Sterilizer,steam,24L

INTENDED USE
A device designed for total elimination and/or 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, or steam. It includes a treatment chamber with an inner container, it may be intended to sterilize wrapped and/or unwrapped devices. The device comes without a heating source and can be heated through a kerosine stove, electrical heater or 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 or an equivalent material.
The removable cover is provided with a handle from Bakelite or 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/or PSI and degrees Fahrenheit and/or 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.

ITEMS REQUIRED, BUT NOT SUPPLIED
S0558100Indicator,TST control spot/PAC-300
S0845176Masking tape, type 1 steam indicator
S0845177Papersheet,crepe,for ster. pack/PAC-250

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)
Weight: 24.2 Kg.
Volume: 153.5 dm³.

INSTALLATION / COMMISSIONING REQUIREMENTS
This device does not require installation

TRAINING REQUIREMENTS
There is no specific user training required, user should follow the instructions as provided in the user manual.

MAINTENANCE/USER REQUIREMENTS
There are some minor maintenance activities, such as cleaning, lubricating the metal-to-metal seal and safety checks which are detailed in the instructions for use.

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ALTERNATIVE PRODUCTS
S0156000, Sterilizer,steam,39L

COMPONENT OF A KIT
S9901029 - IEHK2017,kit,suppl.2-equipment

QUALITY MANAGEMENT SYSTEM
- Manufacturer is certified for ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes.

MARKET CLEARANCE
Approved by USA-FDA for distribution in the USA

NOMENCLATURE
GMDN Code: 38671