Workstation (and in a single care area) should be configured with the same alarm tones to avoid user confusion . Please refer to the individual Pump DFU for more information on alarm tone settings .

• Data logged by the Workstation is stored such that older data will be overwritten by new data when the storage capacity has been reached .

• An explosion hazard exists if the Workstation is used in the presence of flammable anaesthetics . Exercise care to locate the Workstation away from any such hazardous sources .

C• Dangerous Voltage: An electrical shock hazard exists if the Workstation’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 Workstation should not be used .

V• Do not remove the RS232 protective covering when the connector is not in use . Electrostatic discharge

(ESD) precautions are required when connecting RS232/Nurse Call . Touching the pins of the connectors may result in ESD protection failure . In order to prevent any potential failure generated by ESD close to or above 15kV, it is recommended that all actions must be taken by appropriately trained personnel and the Pumps should not be connected to the patient when attaching cables .

• If any of the following conditions occur with the Workstation remove it from service for inspection by Qualified Service Personnel:

– dropped – excessive moisture – fluid spillage – high humidity – high temperature – suspicion of damage

• When transporting or storing the Workstation, use original packaging where possible, and adhere to temperature, humidity and pressure ranges stated in the Specifications section and as well as on the outer packaging .

• The black rubber trim strips on the back of the Workstation are designed to prevent the ingress of liquids and other contamination . The Workstation should not be installed or operated without the strips being in place .

D• The optional barcode reader is a Class 1 laser product . Use of controls or adjustments or performance

of procedures other than those specified herein may result in hazardous laser light exposure . Under no circumstances should the user attempt to service the barcode reader . Never attempt to look at the laser beam, even if the barcode reader appears to be nonfunctional . Never open the scanner in an attempt to look into the device . Doing so could result in hazardous laser light exposure . The use of optical instruments with the laser equipment will increase eye hazard .

• Warning: Alaris Gateway Workstations should not be modified or altered in any way, except where explicitly directed or authorised by BD . Any use of Alaris Gateway Workstations 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 Gateway Workstation that has been so modified or altered . BD product warranty shall not apply in the event the Alaris Gateway Workstation has suffered damage or premature wear, or malfunctions or otherwise operates incorrectly, as a result of unauthorised modification or alteration of the Alaris Gateway Workstation .

BDDF00122 Issue 3 23/36


Workstation Mounting Precautions• When mounting the Workstation to a mounting option other than pole or equipment rail, the following

warnings must be observed: – Warning: Ensure the mounting option is capable of supporting a fully laden Workstation (see

Product Specifications) prior to mounting . – Warning: The Workstation should not be fitted to any other mobile mounting option unless the

stability and strength of the whole assembly has been evaluated to IEC/EN60601-1 . – Warning: Do not overload the mounting option . To ensure stability follow the guidelines given in

the Product Specification section . – Warning: Do not orientate the Workstation with the AC inlet or outlets exposed in the event of a

fluid spill .• Pole Mounting

– Warning: Ensure the pole is capable of supporting a fully laden Workstation (see Product Specifications) prior to mounting .

– Warning: Check that the pole clamp handle is in full working order before use . – Warning: The pole clamp should be used to mount the Workstation on fixed poles / overhead

swing arm poles only . – Warning: People of a weak disposition should not attempt to use / tighten the pole clamp system .

• Equipment Rail/Mobile Trolley Mounting – Warning: Do not overload the trolley . To ensure stability follow the guidelines given in the Product

Specification section . – Warning: The Workstation should not be fitted to any other mobile pole or drip stand unless the

stability and strength of the whole assembly has been evaluated to IEC/EN60601-1 . – Warning: A mobile trolley mounted Workstation is recommended to be transported by two persons

when moving over an uneven surface or when the Workstation is fully loaded . – Warning: Any rail system for supporting medical devices must comply with BSEN 12218:1999 .

Ensure the rail is capable of supporting a fully laden Workstation (see Product Specifications) prior to mounting .

– Warning: Do not orientate the Workstation with the AC inlet or outlets exposed in the event of a spill .

– Warning: When mounted to the Alaris Trolley and not in transport the Trolley brakes should be engaged .

BDDF00122 Issue 3 24/36

Alaris™ Gateway Workstation v1.3.xOperation 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 .

1 . Connect the AC power cord from the AC supply to the AC power inlet socket on the Workstation .2 . Verify the AC Power indicator is illuminated .

3 . Optional: Verify the network cable is attached to the port denoted by the i symbol if connection to PDMS is required

4 . Press the a key once to switch the Workstation on .

Start Up Sequence Steps User Verification

Primary Workstation Auxiliary Workstation

5 . Start of Workstation power on ON status indicator is illuminated ON status indicator is illuminated

6 . Bar code reader test The red LED on the barcode reader (where fitted) is briefly illuminated and the barcode reader emits a beep .

Not applicable

7 . Pump Alarm Location Beacon test, where fitted .

Verify the Pump Alarm Location Beacon (where fitted) illuminates red then amber and is then extinguished .

Verify the Pump Alarm Location Beacon (where fitted) illuminates red then amber and is then extinguished .

8 . Initialization of each tile Verify the System Fault indicator illuminates briefly, emits a series of beeps and is then extinguished .

Verify the System Fault indicator illuminates briefly, emits a series of beeps and is then extinguished .

9 . Nurse call test, when connected Nurse call automatically activated Not applicable

10 . Windows CE software start-up Verify the Workstation emits a brief audible tone .

Not applicable

11 . Initialization of the Workstation internal network

The A and B Status indicators will flash after a long beep

Not applicable

12 . System initiates the power on Self-test Verify the System Fault indicator illuminates briefly and is then extinguished .

Not applicable

13 . Test of internal systems Beep emitted from the second speaker Not applicable

14 . Power on of workstation complete Verify the ON status indicator is illuminated .

Verify the ON status indicator is illuminated .

Caution: Do not switch off the Workstation during this initial 90 second period.Caution: If any of the verification checks fail when the Workstation is switched on, suspect a fault. Remove the Workstation

from service and contact Qualified Service Personnel.

Switching Off

Press the a key and hold for two seconds to switch the Workstation off .

Resetting the Workstation

In the unlikely event that the Workstation needs to be reset, press and hold the a 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 .

Caution: If the Workstation still fails to operate correctly after resetting, remove the Workstation from service and contact Qualified Service Personnel.

Resetting the Workstation is also required to clear any System Fault Indicator.

BDDF00122 Issue 3 25/36


Fitting an Auxiliary Workstation1 . Start with both the primary Workstation (option 2 and 3) and the auxiliary Workstation (option 1) powered off .2 . Connect the auxiliary connector (red ethernet port) on the auxiliary Workstation to the auxiliary connector on the primary

Workstation using the ethernet cable supplied with the auxiliary Workstation .

3 . Press the a key once, on the primary Workstation, to switch the Workstation on .4 . Wait till the primary Workstation has completed the power up sequence and tile registration beep sounds .

5 . Press the a key once, on the auxiliary Workstation, to switch the auxiliary Workstation on .

Removing an Auxiliary Workstation

If the primary Workstation cannot be switched off for whatever reason then the Pumps fitted to the auxiliary Workstation can be removed but the auxiliary Workstation must remain on. If the auxiliary Workstation is turned off or disconnected it may cause the primary Workstation to activate the System Fault Indicator.

1 . On the primary Workstation, press the a key once to switch the Workstation off .

2 . On the auxiliary Workstation, press and hold the a key for approximately four seconds to switch the auxiliary Workstation off .3 . Disconnect the ethernet cable from the auxiliary connector (red ethernet port) on the primary Workstation .4 . Disconnect the ethernet cable from the auxiliary connector on the auxiliary Workstation .

BDDF00122 Issue 3 26/36


Mounting a Pump1 . 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 .3 . Hold the Pump horizontally, push the Pump firmly onto the rectangular bar . 4 . The Pump should click into position when fitted to the bar .5 . Ensure that the Pump is positioned securely . Verify Pump is secure by gently pulling the Pump away from the Workstation without

using the release lever . When the Pump is securely attached, it should not come off the Workstation .Rectangular bar

Rotating cam

Release lever (push to release)

When using volumetric Pumps with the Workstation, it is recommended that, where possible infusion bags are located on a hanger directly above the Pump with which they are being used . This minimises the potential for confusion of lines when multiple volumetric Pumps are used .

If a Pump is removed and replaced while the Workstation is operational, it may take up to 10 seconds for the Pump to establish AC power and data communications once correctly located on the MDI tile.

In order for the Workstation and Pump to communicate correctly, the Pump must be configured to IrDA Communication, not RS232 Communication. Please refer to the individual Pump Technical Service Manual (TSM) for more details.

Caution: The location of the Pumps fitted to the Workstation (above or below the patient) may pose a risk of siphoning or over pressure. Pumps containing critical drugs should be positioned as close to the patient’s heart level as possible. Please refer to the appropriate Pump DFU for further details.

Caution: Before starting an infusion with a volumetric Pump check that the infusion set in the Pump is connected to the correct bag.

Warning: Pump may fall off the Workstation if not properly mounted which could result in user and/or patient harm.

Removing a Pump1 . Holding the Pump with both hands, push the release lever on the right hand side of the Pump backwards .2 . Keeping the lever pushed back, pull the Pump horizontally towards you .3 . Check that the red LED indicator on the MDI tile is extinguished after removal of the Pump .Caution: If the indicator in the MDI tile is illuminated when no infusion Pump is attached to the MDI tile, suspect a fault with

the MDI tile. Remove the Workstation from service and contact Qualified Service Personnel.

BDDF00122 Issue 3 27/36

Alaris™ Gateway Workstation v1.3.xData Communication Interfaces

Data Communication InterfacesThe user should be familiar with the data communications interfaces available on the Workstation before attempting to connect the Workstation to client / server systems . Erroneous connection of data communication cables will not damage the Workstation, but may cause the Workstation to operate incorrectly until the error is fixed .

Caution: Electrostatic Discharge (ESD) precautions are required when connecting the data communications cables to the Workstation. Avoid touching the pins of the connectors as this may result in an ESD protection failure.

Barcode Reader InterfaceA 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 . The barcode reader is configured to support EAN type barcodes .

RS232 Serial InterfacesThe Workstation allows for the connection of a single RS232 device . This electrically isolated interface permits Pumps with RS232 ports that are not compatible with the MDI tile interface to be integrated into the Workstation .

An additional option provides connections to a further three RS232 devices .

Ethernet InterfacesThe Workstation may be used on a 10 Base-T/100 Base-Tx switched LAN . A DHCP client service allows the use of either fixed or dynamic network addressing of the Workstation . Similarly, a DNS client is provided . Configuration of these client services is through the Workstation Web Browser User Interface . The ethernet connection to the Workstation is electrically isolated .

Wireless Ethernet Interface (where fitted)The Workstation may be used with an IEEE 802 .11a/b/g/n 2 .4 or 5 GHz wireless LAN . SSID wireless group selection is supported, as is Wi-Fi Protected Access (WPA, WPA2 and WEP encryption options) . Consult Workstation Technical Service Manual for more information .

The integrated PCB based diversity antennas are fitted within the Dual Band Wireless Internet Adapter unit fitted within the Workstation .

Note: Highly congested wireless networks may result in intermittent or no wireless connectivity .

Auxiliary InterfaceWhere the use of a single Workstation is not practical, two Workstations may be linked together to behave as a single Workstation . To link the Workstations:

1 . Ensure that only one Workstation is fitted with the Communications Upgrade (options 2 or above) and connected to the external client .

2 . Link the two Workstations together using a standard CAT5e ethernet cable inserted into the auxiliary connector (red ethernet port) on each Workstation .

3 . The infusion data from each Workstation will be automatically integrated forming a single connection to the external client .

Caution: The System Fault Indicator will be activated if any device other than an appropriately configured Workstation is fitted into the auxiliary connector.

BDDF00122 Issue 3 28/36

Alaris™ Gateway Workstation v1.3.xBarcode Reader (optional)

Barcode Reader (optional)

OverviewThe barcode reader (where fitted) allows the scanning and recognition of barcodes .

Red LED

Green LED

Laser Aperture

Cable Connection

The Workstation must be powered down before attaching or disconnecting the barcode reader.

Visual IndicatorsThe barcode reader has two LED indicators (green and red) located on the top of the reader . When the reader is on, the LEDs indicate the current status of the reader .

All LEDs off - The barcode reader is not receiving power or the barcode reader is in standby mode .

Steady Green - The laser is active .

Steady Green, Single Red Flash - The barcode has been read successfully .

Scanning a Barcode1 . Make sure that the barcode is in the barcode reader scan field (within approx . 10 cm of the laser aperture) . The barcode reader is

automatically activated and the green LED is illuminated .2 . Align the barcode with the visible laser line .3 . The barcode reader will automatically scan the barcode .4 . When the barcode reader successfully reads the barcode, the red LED will flash and the barcode reader will beep once . The barcode

data is transmitted to the Workstation .

BDDF00122 Issue 3 29/36

Alaris™ Gateway Workstation v1.3.xData Communications Interface Specifications

Data Communications Interface SpecificationsNurse Call InterfaceWorkstation Connector Plug Type: Binder 09 0978 00 03

Mating Connector Socket Type: Binder ‘710’ series 99 0975 100 03

Cable Type: Max . cable sheath diameter 4mm .

Isolation: 1 .5kV

Rating: 30V/1A

Description

1

2

3

Pin 1: NC_COMPin 2: NC_NCPin 3: NC_NO

Barcode Reader InterfaceFor use with BD supplied barcode reader only.Workstation Connector Type: Binder 09 0998 00 05

Cable Type: N/A

Description

1

23

4

5

Pin 1: +5VPin 2: TxDPin 3: GNDPin 4: RxDPin 5: SENSE

Serial RS232 InterfaceConnector Type: D type - 9 pin (female)

Cable Type: Standard RS232 Cable: Length <1 .5m 1,3

Isolation: 1 .5kV

Data Rate: 57 .6k baud

DescriptionPin 1: N/C

5 4 3 2 1

9 8 7 6

Pin 2: RXDPin 3: TXDPin 4: N/CPin 5: GNDPin 6: N/CPin 7: RTSPin 8: CTSPin 9: N/C

Ethernet InterfaceConnector Type: RJ45

Cable Type: CAT5e Ethernet Cable: Length >1 .5m 1

Isolation: 1 .5kV

Data Rate: 10/100Mbps

DescriptionPin 1: TxD+Pin 2: TxD–Pin 3: RxD+Pin 4: N/CPin 5: N/CPin 6: RxD–Pin 7: N/CPin 8: N/C

BDDF00122 Issue 3 30/36

Alaris™ Gateway Workstation v1.3.xData Communications Interface Specifications

Wireless Ethernet Interface (where fitted) Wireless Adapter:

Frequency Range and Power Levels:

Feature Description

Operating frequency ranges (2 .4 GHz) 2 .4 GHz to 2 .5 GHz

Maximum Transmit Power (2 .4 GHz) 20dBm

Operating frequency ranges – 5 GHz 5 .15 to 5 .35 GHz (Europe ETSI)

5 .47 to 5 .725 GHz (DFS band)

Maximum Transmit Power (5 .15 to 5 .35 GHz) 23 dBm

Maximum Transmit Power (5 .47 to 5 .725 GHz) 30 dBm

The Dual Band Wireless Internet Adapter installed in the Workstation is in compliance with the essential requirements and other relevant provisions of Radio Equipment Directive 2014/53/EU .

Features:

– IEEE 802 .11 a/b/g/n – Connects to any existing 2 .4 or 5 GHz network – Wi-Fi Protected Access (WPA, WPA2 and WEP) encryption

Note: If you are upgrading from legacy Workstation to Workstation version 1 .3 .x, Features of RF card:

– IEEE 802 .11 b – WEP encryption – 2 .4 GHz

Auxiliary InterfaceConnector Type: RJ45

Cable Type: CAT5e Ethernet Cable: As required 2

Isolation: 1 .5kV

DescriptionPin 1: Tx+Pin 2: Tx–Pin 3: Rx+Pin 4: N/CPin 5: N/CPin 6: Rx–Pin 7: N/CPin 8: N/C

NOTES:1 Assumes client equipment is non-medical equipment and outside of the patient environment; may be less than 1 .5m if the client

equipment is medical electrical equipment in compliance with EN 60601 .2 Workstation may be used anywhere inside the patient environment .3 Either a cross-over or straight through RS232 cable will be required . Refer to the Directions for Use of the device to be connected for

cable information .

BDDF00122 Issue 3 31/36

Alaris™ Gateway Workstation v1.3.xProduct Specifications

Product Specifications

ElectricalProtection Against Electrical Shock:Class I

Supply Voltage:115-230V, ~50-60Hz

Rating:460VA (Maximum)

Fuses:2 x 4AH Time-Lag T

Consult Qualified Service Personnel for replacement of fuses .

AC Outlets:MDI Tile: 115-230V, ~50-60Hz, 60VA

Protection against fluid ingress:IP22 - Protection against fingers or other object not greater than 80mm in length and 12mm in diameter . Protection against water droplets deflected up to 15° from vertical . Protected against access to hazardous parts with finger .

BatteryType:Nickel Metal Hydride

Charge time:With no Pumps attached: Up to 8 hours to 95% charge time based on battery life cycle .

With Pumps attached: Up to 16 hours to 95% charge time based on battery life cycle and an 11 Pump load .

Operating time:60 minutes

Environmental

Operating Transport and StorageTemperature: +5°C - +40°C -20°C - +50°CHumidity: 20% - 90% 15% - 95%Atmospheric Pressure: 700 - 1060hPa 500 - 1060hPa

ClassificationContinuous Operation

Regulatory ComplianceComplies with IEC/EN60601-1, IEC/EN60601-1-2 and Radio Equipment Directive 2014/53/EU (where applicable)

Potential Equalisation ConductorThe 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 .

PatentsCovered under the following Patents: EP 1502612 (DE, CH, FR, GB, ES & IT), CA 2614658 . Design Patents: DE 49910883; FR 997137; and JP 1117998

BDDF00122 Issue 3 32/36

Alaris™ Gateway Workstation v1.3.xProduct Specifications

Physical

Configuration1 Bag Supports

Height (mm)2

Width (mm)

Depth (mm)

Maximum Weight (kg approx .)

VA Rating4 Beacon

Unladen Laden3

80300UNSxx-30 - 536 170 155 5 .1 16 .1 100 Yes

80300UNSxx-32 2 780 348 155 8 .7 27 .6 220 Yes

80300UNSxx-33 3 780 514 155 11 .8 32 .6 280 Yes

80300UNSxx-34 2/2 780 710 155 14 .1 38 .6 300 No

80300UNSxx-50 - 771 170 155 6 .2 25 .1 180 Yes

80300UNSxx-52 2 1015 348 155 10 .8 36 .1 260 Yes

80300UNSxx-53 3 1015 514 155 12 .9 41 .6 320 Yes

80300UNSxx-54 2/2 1015 710 155 15 .2 47 .1 380 No

80300UNSxx-70 - 1016 170 155 9 .8 33 .5 240 Yes

80300UNSxx-72 2 1260 348 155 14 .4 45 300 Yes

80300UNSxx-73 3 1260 514 155 16 .5 50 360 Yes

80300UNSxx-74 2/2 1260 710 155 18 .8 56 400 No

80300UNSxx-92 2 1500 348 155 13 .3 52 .2 440 Yes

80300UNSxx-035 - 1064 485 155 13 42 .6 320 Yes

80300UNSxx-235 - 1240 485 155 14 .5 50 .5 360 Yes

Trolley Compatibility

Configuration1 Trolley Compatible

(80083UN00-00)5

Alaris Trolley Compatible

(80203UNS00-00)6

80300UNSxx-30

80300UNSxx-32

80300UNSxx-33

80300UNSxx-34

80300UNSxx-50

80300UNSxx-52

80300UNSxx-53

80300UNSxx-54

80300UNSxx-70

80300UNSxx-72

80300UNSxx-73

80300UNSxx-74

80300UNSxx-92

80300UNSxx-035

80300UNSxx-235

1 xx denotes the connectivity option - 01, 02 or 03 .2 Height of the Workstation with bag supports in the lowered position where appropriate . Bag supports can extend by a further 500mm

above the Workstation .3 Includes Pumps, Syringe Pumps with lockboxes and 1 litre fluid bags on each bag support . Note, all weights derived from lockbox

weight . Please refer to the Alaris CC/GH Syringe Pump DFU for more information on lockbox . 4 Total VA Rating for two connected Workstations should not exceed 460VA (includes combinations of Pumps within leakage current

limits) .5 Installation should be as low as possible . The mounting height should not exceed 160cm from the ground to the top of the

Workstation .6 Installation should be as low as possible . Refer to 1000PB01717 latest issue for maximum mounting heights .

BDDF00122 Issue 3 33/36

Alaris™ Gateway Workstation v1.3.xMaintenance

Maintenance

Routine Maintenance ProceduresTo ensure that this Workstation 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 Qualified Service Personnel with reference to the Technical Service Manual (TSM 1000SM00015) .

Circuit diagrams, components parts lists and all other servicing information which will assist the Qualified Service Personnel in performing repair of the parts designated as repairable, are available upon request from BD .

If the Workstation is dropped, damaged, subjected to excessive moisture or high temperature, immediately take it out of service for examination by Qualified Service Personnel.All preventative and corrective maintenance and all such activities shall be performed at a compliant work place in accordance with the information supplied. BD will not be responsible should any of these actions be performed outside the instructions or information supplied by BD. For Preventative and Corrective Maintenance instructions please refer to the Technical Service Manual (TSM).All preventative and corrective maintenance and all such activities should be performed by Qualified Service Personnel only, with reference to the TSM.

Interval Routine Maintenance Procedure

When loading Pumps Check that each Pump is properly located on the MDI and is mechanically locked into position .

When removing Pumps Check that the MDI Warning LED turns off when the Pump is removed . If the LED stays on, the Workstation should be serviced by Qualified Service Personnel .

As per Hospital Policy Thoroughly clean external surfaces of the equipment before and after prolonged periods of storage .

At least once per year

(Refer to TSM for identification of parts)

• Inspect AC outlets, communication connectors and the AC inlet for damage .

• Perform electrical safety checks . The complete unit leakage current must be measured . If more than 500µA the equipment should not be used, but should be serviced by Qualified Service Personnel .

BatteryIt is recommended that only Qualified Service Personnel replace the battery, using only a BD recommended battery . For further information regarding the replacement of batteries refer to the Technical Service Manual .

The battery pack used in this Alaris Gateway Workstation is manufactured by BD and includes a proprietary PCB (printed circuit board) designed specifically for the Alaris Gateway Workstation, and in conjunction with Alaris Gateway 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 . BD product warranty shall not apply in the event the Alaris Gateway Workstation has suffered damage or premature wear, or malfunctions or otherwise operates incorrectly, as a result of use with a battery pack that is not manufactured by BD .

Replacing the AC FusesIf the AC power indicator does not illuminate when the Workstation is connected to the AC power supply, either the power supply fuse in the AC plug or, the AC fuses of the Workstation have blown .

First check the power supply fuse in the AC plug, if the AC power indicator does not illuminate proceed to check the Workstation AC fuses . Switch the power off and disconnect the Workstation from the AC power supply .

It is recommended that only Qualified Service Personnel replace 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, suspect an electrical fault and have the Workstation and power supply checked out by Qualified Service Personnel.

BDDF00122 Issue 3 34/36

Alaris™ Gateway Workstation v1.3.xMaintenance

Cleaning and StorageBefore the transfer of the Workstation to a new patient and periodically during the use, clean the Workstation by wiping over with a lint-free cloth lightly dampened with warm water and a standard disinfectant / detergent solution .

Do not use the following disinfectant types:

• Disinfectants which are known to be corrosive to metals must not be used, these include:• NaDcc (such as Presept), • Hypochlorites (such as Chlorasol), • Aldehydes (such as Cidex), • Cationic Surfactants (such as Benzalkonium Chloride) .

• Use of Iodine (such as Betadine) will cause surface discolouration . • Concentrated Isopropyl alcohol based cleaners will degrade plastic parts .

Recommended cleaners are:

Brand Concentration

Hibiscrub 20% (v/v)

Virkon 1% (w/v)

The following products were tested and are acceptable for use on the Workstation if used in accordance with the specified manufacturer’s guidelines .

• Warm soapy water• Mild detergent in water (e .g . Young’s Hospec)• 70% Isopropyl Alcohol in water• Chlor-Clean• Hibiscrub• TriGene Advance• Tristel Fuse sachets• Tristel Trio wipes system• Tuffie 5 wipe• Virkon Disinfectant

Before cleaning the Workstation always switch it off and disconnect it from the AC power supply. Never allow liquid to enter the casing and avoid excess fluid build up on the Workstation. Do not use aggressive cleaning agents as these may damage the exterior surface of the Workstation. Do not steam autoclave, ethylene oxide sterilise or immerse this Workstation in any fluid.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. Please contact local BD Qualified Service Personnel for further guidance.

DisposalDisposal of Waste Electrical & Electronic Equipment

This U symbol on the product and/or accompanying documents means that used electrical and electronic products should not be mixed with household waste .

To discard electrical and electronic equipment, please contact local 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 .

Disposal in Countries outside the European Union

This U 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 .

BDDF00122 Issue 3 35/36


Spare Parts

Spare PartsA comprehensive list of spare parts for this Workstation is included within the Technical Service Manual .

The Technical Service Manual (1000SM00015) 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 .

Part Number Description0000EL00889 AC Power Lead - UK0000EL00938 AC Power Lead - European

Accessories

Part Number Description1000SP00655 Rail Mounting Kit1000SP00169 Pole Mounting Kit1000SP00436 Bag Hanger Kit (2 hooks, left side)1000SP00437 Bag Hanger Kit (2 hooks, right side)1000SP00438 Bag Hanger Kit (3 hooks, left side)1000SP01187 Trolley Mounting Kit1000SP00657 Tube Tidy Kit1000SP01449 Barcode Reader Kit1000SP02062 Wireless Upgrade Kit

Document HistoryIssue Date Software Version Description

1 July 2017 1 .3 .1 Initial release

2 July 2018 1 .3 .1 Labelling symbols

3 August 2018 1 .3 .x 1 .3 .1, 1 .3 .2, 1 .3 .3, …

BDDF00122 Issue 3 36/36


Contact UsFor full contact information please refer to bd .com .

Customer Service Information

Country Telephone emailAustralia Freephone: 1 800 656 100 AUS_customerservice@bd .comBelgië +32(0)53 720 556 info .benelux@bd .comCanada +1 800 387 8309 CanadaCapital@carefusion .comDanmark +45 43 43 45 66 bddenmark@bd .comDeutschland +49 622 1305 558 GMB-DE-CustService-Alaris@bd .comEspaña +34 902 555 660 info .spain@carefusion .comFrance +33 (0) 1 30 02 81 41 mms_infusion@bd .comItalia +39 (0) 55 303391 customer .service-italy@bd .comMagyarország (36) 1 488 0233 info .cfn .export@bd .comNederland +31(0)20 582 94 20 info .benelux@bd .comNew Zealand Freephone: 0800 572 468 NZ_customerservice@bd .comNorge +47 64 00 99 00 bdnorge@bd .comPolska (48) 22 545 05 80 dok@medicart .euPortugal +351 219 152 593 dl-pt-geral@carefusion .comSouth Africa Freephone: 0860 597 572

+27 11 603 2620bdsa_customer_centre@bd .com

Suomi +358-9-8870 780 bdsuomi@bd .comSverige +46 8-7755160 bdsweden@bd .comSwitzerland +41 61 485 22 66 Customer_Care_Switzerland@bd .comUnited Kingdom Freephone: 0800 917 8776 BDUK_CustomerService@bd .comUnited States of America Freephone: 800 482 4822 CustCareInfusion@carefusion .com中国 400 878 8885 serviceclientbdf@bd .com

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BDDF00122 Issue 3

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