Rigel Medical Rigel BP-SIM User manual

Rigel BP-SIM
Hand-Held Non-Invasive Blood Pressure Simulator
Instruction Manual
370A550 Issue 1.0
October 2008
© 2008 Seaward Group
Issue 1.0

Limited Warranty & Limitation of Liability
Rigel Medical, part of the SEAWARD GROUP guarantees this product for a period of 1
year. The period of warranty will be effective at the day of delivery.
© Copyright 2008
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.
Operating Instructions
Rigel BP-SIM

Index
1. INTRODUCTION .......................................................................................... 7
1.1. Rigel BP-SIM Design Philosophy ............................................................................... 7
1.2. Key Features .............................................................................................................. 8
1.3. Interfaces .................................................................................................................... 9
1.4. Rigel BP-SIM includes: ............................................................................................. 10
1.5. Optional Accessories ................................................................................................ 10
1.6. Test ’n Tag Compatible ............................................................................................ 10
1.7. Unique use of ICONS ............................................................................................... 11
2. LOGGING ON ........................................................................................- 12 -
3. SETTING-UP YOUR TESTER ...............................................................- 13 -
3.1. Test Sequences....................................................................................................- 13 -
3.1.1. User definable tests.................................................................................- 14 -
3.1.2. View, Delete or Copy an existing Test Routine. ......................................- 14 -
3.1.3 Modifying (Edit) Existing Test Sequences...............................................- 15 -
3.1.3. Edit individual Test ..................................................................................- 17 -
3.1.4. Insert an individual test............................................................................- 18 -
3.1.5. Insert Custom Tests or Instructions.........................................................- 20 -
3.1.6. Create a new Test Sequence..................................................................- 22 -
3.2. Asset Trace Variables ..........................................................................................- 24 -
3.3. System Config ......................................................................................................- 25 -
3.3.1. Asset ID ...................................................................................................- 25 -
3.3.2. After Test .................................................................................................- 26 -
3.3.3. Comments ...............................................................................................- 26 -
3.3.4. Language.................................................................................................- 26 -
3.3.5. Date / Time ..............................................................................................- 26 -
3.4. Blue Tooth Favourites ..........................................................................................- 27 -
3.5. User Admin ...........................................................................................................- 31 -
3.5.1. Preferences .............................................................................................- 32 -
3.5.2. Change User ...........................................................................................- 33 -
3.5.3. Change Password ...................................................................................- 33 -
3.5.4. User Profile ..............................................................................................- 34 -
3.6. Memory options ....................................................................................................- 34 -
3.7. Restore Factory Settings ......................................................................................- 36 -
4. AUTOMATIC MODE ..............................................................................- 37 -
4.1. Performing an Automatic Test: .............................................................................- 38 -
4.1.1. Failure Menu............................................................................................- 38 -
Operating Instructions
Rigel BP-SIM

4.2. Test ‘n Tag............................................................................................................- 42 -
4.3. Options Menu .......................................................................................................- 43 -
4.4. View Results .........................................................................................................- 44 -
5. MANUAL MODE ....................................................................................- 45 -
5.1. NIBP Test Settings ...............................................................................................- 46 -
5.2. NIBP Leak Test ....................................................................................................- 48 -
5.3. NIBP Pop-off Test.................................................................................................- 49 -
5.4. NIBP Manometer Mode ........................................................................................- 50 -
5.5. Set Zero ................................................................................................................- 51 -
6. VIEW DATA ...........................................................................................- 52 -
6.1. View Results .........................................................................................................- 54 -
6.2. Search the database ............................................................................................- 55 -
6.3. View Data Options................................................................................................- 56 -
7. DATA TRANSFER.................................................................................- 57 -
7.1. Download to PC....................................................................................................- 57 -
7.2. Upload from PC ....................................................................................................- 58 -
7.3. Configuration Data................................................................................................- 59 -
7.3.1. Receive Config Data................................................................................- 61 -
7.4. Load TnT Logo .....................................................................................................- 62 -
8. ABOUT...................................................................................................- 64 -
9. MAINTAINING THE RIGEL BP-SIM......................................................- 66 -
9.1. Cleaning the BP-SIM ............................................................................................- 66 -
9.2. User Maintenance ................................................................................................- 66 -
9.3. Return Instructions. ..............................................................................................- 67 -
10 TECHNICAL SPECIFICATIONS............................................................- 68 -
Operating Instructions
Rigel BP-SIM

Declaration of Conformity
The Rigel BP-SIM Hand-held NIBP Simulator
Manufactured by:
Seaward Electronic Ltd, Bracken Hill, South West Industrial Estate
Peterlee, County Durham, SR8 2SW, England
Millennium Statement
This product is Millennium compliant, and conforms fully to the document BSI DISC
PD2000-1.
Statement of Conformity
Based on test results using appropriate standards, the product conforms with
Electromagnetic Compatibility Directive 89/336/EEC and Low Voltage Directive
73/23/EEC
Standards used:
EN 61010-1 (1993) Safety Requirements for Electrical Equipment for Measurement,
Control, and Laboratory Use
EN 61326-1 (2006) EMC Requirements for Measurement, Control and Laboratory
Equipment.
The tests have been performed in a typical configuration.
This Conformity is indicated by the symbol , i.e. “Conformité Européenne”
WEEE Directive
The Rigel BP-SIM has been designed and manufactured with
high quality materials and components, which can be recycled
and reused.
Please inform yourself about the local collection system for
electrical and electronic products or contact your local supplier
for further information.
We ask you to respect your local rules and do not dispose of
your old product with your general waist. By offering your old
products for recycling, you will help prevent potential negative
consequences for the environment and human health.
Operating Instructions
Rigel BP-SIM

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 BP-
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.
If the BP-SIM is used in a manner not specified by the manufacturer, the protection
provided by the equipment may be impaired.
The BP-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.
Operating Instructions
Rigel BP-SIM

1. Introduction
The Rigel BP-SIM is a new hand held non invasive blood pressure simulator for the fast
and accurate testing of all types of NIBP monitors. The new lightweight and battery-
powered Rigel BP-SIM utilises patented technology to simulate a wide range of blood
pressures to verify the accuracy and safe operation of all leading NIBP monitors
currently used in healthcare and medical facilities.
The new simulator 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 Rigel BP-SIM is the first hand-held NIBP simulator
combining full performance features with a large capacity internal memory for the data
capture, storage and subsequent downloading of test results for record keeping
purposes.
In addition, the Bluetooth-enabled technology allows the wireless connectivity of the
tester with PCs and other accessory equipment for fast and convenient downloading of
performance data and the uploading of manufacturers’ O-curves and manufacturer
specific test programs.
Other special features of the Rigel BP-SIM include an in-built pump to generate user
specific pressure settings for comprehensive system leak tests and over pressure tests.
An integral digital manometer also enables highly accurate static pressure
measurements to be taken using a wide range of selectable pressure units.
The new Rigel BP-SIM forms part of a comprehensive range of high performance
specialist biomedical test equipment supplied by Rigel Medical, part of the Seaward
Group.
1.1. Rigel BP-SIM Design Philosophy
The BP-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 benefits of the size and weight of a smaller hand-
held NIBP Simulator with the test versatility and convenience of a larger bench-mounted
simulator. 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 BP-SIM.
The test capabilities and functionality exceed that of most common NIBP Simulator yet
the instrument is only a fraction of the size and weight.
No other NIBP simulator on the market offers a hand-held enclosure with the test
capabilities equal to most bench marked version interface, large internal memory, Blue
Tooth communication, asset management facilities, user configurable Performance
Tests and more.
We believe that the new BP-SIM is set to become the new standard in NIBP
performance Testing.
Operating Instructions
Rigel BP-SIM
7

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
•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
Operating Instructions
Rigel BP-SIM
8

1.3. Interfaces
68
7
1
45
3
2
1) Full graphic Monochrone LCD, blue with white backlit, 1/4 VGA
2) Larger Red key Stop/Off Key
3) Larger Green Start/On key
4) 4 Programmable soft keys below display
5) Alpha Numeric keyboard, Up / Down and Left / Right cursor control.
6) Power Supply inlet
7) Pneumatic interface connector
8) Input/Output connector (future use only)
Operating Instructions
Rigel BP-SIM
9

1.4. Rigel BP-SIM includes:
•Battery charger
•Carry case
•5-pc tubing adaptor set
•Instruction manual
•Application disc
•BlueTooth USB adaptor
•Calibration certificate
1.5. Optional Accessories
•Med-eBase PC Download software (p/n 301A920)
•BlueTooth Barcode scanner (p/n 339A923)
•BlueTooth Test ‘N’ Tag System (p/n 331A950)
•BlueTooth Test ‘N’ Tag Elite System (p/n 339A970)
•BlueTooth result printer (50mm) (p/n 339A930)
1.6. Test ’n Tag Compatible
The Rigel BP-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:
•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.
•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 4.
Operating Instructions
Rigel BP-SIM
10