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Rigel SP-SIM Instruction Manual

Sp02 simulator
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RIGEL SP-SIM
SP02 simulator
Copyright © 2016 SEAWARD GROUP
Last Update: 20th April 2016
Innovating Together
Instruction Manual
370A559 Revision 2.2

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  • Page 1 Innovating Together RIGEL SP-SIM SP02 simulator Copyright © 2016 SEAWARD GROUP Instruction Manual Last Update: 20th April 2016 370A559 Revision 2.2...
  • Page 2 Calibration Statement The Rigel SP-SIM SPO2 Simulator 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 © 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 SP-SIM SPO2 Simulator 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 Seaward Electronic Ltd. is registered under BS EN ISO9001 Certificate No.: Q05356. A copy of the Declaration of Conformity and a copy of our ISO certificate are available in the Support & Resources area of the Seaward website www.seaward.co.uk". 1 | Page Rigel Medical SP-SIM user Manual V2.2...

  • Page 6: Table Of Contents

    Index User Notes ......................... 4 Introduction ....................... 5 1.1. Rigel SP-SIM Design Philosophy ................5 1.2. Key Features ......................6 1.3. Rigel SP-SIM includes: ..................6 1.4. Optional Accessories .................... 6 1.5. Test ’n Tag Compatible ..................7 1.6. Interfaces ......................7 Using the PULS-R optical finger with the UNI-SIM ..........
  • Page 7 Maintaining the Rigel SP-SIM................ 65 11.1. Cleaning the SP-SIM .................... 65 11.2. User Maintenance ....................65 11.3. Return Instructions..................... 66 10 Technical Specifications ..................67 Appendix A Firmware Route Map ................. 68 3 | Page Rigel Medical SP-SIM user Manual V2.2...

  • Page 8: User Notes

    The SP-SIM is supplied with a mains power supply unit. The use of any other power supply unit may cause damage to the equipment and may result in a hazard to the user.

  • Page 9: Introduction

    Rigel Medical has introduced a new hand held, high performance pulse oximetry simulator for the fast, accurate and efficient testing of SpO2 devices. The lightweight and battery powered Rigel SP-SiM is the first hand held simulator of its type and utilises new technology to eliminate the inconsistencies that can often be associated with testing using traditional equipment like an optical finger.

  • Page 10: Key Features

    (p/n 399A910)  Med-eBase PC Download software (p/n 383A910)  Med-eBase SIM licence (p/n 383A916)  Bluetooth Barcode scanner (p/n 339A923)  BlueTooth Test ‘N’ Tag Elite 2 Printer (p/n 339A989) 6 | Page Rigel Medical SP-SIM user Manual V2.2...

  • Page 11: Test 'N Tag Compatible

    1.5. Test ’n Tag Compatible The Rigel SP-SIM 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 12: Using The Puls-R Optical Finger With The Uni-Sim

    2. Using the PULS-R optical finger with the UNI-SIM for use only with Rigel SP-SIM and UNI-SIM products The PULS-R optical finger is 2.1. Accuracy of simulation when used with the corresponding R-curves Resolution Range Repeatability* 1% steps 30 - 60% ±5%**...

  • Page 13: Getting Started

    2.2. Getting started Turn on your Rigel UNI/SP-SIM by pressing and holding the green start button until you hear a “beep” and the Rigel splash screen appears. The summary simulation screen appears displaying the settings from the previous simulation for all parameters and can be repeated by simply pressing the green start key For both the Rigel UNI and SP- SIM the user will need to select.

  • Page 14: Performing Sp02 Simulations

    2.3. Performing SP02 simulations The connection between the PULS-R, the UNI/SP-SIM and the monitor is shown in the diagram connected to the SPO2 port on the SP-SIM/UNI-SIM’ or similar text. The correct orientation for probe place is with the LED of the probe on the top side of the PULS-R.

  • Page 15: Unique Use Of Icons

    2.4. Unique use of ICONS The Rigel SP-SIM 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 16: Logging On

    3. Logging on When switching on the Rigel SP-SIM, 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 SP- SIM.

  • Page 17: Setting-Up Your Tester

    4. Setting-up your tester The Rigel SP-SIM 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 18 SPO2, ECG, NIBP, Defib, Infusion, Ventilation, Pressure etc. The input is text only as no measurements are performed by the Rigel SP-SIM during these tests. The user can enter questions or instructions followed by either a PASS/FAIL result or alpha numeric input.
  • Page 19 (see 4.1.2). 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. 15 | Page Rigel Medical SP-SIM user Manual V2.2...
  • Page 20 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) 16 | Page Rigel Medical SP-SIM user Manual V2.2...
  • Page 21 (F3) to return to the previous menu without changes. Now scroll down to the next entry to set the parameters for the simulation by highlighting the “SPO2 Start Simulation” from the screen as shown below; 17 | Page Rigel Medical SP-SIM user Manual V2.2...
  • Page 22 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 4.1.3 18 | Page Rigel Medical SP-SIM user Manual V2.2...
  • Page 23 The individual test has now been inserted and can be edited as described in 3.1.4 Further tests can be inserted or deleted by following the steps described herein. 19 | Page Rigel Medical SP-SIM user Manual V2.2...
  • Page 24 SP-SIM must be set to stop the chronometer test (End chronometer Test) In an example below, the SP-SIM will simulate from 98% to 90%, then down to 85% by inserting the following tests. Start Chronometer Test:...
  • Page 25 Once the final test settings have been selected, the SP-SIM must be instructed to stop the simulation mode. This is done by inserting the END CHRONOMETER TEST; 4.1.6. Insert Custom Tests or Instructions Custom tests or Instructions are intended to allow the user to capture additional information either prior to or after the main SPO2 performance tests.
  • Page 26 (F4) or exit using the button (F3) and return to the previous screen without changes being made. Further tests can be inserted or deleted by following the steps described herein. 22 | Page Rigel Medical SP-SIM user Manual V2.2...
  • Page 27 To exit and save the changes for future press the button followed by pressing the button. If the Escape button (F3) is pressed, the Rigel SP-SIM will return to the previous meny without changes being made. 4.1.7. Create a new Test Sequence To create a new Test Sequence, enter the Menu button (F4) from the home screen, select Setup followed by Test Sequences from the menu.
  • Page 28 Next step is to save the name of the newly create Test Name, by pressing the OK button (F4). Pressing the key (F3) would return to the Test Sequence menu without changes. 24 | Page Rigel Medical SP-SIM user Manual V2.2...

  • Page 29: Asset Trace Variables

    Asset trace variables may consist of a maximum of 25 characters and can be selected prior to each test when using the Rigel SP-SIM in automatic mode. 25 | Page...

  • Page 30: System Config

    The following variables can be added to the test results: The default settings on the Rigel SP-SIM 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 31 On Pass – Comment field is displayed after a passed test only.  On Failure – Comment field is displayed after failed test only  Never – Comment field is not displayed. 27 | Page Rigel Medical SP-SIM user Manual V2.2...
  • Page 32 4.3.4. Language Provides the ability to change the default language in the Rigel SP-SIM. A number of languages are available and will be updated which ach firmware revision. Use the up, down, left and right keys to select from the available languages. Additional languages (firmware upgrades) can be downloaded from www.rigelmedical.com or contact your...

  • Page 33: Blue Tooth Favourites

    4.4. Blue Tooth Favourites In order for the Rigel SP-SIM 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 34 Press (F1). The Rigel SP-SIM 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. A progress bar will show during the search.
  • Page 35 A PIN number can be entered if required for the device to be added to the Favourites list. Note: Seaward and Rigel accessories do not require a PIN. For other Bluetooth devices refer to the manufacturer’s documentation. Note: Devices that are not required can easily be removed by selecting the...
  • Page 36 Press (F4) to store the changes and return to the previous screen. “SELLT023” and “Elite 36-5011” are now a Bluetooth Favourite and the Rigel SP-SIM 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 or connect to “Elite 36-5011”...

  • Page 37: User Admin

    Provides means of configuring the default settings of the tester’s behaviour during normal use. All settings are user specific and stored against the logged-in user :  Set Contrast – Use the up, down, left and right keys to set the contrast 33 | Page Rigel Medical SP-SIM user Manual V2.2...
  • Page 38 Admin rights are required for this feature. Alternatively, new users can be created in the User Profile menu, see below. Note A brand new Rigel SP-SIM will automatically default to admin rights so new users can be created. 34 | Page...
  • Page 39 Select the applicable user name, use the Up & Down Keys to navigate through the menu, use the Left & Right Keys to activiate (yes) or de-activate (no) certain features. See menu below. Press the button (F4) to save user profile. 35 | Page Rigel Medical SP-SIM user Manual V2.2...

  • Page 40: Memory Options

    4.6. Memory options This feature is used to view information about the Rigel SP-SIM 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 41: Restore Factory Settings

    Hint; 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. 37 | Page Rigel Medical SP-SIM user Manual V2.2...

  • Page 42: Manual Mode

    Press SPO2 (F3) from the start screen; When SPO2 is selected, a number of options will be available; Navigate using the Up & Down Keys and change each setting by using the left key. 38 | Page Rigel Medical SP-SIM user Manual V2.2...
  • Page 43 New firmware can be uploaded by the end-user and does not void the calibration of the device. Please go to: http://www.rigelmedical.com/downloads.asp SPO2; Enter the required simulation value in % Heart Rate; Enter the required simulated heart rate; 39 | Page Rigel Medical SP-SIM user Manual V2.2...
  • Page 44 0 – 20% in steps of 0.1% where 5% is average perfusion. Once the selections are complete, select the (F4), to confirm the settings; Press the Green Start key to start the simulation. 40 | Page Rigel Medical SP-SIM user Manual V2.2...
  • Page 45 When the simulation is present (ie the internal SP-SIM valve is closed), a “pulse” symbol will be shown; Whilst the simulation is being performed, the SP-SIM can change settings. Use the arrow keys to scroll to the setting and use the “+” and “-“ keys to change the values.

  • Page 46: Automatic Mode

    Multiple entries can be applied using the same Asset ID number. In this case, the memory will hold all entries and differentiate using the test date. Test Sequence The Rigel SP-SIM comes standard with preset test routines to meet the requirements  Default Adult Sequence ...

  • Page 47: Performing An Automatic Test

    The following procedures describe the setup and completion of an automatic test sequence. The steps are applicable to all available test sequences. As example we describe a default test sequence. 43 | Page Rigel Medical SP-SIM user Manual V2.2...
  • Page 48 Sequence menu. (See 4.1 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. 44 | Page Rigel Medical SP-SIM user Manual V2.2...
  • Page 49 In the following example, a simulation is done in semi automatic mode where the user can enter the results in between each test; An initial simulation is done at 98% foloowed by a chronometer test and capturing of alarm (using a custom test, text input) 45 | Page Rigel Medical SP-SIM user Manual V2.2...
  • Page 50 The results screen is then displayed to confirm the reading as shown below; Following this test in this example, the SP-SIM is setup to perform an an alarm check as shown below; 46 | Page...
  • Page 51 Print Label – Automatically prints the test results to a thermal printer. No further options or viewing of results available. The tester will return to the home screen.  Test ‘n Tag – Automatically prints a Test ‘n Tag label. (see 4.2) 47 | Page Rigel Medical SP-SIM user Manual V2.2...

  • Page 52: Test 'N Tag

    Options Menu – Provides a menu to allow further choices after a test. (see 4.3) 6.2. Test ‘n Tag The Rigel SP-SIM 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.

  • Page 53: View Results

    Press the View result Button to review the data. Use the Up and Down keys to scroll through the screen. Use the button (F2) to return to the Test Details screen. button (F4) provides extra option to print results, label or Test ‘n tag 49 | Page Rigel Medical SP-SIM user Manual V2.2...

  • Page 54: View 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. This will display the Test Details Screen 50 | Page Rigel Medical SP-SIM user Manual V2.2...
  • Page 55 Print Result will print the result on the thermal printer (50 mm roll) (see Appendix B)  Print Label will print a pass/fail label on the thermal printer (50 mm roll) (See Appendix B) 51 | Page Rigel Medical SP-SIM user Manual V2.2...

  • Page 56: View Results

    (F4) to display the view text results screen (see below). Use the button (F2) to return to main menu. Press the button (F4) to provide the options to print the results; 52 | Page Rigel Medical SP-SIM user Manual V2.2...

  • Page 57: 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. 53 | Page Rigel Medical SP-SIM user Manual V2.2...

  • Page 58: View Data Options

    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). 54 | Page Rigel Medical SP-SIM user Manual V2.2...

  • Page 59: Data Transfer

    This feature is used to download records to a PC. Select Download to PC and press the button (F4) to accept. The Rigel SP-SIM will now attempt to make a Bluetooth connection with the Computer that has been configured in the Bluetooth Favourites.

  • Page 60: Upload From Pc

    Toggle between the options by using the left and right arrow keys. The Rigel SP-SIM 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 61: Configuration Data

    Bluetooth connection to the PC as previously described in Download to PC. The Rigel SP-SIM is now ready to receive upload data from a PC. Refer to the Instruction manual of MediGuard plus on how to transmit data from the PC.
  • Page 62 Enter a valid file name for the text file containing the download information; see below. Once the text file has been created, press the Send button (F4) to transfer the Asset Trace variables and User names from the Rigel SP-SIM to the PC. 58 | Page...
  • Page 63 Close down the Application and open the text file using word pad or equivalent. The downloaded information can be used to ‘clone’ other Rigel SP-SIM’s or modified to add additional trace variables. Again these can be uploaded to any Rigel SP-SIM for convenience.

  • Page 64: Clone Data

    This feature can be used to transfer or store the test sequences to/from a PC. It can be used to configure a number of Rigel SP-SIM units with identical sequences. Once the SP-SIM has connected to the PC, the Bluetooth icon will appear. Capture the data using the datatransfer.exe program or Windows hyperterminal.

  • Page 65: Load Tnt Logo

    (F3) button to go back to the start screen. 8.5. Load TnT Logo A bitmap logo can be transferred to the Rigel SP-SIM for use with the Seaward Test ‘n’ Tag print system. The logo must be in .BMP format with a maximum size of 320 pixels by 240 pixels.
  • Page 66 The Rigel SP-SIM is now ready to receive data. The amount of data received is shown numerically on the top left of the display (0 in the screen shot above). When using the Bluetooth Downloader application, select Send File from the File menu in the task bar.

  • Page 67: About

    9. About This screen provides details on the Rigel SP-SIM’s;  Firmware version  Hardware version  Calibration status  Last Calibration Date  Serial Number  Blue Tooth ID Select ABOUT from the menu below; Select using the F4 key and use the scoll keys (F3) to toggle between the different information screens;...

  • Page 68: Trouble Shooting

    SP-SIM power supply to correct this problem. 5. Stop the simulation on the SP-SIM, switching the Oximeter off then on, and then start the simulation again by pressing the green start key. Some Pulse Oximeters will not start up correctly if they are connected to the SP-SIM with the simulation running.

  • Page 69: Maintaining The Rigel Sp-Sim

    11. Maintaining the Rigel SP-SIM 11.1. Cleaning the SP-SIM The Rigel SP-SIM 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 70: Return Instructions

    When asking for a Returns Number, please quote:  Instruments name and model  Serial number (see section 8)  Firmware version (see section 8) 66 | Page Rigel Medical SP-SIM user Manual V2.2...

  • Page 71: Technical Specifications

    Battery life Approx. 11 hours testing Weight <1 kilo Dimensions 26 x 10 x 5.5 cm Operating conditions 10-30'C, 0-90% RH - NC Storage environment -15' - +60'C Environmental Protection IP 40 67 | Page Rigel Medical SP-SIM user Manual V2.2...

  • Page 72: Appendix A Firmware Route Map

    Load T’nT Logo Setup Test Sequences Test Codes Asset Trace Variables System Config Bluetooth Favourites User Admin > Preferences Chance User Change Password User Profile Memory Options Restore Factory Settings About 68 | Page Rigel Medical SP-SIM user Manual V2.2...

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