Pump,suction,airway,electr,battery

GENERAL DESCRIPTION
Mains and battery-operated portable suction unit.

INTENDED USE
Portable suction machine for airway aspiration, minor surgery, emergency, patient transfer, suitable for use in hospitals and at home.

TECHNICAL SPECIFICATIONS
The unit provides intermediate 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 one (1) reusable collection jar.
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.
A hydrophobic bacterial filter is included in the airline to the pump.
The user adjustable suction ranges between 0 and at least 525 mmHg (70 kPa).
The flow rate at maximum vacuum is ≥ 33 L/m (2 m³/h).
The unit is provided with a suction tube of at least 1.5 meters.
The suction tube is made of medical grade silicone which is autoclavable at 121°C.
During operating the unit's noise level does not exceed 65.5 dB.
The weight of the unit does not exceed 5.5 kg.
The unit should be provided with a carrying handle and storage provisions for all accessories, allowing to carry the unit with one hand.
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.
The unit is equipped with a lead-acid battery.
The battery should be able to power the unit for up to 60 min.
A visual alarm should be incorporated in the unit signalling depletion of the batteries.
The unit should be provided with a battery level indicator and a charging indicator.
The unit should be able to simultaneously operate and charge from 12 Volt as well as the main power grid.
Power requirements: 230 Volts - 50Hz (A 110 V / 60Hz unit is available on demand).

THE COLLECTION JAR
The transparent, shatterproof, polycarbonate collection jar has a capacity of 1 litre and has a clear graduation. It is capable of withstanding autoclaving at 121°C.

SUPPLIED WITH
Instructions for assembly, use and maintenance in English, French and Spanish:
1 x spare collection bottle including cover, gasket, and overflow valve.
10 x spare inlet anti-bacterial filters.
2 x spare seal 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
More than 1000 hours of operation (or 3 years).

WARRANTY
Two years from shipping date.

ENVIRONMENTAL CONDITIONS
- Operating conditions: 5°C - 35°C / 20% – 90% RH.
- Storage conditions: -10°C - 55°C / 20 % – 80% RH.
- Atmospheric pressure: 800 ~ 1060hPa.
- Ingress protection rating: IP21.

WEIGHT AND VOLUME
Weight: 8.000 kg.
Volume: 100.00 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 bottles,w/access.
S0002029: Pump,suction,surgical,2 bottles,w/access.
S0760640: Pump, suction, foot-operated.

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.
- ISO 10079-1:1999 Medical suction equipment -- Part 1: Electrically powered suction equipment -- Safety requirements.

NOMENCLATURE
- GMDN code: Emergency airway clearance suction pump, electric (63643)
- UMDNS code: Aspirators, Airway, Nasal (10216)
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