Pump,suction,surgical,1 bottle,w/access

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

Device Classification:
Device should be 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 one (1) collection jar with the following features:
- Made of shatterproof material;
- Be transparent;
- Have clear graduation;
- Is fully autoclavable at 121°C (hence reusable);
- Has at least 1 litre capacity.
The unit has maintenance free operating and is fitted with the following features:
- Operating piston(s) which 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 16 L/m (1 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 to have fully 360-degree swivel;
- Castors/wheels minimum size of 75 mm;
- Castors/wheels are anti-static;
- Castors/wheels are lockable.
The design of the device should be such that it is easy to clean/disinfect by avoiding difficult-to-reach areas and having smooth surfaces.
The device should have a sturdy, shock resistant casing.
The body is to be constructed of 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.

Environmental conditions
Storage conditions: 0 - 50°C / 100% relative humidity
Operating conditions: 10 - 40°C / 100% relative humidity

Required 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 indicated 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. (If applicable).
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.
Used symbols are in accordance with ISO 15223.
Lot number prefixed by the word "LOT" (or equivalent harmonized symbol) (if applicable).
Information for particular storage conditions (temperature, pressure, light, humidity, etc.), as appropriate (or equivalent harmonized symbol).
Information for handling, if applicable (or equivalent harmonized symbol).

Over packaging: Packaging unit
- Max weight per carton: 25 kg.
- Size of carton: Modularized based on EUR1 size pallet: 1200 mm (L) x 800 mm (W) x 1200 mm (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 are 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).
Spare parts availability post-warranty period. (number of years).
Specific maintenance requirements for users.
Specific maintenance requirements for technicians.
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: 7.7 kg (packaged).
Volume: 0.06 m3 (packaged).

Related Products:
S0002029: Pump,suction,surgical,2 bottles,w/access
S0760640: Pump, suction, foot-operated
S0002107: Pump, suction, electrical, incl. battery