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Ніколов_ПРООН_Скан 4.pdf
1. LOT 3
Name of the
equipment
Technical characteristics ISO Quantity, Units
Functional bed
A four-segment mattress frame with segment adjustment by
means of electric drives controlled by a remote control;
electric adjustment of the height and position of individual
segments (at least two);
possibility to adjust the Trendelenburg position and the reverse
Trendelenburg position;
wheels for moving the bed and a mechanism for locking the
wheels;
headboards; a mechanism that allows partial flexion of the lower
limbs;
height-adjustable handrails; the function of returning the bed to its
original position in case of power failure.
Technical characteristics:
Overall width: no more than 1060 mm
Total length: no more than 2130 mm
Mattress frame size: 2000x900 mm ± 10 mm
Height adjustment, not less than 410-700 mm
Adjustment of the main section elevation angle, not less than 0-70°
Adjustment of the leg section elevation angle, not less than 30°
Tilt angle of the Trendelenburg position 0-12° ± 2°
Tilt angle of the reverse Trendelenburg position Trendelenburg 0-
12° ± 2° Maximum load, not less than 175 kg
Power supply ~ 230V, 50Hz
The bed must be equipped with a mattress made of waterproof
material, which ensures ease of cleaning and wiping, and provides
maximum comfort for the user.
Compliance with standards: EN ISO 13485:2016 Medical devices —
Quality management systems — Requirements for regulatory
purposes; EN 60601-1:2006/A2:2021 Medical electrical equipment -
Part 1: General requirements for basic safety and essential
performance; EN 60601-2-52:2010+A1:2015 Medical electrical
equipment Particular requirements for basic safety and essential
performance of medical beds
Warranty period for the equipment – not less than 12 months.
Delivery: up to 80 calendar days from the date of signing the
contract
EN ISO 13485:2016 110
Medical cabinet
with bedside table
High table surface edge to prevent objects and liquids from falling
Drawer cover, partition and table above the bed made of HPL
Aluminium support frame
Side and back panels made of HPL
Telescopic drawer guides
Cross-locking wheels with 360° swivel castors
Folding, swivel bedside table with aluminium frame
Shelves for placing things
Metal parts with electrostatic paint Overall dimensions (H*D*W)
87±5*45±*65±5 cm
Compliance with standards: EN ISO 13485:2016 Medical devices —
Quality management systems — Requirements for regulatory
purposes
Warranty period for the equipment – not less than 12 months.
Delivery: up to 80 calendar days from the date of signing the
contract
EN ISO 13485:2016 100
Corrective mirror
for rehabilitation,
single
The device is designed to observe the geometry of the body when
a person performs physical exercises.
A correction grid (special markings) in the form of vertical and
horizontal lines can be applied to the surface of the mirror to track
the patient's correct posture and perform correct movements.
The mirror frame is made of steel tubes with a closed profile,
powder-coated or stainless steel.
The mirror frame is equipped with four swivel wheels, which
facilitates movement on the floor in the room.
Overall dimensions of the product should ensure stability during
use and transport
Overall dimensions of the mirror, mm:
width not less than 600 and not more than 700 mm
height not less than 1600 The device can be constructed with a
mechanism that allows the mirror to rotate around a horizontal
axis.
Weight: ≤25kg
Compliance with standards: Council Directive 93/42/EEC of 14 June
Council Directive 93/42/EEC 30
2. 1993 concerning medical devices/ Technical Regulation on medical
devices, approved by the Cabinet of Ministers of Ukraine on 2
October 2013, No. 753
Warranty period for the equipment – not less than 12 months.
Delivery: up to 80 calendar days from the date of signing the
contract
Rehabilitation table
The table is designed for rehabilitation and therapy.
Table surface length 203 ± 3 cm.
Table surface width 120 ± 3 cm.
Height adjustment of the table surface by means of an electric
drive with a manual control panel, or hydraulic.
Minimum table surface height no more than 45 cm.
Maximum table surface height not less than 95 cm.
Maximum load capacity not less than 170 kg.
The frame should be made of metal to ensure the stability of the
table during rehabilitation exercises.
The table must be equipped with a retractable chassis on wheels
for easy movement of the table.
Availability of a document confirming that the supplied equipment
meets the established medical safety criteria/indicators.
Compliance with standards: Council Directive 93/42/EEC of 14 June
1993 concerning medical devices/ Technical Regulation on medical
devices, approved by the Cabinet of Ministers of Ukraine on 2
October 2013, No. 753
Warranty period for the equipment – not less than 12 months.
Delivery: up to 80 calendar days from the date of signing the
contract.
Council Directive 93/42/EEC 19
Stairs for restore of
walking skills with
an inclined ramp
The stairs are designed to help restore motor functions, restore
walking skills after injuries of the musculoskeletal system and
nervous system, train leg strength, and for rehabilitation.
Stairs should be made of steel sections.
Stairs should have a non-slip coating.
Handrails must be adjustable in height. The maximum load is not
less than 150 kg.
Minimum handrail height not more than 65 cm.
Maximum handrail height not less than 115 cm.
Possibility to adjust the distance between the handrails.
The minimum distance between the handrails is no more than 35
cm.
The maximum distance between handrails is not less than 75 cm.
The length of the staircase must be at least 330 cm.
The stairs shall be equipped with steps on one side and an inclined
ramp on the other.
Compliance with standards: Council Directive 93/42/EEC of 14 June
1993 concerning medical devices/ Technical Regulation on medical
devices, approved by the Cabinet of Ministers of Ukraine on 2
October 2013, No. 753
Installation and commissioning of equipment is mandatory
Warranty period for the equipment – not less than 12 months.
Delivery: up to 80 calendar days from the date of signing the
contract
Council Directive 93/42/EEC 8
Bars to restore
walking skills with
obstacles
The bars are designed for gait training with support and the ability
to adjust the load level.
The length of the parallel bars is no more than 310 cm.
The width of the parallel bars is no more than 100 cm.
The maximum height of the parallel bars is not less than 115 cm.
Parallel bars must have handrails that are adjustable in height and
width.
The maximum patient weight is not less than 150 kg.
The bars must have at least 6 removable obstacles.
Each barrier must have at least 5 levels of adjustment.
Compliance with standards: Council Directive 93/42/EEC of 14 June
1993 concerning medical devices/ Technical Regulation on medical
devices, approved by the Cabinet of Ministers of Ukraine on 2
October 2013, No. 753
Installation and commissioning of equipment is mandatory
Warranty period for the equipment – not less than 12 months.
Delivery: up to 80 calendar days from the date of signing the
contract
Council Directive 93/42/EEC 7
Rehabilitation
couch for therapy
The product is intended for rehabilitation and therapeutic
manipulation
Electric drive: Available
Number of sections: not less than 3
Height adjustment: from 56 to 85 cm +/- 5
EN 60601-1:2006 1
3. Motor speed Not less than 5 mm/sec
Manual control of the head segment not worse than ± 27°,
Manual control of the leg segment not worse than -25° to + 50°
Electric table height adjustment mechanism Yes
Dimensions in cm: Length: 200 cm, Width: 63 cm +/- 5%.
Load capacity Not less than 150 kg
Power supply 220 50 Hz, +/- 5%.
The work surface must be made of a material resistant to
mechanical impact and disinfectants, be easily cleaned with
detergents and waterproof
Compliance with standards:
EN 60601-1:2006 Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance, EN
60601-1-2:2015 Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential performance -
Collateral Standard: Electromagnetic disturbances - Requirements
and tests, IEC 60601-2-52:2009 Medical electrical equipment - Part
2-52: Particular requirements for the basic safety and essential
performance of medical beds, Council Directive 93/42/EEC of 14
June 1993 concerning medical devices
Warranty period for the equipment – not less than 12 months
Delivery: up to 80 calendar days from the date of signing the
contract