Pump,suction,foot-operated

GENERAL DESCRIPTION
Pump, suction, manually operated by foot.

INTENDED USE
Basic hospital equipment for health structures and emergency situations in wards, emergency room, operating theatre, delivery room, intensive care unit, etc.
High performance suction pump, foot-operated for pharyngeal and tracheal suction and during minor surgical interventions. Supplied with instruction manual and diagrams covering the function of the pump, how to use it, dismantle and assemble it, to clean, disinfect and sterilize it, its maintenance and spare-parts. The suction pump should be operated only by a person who has received adequate training in pharyngeal and tracheal suction techniques.

TECHNICAL SPECIFICATIONS
The unit provides suction a foot operated pedal.
The unit has maintenance free operating requiring little or no oil.
The pump is equipped with a provision preventing fluid flowing to the pump if the collection jar is full.
The user adjustable suction ranges between 0 and at least 525 mmHg (70kPa).
The flow rate at maximum vacuum is 40 L/min (2.4 m³/h).
The unit is provided with a suction tube of at least 1.3 meters.
The suction tube is made of medical grade silicone which is autoclavable at 121°C.
The unit is mounted on a stable platform and easy to carry.
The base has an anti-slip provision, preventing the pump from sliding away when in use.
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 has a sturdy design and shock resistant casing.
The body is constructed of stainless steel or material which is non-corrosive or has a corrosion resistant coating.
Designed for frequent and easy dismount and disinfection with hospital-grade products.

THE COLLECTION JAR(S)
The unit is equipped with one collection jar(s) with a total capacity of no less than 1L.
The collection jar is made of shatterproof polycarbonate.
The collection jar is transparent with clear graduation and is fully autoclavable at 121°C.

SUPPLIED WITH
Instructions for assembly, use and maintenance in English, French and Spanish:
1 x Aspirating tube, 10 mm (internal diameter), at least 135 cm long.
1 x Spare aspirating tube, 10 mm (internal diameter), at least 135 cm long.
1 x Conical nozzle-connector, adjustable distal tip diameter 7 and 10 mm, fits narrow and wide suction catheters.
1 x Spare conical nozzle-connector, adjustable distal tip diameter 7 and10 mm, fits narrow and wide suction catheters.

ESTIMATED LIFE SPAN
5 - 7 years.

WARRANTY
Two years from shipping date.

ENVIRONMENTAL CONDITIONS
- Operating conditions: 0°C - 50°C / 20 % – 80% RH.
- Storage conditions: -10°C - 55°C / 20 % – 90% RH.

WEIGHT AND VOLUME
Weight: 4.00 kg.
Volume: 20.00 dm³.

ESTIMATED DELIVERY LEAD TIME
90 days.

INSTALLATION REQUIREMENTS
This product does not require installation, only simple assembly.

TRAINING REQUIREMENTS
User training prior to utilization is recommended.

MAINTENANCE/USER REQUIREMENTS
Use suction tubes (sterile and disposable) for pharyngeal and tracheal suction. These suction tubes fit with the aspirating tube of the suction pumpwith combination suction tip (narrow nozzle). The aspirating tube of the suction pump, foot-operated, must be supplied with a combination suction tip. This combination suction tip is made of two nozzles.
The narrow nozzle can be used directly or can be connected to a suction cannula (see suction tubes, sterile, disposable). If large amounts of liquids or solid particles have to be aspirated,e.g. vomit, the narrow nozzle can easily be removed and the large nozzle(with an aperture of 10mm) can be used directly.

Safety procedure:
The suction pump and the aspirating tube must be cleaned and disinfected after each use.
All parts can be sterilized in a steam sterilizer.

Important:
After dismantling and cleaning, the pump must be reassembled and tested to make sure that it works correctly. In view of its use, the item is considered an "emergency resuscitation item". This means that it must always be readily available and in a good working condition.
It is recommended to closely follow manufacturer's instruction manual.

RELATED PRODUCTS
S0374010 - Tube, suction, CH08, L50cm, sterile, disposable.
S0374015 - Tube, suction, CH10, L50cm, sterile, disposable.
S0374025 - Tube, suction, CH14, L50cm, sterile, disposable.
S0845132, Tube suction, Yankauer, 270mm

ALTERNATIVE PRODUCTS
S0002028, Pump,suction,surgical,1 bottle,w/access
S0002029, Pump,suction,surgical,2 bottles,w/access
S0002641, Pump,suction,airway,electr,battery

COMPONENT OF A KIT
S9908402 - Resuscitation kit, basic.

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 either under EU MDD 93/42/ECC, or under EU MDR 2017/745 as Class IIa device

SAFETY & PRODUCT STANDARDS
- ISO 10079-2:2014 Medical suction equipment - Part 2: Manually powered suction equipment.

NOMENCLATURE
- GMDN code: Manual emergency suction system (47368)
- UMDNS code: Aspirators, Surgical (10217), Aspirators (10208)