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Rigel 288 PLUS Manual

Electrical safety analyser
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RIGEL 288 PLUS
electrical safety analyser
Copyright © 2016 SEAWARD GROUP
Last Update: 20th April 2016
Innovating Together
Instruction Manual
406A556 Revision 1.1

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Summary of Contents for Rigel 288 PLUS

  • Page 1 Innovating Together RIGEL 288 PLUS electrical safety analyser Copyright © 2016 SEAWARD GROUP Instruction Manual Last Update: 20th April 2016 406A556 Revision 1.1...
  • Page 2 The period of warranty will be effective at the day of delivery. Calibration Statement The Rigel 288 plus Plus 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.
  • Page 3 Disposal of old product The Rigel 288 plus 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 4 As the manufacturer of the apparatus listed, we declare under our sole responsibility that the product: Rigel 288 plus - Electrical Medical Safety Analyser Conforms with the relevant Directives and conformity is indicated by the symbol , i.e. “Conformité Européenne”...

  • Page 5: Table Of Contents

    Earth Leakage Test ________________________________________________ - 43 - 5.11. Enclosure Leakage Test (mains powered) ______________________________ - 44 - 5.12. Point to Point Enclosure Leakage Test (battery powered) _________________ - 45 - 5.13. Patient Leakage ___________________________________________________ - 46 - Rigel 288 plus Instruction Manual – Revision 1.1...
  • Page 6 Upload from PC ___________________________________________________ - 89 - 8.3. Configuration Data ________________________________________________ - 89 - Send Config Data ___________________________________________________ - 89 - 8.3.1. 8.3.2. Receive Config Data ________________________________________________ - 91 - 8.4. Clone Data _______________________________________________________ - 92 - Rigel 288 plus Instruction Manual – Revision 1.1...
  • Page 7 8.5. Load TnT Logo ____________________________________________________ - 92 - About _________________________________________________________ - 94 - Maintaining the Rigel 288 plus ___________________________________ - 95 - 10.1. Cleaning the Analyser ______________________________________________ - 95 - 10.2. User Maintenance _________________________________________________ - 95 - 10.3. Return Instructions. _______________________________________________ - 95 -...

  • 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 288 plus. Warning of electrical danger! Indicates instructions must be followed to avoid danger to persons.

  • Page 9: Introduction

    To further improve the portability and flexibility of the 288 plus+, a range of accessories, including Bluetooth printers and barcode scanners are available. The Rigel 288 plus+ is available in a wide range of power configurations to suit local requirements, and conforms to several international standards including IEC 62353,...

  • Page 10: Rigel 288 Plus Includes

    1.2. Rigel 288 plus includes: Rigel 288 plus Instruction Manual – Revision 1.1...

  • Page 11: Interfaces

    1.3. Interfaces Rigel 288 plus Instruction Manual – Revision 1.1...

  • Page 12: Optional Accessories

    (p/n 331A680) 1.5. Test ’n Tag Compatible The Rigel 288 plus 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: ...

  • Page 13: Unique Use Of Icons

    1.6. Unique use of ICONS The Rigel 288 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 14: Logging On

    2. Logging on When switching on the Rigel 288 plus, 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 plus.

  • Page 15: Getting Started

    2) Setting the correct time and date: See chapter 6.4.7 3) Start automatic safety test See below The Rigel 288 plus is pre-programmed to perform electrical safety tests in accordance with a variety of international standards. To start an automatic safety test, simply Press the button (F4) from the home screen and select Auto Mode.

  • Page 16: Automatic Mode

    (ie “bed”, “ECG5” etc) or 4 digit fast code. The benefit of using the Rigel 288 plus in this way is that similar items can be easily retested using the same parameters. When an existing ASSET ID is entered in the 288 plus, the tester will automatically configure itself to re-perform the test without any additional settings being required.

  • Page 17: Test Period

    The automatic mode provides an option to test in full automatic or semi autoatic mode. In full automatic mode, the Rigel 288 plus will step through the non powered tests and once the powered tests (load and leakage tests) have started, all test conditions including single fault conditions are executed automatically without the required intervention of an operator.
  • Page 18 3. Use the up, down, left and right keys to select the required Test Sequence 4. Select the Run Mode (Semi or Full Automatic) using the up, down, left and right keys. 5. Enter the required test period in months. Rigel 288 plus Instruction Manual – Revision 1.1 - 17 -...
  • Page 19 Sequence menu. (See 6.1 for more information) When all parameters are set, press the button (4) to enter the Asset Trace Variables screen (when applicable). In this example, all Asset Variables are activated. Rigel 288 plus Instruction Manual – Revision 1.1 - 18 -...
  • Page 20 IEC 60601-1 with added Visual Test prior to the safety test and a Custom Test followin the successful safety test. The Applied Part Configuration is set to default and the test is executed in Semi Automatic mode. Rigel 288 plus Instruction Manual – Revision 1.1 - 19 -...
  • Page 21 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 4.6) Press the Green start key to start the earth continuity test. Rigel 288 plus Instruction Manual – Revision 1.1 - 20 -...
  • Page 22 Refer to page 8 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! Warning Mains voltage applied to appliance. Rigel 288 plus Instruction Manual – Revision 1.1 - 21 -...
  • Page 23 The initial powered test is a load test. The Rigel 288 plus will check for a short circuit EUT and ensure the applied load (EUT) is less than 16 A. In case of a short circuit in the EUT, the Rigel 288 plus will not power-up and a warning message is displayed.
  • Page 24 Rigel 288 plus Instruction Manual – Revision 1.1 - 23 -...
  • Page 25 Neutral. This allows the user to properly power down the Medical Device and prevent possible damage caused by interupting the power supply. Note that this message is not available in full automatic mode. The Rigel 288 plus will continue with all warning open neutral measurements.
  • Page 26 The next step is to reverse the power supply. The Rigel 288 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 27 No further options or viewing of results available. The tester will return to the home screen.  Options Menu – Provides a menu to allow further choices after a test. (see 4.8) Rigel 288 plus Instruction Manual – Revision 1.1 - 26 -...

  • Page 28: Failure Menu

    4.7. Test ‘n Tag The Rigel 288 plus is compatible with the Seaward Test ‘n Tag and Test ‘n tag Elite system To use the Test ‘n Tag printer, add your T’nT printer to the Bluetooth Favorites. See 6.5 A detailed application note is available from the Rigel website on the used of Test’...

  • Page 29: View Results

    Pass Fail label. (see 4.7) 4.9. View Results Use the button (F2) to return to the Test Details screen. The button (F4) provides extra option to print results, label or Test ‘n tag Rigel 288 plus Instruction Manual – Revision 1.1 - 28 -...

  • Page 30: Manual Mode

    IEC 62353 > Alternative Differential AP Leakage Test > Direct Alternative Earth leakage IEC 60601-1> Enclosure Leakage Patient Leakage Patient Lkg (Auxiliary) Patient Lkg (F-Type) Load test IEC lead test Rigel 288 plus Instruction Manual – Revision 1.1 - 29 -...
  • Page 31 The screen shows the current measuring condition, ie;  Equipment Leakage (Direct Method)  2 second test duration  limit is [500µA] Rigel 288 plus Instruction Manual – Revision 1.1 - 30 -...

  • Page 32: Earth Continuity

    If an earth bond lead other than that supplied with the Rigel 288 plus is to be used then any resistance associated with this lead can be zeroed out by connecting the supplied earth bond lead to the EUT earth socket on the Rigel 288 plus and pressing the zero button (F2).
  • Page 33 (F3) will exit Settings mode without saving changes. Switching off the Rigel 288 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 pre-set test duration.

  • Page 34: Insulation Resistance Eut

    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. Rigel 288 plus Instruction Manual – Revision 1.1 - 33 -...

  • Page 35: Insulation Resistance Applied Parts

    Press button (F3) to set the Test Duration, Insulation test voltage (500 / 250VDC) and Pass/Fail limit. Use the up, down. left and right keys to highlight and set. Rigel 288 plus Instruction Manual – Revision 1.1 - 34 -...

  • Page 36: Insulation Resistance Applied Parts To Mains

    For both Class 1and Class II appliances, connect the Patient Connections or Applied Parts to the Applied Part Module and fit the Appliance mains plug into the EUT outlet. Rigel 288 plus Instruction Manual – Revision 1.1 - 35 -...

  • Page 37: Equipment Leakage (Direct)

    Refer to page 8 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! Rigel 288 plus Instruction Manual – Revision 1.1 - 36 -...

  • Page 38: Equipment Leakage (Differential)

    All Patient Connections and Applied Parts are grouped together which eliminates the requirement to configure the Applied Part Module as the Rigel 288 plus will short together all 10 connections as part of this test. For this reason, the Applied Part configuration key is not available.
  • Page 39 All Patient Connections and Applied Parts are grouped together which eliminates the requirement to configure the Applied Part Module since the Rigel 288 plus will short all 10 connections together as part of this test. For this reason, the Applied Part configuration key is not available.

  • Page 40: Equipment Leakage (Alternative)

    All Patient Connections and Applied Parts are grouped together which eliminates the requirement to configure the Applied Part Module as the Rigel 288 plus will short together all 10 connections as part of this Rigel 288 plus Instruction Manual – Revision 1.1...

  • Page 41: Applied Part Leakage (Direct)

    (F1) to obtain the schematic representation of this test: Warning – never leave the earth bond, or any other probe attached to any moving parts. Warning – never touch the appliance under test whilst testing is in Rigel 288 plus Instruction Manual – Revision 1.1 - 40 -...

  • Page 42: Applied Part Leakage (Alternative)

    CF) Applied Parts. This is an IEC 62353 test. For a complete description of this test and applicable pass / fail limits, please see Appendix C & D. Press the button (F1) to obtain the schematic representation of this test: Rigel 288 plus Instruction Manual – Revision 1.1 - 41 -...
  • Page 43 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. Rigel 288 plus Instruction Manual – Revision 1.1 - 42 -...

  • Page 44: Earth Leakage Test

    (F3) to set the Test Duration and RMS Pass/Fail limit using the up, down. left and right keys to highlight and set. Press (F4) when complete. Pressing the button (F3) will exit Settings mode without saving changes. Rigel 288 plus Instruction Manual – Revision 1.1 - 43 -...

  • Page 45: Enclosure Leakage Test (Mains Powered)

    Plug the Medical Device in the Rigel 288 plus EUT socket and 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. 5.11. Enclosure Leakage Test (mains powered)

  • Page 46: Point To Point Enclosure Leakage Test (Battery Powered)

    Select Enclosure leakage and connect the Rigel 288 plus as follows: Connect the earth reference to the GREEN (auxiliary) socket on the back panel of the Rigel 288 plus. Connect the test probe to the BLACK socket on the back panel of the Rigel 288 plus. See below Press the GREEN start button, the Rigel 288 plus will inform the user of no incoming mains, press OK to continue.
  • Page 47 BF and CF applied. This is an IEC 60601-1 test. For a complete description of this test and applicable pass / fail limits, please see Appendix A & B. Press the button (F1) to obtain the schematic representation of this test: Rigel 288 plus Instruction Manual – Revision 1.1 - 46 -...
  • Page 48 Parts to the Applied Part Module as per the configuration above. 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. Rigel 288 plus Instruction Manual – Revision 1.1 - 47 -...

  • Page 49: Patient Leakage - F-Type

    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 toggle between the different single fault conditions and mains reversal. Rigel 288 plus Instruction Manual – Revision 1.1 - 48 -...

  • Page 50: Patient Auxiliary Current

    (F1) to obtain the schematic representation of this test: Warning – never leave the earth bond, or any other probe attached to any moving parts. Warning – never touch the appliance under test whilst testing is in Rigel 288 plus Instruction Manual – Revision 1.1 - 49 -...

  • Page 51: Load Test

    Mains voltage applied to EUT. This test provides a means of testing the Load current (in Amps) and power in KVA. Press the button (F1) to obtain the schematic representation of this test: Rigel 288 plus Instruction Manual – Revision 1.1 - 50 -...

  • Page 52: Iec Lead

    To perform an IEC lead test, connect the IEC socket side of the lead into the IEC inlet plug of the Rigel 288 plus. Connect the mains plug side of the lead into the EUT socket, of the Rigel 288 plus.
  • Page 53 As such, this feature can be excluded. See section 3.4.6. The polarity test is performed at mains voltage. The display shows the final result and the pass/fail status. See below. Rigel 288 plus Instruction Manual – Revision 1.1 - 52 -...

  • Page 54: Customising Your Tester

    6. Customising your tester The Rigel 288 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 55: User Definable Tests

    SPO2, ECG, NIBP, Defib, Infusion, Ventilation, Pressure etc. The input is text only as no measurements are performed by the Rigel 288 plus during these tests. The user can enter questions or instructions followed by either a PASS/FAIL result or alpha numeric input.

  • Page 56: Modifying (Edit) Existing Test Sequences

    (see 6.1.2). 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. Rigel 288 plus Instruction Manual – Revision 1.1 - 55 -...
  • Page 57 (F1) and select the required entry. 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) Rigel 288 plus Instruction Manual – Revision 1.1 - 56 -...

  • Page 58: Edit Individual Test

    Change the content using the left and right keys. Rigel 288 plus Instruction Manual – Revision 1.1 - 57 -...

  • Page 59: Insert An Individual Safety Test

    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 6.1.3. Rigel 288 plus Instruction Manual – Revision 1.1 - 58 -...

  • Page 60: Insert A Non-Electrical Safety Test

    Such information could indicate the performance of the Medical Device (eg NIBP reading, Defibrillator Energy, Flow rate on Infusion device, SPO2 reading etc). Rigel 288 plus Instruction Manual – Revision 1.1 - 59 -...
  • Page 61 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. Rigel 288 plus Instruction Manual – Revision 1.1 - 60 -...
  • Page 62 Save the changes for future use by pressing the  key followed by the button. If the Escape button (F3) is pressed, the Rigel 288 plus will return to the previous meny without changes being made. Rigel 288 plus Instruction Manual – Revision 1.1...

  • Page 63: Create A New Test Sequence

    To modify a Test Sequence, please refer to 6.1.3. (test standards are not part of this screen in firmware versions 2.11 and higher) Rigel 288 plus Instruction Manual – Revision 1.1 - 62 -...
  • Page 64 Note; Tests will be inserted before the highlighted position not after. To modify a test sequence, please refer to 6.1.3 Rigel 288 plus Instruction Manual – Revision 1.1 - 63 -...

  • Page 65: Test Codes

    Applied Parts. All this information can be grouped under a 4- digit Test Code and will speed up the tester setup significantly. Once the 4-digit code is entered in the (Semi) Automatic Test, the Rigel 288 plus is preset with all test settings applicable to the device under test.
  • Page 66 Applied Part setup and test mode to Semi or Full Automatic. Enter a 4-digit Test Code, in this example 1234, and use up. Down. Left and right keys to select either Semi Automatic or Automatic. (see 4.5.1) Rigel 288 plus Instruction Manual – Revision 1.1 - 65 -...

  • Page 67: Configuring The Applied Part Module

    Any new name entered will be added to the default list for future reference. A maximum of 20 Applied Parts names can be held within the default list. Any additional entry will replace an entry on a first in first out basis. Rigel 288 plus Instruction Manual – Revision 1.1 - 66 -...
  • Page 68 Applied Part 3 (CF 8..11). To delete Applied Part 3, highlight line 3 using the Up & Down Keys and press the button (F2). There are two options to delete an Applied Part. Rigel 288 plus Instruction Manual – Revision 1.1 - 67 -...
  • Page 69 Test Code 1234 has now been configured and saved. The screen below shows the available Test Code(s) and is / are available for use in the Automatic test mode. (see 4) Rigel 288 plus Instruction Manual – Revision 1.1 - 68 -...

  • Page 70: 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 288 plus in automatic mode. The following variables can be added to the test results: Rigel 288 plus Instruction Manual –...

  • Page 71: System Config

    See 6.4.1 for more information on the use of Asset Trace Variables. The default settings on the Rigel 288 plus include the Site and Location variables. Both are activated. The drop down box is set to [Yes]. To activate or de-activate each variable, use the up and down keys to select the variable and the left and right keys to select yes or no.

  • Page 72: Asset Id

    When an existing ASSET ID is entered in the 288 plus, the tester will automatically configure itself to re- perform the test without any additional settings being required. By using ASSET TRACE VARIABLES, each ASSET can be given a unique identifier in the database ie through the use of a serial number.

  • Page 73: Comments

     Save All – All patient connections in all applied parts are saved. 6.4.5. Language Provides the ability to change the default language in the Rigel 288 plus. A total of 6 languages are available;  English  German ...

  • Page 74: Date / Time

    Changes are saved automatically. 6.5. Blue Tooth Favourites In order for the Rigel 288 plus to automatically connect to the correct Bluetooth accessory, details of that accessory must be entered into the Bluetooth Favourites list. The Bluetooth Favourites list comprises of three sub-lists (device types), each of which can store up to 3 accessories of the same type.
  • Page 75 Make sure that the device you want to add to your new favourites is switched on. Press (F1). The Rigel 288 plus will search for all discoverable Bluetooth devices within a 10m range. The time taken to perform the search will vary depending on the number of Bluetooth devices in range.
  • Page 76 Use the up/down keys to highlight the required device (in this case SELLT023i) and button (F4). SELLT023 is now placed in the “New” field as shown press the below. Rigel 288 plus Instruction Manual – Revision 1.1 - 75 -...
  • Page 77 Favourites list. “SELLT023” is now Bluetooth Favourite and the Rigel 288 plus will automatically establish a connection with “SELLT023” when using functions that communicate with a computer e.g. downloading records to a PC database software package.

  • Page 78: User Admin

    Setup followed be User Admin. The following menu will appear: Navigate through this menu using the Up & Down Keys and select by pressing the button (F4) or the right arrow key. Rigel 288 plus Instruction Manual – Revision 1.1 - 77 -...

  • Page 79: Preferences

    User Rights – For information only. To change the user rights, see 6.6.4 (F2) button allows the user to set the audible warnings and beep on key presses. See menu below: Rigel 288 plus Instruction Manual – Revision 1.1 - 78 -...

  • Page 80: Change User

    Admin rights are required for this feature. Alternatively, new users can be created in the User Profile menu, see below. A brand new Rigel 288 plus will automatically default to admin rights so new users can be created. 6.6.3. Change Password This feature allows a new password to be assigned or changes to an existing password.

  • Page 81: User Profile

    Press the button (F4) to save user profile. 6.7. Memory options This feature is used to view information about the Rigel 288 plus memory status. Press (F4), select setup using the up/down keys and select Memory Options by pressing the press (F4) to accept.

  • Page 82: Restore Factory Settings

    If the Erase (F2) key is pressed, a prompt is shown below. To erase the memory press button (F4). 6.8. Restore Factory Settings The factory settings can be restored at any time using this function. Press button (F4). Select Setup followed by Restore Factory Settings. Rigel 288 plus Instruction Manual – Revision 1.1 - 81 -...
  • Page 83 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 7.4 for further details on Cloning. Rigel 288 plus Instruction Manual – Revision 1.1 - 82 -...

  • Page 84: View Data

    (F2) to return to the main View Data screen. Use the button (F3) to view the Trace Variable and again to view the Applied Part setup. See below. Rigel 288 plus Instruction Manual – Revision 1.1 - 83 -...

  • Page 85: View Results

    Test ‘n tag print or view results. Use the up and down keys to select the view results option. Press the button (F4) to display the view text results screen (see below). Rigel 288 plus Instruction Manual – Revision 1.1 - 84 -...

  • Page 86: Search The Database

    Test Status Allows the user to select search criteria based on PASSED, FAILED or UPLOADED items. To start the search, press the button (F4) or the button (F3) to leave this screen. Rigel 288 plus Instruction Manual – Revision 1.1 - 85 -...

  • Page 87: View Data Options

    PC, setup in Bluetooth favourites. Delete Single Asset – Will delete the single selected record. Delete All Assets – Will delete all records from the memory (this action is irreversible). Rigel 288 plus Instruction Manual – Revision 1.1 - 86 -...

  • Page 88: Data Transfer

    9600. A higher baud rate may result in incorrect data being transmitted. The Rigel 288 plus will now attempt to make a Bluetooth connection with the Computer that has been configured in the Bluetooth Favourites. Initially, the Bluetooth status icon will display the egg timer for a few seconds, as shown Rigel 288 plus Instruction Manual –...
  • Page 89 Details on the RS232 format are available. Please contact our support department at +44(0) 191 5878701. The Rigel 288 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 90: Upload From Pc

    Transfer using the up and down arrow keys, select Data and press the button (F4). The Rigel 288 plus will now attempt to connect to the PC, setup in the Rigel 288 plus Bluetooth Favourites. When a connection has been established the display will be as shown below.
  • Page 91 Once the text file has been created, press the Send button (F4) to transfer the Asset Trace variables and User names from the Rigel 288 plus to the PC. The downloaded text will appear in the Bluetooth Downloader screen. Select Stop Capture from the Capture menu in the task bar.

  • Page 92: Receive Config Data

    Close down the Application and open the text file using word pad or equivalent. The downloaded information can be used to ‘clone’ other Rigel 288 plus’s or modified to add additional trace variables. Again these can be uploaded to any Rigel 288 plus for convenience.

  • Page 93: Clone Data

    This feature can be used to transfer, store and copy the current Test Sequences and Test Codes to/from a PC. It can be used to configure a number of Rigel 288 plus units with identical Test Sequences and Test Codes.
  • Page 94 (F4) to save the logo. The logo is now available for printing using the Seaward Test ’nTag printer. The file transfer can be made using any suitable PC application such as the Seaward Bluetooth Downloader (data transfer.exe) or Hyperterminal. Rigel 288 plus Instruction Manual – Revision 1.1 - 93 -...

  • Page 95: About

    Serial Number  Blue Tooth ID Ensure you have this information available when contacting Rigel Medical for Technical Support or Service. See chapter 9 for more information on Service and Calibration Procedures. Rigel 288 plus Instruction Manual – Revision 1.1...

  • Page 96: Maintaining The Rigel 288 Plus

    10. Maintaining the Rigel 288 plus 10.1. Cleaning the Analyser The Rigel 288 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 97 When asking for a Returns Number, please quote:  Instruments name and model  Serial number (see section 9)  Firmware version (see section 9) Rigel 288 plus Instruction Manual – Revision 1.1 - 96 -...

  • Page 98: Technical Specifications

    F-type only @ 110% of mains Measuring Device As per IEC 60601-1 requirements Measurement Type Separate AC & DC for Patient (-Auxiliary) Leakage to IEC 60601, True RMS for all remaining Leakage tests Rigel 288 plus Instruction Manual – Revision 1.1 - 97 -...
  • Page 99 L – E, N – E Measures Accuracy ± 5% of reading + 2 counts IEC Mains Lead Test Test Duration Test Continuity of all EB conductor, Insulation & Polarity Rigel 288 plus Instruction Manual – Revision 1.1 - 98 -...
  • Page 100 270 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 Rigel 288 plus Instruction Manual – Revision 1.1 - 99 -...

  • Page 101: Appendix A Definition Of Iec 60601 Tests

    Note - SFC 'Open Earth’ cannot be performed as this would result in zero leakage measurements under all circumstances. Diagram A shows a schematic interpretation of the earth leakage measurement including the relays operating the single fault conditions. Rigel 288 plus Instruction Manual – Revision 1.1 - 100 -...
  • Page 102 Note For Class II equipment, the Single Fault Earth Open tests are not required. Diagram B shows a schematic interpretation of the earth leakage measurement including the relays operating the single fault conditions. Rigel 288 plus Instruction Manual – Revision 1.1 - 101 -...

  • Page 103: Patient Leakage

    Open Neutral circuit and Open Earth. Appendix A shows the pass/fail limits as per IEC 60601-1 requirements. Note For Class II equipment, the Single Fault Earth Open tests are not required. Rigel 288 plus Instruction Manual – Revision 1.1 - 102 -...
  • Page 104 Potential(110% of mains input voltage) to the Applied Part connections. Due to the requirements for IEC60601 this test current can be in excess of 5mA under short circuit conditions and as such is hazardous to the user. Caution Rigel 288 plus Instruction Manual – Revision 1.1 - 103 -...
  • Page 105 Note – for this test ‘body model’ selection will be IEC60601. The current is measured through the Measuring Device with S1 and S8 closed. S5 and S9 are switched between normal and reversed. Rigel 288 plus Instruction Manual – Revision 1.1 - 104 -...
  • Page 106 This test measures the patient auxiliary current under a single fault condition (supply open). The current is measured through the Measuring Device with S1 open, S8 closed and S5 normal and then S5 reversed. Rigel 288 plus Instruction Manual – Revision 1.1 - 105 -...
  • Page 107 This test measures the patient auxiliary current under a single fault condition (earth open). The current is measured through the Measuring Device with S1 closed, S8 open and S5 normal and then S5 reversed. Rigel 288 plus Instruction Manual – Revision 1.1 - 106 -...

  • Page 108: Appendix B Pass / Fail Limits Of Iec 60601-1

    * The pass fail limit for Earth Leakage in the 3rd edition of IEC 60601 has been increased from 500μA under normal condition to 5000μA for class I equipment with NO exposed metal parts that may become live when a fault appears. Rigel 288 plus Instruction Manual – Revision 1.1 - 107 -...
  • Page 109 – see Appendix E) 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. Rigel 288 plus Instruction Manual – Revision 1.1 - 108 -...
  • Page 110 Low leakage currents of less than 75µA are difficult to measure using the Differential Leakage method. As such the Differential Leakage method is unsuitable for measuring Rigel 288 plus Instruction Manual – Revision 1.1 - 109 -...
  • Page 111 (either connected or isolated from earth) under the fault condition Mains on Applied Parts. The Applied Part Leakage Test is applicable to Floating type (BF & CF) Applied Parts only either Class I or II. Rigel 288 plus Instruction Manual – Revision 1.1 - 110 -...
  • Page 112 IEC 60601-1 F-type test. Please refer to the manufacturers recommendations. Alternative method; This method is in fact similar to a dielectric test between the Applied Part and all mains parts, EUT earth and Enclosure connected together. Rigel 288 plus Instruction Manual – Revision 1.1 - 111 -...
  • Page 113 The Alternative method is highly repeatable and as such is ideal for trend analysis on Medical Equipment not including active circuitry. Rigel 288 plus Instruction Manual – Revision 1.1 - 112 -...

  • Page 114: Appendix D Pass / Fail Limits Of Iec 62353

    In such a case the manufacturer should give information in accom panying documents. NOTE 2 Particular standards may allow different values of leakage current Rigel 288 plus Instruction Manual – Revision 1.1 - 113 -...

  • Page 115: Appendix Eiec 60601-1 Measuring Device

    Appendix E IEC 60601-1 Measuring Device Rigel 288 plus Instruction Manual – Revision 1.1 - 114 -...

  • Page 116: Appendix F Firmware Route Map

    Load T’nT Logo Setup Test Sequences Test Codes Asset Trace Variables System Config Bluetooth Favourites Preferences User Admin > Chance User Change Password User Profile Memory Options Restore Factory Settings About Rigel 288 plus Instruction Manual – Revision 1.1 - 115 -...

  • Page 117: Appendix G Available Application Notes

    Appendix G 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 Rigel 288 plus Instruction Manual – Revision 1.1 - 116 -...

  • Page 118: Appendix H Connection Diagram Ap Box

    Appendix H Connection diagram AP box Rigel 288 plus Instruction Manual – Revision 1.1 - 117 -...

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