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Summary of Contents for Rigel Medical Rigel BP-SIM
- Page 1 Rigel BP-SIM Hand-Held Non-Invasive Blood Pressure Simulator Instruction Manual 370A550 Issue 1.0 October 2008 © 2008 Seaward Group Issue 1.0...
- Page 2 Rigel BP-SIM Operating Instructions Limited Warranty & Limitation of Liability Rigel Medical, part of the SEAWARD GROUP guarantees this product for a period of 1 year. The period of warranty will be effective at the day of delivery. © Copyright 2008 All rights reserved.
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Page 3: Table Of Contents
Rigel BP-SIM Operating Instructions Index INTRODUCTION..................7 1.1. Rigel BP-SIM Design Philosophy ................7 1.2. Key Features ......................8 1.3. Interfaces ........................9 1.4. Rigel BP-SIM includes:..................... 10 1.5. Optional Accessories ....................10 1.6. Test ’n Tag Compatible .................... 10 1.7. - Page 4 Configuration Data....................- 59 - 7.3.1. Receive Config Data................- 61 - 7.4. Load TnT Logo .....................- 62 - ABOUT....................- 64 - MAINTAINING THE RIGEL BP-SIM............- 66 - 9.1. Cleaning the BP-SIM ....................- 66 - 9.2. User Maintenance ....................- 66 - 9.3.
- Page 5 This Conformity is indicated by the symbol , i.e. “Conformité Européenne” WEEE Directive The Rigel BP-SIM has been designed and manufactured with high quality materials and components, which can be recycled and reused. Please inform yourself about the local collection system for electrical and electronic products or contact your local supplier for further information.
- Page 6 Rigel BP-SIM Operating Instructions 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 BP- SIM. Warning of electrical danger! Indicates instructions must be followed to avoid danger to persons.
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Page 7: Introduction
Operating Instructions 1. Introduction The Rigel BP-SIM is a new hand held non invasive blood pressure simulator for the fast and accurate testing of all types of NIBP monitors. The new lightweight and battery- powered Rigel BP-SIM utilises patented technology to simulate a wide range of blood pressures to verify the accuracy and safe operation of all leading NIBP monitors currently used in healthcare and medical facilities. -
Page 8: Key Features
Rigel BP-SIM Operating Instructions 1.2. Key Features • Portable and Lightweight - Ideal for field service technicians and in-situ testing of NIBP performance • Battery Operated - For convenient and fast testing without mains power • Manufacturer O-curves - To ensure accurate simulations across a wide range of •... -
Page 9: Interfaces
Rigel BP-SIM Operating Instructions 1.3. Interfaces 1) Full graphic Monochrone LCD, blue with white backlit, 1/4 VGA 2) Larger Red key Stop/Off Key 3) Larger Green Start/On key 4) 4 Programmable soft keys below display 5) Alpha Numeric keyboard, Up / Down and Left / Right cursor control. -
Page 10: Rigel Bp-Sim Includes
1.6. Test ’n Tag Compatible The Rigel BP-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 11: Unique Use Of Icons
1.7. Unique use of ICONS The Rigel BP-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 12: Logging On
Operating Instructions 2. Logging on When switching on the Rigel BP-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 BP- SIM. -
Page 13: Setting-Up Your Tester
Operating Instructions 3. Setting-up your tester The Rigel BP-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 14: User Definable Tests
SPO2, ECG, NIBP, Defib, Infusion, Ventilation, Pressure etc. The input is text only as no measurements are performed by the Rigel BP-SIM during these tests. The user can enter questions or instructions followed by either a PASS/FAIL result or alpha numeric input. -
Page 15: Modifying (Edit) Existing Test Sequences
Rigel BP-SIM Operating Instructions 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. - Page 16 Rigel BP-SIM Operating Instructions Pessing the button (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.
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Page 17: Edit Individual Test
Rigel BP-SIM Operating Instructions Confirm the changes with the button (F3) or cancel using the button (F4). 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... -
Page 18: Insert An Individual Test
Rigel BP-SIM Operating Instructions Highlight the required field using the up and down keys. To change the content 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... - Page 19 Rigel BP-SIM Operating Instructions Once the Insert button (F1) has been pressed, a drop down box will appear with all available tests. Activate the drop down box using the left key and or scroll through the available tests using the up and down keys.
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Page 20: Insert Custom Tests Or Instructions
Rigel BP-SIM Operating Instructions 3.1.5. 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 NIBP performance tests. Such information could indicate the condition such as Labels, software version, certain damage or upgrades. - Page 21 Further tests can be inserted or deleted by following the steps described herein. 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 BP-SIM will return to the previous meny without changes being made.
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Page 22: Create A New Test Sequence
Rigel BP-SIM Operating Instructions 3.1.6. 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. The following screen displays the list of default and customised tests available. Copied Test Sequences will appear in the list with an *pre-fix. - Page 23 Rigel BP-SIM Operating Instructions Use the keyboard to activate the text box. When activated, function keys F1 and F2 appear automatically. In this instance ‘Customer test 1’ has been created as Test Name. To change to upper or lower case or use language specific charaters, press the button (F1) and select the required entry.
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Page 24: Asset Trace Variables
Rigel BP-SIM in automatic mode. The following variables can be added to the test results: The default settings on the Rigel BP-SIM include the Site and Location variables. Both are activated. The drop down box is set to [Yes]. -
Page 25: System Config
Additional entries will overwrite on a first in first out basis. 3.3. System Config This feature can setup the Rigel BP-SIM to automatically perform certain features during or after a test as well as allowing the user to set Time and Date preference. To select System Config, press the button (F4) followed by Setup in the menu and System Config from the list as shown below;... -
Page 26: After Test
Never – Comment field is not displayed. 3.3.4. Language Provides the ability to change the default language in the Rigel BP-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 27: Blue Tooth Favourites
3.4. Blue Tooth Favourites In order for the Rigel BP-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 28 Make sure that the device you want to add to your new favourites is switched on. Press (F1). The Rigel BP-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.
- Page 29 Rigel BP-SIM Operating Instructions Note: If more than 10 Bluetooth devices have been found the list will show the last 10 devices found. In the following example, the search has identified Bluetooth devices named “SELLT023”, “SELPC045” and “Elite 36-5011” Note: If the required device is not shown, check that it is powered on with the Bluetooth function active then repeat the search.
- Page 30 Rigel BP-SIM Operating Instructions 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.
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Page 31: User Admin
Rigel BP-SIM Operating Instructions “SELLT023” and “Elite 36-5011” are now a Bluetooth Favourite and the Rigel BP-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 32: Preferences
Rigel BP-SIM Operating Instructions Navigate through this menu using the Up & Down Keys and select by pressing the button (F4) or the right arrow key. 3.5.1. Preferences Provides means of configuring the default settings of the tester’s behaviour during normal use. -
Page 33: Change User
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 BP-SIM will automatically default to admin rights so new users can be created. 3.5.3. Change Password This feature allows a new password to be assigned or changes to an existing password. -
Page 34: User Profile
(F4) to save user profile. 3.6. Memory options This feature is used to view information about the Rigel BP-SIM memory status. Press (F4), select setup using the up/down keys and select Memory Options by pressing the press (F4) to accept. - Page 35 Rigel BP-SIM Operating Instructions 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. The nature of Flash memory is such that when records are deleted only the reference to the data is removed.
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Page 36: Restore Factory Settings
Rigel BP-SIM Operating Instructions 3.7. 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. All the settings provided within the Setup menu will default to Factory Settings including;... -
Page 37: 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 BP-SIM comes standard with preset test routines to meet the requirements • Default Adult Sequence •... -
Page 38: Performing An Automatic Test
Rigel BP-SIM Operating Instructions Run Mode • Semi-Automatic allows the user the enter data after each individual test that forms a test sequence. • Full Automatic will run through the test sequence and provides an opportunity to enter data at the end of the complete sequence. - Page 39 Rigel BP-SIM Operating Instructions Press the button (F4) from the home screen and select Auto Mode. This will show the Asset Details screen as detailed below; Select the right criteria for the Test from the Asset Details screen; 1. Enter the Asset ID number using the keypad or barcode scanner.
- Page 40 Rigel BP-SIM Operating Instructions 6. Use the Up & Down Keys to navigate the menu and the Left & Right Keys to open the drop down boxes [<>]. Select the required input and confirm with the button (F4). Each variable entered during the automatic test will automatically be added to the list for future use.
- Page 41 Rigel BP-SIM Operating Instructions Following the Leak test, the overpressure valve is tested; Following the Overpressure valve test, the BP-SIM is ready to make NIBP simulations as per the test routine; Pressing the (STOP) button (F3) during any test will bring up the failure menu (see 4.1.1)
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Page 42: Test 'N Tag
Options Menu – Provides a menu to allow further choices after a test. (see 4.3) 4.2. Test ‘n Tag The Rigel BP-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. See 3.4 A detailed application note is available from the Rigel website on the used of Test’... -
Page 43: Options Menu
Rigel BP-SIM Operating Instructions 4.3. Options Menu When Options has been selected in the Setup - System Config menu, the Rigel BP-SIM will show a Test Details screen, see below. The test screen provides the following features; • Go to the home screen (F1) •... -
Page 44: View Results
Rigel BP-SIM Operating Instructions 4.4. 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... -
Page 45: Manual Mode
Rigel BP-SIM Operating Instructions 5. Manual Mode The Manual mode provides the user with the features of testing a specific individual test and or test condition for example to test a selection of: • NIBP tests • Leak tests • Static pressure calibration •... -
Page 46: Nibp Test Settings
Rigel BP-SIM Operating Instructions 5.1. NIBP Test Settings Use the NIBP Test Settings to setup a selection of Dynamic Pressure simulations. Navigate using the Up & Down Keys and change each setting by using the left key. Manufacturer; Select between a default O-curve or one specific to a manufacturer, for example;... - Page 47 Rigel BP-SIM Operating Instructions Heart Rate; Enter the required simulated heart rate Pulse Volume: Select the required pulse strength to simulate different volume strength. Note that the settings Low / Medium / High are not directly linked to any physiological condition...
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Page 48: Nibp Leak Test
Rigel BP-SIM Operating Instructions Press the Green Start key to start the simulation and close the internal valve within the BP-SIM. Note when the valve is not closed, the pressure within the cuff will not be contained and the monitor might go into alarm. -
Page 49: Nibp Pop-Off Test
Rigel BP-SIM Operating Instructions The BP-SIM will inflate the system to around the set-point. Once the system is stabilised at the set pressure, the timer will count up for the set duration. This is highlighted below: At the end of the test, the BP-SIM will show;... -
Page 50: Nibp Manometer Mode
Rigel BP-SIM Operating Instructions Select the test from the NIBP menu; To initiate the test, press START (F4). The BP-SIM will inflate the system until the protection valve is activated; At the end of the test, the BP-SIM will show the set-point of the protection valve... -
Page 51: Set Zero
Rigel BP-SIM Operating Instructions Ensure the manometer is set to zero by pressing the SET ZERO (F3) button) whilst the pressure connection at the BP-SIM panel is open. Select the engineering unit from the drop-down box using the left and right keys: The manometer will automatically convert the pressure to the desired pressure unit. -
Page 52: View Data
Rigel BP-SIM Operating Instructions 6. View Data To view the stored data, press the button (F4) and select View Data from the menu; The following screen provides an overview of all available records in the memory, identified by Asset ID, Site and Pass or Fail. - Page 53 Rigel BP-SIM Operating Instructions Use the button (F2) to return to the main View Data screen. Use the button (F3) to view the Trace Variables; Use the button (F2) to return to the main View Data screen. In the Test Details screen, press the button (F4) to view the following options: −...
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Page 54: View Results
Rigel BP-SIM Operating Instructions − 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) 6.1. -
Page 55: Search The Database
Rigel BP-SIM Operating Instructions 6.2. Search the database From the main View Data screen, press the button (F1). Use the up, down, left and right keys to navigate this screen. The default setting is ‘*’ which includes all records that Passed. -
Page 56: View Data Options
Rigel BP-SIM Operating Instructions Note 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 October 2008 use 31102008. -
Page 57: 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 BP-SIM will now attempt to make a Bluetooth connection with the Computer that has been configured in the Bluetooth Favourites. -
Page 58: Upload From Pc
Toggle between the options by using the left and right arrow keys. The Rigel BP-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 59: Configuration Data
Bluetooth connection to the PC as previously described in Download to PC. The Rigel BP-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 60 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 BP-SIM to the PC.
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Page 61: 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 BP-SIM’s or modified to add additional trace variables. Again these can be uploaded to any Rigel BP-SIM for convenience. -
Page 62: Load Tnt Logo
7.4. Load TnT Logo A bitmap logo can be transferred to the Rigel BP-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 63 When a connection has been established the display will be as shown below. The Rigel BP-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).
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Page 64: About
Rigel BP-SIM Operating Instructions 8. About This screen provides details on the Rigel BP-SIM’s; • Firmware version • Hardware version • Calibration status • Last Calibration Date • Serial Number • Blue Tooth ID Select ABOUT from the menu below;... - Page 65 Rigel BP-SIM Operating Instructions 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.
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Page 66: Maintaining The Rigel Bp-Sim
9. Maintaining the Rigel BP-SIM 9.1. Cleaning the BP-SIM The Rigel BP-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 67: Return Instructions
Rigel BP-SIM Operating Instructions 9.3. Return Instructions. For repair or calibration return the instrument to:- Rigel Medical Service Dept., p.a. Seaward Electronic Limited. Bracken Hill South West Industrial Estate Peterlee, Co. Durham SR8 2SW, England Tel : +44 (0)191 5878739 Fax: +44 (0)191 586 0227 sales@rigelmedical.com... -
Page 68: Technical Specifications
Rigel BP-SIM Operating Instructions Technical Specifications Simulation Waveform Oscillometric Envelopes (O-curves) Tbc, updates available through www.rigelmedical.com Simulation via T connection into Cuff and monitor Pulse Volume High, Medium, Low, paediatric Heart rate 1 - 300 bpm Integrated Pump 0 to 350 mmHg user configurable... - Page 69 Rigel BP-SIM Operating Instructions Appendix A Firmware Route Map Manual Mode NIBP Test Settings NIBP Leak Test NIBP Pop-off Test NIBP Manometer Mode Set Zero Auto Mode View Data Data Transfer Download to PC Upload fro PC Configuration Data Load T’nT Logo...
- Page 70 Show test and retest due date, barcode and asset ID number and person who conducted the test. test. Before Bluetooth accessories can be used with the Rigel BP-SIM, each device needs to be efore luetooth accessories can be used with the Rigel BP-SIM, each device needs to be paired witht he BP-SIM.
- Page 71 Rigel BP-SIM Operating Instructions Selecting the right label printer; The two available label printers are: o Seaward Test ‘n Tag (SW T’n’T (Y08-0837) o Test ‘n Tag Elite (XXRD07-33-5049). To select the required printer when printing labels, press the “Settings”...
- Page 72 Rigel BP-SIM Operating Instructions Seaw ar d Test ‘ n Tag Syst em Seaward Test ‘n’ Tag System The Seaw ar d Test ‘ n Tag sys t em has t he f oll owi ng f eat ur es: The Seaward Test ‘n’...
- Page 73 2” x 2.5” (50 x 60 mm) (kiss-cut at 2” x 1.25”) PASS Layout Pass labels will print a next test date which is generate from the Rigel BP-SIM’s automatic test. See paragraph 4 of the Rigel BP-SIM instruction manual.
- Page 74 Rigel BP-SIM Operating Instructions Printing Test Results The Rigel BP-SIM is setup to print the test results on thermal paper (50mm) and supports the following printers: o Citizen Systems (thermal paper) o Seaward Test ‘n Tag Elite (thermal paper) Test result print functions are available directly after a test when the “options menu” is selected in the “System Configuration”.
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