ANNEX F.

TECHNICAL SPECIFICATIONS FOR SURGICAL MASKS

AND HYDROCEPHALUS VALVES

1. SURGICAL MASKS LATEX FREE BOX OF 100

General Description

Surgical masks latex free, fiber glass free, hypo-allergic, with ear loops and nose piece, Box
of 100

Synonym: Procedure /face masks

Intended Use:

Surgical mask is intended to be worn by medical personnel during surgical or other medical
procedures to protect both the patient and the operating personnel from transfer of
microorganisms, body fluid and particulate material transfer

Technical Specifications

Latex Free, Hypoallergenic, Fiberglass fee, Fluid Resistant, Three Ply construction.
3 pleats of folds to allow the user to expand the mask so it covers the area from the nose
to the chin. Mask should be secured with an ear loop to be placed behind the ears.
>99% Bacterial Filtration Efficiency (BFE) at 5 micron capacity; >95% Bacteria
Filtration Efficiency (BFE) at 3 micron capacity.
Reduces exposure to blood and body fluids. Minimizes patient contamination to
exhaled microorganisms. This product is intended for use in infection control practices.

Material; Spunbound polypropylene for inner and outer facings of mask.

Three (3) ply, fluid resistant,

Fiberglass free, latex free mask

Color; Blue

Usage; For Single use only

Size selected: Total length: approximately 175mm.

Width: approximately 90mm.
CE marked

Primary packaging: Unit of use (1) box of 100 masks

Secondary packaging: 6 cases of 100 masks /box (600 pieces/case

1
Labelling on the primary packaging:
Name and/or trademark of the manufacturer.
Manufacturer's product reference.
Type of product and main characteristics. If the packaging is not
transparent, it must bear a diagram (preferably actual size) showing the
essential parts of the product and indicating the position of the
product in the packaging.
Lot number prefixed by the word "LOT" (or equivalent harmonized symbol)
(if applicable).
Expiry date by year and month, prefixed by the word "EXP" (or equivalent
harmonized symbol) (if applicable).
The words "for single use" (or equivalent harmonized symbol).
The words "destroy after use" (if space allows).
Number of units per primary packaging (if applicable).
Information for particular storage conditions (temperature, pressure,
light, humidity, etc.), as appropriate (or equivalent harmonized
symbol).The word single use with equivalent harmonized symbol should be stated
Manufacturer's instruction for use.

2. HYDROCEPHALUS VALVE, 3 PIECE HOLE SYSTEM

General Description of Product:
Low Flow hydrocephalus valve, Three Piece Burr Hole System
Intended Use:
Low flow hydrocephalus valve is used for controlling physiological CSF drainage from
ventricles to the peritoneal cavity or other appropriate drainage site

Technical Specifications

3 piece Hole system valve with integral polysulphone connectors.

Low flow rate that is lower than average CSF Flow and maintain drainage at a constant rate
between 8 -17 ml/hr.

Integral 110 Open ended barium striped peritoneal catheter

6.4 mm burr hole cap with side arm

Regular (2.5 mm) and shallow (0.8mm) burr hole reservoirs

Right angle guide

Straight Propylene connector

Luer connector
2
Ventricular introducing rod

Sterile and non-pyrogenic

Nonadjustable

Usage: For Single use only

Flow rate: 8-17 ml/hr

Size Selected: 40.5mm (L) X 12.5 mm (W) X 7.9 mm (H)

Accessories/Spare parts/Consumables:

15cm Accuracy catheter (Barium striped with numbered depth markers)

Storage:
Capable of being stored continuously in ambient temperature of 10 to 35
deg C and relative humidity of 15 to 90%.
Capable of operating continuously in ambient temperature of 10 to 35 deg
C and relative humidity of 15 to 90%.

Supplied with:
Clear instructions for use / diagrams for assembly in 3 languages
(English, French, Spanish), list of accessories / parts. In addition to these three languages, the
supplier should inform UNFPA if manuals or instructions sheets could also be provided in Portuguese
language.

Packaging, labelling and instructions:

Packaging and Labelling:
Primary packaging
Unit presentation: 1 (one) hydrocephalus valve, set
Manufacturer's name and logo
Manufacturer's product reference
Manufacture and expiry date, lot number
Main characteristics (dimensions, capacity)
Recommended storage conditions
Information for handling
Protective packaging
Number of units/pieces
Manufacturer's name and logo
Manufacturer's product reference
Manufacture and expiry date, lot number
Main characteristics (dimensions, capacity)
Recommended storage conditions

3
Information for handling
The word single use with equivalent harmonized symbol should be stated
Weight/Volume/Dimensions:
Estimated weight: 0.220kg
Estimated volume: 0.532cdm

Instructions for use:

For controlling physiological CSF drainage from ventricles to the peritoneal cavity or other
appropriate drainage site