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

GENERAL DESCRIPTION
Suction unit including two collection jars mounted on a trolley and AC powered.

IMPORTANT: These pumps have been designed run for 30 minutes continuously, after which the unit should be given a 30-minute period to cool down, during this period they should not be run.

INTENDED USE
A mobile/portable surgical aspirator/suction unit capable of creating a vacuum pressure up to 600 mmHg. Used for surgical procedures requiring suctioning to remove blood and irrigating fluids that accumulate in the operative field and obstruct the surgeon's view.

TECHNICAL SPECIFICATIONS
The unit should provide intermittent and continuous suction. Continuous is limited to 30 minutes after which the unit should be given 30 minutes to cool down.
The unit should be provided with two (2) reusable collection jars.
The unit should have maintenance free operating.
The unit is designed in such a way that it requires little or no oil.
The pump is equipped with a provision preventing fluid flowing to the pump if the collection jar is full (overflow control valve).
A gauge indicating the negative pressure generated by the unit (preferably in kPa or mmHg).
A hydrophobic bacterial filter is included in the airline to the pump.
The unit has user-adjustable suction between 0 and at least 600 mmHg (80 kPa).
A vacuum control and on/off switch are present on the casing.
The flow rate at maximum vacuum is ≥ 40 L/m (2.4 m³/h).
A suction tube of at least 1.5 meters is included.
The suction tube is autoclavable at 121°C.
The unit is equipped with a foot switch for control of the suction.
During operating the unit's noise level does not exceed 60.1 dB.
The unit should be mounted on a wheeled, stable, portable stand.
The stand is equipped with 360°, anti-static, swivel castors.
A least two (2) castors should be 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 plastic in accordance with the latest European standards.
Power requirements: 100 - 240 Volts - 50/60 Hz (not necessarily in a single unit).
The collection jar is made of shatterproof polycarbonate.

COLLECTION JAR:
The two collection jars have a combined capacity of 2 litres, are transparent with clear graduation and allow for autoclaving at 121°C.

SUPPLIED WITH
Instructions for assembly, use and maintenance in English, French and Spanish.
1 x Plastic protective dustcover (depending on the model).
2 x spare collection bottle including cover, gasket, and overflow valve.
50 x spare inlet anti-bacterial filters.
4 x spare seals for the collection jar.
1 x set of spare fuses (if applicable).
2 x sets of silicone suction tubes, diameter 8/14 mm (inner/outer), length > 2.5 m.
2 x bi-conical connectors fitting the silicone tubes.

ESTIMATED LIFE SPAN
7 to 10 years.

WARRANTY
Two years from shipping date.

ENVIRONMENTAL CONDITIONS
- Operating conditions: 5°C - 35°C / 30% – 70% RH.
- Storage conditions: -10°C - 55°C / 20% – 80% RH.
- Atmospheric pressure: 700 ~ 1060hPa.

WEIGHT AND VOLUME
Weight: 24.5 kg.
Volume: 290.75 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
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.
S0760640, Pump, suction, foot-operated.
S0002107, Pump, suction, electrical, incl. battery.

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

SAFETY & PRODUCT STANDARDS
- IEC 60601-1:2005 + A1:2012(E) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
- IEC 60601-1-6:2010 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability.
- ISO 10079-1:2015 Medical suction equipment -- Part 1: Electrically powered suction equipment.

NOMENCLATURE
- GMDN code: Surgical suction pump (63642), General-purpose surgical suction system, electric (63648).
- UMDNS code: Aspirators, Surgical (10217), Aspirators (10208), Aspirators, Surgical (102170).
foot-operated.