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Introduction
The Alaris™ Gateway Workstation v1 .3 .x (where x = 1 or 2 denoting software version),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 .
Note: Report any serious incident that has occurred in relation to the Workstation to your BD Representative (or
Manufacturer) and EU National Competent Authority . For incidents occurring outside of the EU, contact your BD
Representative .
Note: All interactions between the Pump and compatible software products occur through either the Alaris™ Gateway
Workstation and Pump using the IrDA port, or through direct connection to a desktop computer using an RS-
232 USB cable to the Pump . In addition, security of the desktop running the compatible software products can
be secured by the user according to their own desktop computing policies, such as locking down ports, antivirus
protection, data backups and patching .
Intended Purpose
The Alaris™ Gateway Workstation is intended to be used within the hospital environment to provide mounting, power
and communication support to the compatible Alaris™ Infusion Pumps . The Workstation transmits infusion data for the
purpose of record keeping and pump alarm monitoring .
The Workstation is designed to accommodate the following pumps which will communicate with the Workstation Alarm
Location Beacon for High, Medium and Low priority alarms where applicable . For further alarm information, refer to the
relevant Pump Directions For Use (DFU) .
The Workstation is designed to work with the following Alaris™ Infusion Pumps:
Pumps with alarms that are compliant with IEC
24:2012
The default alarm system is ORIGINAL ALARMS (EN/IEC
(EN/IEC
60601-1-8 3rd Edition alarms) are also installed. To change the Pump alarm system from ORIGINAL ALARMS
to 3RD EDITION ALARMS, refer to the Technical Service Manual. Note that this change should only be performed by
Qualified Service Personnel.
Pumps have two 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 .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 .
BDDF00794 Issue 4
Alaris™ Gateway Workstation v1.3.x
60601-1-8: 2012 and IEC
60601-1-8 2nd Edition alarms). 3RD EDITION ALARMS
4/46
Introduction
60601-2-
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