I MEDICAL DEVICE SPECIFICATION I
SEMI-AUTOMATED ELISA WASHER & READER
Version no.:
1
Date:
5/12/2014
Done by : (name/institution)
HCT/NHSRC
NAME AND CODING
GMDN name
Semi-automated ELISA reader
GMDN code
GENERAL
1. USE
1.1
Clinical purpose
The enzyme-linked immunosorbent assay (ELISA) is a test that uses
antibodies and color change to identify a substance.ELISA is a popular
format of"wet-lab" type analytic biochemistry assay that uses a solidphase enzyme immunoassay (EIA) to detect the presence of a substance,
usually an antigen, in a liquid sample or wet sample. ELISA evaluates either
the presence of antigen or the presence of antibody in a sample, it is a useful
tool for determining serum antibody concentrations.
1.2
Used by clinical department/
ward
Analytical Laboratories
TECHNICAL
2. TECHNICAL CHARACTERISTICS
2.1
Technical characteristics
Washer:
(specific to this type of device) 1. The device should be fully automated and easy to operate with 8 and 12
channel manifold.
2. It should be capable to wash flat, round and V bottom plates and strips.
3. It should have large display along with more than 40- 50 program storage
facility.
4. System should have calibration facility.
5. System should have warning/alarm for waste container full; wash bottle empty.
6. Residual volume after washing should be < 2u1.
7. It should have specially designed peristaltic pump to dispense 50 - 400 ul.
8. It should be supplied with waste bottle, wash bottle and rinse bottle of
capacity 2 liters with tubings.
9. It should have option of washing cycles.
10. Cross wise aspiration, over flow washing, bottom washing. Automatic
manifold detection.
11. Equipment should be un-pressurized, capable of using any bottle or
container for washing.lt should be suitable for UV & flat bottom micro
plate.
Microplate Reader:
1. Bichromatic/Optics with six wavelenths.
2. Trichromatic Light source.
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3. Internal Printer with port for external printer.
4. Should read ELISA Plate Horizontally A to Hand and verically 1 to 12.
5. Photometric Accuracy should be ±3%.
6. Print Out of whole plate in Matrix Format.
7. Linear measurement range 0 to 4 Absorbance unit.
8. Interference, filters.
9. Filters of 405, 450, 492, 630 nm with two extra positions.
2.3 Software and/or standard of
communication(where ever
required)
Compatibilty with external Printer.
3.1
Dimensions (metric)
NA
3.2
Weight (lbs, kg)
NA
3.3
Configuration
NA
3.4
Noise (in dBA)
NA
3.5
Heat dissipation
Heat Dissipation: Should maintain nominal Temp and the heat should be
disbursed through an cooling mechanism.
3.6
Stationary lab Installation.
Mobility, portability
4. ENERGY SOURCE (electricity, UPS, solar, gas, water, CO2 ....)
4.1
Power Requirements
Operable at- Input voltage- 220V-240V AC, 50Hz.
4.2
Battery operated
No
4.3
Tolerance (to variations,
shutdowns)
±10%
3. PHYSICAL CHARACTERISTICS
4.4
Protection
4.5
Power consumption
5.1
1. External dot matrix printer.
Accessories (mandatory,
standard, optional); Spare parts 2. Light/Lamp source.
(main ones); Consumables/
3. Multichannel pipette with variable dispensing volume 50-200 ul.
reagents (open, closed system)
4. Paper rolls for internal printer- 10 nos.
5. ACCESSORIES, SPARE PARTS, CONSUMABLES
BIDDING/PROCUREMENT TERMS/DONATION REQUIREMENTS
6. ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATONS
6.1
1. Operating condition: Capable of operating continuously in ambient
Atmosphere/Ambiance (air
temperature of 10 to 50 deg C and relative humidity of 15 to 90% in ideal
conditioning, humidity, dust ...)
circumstances.
2. Storage condition: Capable of being stored continuously in ambient
temperature of 0 to 50 deg C and relative humidity of 15 to 90%.
6.2
User's care, Cleaning,
Disinfection & Sterility issues
1. Disinfection: Parts of the Device that are designed to come into contact
with the patient or the operator should either be capable of easy
disinfection or be protected by a single use/disposable cover.
2. Sterilization not required.
7. STANDARDS AND SAFETY
7.1
Certificates (pre-market,
sanitary, ...); Performance and
safety standards (specific to
the device type); Local and/or
international
1. Should be FDA/CE/BIS approved product.
2. Manufacturer and Supplier should have ISO 13485/US(FDA)/EU(CE)
certification for quality standards.
3. Shall meet internationally recognised for Electromagnetic.
Compatibility(EMC) for electromedical equipment: 61326-1.
4. Certified to be compliant with IEC 61010-1, IEC 61010-2-281, IEC 61010101, IEC 61010-2-40 for safety.
7.2
Local and/or international
Manufacturer/supplier should have ISO certificate for quality standard.
Technical Specifications of Medical Devices for
LABORATORY 33
8. TRAINING AND INSTALLATION
8.1
8.2
8.3
Pre-installation requirements: 1. Should be operable at 220 -240 volts (50 - 60 Hz).
nature, values, quality,
2. Safety and operation check before handover.
tolerance
Certificate of calibration and inspection from the manufacturer.
Requirements for sign-off
Training of staff (medical,
paramedical, technicians)
1. Training of users on operation and basic maintenance.
2. Advanced maintenance tasks required shall be documente.
9. WARRANTY AND MAINTENANCE
9.1
Warranty
3 years
9.2
Maintenance tasks
CMC 5 years 2 PM Visits Annually.
Service contract clauses,
including prices
The spare price list of all spares and accessories (including minor) required
for maintenance and repairs in future after guarantee/warranty period
All Breakdown calls to be attended within 24 hrs of registartion.
93
should be attached;
10. DOCUMENTATION
10.1 Operating manuals, service
manuals, other manuals
I Should provide 2 sets (hardcopy and soft-copy) of:
1. User, technical and maintenance manuals to be supplied in english/hindi
language along with machine diagrams;
2. List of equipment and procedures required for local calibration and
routine maintenance;
3. Service and operation manuals (original and copy) to be provided;
4. Advanced maintenance tasks documentation;
10.2
Other accompanying
documents
5. Certificate of calibration and inspection;
List of important spares and accessories, with their part numbers and cost;
11. NOTES
Service Support Contact details Contact details of manufacturer, supplier and local service agent to be
(Hierarchy Wise; including a toll provided;
free/landline number)
11.2
Recommendations or
warnings
Any warning signs would be adequately displayed.
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