Instruction Manual
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Rigel 288 Handheld electrical safety analyser
Copyright © 2009 SEAWARD GROUP Last Update: 15th October 2013
Instruction Manual 331A550 Revision 4.1
Rigel 288 Hand-Held Electrical Safety Analyser
Instruction Manual 331A550 Issue 4.1 October 2013 © 2009 Seaward Group Issue 4.1
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.
Calibration Statement The Rigel 288 hand-held electrical safety analyser is fully calibrated and found to be within the specified performance and accuracy at the time of production. The Seaward Group provides its products through a variety of channels, therefore it may be possible that the calibration date on the provided certificate may not represent the actual date of first use. Experience has indicated that the calibration of this instrument in not effected by storage prior to receipt by the user. We therefore recommend that the recalibration period be based on a 12 month interval from the first date the unit is placed in to service.
Date received into service ;
/
/
.
© Copyright 2009 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 ... 10
1.4.
Rigel 288 includes: ... 10
1.5.
Optional Accessories ... 11
1.6.
Test ’n Tag Compatible ... 11
1.7.
Unique use of ICONS ... 12
2.
LOGGING ON ...- 13 -
3.
SETTING-UP YOUR TESTER ...- 14 3.1.
3.2.
Test Sequences... - 14 3.1.1.
User definable tests... - 15 -
3.1.2.
View, Delete or Copy an existing Test Routine. ... - 15 -
3.1.3.
Modifying (Edit) Existing Test Sequences... - 16 -
3.1.4.
Edit individual Test ... - 18 -
3.1.5.
Insert an individual safety test ... - 19 -
3.1.6.
Insert a non-electrical safety test... - 20 -
3.1.7.
Create a new Test Sequence ... - 23 -
Test Codes ... - 25 3.2.1.
Create New Test Codes ... - 25 -
3.2.2.
Configuring the Applied Part Module... - 27 -
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 ... - 33 -
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 ... - 34 -
3.5.
Blue Tooth Favourites ... - 34 -
3.6.
User Admin ... - 38 3.6.1.
Preferences ... - 39 -
3.6.2.
Change User ... - 40 -
3.6.3.
Change Password ... - 40 -
3.6.4.
User Profile ... - 41 -
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4.
5.
6.
7.
3.7.
Memory options ... - 41 -
3.8.
Restore Factory Settings ... - 42 -
AUTOMATIC MODE ...- 44 4.1.
Asset ID ... - 44 -
4.2.
Test Codes ... - 44 -
4.3.
Test Period ... - 45 -
4.4.
Trace Variables ... - 45 -
4.5.
Performing an Automatic Test: ... - 45 4.5.1.
Semi Automatic Test Mode ... - 45 -
4.5.2.
Failure Menu... - 46 -
4.6.
Test ‘n Tag... - 55 -
4.7.
Options Menu ... - 56 -
4.8.
View Results ... - 56 -
MANUAL MODE ...- 57 5.1.1.
Earth Continuity ... - 59 -
5.1.2.
Insulation Resistance EUT ... - 61 -
5.1.3.
Insulation Resistance Applied Parts... - 62 -
5.1.4.
Insulation Resistance Applied Parts to Mains ... - 63 -
5.1.5.
Equipment Leakage (Direct)... - 64 -
5.1.6.
Equipment Leakage (Differential) ... - 65 -
5.1.7.
Equipment Leakage (Alternative) ... - 67 -
5.1.8.
Applied Part Leakage (Direct) ... - 68 -
5.1.9.
Applied Part Leakage (Alternative)... - 69 -
5.1.10.
Earth Leakage Test ... - 71 -
5.1.11.
Enclosure Leakage Test... - 72 -
5.1.12.
Patient Leakage ... - 73 -
5.1.13.
Patient Leakage – F-Type ... - 75 -
5.1.14.
Patient Auxiliary Current... - 76 -
5.1.15.
Load Test ... - 78 -
5.1.16.
IEC Lead... - 78 -
VIEW DATA ...- 80 6.1.
View Results ... - 81 -
6.2.
Search the database ... - 82 -
6.3.
View Data Options ... - 83 -
DATA TRANSFER ...- 84 7.1.
Download to PC... - 84 -
7.2.
Upload from PC ... - 86 -
7.3.
Configuration Data... - 86 -
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7.3.1.
Send Config Data ... - 86 -
7.3.2.
Receive Config Data... - 88 -
7.4.
Clone Data... - 89 -
7.5.
Load TnT Logo ... - 89 -
8.
ABOUT...- 90 -
9.
MAINTAINING THE RIGEL 288 ...- 91 -
10
9.1.
Cleaning the Analyser ... - 91 -
9.2.
User Maintenance ... - 91 -
9.3.
Return Instructions. ... - 92 -
TECHNICAL SPECIFICATIONS...- 93 -
APPENDIX A
DEFINITION OF IEC 60601 TESTS...- 95 -
APPENDIX B
PASS / FAIL LIMITS OF IEC 60601-1...- 102 -
APPENDIX C
DEFINITION OF IEC 62353 TESTS...- 103 -
APPENDIX D
PASS / FAIL LIMITS OF IEC 62353 ...- 108 -
APPENDIX E
IEC 60601-1 MEASURING DEVICE ...- 109 -
APPENDIX F
FIRMWARE ROUTE MAP ...- 110 -
APPENDIX G
AVAILABLE APPLICATION NOTES ...- 111 -
APPENDIX H
CONNECTION DIAGRAM AP BOX ...- 112 -
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Declaration of Conformity 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 2004/108/EC and Low Voltage Directive 2006/95/EC Standards used: EN 60601-1 (2006) Medical Electrical Equipment. General Requirements for Safety EN 61010-1 (2010) Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use EN 61326-1 (2006) Electrical Equipment for measurement, control and laboratory use – EMC requirements – Part 1; general requirements. The tests have been performed in a typical configuration. This Conformity is indicated by the symbol
, i.e. “Conformité Européenne”
Disposal of old product The Rigel 288 has been designed and manufactured with high quality materials and components, which can be recycled and reused. When this symbol is attached to the product it means the product is covered by the European Directive 2012/19/EU. 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.
Symbol used for tips and guidance notes in this manual.
Application note(s) available see Appendix G.
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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/EN60601-1 and IEC/EN 62353 as well as; AAMI and NFPA (USA version) AS/NSZ 3551 (Australian / New Zealand version
Dedicated measuring devices are available according to IEC 60601 and AAMI requirements Hand-held - Using purpose designed robust enclosure, the Rigel 288 is truly hand-held, 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.
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1.3. Interfaces
1) Alpha Numeric keyboard, Up / Down and Left / Right cursor control. 2) 4 Programmable soft keys below display 3) Larger Green and Red key 4) Full graphic Monochrone LCD, blue with white backlit, 1/4 VGA 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 way Applied Part adapter box (see appendix H for connection diagram) 10) 4mm Earth bond probe socket 11) 4 mm Earth bond Auxiliary socket 12) RS232 connection
1.4. Rigel 288 includes:
Calibration Certificate Carrying Case Earth bond test probe with clip Earth bond clip lead Patient Applied Part adaptor box 10 Applied part adaptors Detachable 2 meter mains cable Blue Tooth USB dongle Electronic Instruction Manual Removable ‘quick start’ card
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1.5. Optional Accessories
Med-eBase PC Download software RS232 download cable Single Applied Part leakage lead 10-way Applied part adaptor box Bluetooth Barcode scanner Bluetooth Test ‘N’ Tag System Black & white cartridge Bluetooth Test ‘N’ Tag Elite System Bluetooth result printer (50mm) Test ‘N’ Tag Elite roll of 180 labels Rigel 288 filed service kit
(p/n 301A920) (p/n 331A952) (p/n 331A953) (p/n 331A680) (p/n 339A923) (p/n 331A950) (p/n 342A912) (p/n 339A970) (p/n 339A930) (p/n 339A041) (p/n 331A923)
1.6. Test ’n Tag Compatible The Rigel 288 is compatible with the Seaward Test ‘n Tag and Elite system. Our Test ‘n Tag systems 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
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 5878701 or contact your local distributor and quote the 8digit code (shown below the password field) and the serial number of the tester to allow a temporary password being created. For security reasons, passwords can only be provided to 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 posttext 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]
The underlined character acts as a short key to allow swift navigation through the menu structure.
Available options Test Sequences Test Codes Asset Trace Variables Systems Config Blue Tooth Favourites User admin Memory Options Restore Factory Settings
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)
3.1. 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 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.
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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.
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.
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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. 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. To Delete a character, press the
button (F2)
To return to the previous menu without changes, press the To confirm the entry, press the
button (F3)
button (F4)
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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)
3.1.4. Edit individual Test
Press the button (F4) as shown above. The sub menu will allow you to alter the settings for; Test duration, Mains Limit, Single Fault Limit, Neutral Open*, Earth Open*, Mains Reversal*. Default test sequences 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.
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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.
Repeat this action for every test that requires editing. Once all the requires tests are programmed, press
(F3) to exit.
3.1.5. 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.
Tests will be inserted before the highlighted position not after.
To modify a test sequence, please refer to 3.1.3.
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