Automated Safety Testers - Medset Specialties Ltd.

Automated Safety Testers - Medset Specialties Ltd.
rigel 288
Electrical Medical Safety Analyser
Key Features
■ Versatile
Test in Accordance with the leakage requirements of
IEC/EN 60601-1, AAMI and NFPA, IEC 62353 (VDE 0751-1)
using separate IEC 60601 and AAMI Body Model
■ Hand-held
Using purpose designed robust enclosure, the Rigel 288
is truly hand-held, easy to hold single handedly and
enables one hand operation and navigation
■ Easy to use
A full graphic, monochrome LCD display (1/4 VGA
minimum) in combination with an integral alpha-numeric
■ Manual and Automatic test modes
Able to perform UTS (Unique Test Sequence) and allows
fully automatic, semi automatic and fully manual testing.
■ User definable test routines,
Users have the ability to amend the default programs or
create new programs by copying the preset test programs.
Each program will have a unique Identifier.
The Rigel 288 is the FIRST universal truly hand-held medical electrical
safety tester to combine the features of an automatic / manual tester with
■ Multiple Applied Part function
a data logging / asset management facility. A compact lightweight design
This feature gives the user the capability of testing up to 10
and long life battery power reduces downtime between tests, making the
individual Applied Parts from different Modules or classes
instrument totally practical and highly portable for multi site use.
e.g. BF and CF class, or Bf ECG and Bf SPO2 module.
In addition to IEC 60601-1 and AAMI / NFPA 99, the Rigel 288 tests to the
new standard for in-service and after repair testing of medical electronic
devices, currently drafted in as the IEC 62353.
■ Internal Asset management
Store up to 10,000 test records, custom test routines, visual
The Rigel 288’s large internal memory facilitates the storage of test results
for safety audit and traceability purposes. Comprehensive database
software is available to ensure fast and easy download of test results,
managing your asset database, creation of test sequences, scheduling of
Preventative Product Maintenance and producing test certificates.
Wireless connection means that stored data can be transferred
inspections and performance tests and download to and
from PC via Blue Tooth Interface.
■ Routine testing of Medical Electrical
immediately and directly from the tester to PC-based record keeping
■ Service tool for Performance Testing
systems at the touch of a button.
■ Asset Management
■ Fast and efficient testing of IEC leads
The highly versatile Rigel 288 represents the next generation of electrical
medical safety analysers.
■ Earth bond testing on (Medical)
Installations and non Medical Equipment
Medset Specialties Ltd.
3334 Mainway Drive Burlington,
Ontario L7M 1A7
Tel: 905-335-4455 / 800-331-3187
Fax: 905-335-4456
The Market Place
The market for hand-held medical safety testers is soon to change
with the imminent introduction of a new standard for in-service and
after-repair testing of medical electronic devices. The new standard is
currently in draft as IEC 62353 and expected to become the general
guideline for in-service / after-repair testing. At present, the IEC
60601-1 standard is used as a reference in many countries as local
guidelines do not always exist for in-service and after-repair testing.
The Rigel 288 combines the current IEC 60601-1 and AAMI/NFPA
leakage requirements with the new IEC 62353. The Rigel 288 is the
first hand-held tester to combine graphics with an alphanumeric
keyboard and Blue Tooth connection to various peripherals such as
RFID, Label Printer, barcode scanners, PDA's and PC's. This will allow
for high flexibility in the field.
Also Available from Rigel Medical:
■ Rigel 266 Plus Manual Safety Analyser
■ Rigel 277 Plus Automatic Safety Analyser
■ Rigel 311 NIBP Simulator
■ Rigel 322 SPO2 Simulator
■ Rigel 333 Patient Simulator
■ Rigel 344 Defibrillator Tester
■ Rigel 355 Ventilator Tester
■ Rigel 601 Plus
■ MediGuard – Software Application
Custom Test Settings
The unique setup in the Rigel 288 not only allows you to configure
your own test sequences or modify existing ones to suit your specific
needs, the Rigel 288 also provides the unique feature to configure
your own visual or acceptance test routines prior to an electrical
safety test. These could be simple instructions to the user,
observations required for your own maintenance procedures such as
checking for certain labels, software versions and upgrades etc.
In addition, you can configure post safety test procedures such as
recording readings during a performance test on a patient monitor
(SPO2, NIBP, ECG, Temperature, IBP etc), Defibrillators (Energy,
Synch time, Charge time etc) and so on.
These features make the Rigel 288 a truly versatile service tool to
ensure all test data is captured and processed in one single test
record thus maximising the traceability and allowing full flexibility in
the field.
Test ’n Tag Compatible
Our Test ‘n Tag system allows you to print customised Thermal PASS
/ FAIL Labels. The benefits of using the Test ‘n Tag printer 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.
Also Available From the Seaward Group:
Portable Appliance Testers
IEC Lead Tester
Insulation Resistance Testers
RCD Testers
Earth Loop Impedance Testers
Installation Testers
Current Clamps
Hipot Testers
Earthbond Testers
Micro Ohmmeters
To find out more about these products,
call: +44(0)191 5878730 or visit
Medset Specialties Ltd.
3334 Mainway Drive Burlington,
Ontario L7M 1A7
Tel: 905-335-4455 / 800-331-3187
Fax: 905-335-4456
Comprehensive PC Software
The Rigel 288 is compatible with a new and
comprehensive download software package
capable of producing asset management
records and work schedules.
Use the software to configure a number of Rigel
288’s at the same time to ensure that all
engineers work to the same test routines.
Create customer test routines including test protocols for testing Patient
Monitors (NIBP, SPO2, ECG etc.), Defibrillators etc. Test protocols can be easily
uploaded to the Rigel 288 using either the blue tooth or RS 232 connection.
Unique use of ICONS
The Rigel 288 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 288:
Use your Rigel 288 to collect readings during functional testing to collect not
only the electrical safety test record but also the performance of the Medical
Device. The complete PPM in one single record.
Single Fault
Furthermore, the software allows you to produce certificates both via the printer
and email to make sure test records are kept for future reference.
Key Features
1. Windows Explorer type user interface - layout
2. Download from Rigel 288 to PC via BT or RS 232
3. Upload from PC to Rigel 288 via BT or RS 232
4. Create Test Routines and configure multiple testers
5. Output of database to Excel / Access.
6. Database function
7. Test schedule function
8. Printing of Test Certificate
9. Store Test certificate as HTML for easy email application
Rigel 288 Design Philosophy
The Rigel 288 has been designed to address the increasing demand for
smaller more comprehensive test equipment within the Healthcare Industry.
What better way than to combine such tester with the new International InService Test required as per IEC 62353.
The challenge was to combine the benefits of the size and weight of a
smaller hand-held and portable Analyser with the test power and
convenience of a larger bench-mounted automatic safety analyser. 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 Rigel 288. The test capabilities and functionality exceed
that of most common bench mounted safety analysers yet the instrument is
only a fraction of the size and weight.
No other safety tester on the market offers a hand-held enclosure with the
test capabilities of that of an automatic safety analyser; including IEC 60601
and IEC 62353 leakage tests, up to 10 Patient Connections, alpha numeric
keyboard, graphic user interface, large internal memory, Blue Tooth
communication, asset management facilities, user configurable
Performance Tests and more.
We believe that the new Rigel 288 is set to become the new standard in
Electrical Medical Safety Testing.
Medset Specialties Ltd.
3334 Mainway Drive Burlington,
Ontario L7M 1A7
Tel: 905-335-4455 / 800-331-3187
Fax: 905-335-4456
Seaward Group, parent company of Rigel Medical has developed a new
method of carrying out earth continuity tests undertaken as part of the
process to verify the electrical safety of portable Medical and Domestic
The Seaward Group has filed a patent application for the new test
technology that uses a dual current high intensity test to overcome contact
resistance problems or other situations where weak conductor connections
may inhibit protective earth testing with conventional test currents such as
1A or 200mA.
The patent recognises that a 200mA test current is rapidly becoming the
International Standard for in-service testing and testing after repair of
Medical Electronic Equipment such as the imminent IEC 62353.
However, the new concept has been specially designed to help overcome
variations in measurement that can be caused by contact resistance
between the test probe and the device under test, for example, when
measuring continuity of tarnished or corroded parts often seen in the
commonly used detachable IEC power cable.
The unique technology introduced by Seaward Group enables valid earth
continuity tests to be carried out using battery powered testers and is being
incorporated into the new Rigel 288 hand held electrical medical safety
Electrical Safety Tests performed
Earth bond*
■ Insulation
Specific to IEC 60601-1;
Earth Leakage
Enclosure Leakage
Patient Leakage
Patient Auxiliary
Patient F-type
Specific to pr IEC 62353 – VDE 0751;
■ Equipment Leakage (Direct, Differential and
Alternative Method)
■ Applied Part Leakage (Direct and Alternative Method)
Specific to AAMI & NFPA;
Custom tests can be created using a variation or
combination of the above.
* Using unique patented technology proving hi-current
(>25A) test capability
The innovative new Rigel 288 has been specifically designed to provide a
hand-held test solution for those demanding versatility and portability yet
not compromising the validity of tests being carried out. The Rigel 288 meets
the in-service and post-repair test demands of the IEC 60601 standard, as
well as being prepared for the new IEC 62353 standard for in-service testing
of Medical Devices.
Medset Specialties Ltd.
3334 Mainway Drive Burlington,
Ontario L7M 1A7
Tel: 905-335-4455 / 800-331-3187
Fax: 905-335-4456
Earth Continuity
2 wire technique, using 'zero' lead function.
Test Current
>+200mA, -200mA DC into 2 ohms
Max Test Voltage
4-24V rms o/c (6V for IEC 60601 tests)
Measuring Range (low range) 0.001 – 0.999 ohms @ 0.001 ohms resolution
Measuring Range (mid range) 1.00 – 9.99 ohms /@ 0.01 ohms resolution
The Rigel 288 is a small comprehensive electrical safety
analyser and is designed to comply with IEC 60601-1,
AAMI / NFPA-99 and IEC 62353. The Rigel 288 has
been designed with the customer’s requirements in
mind, offering the tests and usability they need.
It is the right product at the right time.
The Rigel 288 is the smallest and lightest
comprehensive electrical safety analszer on the market
making it easier to work effectively across multiple sites.
Measuring Range (high range) 10.0 – 19.9 ohms @ 0.1 ohms resolution
± 3% of reading + 10 m ohms
Insulation Resistance
EUT to Earth / Ground, EUT to AP, AP to Ground
250V DC, 500 V DC @1mA.
Range (low range)
0.01Mohms - 20 Mohms
Accuracy (low range)
± 5% of reading +2 counts
Range (high range)
20Mohms – 100Mohms
Accuracy (high range)
±10% +2 counts
Upgradeable to meet test requirements. The customer
only pays for what they need.
Rigel 288 includes:
Calibration Certificate
Carrying Case
Earth bond test probe with clip
Earth bond clip lead
Patient Applied part module
10 Applied part adaptors
Detachable 2 meter mains cable
Blue Tooth USB dongle
Electronic Instruction Manual
Removable ‘quick start’ card
Direct Leakage Measurement
Measuring Range
4µA to 9999µA
± 5% or reading +2 counts
Mains on A.P. voltage
F-type only @ 110% of mains
Measuring Device
As per IEC 60601-1 requirements
Measurement Type
Separate AC & DC for Patient (-Auxiliary) Leakage to
IEC 60601
True RMS for all remaining Leakage tests
Differential Leakage Measurement
Measuring Range
75µA to 9999µA
±5% of reading + 5 counts
Measurement / display resolution1µA
Measurement Type
Measuring Device
True RMS
Similar frequency response characteristics to
IEC 60601-1.
Alternative Leakage Measurements:
Test Voltage
250V at mains frequency
Test Current
3.5 mA current limited
Measurement Range
4µA to 9999µA
Measurement Resolution
Measurement Accuracy
±5% of reading + 2 counts
Measurement Type
True RMS
Measuring Device
As per IEC 60601-1
Medset Specialties Ltd.
3334 Mainway Drive Burlington,
Ontario L7M 1A7
Tel: 905-335-4455 / 800-331-3187
Fax: 905-335-4456
Power Measurement
VA rating.
0.1KVA – 4KVA
±10% + 2 counts
How to Order
UK/Ireland version
Euro/Schuko version
French version
Danish version
Czech / Polish version
USA version (110V – 60Hz)
Australian version
Mains Outlet Test
Input voltage range:
0-300V AC, max current 16A
Other variants available upon request
L – E, N – E & L – N
± 5% of reading + 2 counts
IEC Mains Lead Test
Test Duration:
Continuity of all conductors, Earth bond,
Insulation & Polarity
PC Download software
Barcode scanner with embedded Blue Tooth
Blue Tooth Test ‘N’ Tag System
Brain Cell Read / Write Scanner with embedded
■ Download software for PDA (please check for
■ Blue Tooth Serial Adaptor
Mains power
230 VAC ±10%, 50Hz +/- 1Hz
120 VAC ±10%, 60Hz +/- 1Hz (USA model)
6 x 1.5V Alkaline AA
1.6 kg including batteries
Size (L x W x D)
270 x 110 x 75 mm / 10.5 x 4 x 3”
Operating conditions
0' - 40'C, 0-90% RH - NC
Storage environment
-15' - +60'C
Environmental Protection
IP 40
Shipping Information:
Corrugated cardboard box
Related Interest
Rigel 266 Plus
Rigel 277 Plus
IEC 62353 Booklet
IEC 60601 Booklet
Available online
Medset Specialties Ltd.
3334 Mainway Drive Burlington,
Ontario L7M 1A7
Tel: 905-335-4455 / 800-331-3187
Fax: 905-335-4456
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