Pump,suction,surgical,2 bottles,w/access

General Descriptions:
An electrical operated suction unit suitable for minor surgery, medical interventions, resuscitation and aspiration of secretions, puss, blood, irrigating fluids, etc.

Device Classification:
Device is classified as a Class IIa device under the MDD 93/42/EEC, or an equivalent classification under regulatory authorities from the following countries: Australia, Canada, Japan, or the USA.

Technical Specifications:
The unit provides intermittend and continuous suction.
The unit is provided with two (2) collection jars with the following features:
- Made of shatterproof material.
- Transparent.
- Clear graduation.
- Fully autoclavable at 121°C (hence reusable).
- Has at least 2-liter capacity.
The unit has maintenance free operating and is fitted with the following features.
- Operating piston(s) requires little or no oil.
- A provision which prevents fluid to flow to the pump if the collection jar is full.
- A gauge indicating the negative pressure generated by the unit. (preferably in kPa or mmHg)
- Fitted with a bacterial filter in the airline to the pump.
- User adjustable suction between 0 and at least 600 mmHg (800 mbar).
- A vacuum control and on/off switch on the casing.
- Aspiration capacity at least 60 L/m (2.4 m3/h).
- A suction tube of at least 1.5 meters with the following specifications:
- Autoclavable at 121°C.
- Made of medical grade silicone.
- A foot switch for control of the suction.
During operating the unit's noise level will not exceed 60.5 dB.
The unit is mounted on a stable, portable stand with:
- Castors/wheels, fully 360-degree swivel.
- Castors/wheels minimum size of 75 mm.
- Castors/wheels are anti-static:
- Castors/wheels are lockable.
Easy to clean/disinfect by avoiding difficult-to-reach areas and having smooth surfaces.
Sturdy, shock resistant casing.
The body is to be constructed from stainless steel or material which is non-corrosive or has a corrosion resistant coating.
UNICEF has a preference for units equipped with simple and logical structured user interfaces suitable for staff working at different levels in the health care system.

Electrical requirements
The power requirements will depend on the country where the equipment will be shipped. Units are available for either 100-110 volt / 60 Hz or 220-240 Volts / 50 Hz versions, or both simultaneously.
The power consumption will not exceed 200 Watts.

Included accessories, supplies and/or consumables:
One (1) spare collection bottle including cover, gasket, and overflow valve.
Ten (10) spare inlet anti-bacterial filters.
Two (2) spare seal for the collection jar.
One (1) set of spare fuses. (if applicable)
Two (2) sets of silicone suction tubes, diameter 8/14 mm (inner/outer), length > 2.5 m
Two (2) bi-conical connectors fitting the silicone tubes.
Instructions for assembly, use and maintenance in English, French and Spanish.

Warranty
Two (2) years.

Packaging and labelling:
Primary packaging: Unit of use:
Labelling on the primary packaging indicate the name and/or trademark of the manufacturer in addition to:
- Manufacturer's product reference.
- Type of product and main characteristics.
- CE marked, indicate the CE mark and notified body number.
Goods defined as dangerous under the United Nations Recommendations on the Transport of Dangerous Goods, ICAO’s Technical Instructions, IATA’s Dangerous Goods Regulations and the IMO’s International Maritime Dangerous Goods Code follow ISO 16495 for transport and packaging.
Bear a diagram (preferably actual size) showing the essential parts of the product and indicating the position of the product in the packaging. (If the packaging is not transparent)
Used symbols in accordance with ISO 15223.
Lot number prefixed by the word "LOT" (or equivalent harmonised symbol) (if applicable).
Information for particular storage conditions (temperature, pressure, light, humidity, etc.), as appropriate (or equivalent harmonised symbol).
Information for handling, if applicable (or equivalent harmonised symbol).

Over packaging: Packaging unit
- Max weight per carton: 25 kg.
- Size of carton: Modularized EUR1 size pallet: 120cm (L) x 80cm (W) x 120cm (H incl. pallet.)
- Labelling on the packaging unit: Labelling to be the same as primary packaging.
- Extra information required: Number of units per box.
Strength of carton: For storage and handling the following minimum values met: Corrugated carton in BC profile (7 mm), with edgewise crush resistance value 15 or more in temperate climate and at least half that in tropical climate (90% humidity and 40°C), measured according to SIS 84 30 03 (Swedish Standard) or similar.

Training, installation, utilization and decommissioning:
Pre-installation requirements: attached explanatory document(s). (If applicable).
Installation required: specify or attached explanatory document(s).
Consumables/accessories: (A list including their source, reference numbers and prices).
Most commonly requested spare parts. (Source, reference numbers and prices): (if applicable).
Spare parts availability post-warranty period (Number of years).
Specific maintenance requirements for users. (if applicable).
Specific maintenance requirements for technicians: (if applicable).
Estimated life span: (if applicable).
Requirements for disposal and/or decommissioning: (if applicable).
User training related costs: (If applicable).

Environmental considerations:
Compliant with RoHS (EU Directive 2002/95/EC).

Estimated Weight and volume:
Weight: 25 Kg. (including packaging)
Volume: 0.300 m3.

Related Products:
S0002028: Pumps, suction, surgical, 1 bottle, w/access.
S0002107: Pump, suction, electrical, incl. battery
S0760640: Pump, suction, foot-operated.