Table,gynaeco,delivery,w/access

General Description:
Table, gynecology, delivery, with accessories

Intended use:
To support a woman's body during labour and delivery as well as other gynaecological examinations related to pregnancy. Manually-operated.

Technical specification:
Gynecological examination and delivery table, 3 sections.
Mounted on 4 sturdy supports, all finished with height adjustable feet.
All sections fitted with non-removable padded upholstery.
Robust mechanics allow for manual repositioning of all sections between gynecological and obstetric use.
Single or multiple transfer bars connect lower distal portions of the 4 supports, providing maximal structural strength.
Back section:
Adjustable via secured pawl and gear ratchet, safe for patient and operator.
Pelvic section:
Can be tilted to Trendelenburg position with lever handle.
Sides of this section are fit with vertical handgrips, length 20 cm.
Padded knee crutches are height and width adjustable, set with robust clamps with heavy knob.
Fixing of the crutch holders is solid steel and welded to the frame of the bed.
Pelvic section integrates a support for a slide-out basin-tray.
Leg section:
Recesses entirely downwards, 90 degrees.
When elevated and fully extended, all sections align to perfectly flat surface.

Materials:
High resistance to corrosion (tropical environment).
Frame: epoxy coated tubular steel.
Adjustable feet: rubber or nylon.
Sliders/fixtures for the knee crutches: tubular steel, welded to the bedframe.
Padded upholstery: high-density polyurethane foam, density 27-33 kg/m3.
Cover: plastic, flexible, highly tear resistant, anti-static, flame-retardant, non-absorbing, waterproof and cleanable with hospital-grade disinfection products.
Basin-tray: Austenitic stainless steel, grade 304.

Dimensions:
All 3 sections extended, including padding: 180 x 80 x 80 cm (l x wx h)
Frame: 3 cm (outside, across), 1.8 - 2 mm (thickness)
Padded upholstery: 5-6 cm (h)
Carrying capacity: minimum 150 kg
Slide-out basin-tray, capacity: 4L
Knockdown construction: yes

Items supplied with:
1 x complete set of tools required for assembly
2 x leg holders with canvas straps, adjustable height and width
2 x knee crutches, adjustable height and width
1 x basin-tray
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: 36065 - Gynaecological examination/treatment table, manual

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