Operating Table for Fistula Repair

General Description:
Operating table for fistula repair

Intended use:
Operating table for fistula repair surgery and other gynaecological surgical procedures. Manually-operated.

Technical Specification:
Mechanical manual-hydraulic operating table.
Mobile stainless steel base on ball bearing castors with central brake.
Divided in four sections (4): head, torso, pelvic and legs.
All sections fitted with antistatic radiolucent mattress, detachable for easy cleaning.
Adjustable head section (+40-45) to – (-70-110) degrees.
Adjustable torso, pelvic and leg sections.
Detachable leg section.
Adjustable to the following positions:
Adjustable from 20 up to min 45 degrees (allows a steep Tredelenburg position).
Reverse Tredelenburg 15-25 degrees.
Lateral tilt both sides: to 20-30 degrees.
Allows lithotomy position; proctology position, flexion, extension.
When elevated and fully extended all sections align to perfectly flat surface (supine position).
Radiolucent table top with integrated standard size X-ray cassette channel (double table top).
Table top rotation independent of base, 360 degrees.
Height adjustment: (75-81) to (100-105) cm (h).
Mechanical operated control or crank handles for three sections: back, pelvic, legs with auto locking gear mechanism.

Material:
High resistant to corrosion and cleaning agents.
Frame: Austenitic stainless steel, smooth finishing for easy cleaning.
Sliders/fixtures for accessories: Stainless steel welded to the table frame.
Mattress: Plastic, flexible, highly tear resistant, anti-static, flame-retardant, non absorbing, waterproof and cleanable with hospital-grade disinfection products, washable.

Dimensions:
Overall: (200-210) X (50-60) x (75-81 to 100-105) cm (l x w x h). Width including side frame 55-64 cm.
Carrying capacity: minimum 150 kg.

Supplied with:
Detailed step by step pictorial based instructions for assembly and use.
Operating manual (instruction manual) and installation manual in English, French and Spanish.
Cleaning and disinfection instructions.
1 x set of tools required for assembly (if required).
2 x shoulder support.
1 x spare set of 4 fixation clamps.
1 x set fitting mattresses.
Set of accessories, each with fixation clamp:
1 x anaesthesia screen.
2 x thigh support.
2 x arm board, with arm strap.
2 x knee support, lithotomy crutch, with strap.
1 x body strap.
1 x foot rest for proctology position.
List of all parts supplied with the operating table.
Warranty of minimum 2 years.

Quality Management System:
ISO 13485:2016: Medical devices - Quality management systems

Regulation & conformity requirements:
Regulation (EU) 2017/745, Class I (or equivalent internationally recognised marketing clearance)

Nomenclature:
GMDN code: 58034 - Universal operating table, hydraulic

Environmental compliance and safety:
All furniture components contain less than 100 parts per million of the below chemical groups, as applicable:
Urea formaldehyde
Heavy metals including mercury, cadmium, lead, antimony
Hexavalent chromium in plated finishes
Stain and non-stick treatments derived from Perfluorinated Compounds (PFCs), including Perfluorooctanoic Acid (PFOA)
Added antimicrobial treatments

Number of units per primary packaging:
One (1) unit per box.
Compliance with EAN 128 bar code.