Sterilizer,steam,large,elect,floor model

GENERAL DESCRIPTION
Large freestanding, steam, sterilizer (autoclave), with a usable capacity of 75 litre, electric, with a front-loading door.

IMPORTANT: To ensure the sterilizer is capable to perform as per manufacturers specifications certain infrastructure as well as specific power grids provisions will be required. Therefore, these sterilizers should only be purchased after consultation of the Medical Devices Unit in Supply Division. (Medical-Technical@unicef.org)

INTENDED USE
Steam sterilizers use pressurized steam to generate moist heat to eliminate viable microbes from non-heat-sensitive medical devices, including heat-tolerant products used for surgical and general patient care. Steam sterilization kills microbes effectively and is often viewed as the gold standard of healthcare sterilization methods. Typical items to be sterilized include surgical instrument packs, surgical implants, irrigation fluids, devices intended for and used by patients in isolation, and obstetric and dental instruments.

Large steam sterilizers are used for bulk sterilization processing and are typically found in the hospital's central supply department. Most operating suites and labour and delivery areas are equipped with smaller units for their own routine needs; however, areas that perform a great deal of sterilization may require large sterilizers.

TECHNICAL SPECIFICATIONS
The sterilizer is suitable for wrapped, unwrapped, solid and hollow items as well as porous loads such as drapes and gowns.
The unit fitted with a front-loading door.
The internal chamber made from stainless steel 316L.
The internal chamber has a usable capacity of 75 Litre.
Vacuum relief line should be filtered with ≤0.2 µm pore size to allow sterile air into chamber.
The unit is provided with a minimum of two (2) internal shelves.
The unit has a standard program at 2.2 bar at a temperature of 134°C.
The unit has a standard program between 1.0 and 1.1 bar with a temperature between 118 – 121°C.
The unit is fitted with a safety lock on the front door, preventing the door to be opened when the unit is under pressure.
The unit is provided with an automatic cycle shut-off.
The unit provided with two internal water tanks, one for the vacuum system and one for the steam generator.
The unit equipped with a steam generator.
The unit is fitted with a reusable water circuit filter (so called outlet strainer).
The unit is designed in such a way that outer surfaces remain at safe temperatures when the unit is in operation.
The unit is designed and constructed in such a way that it is able to withstand frequent disinfection with hospital-grade products.
Two models available:
Model 1:
- Only suitable for 3-phased power grid supplying: 400 Volts at 50Hz, 11 kW.
Model 2:
- Suitable for 1-phased grids: 220 Volt / 50-60 Hz / 16 Amp (Requires extra switchbox)
Or,
- Suitable for 3-phased grids: 208, 220, 230, 380, or Volts / 50-60Hz / 11 kW.

DISPLAY FEATURES
The unit is fitted with a front panel providing information on the unit.
The display shows the ongoing cycle.
The display indicates the time until the programme is finished.
The display indicates the current internal temperature.
The display indicates the current internal pressure.
The display will show any alerts or alarms.

ALARM AND SAFETY FEATURES
Alarms are audible as well as visual.
Alarms are available for low water.
Alarms are available for door not closed.
Alarms are available for exceeding high temperature limit.
Alarms prior to temperature reaching limits of the equipment.
Alarms prior to pressure reaching limits of the equipment.
Alarms to indicate:
- Low / high temperature
- Low heat
- Low / high pressure
- Low vacuum
- Power on
- Door unlock
- Stand by
A notification that the end of sterilization cycle has been reached.
The unit is provided with an over-pressure safety system.

SUPPLIED WITH
Instructions for assembly, use and maintenance in English, French and Spanish.
3 x sterilizer baskets.
3 x spare gaskets (chamber/door) in sealed packages.
1 x set of spare fuses, if required.
1 x spare parts/maintenance kit (air filters, tubing, O-rings).

OPTIONAL ACCESSORIES AVAILABLE
At extra costs additional optional features can be requested:
- Filtration system or distiller solution which will allow the unit to accept so-called "hard water", (water with high mineral content, especially calcium and magnesium.) without causing internal damage and/or deposits.

ESTIMATED LIFE SPAN
Eight years.

WARRANTY
Two years from shipping date.

ENVIRONMENTAL CONDITIONS
- Operating conditions: 10°C - 40°C / 85% RH.
- Storage conditions: 0°C - 50°C / < 65% RH.
- Atmospheric pressure range: 795 to 1100 mbar

WEIGHT AND VOLUME
Weight: 380 kg
Volume: 1,870 dm3

ESTIMATED DELIVERY LEAD TIME
120 days.

INSTALLATION REQUIREMENTS
Assembly and commissioning this product should be carried out by qualified technician.

TRAINING REQUIREMENTS
User training prior to utilization is recommended.

MAINTENANCE/USER REQUIREMENTS
As per user and service manuals.

RELATED PRODUCTS
S0167100 Papersheet,crepe,for ster. pack/PAC-100.
S0558100 Indicator,TST control spot/PAC-300.
S0845176 Masking tape, type 1 steam indicator

ALTERNATIVE PRODUCTS
S0002020 Sterilizer,steam,20L,electric,w/access.
S0002022 Sterilizer,steam,40L,electric,w/access.
S0004045 Sterilizer,steam,large,electric,waccess
S0156000, Sterilizer,steam,39L.
S0157000, Sterilizer,steam,24L.

COMPONENT OF A KIT
No part of a kit.

QUALITY MANAGEMENT SYSTEM
- Manufacturer is certified for ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes.
- Supplier (if not the manufacturer) at a minimum is certified for ISO 9001 Quality management systems – Requirements.

CLASSIFICATION
Classified under EU MDD 93/42/ECC as a class IIb device and certified under 2014/68/EU PED.

SAFETY & PRODUCT STANDARDS
- IEC 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- IEC 61010-1 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements.
- IEC 61010-2-040: Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials.

NOMENCLATURE
- GMDN code: Steam sterilizer (38671).
- UMDNS code: Sterilizing Units, Steam, Bulk (16141).