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Shipping to an authorised service centre is the responsibility of the sender. *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.
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UNI-SiM USER MANUAL Disposal of old product The Rigel Uni-SIM Vital Signs 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.
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These operating instructions are intended for the use of adequately trained personnel. The UNI-SiM has been designed to be operated for indoor use in a dry environment, at a temperature of 0 to 40 degrees C without moisture condensation, and at an operating altitude 0 2000m.
1.2. Key Features 1.3. Interfaces 1.4. Included accessories 1.5. Additional & Optional Accessories 2. Using the PULS-R optical finger with the UNI-SIM 2.1. Repeatability of simulation when used with the corresponding R-curves 2.2. Getting started 2.3. Performing SP02 simulations 2.4. Unique use of ICONS 3.
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RIGEL MEDICAL UNI-SiM USER MANUAL 8.1.3. Insert SPO2 test settings 8.1.4. Insert Patient Simulator settings 8.1.5. Start Simulations 8.1.6. NIBP Leak Test 8.1.7. NIBP Pop-off test 8.1.8. NIBP Static Pressure test 8.1.9. NIBP Stop Static Pressure test 8.1.10. IBP Static Test 8.1.11.
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11.1. Download to PC 11.2. Upload from PC 11.3. Configuration Data 11.3.1. Receive Config Data 11.4. Load TnT Logo 12. About 13. Maintaining the Rigel UNI-SIM 13.1. Cleaning the UNI-SIM 13.2. User Maintenance 13.3. Return Instructions 14. Technical Specifications 14.1 General Specifications...
UNI-SiM USER MANUAL 1. Introduction The Rigel UNI-SiM is the only simulator of its type which enables medical device engineers to quickly, easily, and accurately undertake NIBP, SpO2, ECG, temperature, IBP and respiration functionality tests simultaneously using a single portable instrument.
Bluetooth communication, asset management facilities, user configurable Performance Tests and more. We believe that the new UNI-SIM is set to become the new standard in vital signs performance Testing. 1.2. Key Features •...
RIGEL MEDICAL UNI-SiM USER MANUAL 1.3. Interfaces Alpha Numeric keyboard, Up / Down and Left / Right cursor control. 4 Programmable soft keys below display Colour Green / Red for start /stop and On / Off Full graphic Monochrone LCD, blue with white backlit, 1/4 VGA...
RIGEL MEDICAL UNI-SiM USER MANUAL 1.5. Additional & Optional Accessories For a full range of UNI-SIM accessories and cables, please visit: https://www.rigelmedical.com/gb/products/patient-simulation/patient- simulators/370a930-uni-sim/ tible The Rigel UNI- Tag systems allows you to print customised Thermal PASS / FAIL labels. •...
RIGEL MEDICAL UNI-SiM USER MANUAL 2. Using the PULS-R optical finger with the UNI-SIM The PULS-R optical finger is for use only with Rigel SP-SIM and UNI-SIM products 2.1. Repeatability of simulation when used with the corresponding R-curves Resolution Range...
For both the Rigel UNI and SP- SIM the user will need to select. SPO2 Simulation. Image 1 of the UNI-SIM shows NIBP, SPO2, ECG, IBP, Respiration and Temperature and Image 2 shows the same for the SP-SIM. The connection between the PULS-R, the UNI/SP-SIM and the monitor is shown in the...
• Nellcor (PULS-R) Nellcor OxiMax (PULS-R) • • Nihon Kohden (PULS-R) • Nonin (PULS-R) • Novametrix (PULS-R) • Philips/HP (PULS-R) To customise your own R curves please see application note 0061 Creating and uploading R Curves for UNI-SIM and SP-Sim.
UNI-SiM USER MANUAL 2.4. Unique use of ICONS The Rigel UNI-SiM features a high 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.
To increase the security and protection of the user, a password can be set prior to using the Rigel UNI-SIM. See 0 for further details. The default password setting is OFF and the login screen will not require a password.
UNI-SiM USER MANUAL 4. Getting Started The Rigel UNI-SIM can be used as a manual simulator or an automatic simulator. Upon power-up, the user is presented with the summary simulation screen. This displays the previous simulation settings and can be repeated by simply pressing the green start key.
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RIGEL MEDICAL UNI-SiM USER MANUAL • SPO2 (F2) simulate SPO2 signals, response times, artefacts and check probe performance • PAT (F1) (full 12 lead patient simulator including ECG, Arrhythmia and performance waveforms, respiration signals, temperature simulation and invasive blood pressure simulation) To change any of the default settings on each simulation, please refer to the relevant manual mode sections in this manual, chapter Error! Reference source not found.,Error! Re...
RIGEL MEDICAL UNI-SiM USER MANUAL 5. Manual Mode NIBP 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 •...
RIGEL MEDICAL UNI-SiM USER MANUAL 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;...
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Select the required pulse strength to simulate different volume strength. Note: The settings Low / Medium / High are not directly linked to any physiological condition Note: High pulse volume settings can only be achieved when the UNI-SIM is connected to the mains through the correct power supply.
When the valve is not closed, the pressure within the cuff will not be contained and the monitor might go into alarm. When the simulation is present (i.e. the internal UNI-SIM will be shown; Using the Function keys (F1-F2), and up and down arrow keys, the highlighted field - function keys F1 and F2.
(F2) to return to start menu 5.3. Static Pressure test The UNI-SIM is able to perform a static pressure test similar to that used in the leak test. Enter a pressure value in the UNI-SIM screen below, which will inflate the system to the...
If the s open, the leak test will not be able to pressurise the system. Select the test from the NIBP menu; To initiate the test, press (F4). The UNI-SIM will inflate the system until the protection valve is activated;...
RIGEL MEDICAL UNI-SiM USER MANUAL At the end of the test, the UNI-SIM will show the set-point of the protection valve (ie 331 mmHg) Press (F4) to repeat the test Press (F2) to return to start menu 5.5. NIBP Manometer Mode The UNI-SIM has a built-in manometer function which allows the user to measure the pressure in a number of engineering units;...
RIGEL MEDICAL UNI-SiM USER MANUAL The manometer will automatically convert the pressure to the desired pressure unit. Press (F2) to return to start menu 5.6. Set Zero The Set Zero function is required to ensure the manometer is pressurised to the ambient...
RIGEL MEDICAL UNI-SiM USER MANUAL 6. Manual Mode SPO2 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: • SPO2 value • Heart rate •...
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RIGEL MEDICAL UNI-SiM USER MANUAL The list of available R-curve data is under constant development. Please monitor our website for new firmware releases. New firmware can be uploaded by the end-user and does not void the calibration of the device. Please go to: https://www.rigelmedical.com/gb/support/patient-simulation/370a930-uni-sim/software-...
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RIGEL MEDICAL UNI-SiM USER MANUAL Skin Colour; Select different levels of simulations of different skin colours. Perfusion: Select the required signal strength to simulate different patient conditions ie infant, obese, average. Enter a value between 0 20% in steps of 0.1% where 5% is average perfusion.
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Press the Green Start key to start the simulation or press the key to return to the main summary screen. Whilst the simulation is being performed, the UNI-SIM can change settings. Use the arrow Use the timer key to start the chronometer function which will record the time taken from one simulation setting to the next.
RIGEL MEDICAL UNI-SiM USER MANUAL 7. Manual Mode Patient Simulator 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: • ECG wave forms •...
RIGEL MEDICAL UNI-SiM USER MANUAL 7.1. Patient Test Settings Select the Patient test Settings, to set the parameters for: • Heart rate • • Invasive blood pressure settings • Temperature simulation settings • Respiration settings The different options above are available across three individual screens accessible using...
RIGEL MEDICAL UNI-SiM USER MANUAL 7.1.1. Changing the ECG or Arrhythmia simulation Referring to Patient Screen 1 (fig 1), manually enter the required heart rate. The preferred ECG waveform or Arrhythmia and amplitude can be selected by selecting the dropdown box (right arrow key) and use the up and down keys to select;...
RIGEL MEDICAL UNI-SiM USER MANUAL 7.1.2. Changing the Invasive blood pressure settings Referring to Patient Screen 2 (fig 2), manually enter the required heart rate, Systolic and Diastolic pressures and press ENTER to confirm; 7.1.3. Changing the Temperature settings The preferred Temperature simulation (YSI 400 and 700) can be selected by selecting the dropdown box (right arrow key) and use the up and down keys to select;...
RIGEL MEDICAL UNI-SiM USER MANUAL 7.1.4. Changing the Respiration settings Referring to Patient Screen 3 (fig 3), choose the respiration rate from the drop down box; Select by pressing the key (F4). Repeat the same for the Base Impedance and Delta Impedance;...
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RIGEL MEDICAL UNI-SiM USER MANUAL Select by pressing the key (F4) To simulate an Apnoea, enter the duration and interval (time between Apnoea)in seconds: Note: would result in a constant Apnoea if a value greater than Apnoea duration. Confirm by pressing the...
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RIGEL MEDICAL UNI-SiM USER MANUAL Whilst the simulation is being performed, the UNI-SIM can change settings. Use the arrow Press the Green Start key to start the simulation or press the key to return to the main summary screen.
UNI-SiM USER MANUAL 7.2. Static IBP Test The Rigel UNI-SIM can simulate a static pressure using the invasive output. Select the Static IBP Test from the PAT menu, see below: In the next screen, enter the required static pressure setting; The value entered is in mmHg and the UNI-SIM will simulate using an output of 5μV/V/mmHg.
UNI-SiM USER MANUAL 7.3. Performance Wave Test The Rigel UNI-SIM is able to simulate a number of performance waveforms to calibrate the input circuit of ECG recorders and monitors. Select the Performance Wave test from the PAT menu, see below:...
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UNI-SiM USER MANUAL Confirm by pressing the key (F4). The simulation is only running whilst in this screen. When exiting this screen, the UNI-SIM will revert back to the ECG simulation settings, see 0 Press the key (F2) to return to the previous screen...
UNI-SiM USER MANUAL 8. Setting-up your tester The Rigel UNI-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 All custom facilities can be found under the SETUP menu. Simply press the [F4] from the home screen and select Setup from the menu.
Arrhythmia, IBP, temperature and respiration settings. Start Simulations This must be inserted in order to start the simulation part of the UNI-SIM and defines the duration of the simulations. Without this instruction, none of the above settings will be simulated. If more then one setting for...
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RIGEL MEDICAL UNI-SiM USER MANUAL Table 1: Available tests for insertion in auto 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.
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RIGEL MEDICAL UNI-SiM USER MANUAL Use the keyboard to activate the text box. When activated, function keys F1 and F2 as Test Name. To change to upper or lower case or use language specific charaters, press the button (F1) and select the required entry.
RIGEL MEDICAL UNI-SiM USER MANUAL Once the Test Sequence has been opened, individual tests can be inserted by highlighting the place where a new test needs inserting using the up and down keys. To modify a test sequence, please refer to 0 To insert a test, press the key (F1).
RIGEL MEDICAL UNI-SiM USER MANUAL 8.1.3. Insert SPO2 test settings Use the SPO2 test settings to set the required parameters for SPO2 simulation; • SPO2 value Heart rate • • Manufacturer R-curves • Skin colour • Perfusion • • Artefacts (upgrade) •...
Confirm and insert by pressing the key (F4). 8.1.5. Start Simulations To start the simulations on the UNI-SIM, instruction must be inserted and defines the duration of the simulations. Without this instruction, none of the simulations will be simulated. If more then one setting for individual simulations is required ie 2 x NIBP, this instruction must be inserted after each simulation setting.
RIGEL MEDICAL UNI-SiM USER MANUAL Navigate using the Up & Down Keys and enter the required values. Refer to the instructions in 00 for further instructions on the options available. Confirm and insert by pressing the key (F4). 8.1.7. NIBP Pop-off test Perform a system overpressure release test recording the sudden pressure release.
RIGEL MEDICAL UNI-SiM USER MANUAL 8.1.9. NIBP Stop Static Pressure test This must be inserted in order to stop the static pressure tests and release the pressure from the system prior to starting the simulations. Without this instruction, none of the simulations will start.
The input is text only and no simulations or measurements are performed by the Rigel UNI-SIM during these tests. The maximum number of characters in the test description or instruction is 255.
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RIGEL MEDICAL UNI-SiM USER MANUAL Once the Insert button (F1) has been pressed, a drop down box will appear with all available tests and inspection available. Activate the drop down box using the left key and select the Custom Test option.
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 UNI-SIM will return to the previous meny without changes being made. 8.1.13. View, Delete or Copy an existing Test Routine.
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RIGEL MEDICAL UNI-SiM USER MANUAL The following overview is provided and shows the list of default and customised test sequences availble. Copied Test Sequences will appear in the list with an *pre-fix. From this menu, the user is able to View a test sequence by pressing the View button (F4).
RIGEL MEDICAL UNI-SiM USER MANUAL Use the Up & Down Arrow keys to select the required action and press the (F4) to confirm. Press Escape (F3) to cancel and return to previous screen. Copied Test Sequences will appear in the list with an *pre-fix. All Copied test Sequences can be edited.
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RIGEL MEDICAL UNI-SiM USER MANUAL To change the Name and or Class of the Test Sequence, press the Button (F4) and enter the Name and or Class required. To change to upper or lower case or use language specific characters, press the button (F1) and select the required entry.
RIGEL MEDICAL UNI-SiM USER MANUAL To modify an individual test, highlight the test using the Up & Down arrow keys and press Button (F4) 8.1.15. Edit individual Test Press the button (F4) as shown above. The Leak Test sub menu will allow you to alter the settings for;...
RIGEL MEDICAL UNI-SiM USER MANUAL When the right settings have been achieved, press the button (F4) to save the changes or press (F3) to return to the previous menu without changes. Repeat this action for every test that requires editing. Once all the requires tests are programmed, press (F3) to exit.
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RIGEL MEDICAL UNI-SiM USER MANUAL Once the desired test has been highlighted, confirm using the OK button (F4) and finally confirm to insert into the test Sequence. Pressing the button (F3) will return to the previous screen without changes being made.
Rigel UNI-SIM in automatic mode. The following variables can be added to the test results: The default settings on the Rigel UNI-SIM include the Site and Location variables. Both are activated. The drop down box is set to [Yes].
UNI-SiM USER MANUAL 8.3. System Config This feature can setup the Rigel UNI-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;...
Never Comment field is not displayed. 8.3.4. Language Provides the ability to change the default language in the Rigel UNI-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...
Changes are saved automatically. 8.4. Bluetooth Favourites For the Rigel UNI-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.
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Make sure that the device you want to add to your new favourites is switched on. Press (F1). The Rigel UNI-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.
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RIGEL MEDICAL UNI-SiM USER MANUAL open the list of devices which have been found during the search. Note: If more than 10 Bluetooth devices have been found the list will show the last 10 devices found. Note: If the required device is not shown, check that it is powered on with the Bluetooth function active then repeat the search.
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All Bluetooth devices have a unique ID. The Bluetooth ID is shown when a device is added to the Favourites list. Repeat the actions above to select a printer for the UNI-SIM; Ensure when selecting the printer, that the Printer type is selected corresponding with the...
RIGEL MEDICAL UNI-SiM USER MANUAL UNI-SIM will automati communicate with a computer e.g. downloading records to a PC database software -out. Note: Press (F2) to exit without saving changes. Press (F3) if necessary, to select another device.. Press (F4) button to save changes.
RIGEL MEDICAL UNI-SiM USER MANUAL Navigate through this menu using the Up & Down Keys and select by pressing the button (F4) or the right arrow key. 8.5.1. Preferences use. All settings are user specific and stored against the logged-in user : •...
This feature allows an operator to default to a different existing user or setup a new 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 UNI-SIM will automatically default to admin rights so new users can be created.
RIGEL MEDICAL UNI-SiM USER MANUAL 8.5.3. Change Password This feature allows a new password to be assigned or changes to an existing password. To create a new password, highlight the New Password field using the Up & Down Keys and enter a new password followed by confirmation of the new password. Use the key (F4) to finish and press the button (F4) to confirm and save the new password.
Press the button (F4) to save user profile. 8.6. Memory options This feature is used to view information about the Rigel UNI-SIM memory status. Press (F4), select setup using the up/down keys and select Memory Options by pressing the press (F4) to accept.
RIGEL MEDICAL UNI-SiM USER MANUAL 8.7. 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;...
RIGEL MEDICAL UNI-SiM USER MANUAL 9. Automatic Mode The Automatic mode provides the user with the ability to run a preset test sequence and store the data afterwards. Press (F4), select Auto Mode using the up/down keys, Select by pressing the press (F4) to accept.
RIGEL MEDICAL UNI-SiM USER MANUAL Asset Trace Variables To increase the traceability of the safety test, the user can include valuable data with the test record such as Re-test period and Asset variables (see 0 for more information). Trace variables can be added once the above data has been entered and confirmed 9.1.
RIGEL MEDICAL UNI-SiM USER MANUAL 9.1.1. Failure Menu When a specific test fails, the user will be provided with a number of options depending on the nature of the fault. The Failure Menu will enable the user to: • Restart Test (Individual test) •...
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RIGEL MEDICAL UNI-SiM USER MANUAL Returning to the Asset Details screen, the button (F2) provides the user with the option to modify or create a new Test Sequence from this menu. This feature is identical to that of the Test Sequence feature in the Setup - Test Sequence menu.
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The first test of the Default test setting is the the NIBP Leak Test Following the Leak test, the overpressure valve is tested; Following the Overpressure valve test, the UNI-SIM is ready to make all simulations as per the test routine;...
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RIGEL MEDICAL UNI-SiM USER MANUAL Pressing the (STOP) button (F3) during any test will bring up the failure menu (see At the end of the test, the user has the ability to enter comments. See 0 for more information on how to activiate comments after a test.
Rigel UNI-SIM. Please visit; http://www.rigelmedical.com/support 9.3. Options Menu When Options has been selected in the Setup - System Config menu, the Rigel UNI-SIM will show a Test Details screen, see below. The test screen provides the following features; •...
RIGEL MEDICAL UNI-SiM USER MANUAL • View Results will display the results of the test (see section 0) • User Comment will allow the user to enter comments if required • Print Label will print a pass/fail label on the thermal printer (50 mm roll) •...
RIGEL MEDICAL UNI-SiM USER MANUAL 10. 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.
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RIGEL MEDICAL UNI-SiM USER MANUAL 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: •...
RIGEL MEDICAL UNI-SiM USER MANUAL 10.1 View Results From the Test Details screen, select button (F4). 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 MEDICAL UNI-SiM USER MANUAL 10.2. 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. includes all records that Passed.
RIGEL MEDICAL UNI-SiM USER MANUAL To search for more specific criteria, fill in the required fields by either using the keyboard or drop down boxes. Note: The entered data must be identical to the data stored with the test. This includes visible and invisible SPACE characters.
This feature is used to download records to a PC. Select Download to PC and press the button (F4) to accept. The Rigel UNI-SIM will now attempt to make a Bluetooth connection with the Computer that has been configured in the Bluetooth Favourites.
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Toggle between the options by using the left and right arrow keys. The Rigel UNI-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).
Bluetooth connection to the PC as previously described in Download to PC. The Rigel UNI-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.
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RIGEL MEDICAL UNI-SiM USER MANUAL Press the SEND (F4) button to send data to the PC. The UNI-SIM will automatically receive data when the ready message is shown as above. Press the (F3) button to go back to the start screen.
Comments configuration data. Select the require file and click on Open. The Bluetooth Downloader will now transfer the configuration file to the Rigel UNI-SIM. When the transfer is complete the Rigel UNI-SIM screen will display a message as shown below.
(F4), select Data Transfer using the up/down keys, s and press the button (F4); The Rigel UNI-SIM will now attempt to connect to the PC, setup in Bluetooth Favourites. When a connection has been established the display will be as shown below.
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RIGEL MEDICAL UNI-SiM USER MANUAL The Rigel UNI-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.
Use the scroll keys (F3) to toggle between the different information screens; See next page. 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.
13. Maintaining the Rigel UNI-SIM 13.1. Cleaning the UNI-SIM The Rigel UNI-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.
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RIGEL MEDICAL UNI-SiM USER MANUAL Prior to returning your unit for service, please contact our service department to obtain a Returns Number. By obtaining a Returns Number, your service request can be booked in advance thus reducing the down time of your equipment.
RIGEL MEDICAL UNI-SiM USER MANUAL R Wave Detection Heart Rate 70 bpm R wave width 10 120 ms (steps of 10ms) Temperature Simulation Simulation YSI 400 / 700 Static Range Preset at 25, 33, 37and 41°C Accuracy ±0.1 °C Default setting YSI 400 37°C...
RIGEL MEDICAL UNI-SiM USER MANUAL Appendix A Firmware Route Map NIBP Manual NIBP Test Settings Mode NIBP Leak Test NIBP Static Pressure Test NIBP Pop-off Test NIBP Manometer Mode Set Zero SPO2 SPO2 simulation settings Patient Test Settings Static IBP Test...
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