dopplexAssist Range Host User Manual Rev I

Contents 1.0 1.1 1.2 2.0 2.1

Introduction...3 Warnings...4 List of Symbols...5 Dopplex Assist generic features...6 Battery pack ...7

2.1.1

Battery pack removal and installation...8

2.1.2

Universal power adapter

...8

2.1.3 Using the universal power adapter...9 2.2 Module installation ...9 2.3 Graphical User Interface (GUI)...9 2.3.1 Description of keypad ...10 2.4 Input / Output...11 3.0 Care of your Dopplex Assist...12 3.1 Cleaning the system...12 3.2 Cleaning the universal power adapter...12 3.3 Disinfecting...12 4.0 Trouble shooting...13 5.0 Warranty and Service ...14 5.1 Service Returns...14 6.0 Technical data...15 Appendix A Accessories ...17 1.0 Introduction...17 Appendix B Printing ...18 Appendix C Docking Station...20 1.0 Introduction...20 2.0 List of symbols ...20 3.0 Installing and removing the Assist...21 4.0 Input / Output connections ...21 5.0 Connecting power to the Docking station...22 6.0 Connecting the Docking station to the printer ...22 7.0 Cleaning the system...22 8.0 Care of your Docking station ...23 9.0 Technical Data ...23 Appendix D PCMCIA Type modem card ...24 1.0 Introduction...24 Appendix E Network card ...25 1.0 Introduction...25 Appendix F Memory module ...26 1.0 Introduction...26 2.0 Transferring Files to Memory Card ...27 Appendix G Smartcard...29

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1.0 Introduction Before using this equipment, please study this manual carefully and familiarise yourself with the controls, display features and operating techniques. The Dopplex Assist range of modular medical systems is a new generation of medical devices designed to meet the demands of healthcare providers worldwide. Using its modular approach, the Dopplex Assist provides the user with a compact, flexible functional solution. System flexibility allows the user to connect ‘application specific’ modules to the Host. This section covers the common generic features, which apply to the Host. Application specific sections are issued with their respective modules. We recommend that you insert these sections into this manual.

Host

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Application module

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1.1

Warnings

Do not use this equipment in the presence of flammable gases. Do not use in a sterile field unless additional barrier precautions are taken. Do not immerse any part of the equipment in any liquid. Do not use solvent cleaner on any part of the system. Do not use high temperature sterilising or E-beam / gamma sterilisation processes. Do not attempt to use alternative universal power adapters with the system, the universal power adapter (part number ACC 105) supplied with the system is the only one certified for use with the ‘Assist’ range. Ensure peripheral devices comply with relevant IEC standards, e.g. IEC 60950 IT equipment, IEC 60601-1 Powered Medical Equipment and the ‘configured system’ must comply with the requirements of IEC 60601-1-1. If any doubt exists concerning the use of this equipment, an alternative method should be used. This product contains sensitive electronic devices; strong radio frequency fields (i.e. those generated by Mobile telephones during transmission) could interfere with the system. In the event when this occurs, we suggest that the source of interference is identified and used out of range of the Assist. The use of mobile telecommunication equipment should be avoided during monitoring sessions – for ‘Tele-monitoring’ applications, see specific section. Do not destroy packaging, either retain for future use or return to supplier.

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1.2

List of Symbols

The following symbols are used either on the system or outer packaging and their definitions are described below: -

Type B applied part

Attention: consult accompanying documents

Alternating Current

Direct Current

On / Off

The following symbols are used on the outer packing and are concerned with protection from mechanical and environmental hazards: -

Fragile equipment

Storage temperature -10 to +40°C

Do not use hooks

Keep dry 90% RH

This way up

Atmospheric Pressure range 700hPa to 1060hPa

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2.0 Dopplex Assist generic features

The Dopplex Assist comprises a hand held battery / mains operated microprocessor based host system, which accepts a range of ‘plug in’ application specific modules. Each system is supplied with the following: Description

Qty

Dopplex Assist Host

1

NiMH Rechargeable battery pack

1

Universal power adapter / charger

1

IEC mains lead* market specific

1

User manual

1

A wide range of accessories are available for the Dopplex Assist, and can be ordered from your supplier or by contacting Huntleigh Healthcare directly. The following list is a description of the features provided by the Host: •

A high-resolution ½ VGA colour graphic display.

•

Touch screen data entry facility enables patient information to be entered through the screen user interface.

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•

Rechargeable NiMH battery pack provides up to 4 hrs continuous use (application dependent).

•

Internal memory stores patient records before downloading to a central filing system.

•

PCMCIA slot allows connection to either the telephone or network system or expands its memory capability.

•

Smartcard reader enables indirect patient data entry where national systems are in place.

•

RS232 port for connection to peripheral devices (external keyboard, mouse, serial printer, and serial port of PC).

•

High quality audio output via internal loudspeaker.

•

External universal power adapter enables universal AC line input selection.

2.1

Battery pack NOTE: It is recommended that the battery pack is charged for 16 hours before using the system for the first time.

The system uses a removable NiMH rechargeable battery pack. The pack provides up to 4 hours of continuous use (dependent on application). Battery charging can be effected using the universal power adapter connected: •

Through the Docking station (see appendix A). or

•

Via the direct connection to the charging socket on the top of the battery pack.

The battery indicator (amber LED mounted on the top of the battery pack) has 3 states indicating the following conditions: •

Flashing:

•

On permanently: Battery charging

•

Off :

Pre charge conditioning

Charging complete

DC Charging input Battery status LED 90% capacity is achieved after approximately 1.5 hours charging, whilst full capacity is achieved after a 16 hour charge cycle.

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Battery level is indicated by a graphical symbol on the screen. This symbol displayed for 5 seconds on each screen. When the battery level reduces to 15% capacity, an audible ‘beep’ is produced by the system – charge the battery immediately.

System memory is displayed by the symbol in the top left-hand corner of the display (only displayed on the opening screen). If a memory card is inserted into the slot on the top of the unit, displayed, indicating available memory on the card.

will be

button should be pressed before the memory card is ejected. Failure to do The so may incur loss of data. 2.1.1 Battery pack removal and installation Ensure the system is held in an upright position when releasing the battery retaining clip. To remove the battery pack, slide the retaining clip to its open position (1) and carefully withdraw the pack from the top of the Host (2). The battery pack may be charged outside the Host unit by connecting the universal power adapter to the charging socket on the top of the battery pack. Refit by sliding it into the Host and ‘snap lock’ the retaining clip to its closed position. Ensure the clip is firmly closed. Do not dispose of damaged or unserviceable battery packs; refer to local environmental controls. 2.1.2 Universal power adapter The Dopplex Assist’s universal power adapter accepts a wide range of international voltages and frequencies via the IEC inlet (see specification). The adapter produces a DC output voltage of +15VDC @ 2.2A for battery charging and / or system operation. Where the integrity of the external earth conductor is in doubt, to maintain safety, the user MUST ensure that the system is operated from its rechargeable battery pack. Document number - 708343/1

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Host 8

2.1.3 Using the universal power adapter Connect the adapter to the wall socket / mains supply via the mains lead supplied. Check the green lamp on the top of the adapter illuminates. Place the adapter safely on a level surface; connect the adapter output lead to either the Dopplex Assist battery pack or Docking station as required. NOTE: To maintain safety, the user should only use approved adapters (part number ACC 105) supplied by Huntleigh Healthcare.

2.2

Module installation

Application modules connect to the underside of the host. NOTE - Ensure the unit is switched off before the module is either connected or disconnected. To connect the module to the Host, align the 4 retaining latches on the module with the 4 slots on the underside of the Host. Carefully ‘snap lock’ the module into position.

2.3

Graphical User Interface (GUI)

The hand held Host includes a high-resolution ½ VGA colour display and membrane keypad. System control and functions are managed through the membrane keypad, touch screen and / or programmable ‘soft keys’.

Touch screen

Soft Keys 1 to 5

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2.3.1 Description of keypad The following diagram and table describes the symbols and function / arrangement of the Host membrane keypad. 1

6

2

7

3

4

8

5

9

Key

Function

1

Soft keys 1 – 5 (from left to right).

2

Increases / decreases audio volume, brightness or contrast.

3

Help – provides ‘on-line’ help.

4

OK - accepts screen / input.

5

Cursor keys – enables the user to navigate around screen display area and ‘drop down’ menus.

6

ON / OFF.

7

ON indicator.

8

Multi function key – selects volume, brightness or contrast.

9

Cancel – cancels screen / input.

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2.4

Input / Output

The Dopplex Assist has a choice of input / output connections. Refer to specific appendices and application module for installation / interconnection detail: PCMCIA Interface Modem, memory or network card Note Equipment must comply with the safety requirements of EN60601-1 and or IEC60950.

Rechargeable Battery Pack c/w recharging input

Loudspeaker

Graphical Interface Touchscreen

Smartcard Interface

Applied part I/O Refer to application module for specification detail.

Docking station retaining slots RS232 I/O Connection to peripheral devices. Note Equipment must comply with the safety requirements of EN60601-1 and or IEC60950.

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Stereo Headphones When connected, mutes the internal loudspeaker (for use by the clinician only)

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3.0 Care of your Dopplex Assist Although the Dopplex Assist is robust and has been designed to withstand normal use, the unit contains delicate components and should be treated with care. Other than careful routine cleaning, the Dopplex Assist does not require routine maintenance, however, we suggest that the system is included into an annual maintenance programme. Details of electrical safety testing are contained within the Service Manual. If any parts of the system appear damaged, the system should be returned to your service centre or Huntleigh Healthcare for repair.

3.1

Cleaning the system

Ensure the system is switched OFF and disconnected from the local main supply before cleaning. The unit can be wiped with a soft disposable cloth dampened with a mild detergent and warm water solution, avoiding the electrical contacts and connectors. Do not allow any fluid to seep into the module. Ensure the unit is completely dry before use. Check local protocols regarding cleaning procedures. Additional cleaning instructions can be found in the application specific sections of this manual.

3.2

Cleaning the universal power adapter

Disconnect the universal mains adapter from the main supply and the Dopplex Assist before cleaning. The adapter including cable can be cleaned with a soft disposable cloth dampened with a mild detergent and warm water solution. Avoid direct cleaning of the inlet and output connectors. Do not allow fluids to seep into the adapter. The assembly should be thoroughly wiped dry before use.

3.3

Disinfecting

Check your local infection control policies or equipment cleaning procedures. Caution Phenolic detergent based disinfectants containing cationic surfactants, ammonia based compounds or antiseptic solutions such as Steriscol or Hibiscrub should not be used on any part of the system as permanent damage will result.

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4.0 Trouble shooting The following table is intended to help the user in the event of encountering problems:Problem Unit will not switch ON

Cause Discharged battery pack

Solution Recharge / replace battery. Connect to universal adapter and operate from mains supply.

Membrane panel does not respond to key presses. System will not respond

Refer to service department.

Module not properly connected Connect module to host.

Unit displays incorrect time & Internal clock incorrectly set date

Reset clock - refer to application specific section for details.

Unit ‘beeps’ continuously

Recharge / replace battery

Low battery condition

Touch screen does not respond Touch screen requires calibration

Refer to service department.

Unable to print

Incorrect printer set up

Configure printer – refer to application specific section for details.

Printer not connected

Connect printer

Printer not ‘on-line’

Refer to printer user manual

If trouble persists, consult your service centre or Huntleigh Healthcare using the contact details at the rear of this manual.

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5.0 Warranty and Service Huntleigh Healthcare’s standard terms and conditions apply to all sales. Copies are available on request. These contain full details of warranty terms and do not limit the statutory rights of the consumer.

5.1

Service Returns

If for any reason the Assist has to be returned, please •

Clean the product following the instructions in this manual.

•

Pack it in suitable packing.

•

Attach a decontamination certificate (or other statement declaring that the product has been cleaned) to the outside of the package.

•

Mark the package ‘Service Department – Assist’.

For further details, refer to NHS document HSG(93)26 (UK only). Huntleigh Healthcare reserve the right to return product that does not contain a decontamination certificate. A service manual is available for the Dopplex Assist. It contains service information, parts lists and faultfinding guidelines. The service manual can be obtained by contacting your local supplier or: -

Tel: Tel: Fax: email:

Customer Care Department. Huntleigh Healthcare – Diagnostic Products Division, 35, Portmanmoor Rd., Cardiff. CF24 5HN United Kingdom. +44 (0)29 20496793 - Service (24hr answer machine) +44 (0)29 20485885 +44 (0)29 20492520 [email protected] [email protected]

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6.0 Technical data Physical Size - Host: Weight:

93mm x 380mm x 250mm (HxWxD) 1.2Kg (including battery)

Environmental Operating Temperature: Storage Temperature: Atmospheric Pressure range Relative Humidity

+10°C to +30°C -10°C to +40°C 700hpa to 1060hpa 90% non condensing

Electrical NiMH battery pack: Fuse Type / Rating: Audio Power:

8.4V @ 4A/Hr Internal thermal fuse 70°C (Resettable) Internal T3.5A (Resettable) 1 W rms. max. 100 mW Headphones output

Regulatory Compliance Complies with:

EN60601-1:1990

EN60601-1 Classification: Type of protection against electric shock:

Class 1 (when operated via supplied psu) / internally powered.

Degree of protection against electric shock: Type B equipment - refer to application module Degree of protection against Ingress of liquids: IPX0 Degree of Safety in Presence of Flammable Gases: Not suitable for use in the presence of flammable gases. Mode of Operation:

Continuous

Power Adapter

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Input voltage: Input frequency: Inrush current: Input current: Output voltage: Output current: Operating temperature: Storage temperature:

100 – 240 VAC 50 – 60 Hz <16A 0.34 – 0.62A 15V +/- 0.7V regulated to 2.2A max +10°C to +30°C -10°C to +40°C

Degree of protection against Ingress of fluid: Mode of operation:

IP40 Continuous

Degree of protection In the presence of flammable anaesthetics Dimensions:

Not suitable for use in the presence of flammable anaesthetics. 134mm x 55mm x 80mm

Safety Earth leakage current: Patient leakage current: Protection class: Safety standards:

<0.5mA <10µA DC, <100µA AC 1 EN60601-1, UL2601-1

Indicators Green LED:

Power ON

Medical Devices Directive 93/42/EEC Manufactured in the UK by Huntleigh Healthcare Ltd – Diagnostic Products Division. As part of the ongoing development programme, the company reserves the right to modify specifications and materials of the Assist range without notice. Huntleigh Healthcare Ltd – A Huntleigh Technology PLC company. Dopplex, Huntleigh and ‘H’ logo are registered trademarks of Huntleigh Technology PLC. ©Huntleigh Technology PLC 2000.

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Appendix A 1.0

Accessories

Introduction

The following accessories are available for the Dopplex Assist. They can be ordered using the following order codes from your supplier or by contacting Huntleigh Healthcare directly: Description

Order Code

Carry case / shoulder bag

ACC 101

Carry pouch

ACC 102

Docking station

ACC 214

Pole stand

ACC 103

Printer cable (USB)

ACC 208

Universal power adapter / battery charger

ACC 105

IEC Power cord - UK*

004327 – UK

*note market specific options

004165 - Euro

PCMCIA type Modem (land line)*

ACC 106

*market specific PCMCIA Memory Card – 64Mb

ACC 191

PCMCIA Memory Card – 128Mb

ACC192

PCBCIA Memory Card – 256Mb

ACC193

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Appendix B

Printing

The user can print traces to any supported printer through the USB interface on the rear of the optional Docking Station or via the RS232 mini-din socket located on the side of the Host. NOTE – A USB converter (part no. ACC208 available from Huntleigh Healthcare) is required for printing through the Mini-din facility. From the opening screen, press

to display the system controls.

Press

to enter the printer selection page.

Press used.

(next to driver name). Select the driver appropriate to the printer being

Select the Port, paper type and number of copies. Ensure the printer is connected to either the docking station or the mini-din connector on the side of the Host unit, and is turned on.

Press

. A Huntleigh test page should be printed.

If margins require adjustment, select

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and enter ‘1353’ and

HOST

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Host 18

Soft key 1

Soft key 2

Soft key 3

Soft key 4

Soft key 5

Print Test Page

Restore factory default settings

Delete Driver

Copy Driver

Accept changes

A printer driver can be copied and changed to suit the users needs by pressing

Press

to accept changes and ensure that the new driver is displayed.

Press

to return to the Setup screen.

.

The following printers are currently supported: Please refer to attached addendum sheet.

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Appendix C 1.0

Docking Station

Introduction

The Docking station provides a platform for the Dopplex Assist. Facilities include: •

Storage platform.

•

4W Audio power amplifier – (separated stereo signals).

•

Interface to external printer. NOTE – Printer must comply with IEC 60950 IT equipment or IEC 60601-1 Powered Medical Equipment. The Docking station contains sensitive electronic devices; strong radio frequency fields (i.e. those generated by Mobile telephones during transmission) could interfere with the system. In the event when this occurs, we suggest that the source of interference is identified and used out of range of the Assist.

2.0

List of symbols

The following symbols are used on the Docking station: -

Attention consult accompanying documents

Type B applied part Direct current

Printer connection

Fuse

Printer Activity

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