CareFusion

Alaris Gateway Workstation and DS Docking Station

Alaris Gateway Workstation Directions for Use Issue 3 ver 1.3.x

Directions for Use

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File Name: Alaris Gateway Workstation Directions for Use Issue 3 ver 1.3.x.pdf

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Page 1

Alaris™ Gateway Workstation v1.3.x

Directions For Use en

Alaris™ Gateway Workstation v1.3.x

Contents

Page

Introduction... 3 Workstation Hardware Options... 3 Workstation Software Options... 4 Intended Use... 5 Workstation Identification... 9 About This Manual... 10 Conventions used in this manual... 10 Controls and Indicators... 11 Controls... 11 Indicators... 11 Symbol Definitions... 12 Labelling Symbols... 12 Features of the Workstation... 13 Modular Design... 13 Infusion Line Tidies (where fitted)... 15 Alaris Trolley... 15 Adjustable Height Bag Hangers (where fitted)... 16 Power Input... 16 Battery Supply... 16 AC Power Output to Infusion Pumps... 17 Powering an auxiliary Workstation... 17 System Notifications... 18 System Fault Indication... 19 Nurse Call Interface... 19 Pump Alarm Location Beacon (where fitted)... 20 Operating Precautions... 21 Operating Environment... 21 Electromagnetic Compatibility and Interference... 21 Hazards... 22 Workstation Mounting Precautions... 23 Operation of Workstation... 24 Switching On... 24 Switching Off... 24 Resetting the Workstation... 24 Fitting an Auxiliary Workstation... 25 Removing an Auxiliary Workstation... 25 Mounting a Pump... 26 Removing a Pump... 26 Data Communication Interfaces... 27 Barcode Reader Interface... 27 RS232 Serial Interfaces... 27 Ethernet Interfaces...27 Wireless Ethernet Interface (where fitted)... 27 Auxiliary Interface... 27 Barcode Reader (optional)... 28 Overview... 28 BDDF00122 Issue 3

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Alaris™ Gateway Workstation v1.3.x

Visual Indicators... 28 Scanning a Barcode... 28 Data Communications Interface Specifications... 29 Nurse Call Interface... 29 Barcode Reader Interface... 29 Serial RS232 Interface... 29 Ethernet Interface... 30 Wireless Ethernet Interface (where fitted)... 30 Auxiliary Interface... 30 Product Specifications... 31 Electrical... 31 Battery... 31 Environmental... 31 Classification... 31 Regulatory Compliance... 31 Potential Equalisation Conductor... 31 Patents... 31 Physical... 32 Trolley Compatibility... 32 Maintenance... 33 Routine Maintenance Procedures... 33 Battery... 33 Replacing the AC Fuses... 33 Cleaning and Storage... 34 Disposal... 34 Spare Parts... 35 Spare Parts... 35 Document History... 35 Contact Us... 36 Customer Service Information... 36

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Alaris™ Gateway Workstation v1.3.x Introduction

Introduction The 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: 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 80300UNS02-32 SN: 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 26 Pumps to third party systems.

Option 3. Primary wireless Workstation REF 80300UNS03-32 SN: 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 23 Pumps to third party systems.

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Alaris™ Gateway Workstation v1.3.x 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 BD representative for further information about Workstation versions, upgrade options and product availability. Alaris Gateway Workstation

Alaris Gateway Workstation

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

(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.

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Alaris™ Gateway Workstation v1.3.x Introduction

Intended Use The 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

The 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 60601-224:2012 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

Alaris GH Syringe Pump (with Plus Software) MK4 Alaris CC Syringe Pump (with Plus Software) MK4 Alaris GH Guardrails™ Syringe Pump (with Plus Software) MK4 Alaris CC Guardrails Syringe Pump (with Plus Software) MK4 Alaris PK Plus Syringe Pump MK4 Alaris Enteral Plus Syringe Pump MK4 Alaris GP Volumetric Pump (with Plus Software) Alaris GP Guardrails Volumetric Pump (with Plus Software) Alaris VP Plus Guardrails Volumetric Pump

Model Code

Minimum Supported Software Version

8002TIG03

v4.3.x

Beacon High (flashing red) Yes

8003TIG03

v4.3.x

Yes

8002TIG03-G

v4.3.x

Yes

8003TIG03-G

v4.3.x

8005TIG03 8007ENT03 9002TIG03

Medium (flashing amber) Yes

Low (solid amber) Yes

Nurse Call High Medium

Yes

v3.5.x v4.5.x v2.3.x

Yes Yes Yes

9002TIG03-G

v2.3.x

Yes

9003TIG03-G

v1.3.x

Yes

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Alaris™ Gateway Workstation v1.3.x Introduction

3RD EDITION ALARMS Alarm Tone Set Infusion Pump

Model Code

Minimum Supported Software Version

8002TIG03

v4.3.x

Beacon High (flashing red) Yes

8003TIG03

v4.3.x

Yes

8002TIG03-G

v4.3.x

Yes

8003TIG03-G

v4.3.x

Yes

8005TIG03 8007ENT03 9002TIG03

v3.5.x v4.5.x v2.3.x

Yes Yes Yes

9002TIG03-G

v2.3.x

Yes

9003TIG03-G

v1.3.x

Yes

Nurse Call High Medium

Low

Yes

N/A

Medium (flashing amber) Yes

Low (solid amber) Yes

Nurse Call High Medium

Low

Yes

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

Alaris GW 800 Volumetric Pump Alaris Enteral Plus Syringe Pump MK4

Model Code

Minimum Supported Software Version

800TIG2xxx1*

V6r1x

Beacon High (flashing red) Yes

8007ENT01

(V61x)** v4.4.9

N/A

Medium (flashing amber) No

Low (solid amber) No

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.

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Alaris™ Gateway Workstation v1.3.x Introduction

Legacy Pumps Note: Legacy Pumps do not have Low priority alarms. Note: Information signals are not clearly distinguishable from Pump alarms in legacy Pump versions. Infusion Pump

Model Code

Beacon High Medium (red) (amber)

Nurse Call High Medium

80013UN01

Minimum Supported Software Version v2.3.6

Alaris GS Syringe Pump

Yes

Alaris GH Syringe Pump Alaris CC Syringe Pump Alaris TIVA Syringe Pump Alaris PK Syringe Pump Alaris Enteral Syringe Pump

80023UN01 80033UND1 80043UN01 80053UN01 8002ENT01

v2.3.6 v2.3.6 v2.3.6 v3.2.16 v4.1.6

Yes Yes Yes Yes Yes

Alaris GH Guardrails™ Syringe Pump Alaris CC Guardrails Syringe Pump Alaris GH Syringe Pump (with Plus Software) MK3 Alaris CC Syringe Pump (with Plus Software) MK3 Alaris GH Guardrails Syringe Pump (with Plus Software) MK3 Alaris CC Guardrails Syringe Pump (with Plus Software) MK3 Alaris GH Syringe Pump (with Plus Software) MK4

v4.2.1 80023UN01-G v3.1.4 80033UND1-G v3.1.4 8002MED01 v4.1.4 8003MED01 v4.1.4 8002MED01-G v4.1.4 8003MED01-G v4.1.4 8002MED01 v4.1.8

Yes Yes Yes Yes Yes Yes Yes

Alaris CC Syringe Pump (with Plus Software) MK4

8002TIG01 8003MED01

v4.1.8

Yes

Alaris GH Guardrails Syringe Pump (with Plus Software) MK4

8003TIG01 8002MED01-G v4.1.8

Yes

Alaris CC Guardrails Syringe Pump (with Plus Software) MK4

8002TIG01-G 8003MED01-G v4.1.8

Yes

Alaris GW Volumetric Pump

8003TIG01-G 2504xxxx1*

v5r1F (v51F) Yes **

Yes

Yes Yes Yes

Yes*** Yes Yes

Yes Yes Yes

v5r2A (v52A) ** v1.7.18 v1.9.2 v2.1.14

Alaris GP Volumetric Pump Alaris GP Guardrails Volumetric Pump Alaris GP Volumetric Pump (with Plus Software)

80263UN01 80263UN01-G 9002MED01

Alaris GP Guardrails Volumetric Pump (with Plus Software)

9002TIG01 v2.1.15 9002MED01-G v2.1.14

Yes

Alaris VP Plus Guardrails Volumetric Pump

9002TIG01-G v2.1.15 9003MED01-G v1.1.28

Yes

Alaris SE Pump

9003TIG01-G 7131xxxxxx*

v2.79

Yes

7231xxxxxx*

v2.80 v4.54 v8.53

* 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.

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Alaris™ Gateway Workstation v1.3.x Introduction 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

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.

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Alaris™ Gateway Workstation v1.3.x Introduction

Workstation Identification The Workstation can be confirmed by viewing the serial number label on the rear of the Workstation and checking the SKU is 80300UNSxx, where xx indicates the connectivity option. The two or three numbers at the end of the SKU identifies the Workstation configuration, see below for all available configurations.

Available Configurations

80300UNSxx-30

80300UNSxx-32

80300UNSxx-33

80300UNSxx-34

80300UNSxx-035

80300UNSxx-50

80300UNSxx-52

80300UNSxx-53

80300UNSxx-54

80300UNSxx-235

80300UNSxx-70

80300UNSxx-72

80300UNSxx-73

80300UNSxx-74

80300UNSxx-92

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Alaris™ Gateway Workstation v1.3.x 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.



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.

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Alaris™ Gateway Workstation v1.3.x Controls and Indicators

Controls and Indicators

Controls Symbol

a a

Description ON/OFF Button - Press once to switch the Workstation on. Press and hold for two seconds to switch the Workstation off. In the event that the system needs to be reset, press and hold for at least four seconds, then press again to switch the Workstation on. Note: Logs are maintained for power down events including when the Workstation is powered down or unexpected power loss.

Indicators Symbol

j j k k

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

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.

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

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Alaris™ Gateway Workstation v1.3.x Symbol Definitions

Symbol Definitions Labelling Symbols Symbol

Description Nurse call Connector

RS232 Connector

c p i g

Auxiliary Connector Interface Device, General (Barcode Reader Connector) Ethernet Network Connector AC Inlet AC Outlet - Do Not Use

This equipment contains an RF transmitter (where fitted)

Fuse Rating

Consult accompanying documents

Potential Equalisation (PE) Connector

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. Alternating Current

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

IP22

T t

Date of Manufacture Manufacturer

Not for Municipal Waste

Class 1 Laser Product Pushing Prohibited - see ‘Operating Precautions’ section for details.

C V m l

Warning electrical shock hazard do not tamper. Electrostatic discharge (ESD) precautions Wired Workstation Wireless Workstation

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Alaris™ Gateway Workstation v1.3.x Features of the Workstation

Features of the Workstation Modular Design The Workstation is a modular design. The Base Module comprises 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: Base Module (3 MDI Tile Base) Front View

Bag Supports Adjustable Height Pole

Pump Alarm Location Beacon (Not fitted on 4 MDI Tile Horizontal Module)

Pole Clamp

ON Status Indicator

AC Power Indicator

System Fault Indicator

Slip Catch

Infusion Line Tidies

A/B Status Indicators

Battery Indicator

ON/OFF

Rear View

Pump Mounting Rail Warning Light Emitting Diode (LED)

Barcode Reader

RS232 Serial Interface (optional)

AC supply outlet

RS232 Serial Interface (optional)

RS232 Serial Interface (optional) Infrared communications port Nurse Call Interface MDI Tile

Auxiliary Interface

Standard RS232 Serial Interface

Ethernet Interface Alaris™ Gateway Workstation v1.3

IP22B

Potential Equalisation (PE) Connector

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

AC Power Input

Alaris® Gateway Workstation 1.5

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AC Power Output

Alaris™ Gateway Workstation v1.3.x Features of the Workstation Configuration 80300UNSxx-235, shown mounted on an Alaris Trolley:

Bag Supports Bag Support Rail Mounting Rail Infusion Line Tidies

Mounting Rail

Trolley

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 v1.3.x 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.



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.

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Alaris™ Gateway Workstation v1.3.x Features of the Workstation

Adjustable Height Bag Hangers (where fitted) The 18 mm diameter adjustable height pole has been designed as a convenient means of securing the fluid bags onto the Workstation. The pole supports a maximum load to 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. 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.

3b 2

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 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.



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 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.

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Alaris™ Gateway Workstation v1.3.x Features of the Workstation

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 v1.3.x Features of the Workstation

System Notifications The 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 Workstation AC Power Disconnect Alarm Beacon Barcode Reader Docking Pump

Visual Indicator Battery Indicator and System Fault Indicator Pump Alarm Location Beacon Barcode LED Warning LED

Audio Indicator Secondary Speaker

Category Status

Description See ‘Battery Supply’

N/A Primary Speaker N/A

Pump Alarm Status Status

Nurse Call Power on SFI

Nurse Call On Status Indicator System Fault Indicator

N/A Both Speakers Secondary Speaker

Nurse Call Status Fault

See ‘Pump Alarm Location Beacon’ See ‘Barcode Reader’ See ‘Docking a Pump’ and ‘Removing a Pump’ See ‘Nurse Call’ See ‘Operation of Workstation’ 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.

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Alaris™ Gateway Workstation v1.3.x 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. 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.

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The Workstation auditory SFI signal is a continuous tone.

Nurse Call Interface A 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.

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