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Calibration Statement The Rigel UNI-SiM Lite Patient 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.
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Disposal of old product The Rigel UNI-SiM Lite Patient 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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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 UNI-SIM LITE user Manual V1.1...
Index User Notes ......................... 4 Introduction ....................... 5 Key Features ......................6 Getting to know your Rigel UNI-SIM Lite ............. 7 Additional & Optional Accessories ................ 7 Icons used in the UNI-SIM Lite ................8 Getting started ....................9 Quick NIBP simulation ..................9 Quick SPO2 verification ..................
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Upload from PC ....................86 10.3 Configuration Data ..................... 86 10.4 Load TnT Logo..................... 90 11 About ....................... 92 12 Maintaining the Rigel UNI-SIM Lite ..............94 12.1 Cleaning the UNI-SIM Lite ................... 94 12.2 User Maintenance ....................94 12.3 Need help or want to return the product for service? ..........
The UNI-SIM LITE 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.
PM’s on vital signs monitors wherever the job takes you. Fast boot-up and single button simulation repeats the last simulation values in seconds, making the UNI-SIM LITE both quick and easy to use when carrying out basic spot checks.
NIBP simulator. Universal SPO2 simulation Reduce the need for separate accessories with the universal PULS-R SPO2 simulation finger which is compatible with all of the common SPO2 technologies. 6 | Page Rigel Medical UNI-SIM LITE user Manual V1.1...
2 Getting to know your Rigel UNI-SIM Lite Additional & Optional Accessories For a full range of UNI-SIM LITE accessories and cables, please visit: http://www.rigelmedical.com/downloads/Rigel-SIM-Range-Accessory-Datasheet-Rev1- 1.pdf 7 | Page Rigel Medical UNI-SIM LITE user Manual V1.1...
Icons used in the UNI-SIM Lite The Rigel UNI-SIM LITE features a graphics 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.
3 Getting started Turn on your Rigel UNI-SiM Lite by pressing and holding the green start button until you hear a “beep” and the Rigel splash screen appears. A 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.
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Press the NIBP button (F3) to enter the possible settings and functions that can be altered; Use “custom O curve” to enter the required Systolic and Diastolic simulation values For more information on the use of these additional functions, please go to 4. 10 | Page Rigel Medical UNI-SIM LITE user Manual V1.0...
3.2 Quick SPO2 verification Connect the PULS-R to the SPO2 output connector on the UNI-SIM Lite, and place the SPO2 probe as shown below: The correct orientation for probe place is with the LED of the probe on the top side of the PULS-R.
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Parameters can be varied to validate the monitor and probe including: Technology. E.g.: PULS-R, Masimo, Nellcor.. SPO2 (%) simulated Heart Rate For more information on the use of these additional functions, please go to 0. 12 | Page Rigel Medical UNI-SIM LITE user Manual V1.0...
Connect the ECG cables to the ECG breakout box and connect the ECG breakout box to the To change the current ECG, Respiration, Temperature or IBP simulation, simply select the SPO2 function from the home screen; 13 | Page Rigel Medical UNI-SIM LITE user Manual V1.0...
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Press the PAT button (F3) to enter the possible settings and functions that can be altered; To change any of the default settings on each simulation, please refer to the relevant manual mode sections in this manual, chapter 4,4.7 and6. 14 | Page Rigel Medical UNI-SIM LITE user Manual V1.0...
When NIBP is selected, a number of options will be available; NIBP Test Settings (see 4.1) NIBP Leak Test (See 4.2) NIBP Pop-off Test (see 4.4) NIBP Manometer Mode (see 4.5) Set Zero (see 4.6) 15 | Page Rigel Medical UNI-SIM LITE user Manual V1.0...
Toggle between Adult or Infant settings. Default settings such as heart rate and pulse volume will be adjusted automatically. Systolic / Diastolic; Select a pre-set range of NIBP setting from the drop down list 16 | Page Rigel Medical UNI-SIM LITE user Manual V1.0...
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Note that the settings Low / Medium / High are not directly linked to any physiological condition Note that High pulse volume settings can only be achieved when the UNI-SIM LITE is connected to the mains through the correct power supply. 17 | Page Rigel Medical UNI-SIM LITE user Manual V1.0...
Note 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 LITE valve is closed), a “pulse” symbol will be shown;...
(F2) to return to start menu Static Pressure test The UNI-SIM LITE is able to perform a static pressure test similar to that used in the leak test. Enter a pressure value in the UNI-SIM LITE screen below, which will inflate the system to the set pressure.
If the monitor’s internal valve is 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 LITE will inflate the system until the protection valve is activated; 20 | Page Rigel Medical UNI-SIM LITE user Manual V1.0...
At the end of the test, the UNI-SIM LITE 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 NIBP Manometer Mode The UNI-SIM LITE has a built-in manometer function which allows the user to measure the pressure in a number of engineering units;...
Custom O Curve Users can enter their required Systolic and Diastolic pressures by selecting the Custom O Curve option. Use up and down keys to select Custom O Curve; 22 | Page Rigel Medical UNI-SIM LITE user Manual V1.0...
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The heart rate setting will default to the last set heart rate. When the test is running, the cuff pressure is also being displayed. To stop the simulation, press the key (F3). 23 | Page Rigel Medical UNI-SIM LITE user Manual V1.0...
Press SPO2 (F2) 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. 24 | Page Rigel Medical UNI-SIM LITE user Manual V1.0...
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New firmware can be uploaded by the end-user and does void calibration device. Please http://www.rigelmedical.com/downloads.asp SPO2; Enter the required simulation value in % Heart Rate; Enter the required simulated heart rate; 25 | Page Rigel Medical UNI-SIM LITE user Manual V1.0...
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Enter a value between 0 – 20% in steps of 0.1% where 5% is average perfusion. Once the selections are complete, select the (F4), to confirm the settings; 26 | Page Rigel Medical UNI-SIM LITE user Manual V1.0...
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When the simulation is in progress, a “pulse” symbol will be shown; Whilst the simulation is being performed, the UNI-SIM LITE can change settings. Use the arrow keys to scroll to the setting and use the “+” and “-“ keys to change the values.
Press PAT (F1) from the start summary screen; When PAT is selected, a number of options will be available; Patient Test Settings (see 6.1) Static IBP Test (See 6.2) Performance Wave Test (see 6.3) 28 | Page Rigel Medical UNI-SIM LITE user Manual V1.0...
The different options above are available across three individual screens accessible using the tab button (F2) Figure 1 Patient Screen 1 Figure 2 Patient Screen 2 Figure 3 Patient Screen 3 29 | Page Rigel Medical UNI-SIM LITE user Manual V1.0...
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Repeat the same actions to change the signal amplitude; Select by pressing the key (F4) and confirm again using the key (F4) or press the Key (F2) to make further changes. 30 | Page Rigel Medical UNI-SIM LITE user Manual V1.0...
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(right arrow key) and use the up and down keys to select; Select by pressing the key (F4) and confirm again using the key (F4) or press the Key (F2) to make further changes. 31 | Page Rigel Medical UNI-SIM LITE user Manual V1.0...
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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; Select by pressing the key (F4) Select by pressing the key (F4) 32 | Page Rigel Medical UNI-SIM LITE user Manual V1.0...
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The updated information is now available from the Patient Simulator Summary Screen below: Press the Green Start key to start the simulation or press the key to return to the main summary screen. 33 | Page Rigel Medical UNI-SIM LITE user Manual V1.0...
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When the simulation is in progress, a “pulse” symbol will be shown; Whilst the simulation is being performed, the UNI-SIM LITE can change settings. Use the arrow keys to scroll to the setting and use the “+” and “-“ keys to change the values.
Static IBP Test The Rigel UNI-SIM LITE is able to 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 LITE will simulate using an output of 5μV/V/mmHg.
Performance Wave Test The Rigel UNI-SIM LITE 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: In the next screen, select the required wave form, frequency and amplitude settings: The preferred wave form and amplitudes can be selected by selecting the dropdown box (right arrow key) and use the up and down keys to select.
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Confirm by pressing the key (F4). The simulation is only running whilst in this screen. When exiting this screen, the UNI-SIM LITE will revert back to the ECG simulation settings, see 6.1.1 Press the key (F2) to return to the previous screen 37 | Page Rigel Medical UNI-SIM LITE user Manual V1.0...
7 Setting-up your tester The Rigel UNI-SIM LITE 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.
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Start Simulations This must be inserted in order to start the simulation part of the UNI-SIM LITE and defines the duration of the simulations. Without this instruction, none of the above settings will be simulated. If more then one...
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The following screen displays the list of default and customised tests available. Copied Test Sequences will appear in the list with an *pre-fix. From this menu, the user is able to create a new Test Sequence by pressing the button (F1). 40 | Page Rigel Medical UNI-SIM LITE user Manual V1.0...
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The newly created Test Name now appears in the Test Sequence menu and can be modified to include the required individual tests. Press the button (F4) to open the sequence for editing. 41 | Page Rigel Medical UNI-SIM LITE user Manual V1.0...
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To modify a test sequence, please refer to 7.1.15 To insert a test, press the key (F1), Note; Tests will be inserted before the highlighted position not after. 42 | Page Rigel Medical UNI-SIM LITE user Manual V1.0...
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Artefacts (upgrade) Checking of LED quality (both Red and InfraRed) Insert the SPO2 Test Settings from the drop down list and press the key to edit the test settings. 43 | Page Rigel Medical UNI-SIM LITE user Manual V1.0...
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The different options above are available across three individual screens accessible using the tab button (F2) Navigate using the Up & Down Keys and change each setting by using the left key. 44 | Page Rigel Medical UNI-SIM LITE user Manual V1.0...
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Insert the NIBP Pop-off test from the drop down list. Note that there are no settings to change. Refer to the instructions in 4.44.1 for further instructions on the options available. 45 | Page Rigel Medical UNI-SIM LITE user Manual V1.0...
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Perform a static IBP test by setting the required value. Insert the IBP Static Test Settings from the drop down list and press the key to edit the test settings. 46 | Page Rigel Medical UNI-SIM LITE user Manual V1.0...
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Navigate using the Up & Down Keys and enter the required values. Refer to the instructions in 4.16.3 for further instructions on the options available. Confirm and insert by pressing the key (F4). 47 | Page Rigel Medical UNI-SIM LITE user Manual V1.0...
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The input is text only and no simulations or measurements are performed by the Rigel UNI-SIM LITE during these tests. The maximum number of characters in the test description or instruction is 255.
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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 LITE will return to the previous meny without changes being made. 49 | Page...
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Sequences from the list and press (F4). 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. 50 | Page Rigel Medical UNI-SIM LITE user Manual V1.0...
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Bluetooth Printer. See 7.4 for help on setting up Bluetooth devices. Delete Sequence will remove the highlighted test sequence from the memory of the Rigel UNI-SIM. Note: Default Test Sequences cannot be Deleted. 51 | Page Rigel Medical UNI-SIM LITE user Manual V1.0...
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(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. 52 | Page Rigel Medical UNI-SIM LITE user Manual V1.0...
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To Delete an individual test, highlight the test using the Up & Down arrow keys and press the button (F2) To go back to the previous menu, highlight the test using the Up & Down arrow keys and press the button (F3) 53 | Page Rigel Medical UNI-SIM LITE user Manual V1.0...
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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. 54 | Page Rigel Medical UNI-SIM LITE user Manual V1.0...
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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 7.1.15 55 | Page Rigel Medical UNI-SIM LITE user Manual V1.0...
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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. 56 | Page Rigel Medical UNI-SIM LITE user Manual V1.0...
Asset trace variables may consist of a maximum of 25 characters and can be selected prior to each test when using the Rigel UNI-SIM LITE in automatic mode. The following variables can be added to the test results: The default settings on the Rigel UNI-SIM LITE include the Site and Location variables.
Additional entries will overwrite on a first in first out basis. System Config This feature can setup the Rigel UNI-SIM LITE to automatically perform certain features during or after a test as well as allowing the user to set Time and Date preference.
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Never – Comment field is not displayed. 7.3.4 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 or contact your...
Changes are saved automatically. Bluetooth Favourites In order for the Rigel UNI-SIM LITE 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 LITE 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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Favourites. 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. 62 | Page Rigel Medical UNI-SIM LITE user Manual V1.0...
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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...
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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 UNI-SIM LITE 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”...
(F4) or the right arrow key. 7.5.1 Preferences 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 : 65 | Page Rigel Medical UNI-SIM LITE user Manual V1.0...
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User Rights – For information only. To change the user rights, see 7.5.4 (F2) button allows the user to set the audible warnings and beep on key presses. See menu below: 66 | Page Rigel Medical UNI-SIM LITE user Manual V1.0...
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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 LITE will automatically default to admin rights so new users can be created.
Press the button (F4) to save user profile. Memory options This feature is used to view information about the Rigel UNI-SIM LITE memory status. Press (F4), select setup using the up/down keys and select Memory Options by pressing the press (F4) to accept.
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If the Erase (F2) key is pressed, a prompt is shown below. To erase the memory press button (F4). 69 | Page Rigel Medical UNI-SIM LITE user Manual V1.0...
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. 70 | Page Rigel Medical UNI-SIM LITE user Manual V1.0...
Choose a selection of default and custom made test sequences. A total of 50 preset test sequences can be stored to meet specific requirements. (See 7.1 more information on creating new test sequences) 71 | Page Rigel Medical UNI-SIM LITE user Manual V1.0...
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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 7.2 for more information). Trace variables can be added once the above data has been entered and confirmed 72 | Page Rigel Medical UNI-SIM LITE user Manual V1.0...
1. Enter the Asset ID number using the keypad or barcode scanner. 2. Enter the Test Code if this has been created (see 3.2) 3. Use the up, down, left and right keys to select the required Test Sequence 73 | Page Rigel Medical UNI-SIM LITE user Manual V1.0...
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Note that a maximum of 40 individual entries are available for each Trace Variable. Additional entries will overwrite on a first in first out basis. When all information is provided, press the button (F4) to start the safety test. 74 | Page Rigel Medical UNI-SIM LITE user Manual V1.0...
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After an initial message: The first test of the Default test setting is the the NIBP Leak Test Following the Leak test, the overpressure valve is tested; 75 | Page Rigel Medical UNI-SIM LITE user Manual V1.0...
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Following the Overpressure valve test, the UNI-SIM LITE is ready to make all simulations as per the test routine; Pressing the (STOP) button (F3) during any test will bring up the failure menu (see 8.1.1) At the end of the test, the user has the ability to enter comments. See 7.3.3 for more information on how to activiate comments after a test.
Options Menu – Provides a menu to allow further choices after a test. (see 4.3) Test ‘n Tag The Rigel UNI-SIM LITE 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.
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 78 | Page Rigel Medical UNI-SIM LITE user Manual V1.0...
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 79 | Page Rigel Medical UNI-SIM LITE user Manual V1.0...
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(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: 80 | Page Rigel Medical UNI-SIM LITE user Manual V1.0...
(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; 81 | Page Rigel Medical UNI-SIM LITE user Manual V1.0...
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). 83 | Page Rigel Medical UNI-SIM LITE user Manual V1.0...
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 LITE will now attempt to make a Bluetooth connection with the Computer that has been configured in the Bluetooth Favourites.
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When the connection is established and ready to communicate the Bluetooth status icon will change to show the Bluetooth icon as shown on the right. The Rigel UNI-SIM LITE is able to download in a number of formats to suit individual requirements. These are; ...
This feature can be used to transfer store or modify the current Trace Variables, User Profiles and Comment lists to/from a PC. It can be used to configure a number of Rigel UNI-SIM LITE units with identical Trace Variable, User Profile and Comment lists.
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Press the SEND (F4) button to send data to the PC. The UNI-SIM LITE will automatically receive data when the ready message is shown as above. Press the (F3) button to go back to the start screen. Open the Bluetooth Downloader (Data Transfer.exe) application on your PC and check that the Com Port is correct for the Bluetooth USB adaptor being used with the P.C.
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Once the text file has been created, press the Send button (F4) to transfer the Asset Trace variables and User names from the Rigel UNI-SIM LITE to the PC. The downloaded text will appear in the Bluetooth Downloader screen. Select Stop Capture from the Capture menu in the task bar.
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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 LITE screen will display a message as shown below.
10.4 Load TnT Logo A bitmap logo can be transferred to the Rigel UNI-SIM LITE 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.
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When the transfer is complete the Rigel UNI-SIM LITE screen will display a message as shown below. Press the OK button (F4) to save the logo. The logo is now available for printing using the Seaward Test ’n’ Tag printer.
Use the scoll 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.
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12 Maintaining the Rigel UNI-SIM Lite 12.1 Cleaning the UNI-SIM Lite The Rigel UNI-SIM LITE 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.
Downloads tab. Application Notes are regularly updated and will most likely cover any common issues. For further assistance please contact your Rigel Medical supplier or use the following contact details to speak to a member of the Rigel Medical team:...
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 99 | Page Rigel Medical UNI-SIM LITE user Manual V1.0...
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