Rigel UNI-SIM Lite User manual

Innovating Together
RIGEL UNI-SIM Lite
Patient simulator
Copyright © 2016SEAWARD GROUP
Last Update: April 20th 2016
Instruction Manual
370A5521 Revision 1.1

i
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 & 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 conditions without prior notice.
Calibration Statement
The Rigel UNI-SiM Lite Patient Simulator is fully calibrated and found to be within
the specified performance and accuracy at the time of production. The Seaward
Group provides its products through a variety of channels; therefore it may be
possible that the calibration date on the provided certificate may not represent
the actual date of first use.
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; / / .

ii
© Copyright 2016
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.

iii
Disposal of old product
The Rigel UNI-SiM Lite Patient Simulator has been designed and manufactured
with high quality materials and components, which can be recycled and reused.
Please familiarise yourself with the appropriate local separate collection system
for electrical and electronic products or contact your local supplier for further
information.
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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Statement of Conformity
This product is manufactured by:
Seaward Electronic Ltd, Bracken Hill, South West Industrial Estate, Peterlee,
County Durham, SR8 2SW, UK
As the manufacturer of the apparatus listed, we declare under our sole
responsibility that the product:
Rigel Uni-Sim Lite –Patient Simulator
Conforms with the relevant Directives and conformity is indicated by the symbol
, i.e. “Conformité Européenne”
Seaward Electronic Ltd. is registered under BS EN ISO9001 Certificate No.:
Q05356.
A copy of the Declaration of Conformity and a copy of our ISO certificate are
available in the Support & Resources area of the Seaward website
www.seaward.co.uk".

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Index
User Notes.................................................................................................................4
1Introduction .......................................................................................................5
1.1 Key Features........................................................................................................ 6
2Getting to know your Rigel UNI-SIM Lite.............................................................7
2.1 Additional & Optional Accessories........................................................................ 7
2.2 Icons used in the UNI-SIM Lite.............................................................................. 8
3Getting started...................................................................................................9
3.1 Quick NIBP simulation ......................................................................................... 9
3.2 Quick SPO2 verification.......................................................................................11
3.3 Quick ECG verification.........................................................................................13
4Manual Mode NIBP ..........................................................................................15
4.1 NIBP Test Settings...............................................................................................16
4.2 NIBP Leak Test....................................................................................................18
4.3 Static Pressure test .............................................................................................19
4.4 NIBP Pop-off Test................................................................................................20
4.5 NIBP Manometer Mode ......................................................................................21
4.6 Set Zero..............................................................................................................22
4.7 Custom O Curve..................................................................................................22
5Manual Mode SPO2..........................................................................................24
6Manual Mode Patient Simulator.......................................................................28
6.1 Patient Test Settings ...........................................................................................29
6.2 Static IBP Test.....................................................................................................35
6.3 Performance Wave Test......................................................................................36
7Setting-up your tester.......................................................................................38
7.1 Test Sequences...................................................................................................38
7.2 Asset Trace Variables ..........................................................................................57
7.3 System Config.....................................................................................................58
7.4 Bluetooth Favourites ..........................................................................................60
7.5 User Admin ........................................................................................................65
7.6 Memory options.................................................................................................68
7.7 Restore Factory Settings .....................................................................................70
8Automatic Mode ..............................................................................................71
8.1 Performing an Automatic Test:............................................................................73

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8.2 Test ‘n Tag ..........................................................................................................77
8.3 Options Menu ....................................................................................................77
8.4 View Results.......................................................................................................78
9View Data ........................................................................................................79
9.1 View Results.......................................................................................................81
9.2 Search the database ...........................................................................................82
9.3 View Data Options..............................................................................................83
10 Data Transfer ...................................................................................................84
10.1 Download to PC..................................................................................................84
10.2 Upload from PC ..................................................................................................86
10.3 Configuration Data .............................................................................................86
10.4 Load TnT Logo.....................................................................................................90
11 About...............................................................................................................92
12 Maintaining the Rigel UNI-SIM Lite...................................................................94
12.1 Cleaning the UNI-SIM Lite ...................................................................................94
12.2 User Maintenance ..............................................................................................94
12.3 Need help or want to return the product for service? ..........................................95
Technical Specifications ...........................................................................................96
Appendix A Firmware Route Map.........................................................................99
Appendix B IBP Interconnect cable wiring diagram.................................................100
Appendix C Temperature cable wiring diagram ......................................................101

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User Notes
These operating instructions are intended for the use of adequately trained
personnel.
The following symbols are used in these operating instructions and on the Rigel 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.
The UNI-SIM LITE is supplied with a mains power supply unit. The use of any other
power supply unit may cause damage to the equipment and may result in a hazard to
the user.
If the UNI-SIM LITE is used in a manner not specified by the manufacturer, the
protection provided by the equipment may be impaired.

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1 Introduction
This manual is constructed in 7 main parts:
1. Introduction
2. Get to know your simulator (see 0)
3. Quick start to get you up and running (see 3)
4. Manual mode (see 4,4.7,6)
5. Setting-up your tester (see 7)
6. Automatic mode (8)
7. Data management (9,10)
The UNI-SIM LITE is the smallest and most cost effective patient simulator capable of
undertaking six synchronised vital signs parameters.
Its rugged design and battery operation make the UNI-SIM LITE the ideal tool for
carrying out quick spot checks as well as full PM’s on vital signs monitors wherever the
job takes you. Fast boot-up and single button simulation repeats the last simulation
values in seconds, making the UNI-SIM LITE both quick and easy to use when carrying
out basic spot checks.
User configurable heart rate, SPO2 values, Systolic and Diastolic NIBP pressures make
the UNI-SIM LITE a truly versatile tool capable of meeting even the most demanding
test protocols.
The universal SPO2 simulation finger provides accurate and repeatable SPO2 values
using unique probe positioning LEDS to help the correct positioning of SPO2 probes,
improving accuracy and repeatability.
The new Rigel UNI-SIM LITE 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 Key Features
Compact and cost effective
Cost effective and compact solution for testing 6 of the most common vital signs
into a single battery powered enclosure
Fast start up and single button simulation
Automatic power-up of last simulation settings, providing a single button press
simulation of all 6 vital signs, saving valuable time setting up your simulator.
Accurate and real-life
Fully synchronised simulation signals provide the closest and most accurate
representation of a real patient.
User definable NIBP simulations
User configurable and physiologically correct systolic and diastolic pressures
provide a truly universal and accurate NIBP simulator.
Universal SPO2 simulation
Reduce the need for separate accessories with the universal PULS-R SPO2
simulation finger which is compatible with all of the common SPO2 technologies.

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2 Getting to know your Rigel UNI-SIM Lite
2.1 Additional & Optional Accessories
For a full range of UNI-SIM LITE accessories and cables, please visit:
http://www.rigelmedical.com/downloads/Rigel-SIM-Range-Accessory-Datasheet-Rev1-
1.pdf

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2.2 Icons used in the UNI-SIM Lite
The Rigel UNI-SIM LITE features a graphics back lit display which not only provides
highly visible and easy to follow menu structures but also allows the user to operate the
tester using intuitive icons to speed up their test routines.
Below are of some of the icons used in the Rigel UNI-SIM:
Escape
Add
Copy
Delete
Edit
Help
Menu –List
Home
New
OK –PASS
Print
Less
Repeat
Save
Search
Settings
Shift
Mute
Sound

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3 Getting started
Turn on your Rigel UNI-SiM Lite by pressing and holding the green start button
until you hear a “beep” and the Rigel splash screen appears.
A summary simulation screen appears, displaying the settings from the previous
simulation for all parameters and can be repeated by simply pressing the green
start key.
Use your UNI-SIM LITE as a simple manual simulator from the summary screen by
selecting the simulation function you want:
3.1 Quick NIBP simulation
Connecting the UNI-SIM Lite to the NIBP monitor and cuff:

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To change the current NIBP setting to a different value, or perform a system leak test,
overpressure test, static pressure test or manometer function, simply select the NIBP
function from the home screen;.
Press the NIBP button (F3) to enter the possible settings and functions that can be
altered;
Use “custom O curve” to enter the required Systolic and Diastolic simulation values
For more information on the use of these additional functions, please go to 4.

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3.2 Quick SPO2 verification
Connect the PULS-R to the SPO2 output connector on the UNI-SIM Lite, and place the
SPO2 probe as shown below:
The correct orientation for probe place is with the LED of the probe on the top
side of the PULS-R.
To change the current SPO2 setting to a different value, or to change to a different
manufacture R-curve, simply select the SPO2 function from the home screen;.

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Press the SPO2 button (F3) to enter the possible settings and functions that can be
altered;
Parameters can be varied to validate the monitor and probe including:
Technology. E.g.: PULS-R, Masimo, Nellcor....
SPO2 (%) simulated
Heart Rate
For more information on the use of these additional functions, please go to 0.

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3.3 Quick ECG verification
Connect the ECG cables to the ECG breakout box and connect the ECG breakout box
to the
To change the current ECG, Respiration, Temperature or IBP simulation, simply select
the SPO2 function from the home screen;

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Press the PAT button (F3) to enter the possible settings and functions that can be
altered;
To change any of the default settings on each simulation, please refer to the relevant
manual mode sections in this manual, chapter 4,4.7 and6.

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4 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 4.1)
NIBP Leak Test (See 4.2)
NIBP Pop-off Test (see 4.4)
NIBP Manometer Mode (see 4.5)
Set Zero (see 4.6)

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Custom O Curve (see
4.1 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