Bed,labour/delivery,w/access

General Description:
Bed, labour/delivery, with accessories

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

Technical Specifications:
Bed, labour and delivery, 2 sections.
All sections fit with padded mattresses, entirely detachable from bed for easy cleaning.
Mattress covers removable via side zipper.
Transfer bars connect all lower distal portions of the 4 supports, providing maximal structural strength.

Body section:
Mounted on 4 sturdy supports, all finished with height adjustable feet.
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.

Leg section:
Mounted on 4 swivel castors, heavy duty, all 4 with brakes.
This section can be lowered and recesses entirely under the body section.
When fully extended, both the body and leg section align to perfectly flat surface.

Material:
Frame: epoxy coated tubular steel.
High resistance to corrosion (tropical environment).
Adjustable feet: rubber or nylon.
Sliders/fixtures for the knee crutches: tubular steel, welded to the bedframe.
Recession track and guiding wheel for the leg section are smoothly finished for easy in/out sliding
Mattress: high-density polyurethane foam, density 30 kg/m3.
Cover: plastic, flexible, highly tear resistant, anti-static, flame-retardant, non-absorbing, waterproof and cleanable with hospital-grade disinfection products.
Caster frame/bracket: steel or nylon.
Caster brake: total-lock type (wheel and rotational lock).
Caster wheel: single wheel, mold-on type, non-hooded (for easy maintenance).
Wheel bearing: sealed bearing in the swivel and the wheel.
Swivel is ball-bearing.

Dimensions:
Body section, including mattress: (110-120) x (72-80) x (80-84) cm (l*w*h).
Leg section, including mattress: (65-70) x (65-75) x (80-84) cm (l*w*h).
Frame: 3 cm (outside, across), approx. 2.0 mm (thickness).
Swivel castor wheel: (2.5-3) x (10) cm (w*diameter).
Mattresses: 9-10 cm (h).
Carrying capacity: min. 135 kg
Knockdown construction.

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 set fitting removable mattresses, body and leg section
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: 36847 - Birthing bed/table, non-powered

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:
Each Item is to be packed in carton box. One item per box.
Compliance with EAN 128 bar code.