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Rigel 62353 PLUS Instruction Manual

Electrical safety analyser
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RIGEL 62353 PLUS
electrical safety analyser
Copyright © 2016 SEAWARD GROUP
Last Update: 20th April 2016
Innovating Together
Instruction Manual
407A556 Revision 1.4

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  • Page 1 Innovating Together RIGEL 62353 PLUS electrical safety analyser Copyright © 2016 SEAWARD GROUP Instruction Manual Last Update: 20th April 2016 407A556 Revision 1.4...
  • Page 2 *Terms and Conditions of 24 Month Warranty The Rigel product must be registered with Rigel Medical within 30 days of purchase to be eligible for the extended 24-month warranty. Instruments must be returned to an authorised service centre complete with proof of purchase within 13 months of purchase for calibration at the current rate.
  • Page 3 © Copyright 2016 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...
  • Page 4 Disposal of old product The Rigel 62353+ has been designed and manufactured with high quality materials and components, which can be recycled and reused. Please familiarise yourself with the appropriate local separate collection system for electrical and electronic products or contact your local supplier for further information.
  • Page 5 Durham, SR8 2SW, UK As the manufacturer of the apparatus listed, we declare under our sole responsibility that the product: Rigel 62353 plus - Electrical Medical Safety Analyser Conforms with the relevant Directives and conformity is indicated by the symbol i.e. “Conformité Européenne”...

  • Page 6: Table Of Contents

    Data Transfer ....................- 59 - Memory options ..................... - 65 - Trouble Shooting ..................- 66 - Maintaining the Rigel 62353 Plus ..............- 67 - Cleaning the Analyser ..................- 67 - User Maintenance ..................- 67 - Return Instructions.
  • Page 7 IEC 60601-1 Measuring Device ............- 78 - Appendix D Firmware Route Map ..............- 79 - Appendix E Available Application Notes ............- 80 - Appendix F Connection diagram AP lead ............- 81 - 3 | Page Rigel Medical 62353+ user Manual V1.4...

  • Page 8: User Notes

    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 62353 Plus. Warning of electrical danger! Indicates instructions must be followed to avoid danger to persons.

  • Page 9: Introduction

    1 Introduction The Rigel 62353 Plus is the first dedicated IEC 62353 Plus safety analyser that is able to provide automatic test sequences, onboard data storage and data entry in a ergonomic hand-held enclosure. This will allow for high flexibility in the field.

  • Page 10: Key Features

    1.3 Key Features Hand-held - Using purpose designed robust enclosure, the Rigel 62353 Plus 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.

  • Page 11: Interfaces

    8) 2 way Applied Part adapter box (see Appendix F for connection diagram) 9) 4mm Earth bond probe socket (Black) 10) 4 mm Earth bond Auxiliary socket (Green) 11) RS232 connection 7 | Page Rigel Medical 62353+ user Manual V1.4...

  • Page 12: Unique Use Of Icons

    1.5 Unique use of ICONS The Rigel 62353 Plus 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.

  • Page 13: Setting-Up Your Tester

    2 Setting-up your tester The Rigel 62353 Plus 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.
  • Page 14 SPO2, ECG, NIBP, Defib, Infusion, Ventilation, Pressure etc. The input is text only as no measurements are performed by the Rigel 62353 Plus during these tests. The user can enter questions or instructions followed by either a PASS/FAIL result or alpha numeric input.
  • Page 15 (see 2.1.2). Non-default Test Sequences can be modified from the Test Sequences menu. When non-default Test Sequences are highlighted, the (F4) will appear in the menu screen. - 11 - | Page Rigel Medical 62353+ user Manual V1.4...
  • Page 16 (F4) will open the Test Sequence for Editing as shown below; To change the Name and or Class of the Test Sequence, press the Button (F4) and enter the Name and or Class required. - 12 - | Page Rigel Medical 62353+ user Manual V1.4...
  • Page 17 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) - 13 - | Page Rigel Medical 62353+ user Manual V1.4...
  • Page 18 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. - 14 - | Page Rigel Medical 62353+ user Manual V1.4...
  • Page 19 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 2.1.3. - 15 - | Page Rigel Medical 62353+ user Manual V1.4...
  • Page 20 2.1.6 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 - 16 - | Page Rigel Medical 62353+ user Manual V1.4...
  • Page 21 Once the Insert button (F1) has been pressed, a drop down box will appear with all available safety tests and inspection available. Activate the drop down box using the left key and select the Custom Test option. - 17 - | Page Rigel Medical 62353+ user Manual V1.4...
  • Page 22 To insert the new Custom Test, press the button (F4) or exit using the button (F3) and return to the previous screen without changes being made. - 18 - | Page Rigel Medical 62353+ user Manual V1.4...
  • Page 23 Save the changes for future use by pressing the  key followed by the button. If the Escape button (F3) is pressed, the Rigel 62353 Plus will return to the previous meny without changes being made. 2.1.7 Create a new Test Sequence To create a new Test Sequence, enter the Test Sequences menu by clicking on followed by Setup.
  • Page 24 F2 appear automatically. In this instance ‘CUSTOM TEST 2’ has been created as Test Name, with Class I and to Test Standard IEC 62353 Plus. To change to upper or lower case or use language specific charaters, press button (F1) and select the required entry.
  • Page 25 Note; Tests will be inserted before the highlighted position not after. To modify a test sequence, please refer to 2.1.3. - 21 - | Page Rigel Medical 62353+ user Manual V1.4...

  • Page 26: Asset Trace Variables

    Asset trace variables may consist of a maximum of 25 characters and can be selected prior to each electrical safety test when using the Rigel 62353 Plus in automatic mode.

  • Page 27: System Config

    Change time / date (see 2.3.2)  Change beep on key press 2.3.1 Language Provides the ability to change the default language in the Rigel 62353 Plus. A total of 6 languages are available;  English  German  French ...
  • Page 28 Confirm the settings by pressing the button (F4) Ones all System Configurations have been completed, press the button (F4). Changes are saved automatically. - 24 - | Page Rigel Medical 62353+ user Manual V1.4...

  • Page 29: Change User

    All customised settings within Setup can be cloned to a PC. We advise that this is done on a regular basis to ensure custom settings are saved for back-up. See 5.3.4 for further details on Cloning. - 25 - | Page Rigel Medical 62353+ user Manual V1.4...

  • Page 30: About

     Serial Number  Technical support line Ensure you have this information available when contacting Rigel Medical for Technical Support or Service. See chapter 7.3 for more information on Service and Calibration Procedures. - 26 - | Page Rigel Medical 62353+ user Manual V1.4...

  • Page 31: Automatic Mode

    The steps are applicable to all available test sequences. As example we describe a typical automatic test to IEC 62353 Plus. Upon power-up of the Rigel 62353 Plus (or when in the tester is in the main menu, select AUTOM MODE), the following screen will appear: (the Asset Details screen) Select the right criteria for the Satety Test from the Asset Details screen;...

  • Page 32: Asset Id

    ID records, ie when the ASSET ID field is used to enter the Model or 4 digit fast code. The benefit of using the Rigel 62353 Plus in this way is that similar items can be easily retested using the same parameters.

  • Page 33: Test Period

    3.4 Configure the Applied Parts To configure the Applied Parts, press the button (F1). Note that the Applied harness supplied with the Rigel 62353 Plus has the following configuration: = AP1 Black = AP2 The following screen presents a default setup for:...
  • Page 34 Test Sequence feature in the Setup - Test Sequence menu. (See 3.1 for more information) When all parameters are set, press the button (4) to enter the Asset Trace Variables screen (when applicable). - 30 - | Page Rigel Medical 62353+ user Manual V1.4...

  • Page 35: Trace Variables

    In this example we will perform a safety test on Class I equipment, using a preset test sequence, based on IEC 62353 Plus with added Visual Test prior to the safety test and a Custom Test followin the successful safety test.
  • Page 36 Press the Calc button (F2) to calculate the pass fail limit based on the type of cable (mm²) and cable length. Pressing the button (F3) will bring up the failure menu (see 3.5.1) - 32 - | Page Rigel Medical 62353+ user Manual V1.4...
  • Page 37 Refer to Page 4 for notes on precautions required for compliance with the relevant safety standards. Do not exceed the maximum permitted voltage of 30 V AC/DC with respect to earth potential! Electric Shock danger! - 33 - | Page Rigel Medical 62353+ user Manual V1.4...
  • Page 38 , the Rigel 62353 Plus will start the measurements immediately after the EUT has been switched on. The initial powered test is a load test. The Rigel 62353 Plus will check for a short circuit EUT and ensure the applied load (EUT) is less than 16 A.
  • Page 39 The next step is to reverse the power supply. The Rigel 62353 Plus will automatically reverse the power and start the test sequence again. In the semi automatic mode, the user can determine when the measurements start. In full automatic mode, the power reversal is instant and measurements will start directly after mains reversal.
  • Page 40 At the end of the test, the user has the ability to enter comments. - 36 - | Page Rigel Medical 62353+ user Manual V1.4...
  • Page 41 The options menu provides the following sub menu: View Results will display the results of the test (see section 3.6) User Comment will allow the user to enter comments if required - 37 - | Page Rigel Medical 62353+ user Manual V1.4...

  • Page 42: View Results

    Use the Up and Down arrow keys to scroll up and down through the results page: Use the button (F2) to return to the Test Details screen. - 38 - | Page Rigel Medical 62353+ user Manual V1.4...

  • Page 43: Manual Mode

    Earth Bond Insulation EUT Insulation > Insulation AP Insulation AP to mains IEC 62353 > Equipment Leakage > Direct Alternative Differential AP Leakage Test > Direct Alternative IEC lead test - 39 - | Page Rigel Medical 62353+ user Manual V1.4...
  • Page 44 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. - 40 - | Page Rigel Medical 62353+ user Manual V1.4...
  • Page 45 If an earth bond lead other than that supplied with the Rigel 62353 Plus is to be used then any resistance associated with this lead can be zeroed out by connecting the...
  • Page 46 (F3) will exit Settings mode without saving changes. Switching off the Rigel 62353 Plus will not cancel the ‘probe zero’ Fit the Appliance mains plug into the EUT socket. Connect the Earth Bond lead to the appliance metal part. Press the green START key to begin the test. The test will run for a preset test duration.
  • Page 47 Press the class button (F2) to set the class of the appliance under test. For a class II appliance the probe symbol will be displayed at the top of the LCD display. - 43 - | Page Rigel Medical 62353+ user Manual V1.4...
  • Page 48 (F3) to set the Test Duration, Insulation test voltage (50 / 100 / 250 & 500 VDC) and Pass/Fail limit. Use the up, down, left and right keys to highlight - 44 - | Page Rigel Medical 62353+ user Manual V1.4...
  • Page 49 250 & 500 VDC) and Pass/Fail limit. Use the up, down, left and right keys to highlight and set. Press the button (F4) when complete. Pressing the button (F3) will exit Settings mode without saving changes. - 45 - | Page Rigel Medical 62353+ user Manual V1.4...
  • Page 50 Doing so could result in injury due to electric shock and / or sudden movement of any mechanical parts on the appliance. Refer to Page 4 for notes on precautions required for compliance with the relevant safety standards. - 46 - | Page Rigel Medical 62353+ user Manual V1.4...
  • Page 51 Parts, Enclosure and Mains Parts combined to real earth. This test is applicable to Class I and Class II B, BF and CF equipment. This is an IEC 62353 Plus test. For a complete description of this test and applicable pass / fail limits, please see Appendix B.
  • Page 52 For both Class I and Class II appliances, connect ALL Patient Connections or Applied Parts to the Applied Part Module and fit the Appliance mains plug into the EUT outlet. - 48 - | Page Rigel Medical 62353+ user Manual V1.4...
  • Page 53 All Patient Connections and Applied Parts are grouped together which eliminates the requirement to configure the Applied Parts since the Rigel 62353 Plus will short all connections together as part of this test. For this reason, the Applied Part configuration key is not available.
  • Page 54 All Patient Connections and Applied Parts are grouped together which eliminates the requirement to configure the Applied Parts as the Rigel 62353 Plus will short together all connections as part of this test. For this reason, the Applied Part configuration key is not available.
  • Page 55 Do not exceed the maximum permitted voltage of 30 V AC/DC with respect to earth potential! Electric Shock danger! Press the button (F2) to change the mains polarity. - 51 - | Page Rigel Medical 62353+ user Manual V1.4...
  • Page 56 CF) Applied Parts. This is an IEC 62353 test. For a complete description of this test and applicable pass / fail limits, please see Appendix B. Press the button (F1) to obtain the schematic representation of this test: - 52 - | Page Rigel Medical 62353+ user Manual V1.4...
  • Page 57 Press the green START key to begin the test. The test will run for the duration set or until the red STOP key is pressed. - 53 - | Page Rigel Medical 62353+ user Manual V1.4...
  • Page 58 To perform an IEC lead test, connect the IEC socket side of the lead into the IEC inlet plug of the Rigel 62353 Plus. Connect the mains plug side of the lead into the EUT socket, of the Rigel 62353 Plus.
  • Page 59 The polarity test is performed at mains voltage. The display shows the final result and the pass/fail status. See below. - 55 - | Page Rigel Medical 62353+ user Manual V1.4...

  • Page 60: Data

    Use the up and down arrow keys to scroll through the database. When the desired record is highlighted, press the button (F4) to enter the record and view the data. - 56 - | Page Rigel Medical 62353+ user Manual V1.4...
  • Page 61 View Results will display the results of the test (see section 5.1.1)  View Sequence will display the test Sequence  User Comment will allow the user to enter comments if required - 57 - | Page Rigel Medical 62353+ user Manual V1.4...
  • Page 62 The entered data must be identical to the data stored with the test. This includes visible and invisible SPACE characters. For Date entry use format DDMMYYYY or DD MM YYYY. For example for 31 October 2009 us 31102009. - 58 - | Page Rigel Medical 62353+ user Manual V1.4...

  • Page 63: View Data Options

    The Data Transfer functions are accessed by pressing the button (F4), selecting Data > Data Transfer using the up and down keys and pressing the button (F4). - 59 - | Page Rigel Medical 62353+ user Manual V1.4...
  • Page 64 Please default to a baud rate of 9600. A higher baud rate may result in incorrect data being transmitted. The Rigel 62353 Plus is able to download in a number of formats to suit individual requirements. These are; ...
  • Page 65 The Rigel 62353 Plus is now ready to transfer data. The No. of assets field shows the number of records that will be downloaded. Ensure that the PC application is ready to receive data then press the Send button (F4).
  • Page 66 Transfer using the up and down arrow keys, select Data and press the button (F4). The Rigel 62353 Plus will now connect to the PC. When a connection has been established the display will be as shown below. Open the Data Transfer.exe application on your PC and check that the Com Port is correct.
  • Page 67 Close down the Application and open the text file using word pad or equivalent. The downloaded information can be used to ‘clone’ other Rigel 62353 Plus’s or modified to add additional trace variables. Again these can be uploaded to any Rigel 62353 Plus for convenience.
  • Page 68 5.3.4 Clone Data This feature can be used to transfer, store and copy the current Test Sequences to/from a PC. It can be used to configure a number of Rigel 62353 Plus units with identical Test Sequences. The process is identical to transferring the Configuration Data as mentioned above.

  • Page 69: Memory Options

    5.4 Memory options This feature is used to view information about the Rigel 62353 Plus memory status. Press (F4), select setup using the up/down keys and select Memory Options by pressing the press (F4) to accept. The display shows the number of asset records currently stored, the remaining memory space, number of assets deleted and number of assets in upload memory.

  • Page 70: Trouble Shooting

    To ensure the measurements are performed under valid and consistent conditions, the the Rigel 62353 Plus is programmed with the ability to perform a number of self checks and test setup verification checks upon power up and prior to a powered safety test (leakage test).

  • Page 71: Maintaining The Rigel 62353 Plus

    7 Maintaining the Rigel 62353 Plus 7.1 Cleaning the Analyser The Rigel 62353 Plus case can be cleaned with a damp cloth with, if necessary, a small amount of mild detergent. Prevent excessive moisture around the socket panel or in the lead storage area.

  • Page 72: Return Instructions

    When asking for a Returns Number, please quote:  Instruments name and model  Serial number (see section 2.6)  Firmware version (see section 2.6) - 68 - | Page Rigel Medical 62353+ user Manual V1.4...

  • Page 73: Technical Specifications

    F-type only @ 110% of mains Measuring Device As per IEC 60601-1 requirements Separate AC & DC for Patient (-Auxiliary) Leakage Measurement Type to IEC 60601, True RMS for all remaining Leakage tests - 69 - | Page Rigel Medical 62353+ user Manual V1.4...

  • Page 74: Power Measurement

    ± 5% of reading + 2 counts IEC Mains Lead Test Test Duration Test Continuity of all EB conductor, Insulation & Polarity General Mains power 230 VAC ±10%, 50-60Hz +/- 1Hz - 70 - | Page Rigel Medical 62353+ user Manual V1.4...
  • Page 75 270 x 110 x 75 mm / 10.5 x 4 x 3” Size (L x W x D) 0˚C - 40˚C, 0-90% RH - NC Operating conditions Storage environment -15˚C - +60˚C Environmental Protection IP 40 - 71 - | Page Rigel Medical 62353+ user Manual V1.4...

  • Page 76: Appendix A Definition Of Iec 62353 Tests

    – see Appendix C) is positioned in the leakage return path to earth. Measurements are done in both polarities of the incoming mains with the protective earth to the EUT interrupted. - 72 - | Page Rigel Medical 62353+ user Manual V1.4...
  • Page 77 Due to the Differential measuring method, potential secondary earth connections are included in the total measurement and as such, the EUT doesn’t require to be positioned isolated from earth. - 73 - | Page Rigel Medical 62353+ user Manual V1.4...
  • Page 78 The Alternative method is highly repeatable and as such is ideal for trend analysis on Medical Equipment not including active circuitry. - 74 - | Page Rigel Medical 62353+ user Manual V1.4...
  • Page 79 Warning This Applied Part Direct Leakage test is similar to that of the F-Type leakage test according to IEC 60601 using a equivalent current limited voltage source to - 75 - | Page Rigel Medical 62353+ user Manual V1.4...
  • Page 80 The Alternative method is highly repeatable and as such is ideal for trend analysis on Medical Equipment not including active circuitry. - 76 - | Page Rigel Medical 62353+ user Manual V1.4...

  • Page 81: Appendix B Pass / Fail Limits Of Iec 62353

    In such a case the manufacturer should give information in accompanying documents. NOTE 2 Particular standards may allow different values of leakage current - 77 - | Page Rigel Medical 62353+ user Manual V1.4...

  • Page 82: Appendix Ciec 60601-1 Measuring Device

    Appendix C IEC 60601-1 Measuring Device - 78 - | Page Rigel Medical 62353+ user Manual V1.4...

  • Page 83: Appendix D Firmware Route Map

    Data Transfer Download to PC Upload fro PC Configuration Data Clone Data Memory Options Setup Test Sequences Asset Trace Variables System Config User Admin > Restore Factory Settings About - 79 - | Page Rigel Medical 62353+ user Manual V1.4...

  • Page 84: Appendix E Available Application Notes

    Appendix E Available Application Notes Please note that this section refers to our website where the most up to date application notes are available: http://www.rigelmedical.com/rigel-downloads - 80 - | Page Rigel Medical 62353+ user Manual V1.4...

  • Page 85: Appendix F Connection Diagram Ap Lead

    Appendix F Connection diagram AP lead - 81 - | Page Rigel Medical 62353+ user Manual V1.4...

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