Rigel 288 Instruction Manual Issue 1.0

Limited Warranty & Limitation of Liability Rigel Medical, part of the SEAWARD GROUP guarantees this product for a period of 1 year. The period of warranty will be effective at the day of delivery.

© Copyright 2007 All rights reserved. Nothing from this edition may be multiplied, or made public in any form or manner, either electronically, mechanically, by photocopying, recording, or in any manner, without prior written consent from the SEAWARD GROUP. This also applies to accompanying drawings and diagrams. Due to a policy of continuous development the SEAWARD GROUP reserves the right to alter the equipment specification and description outlined in this publication without prior notice and no part of this publication shall be deemed to be part of any contract for the equipment unless specifically referred to as an inclusion within such contract.

Index 1.

INTRODUCTION... 8 1.1.

Rigel 288 Design Philosophy... 8

1.2.

Key Features ... 9

1.3.

Interfaces ... 9

1.4.

Rigel 288 includes: ...10

1.5.

Optional Accessories...10

1.6.

Test ’n Tag Compatible ...10

1.7.

Unique use of ICONS ...11

2.

LOGGING ON ...- 12 -

3.

SETTING-UP YOUR TESTER ...- 13 3.1.

3.2.

Test Sequences... - 13 3.1.1.

User definable tests... - 14 -

3.1.2.

View, Delete or Copy an existing Test Routine. ... - 14 -

3.1.3

Modifying (Edit) Existing Test Sequences... - 15 -

3.1.3.

Edit individual Test ... - 18 -

3.1.4.

Insert an individual safety test... - 19 -

3.1.5.

Insert a non-electrical safety test ... - 20 -

3.1.6.

Create a new Test Sequence ... - 22 -

Test Codes ... - 24 3.2.1.

Create New Test Codes ... - 25 -

3.2.2.

Configuring the Applied Part Module... - 26 -

3.3.

Asset Trace Variables ... - 30 -

3.4.

System Config ... - 31 3.4.1.

Asset ID ... - 32 -

3.4.2.

After Test ... - 32 -

3.4.3.

Comments ... - 32 -

3.4.4.

Applied Part Results... - 33 -

3.4.5.

Language... - 33 -

3.4.6.

Check IEC lead Polarity... - 33 -

3.4.7.

Date / Time ... - 33 -

3.5.

Blue Tooth Favourites ... - 34 -

3.6.

User Admin ... - 38 3.6.1.

Preferences ... - 38 -

3.6.2.

Change User... - 40 -

3.6.3.

Change Password ... - 40 -

3.6.4.

User Profile ... - 40 -

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4.

3.7.

Memory options ... - 41 -

3.8.

Restore Factory Settings ... - 42 -

AUTOMATIC MODE ...- 43 4.1.

5.

6.

7.

Performing an Automatic Test: ... - 43 4.1.1.

Semi Automatic Test Mode... - 44 -

4.1.2.

Failure Menu ... - 44 -

4.2.

Test ‘n Tag... - 54 -

4.3.

Options Menu ... - 55 -

4.4.

View Results ... - 56 -

4.5.

Warning when testing to IEC 62353... - 56 -

MANUAL MODE ...- 58 5.1.1.

Earth Continuity... - 60 -

5.1.2.

Insulation Resistance EUT... - 61 -

5.1.3.

Insulation Resistance Applied Parts... - 63 -

5.1.4.

Insulation Resistance Applied Parts to Mains... - 64 -

5.1.5.

Equipment Leakage (Direct) ... - 65 -

5.1.6.

Equipment Leakage (Differential) ... - 66 -

5.1.7.

Equipment Leakage (Alternative)... - 68 -

5.1.8.

Applied Part Leakage (Direct)... - 69 -

5.1.9.

Applied Part Leakage (Alternative) ... - 71 -

5.1.10.

Earth Leakage Test ... - 72 -

5.1.11.

Enclosure Leakage Test... - 73 -

5.1.12.

Patient Leakage... - 74 -

5.1.13.

Patient Leakage – F-Type ... - 76 -

5.1.14.

Patient Auxiliary Current... - 77 -

5.1.15.

Load Test ... - 79 -

5.1.16.

IEC Lead... - 79 -

VIEW DATA ...- 82 6.1.

View Results ... - 83 -

6.2.

Search the database ... - 84 -

6.3.

View Data Options... - 85 -

DATA TRANSFER ...- 86 7.1.

Download to PC... - 86 -

7.2.

Upload from PC ... - 87 -

7.3.

Configuration Data... - 87 -

7.4.

7.3.1.

Send Config Data ... - 88 -

7.3.2.

Receive Config Data... - 90 -

Clone Data... - 91 -

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7.5.

Load TnT Logo ... - 91 -

8.

ABOUT...- 92 -

9.

MAINTAINING THE RIGEL 288 ...- 93 -

10

9.1.

Cleaning the Analyser ... - 93 -

9.2.

User Maintenance ... - 93 -

9.3.

Return Instructions. ... - 93 -

TECHNICAL SPECIFICATIONS...- 95 -

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Declaration of Conformity The Rigel 288 Hand-held Electrical Medical Safety Analyser Manufactured by: Seaward Electronic Ltd, Bracken Hill, South West Industrial Estate Peterlee, County Durham, SR8 2SW, England Millennium Statement This product is Millennium compliant, and conforms fully to the document BSI DISC PD2000-1. Statement of Conformity Based on test results using appropriate standards, the product conforms with Electromagnetic Compatibility Directive 89/336/EEC and Low Voltage Directive 73/23/EEC Standards used: EN 60601-1 (1990) Medical Electrical Equipment. General Requirements for Safety EN 61010-1 (1993) Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use EN 50081-1 (1992) Electromagnetic Compatibility. Generic Emission Standard: EN55022 Class B EN 50082-1 (1992) Electromagnetic Compatibility. Generic Immunity Standard: IEC1000-4-2, -4-3, -4-4, -4-5 The tests have been performed in a typical configuration.

This Conformity is indicated by the symbol

, i.e. “Conformité Européenne”

WEEE Directive The Rigel 288 has been designed and manufactured with high quality materials and components, which can be recycled and reused. Please inform yourself about the local collection system for electrical and electronic products or contact your local supplier for further information. We ask you to respect your local rules and do not dispose of your old product with your general waist. By offering your old products for recycling, you will help prevent potential negative consequences for the environment and human health.

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User Notes These operating instructions are intended for the use of adequately trained personnel.

The following symbols are used in these operating instructions and on the Rigel 288. Warning of electrical danger! Indicates instructions must be followed to avoid danger to persons. Important, follow the documentation! This symbol indicates that the operating instructions must be adhered to in order to avoid danger. Warning, during many of the leakage tests the PROTECTIVE EARTH CONDUCTOR to the appliance under test is interrupted. For this reason additional means of protection are required in order to comply with the relevant safety standards. For EN60601-1 leakage tests, it is recommended that this additional protection is in the form of an isolation transformer, with an isolated reference ground, used to power the entire system. Do not connect any probe combination to the maximum permitted voltage of 30 V AC/DC with respect to earth potential when performing non-power tests. Danger of electric shock.

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1. Introduction The Rigel 288 is the FIRST universal truly hand-held medical electrical safety tester to combine the features of an automatic / manual tester with a data logging / asset management facility. A compact lightweight design and long life battery power reduces downtime between tests, making the instrument totally practical and highly portable for multi site use. In addition to IEC 60601-1 and AAMI / NFPA 99, the Rigel 288 tests to the new standard for in-service and after repair testing of medical electronic devices, currently drafted in as the IEC 62353. The Rigel 288’s large internal memory facilitates the storage of test results for safety audit and traceability purposes. Comprehensive database software is available to ensure fast and easy download of test results, managing your asset database, creation of test sequences, scheduling of Preventative Product Maintenance and producing test certificates. Wireless connection means that stored data can be transferred immediately and directly from the tester to PC-based record keeping systems at the touch of a button. The highly versatile Rigel 288 represents the next generation of electrical medical safety analysers.

1.1.

Rigel 288 Design Philosophy

The Rigel 288 has been designed to address the increasing demand for smaller more comprehensive test equipment within the Healthcare Industry. What better way than to combine such tester with the new International In-Service Test required as per IEC 62353. The challenge was to combine the benefits of the size and weight of a smaller handheld and portable Analyser with the test power and convenience of a larger benchmounted automatic safety analyser. Today’s industry demands test equipment that can save time and cost, thus offering greater flexibility. These factors have all been taken into account during the development of the Rigel 288. The test capabilities and functionality exceed that of most common bench mounted safety analysers yet the instrument is only a fraction of the size and weight. No other safety tester on the market offers a hand-held enclosure with the test capabilities of that of an automatic safety analyser; including IEC 60601 and IEC 62353 leakage tests, up to 10 Patient Connections, alpha numeric keyboard, graphic user interface, large internal memory, Blue Tooth communication, asset management facilities, user configurable Performance Tests and more. We believe that the new Rigel 288 is set to become the new standard in Electrical Medical Safety Testing.

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1.2.

Key Features

Versatile - Test in Accordance with the leakage requirements of IEC/EN 60601-1, AAMI and NFPA, IEC 62353 (VDE 0751-1) using separate IEC 60601 and AAMI Body Model Hand-held - Using purpose designed robust enclosure, the Rigel 288 is truly handheld, easy to hold single handed thus enabling one hand operation and navigation Easy to use - A full graphic, monochrome LCD display (1/4 VGA minimum) in combination with an integral alpha-numeric ABCD-key-board. Manual and Automatic test modes - Able to perform UTS (Unique Test Sequence) and allows fully automatic, semi automatic and fully manual testing. User definable test routines - Users have the ability to amend the default programs or create new programs by copying the preset test programs. Each program will have a unique Identifier. Multiple Applied Part function - This feature gives the user the capability of testing up to 10 individual Applied Parts from different Modules or classes e.g. BF and CF class, or Bf ECG and Bf SPO2 module. Internal Asset management facilities - Store up to 10,000 test records, custom test routines, visual inspections and performance tests and download to and from PC via Blue Tooth Interface.

1.3.

1) 2) 3) 4)

Interfaces

Alpha Numeric keyboard, Up / Down and Left / Right cursor control. 4 Programmable soft keys below display Larger Green and Red key Full graphic Monochrone LCD, blue with white backlit, 1/4 VGA

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5) Blue Tooth Input / Output 6) EUT socket to meet local requirements 7) IEC input socket (IEC lead test) 8) Custom detachable mains cable inlet 9) 10 x Patient Applied part connector (B/Bf & Cf) 10) 4mm Earth bond probe socket (Green) 11) 4 mm Earth bond Auxiliary socket 12) RS232 connection

1.4. • • • • • • • • • •

Calibration Certificate Carrying Case Earth bond test probe with clip Earth bond clip lead Patient Applied part module 10 Applied part adaptors Detachable 2 meter mains cable Blue Tooth USB dongle Electronic Instruction Manual Removable ‘quick start’ card

1.5. • • • • •

Rigel 288 includes:

Optional Accessories

PC Download software Barcode scanner with embedded Blue Tooth Blue Tooth Test ‘N’ Tag System Blue Tooth Download software for PDA (please check for availability) Blue Tooth Serial Adaptor

1.6.

Test ’n Tag Compatible

The Rigel 288 is compatible with the Seaward Test ‘n Tag system. Our Test ‘n Tag system allows you to print customised Thermal PASS / FAIL labels. The benefits of using the Test ‘n Tag printers are: • Robust and durable labels • Resistant to most solvents used in the medical sector • Free opportunity to advertise your logo and company details or emergency telephone number with every item you Test ‘n’ Tag. • Automatic barcode generation to provide easy use of the barcode scanner thus speeding up your test time. The unique Test ‘n’ Tag label provides test status and retest due date, barcode and asset ID number, and person conducting the test. For more information on using the Test ‘n Tag printer, see section 4.

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1.7.

Unique use of ICONS

The Rigel 288 features a hi resolution graphic back lit display which not only provides highly visible and easy to follow menu structures but also allows the user to operate the tester using intuitive icons to speed up their test routines. Below are of some of the icons used in the Rigel 288:

Escape

OK – PASS

Add

Print

Applied Parts

Less

Copy

Repeat

Delete

Save

Edit

Search

Help

Settings

Menu – List

Single Fault

Home

Shift

New

Mute

Sound

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2. Logging on When switching on the Rigel 288, the user will be able to log-in to allow for specific default user preferences and to provide traceability of test results. To increase the security and protection of the user, a password can be set prior to using the Rigel 288. See 3.6.3 for further details. The default password setting is OFF and the login screen will not require a password. In case a user and password are set, the tester will default to the last user / password.

To change the user, use the drop down menu provided [<>] and select the new user. In case a password is set for the new user, please enter the password (case sensitive). In case a password is lost and the unit is blocked, please call our helpdesk on: +44 (0) 191 5878718 or contact your local distributor and quote the 8-digit code (shown below the password field) and the serial number of the tester. A new password will then be created. For security reasons, this new password can only be provided to the email address of the original purchaser of the device. The Rigel 288 is designed to allow a user to customise test sequences and allow default settings. This customisation can speed up testing by providing the user with default manufacturer lists, model numbers, user text protocols, automatic printing post-text and fault menus.

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3. Setting-up your tester The Rigel 288 is designed to allow the user to customise the device to allow default setting in order to speed up the testing such as, default lists of manufacturers, model numbers, user test protocols, automatic printing following test, fault menu’s and so on. All custom facilities can be found under the SETUP menu. Simply press the from the home screen and select Setup from the menu.

[F4]

Hint: The underlined character acts as a short key to allow swift navigation through the menu structure.

Options available Test Sequences Test Codes Asset Trace Variables Systems Config Blue Tooth Favourites User admin Memory Options Restore Factory Settings

3.1.

Modify or create test sequences (see 3.1) Generate 4-digit test routine short cuts (see 3.2) Generate default list of variables (see 3.3) Configure default test options (see 3.4) Setup your Blue Tooth devices (see 3.5) Setup users and preferences (see 3.6) Manage the tester’s memory (see 3.7) Defaults the tester to factory settings (see 3.8)

Test Sequences

The Rigel 288 can be set-up to create new test sequences to meet local requirements or to modify existing test sequences to meet personal preference. The preset Test Sequences are according to the applicable medical standard. Preset test sequences cannot be changed by the user, however alterations are possible by producing a copy of the default test sequence setting. The total number of possible preset test sequences is 50 including 12 default test sequences. Each sequence can be linked to a specific configuration of Applied Parts

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by designating a unique 4 digit Test Code (see 3.2) which can be entered prior to each test as a short cut / menu bypass function.

3.1.1. User definable tests This feature gives the Rigel 288 the capability of recording user defined visual inspections, checks or tests including measurements from SPO2, ECG, NIBP, Defib, Infusion, Ventilation, Pressure etc. The input is text only as no measurements are performed by the Rigel 288 during these tests. The user can enter questions or instructions followed by either a PASS/FAIL result or alpha numeric input. Preset engineering units e.g. %, Joules, mmHg, PSI, CmH2O etc are available.

3.1.2. View, Delete or Copy an existing Test Routine. Preset test sequences cannot be deleted or changed by the user however, alterations are possible by producing a copy of the default test sequence. To enter the Test Sequences menu, click on Sequences from the list and press

, followed by Setup. Select the Test

(F4).

The following overview is provided and shows the list of default and customised test sequences availble. Copied Test Sequences will appear in the list with an *pre-fix.

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From this menu, the user is able to View a test sequence by pressing the View button (F4). Default test settings cannot be altered at any stage. To Copy, Delete or Print an existing or default test sequence, use the Up & Down arrow keys to highlight the test sequence and press the

button (F2).

Use the Up & Down Arrow keys to select the required action and press the (F4) to confirm. Press Escape (F3) to cancel and return to previous screen. Copied Test Sequences will appear in the list with an *pre-fix. All Copied test Sequences can be edited. See 3.1.3 for more on editing test sequences. Print Test Sequence will provide an overview of the Test Sequence on the Favourite Blue Tooth Printer. See 3.5 for help on setting up Blue Tooth devices. Delete Sequence will remove the highlighted test sequence from the memory of the Rigel 288. Note: Default Test Sequences cannot be Deleted. 3.1.3

Modifying (Edit) Existing Test Sequences

Preset test sequences cannot be modified by the user, however alterations are possible by producing a copy of the default test setting (see 3.1.2). Non-default Test Sequences can be modified from the Test Sequences menu. When non-default Test Sequences are highlighted, the screen.

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(F4) will appear in the menu

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Pressing the below;

button (F4) will open the Test Sequence for Editing as shown

To change the Name and or Class of the Test Sequence, press the and enter the Name and or Class required.

Button (F4)

To change to upper or lower case or use language specific characters, press the button (F1) and select the required entry.

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To Delete a character, press the

button (F2)

To return to the previous menu without changes, press the

button (F3)

To confirm the entry, press the

button (F4)

Confirm the changes with the (F4).

button (F3) or cancel using the

button

To Insert a new test, highlight the test using the Up & Down arrow keys and press the Insert button (F1) To Delete an individual test, highlight the test using the Up & Down arrow keys and press the

button (F2)

To go back to the previous menu, highlight the test using the Up & Down arrow keys and press the

button (F3)

To modify an individual test, highlight the test using the Up & Down arrow keys and press the

Button (F4)

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3.1.3. Edit individual Test

button (F4) as shown above. The sub menu will allow you to alter the Press the settings for; Test duration, Mains Limit, Single Fault Limit, Neutral Open*, Earth Open*, Mains Reversal*. * The default Test sequences will have the appropiate Single Fault Conditions set to meet the Standard Requirements. For specifc use, Single Fault Conditions could be de-activated by selecting the drop down box using the up and down keys and highlight the drop down box. Change the content using the left and right keys.

Highlight the required field using the up and down keys. To change the content either use the left and right keys or use the keypad to enter the correct data. To Delete the field content, press the

button as shown below.

When the right settings have been achieved, press the changes or press

button (F4) to save the

(F3) to return to the previous menu without changes.

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Repeat this action for every test that requires editing. Once all the requires tests are programmed, press

(F3) to exit.

3.1.4. Insert an individual safety test To insert an individual safety test we use the up and down keys to highlight the position where a new test needs inserting and press the Insert button (F1) from the menu below. Note; Tests will be inserted before the highlighted position not after. To modify a test sequence, please refer to 3.1.3.

Once the Insert button (F1) has been pressed, a drop down box will appear with all available safety and inspection tests. Activate the drop down box using the left key and or scroll through the available tests using the up and down keys.

Once the desired test has been highlighted, confirm using the OK button (F4) and finally confirm to insert into the test Sequence. Pressing the return to the previous screen without changes being made.

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button (F3) will

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The individual test has now been inserted and can be edited as described in 3.1.4

Further electrical safety tests can be inserted or deleted by following the steps described herein. Proceed with non-electrical safety tests as described in the following or save the new Test Sequence by following the steps below.

3.1.5. Insert a non-electrical safety test Non-electrical safety tests are intended to allow the user to capture additional information either prior to or after a safety test is completed. Such information could indicate the performance of the Medical Device (eg NIBP reading, Defibrillator Energy, Flow rate on Infusion device, SPO2 reading etc). This feature can also be used to instruct the user to inspect certain criteria (eg. Labels, software version, certain damage or upgrades) prior to a safety test as part of the Visual Inspection. To create customised visual inspections, use the insert Custom Test function using the instructions below and set the engineering units to blank. Hint: Create a unique range of visual tests or instructions by creating a new test sequence (see 3.1.7) and select Custom Test as the nature of the test. This will create a unique test sequence which can be linked to other Test Sequences or Applied Part Configurations using Test Codes. See 3.2 for more information. This allows the user to insert default customised visual checks or perfomance tests (eg when testing NIBP monitors, Defibrillators etc) The maximum number of characters in the test description or instruction is 255. To insert a non-electrical safety test, highlight the place where a new test needs inserting using the up and down keys and press the Insert button (F1) from the menu below. Note; Tests will be inserted before the highlighted position not after.

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