Intended Users; Patient Target Groups; Clinical Benefits; Conditions For Use - BD Alaris Directions For Use Manual

Intended Users

Primary Users
• Biomedical Engineer/ Technicians (configuration & repair)
• Nurses/ Clinician (docking and undocking of pumps)
• Clinical Equipment Specialists (devices transport, docking and undocking of pumps)
Secondary Users
• Medical or IT professionals (configuration)

Patient Target Groups

Alaris™ Gateway Workstations are primarily used in acute hospital environments where critical drugs need to be
administered . Alaris™ Gateway Workstations are typically installed in the Intensive Care Unit (ICU), Post-Anesthesia Care
Unit (PACU), Neonatal Intensive Care Unit (NICU), Pediatric Intensive Care Unit (PICU) and Operating Room (OR) care
areas and may be placed in isolation rooms .

Clinical Benefits

The Alaris™ Gateway Workstation is a modular system intended for use with the Alaris™ Infusion Pump range . It allows
numerous Alaris™ Infusion Pumps to be connected to one central management system . It reduces cable-clutter by use
of a single mains inlet and allows efficient organisation of multi-tube configurations . It is intended to be used to provide
mounting, power and communications support to the Alaris™ Infusion Pumps range . It is designed for use in the hospital
environment . The Alaris™ Gateway Workstation is a modular system intended to provide a communications gateway
between an Alaris™ Infusion 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 Pumps .

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™
Infusion Pumps and BD Alaris™ neXus Pumps . For the Conditions for Use for the Alaris™ Infusion Pumps, refer to the
following Directions For Use (DFUs):
• Alaris™ Enteral Plus Syringe Pump Mk4
• Alaris™ Plus Syringe Pumps Mk4
• Alaris™ GW 800 Volumetric Pump
• Alaris™ GW 800 Volumetric Pump (with Set Detection Mode disabled)
• Alaris™ GP (Guardrails™) Volumetric Pumpwith Plus Software)
• Alaris™ VP Plus Guardrails™ Volumetric Pump
• Alaris™ PK Plus Syringe Pump Mk4
• BD Alaris™ neXus GP Volumetric Pump
• BD Alaris™ neXus CC Syringe Pump

Indications

The Alaris™ Gateway Workstation is not directly used in patient care, and so has no defined indications . For the
Indications for the Alaris™ Infusion Pumps and BD Alaris™ neXus Pumps, refer to the following Directions For Use (DFUs):
• Alaris™ Enteral Plus Syringe Pump Mk4
• Alaris™ Plus Syringe Pumps Mk4
• Alaris™ GW 800 Volumetric Pump
• Alaris™ GW 800 Volumetric Pump (with Set Detection Mode disabled)
• Alaris™ GP (Guardrails™) Volumetric Pumpwith Plus Software)
• Alaris™ VP Plus Guardrails™ Volumetric Pump
• Alaris™ PK Plus Syringe Pump Mk4
• BD Alaris™ neXus GP Volumetric Pump
• BD Alaris™ neXus CC Syringe Pump

Contraindications

The Alaris™ Gateway Workstation is not designed to be used in Home Care environments . Refer to the 'Product
Specifications' section for more information .
BDDF00794 Issue 4
Alaris™ Gateway Workstation v1.3.x
9/46
Introduction