Table,operating theatre,w/access

General Description:
Table, operating theatre, with accessories

Intended use:
General purpose operating table designed for patient positioning during surgical procedures.

Technical specifications:
General purpose operating table, 4 areas, 5 sections.
Stainless steel finished base on 4 castors.
Central brake lowers the table onto 4 robust, height adjustable feet.
Solid reinforced base creates maximum stability, with patient, up to the limits of each position.
Base is fit with earth connection.
Gear, lever and crank mechanisms are all manually operated, no gas springs.
Radiolucent table top with integrated standard size x-ray cassette channels.
All sections fit with a mattress, detachable for easy cleaning.
Mattresses have welded seams, core and surface are joined.
Table adjustable to all essential positions.
Height adjustable with foot-pedal via hydraulic lever system.
Factory or user filled with hydraulic oil.
Three areas adjustable via manual crank: back, pelvic and legs.
Backrest adjustable (-15 to +5) to (+75-90) degrees.
Trendelenburg and reverse Trendelenburg: +/- 20-25 degrees.
Lateral tilting, both sides: +/- 20 degrees.
Leg area removable, consists of 2 independent sections, each adjustable to a combination of up/down and left/right.
Head area removable, and independently adjustable, (+20-45) to -90 degrees.
Accessories on both sides clamp on standard stainless steel medical rail.
When elevated and fully extended, all sections align to perfectly flat surface.

Material:
High resistance to corrosion (tropical environment).
Base, frame, sliders/fixtures rail for accessories: Austenitic stainless steel, grade 304
Table top: radiolucent epoxy resin.
Mattress: highly tear resistant, anti-static, flame-retardant, non absorbing, waterproof and cleanable with hospital-grade disinfection products, washable.
Caster wheel: single wheel, solid, non-hooded (for easy maintenance).

Dimensions:
Operating table, all areas extended:
Length: 200-210 including leg section.
Width: 48-50 cm
Height: 75-77cm (h) from floor to frame. 80-95cm from floor to surface without the matress.
Height adjustment: 75 to 105 cm (h)
Height adjustable feet: lenght 6-9 cm and width: 2-3.5 cm.
Mattress: 5 cm (h)
Carrying capacity: minimum 150 kg
Knockdown construction: No

Items supplied with:
1 x complete set of tools required for assembly
4 x spare fixation clamps
1 x set fitting mattresses
1 x spray bottle of silicon (for mattress maintenance)
Set of accessories, each with fixation clamp:
1 x anesthesia screen arc
2 x lateral support, height adjustable only
2 x shoulder support, height and width adjustable
2 x leg support
2 x arm board, with arm fixation strap, vertical and horizontal adjustable
2 x padded knee support, lithotomy crutch, with fixation strap
1 x body strap
List of accessories and parts
Detailed step-by-step instructions for assembly and safe use, text-free pictorial based (i.e. line-drawings only)
Instructions for use including cleaning and disinfection instructions in English, French and Spanish.
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

Packaging and labeling:
One (1) unit per box
Compliance with EAN 128 bar code requirements