| MEDICAL DEVICE SPECIFICATION |
Operation table hydraulic minor
Version no. : 1
Date: 5/12/2014
Done by : (name / institution) HCT/NHSRC
NAME AND CODING
GMDN name Operation table hydraulic minor
GMDN code(s) NA
GENERAL
1 USE
1.1 Clinical purpose An operating table, sometimes called operating room table, is the
table on which the patient lies during a surgical operation.This surgical
equipment is usually found inside the surgery room of a hospital.
1.2 Used by clinical Operation theatre
department/ward
TECHNICAL
2 TECHNICAL CHARACTERISTICS
2.1 Technical characteristics 1) Should have Stainless steel top 304 grade
(specific to this type of 2) Should have Castor wheel for easy mobility
device)
3 )Head & Leg section should be detachable and interchangeable
4) Four section table
5) Durable and leak proof hydraulic pump with heavy pillar fitted in
center of the table
6) Archived by gear mechanism
7) Trendelenburg: 25°-30°
8) Lateral tilt (Left & Right):15°-20°
9) Leg Section 90°
2.2 User’s interface Manual
2.3 Software and/ NA
or standard of
communication(where
ever required)
3 PHYSICAL CHARACTERISTICS
3.1 Dimensions (metric) Table Top dimension 1900 mm x 525 mm ± 15%
Table elevation 700 mm – 1000 mm± 10%
3.2 Weight (lbs, kg) Should be able to support the weight of the patient upto 160 kg.
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 Mobility, portability Not portable
Technical Specifications of Medical Devices for
56 OPERATION THEATRES
4 ENERGY SOURCE (electricity, UPS, solar, gas, water, CO2 ....)
4.1 Power Requirements Recharging unit: Input voltage- 220V-240V AC, 50Hz
4.2 Battery operated Yes
4.3 Tolerance (to variations, NA
shutdowns)
4.4 Protection Should have over-charging cut-off with visual symbol.
4.5 Power consumption NA
5 ACCESSORIES, SPARE PARTS, CONSUMABLES
5.1 Accessories (mandatory, 1) side rail clamp,
standard, optional); 2) shoulder support,
Spare parts (main ones); 3) Arm support(2 nos)
Consumables / reagents 4) IV pole
(open, closed system) 5) Body restraining belt
6) Leg supports:2 nos
7) Lateral supports
8) Anti-static mattress
BIDDING / PROCUREMENT TERMS / DONATION REQUIREMENTS
6 ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATONS
6.1 Atmosphere / 1) Operating condition: Capable of operating continuously in ambient
Ambiance (air temperature of 10 to 40 deg C and relative humidity of 15 to 90% in
conditioning, humidity, ideal circumstances.
dust ...) 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, 1) Disinfection: Parts of the Device that are designed to come into
Disinfection & Sterility contact with the patient or the operator should either be capable of
issues easy disinfection or be protected by a single use/disposable cover.
2) Sterilization not required.
7 STANDARDS AND SAFETY
7.1 Certificates (pre- 1. Should be FDA/CE/BIS approved product.
market, sanitary, ..); 2. All mechanical tests.
Performance and safety 3. Shall meet internationally recognised standard IEC 60601-2-46 for
standards (specific to usability.
the device type); Local
and/or international
7.2 Local and/or Manufacturer / supplier should have ISO 13485 certificate for quality
international standard.
8 TRAINING AND INSTALLATION
8.1 Pre-installation 1) Availability of 5 amp socket;
requirements: nature, 2) Safety and operation check before handover;
values, quality,
tolerance
8.2 Requirements for sign- Certificate of calibration and inspection from the manufacturer
off
8.3 Training of staff 1) Training of users on operation and basic maintenance;
(medical, paramedical, 2) Advanced maintenance tasks required shall be documented
technicians)
9 WARRANTY AND MAINTENANCE
9.1 Warranty 3 years
9.2 Maintenance tasks 1) Maintenance manual detailing;
2) Complete maintenance schedule;
9.3 Service contract clauses, The spare price list of all spares and accessories (including minor) required
including prices for maintenance and repairs in future after guarantee / warranty period
should be attached;
Technical Specifications of Medical Devices for
OPERATION THEATRES 57
10 DOCUMENTATION
10.1 Operating manuals, Should provide 2 sets (hard copy and soft-copy) of:-
service manuals, other 1) User, technical and maintenance manuals to be supplied in english/
manuals 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;
5) Certificate of calibration and inspection
10.2 Other accompanying List of important spares and accessories, with their part numbers and cost;
documents
11 NOTES
11.1 Service Support Contact Contact details of manufacturer, supplier and local service agent to be
details (Hierarchy Wise; provided;
including a toll free/ Any Contract (AMC/CMC/add-hoc) to be declared by the manufacturer;
landline number)
11.2 Recommendations or Any warning signs would be adequately displayed
warnings
Technical Specifications of Medical Devices for
58 OPERATION THEATRES
