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1. DOOI o H6n0000 200000 g 500000 1 Alpha Numeric keyboard Up Down and Left Right cursor control 2 4 Programmable soft keys below display 3 Colour Green Red for start stop and On Off 4 Full graphic Monochrone LCD blue with white backlit 1 4 VGA 5 Temperature simulation output 6 NIBP simulation Pneumatic interface connector 7 Power Supply inlet 8 12 lead ECG simulation output 9 SPO2 simulation output 10 IBP simulation output 11 High level ECG simulation output 7 Page Rigel Medical UNI SIM user Manual V3 2 1 4 Connecting the accessories CONNECTION TO OXIMETER N ES x PN KS FN e S a Ne E C G ADAPTOR BOX PROBE CONNECTION i ADAPTOR BOX rg m m I f j i n ADAPTOR CABLE EE ER EjBIGEL UNI SiM POWER SUPPLY The Rigel UNI SIM is supplied in two parts The basic unit 3704930 and the accessory pack 370A931 see below for a list of items included in the accessory pack 1 5 Rigel UNI SIM accessory pack includes pn 370A931 e ECG interconnect module 370A688 e 10 ECG adaptor studs 274A725 e Universal Power Supply 230 110V 370A010 e UNI SiM carry case 71G098 e 5 pc
2. Once the selections are complete select the v F4 to confirm the settings 27 Page Rigel Medical UNI SIM user Manual V3 2 80 bpm ele 100 Adaptor 0 Medium Perfusion 5 0 LED State RED Press the Green Start key to start the simulation or press the at key to return to the main summary screen When the simulation is in progress a pulse symbol will be shown Nellcor laa 80 bpm Oximax SPO2 100 96 Adaptor 1 Skin Medium Colour Perfusion 5 0 RED Whilst the simulation is being performed the UNI SIM can change settings Use the arrow keys to scroll to the setting and use the and keys to change the values Use the timer key to start the chronometer function which will record the time taken from one simulation setting to the next Note The UNI SIM simulates both Red and Infrared data through either of the Red or InfraRed LED s at any given time This allows the user to test the quality of individual probes and circuits Tests have shown that worn probes might still provide a reading on the monitor though the accuracy or functionality is not guaranteed By altering the simulation through the Red and Infrared circuits one can detect anomalies between the two simulations should be within 1 which would indicate a potential problem with either one of the circuits 28 Page Rigel Medical UNI SIM user Manual V3 2 7 Manual Mode Patient Simulator The Manual mode provides the
3. New Test Sequence MPM 30001 To change to upper or lower case or use language specific charaters press the tT button F1 and select the required entry To Delete a character press the button F2 To return to the previous menu without changes press the x button F3 To confirm the entry press the button F4 Next step is to save the name of the newly create Test Name by pressing the OK button F4 Pressing the x key F3 would return to the Test Sequence menu without changes The newly created Test Name now appears in the Test Sequence menu and can be L modified to include the required individual tests Press the the sequence for editing button F4 to open 42 Page Rigel Medical UNI SIM user Manual V3 2 Default Adult MPM 3000 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 8 1 15 To insert a test press the Foy F1 Note Tests will be inserted before the highlighted position not after 43 Page Rigel Medical UNI SIM user Manual V3 2 8 1 2 Insert NIBP test settings Use the NIBP Test Settings to setup a selection of Dynamic Pressure simulations NIBP Test Setting Monitor Type e Adult Infant Adult lt gt systolic Diastolic 120 80 lt gt Heart Rate Pulse volume Medium lt gt Navigate using the U
4. To change any of the default settings on each simulation please refer to the relevant manual mode sections in this manual chapter 5 6 and7 This manual is constructed in four main parts Manual mode see 5 6 7 Setting up your tester see 0 Automatic mode 9 Data management 10 11 AON 16 Page Rigel Medical UNI SIM user Manual V3 2 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 Static pressure calibration Pop off valve test Manometer function From the main summary screen select the NIBP fact key F2 Press NIBP F3 from the start screen Heart 70 bpm Default Rate Systolic 1 20 mmHg Diastolic 80 MAP 93 Pulse volume Medium Heart b Default Rate pm Defau Systolic mmHg NIBP Test Settings Diastolic NIBP Leak Test NIBP Static Pressure Test MAP NIBP Pop off Test NIBP Manometer Mode Pulse volume Set ZERO NIBP Test Settings see 5 1 NIBP Leak Test See 5 2 NIBP Pop off Test see 5 4 NIBP Manometer Mode see 5 5 Set Zero see 5 6 17 Page Rigel Medical UNI SIM user Manual V3 2 5 1 NIBP Test Settings Use the NIBP Test Settings to setup a selection of Dynamic Pressure simulations NIBP Test Setting Monitor Type z gt Adult Infant Adult lt gt systolic Diastolic 120 80 lt gt Heart Rate Pulse volume Medium lt g
5. 98 Page Rigel Medical UNI SIM user Manual V3 2 Performance Waveforms Shape Rates Amplitudes Pulse Pacer Waveforms Available QRS Pacer Pulse Amplitude Pacer pulse Polarity Pacer pulse width R Wave Detection Heart Rate R wave width Temperature Simulation Simulation Range Accuracy Default setting Respiration Simulation Rates Base resistances Accuracy Resistance Variations Accuracy Default Settings Apnoea Simulation Sine Square Triangle and Pulse 0 1 to 0 9Hz in steps of 0 1 1 to 100Hz in steps of 1 0 5 1 1 5 2 2 5 3 3 5 4 4 5 5 mV 1mV 4 sec delay 20ms pulse duration synchronous atrial asynchronous atrial paver only ventricular pacer atrial amp ventricular pacer 1mV 0 1 2 mV positive negative 0 1 2ms 70 bpm 10 120 ms steps of 10ms YSI 400 700 Static preset at 25 33 37and 41 C 0 1 C YSI 400 37 C 5 10 15 30 60 120 180 Breaths per Minute 250 500 750 1000 ohms 5 0 1 0 5 1 0 1 5 ohms 10 15bpm 2500 0 10 0 60 seconds duration 0 300 seconds interval 99 Page Rigel Medical UNI SIM user Manual V3 2 Appendix A Firmware Route Map Manual Mode NIBP NIBP Test Settings NIBP Leak Test NIBP Static Pressure Test NIBP Pop off Test NIBP Manometer Mode Set Zero SPO2 SPO2 simulation settings PAT Patient Test Settings Static IBP Test Performa
6. In the following example the search has identified Bluetooth devices named SELLTO23 SELPC045 and Elite 36 5011 Setup Computer Sd Bluetooth ID Elite 36 5011 Nev SELLTO23 TT Te Note f the required device is not shown check that it is powered on with the Bluetooth function active then repeat the search Note Some Bluetooth devices do not report a recognisable name and may cause confusion when setting up Favourites Turn off or disable unused Bluetooth devices when configuring Favourites Use the up down keys to highlight the required device in this case SELLTO23i and press the V button F4 SELLTO23 is now placed in the New field as shown below 63 Page Rigel Medical UNI SIM user Manual V3 2 TFC ANANI Setup Computer SELLTO23 lt gt Bluetooth ID 000A3A7BASSB PIN number New SELLTO23 m Press F3 to add SELLT023 to the Favourite Computer list To add further devices to the list of available computers select the new field again use the up down left and right keys to select the required device and press F3 to add the chosen device SELLTO23 has been added to the Computer field with Bluetooth ID Press v F4 to store the changes and return to the previous screen 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
7. NIBP ECG temperature respiration and IBP simulations as well as a system Leak test Static pressure tests and Overpressure test in an automatic sequence 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 e Restart Test Individual test e Restart Test Sequence Whole Test sequence e Resume Test Skip the failed test Restart Test Sequence e End Test Sequence store result Resume Test Sequence and follow options See 9 3 End Test Sequence Abort Test Sequence e Abort Test Sequence no information stored return to home screen 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 Press the button F4 from the home screen and select Auto Mode This will show the Asset Details screen as detailed below Asset Details Admin Default Adult lt gt Automatic User Name Asset ID Test Sequence Run Mode Select the right criteria for the Test from the Asset Details screen 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 74 Page Rigel Medical UNI SIM user Manual V3 2 4
8. 126 79 Atrial Fibrillation Temperature YSIZ00 37C Respiration 15 bpm Apnoea Continuous Press the Green Start key to start the simulation or press the ta key to return to the main summary screen 34 Page Rigel Medical UNI SIM user Manual V3 2 When the simulation is in progress a pulse symbol will be shown Heart b Rate 80 pm IBP 1267 79 ECG Atrial Fibrillation Temperature YSI700 37C Respiration 15 bpm Apnoea Continuous S E Whilst the simulation is being performed the UNI SIM can change settings Use the arrow keys to scroll to the setting and use the and keys to change the values Press the Green Start key to start the simulation or press the fat key to return to the main summary screen 12080 ao T YSI700 37C E 100 s IBP 126 79 35 Page Rigel Medical UNI SIM user Manual V3 2 72 Static IBP Test The Rigel UNI SIM is able to simulate a static pressure using the invasive output Select the Static IBP Test from the PAT menu see below Heart 80 bpm Rate IBP 1267 79 ECG Atrial Fibrillation Temperature Respiration 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 5uV V mmHg Patient Simylator Settings Pressure The simulation is continuously running whilst in this screen When exiting this screen the UNI SIM will revert back to the systolic an
9. 2 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 Dationt Cimiilator Sattinae Normal Sinus Rhythm Atrial Flutter Atrial Fibrillation Right Bundle Branch Block Premature Ventricular Contraction Bigeminy Select by pressing the v key F4 and confirm Repeat the same actions to change the signal amplitude V v 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 user Manual V3 2 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 Patient Simulator Settings Heart Rate Systolic Diastolic Temperature SI400 25C lt gt ome em ene 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 Patient Simulator Settings Heart Rate STRIPE Systolic YSI400 33C Diastolic YSI400 37C Temperature YSIA00 41C YSI 00 25C YSI 00 33C Select by pressing the v key F4 and confir
10. Enter the required test period in months User Name Asset ID 5 Returning to the Asset Details screen the 5C 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 See 8 1 for more information When all parameters are set press the v button 4 to enter the Asset Trace Variables screen when applicable In this example all Asset Variables are activated Service Code Site Peterlee Location Building BA6 Make DG Medical Model JB4000 Description Patient Monitor Serial Number XYZ1234567890 Client North East NHS 6 Use the Up amp Down Keys to navigate the menu and the Left amp Right Keys to open the drop down boxes Select the required input and confirm with the v button F4 Each variable entered during the automatic test will automatically be added to the list for future use Trace Variables that are de activated set to NO in the Setup menu section 8 2 will not appear during the automatic tests 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 V button F4 to start the safety test 75 Page Rigel Medical UNI SIM user Manual V3 2 After an initial message The test about to start requires the unit to be i
11. Poo e E Eae FEX NER PAPE ER PYR ACRES E Eo eve Elo Pera 85 11 2 Upload from PC ieri e eniti eee tue o ores uae c eoe Ye Pa o SE aa oo eo aka on oosa E Oo speeds 87 11 3 Config ration Data 10 oiii eor ei ea eed na ee coa EARE Pe Pase c ESN SBAA FAAEA nS NAANA ES PENNS EI 87 11 4 Load TNT L0BO 5 eorr eee oo etait e kann ec taa iae ida anco eaa gU ee ka nh oa a ae ngo na ke an danse 91 I12 JADOUL d site sates rire e eere aaa Dodo eui de ae rh XE RE RERO Vebo nu eie O 93 13 Maintaining the Rigel UNI SIM 44 eese e ee eese eene een nnne nane n snae nu 95 13 1 Cleaning the UNI SIM 21 eo ert eei oro e oper n eus a oon euo ooa oss Do oen ea oo ooa e Ee so oo Eno opu 95 13 2 User Maintenance eeeeeeeeeeee eene eene enne nn nnne tent nh snas nanus nsns assa nnne sette na ansa 95 13 3 Return Instructions 5 ctor er rese no beso ei vrpa o eoo sacsaasennsesdessacscasasosoedsscasasesanedeoesscass 96 Technical Specifications Sector tette reto arator raa dp aki ia tug asa semi qv dua Va 97 Technical Specifications 25 ad E teres naniuhi IE Qu ipe oe ren opa X MEL araa iaaea ladies 97 Appendix B IBP Interconnect cable wiring diagram eee ee ee eene 101 Appendix C Temperature cable wiring diagram ecce eee eese eene enne 102 3 Page Rigel Medical UNI SIM user Manual V3 2 User Notes These operating instructions are
12. Pulse volume Rigel Medical UNI SIM user Manual V3 2 v Once the selections are complete select the F4 to confirm the settings Press the Green Start key to start the simulation and close the internal valve within the UNI SIM 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 valve is closed a pulse symbol will be shown pn 70 bpm WA ProPaq Systolic 1 20 mmHg Diastolic 80 MAP 93 Pulse volume Medium Using the Function keys F1 F2 and up and down arrow keys the highlighted field change using arrow keys can be changed using the and function keys F1 and F2 5 2 NIBP Leak Test In the NIBP leak test the user is able to test the pneumatic leakage within the system The settings available are e Start Pressure e Timer seconds Note Prior to initiating the test some NIBP monitors might have to be set to a service mode to ensure that the internal monitor valves are shut for incoming pressures If the monitor s internal valve is open the leak test will not be able to pressurise the system 20 Page Rigel Medical UNI SIM user Manual V3 2 NIBP Leak Test 0 0 Start P 0 0 Timer The UNI 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
13. The three sub lists are shown below e Barcode Scanner e Printer e Computer To select Bluetooth Favourites press the button F4 followed by Setup in the v Menu and Bluetooth Favourites from the list as shown below Press F4 to select 61 Page Rigel Medical UNI SIM user Manual V3 2 Heart Rate Def ault Systolil Test Sequences Asset Trace Variables Data T User Admin gt Slee Memory Options Restore Factory Settings The following shows how to add a Computer to Bluetooth Favourites Bluetooth Favourites Barcode lt gt Printer Use the up down arrow keys to highlight the device type in this case Computer then i press C F3 Make sure that the device you want to add to your new favourites is switched on Press a 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 A progress bar will show during the search When the search is completed the progress bar will disappear 62 Page Rigel Medical UNI SIM user Manual V3 2 Setu Computer Bluetooth ID PIN number Use the arrow keys to highlight the field labelled New and press the left or right keys to open the list of devices which have been found during the search Note f more than 10 Bluetooth devices have been found the list will show the last 10 devices found
14. User Admin gt Ji Memory Options Restore Factory Settings The System Config menu is displayed below System Config Asset IDBlank m After Test New Test e gt Comments Always lell Qi LanguagefEngish e gt ty Date o wb gt The System Config menu provides the following features 59 Page Rigel Medical UNI SIM user Manual V3 2 8 3 1 Asset ID Provides automatic Asset ID configuration Use the Left amp Right Keys to select between 8 3 2 Increment Automatically increments the next Asset ID s least significant number by 1 Blank Will leave the next Asset ID field blank Repeat Last Will copy the previous Asset ID into the next Asset ID field After Test Provides automatic action after a test is completed Use the left and right keys to select from the following 8 3 3 New Test Automatically brings up the next test screen Download Automatically down loads the test results to the PC see 11 1 Print Label Automatically prints the test results or label to a printer see Appendix D Options Menu Provides a menu to allow further choices after a test see 9 3 Comments Provides the ability to enter further comments after successful or failed tests Use the left and right keys to select from the following 8 3 4 Always Comment field is displayed after each passed or failed test On Pass Comment field is displayed after a passed test only On Failur
15. been created press the Send button F4 to transfer the Asset Trace variables and User names from the Rigel UNI SIM to the PC The downloaded text will appear in the Bluetooth Downloader screen Select Stop Capture from the Capture menu in the task bar See below amp Data Transfer EE Fle eee TE Hap v Start Capture EF rz ES SIGHTS z Tire C00220 Estir aed lime u comm leli_n 20 00 0C Ready E r9 Zala rezeivac rcr aeter Cadiac ulpul EMDI Capture Os D 1Doz rac ks and Szziras ohnzAZeslkopbp sim txt Close down the Application and open the text file using word pad or equivalent 89 Page Rigel Medical UNI SIM user Manual V3 2 The downloaded information can be used to clone other Rigel UNI SIM s or modified to add additional trace variables Again these can be uploaded to any Rigel UNI SIM for convenience Note The file transfer can be made using any suitable PC application such as the Seaward Bluetooth Downloader Data Transfer exe or Hyperterminal capable of sending and receiving a text file Note The maximum number of entries for each field is SiteName 40 LocationName 50 UserName 40 and Comment 80 11 3 1 Receive Config Data Follow the steps above in Send Config Data to run the Bluetooth Downloader and connect the Rigel UNI SIM to your PC Click on File on the Bluetooth Downloader menu and select Send File This will open a window allowing you to select the text file containing
16. 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 All custom facilities can be found under the SETUP menu Simply press the F4 from the home screen and select Setup from the menu Hint The underlined character acts as a short key to allow swift navigation through the menu structure Asset Trace Variables System Config Data T User Admin gt SHU Memory Options Restore Factory Settings Options available Test Sequences Modify or create test sequences see 8 1 Asset Trace Variables Generate default list of variables see 8 2 Systems Config Configure default test options see 8 3 Bluetooth Favourites Setup your Bluetooth devices see 8 4 User admin Setup users and preferences see 8 5 Memory Options Manage the tester s memory see 8 6 Restore Factory Settings Defaults the tester to factory settings see 8 7 8 1 Test Sequences The Rigel UNI SIM can be set up to create new test sequences to meet monitor specific requirements or to modify existing test sequences to meet personal preference Preset test sequences cannot be changed by the user however alterations are possible by producing a copy of the default test sequence setting The total number of possible preset test sequences is 50 including 12 default test sequences 39 Page Rigel Medical UNI SIM user Manual V3 2 8 1 1 C
17. intended for the use of adequately trained personnel The following symbols are used in these operating instructions and on the Rigel UNI SIM Warning of electrical danger A Indicates instructions must be followed to avoid danger to persons Important follow the documentation This symbol indicates that the AN operating instructions must be adhered to in order to avoid danger The UNI 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 If the UNI SIM is used in a manner not specified by the manufacturer the protection provided by the equipment may be impaired 4 Page Rigel Medical UNI SIM user Manual V3 2 1 Introduction The new 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 The battery powered vital signs simulator reduces the time taken to test the correct performance of a wide range of medical devices and equipment used in hospitals operating theatres and other facilities It utilises the full synchronised functionality of Rigel s BP Sim and SP Sim as well as a comprehensive patient simulator ECG invasive blood pressure respiration and temperature to cut simulation times and deliver cost saving benefits eng
18. is highlighted below NIBP Leak Test P Drop Start P mmHg 149 9 Timer At the end of the test the UNI SIM will show e the start pressure i e 157 1 mmHg e the final pressure i e 149 9 mmHg e the pressure drop over 60 seconds i e 7 2 mmHg Press V F4 to repeat the test at Press 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 set pressure The user is then able to enter a new higher value for further testing 21 Page Rigel Medical UNI SIM user Manual V3 2 Select the Static Pressure Test from the NIBP menu NIBP Static Pressure Test Start P mmHg 0 0 Press V F4 to repeat the test Press A F2 to return to start menu 5 4 NIBP Pop off Test The Pop off test allows the user to verify the correct operation of the protection valve within the NIBP monitor Note Prior to initiating the test some NIBP monitors might have to be set to a service mode to ensure that the internal monitor valves are shut for incoming pressures 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 NIBP Pop off Test Set Level mmHg To initiate the test press V F4 The UNI SIM will inflate the system until the protection valve is activa
19. mmHg user configurable Leak test user configurable between 0 350mmHg Chronometer configurable upto 999 secs Digital Manometer 0 410 mmHg Pressure Accuracy 0 5 FS Pressure Units mmHg inHg kg cm2 cmH2O mBar PSI inH2O and kPa Oxygen Saturation Simulation SP02 Adapter boxes Simulation Optronic Electronic amp Optical Simulation via probe amp full chain Range 50 to 10096 Accuracy 0 596 of reading between 80 100 SPO2 196 of reading between 50 79 SPO2 Heart rate 20 300 bpm Accuracy 1 bpm Compatible technology GE Datex Nellcor N Oximax Masimo Datascope Mindray Nonin Philips HP Perfusion Index 0 20 5 default Chronometer test option to test response time SPO2 monitor Oxygen Saturation Simulation PULS R Range 30 to 100 Repeatability 5 of reading between 30 59 SPO2 3 of reading between 60 99 SPO2 3 of reading between 90 100 SPO2 Accuracy of simulation when used with the corresponding R curves Based on using the same probe and monitor setup Note that some monitor types might not be able to display low range sats Heart rate 30 300 bpm Accuracy 1 bpm Compatibility Beijing Choice Criticare GE Tuffsat Masimo Mindray Nellcor Nellcor Oximax Nihon Kohden 97 Page Rigel Medical UNI SIM user Manual V3 2 Subject to monitor capability ECG Arrhythmia Simulator Simulation Heart rate Accuracy Amplitudes Accuracy Connection high level ECG S
20. post text and fault menus 14 Page Rigel Medical UNI SIM user Manual V3 2 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 120 80 MAP 93 99 Alternatively the user can choose between selecting a single or all of the simulation settings ie NIBP F3 SPO2 F2 or PATient F1 simulator or entering the menu F4 allowing for automatic testing modifying the simulators default settings viewing and downloading data and other user settings Use your UNI SIM as a simple manual simulator from the summary screen by selecting the simulation function you want e NIBP F3 simulate NIBP perform a system leak test overpressure test static pressure test or manometer function MAP Pulse volume Medium 15 Page Rigel Medical UNI SIM user Manual V3 2 e SPO2 F2 simulate SPO2 signals response times artefacts and check probe performance 70 bpm Masimo 99 06 Adaptor Medium Perfusion 1 8 LED State RED e PAT F1 full 12 lead patient simulator including ECG Arrhythmia and performance waveforms respiration signals temperature simulation and invasive blood pressure simulation O bpm 120 80 Normal Sinus Rhythm Temperature S1400 25C Respiration 15 bpm fApnoea None
21. 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 Parameters can be varied to validate the monitor and probe including e Technology E g PULS R Masimo Nellcor e SPO2 simulated e Heart Rate Supported Default curves e Beijing Choice PULS R Criticare PULS R GE Ohmeda Tuffsat PULS R Masimo PULS R Mindray PULS R 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 12 Page Rigel Medical UNI SIM user Manual V3 2 2 4 Unique use of ICONS The Rigel UNI 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 Below are of some of the icons used in the Rigel UNI SIM x A Escape OK PASS izi Add Print Iu Copy Less i Delete O Repeat P Edit m Save Help i Search ca Menu List Ter Settings fat D Home Shift E
22. the Test Sequence on the Favourite Bluetooth Printer See 8 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 52 Page Rigel Medical UNI SIM user Manual V3 2 8 1 14 Modifying Edit Existing Test Sequences Preset test sequences cannot be modified by the user however alterations are possible by producing a copy of the default test setting see 8 1 13 Non default Test Sequences can be modified from the Test Sequences menu When non default Test Sequences are highlighted the G F4 will appear in the menu screen Default Adult L Pessing the below Custom Test Visually inspect the unit an To change the Name and or Class of the Test Sequence press the G Button F4 and enter the Name and or Class required 53 Page Rigel Medical UNI SIM user Manual V3 2 Multi Parameter A6 To change to upper or lower case or use language specific characters press the tT button F1 and select the required entry To Delete a character press the button F2 To return to the previous menu without changes press the x button F3 Confirm by pressing the V key F4 or cancel using the x button F4 Custom Test Visually inspect the unit and ensure it To Insert a new test highlight the test using the Up amp Down arrow keys and press the Insert button F1 To
23. the manufacturer s documentation Note Devices that are not required can easily be removed by selecting the Computer field pressing the left of right keys to open the list highlighting a device using the up down keys and pressing U F2 Confirm the 4 deletion by pressing the V button F4 Press the button F4 to save Bluetooth Favourites settings 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 64 Page Rigel Medical UNI SIM user Manual V3 2 Printer Elite 36 5011 lt gt Printer Type Test n Tag Elite lt gt Bluetooth ID OO037A417E631 PIN number New Elite 35 5011 lt gt Ensure when selecting the printer that the Printer type is selected corresponding with the print media Printer used BT ID Printer type Test and Tag Elite Elite 36 xxxx Test n Tag Elite Citizen list printer CITIZEN SYSTEMS Citizen CMP 10 Test and Tag SW T nT 6Goo xxxx Test n Tag Press v F4 to store the changes and return to the previous screen Bluetooth Favourites Barcode Printer Elite 36 5011 lt gt Computer SELLTO23 lt gt SELLT023 and Elite 36 5011 are now a Bluetooth Favourite and the Rigel UNI SIM will automatically establish a connection with SELLT023 when using functions that communicate with a computer e g downloading reco
24. tubing adaptor set 370A005 e Adaptor connect cable 370W505 e Instruction manual 370A564 e Rigel utility disc 331A557 e Bluetooth USB adaptor 339A910 e Safeguard Warranty Card 74B004 8 Page Rigel Medical UNI SIM user Manual V3 2 1 6 Additional amp Optional Accessories For a full range of UNI SIM accessories and cables please visit http www rigelmedical com downloads Rigel SIM Range Accessory Datasheet Rev1 1 pdf 1 7 Test n Tag Compatible The Rigel UNI 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 e Robust and durable labels Resistant to most solvents used in the medical sector Free opportunity to advertise your logo and company details or emergency telephone number with every item you Test n Tag e Automatic barcode generation to provide easy use of the barcode scanner thus speeding up your test time The unique Test n Tag label provides test status and retest due date barcode and asset ID number and person conducting the test For more information on using the Test n Tag printer see section 9 2 9 Page Rigel Medical UNI SIM user Manual V3 2 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 j i cag PRISE o UNL SIM
25. Delete an individual test highlight the test using the Up amp Down arrow keys and press the button F2 To go back to the previous menu highlight the test using the Up amp Down arrow keys and press the x button F3 54 Page Rigel Medical UNI SIM user Manual V3 2 To modify an individual test highlight the test using the Up amp Down arrow keys and press the G Button F4 jin eal 8 1 15 Edit individual Test Press the G button F4 as shown above The Leak Test sub menu will allow you to alter the settings for Test duration and Pressure set point est Settings Pressure IEEE nnns 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 55 Page Rigel Medical UNI SIM user Manual V3 2 est Settings Pressure 275 mmHg Timer When the right settings have been achieved press the V button F4 to save the changes or press x 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 x F3 to exit 8 1 16 Insert an individual test To insert an individual test we use the up and down keys to highlight the position where a new test needs inserting and press the Insert button F1 from the menu below Note Tests will be inserted before the highlighted position n
26. ERIGEL 2 1 Accuracy of simulation when used with the corresponding R curves Resolution Range Repeatability 1 steps 30 60 5 1 steps 60 90 t3 1 steps 90 100 1 Based on using the same probe and monitor setup Note that some monitor types might not be able to display low range sats Operating temperature 0 40 C Dimensions 78 x 68 x 29 mm Finger shape 40 x 18 mm Heart Rate 30 300 bpm Part number 399A910 10 Page Rigel Medical UNI SIM user Manual V3 2 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 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 20 80 oos MAP 93 99 z i3 2c B IBP 120 80 Nellcor 80 bpm Oximax Rate spo 100 Adaptor 0 Skin Colour NIA Perfusion NIA LED State NIA Sau 9 jee 8 GN The connection between the PULS R the UNI SP SIM and the monitor is shown in the diagram using the SP02 connector lead 11 Page Rigel Medical UNI SIM user Manual V3 2 2 3 Performing SP02
27. ERIGEL MEDICAL _ RIGEL UNI SIM vital signs simulator Copyright 2015 SEAWARD GROUP Instruction Manual d Last Update 7th August 2015 370A564 Revision 3 2 Rigel Medical 24 Month Warranty Statement Rigel Medical provides a standard 12 month manufacturer s warranty against breakdown during normal use This warranty can be upgraded to a 24 month warranty terms and conditions apply Problems caused through misuse damage fair wear amp tear consumables and accessories are excluded from standard warranty Such components found to be being used in excess of their manufacturer s operating recommendations are also excluded 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 Any items returned for calibration outside of the 13 month period stated above may not be eligible for the second 12 month section of warranty The second 12 month section of the warranty begins at the expiry of the initial 12 month period not when the unit is calibrated Details correct at time of going to print The manufacturer retains the right to make amendments to the above terms and cond
28. LED quality both Red and InfraRed Press SPO2 F2 from the start screen 70 bpm Masimo 99 Of Adaptor 0 Medium Perfusion 1 8 LED State RED Technology lt gt seoa Heart Rate Skin Colour Perfusion 96 Navigate using the Up amp Down Keys and change each setting by using the left key 25 Page Rigel Medical UNI SIM user Manual V3 2 Technology Select between the various R curves SPO REMESLE Heart R 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 http www rigelmedical com downloads as SPO2 Enter the required simulation value in Technology N SPO2 as Heart Rate Skin Colour Perfusion 96 Heart Rate Enter the required simulated heart rate 26 Page Rigel Medical UNI SIM user Manual V3 2 SP02 Heart Rate I Skin Colour Technology Nellcor Oximax lt gt 00 Perfusion Skin Colour Select different levels of simulations of different skin colours SPO2 96 Heart Rate Skin Colour Perfusion 96 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 Technology SPO2 96 Heart Rate Skin Colour Perfusion 96
29. S 1 2 reir trace ee peers Duy o Foe to sana goo deniuecesisnccbedaacddeeceseds 13 BS LOGGING mE 14 Getting Started iiio rie Dezic kb gas ee ida dapes VRPRE CR ARRAS V PMRARK R Edu RR RENDER iS 15 Manual Mode NIBP 5 roin krip mn roro tail ean eva couinensaseendes vers Cu ga dhol anaeevecias EY ROI RE 17 5 1 NIBP Test Settirngs ii oorr riore ENEA nando Fo aka o Do ab Ra S o gua Ea DER RR RR Te oakRa RO 18 5 2 NIBP Leak Test nee ror eit teo ann Pe eot Yann Pes YU Fase rads Pe eg Pago Thes n REPE RUF sedo bea a ads 20 5 3 Static dr DIC m 21 5 4 NIBP Pop Off Teston eo eee onere rre reor exe Ee opa n EE POS ENES TR DSRRREREESRRRREE 22 5 5 NIBP Manometer Mode eeeeeeeeeeee eene eene n nnn nn nennt nn nnns sein sete nn nnn 23 5 6 Ergo M 24 6 Manual Mode SPOS usse nte di RYE rns kue ee nnn A INIR VER duae a E NA a au vu eie uve iM IRE 25 7 Manual Mode Patient Simulator ee ee eese e esee esee eene enne nn na nant nn 29 7 1 Patient Test Settihngs oerte teorie nn ep sexceddsbactccesssteccdssacescussesseddsbssecdussstesc 30 7 2 Static IBP Test i oce neri oaiae E OR E E EY a a ER e EUREN RP ANN RR ERREUR IEEE a 36 7 3 Performance Wave TeSt ccccccccscssssseesececeseeeececssceceeeseesececssseseeseeseaeecseeeseeeeseees 37 8 SCttinG UP your tester ccciccccckecccccctscoasscessecncseseccerdccguedcossscabecetouseceeatscoastt
30. T Elevation Depression Heart rate Elevation Elevation slope Myocardial Infarction Type Heart rate Tall T Heart Rate T wave Amplitude Arrhythmia Waveforms Atrial Simulation Amplitudes Heart rate where applicable Atrial Nonin Novametrix Philips HP 5 lead simulation including high level output on Normal Sinus Rhythm NSR ST Elevation ST Depression Myocardial Infarcation Tall T 20 300 BPM 1 BPM 0 5 1 1 5 2 2 5 3 3 5 4 4 5 5 mV 2 3 5 mm jack plug 20 300 BPM 7 13 20 positive negative flat Ischemia Injury Infarction Inferior Infarction 20 300 BPM 80 bpm 0 1 2mV steps of 0 1mV full 12 lead simulation 0 5 1 1 5 2 2 5 3 3 5 4 45 5 mV 20 300 BPM Sinus Arrhythmia SA Missing beat Atrial Flutter AFLT Atrial Fibrillation AFB Paroxysmal Atrial Tachycardia PAT Junctional Premature Contraction Atrial Conduction First Degree AV Block Second Degree AV Block Mobitz Second Degree AV Block Mobitz Il Third Degree AV Block Right Bundle Branch Block RBB Left Bundle Branch Block LBB Left Anterior Hemiblock Ventricular Premature Ventricular Contraction Intermittent Premature Ventricular Contraction Continuous Bigeminy Trigeminy Ventricular Flutter VFLT Ventricular Fibrillation Fine VFBF Ventricular Fibrillation Coarse VFBC Monomorphic Ventricular Tachycardia MVT Polymorphic Ventricular Tachycardia PVT Right Focal PVC
31. TE TEN New Mute 4 Sound 13 Page Rigel Medical UNI SIM user Manual V3 2 3 Logging on When switching on the Rigel UNI 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 UNI SIM See 8 5 3 for further details The default password setting is OFF and the login screen will not require a password In case a user and password are set the tester will default to the last user password User Name Enter Password XXXXXI 95672179 To change the user use the drop down menu provided and select the new user In case a password is set for the new user please enter the password case sensitive In case a password is lost and the unit is blocked please call our helpdesk on 44 0 191 5878701 or contact your local distributor and quote the 8 digit code shown below the password field and the serial number of the tester A new password will then be created For security reasons this new password can only be provided to the email address of the original purchaser of the device The Rigel UNI SIM is designed to allow a user to customise test sequences and allow default settings This customisation can speed up testing by providing the user with default manufacturer lists model numbers user text protocols automatic printing
32. V3 2 Refer to the instructions in 5 17 1 for more options available Confirm and insert by pressing the V key F4 8 1 5 Start Simulations In order to start the simulations on the UNI SIM Start All Tests 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 8 1 6 NIBP Leak Test Perform a system or cuff leak test by setting the set value and time duration Insert the NIBP Leak Test Settings from the drop down list and press the P key to edit the test settings est Settings Pressure EXE iar Timer n js Navigate using the Up amp Down Keys and enter the required values Refer to the instructions in 5 15 2 for further instructions on the options available Confirm and insert by pressing the v key F4 8 1 7 NIBP Pop off test Perform a system overpressure release test recording the sudden pressure release Insert the NIBP Pop off test from the drop down list Note that there are no settings to change Refer to the instructions in 5 45 1 for further instructions on the options available 46 Page Rigel Medical UNI SIM user Manual V3 2 8 1 8 NIBP Static Pressure test Perform a static pressure test by setting the required value Multiple static pressure tests can be inserted starting wit
33. aeedeceos 39 8 1 Uere 39 8 2 Asset Trace Variables ni sicssesscsnsnvesoseosececcnanncssscasessanncnnesedeosecedssasnessdsdsessonecnnesovesse 58 8 3 Erik M 59 8 4 Bluetooth Favourites eeeeee ecce eese essen enn eene nenne nnne nnn ennt nn nnns sain sete nnnt anna 61 2 Page Rigel Medical UNI SIM user Manual V3 2 8 5 User Admih siccacccascscceccsesdsscusavacscwsaceccssseecceccscsuoscdaswecdscdovacscuiseedeccseseessasvoceeweceess 66 8 6 MOMOPy Eni E 69 8 7 Restore Factory Settings 1 rores corse octo k oa See eo saga ge oo auae Oo SERRE a OL PERRA DU eon R Ra Ue 71 9 Automatic MODE sisinsdiran iaia i VAR ean Cute i iaa 72 9 1 Performing an Automatic Test eeeeie esee esee eese eene eese eene esset nnno stans sesto 74 9 2 DOMUI ATTI TL TM 78 9 3 leniDnmurmmem ains 78 9 4 MATS ACTI cp A 79 10 WICW Nep M 80 10 1 View Results irit trennt rnt En boo Eoo oe Re EAE ssas ooa sereta bo kao Eo sa Re PEE ES ER Or PRSE YR Ra 82 10 2 Search the database ccscscececececsecssesseceeececcecscssseseeeeessececsseseeeseeseesaceseeeeees 83 10 3 View Data OptiOns 1 enter cree eo cL eruere ee tu ea es orna a s oe eaa oo soe aa ao an osi a n oan auras eda as 84 II Data Iransfer isssace e deua een a soars aaa Dae Ra i aaa eia xwv 85 11 1 Downlo ad to PC ooi rtr EE nnne Eo
34. amage and wear before use e Do not open the Rigel UNI SIM under any circumstances e Keep the instrument clean and dry e Avoid testing in conditions of high electrostatic or electromagnetic fields e Maintenance should only be performed by authorised personnel e There are no user replaceable parts in the Rigel UNI SIM e The unit should be regularly calibrated at least annually 95 Page Rigel Medical UNI SIM user Manual V3 2 13 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 calibration seaward co uk www seaward co uk www rigelmedical com 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 When asking for a Returns Number please quote e Instruments name and model e Serial number see section 8 e Firmware version see section 8 96 Page Rigel Medical UNI SIM user Manual V3 2 Technical Specifications Technical Specifications Non invasive Blood pressure Simulation Waveform Oscillometric Pulse Volume High Medium Low paediatric Heart rate 20 300 bpm Integrated Pump 0 to 350
35. ast verified x xI l 94 Page 44 191 587 8718 About O6B 0633 Serial Number Processor info 2 Bluetooth ID Q012F30B5322 Bluetooth ID Status Pass 1 25 EN 2 3T4T5T5 NIBP Calibration Status Last calibrated Last verified OK 22 Feb 2010 22 Feb 2010 0 41 AK 2 0 12 ECG Cal Status IBP Cal Status Resp Cal Status Last calibrated Last verified 23 Feb 2010 23 Feb 2010 AK 22 Mar 2010 AA 22 Mar 2010 3 4 5 e MEEA Rigel Medical UNI SIM user Manual V3 2 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 Do not allow liquid inside the Rigel UNI SIM or near the sockets Do not use abrasives solvents or alcohol If any liquid is spilt into the Rigel UNI SIM case the simulator should be returned for repair stating the cause of the defect 13 2 User Maintenance The Rigel UNI SIM is a rugged quality instrument However care should always be taken when using transporting and storing this type of equipment Failure to treat the product with care will reduce both the life of the instrument and its reliability If the Rigel UNI SIM is subject to condensation allow the Analyser to completely dry before use e Always check the Rigel UNI SIM and supplied accessories for signs of d
36. d diastolic settings see 7 1 2 Press the lt key to return to the previous screen 36 Page Rigel Medical UNI SIM user Manual V3 2 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 Heart b Rate 80 2 IBP 1267 79 ECG Atrial Fibrillation Temperature piration Patient Test Settings Static IBP Test In the next screen select the required wave form frequency and amplitude settings Patient Simulator Settings Waveform i Frequency Amplitude 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 The frequency can be entered manually Note that the Pulse Wave has no frequency option it is a fixed 20ms pulse every 4 seconds 37 Page Rigel Medical UNI SIM user Manual V3 2 WV ave Square Wave Triangle Wave Amplitude pulse Wave Frequency Confirm by pressing the v 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 7 1 1 Press the x key F2 to return to the previous screen 38 Page Rigel Medical UNI SIM user Manual V3 2 8 Setting up your tester The Rigel UNI SIM is designed to allow the user to customise the device to allow
37. e Comment field is displayed after failed test only Never Comment field is not displayed 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 local Rigel sales office UK 44 0 191 5878701 8 3 5 Date Time Allows the user to set the current date time and preferred formats Press the Date Time button F2 The following menu will be displayed 60 Page Rigel Medical UNI SIM user Manual V3 2 Day Enter current day Month Use the up down left and right keys to select the current month Year Enter current year Time Enter current time Use the F1 to separate hours from minutes to ensure the correct time is entered and saved v Confirm the settings by pressing the button F4 Ones all System Configurations have been completed press the V button F4 Changes are saved automatically 8 4 Bluetooth Favourites In order 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
38. e default setting is which includes all records that Passed 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 For Date entry use format DDMMYYYY or DD MM YYYY For example for 31 October 2008 use 31102008 Test Status Allows the user to select search criteria based on PASSED FAILED or UPLOADED items To start the search press the v button F4 or the e button F3 to leave this Screen 10 3 View Data Options s From the main View Data screen press the button F2 View Data Search Result Download to PC Delete Single Asset Delete All Assets This will present an options menu to allow the user to e Print All Labels Will download all records within the search criteria to the Test n Tag printer setup in Bluetooth favourites e Download to PC Will download all records within the search criteria to the PC setup in Bluetooth favourites e Delete Single Asset Will delete the single selected record Delete All Assets Will delete all records from the memory this action is irreversible 84 Page Rigel Medical UNI SIM user Manual V3 2 11 Data Transfer Data transfer is used to transfer records and configuration data to and from a PC load a logo in bitmap format for use with the Seaward Test n Tag print
39. el 275 mmHg Duration 160s NIBP Pop off Test 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 Visual Test NIBP Leak Test NIBP Settings o curve NIBP Simulation Custom Test 49 Page Rigel Medical UNI SIM user Manual V3 2 Confirm using the v button F4 The following menu will define the nature of the test eg test Instruction prior to leak test Use the drop down box to choose a preset instruction and engineering unit or simply type in the boxes provided Newly entered data will be added to the drop down box ona first come first serve basis Edit Custom Test Custom Test Name urn into service mode Custom Test Units To insert the new Custom Test press the button F4 or exit using the x button F3 and return to the previous screen without changes being made NIBP Settings o curve P systolic 30720mmHg Diastolic 80mmHg Custom Test urn into service OGA Further tests can be inserted or deleted by following the steps described herein To exit and save the changes for future press the e button followed by pressing the 1 button If the Escape button F3 is pressed the Rigel UNI SIM will return to the previous meny without changes being made 50 Page Rigel Medical UNI SIM user Manual V3 2 Save changes 8 1 13 V
40. equired Print Label will print a pass fail label on the thermal printer 50 mm roll Print Result will print the result on the thermal printer 50 mm roll 9 44 View Results Press the View result Button to review the data Use the Up and Down keys to scroll through the screen Leak Test Drop 5 000 mmHg Use the e button F2 to return to the Test Details screen The button F4 provides extra option to print results label or Test n tag 79 Page Rigel Medical UNI SIM user Manual V3 2 10 View Data gt To view the stored data press the button F4 and select View Data from the menu Heart Rate 80 bpm Default Systolic 1 20 mmHg Auto Mode Data Transfer gt Setup gt About The following screen provides an overview of all available records in the memory identified by Asset ID Site and Pass or Fail View Data Search Result Use the up and down arrow keys to scroll through the database When the desired record is highlighted press the v button F4 to enter the record and view the data This will display the Test Details Screen 80 Page Rigel Medical UNI SIM user Manual V3 2 Asset ID 123456 Tested by Tested on Mode Status Test Period months t Use the button F2 to return to the main View Data screen Use the gt button F3 to view the Trace Variables Asset Trace Variables Service Code Site Location Make Model Description Serial Number Cl
41. et test sequences can be stored to meet specific requirements See 8 1 more information on creating new test sequences 72 Page Rigel Medical UNI SIM user Manual V3 2 Run Mode e Semi Automatic allows the user the enter data after each individual test that forms a test Sequence e Full Automatic will run through the test sequence and provides an opportunity to enter data at the end of the complete sequence Test Period The re test period allows the user to include the next test date on printed labels and PC downloads that make it easier to schedule future work More details on printing labels see 9 2 v When all information is entered press the F4 to accept and continue to the next screen for Asset Trace Variables User Name Asset ID 12345 Test Sequence Default Adult lt gt Run Mode Automatic 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 8 2 for more information Trace variables can be added once the above data has been entered and confirmed Service Code Site Peterlee Location Building BAG Make DG Medical Model JB4000 Description Patient Monitor Serial Number X YZ1234567890 Client North East NHS 73 Page Rigel Medical UNI SIM user Manual V3 2 9 1 Performing an Automatic Test The automatic mode provides an option to test all available tests inlcuding SPO2
42. guences Asset Trace Variables system Config Bluetooth Favourites User Admin gt Ji Memory Options Restore Factory Settings Service Code Site Location Make Model Description Serial Number Client 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 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 Once a variable has been activated the user is given the ability to enter Trace Variables prior to a safety test by selecting from or adding to the list of default items Each variable entered during the automatic test will automatically be added to the list for future use Trace Variables that are de activated set to NO will not appear during the automatic tests 58 Page Rigel Medical UNI SIM user Manual V3 2 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 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 Heart Rate Default i Test Sequences Asset Trace Variables Bluetooth Favourites
43. h the lowest value and going up See 8 1 9 for instructions on ending the static pressure test Insert the NIBP Static Pressure Test Settings from the drop down list and press the e key to edit the test settings est Settings Pressure EE mmHg Timer E js Navigate using the Up amp Down Keys and enter the required values Refer to the instructions in 5 15 3 for further instructions on the options available Confirm and insert by pressing the v key F4 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 Insert the NIBP Stop Static Pressure Test from the drop down list Note that there are no settings to change 8 1 10 IBP Static Test Perform a static IBP test by setting the required value G Insert the IBP Static Test Settings from the drop down list and press the the test settings key to edit 47 Page Rigel Medical UNI SIM user Manual V3 2 est Settings IBP Static EE mmHg Timer po s Navigate using the Up amp Down Keys and enter the required values Refer to the instructions in 5 17 2 for further instructions on the options available Confirm and insert by pressing the v key F4 8 1 11 Performance Wave test Simulate a performance waveform Insert the Performance Wave Test Settings from the drop down l
44. he UNI SIM offers the test capabilities equal to most bench mounted versions a simple user interface large internal memory 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 e Portable and Lightweight Ideal for field service technicians and in situ testing of NIBP performance e Battery Operated For convenient and fast testing without mains power e Manufacturer O curves To ensure accurate simulations across a wide range of different brands and models e Internal Pump Easy testing of pneumatic leaks and over pressure valves e Manufacturer R curves To ensure accurate simulations across a wide range of different brands of SPO2 probes e Prepared for PPM Protocols Configured for automatic performance testing of a variety of parameters e Full Keyboard Easy data capturing and asset management e Intuitive User Interface Fast and easy navigation using graphics display e Graphics Display Allowing real time display of pressure curves and simulation data e Bluetooth Communication PC download and future field upgrades e Web Updates Enjoy easy updates through our website to benefit from the latest features 6 Page Rigel Medical UNI SIM user Manual V3 2 1 3 Interfaces C N HH e eoooo OOO Q GS OOQUCS o OOO
45. ient Use the K button F2 to return to the main View Data screen In the Test Details screen press the button F4 to view the following options View Sequence User Comment Print Result Print Label 81 Page Rigel Medical UNI SIM user Manual V3 2 View Results will display the results of the test see section 10 1 View Sequence will display the test Sequence User Comment will allow the user to enter comments if required Print Result will print the result on the thermal printer 50 mm roll see Appendix D Print Label will print a pass fail label on the thermal printer 50 mm roll See Appendix D 10 1 View Results i E From the Test Details screen select button F4 View Sequence User Comment Print Result Print Label Use the up and down keys to select the view results option Press the v button F4 to display the view text results screen see below View Test Results Visual Test Put in service mode Use the K button F2 to return to main menu Press the button F4 to provide the options to print the results 82 Page Rigel Medical UNI SIM user Manual V3 2 10 2 Search the database From the main View Data screen press the a button F1 View Data Search Result Asset ID Test Status Date from Date to Service Code 83 Page Rigel Medical UNI SIM user Manual V3 2 Use the up down left and right keys to navigate this screen Th
46. iew Delete or Copy an existing Test Routine Preset test sequences cannot be deleted or changed by the user however alterations are possible by producing a copy of the default test sequence To enter the Test Sequences menu click on El followed by Setup Select the Test Sequences from the list and press v F4 Heart Rate 80 bpm Default Systoli Asset Trace Variables system Config View J Bluetooth Favourites Data T User Admin gt Ju Memory Options Restore Factory Settings 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 51 Page Rigel Medical UNI SIM user Manual V3 2 Default Adult From this menu the user is able to View a test sequence by pressing the View button F4 Default test settings cannot be altered at any stage To Copy Delete or Print an existing or default test sequence use the Up amp Down arrow keys to highlight the test sequence and press the button F2 Default Adult Delete Sequence Print Sequence v Use the Up amp 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 See 8 1 14 for more on editing test sequences Print Test Sequence will provide an overview of
47. ight Keys to activiate yes or de activate no certain features See menu below User Name System Config Download ta PC Upload fram PC Erase Restore Factory Settings Edit Test Sequences Press the V 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 v F4 to accept 69 Page Rigel Medical UNI SIM user Manual V3 2 Memory No of assets o Space available 100 0 Assets Deleted a Assets Uploaded 0 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 The data still remains and will use memory space The memory must be erased in order to release memory used by deleted records If the Erase F2 key is pressed a prompt is shown below To erase the memory press v button F4 Clear Results Memory Are you sure 70 Page Rigel Medical UNI SIM user Manual V3 2 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 Heart Rate 80 bpm Default i Test Sequences Asset Trace Variables System Co
48. ineers no longer need to use a variety of different instruments for testing these functions separately Whilst the instrument incorporates a range of custom settings that include a variety of paediatric and adult NIBP pressures pulse volume adjustments heart rate and manufacturer specific O curves the UNI SiM can be fully customisable to meet specific performance test conditions The Rigel UNI SiM also utilises new and advanced technologies to maximise the accuracy of each simulation such as using both electronic and optical SPO2 simulation methods in a single test setup and manufacturer specific simulation curves during the NIBP simulation reducing uncertainties thus improving the test time Featuring Bluetooth connectivity simulation test results can be stored within the instrument and printed wirelessly to the rugged battery operated Elite Test n Tag printer Traceability is improved as information can be downloaded into Med eBase the easy to use asset management software This enables the user to store and manage test results email html test certificates to clients and schedule new work orders which can then be fully uploaded into a large onboard memory The compact lightweight design and long life battery power of the UNI SiM reduces downtime between tests making the instrument practical and highly portable for multi site use It features easy to follow menu driven instructions for ease of operation and test control of all requ
49. ired electrical safety tests in manual semi automatic or fully automatic test modes A large internal memory facilitates the storage of test results for safety audit and traceability purposes In addition as well as storing the results of electrical tests there is also the ability to record user defined inspections and measurements from other equipment such as SpO NIBP ECG and other electro medical patient equipment The new Rigel UNI SIM forms part of a comprehensive range of high performance specialist biomedical test equipment supplied by Rigel Medical part of the Seaward Group 5 Page Rigel Medical UNI SIM user Manual V3 2 1 1 Rigel UNI SIM Design Philosophy The UNI SIM has been designed to address the increasing demand for smaller more comprehensive test equipment within the Healthcare Industry The challenge was to combine the functionality of three separate simulators into a single hand held device without compromising on the accuracy and functionality Today s industry demands test equipment that can save time and cost thus offering greater flexibility These factors have all been taken into account during the development of the UNI SIM The test capabilities and functionality exceed that of most individual simulators yet the instrument is only a fraction of the size and weight of No other single simulator on the market is able to simulate all six vital signs like the UNI SIM does Housed in a hand held enclosure t
50. ist and press the P key to edit the test settings Patient Simulator Settings Waveform Frequency Amplitude Duration Navigate using the Up amp Down Keys and enter the required values Refer to the instructions in 5 17 3 for further instructions on the options available Confirm and insert by pressing the v key F4 48 Page Rigel Medical UNI SIM user Manual V3 2 8 1 12 User definable tests Custom tests or Instructions are intended to allow the user to capture additional information either prior to or after the main simulation and performance tests Such information could indicate the condition such as Labels software version certain damage or upgrades To create customised inspections use the insert Custom Test function using the instructions below and set the engineering units to blank 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 Hint Create a unique range of visual tests or instructions by creating a new test sequence see 8 1 1 and select Custom Test as the nature of the test This will create a unique test sequence To insert a Custom Test highlight the place where a new test needs inserting using the up and down keys and press the Insert button F1 from the menu below Note Tests will be inserted before the highlighted position not after NIBP Leak Test Set Lev
51. itions without prior notice Calibration Statement The Rigel Uni SIM Vital Signs 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 Experience has indicated that the calibration of this instrument in not effected by storage prior to receipt by the user We therefore recommend that the recalibration period be based on a 12 month interval from the first date the unit is placed in to service Date received into service i 1 Copyright 2015 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 be part of any contract for the equipment unless specifically referred to as an inclusion within such contract Disposal of old product The Rigel Uni SIM Vital Signs Simulator has been designed and manufactured wi
52. lect the Bitmap file Select the required Bitmap and click on Open The Bluetooth Downloader will now transfer the file to the Rigel UNI SIM 91 Page Rigel Medical UNI SIM user Manual V3 2 When the transfer is complete the Rigel UNI SIM screen will display a message as shown below v Press the OK button F4 to save the logo The logo is now available for printing using the Seaward Test n Tag printer Note The file transfer can be made using any suitable PC application such as the Seaward Bluetooth Downloader data transfer exe or Hyperterminal 92 Page Rigel Medical UNI SIM user Manual V3 2 12 About This screen provides details on the Rigel UNI SIM s Firmware version Hardware version Calibration status Last Calibration Date Serial Number Bluetooth ID Select ABOUT from the menu below 80 bpm 126 79 al Fibrillation Auto Mode View Data Data Transfer gt 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 93 Page Rigel Medical UNI SIM user Manual V3 2 Rigel UNI SiM Tech Support Firmware Version am Steere eee NIBP SPO2 Hardware Version Firmware Version PAT Hardware Version Firmware Version SPO2 Calibration Status Last calibrated L
53. m again using the press the Key F2 to make further changes 32 Page Rigel Medical UNI SIM user Manual V3 2 key F4 or 7 1 4 Changing the Respiration settings Referring to Patient Screen 3 fig 3 choose the respiration rate from the drop down box Patient Simulator Sattinde Respiration Rate 5 Base Imped Delta Imped m WA Li i Select by pressing the V key F4 Repeat the same for the Base Impedance and Delta Impedance Respiration Rate Base Imped Delta Imped Apnoea Duration ju Select by pressing the V key F4 Patient Simulator Settings Respiration Rate g 1 Base Imped Delta Imped Apnoea Duration Apnoea Interval ju Select by pressing the v key F4 33 Page Rigel Medical UNI SIM user Manual V3 2 To simulate an Apnoea enter the duration and interval time between Apnoea in seconds Patient Settings Respiration Rate Base Imped ax Delta Imped 1 0 lt gt Apnoea Duration Apnoea Intera f Note that an Apnoea Duration of 0 equals no Apnoea A value of 0 for Apnoea Interval would result in a constant Apnoea if a value greater then 0 is entered for the Apnoea duration Confirm by pressing the v key F4 and confirm again using the v key F4 or press the Key F2 to make further changes The updated information is now available from the Patient Simulator Summary Screen below 80 bpm
54. me mins Use the up down left and right keys to set the power off time on the tester Settings between 0 10 minutes Note 0 minutes will deactivate the AutoSwitch Off feature e Data Entry Sets the tester up to take data entry from Barcode or Keypad only Use the up down left and right keys to select Barcode or Keypad only Note n data entry mode the unit will automatically try to connect to a barcode scanner via the internal Bluetooth module if the scanner is available this feature will drain the batteries u necessarily In this instance it is recommended that the unit be set to Keypad only e Backlight Mode Chose between Always Off Always On Power Save Back light on for 30 secs after each key press Use the up down left and right keys to select e User Rights For information only To change the user rights see 8 5 4 4 The F2 button allows the user to set the audible warnings and beep on key presses See menu below one preferences Beep on key press Beep on Heartbeat Beep on Barcode Beep on warning Beep on data entry Beep on Tests 67 Page Rigel Medical UNI SIM user Manual V3 2 Navigate using the Up amp Down Keys and change between Yes No using the left key Confirm the settings using v o button F4 this will return to the Home screen o e button F2 will return to previous menu and save data x o button F3 will return to the home screen without changes being sa
55. n service mode switch to service mode now The first test of the Default test setting is the the NIBP Leak Test NIBP Leak Test P Drop Start P mmHg 155 5 Timer Following the Leak test the overpressure valve is tested NIBP Pop off Test Set Level mmHg 272 7 76 Page Rigel Medical UNI SIM user Manual V3 2 Following the Overpressure valve test the UNI SIM is ready to make all simulations as per the test routine 120 80 Sow MAP 93 0 T YSI700 370 B 100 96 s IBP 126 79 Pressing the x STOP button F3 during any test will bring up the failure menu see 9 1 1 At the end of the test the user has the ability to enter comments See 8 3 3 for more information on how to activiate comments after a test Generated by Rigel UNI SiM Press the button F4 to store the comments Depending on the settings in Menu Setup System Config see 8 3 2 a number of After Test options are possible e New Test Automatically brings up the next test screen No further options or viewing of results available e Download Automatically down loads the test results to the PC see 7 1 No further options or viewing of results available The tester will return to the home screen e Print Label Automatically prints the test results to a thermal printer 77 Page Rigel Medical UNI SIM user Manual V3 2 No further options or viewing of results available The tester will return to the h
56. nce Wave forms Auto Mode View Data Data Transfer Download to PC Upload fro PC Configuration Data Load T nT Logo Setup Test Sequences Test Codes Asset Trace Variables System Config Bluetooth Favourites User Admin gt Preferences Chance User Change Password User Profile Memory Options Restore Factory Settings About 100 Page Rigel Medical UNI SIM user Manual V3 2 5 WAY LEMO FGGOB 305 CLADSeZ RS 215 6010 43211 Im LONG HEATSHRINK SLEEVING AS REQUIRED FOR CABLE CLAMP RED 4 Ext WHITE 2 SIG GREEN 3 S1G2 YELLOW 4 SIGI BLACK 5 EXC SCREEN SHELL Appendix B IBP Interconnect cable wiring diagram Rigel Medical UNI SIM user Manual V3 2 101 Page Appendix C Temperature cable wiring diagram STRIP BACK amp TIN Smm T 43304 1m LONG 3 WAY LEMO FGGOB 303CLADS8SZ RS 215 5988 RED YELLOW GREEN SCREEN PI I TIP 2 RING 3 SHIELD SHELL Rigel Medical UNI SIM user Manual V3 2 102 Page
57. nfig Bluetooth Favourites User Admin gt JR Memor ptions Restore Factory Settings All the settings provided within the Setup menu will default to Factory Settings including All Asset Trace Variables Test Sequences User Admin Test Codes and System Config Warning Restore Factory Settings cannot be undone and will remove all the customised items described above 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 71 Page Rigel Medical UNI SIM user Manual V3 2 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 V F4 to accept Heart Rate 80 bpm Default Systolic 1 20 mmHg View Data Data Transfer Setup gt About Asset Details User Name Admin asam i Test Sequence Default Adult i Run Mode Test Period months Asset ID Each test record is stored using the Asset ID number 25 character max and date time of test 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 Choose a selection of default and custom made test sequences A total of 50 pres
58. ome screen e Test n Tag Automatically prints a Test n Tag label see 4 2 No further options or viewing of results available The tester will return to the home screen e Options Menu Provides a menu to allow further choices after a test see 4 3 9 2 Test n Tag The Rigel UNI 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 8 4 A detailed application note is available from the Rigel website on the used of Test n Tag printers with the Rigel UNI SIM Please visit http www rigelmedical com knowledgebase 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 Asset ID 123456 Tested by Admin Tested on 08 Oct 2008 12 12 PM Automatic Status Test Period months The test screen provides the following features e Goto the home screen F1 e Continue with the next test F2 e Options F3 To view the options menu select the button F4 from the test details screen The options menu provides the following sub menu 78 Page Rigel Medical UNI SIM user Manual V3 2 Asset ID 123456 Tested by Tested on 08 Oct 2008 12 12 PM Print Label Print Result View Results will display the results of the test see section 9 4 User Comment will allow the user to enter comments if r
59. ot after To modify a test sequence please refer to 8 1 15 NIBP Leak Test Set Level 275 mmHg Duration 180s NIBP Pop off Test OOGA 56 Page Rigel Medical UNI SIM user Manual V3 2 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 Visual Test NIBP Leak Test NIBP Settings o curve NIBP Simulation Custom Test Once the desired test has been highlighted confirm using the OK button F4 and finally confirm to insert into the test Sequence Pressing the x button F3 will return to the previous screen without changes being made The individual test has now been inserted and can be edited as described in 3 1 4 NIBP Leak Test Set Level 275 mmHg Duration 180s NIBP Settings fo curve P Systolic 20mmHg jin eiA Further tests can be inserted or deleted by following the steps described herein 57 Page Rigel Medical UNI SIM user Manual V3 2 8 2 Asset Trace Variables The Asset Trace Variables allow the user to include valuable data to the test results to enhance the traceability and to provide increased search criteria when using database software 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 in automatic mode Heart Rate 80 bpm Default Test Se
60. p amp Down Keys and change each setting by using the left key Refer to the instructions in 5 1 for more options available Confirm and insert by pressing the v key F4 8 1 3 Insert SPO2 test settings Use the SPO2 test settings to set the required parameters for SPO2 simulation SPO value Heart rate Manufacturer R curves Skin colour Perfusion Arrhythmia s upgrade Artefacts upgrade Checking of LED quality both Red and InfraRed Insert the SPO2 Test Settings from the drop down list and press the 9 key to edit the test settings 44 Page Rigel Medical UNI SIM user Manual V3 2 Technology SPO2 Heart Rate Skin Colour Perfusion Navigate using the Up amp Down Keys and change each setting by using the left key Refer to the instructions in 5 16 for more options available Confirm and insert by pressing the v key F4 8 1 4 Insert Patient Simulator settings Select the Patient test Settings to set the parameters for Heart rate ECG waveforms Arrhythmia s and amplitudes Invasive blood pressure settings Temperature simulation settings Respiration settings Heart Rate EE ECG Wavef Normal Sinus Amplitude The different options above are available across three individual screens accessible using the tab button F2 Navigate using the Up amp Down Keys and change each setting by using the left key 45 Page Rigel Medical UNI SIM user Manual
61. rds to a PC database software package or connect to Elite 36 5011 when requiring a print out Note Press X F2 to exit without saving changes Press C F3 if necessary to select another device Press v F4 button to save changes 65 Page Rigel Medical UNI SIM user Manual V3 2 When all your favourite devices have been set up press F4 and they will be saved 8 5 User Admin The User Admin feature allows the user to personalise the way in which the tester behaves during normal use and include features such as Preferences see 8 5 1 Change User see 8 5 2 Change Password see 8 5 3 User Profile see 8 5 4 To enter the User Admin feature press the button F1 from the home screen select Setup followed be User Admin The following menu will appear Default Test Sequences Systoli Asset Trace Variables system Config Navigate through this menu using the Up amp Down Keys and select by pressing the v button F4 or the right arrow key 8 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 66 Page Rigel Medical UNI SIM user Manual V3 2 Preferences User Mame Admin Set Contrast Auto Off Time mins lt gt Data Entry gt Backlight Mode User Rights e Set Contrast Use the up down left and right keys to set the contrast e Auto Off Ti
62. reate a new Test Sequence The available options for inseting tests are provide in table T1 below Pos Title Description Ref 1 NIBP Simulation Settings Select the type of O curve systolic and diastolic simulation values heart rate and pulse volume NIBP Test Settings 5 1 SPO2 Simulation Settings Select the type of R curve SPO2 simulation values heart rate red infra red simulation perfusion and skin colour 6 Patient Simulation Settings Select the type of ECG waveform Arrhythmia IBP temperature and respiration settings 7 1 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 individual simulations is required ie 2 x NIBP this instruction must be inserted twice at the end of each new setting NA NIBP Leak Test Perform a system of cuff leak test by setting the set value and time duration 5 2 NIBP Pop off test Perform a system overpressure release test recording the sudden pressure release 5 4 NIBP Static Pressure test Perform a static pressure test by setting the required value Multiple static pressure tests can be inserted starting with the lowest value and going up 5 3 NIBP Stop Static Pressure test This must be inserted in order to stop the s
63. row 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 A progress bar as shown below will now follow the data transfer until download is complete Download ta PC Computer Baud Wo of assets Format Rigel SSS aiting to connect Connected Note To download a selection of the database refer to View Data section 6 Search on the required criteria then select download to pc from the options menu 86 Page Rigel Medical UNI SIM user Manual V3 2 11 2 Upload from PC This feature is only available when used in combination with the new Med eBase PC software and when the SSS format is activated on your device Select the Upload from PC option from the Data Transfer menu The Rigel UNI SIM will now attempt to establish a 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 To activate the SSS format on your Rigel UNI SIM tester please download the SSS Application note from our knowledge base Please visit www rigelmedical com knowledgebase 11 3 Configuration Data This feature can be used to transfer store or modify the current Trace Variables User Profiles and Comment list
64. s to from a PC It can be used to configure a number of Rigel UNI SIM units with identical Trace Variable User Profile and Comment lists Heart Rate 80 bpm Default Systolic 1 mmHg Once the UNI SIM has connected to the PC the Bluetooth icon will appear Capture the data using the datatransfer exe program or Windows hyperterminal 87 Page Rigel Medical UNI SIM user Manual V3 2 aiting to connect Connected Ready to Send And Receive Data 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 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 The baud rate will default to the correct value of 57600 In the application select Start Capture from the Capture menu in the task bar Data Transfer Fie fs lp v Z Configure COM Port ure OIL Time 00 00 00 Estimated time to completion 00 00 00 Ready Data received from Tester Capture OFF Fie Name Enter a valid file name for the text file containing the download information see below 88 Page Rigel Medical UNI SIM user Manual V3 2 Save in e Config Data x aaea O My Recent Documents Desktop Save as type X Cancel iini File name Once the text file has
65. system and clone data _ The Data Transfer functions are accessed by pressing the button F4 selecting Data Transfer using the up and down keys and pressing the V button F4 Heart Rate 80 bpm Default Systolic 1 20 mmHg ada E Upload from PC Configuration Data Load TnT Logo 11 1 Download to PC This feature is used to download records to a PC Select Download to PC and press the v 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 Download to PC Computer Baud Wo of assets sELLTO23 57600 Format Rigel SSS aiting to connect Initially the Bluetooth status icon will display the egg timer for a few seconds as shown 85 Page Rigel Medical UNI SIM user Manual V3 2 on the left while the connection is established 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 Download to PC Computer Baud Mo of assets sELLTO23 57600 Format Rigel SSS aiting to connect Connected The Rigel UNI SIM is able to download in a number of formats to suit individual requirements These are e CSV Full Comma Separate Value download only CSV Summary Comma Separate Value download only e Rigel SSS Up and download format Toggle between the options by using the left and right ar
66. t Navigate using the Up amp 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 NIBP Tact Gattinac Monitor Type Default Adult Infant WA ProPaq Systolic Dias Acutor llus Heart Rate Pulse volume Additional manufactures will be developed and can be uploaded through new firmware revisions from our website http www rigelmedical com downloads as Adult Infant 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 18 Page Rigel Medical UNI SIM user Manual V3 2 Heart Rate Pulse Volume Note that the settings Low Medium High are not directly linked to any Manufacturer Adult Infant systolic Diastolic Heart Rate Pulse volume Enter the required simulated heart rate Select the required pulse strength to simulate different volume strength NIBP Test Setting Manufacturer Adult Infant Heart Rate Pulse volume L IET Te physiological condition Note that High pulse volume settings can only be achieved when the UNI SIM is connected to the mains through the correct power supply 19 Page NIBP Test Settings Monitor Tyne Adult Infant lt gt Systolic Diastolic 120 80 Heart Rate eo
67. tatic pressure tests and release the pressure from the system prior to starting the simulations Without this instruction none of the simulations will start NA 10 IBP Static Test Perform a static IBP test by setting the required value 7 2 11 Performance Wave test Simulate a performance waveform 7 3 12 Custom Test Insert cusom tests or instructions by using free text fields The user must confirm or enter a value in each field Insert as many fields as required at the appropiate position in the test sequence 8 1 12 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 40 Page Rigel Medical UNI SIM user Manual V3 2 est Sec Asset Trace Variables system Config Data T User Admin gt Slee Memory Options Restore Factory Settings The following screen displays the list of default and customised tests available Copied Test Sequences will appear in the list with an pre fix Adult arameter AG From this menu the user is able to create a new Test Sequence by pressing the LE button F1 41 Page Rigel Medical UNI SIM user Manual V3 2 Use the keyboard to activate the text box When activated function keys F1 tT and F2 U appear automatically In this instance Customer test 1 has been created as Test Name
68. ted 22 Page Rigel Medical UNI SIM user Manual V3 2 NIBP Pop off Test Set Level mmHg 272 7 At the end of the test the UNI SIM will show the set point of the protection valve ie 331 mmHg Press V F4 to repeat the test fa F2 Press 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 Select the Manometer mode from the NIBP menu NIBP Manometer Mode mmHg Pressure Units Ensure the manometer is set to zero by pressing the SET ZERO F3 button whilst the pressure connection at the UNI SIM panel is open Select the engineering unit from the drop down box using the left and right keys 23 Page Rigel Medical UNI SIM user Manual V3 2 NIBP Manometer Mode mBar cmH20 The manometer will automatically convert the pressure to the desired pressure unit fa F2 Press to return to start menu 5 6 Set Zero The Set Zero function is required to ensure the manometer is pressurised to the ambient pressure 24 Page Rigel Medical UNI SIM user Manual V3 2 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 Manufacturer R curves Skin colour Perfusion Arrhythmia s upgrade Artefacts upgrade Chronometer function Checking of
69. th high quality materials and components which can be recycled and reused When this symbol is attached to a product it means the product is covered by the European Directive 2012 19 EC Please familiarise yourself with the appropriate local separate collection system for electrical and electronic products or contact your local supplier for further information Please dispose of this product according to local regulations Do not dispose of this product along with normal waste material By offering your old products for recycling you will help prevent potential negative consequences for the environment and human health Certificate of Conformity This product is manufactured by Seaward Electronic Ltd Bracken Hill South West Industrial Estate Peterlee County Durham SR8 2SW UK Statement of Conformity As the manufacturer of the apparatus listed declare under our sole responsibility that the product Rigel Uni SIM Vital Signs Simulator To which the declaration relates are in conformity with the relevant clauses of the following standard BS EN 61010 1 Safety requirements for electrical equipment for measurement control and laboratory use Part 1 General requirements BS EN 61326 Electrical equipment for measurement control and laboratory use EMC requirements Performance The instrument operates within specification when used under the conditions in the above standards EMC and Safety Standards The product iden
70. tified above conforms to the requirements of Council Directive 2004 108 EC and 2006 95 EC This Conformity is indicated by the symbol i e Conformit Europ enne Seaward Electronic Ltd is registered under BS EN I809001 20068 Certificate No Q05356 1 Page Rigel Medical UNI SIM user Manual V3 2 User Prom M EAAS 4 EMEN sss M 5 1 1 Rigel UNI SIM Design Philosophy eeeeee ee eene ee eene nn enne nnn nnne nannten 6 1 2 CH II EPHTOTOTDOTIIDU EID TIL CI CQ IDLITILLITLICILDOITL LLE 6 1 3 TEILE 7 1 4 Connecting the accessories 11 oor e ora ese su oo no raso poaae pai P nae a Fa phan se pa OENo S Ro oeaa epa din 8 1 5 Rigel UNI SIM accessory pack includes pn 370A931 eere 8 1 6 Additional amp Optional Accessories eeeeee esee ee esee esee eene e nennen enses e nnno 9 1 7 Test n Tag Comipatible 21e cii ore e een eren cette ena o SG saga a c do arena neon ka o coeur naa Ee uaa 9 2 Using the PULS R optical finger with the UNI SIM eere eee eene 10 2 1 Accuracy of simulation when used with the corresponding R curves 10 2 2 Gettirig started oe tere rre REESE eh xe Ee epe Rosen ees eR een EN SP pNS 11 2 3 Performing SP02 simulations 1 eese eeee eese eniin eee eene enne enne nnns tt nnno stan 12 2 4 Unique use of ICON
71. user with the features of testing a specific individual test and or test condition for example to test a selection of ECG wave forms Arrhythmia s Performance wave forms Respiration Temperature Invasive blood pressure Press PAT F1 from the start summary screen 80 bpm 120 80 Normal Sinus Rhythm Temperature S1400 25C Respiration 15 bpm Apnoea None bpm 120 80 Normal Sinus Rhythm Temperature Respiration Static IBP Test Performance Wave Test e Patient Test Settings see 7 1 e Static IBP Test See 7 2 e Performance Wave Test see 7 3 29 Page Rigel Medical UNI SIM user Manual V3 2 7 1 Patient Test Settings Select the Patient test Settings to set the parameters for e Heart rate ECG waveforms Arrhythmia s and amplitudes Invasive blood pressure settings Temperature simulation settings Respiration settings The different options above are available across three individual screens accessible K using the tab button F2 Patient Simulator Settings Heart Rate z E ECG Wavef Normal Sinus Amplitude Figure 1 Patient Screen 1 Patient Simulator Settings Heart Rate ld Systolic Diastolic Temperature YSI400 25C lt gt Figure 2 Patient Screen 2 Patient Simulator Settings Respiration Rate 15 Base Imped Delta Imped Apnoea Duration Figure 3 Patient Screen 3 30 Page Rigel Medical UNI SIM user Manual V3
72. ved 8 5 2 Change 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 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 amp Down Keys and enter a new password followed by confirmation of the new password Use the key F4 to finish and press the V button F4 to confirm and save the new password To change an existing password enter current password and repeat the steps above See menu below for an overview of the Change Password screen Change Password User Name Admin Current Password New Password X XxXxX Confirm New Passw XXXXXI 68 Page Rigel Medical UNI SIM user Manual V3 2 8 5 4 User Profile This feature allows the administrator to setup new and existing users and inhibit or assign certain feautures to individual users Note that the User Profile is only valid when the ADMIN user has been setup with a PASSWORD See item above If no ADMIN password has been set all users have FULL User Rights Select the applicable user name use the Up amp Down Keys to navigate through the menu use the Left amp R
73. your Trace Variables User Profiles and 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 If the transfer is not successful check that the format of the configuration file exactly matches that specified Note The Config file must be ASCII text and the last entry must be the END statement 90 Page Rigel Medical UNI SIM user Manual V3 2 11 4 Load TnT Logo A bitmap logo can be transferred to the Rigel UNI 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 A Press button F4 select Data Transfer using the up down keys select load T n T logo and press the v button F4 Heart Rate 80 bpm Default systolic 1 20 mmHg bu Download to PC Upload from PC YEME Data 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 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 This will open a window allowing you to se

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