Rigel Medical UNI-SiM User manual

rigelmedical.com
UNI-SiM
USER MANUAL

RIGEL MEDICAL UNI-SiM USER MANUAL
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Rigel Medical 24 Month Warranty Statement
Rigel Medical provides a standard 12-
during normal use. This warranty can be upgraded to a 24-month warranty (terms and
conditions apply*). Problems caused through misuse, damage, fair wear & tear,
consumables and accessories are excluded from standard warranty. Such components
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 conditions 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; / / .
© Copyright 2021
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.

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Disposal of old product
The Rigel Uni-SIM Vital Signs Simulator has been designed and manufactured with high
quality materials and components, which can be recycled and reused.
Please familiarise yourself with the appropriate local separate collection system for
electrical and electronic products or contact your local supplier for further information.
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.

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User Notes
These operating instructions are intended for the use of adequately trained personnel.
The UNI-SiM has been designed to be operated for indoor use in a dry environment, at a
temperature of 0 to 40 degrees C without moisture condensation, and at an operating
altitude 0 2000m.
The UNI-SiM has a protection rating of IP40 and is rated for operation at pollution degree
2 according to IEC 60529.
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.
The following symbols are used in these operating instructions and on the Rigel UNI-SiM.
Warning of electrical danger!
Indicates instructions must be followed to avoid danger to persons.
Important, follow the documentation! This symbol indicates that the operating
instructions must be adhered to in order to avoid danger.

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1. Introduction 7
1.1. Rigel UNI-SIM Design Philosophy 8
1.2. Key Features 8
1.3. Interfaces 9
1.4. Included accessories 9
1.5. Additional & Optional Accessories 10
10
2. Using the PULS-R optical finger with the UNI-SIM 11
2.1. Repeatability of simulation when usedwith the corresponding R-curves 11
2.2. Getting started 12
2.3. Performing SP02 simulations 13
2.4. Unique use of ICONS 14
3. Logging on 15
4. Getting Started 16
5. Manual Mode NIBP 18
5.1. NIBP Test Settings 19
5.2. NIBP Leak Test 21
5.3. Static Pressure test 22
5.4. NIBP Pop-off Test 23
5.5. NIBP Manometer Mode 24
5.6. Set Zero 25
6. Manual Mode SPO2 26
7. Manual Mode Patient Simulator 30
7.1. Patient Test Settings 31
7.1.1. Changing the ECG or Arrhythmia simulation 32
7.1.2. Changing the Invasive blood pressure settings 33
7.1.3. Changing the Temperature settings 33
7.1.4. Changing the Respiration settings 34
7.2. Static IBP Test 37
7.3. Performance Wave Test 38
8. Setting-up your tester 40
8.1. Test Sequences 40
8.1.1. Create a new Test Sequence 41
8.1.2. Insert NIBP test settings 44

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8.1.3. Insert SPO2 test settings 45
8.1.4. Insert Patient Simulator settings 45
8.1.5. Start Simulations 46
8.1.6. NIBP Leak Test 46
8.1.7. NIBP Pop-off test 47
8.1.8. NIBP Static Pressure test 47
8.1.9. NIBP Stop Static Pressure test 48
8.1.10. IBP Static Test 48
8.1.11. Performance Wave test 48
8.1.12. User definable tests 49
8.1.13. View, Delete or Copy an existing Test Routine. 51
8.1.14. Modifying (Edit) Existing Test Sequences 53
8.1.15. Edit individual Test 55
8.1.16. Insert an individual test 56
8.2. Asset Trace Variables 58
8.3. System Config 59
8.3.1. Asset ID 60
8.3.2. After Test 60
8.3.3. Comments 60
8.3.4. Language 60
8.3.5. Date / Time 60
8.4. Bluetooth Favourites 61
8.5. User Admin 65
8.5.1. Preferences 66
8.5.2. Change User 67
8.5.3. Change Password 68
8.5.4. User Profile 68
8.6. Memory options 69
8.7. Restore Factory Settings 70
9. Automatic Mode 71
9.1. Performing an Automatic Test: 72
9.1.1. Failure Menu 73
77
9.3. Options Menu 77

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9.4. View Results 78
10. View Data 79
10.1 View Results 81
10.2. Search the database 82
10.3. View Data Options 83
11. Data Transfer 84
11.1. Download to PC 84
11.2. Upload from PC 86
11.3. Configuration Data 86
11.3.1. Receive Config Data 88
11.4. Load TnT Logo 89
12. About 91
13. Maintaining the Rigel UNI-SIM 93
13.1. Cleaning the UNI-SIM 93
13.2. User Maintenance 93
13.3. Return Instructions 93
14. Technical Specifications 95
14.1 General Specifications 97
Appendix A Firmware Route Map 98
Appendix B IBP Interconnect cable wiring diagram 99
Appendix C Temperature cable wiring diagram 100

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1. Introduction
The Rigel UNI-SiM is the only simulator of its type which enables medical device engineers
to quickly, easily, and accurately undertake NIBP, SpO2, ECG, temperature, IBP and
respiration functionality tests simultaneously using a single portable instrument.
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 -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 engineers 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 on-board 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 required simulations.
A large internal memory facilitates the storage of test results for audit and traceability
purposes. In addition, as well as storing the results of patient simulations, there is also the
ability to record user defined inspections and measurements from other equipment such
as SpO2, NIBP, ECG and other electro medical patient equipment.
The 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.

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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.
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.
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, the 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
•Portable and Lightweight - Ideal for field service technicians and in-situ testing of
NIBP performance
•Battery Operated - For convenient and fast testing without mains power
•Manufacturer O-curves - To ensure accurate simulations across a wide range of
different brands and models
•Internal Pump - Easy testing of pneumatic leaks and over-pressure valves
•Manufacturer R-curves - To ensure accurate simulations across a wide range of
different brands of SPO2 probes
•Prepared for PPM Protocols - Configured for automatic performance testing of a
variety of parameters
•Full Keyboard - Easy data capturing and asset management
•Intuitive User Interface - Fast and easy navigation using graphics display
•Graphics Display - Allowing real-time display of pressure curves and simulation data
•Bluetooth Communication - PC download and future field upgrades
•Web Updates - Enjoy easy updates through our website to benefit from the latest
features

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1.3. Interfaces
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
1.4. Included accessories
•Quick start guide
•ECG interconnect module 370A688
•10 ECG adaptor studs 274A725
•Universal Power Supply (230/110V) 370A010
•UNI-SiM carry case 71G098
•5-pc tubing adaptor set 370A005

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1.5. Additional & Optional Accessories
For a full range of UNI-SIM accessories and cables, please visit:
https://www.rigelmedical.com/gb/products/patient-simulation/patient-
simulators/370a930-uni-sim/
tible
The Rigel UNI-
Tag systems allows you to print customised Thermal PASS / FAIL labels.
•Robust and durable labels
•Resistant to most solvents used in the medical sector
•Free opportunity to advertise your logo and company details or emergency
•Automatic barcode generation to provide easy use of the barcode scanner thus
speeding up your test time.
printer, see section 9.2.

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2. Using the PULS-R optical finger with the UNI-SIM
The PULS-R optical finger is for use only with Rigel SP-SIM and UNI-SIM products
2.1. Repeatability of simulation when used with the corresponding
R-curves
Resolution
Range
Repeatability*
1% steps
30 - 60%
±5%**
1% steps
60 - 90%
±3%
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

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2.2. Getting started
Turn on your Rigel UNI/SP-SIM by pressing and holding the green start button until you
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.
The connection between the PULS-R, the UNI/SP-SIM and the monitor is shown in the
diagram using the SP02 connector lead.

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2.3. Performing SP02 simulations
The connection between the PULS-R, the UNI/SP-SIM and the monitor is shown in the
diagram connected to the SPO2 port on the SP-SIM/UNI-
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:
•Technology. E.g.: PULS-R, Masimo, Nellcor....
•SPO2 (%) simulated
•Heart Rate
Supported Default curves:
•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.

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2.4. Unique use of ICONS
The Rigel UNI-SiM features a high resolution graphic back lit display which not only
provides highly visible and easy to follow menu structures but also allows the user to
operate the tester using intuitive icons to speed up their test routines.
Below are of some of the icons used in the Rigel UNI-SiM:
Escape
Print
Add
Less
Applied Parts
Repeat
Copy
Save
Delete
Search
Edit
Settings
Help
Single Fault
Menu List
Shift
Home
Mute
New
Sound
OK - PASS

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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 0
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.
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 visit
https://www.rigelmedical.com/gb/support-ticket/ 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 post-
text and fault menus.

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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.
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:
•NIBP (F3) simulate NIBP, perform a system leak test, overpressure test, static
pressure test or manometer function.

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•SPO2 (F2) simulate SPO2 signals, response times, artefacts and check probe
performance
•PAT (F1) (full 12 lead patient simulator including ECG, Arrhythmia and
performance waveforms, respiration signals, temperature simulation and invasive
blood pressure simulation)
To change any of the default settings on each simulation, please refer to the relevant
manual mode sections in this manual, chapter Error! Reference source not found.,Error! Re
ference source not found. andError! Reference source not found..
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1. Manualmode(seeError! Reference source not found.,Error! Reference source not fo
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2. Setting-up your tester (see Error! Reference source not found.)
3. Automatic mode (0)
4. Data management (0,0)

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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;
When NIBP is selected, a number of options will be available;
•NIBP Test Settings (see 0)
•NIBP Leak Test (See 0)
•NIBP Pop-off Test (see 0)
•NIBP Manometer Mode (see 0)
•Set Zero (see 0)

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5.1. NIBP Test Settings
Use the NIBP Test Settings to setup a selection of Dynamic Pressure simulations.
Navigate using the Up & Down Keys and change each setting by using the left key.
Manufacturer; Select between a default O-curve or one specific to a manufacturer,
for example;
Additional manufactures will be developed and can be uploaded through new firmware
revisions from our website; http://www.rigelmedical.com/downloads.asp
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