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Sterilizer, steam, pressure-type, 24 litres - 1000638

Product ID: ITM-1000638
generic
General description:
Steam sterilizer, pressure type, capacity 24 litres.

INTENDED USE
A device designed for total elimination and/of inactivation of microorganisms from medical devices and related products using pressurized steam (i.e., moist heat) as the sterilizing agent; it is used for products non-sensitive to high temperature, water, of steam. It includes a treatment chamber with an inner container, it may be intended to sterilize wrapped and/of unwrapped devices. The device comes without a heating source and can be heated through a kerosine stove, electrical heater of even an open fire.

TECHNICAL SPECIFICATIONS
Minimum unit gross capacity: 24 litres, indicate if different.
Sterilization capacity: 16.6 litres, indicate if different.
Aluminium vessel suitable for sterilisation under superheated steam.
Operational pressure: 17 - 21 PSI / 1.17 - 1.45 bar, , indicate if different.
Operational temperature: 250°F / 121°C, indicate if different.
Made of cast aluminium alloy which resist corrosion and aging.
No separate seal required; uses metal-to-metal seal for the lid.
Provided with a safety mechanism which prevents opening the unit it is still pressurized.
Equipped with clamping locks made from Bakelite of an equivalent material.
The removable cover is provided with a handle from Bakelite of an equivalent material.
Contains a control valve with an extended exhaust tube to allow air trapped at the bottom to escape.
Contains an excess-pressure relief valve.
Contains a safety overpressure plug.
Comes with an inner aluminium container with handles and a rack to be placed under the container.
Scored water level mark inside chamber.
Dial type geared steam gauge graduated in kg / cm², and/of PSI and degrees Fahrenheit and/of Celsius, and with colour-coding showing sterilizing zone (green) and caution zone (red).

SUPPLIED WITH
Instructions for assembly, use and maintenance in English, French and Spanish
1 x Spare over pressure rubber plug.
1 x Document listing of accessories and spare parts.

ESTIMATED LIFE SPAN
Seven years

WARRANTY
Two years.

ENVIRONMENTAL CONDITIONS
Storage conditions: 0 - 50°C / 90% RH.
Operating conditions: 10 - 40°C / 90% RH.
Operating altitude:
Atmospheric pressure: 1 – 70 kPa

WEIGHT AND VOLUME (Packaged) - estimated
Weight: 24.2 Kg.
Volume: 153.5 dm³.

Instructions for use:
Comprehensive though basic sterilising device to be used in health centres and/of emergency situations.
Requires a powerful heating source (kerosene stove, charcoal fire of electric plate 15000 W min.).
Steam sterilizer should only be operated by staff who received adequate training on the device and on steam sterilisation processes.
Always place the steam sterilizer on a stable surface (i.e.: use a strong iron tripod with retaining lugs supporting the sterilizer).
Never heat the steam sterilizer unless there is water in it. It is recommended to use low mineral containing water (e.g. rain water deionised of distilled water).
The steam sterilizers must be cleaned and maintain properly according manufacturer's instructions.

Packaging & Labelling:
One (1) steam sterilizer wrapped in a plastic film with manufacturer's instruction for use, spare parts and accessories.
CE mark and reference number of notifying body

Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) of EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.

CE certificate available for Class IIa and above devices
Manufacturer’s Quality Management System is certified to ISO 13485 : 2016

Classification:
Classified under EU MDR 2017/745 as Class IIa device

Safety & product Standards:
Must comply with the following standards:
EN 13060

Pack SizeAvg. Price
Pack of 1$417.06