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 -
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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.
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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
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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)
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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.
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1.7. Unique use of ICONS
The Rigel BP-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 BP-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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2. Logging on
When switching on the Rigel BP-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 BP-
SIM. See 3.5.3 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.
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:
[phone] 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 BP-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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3. Setting-up your tester
The Rigel BP-SIM is designed to allow the user to customise the device to allow default
setting in order to speed up the testing such as, default lists of manufacturers, model
numbers, user test protocols, automatic printing following test, fault menu’s and so on.
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.
Options available
Test Sequences Modify or create test sequences (see 3.1)
Asset Trace Variables Generate default list of variables (see 3.2)
Systems Config Configure default test options (see 3.3)
Blue Tooth Favourites Setup your Blue Tooth devices (see 3.4)
User admin Setup users and preferences (see 3.5)
Memory Options Manage the tester’s memory (see 3.6)
Restore Factory Settings Defaults the tester to factory settings (see 3.7)
3.1. Test Sequences
The Rigel BP-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.
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3.1.1. User definable tests
This feature gives the Rigel BP-SIM the capability of recording user defined visual
inspections, checks or tests including measurements from SPO2, ECG, NIBP, Defib,
Infusion, Ventilation, Pressure etc.
The input is text only as no measurements are performed by the Rigel BP-SIM during
these tests. The user can enter questions or instructions followed by either a
PASS/FAIL result or alpha numeric input. Preset engineering units e.g. %, Joules,
mmHg, PSI, CmH2O etc are available.
3.1.2. View, 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 , followed by Setup. Select the Test
Sequences from the list and press (F4).
The following overview is provided and shows the list of default and customised test
sequences availble. Copied Test Sequences will appear in the list with an *pre-fix.
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.
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To Copy, Delete or Print an existing or default test sequence, use the Up & Down arrow
keys to highlight the test sequence and press the button (F2).
Use the Up & 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 3.1.3 for more on editing test sequences.
Print Test Sequence will provide an overview of the Test Sequence on the Favourite
Blue Tooth Printer. See 3.4 for help on setting up Blue Tooth devices.
Delete Sequence will remove the highlighted test sequence from the memory of the
Rigel BP-SIM.
Note: Default Test Sequences cannot be Deleted.
3.1.3 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 3.1.2).
Non-default Test Sequences can be modified from the Test Sequences menu. When
non-default Test Sequences are highlighted, the (F4) will appear in the menu
screen.
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Pessing the button (F4) will open the Test Sequence for Editing as shown
below;
To change the Name and or Class of the Test Sequence, press the Button (F4)
and enter the Name and or Class required.
To change to upper or lower case or use language specific characters, press the
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 button (F3)
To confirm the entry, press the button (F4)
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Confirm the changes with the button (F3) or cancel using the button
(F4).
To Insert a new test, highlight the test using the Up & Down arrow keys and press the
Insert button (F1)
To Delete an individual test, highlight the test using the Up & Down arrow keys and
press the button (F2)
To go back to the previous menu, highlight the test using the Up & Down arrow keys
and press the button (F3)
To modify an individual test, highlight the test using the Up & Down arrow keys and
press the Button (F4)
3.1.3. Edit individual Test
Press the button (F4) as shown above. The Leak Test sub menu will allow you
to alter the settings for; Test duration and Pressure set point.
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Highlight the required field using the up and down keys. To change the content use the
keypad to enter the correct data. To Delete the field content, press the button as
shown below.
When the right settings have been achieved, press the button(F4)tosavethe
changes or press (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 (F3) to exit.
3.1.4. 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 not after.
To modify a test sequence, please refer to 3.1.3
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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.
Once the desired test has been highlighted, confirm using the OK button (F4) and finally
confirm to insert into the test Sequence. Pressing the 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
Further tests can be inserted or deleted by following the steps described herein.
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3.1.5. Insert Custom Tests or Instructions
Custom tests or Instructions are intended to allow the user to capture additional
information either prior to or after the main NIBP 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.
Hint: Create a unique range of visual tests or instructions by creating a new test
sequence (see 3.1.6) and select Custom Test as the nature of the test. This will
create a unique test sequence.
The maximum number of characters in the test description or instruction is 255.
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.
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.
Confirm using the button (F4). The following menu will define the nature of the
test (eg test Instruction prior to leak test)
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