Alaris Gateway Workstation Technical Service Manual Issue 11

Alaris™ Gateway Workstation 

Contents General Information... 6 Introduction... 6 Workstation Compatibility... 7 Functional Configurations... 8 Mechanical Configurations... 9 Product Familiarity... 10 Purpose of this Manual... 10 General Precautions... 11 Workstation Handling... 12 Workstation Mounting... 12 Alaris Trolley... 12 Features of the Workstation... 13 Controls and Indicators... 14 Controls... 14 Indicators... 14

Mounting Options... 15 Available Kits... 15 Trolley Mounting Kit... 15 Bar Mounting Kit... 16 Pole Mounting Kit... 17 Mounting Locations... 18 3x0, 3x2, 3x3 and 3x4 Configuration... 18 5x0, 5x2, 5x3 and 5x4 Configuration... 19 7x0, 7x2, 7x3 and 7x4 Configuration... 19 9x2 Configuration... 20 0x3x5 Configuration... 21 2x3x5 Configuration... 22

Web Browser User Interface... 23 Accessing The Web Browser User Interface using the Auxiliary Interface... 23 Monitoring Page... 25 Event Logs... 26 PDMS Connectivity... 26 Configuration... 27 Identification... 27 Date and Time... 27 Alarm Settings / Visual Status Indicator (VSI)... 28 Wired Networking... 28 Wireless Networking... 29 Serial Ports... 29

Preventative Maintenance... 30 Preventative Maintenance... 30 Required Tests... 30 1000SM00015 Issue 11

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Required Test Equipment... 30 Visual Inspection... 30 Recommended Cleaning and Inspection... 31 Cleaning the Workstation... 31 Software Install/Upgrade... 32 Settings Confirmation... 32 Software Install/Upgrade... 32 Power-up Check... 33 Pump Alarm Location Beacon (where fitted)... 33 Pump Loading/Removal Checks... 33 Battery Test... 33 Electrical Safety Test... 34 Electrical Safety Test... 34 Performance Verification Procedure... 35

Troubleshooting... 36 Troubleshooting Guide... 36 Warnings... 36 Workstation has been Dropped or Damaged... 36 Workstation has been Exposed to Fluids... 36 Workstation Will Not Power Up... 36 Power Not Present at Pump... 36 Warning LED Remains Lit when Pump is Removed from Tile... 36 Tiles not Shown in the Web Browser User Interface or PDMS (Software v1.1.3)... 37 Tile Failure and System Fault Indicator (SFI) activation when Pump is fitted to a MDI Tile... 37 System Fault Indicator (SFI) Activation - Compact Flash (CF) Card Failures... 37

Circuit Descriptions... 38 Functional Module Block Diagram... 38 Module Overview Functional Description... 39 Services Board and Single Board Computer... 39 Low Voltage Power System Board... 39 MDI Tile Assembly... 39 Ethernet Isolation Board... 39 Power Supply Unit... 39 Battery Pack... 39

Corrective Maintenance... 40 Introduction... 40 Torque Guide... 40 Base Module... 41 MDI Tile Assembly... 41 Tile Assemblies... 43 Front Cover and LVPS PCB... 44 Power Supply Unit... 46 Battery Pack... 47 Services Board... 48 1000SM00015 Issue 11

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Upper Comms Pod... 50 Lower Comms Pod... 51 IEC Pod/Rear Cover... 53 Saddle Kit... 55 Horizontal Module Assy...56 Hand knob... 58 Labels... 59

Appendix... 60 Electromagnetic Compatibility... 60 Warning... 60 Caution... 60 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions... 60 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity... 61 Guidance and Manufacturer’s Declaration-Electromagnetic Immunity - LIFE SUPPORT Equipment . 62 Recommended Separation Distances for LIFE SUPPORT Equipment between portable and mobile RF communications equipment and the Alaris Gateway Workstation... 63 Spare Parts Listing... 64 Module Assemblies... 64 Cables... 65 AC Power Cables... 65 Rear Cover... 65 Saddle Kit... 65 Pod Kit... 65 Front Cover Kit... 65 LVPS Board... 66 PSU Kit... 66 Battery Pack... 66 Tile Assemblies... 66 Ethernet Isolation Board... 66 Services Board... 66 Compact Flash Cards... 66 Keypads... 67 Labels... 67 Hardware Kit... 67 Trolley Mounting Kit... 67 Bar Mounting Kit... 67 Pole Mounting Kit... 67 End Covers/Tile Spacers... 67 Beacon Horizontal... 68 Beacon Vertical... 68 Miscellaneous Hardware... 68 Disposal... 70 Disposal of Waste Electrical and Electronic Equipment... 70 Disposal in Countries outside the European Union... 70 Battery Removal Procedure... 70 1000SM00015 Issue 11

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Service Contacts... 71 Document History... 72 Software Upgrade Record... 73

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Alaris™ Gateway Workstation General Information

1 General Information Introduction The Alaris™ Gateway Workstation (hereinafter referred to as Workstation) has been designed as a communications gateway between the 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. The software version of Workstation can be identified by the labelling on the front or by accessing the web browser user interface. Please contact local CareFusion representative for further information about Workstation versions, upgrade options and product availability. Alaris Gateway Workstation v1.6

Alaris Gateway Workstation v1.2 and v1.3

Alaris Gateway Workstation (software versions 1.1.6 and below)

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 and for further information. 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 provides for remote Pump Alarm monitoring of Pumps attached to the Workstation MDI Tiles.

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Functional Configurations There are three different configuration options for the Workstation. To identify its configuration refer to the SKU code which can be found on the label on the back of the Workstation. Last digit before the dash sign denotes the connectivity option: 1, 2 or 3. For Workstation v1.2 and above connectivity option can also be distinguished by an icon on the front keypad label of the Workstation.

Option 1. Basic or Auxiliary Workstation REF 80203UNS01-32 SN: 135070253

16.03.2016

T

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. This option can be distinguished by the digit 1 before the dash in the SKU. For v1.2 and above this option has no icon on the front keypad label. Workstation option 1 can be upgraded to option 2 by installing the appropriate upgrade kit.

Option 2. Primary wired Workstation REF 80203UNS02-32 SN: 135070253

16.03.2016

T

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. This option can be distinguished by the digit 2 before the dash in the SKU. For v1.2 and above this option can be also recognized by the network icon on the keypad label.

Option 3. Primary wireless Workstation REF 80203UNS03-32 SN: 135070253

16.03.2016

T

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. This option can be distinguished by the digit 3 before the dash in the SKU. For v1.2 and above this option can be also recognized by the wireless icon on the keypad label.



Please note that software version 1.6 is compatible with Option 2 (Primary Wired Workstation) only.

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Mechanical Configurations The Workstation can be confirmed by viewing the serial number label on the rear of the Workstation and checking the SKU. The two or three numbers at the end of the SKU identifies the Workstation mechanical configuration, see below for all available mechanical configurations.

Available Configurations

80203UNS0x-30

80203UNS0x-32

80203UNS0x-33

80203UNS0x-34

80203UNS0x-035

80203UNS0x-50

80203UNS0x-52

80203UNS0x-53

80203UNS0x-54

80203UNS0x-235

80203UNS0x-70

80203UNS0x-72

80203UNS0x-73

80203UNS0x-74

80203UNS0x-92

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Alaris™ Gateway Workstation General Information

Product Familiarity The Workstation provides power and communications for the Pumps specified in the 'Workstation Compatibility' section. Prior to operation of the Workstation and prior to attempting any repairs or servicing, carefully read the Directions for Use (DFU) As part of continuous improvement, product enhancements and changes are introduced from time to time.

Purpose of this Manual This Technical Service Manual describes how to set up, test and maintain the Workstation. This manual is intended for use by personnel experienced in medical equipment testing and maintenance procedures­. This manual has been prepared for use by Qualified Service Personnel only. We recommend that all servicing should only be carried out by a CareFusion certified Qualified Service Personnel



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 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. For example, see Chapter 2, 'Routine Maintenance'.

underline

Used to indicate a link to another section within this manual.

Italics

Used to refer to other documents or manuals. For example, refer to the relevant Directions for Use (DFU) for further information. Also used for emphasis, for example, ...if the gap still measures less than... Wherever this symbol is shown a Hints and Tips note is found. These notes provide useful advice or information that may help to perform the task more effectively.

Wherever this symbol is shown an Update note is found. A typical example is drawing attention to a software upgrade that should be confirmed has been installed.



Wherever this symbol is shown an Important note is found. These notes highlight an aspect of test or maintenance that is important to know about.

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Alaris™ Gateway Workstation General Information

General Precautions

F V

Prior to using the Workstation, carefully read the Operating Precautions in the Directions for Use (DFU). This Workstation contains static sensitive components. Observe strict precautions for the protection of static sensitive components when attempting to repair and service the Workstation. 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.

A

Dangerous Voltage. An electrical shock hazard exists if the Workstation casing is opened or removed. Refer all servicing to Qualified Service Personnel only. If the Workstation is dropped, subjected to excessive moisture or spillage, excessive humidity, high temperature or otherwise suspected to have been damaged, remove it from service for inspection by Qualified Service Personnel .

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). Contact your local CareFusion representative for further guidance. To isolate the Workstation from AC power supply remove the AC Power connector from the source socket. The Workstation should be positioned to allow access for disconnecting the AC Power connector.

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Alaris™ Gateway Workstation General Information

Workstation Handling 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. Note: Qualified Service Personnel are required to assemble the Trolley and to mount the Workstation on the Trolley. Note: Refer to the Directions For Use for further information e.g. specifications of loading, operating precautions.

Workstation Mounting The Workstation should be mounted as specified in the 'Corrective Maintenance' section. When mounting the Workstation to a mounting option other than pole or equipment rail, the following warnings must be observed:

Workstation Mounting Precautions Warning: Ensure the mounting option is capable of supporting a fully laden Workstation (see Workstation Directions For Use) 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 Directions For Use. Warning: Do not orientate the Workstation with the AC inlet or outlets exposed in the event of a fluid spill.

Pole Mounting Precautions Warning: Ensure the pole is capable of supporting a fully laden Workstation (see Workstation Directions For Use) 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 Precautions Warning: Do not overload the trolley. To ensure stability follow the guidelines given in the Directions For Use. 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.

Alaris Trolley When the Workstation is mounted to the Alaris Trolley and is not being transported, the brakes should be engaged. Prior to moving the Alaris Trolley all brakes should be disengaged. 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.

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Features of the Workstation 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

Slip Catch

Infusion Line Tidies

Warning Light Emitting Diode (LED)

AC supply outlet

ON Status Indicator

AC Power Indicator

System Fault Indicator ON/OFF button

Pump Mounting Rail

Status Indicators

Battery Indicator

Rear View

RS232 Serial Interface (optional) RS232 Serial Interface (optional)

Barcode Reader RS232 Serial Interface (optional) Nurse Call Interface Standard RS232 Serial Interface AU Patent No. 144,124; CA Patented/Breveté 90,905; GB Patent No. 2,083,562; IE Patent No. D13002; JP Patent No.⊓㍳╙1,117,998ภ; U.S. Patent No. 6,593,528; 6,407,335.

115-230V ~50-60Hz 350VA

Infrared communications port

AC Power Input

AC Power Output (for v1.1.6 and below only)

MDI Tile



115-230V AUX ~50-60Hz

Auxiliary Interface Ethernet Interface Potential Equalisation (PE) Connector

Refer to the relevant Workstation DFU for specific feature availability, as not all features are available on all Workstations.

Alaris® Gateway Workstation 1.5

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Alaris™ Gateway Workstation General Information

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 A B

b c d

w

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. ACE Status Indicator - When illuminated the Workstation is connected to ACE. AUX Status Indicator - Not in use

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 General Information

Features of the Workstation (v1.6) 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

ACE/AUX Status Indicators

AC Power Indicator

ON Status Indicator System Fault Indicator

Slip Catch

Infusion Line Tidies

Battery Indicator

ON/OFF

Rear View

Pump Mounting Rail Warning Light Emitting Diode (LED)

CareFusion Switzerland 317 Sàrl, A-One Business Centre, Z.A Vers -La-Pièce n° 10, CH-1180, Rolle

Not Used

Not Used

AC supply outlet Not Used Not Used Infrared communications port

CareFusion Switzerland 317 Sàrl, A-One Business Centre, Z.A Vers -La-Pièce n° 10, CH-1180, Rolle X MA /1A 30V

Workstation Configuration Connector Ethernet Interface

Nurse Call Interface MDI Tile

Not Used Alaris™ Gateway Workstation v1.6

IP22B Made in U.K.

AC Power Input

Alaris® Gateway Workstation 1.5

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Potential Equalisation (PE) Connector

Not Used

Alaris™ Gateway Workstation Mounting Options

2 Mounting Options Available Kits Trolley Mounting Kit Fitting Procedure 1. Remove the plastic coating from the inner and outer surfaces of the Ring Clamp A. 2. Slide one ring clamp over each trolley pole. 3. Align the Cross Bar B fixing holes with those in each of the Ring Clamps. 4. Insert the Fixing Screw C through the assembly positioning washers D and E as shown. 5. Position the support bar and tighten the Thin Nut G, Dome Nut F and screw to 3Nm.

C Screw E Bellville Spring (x4)

A Ring Clamp F Dome Nut

E Washer (x4) B Cross Bar G Nut (x2)

Item

Description

Part Number

Mounting Kit Assembly DS Trolley

1000SP01187

a

Ring Clamp

b

Cross Bar

c

Screw Skt Tap M6 X 25 Din 912

d

Washer Plain M6 Din 125

e

Bellville Washer, Lee Springs 250-025-500

f

Nut Dome M6 Din 1587



When fixing the Workstation to the trolley, the mounting kits should be positioned and tightened so that the mount clamps align with the 10 x 25mm bars on the trolley.

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Alaris™ Gateway Workstation Mounting Options

Bar Mounting Kit Fitting Procedure 1. Remove Sealing Cord from the channel. Using an Allen key, remove the fasteners from the pre-fitted square nuts in the extrusion channel. Using a screwdriver or similar pointed tool, slide the loosened Square Nuts along the channel to the required position. 2. Insert the two Screws B through the Clamp A and Spacers C. 3. Tighten the Screws ensuring that the mounting kit remains level. 4. Insert the Mounting Knobs D into the Clamp. 5. Repeat the process for the remaining kits. 6. Cut a length of Sealing Cord to fill the channel between the mounting kit and the end caps. 7. Carefully press the cord into place. 8. Repeat the operation for the remaining sections of the channel. NOTE: CareFusion only recommend mounting kits to be fitted to the vertical extrusion.

B Screw (x2)

A Clamp C Spacer

D Mounting Knob (x2) Square Nut (x2)

Item

Description

Part Number

Gateway Mounting Kit Extended Type 1

1000SP00655

a

Rail Mounting Clamp DS/IDS

b

M6 x 100 Soc Hd A2 S/S Cap Scrw

c

Spacer, Mounting Long

d

Knob Mounting



It is important that the mounting brackets are located exactly as detailed in the Mounting Locations section.

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Alaris™ Gateway Workstation Mounting Options

Pole Mounting Kit Fitting Procedure 1. Remove Sealing Cord from the channel. Using an Allen key, remove the fasteners from the pre-fitted square nuts in the extrusion channel. Using a screwdriver or similar pointed tool, slide the loosened square nuts along the channel to the required position. 2. Insert the two Screws B through the Clamp A and Spacers C. 3. Tighten the Screws ensuring that the mounting kit remains level. 4. Repeat the process for the remaining kits. 5. Cut a length of Sealing Cord to fill the channel between the mounting kit and the end caps. 6. Carefully press the cord into place. 7. Repeat the operation for the remaining sections of the channel.

B Screw (x2)

A Clamp C Spacer

Square Nut (x2)

Item

Description

Part Number

Assembly P/CLAMP Docking Station Asena

1000SP00169

a

Assembly P/Clamp Docking Station Asena

b

M6 x 100 Soc Hd A2 S/S Cap Scrw

c

Spacer, Mounting Long Ensure that all clamps A with the T-Bar handle are updated to the new design.

Old design



New design

It is important that the mounting brackets are located exactly as detailed in the Mounting Locations section.

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Alaris™ Gateway Workstation Mounting Options

Mounting Locations It is important that the mounting brackets are located exactly as detailed in the diagrams below. Each mounting bracket must be attached to a load bearing Dräger type mounting rail when the Bar Mounting kit is used or a load bearing pole when the Pole Mounting kit is used.



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.

Note: The mounting brackets detailed in the following diagrams are the Rail Mounting Kit (1000SP00655). The indicated mounting positions also apply to the Pole Mounting Kit (1000SP00169).

3x0, 3x2, 3x3 and 3x4 Configuration Mounting kits required: 2

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Alaris™ Gateway Workstation Mounting Options

5x0, 5x2, 5x3 and 5x4 Configuration Mounting kits required: 3

7x0, 7x2, 7x3 and 7x4 Configuration Mounting kits required: 3

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Alaris™ Gateway Workstation Mounting Options

9x2 Configuration Mounting kits required: 4

Note: This configuration cannot be mounted on the Docking Station Trolley (80083UN00-00).

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