BD Alaris v1.2 Operating instructions

Category
Gateways/controllers
Type
Operating instructions
Alaris™ Gateway Workstation
v1.2
Directions For Use
en
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Alaris™ Gateway Workstation v1.2
Contents
Page
Introduction ..............................................................................................3
Workstation Hardware Options ........................................................................3
Workstation Software Options ..........................................................................4
Intended Use ..........................................................................................5
Workstation Identification ..............................................................................7
About This Manual ........................................................................................8
Conventions used in this manual .......................................................................8
Controls and Indicators ....................................................................................9
Controls ...............................................................................................9
Indicators ..............................................................................................9
Symbol Definitions .......................................................................................10
Labelling Symbols ....................................................................................10
Features of the Workstation ...............................................................................11
Modular Design .......................................................................................11
Infusion Line Tidies (where fitted) .....................................................................13
Alaris Trolley ..........................................................................................13
Adjustable Height Bag Hangers (where fitted) .........................................................13
Power Input ..........................................................................................14
Battery Supply ........................................................................................14
AC Power Output to Infusion Pumps ...................................................................14
Powering an auxiliary Workstation .....................................................................14
System Fault Indication ...............................................................................15
Pump Alarm Location Beacon (where fitted) ...........................................................15
Nurse Call Interface ...................................................................................15
Operating Precautions ...................................................................................16
Operating Environment ...............................................................................16
Electromagnetic Compatibility and Interference .......................................................16
Hazards ..............................................................................................17
Workstation Mounting Precautions ....................................................................18
Operation of Workstation .................................................................................19
Switching On .........................................................................................19
Switching Off .........................................................................................19
Resetting the Workstation .............................................................................19
Fitting an Auxiliary Workstation .......................................................................19
Removing an Auxiliary Workstation ....................................................................20
Mounting a Pump ....................................................................................20
Removing a Pump ....................................................................................20
Data Communication Interfaces ..........................................................................21
Barcode Reader Interface .............................................................................21
RS232 Serial Interfaces ................................................................................21
Ethernet Interfaces. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21
Wireless Ethernet Interface (where fitted) ..............................................................21
Auxiliary Interface ....................................................................................21
Barcode Reader (optional) ................................................................................22
Overview .............................................................................................22
Visual Indicators ......................................................................................22
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Alaris™ Gateway Workstation v1.2
Scanning a Barcode ...................................................................................22
Data Communications Interface Specifications ............................................................23
Nurse Call Interface ...................................................................................23
Barcode Reader Interface .............................................................................23
Serial RS232 Interface .................................................................................23
Ethernet Interface ....................................................................................24
Wireless Ethernet Interface (where fitted) ..............................................................24
Auxiliary Interface ....................................................................................24
Product Specifications ....................................................................................25
Electrical .............................................................................................25
Battery ...............................................................................................25
Environmental ........................................................................................25
Classification .........................................................................................25
Regulatory Compliance ...............................................................................25
Potential Equalisation Conductor ......................................................................25
Patents ...............................................................................................25
Physical ..............................................................................................26
Trolley Compatibility ..................................................................................26
Maintenance .............................................................................................27
Routine Maintenance Procedures .....................................................................27
Battery ...............................................................................................27
Replacing the AC Fuses ...............................................................................27
Cleaning and Storage .................................................................................28
Disposal ..............................................................................................28
Spare Parts ...............................................................................................29
Service Contacts .........................................................................................30
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Alaris™ Gateway Workstation v1.2
Introduction
Introduction
The Alaris™ Gateway Workstation v1.2 (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
80203UNS01-32
SN:
T
135070253 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
80203UNS02-32
SN:
T
135070253 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 22 Pumps to third party systems.
Option 3. Primary wireless Workstation
REF
80203UNS03-32
SN:
T
135070253 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 22 Pumps to third party
systems.
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Alaris™ Gateway Workstation v1.2
Introduction
Workstation Software Options
There are different software versions that can be ordered for each Primary Workstation.
The software version of Workstation can be identified by the labelling on the front. Please contact local CareFusion representative for
further information about Workstation versions, upgrade options and product availability.
Alaris Gateway Workstation v1.2 Alaris Gateway Workstation
(software versions 1.1.6 and below)
This software version enables connectivity to third party systems
and meets the latest compliance standards.
This software version enables connectivity to third party systems.
Alaris
®
Gateway Workstation
A
The Alaris DS Docking Station, although similar in appearance to the
Workstation, does not have any connectivity features and does not
work with the Alaris Communication Engine. 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
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.
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Alaris™ Gateway Workstation v1.2
Introduction
Intended Use
The Alaris Gateway Workstation v1.2 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:
Infusion Pump Model Code Supported
Software
Version
Beacon Nurse Call
High
(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 Yes
Alaris CC Syringe Pump 80033UND1 v2.3.6 Yes Yes Yes Yes
Alaris TIVA Syringe Pump 80043UN01 v2.3.6 Yes Yes Yes Yes
Alaris PK Syringe Pump 80053UN01 v3.2.16 Yes Yes Yes Yes
Alaris 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 Yes
Alaris CC Guardrails Syringe Pump 80033UND1-G v3.1.4 Yes Yes Yes Yes
Alaris GH Syringe Pump (with Plus Software) MK3 8002MED01 v4.1.4 Yes Yes Yes Yes
Alaris CC Syringe Pump (with Plus Software) MK3 8003MED01 v4.1.4 Yes Yes Yes Yes
Alaris GH Guardrails Syringe Pump (with Plus Software) MK3 8002MED01-G v4.1.4 Yes Yes Yes Yes
Alaris CC Guardrails Syringe Pump (with Plus Software) MK3 8003MED01-G v4.1.4 Yes Yes Yes Yes
Alaris 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
v4.1.8 Yes Yes Yes Yes
Alaris GH Guardrails Syringe Pump (with Plus Software) MK4 8002MED01-G
8002TIG01-G
v4.1.8 Yes Yes Yes Yes
Alaris CC Guardrails Syringe Pump (with Plus Software) MK4 8003MED01-G
8003TIG01-G
v4.1.8 Yes Yes Yes Yes
Alaris GW Volumetric Pump 2504xxxx1* v5r1F
(v51F) **
v5r2A
(v52A) **
Yes No Yes No
Alaris GP Volumetric Pump 80263UN01 v1.7.18 Yes Yes*** Yes Yes
Alaris GP Guardrails Volumetric Pump 80263UN01-G v1.9.2 Yes Yes Yes Yes
Alaris 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
v1.1.28 Yes Yes Yes Yes
Alaris SE Pump 7131xxxxxx*
7231xxxxxx*
v2.79
v2.80
v4.54
v8.53
Yes Yes Yes Yes
* xxxx and xxxxxx denotes the language and country specific model codes
** The display on the Alaris GW 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.
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Alaris™ Gateway Workstation v1.2
Introduction
A
The pumps listed above, except the Alaris GW Volumetric Pump, will activate the Pump Alarm Location Beacon and
nurse call for high and medium priority alarms.
The Alaris GW Volumetric Pump will not activate the Pump Alarm Location Beacon and nurse call for medium priority
alarms, however will activate the Pump Alarm Location Beacon and nurse call for high priority alarms.
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 CareFusion.
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Alaris™ Gateway Workstation v1.2
Introduction
Workstation Identification
The Workstation can be confirmed by viewing the serial number label on the rear of the Workstation and checking the SKU is
80203UNSxx, 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
80203UNSxx-30 80203UNSxx-32 80203UNSxx-33 80203UNSxx-34 80203UNSxx-035
80203UNSxx-50 80203UNSxx-52 80203UNSxx-53 80203UNSxx-54 80203UNSxx-235
80203UNSxx-70 80203UNSxx-72 80203UNSxx-73 80203UNSxx-74 80203UNSxx-92
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Alaris™ Gateway Workstation v1.2
About This Manual
About This Manual
The 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.
A
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 CareFusion products. These documents are referenced on www.carefusion.com. Copies can be
obtained by contacting your local CareFusion representative.
Conventions used in this manual
BOLD Used for Display names, software commands, controls and indicators referenced in this manual, for
example, Battery Indicator, PURGE, 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.
A
Important Information: 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.
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Alaris™ Gateway Workstation v1.2
Controls 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.
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.
w
System Fault Indicator - The Workstation will illuminate this indicator when an internal fault is present and
detected.
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Alaris™ Gateway Workstation v1.2
Symbol Definitions
Symbol Definitions
Labelling Symbols
Symbol Description
n
Nurse call Connector
o
RS232 Connector
c
Auxiliary Connector
p
Interface 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
E
Consult accompanying documents
x
Potential Equalisation (PE) Connector
IPX1
Protected against vertically falling drops of water
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
EC REP Authorised representative in the European Community
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
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Alaris™ Gateway Workstation v1.2
Features of the Workstation
Features of the Workstation
Modular Design
The 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 80203UNSxx-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
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)
RS232 Serial
Interface (optional)
Barcode Reader
RS232 Serial
Interface (optional)
AC Power
Input
AC Power
Output
Base Module (3 MDI Tile Base)
Front View
A/B Status
Indicators
Battery
Indicator
AC Power
Indicator
ON/OFF
ON Status
Indicator
System Fault
Indicator
Infusion
Line Tidies
Alaris® Gateway Workstation 1.5
MDI Tile
Pole Clamp
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Alaris™ Gateway Workstation v1.2
Features of the Workstation
Configuration 80203UNSxx-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.
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Alaris™ Gateway Workstation v1.2
Features of the Workstation
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 Trolley
When 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.
A
Prior to moving the Alaris Trolley all brakes should be disengaged.
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.
Caution: To reduce the risk of excess pressure and siphoning the fluid bag should be placed a minimum height of 300mm
above the Pump.
A
When bag hanger poles are available they should be adjusted to the height recommended in the specific Pump
Directions For Use.
For Workstation configurations 80203UNSxx-235 and 80203UNSxx-035, use the bag hanger assembly PN 1000SP01414
to secure fluid bags onto the Workstation.
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Alaris™ Gateway Workstation v1.2
Features of the Workstation
Power Input
The 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.
A
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 Supply
The 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 approximately 20 minutes of communications only. 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. This audible tone will escalate to every 15 seconds after 14 minutes until
the battery is fully depleted.
A
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.
AC Power Output to Infusion Pumps
The 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 Workstation
Workstations 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.
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Alaris™ Gateway Workstation v1.2
Features of the Workstation
System Fault Indication
Continuous 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. The
Workstation briefly illuminates the System Fault Indicator and activates the audible tone each time the Workstation is switched on.
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 practical and contact
Qualified Service Personnel.
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 or warning state. When lit, the Pump Alarm Location Beacon colour matches that of the visual status indicator
on the Pumps; red for alarms and amber for warnings. Alarms of high priority, such as when an infusion is terminated are reflected
as Red. Alarms or warnings of lower priority, such as Near-end-of-Infusion, are reflected as 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 or warning 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 or warnings to be easily located; it does not
replace the alarm or warning on the Pump which remains the principle indicator that the attention of a clinician is required.
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.
A
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 and it is the hospital’s responsibility to monitor.
A
For the Alaris GW Volumetric Pump, which does not have a visual status indicator:
Alarm State - will activate the Pump Alarm Location Beacon of the Workstation
Warning State - will not activate the Pump Alarm Location Beacon of the Workstation
Note: See the ‘Introduction’ section for lists of the Pump Alarm Location Beacon and Nurse Call compatibility between the
Pumps and Workstation.
Nurse Call Interface
A nurse call interface is provided which is activated whenever any Pump attached to the Workstation enters an alarm or warning 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 or warning condition to the Workstation via the IrDA interface or RS232 for Alaris SE Pump. The
communication of such an alarm or warning 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 will be a delay, of up to 5 seconds, between the Pump going into alarm and the Nurse Call Interface activating
via the Workstation.
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.
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Alaris™ Gateway Workstation v1.2
Operating Precautions
Operating Precautions
Operating 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 CareFusion 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.
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 and IEC/EN60601-1-2.
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 CareFusion 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 CareFusion 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 CareFusion
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 CareFusion may result in increased emissions
or decreased Workstation immunity.
The Workstation features an optional radio frequency IEEE 802.11b Wireless Local Area Network interface
(RF card). 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.
1000DF00742 Issue 2
17/30
Alaris™ Gateway Workstation v1.2
Operating Precautions
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.
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.
The Workstation is not intended to be used in the presence of a flammable anaesthetic mixture with air,
oxygen or nitrous oxide.
C
Dangerous Voltage: An electrical shock hazard exists if the Workstations 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 CareFusion. Any use of Alaris Gateway Workstations which have been
altered or modified otherwise than in strict application of directions provided by CareFusion, is at your sole
risk, and CareFusion does not provide any warranty for or endorsement on any Alaris Gateway Workstation
that has been so modified or altered. CareFusion 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.
1000DF00742 Issue 2
18/30
Alaris™ Gateway Workstation v1.2
Operating Precautions
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.
1000DF00742 Issue 2
19/30
Alaris™ Gateway Workstation v1.2
Operation of Workstation
Operation of Workstation
Switching On
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 xxx 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 fails 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.
A
Resetting the Workstation is also required to clear any System Fault Indicator.
Fitting an Auxiliary Workstation
1. 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.
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BD Alaris v1.2 Operating instructions

Category
Gateways/controllers
Type
Operating instructions

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