Life is priceless, Bio Gene Medical Suction Machine are manufactured under strict WHO guidelines confirming to FDA, CE, ISO etc.
Today Portable Suction Machine from Bio Gene Command respects due to is repeated performance utility and very effective operations.
Wether Hospitals, ICU, EMERGENCY WARDS etc, where fluid aspiration is the need of the hour.
Bio Gene offers Portable medical suction machine primary intended for use in emergency medical services to aspirate fluids, secretions foreign material from patient air ways.
• Vacuum knob & gauge range 760mm/Hg.
• Operating Temperature. 0 to 50°C.
• Operating continuously in ambient temperature 10 to 40°C.
• Humidity .: 15-90%
• Size .: 22 x 13 x 27 inches on castor wheels.
• Pumping rate: 2.0L – 14 L/min
• Reservoir capacity: 1500 - 2000mL
• Noise: 60 dB (A)
• Power: AC 220-240VA 50Hz
• Bottle have Automatic cut off to prevent ingress of fluid to pump
• Filter overflow valve to prevent cross contamination.
• Bacterial filter in airline.
• Tube 0.5mm Long, Non collapsible neoprene type.
• Easy Lubrication.
Standard Scope
• Bottles 1500 - 2000ml
• Gauge with color code
• Tube neoprene, Filter
• Handle with trolley
• Castor wheel for easy operation.
STANDARDS
• Class B (GHTF Rule 11); Class II (USA); Class II (EU, Japan, Canada and Australia).
INTERNATIONAL STANDARDS
• ISO 13485 FDA , CE.
• ISO 13485:2003 Medical devices – Quality management system.
• ISO 14971:2007 Medical devices – Application of risk management to medical devices.
• IEC 60601-1-1:2012 Medical electrical equipment Part 1: general requirement for basic safety and essential performance.
• IEC 60601-1-1:2000 Medical electrical equipment Part 1-1: general requirement for safety collateral standards safety requirements for medical electrical system.
• IEC 60601-1-2:2007 Medical electrical equipment Part 1-2: General requirement for basic safety and essential performance -collateral standards Electromagnetic compatibility requirements and tests.
• ISO 10079-1:1999 Medical suction equipment – Part 1 Electrically powered suction equipments – safety equipments
• ISO 10079-3:1999 Medical suction equipment – Part 3 suction equipments powdered from a vacuum or pressure source.
• ISO 5359 : 2008 Low pressure hose assemblies for use with medical gase.
• JIS T 7111 : 2006 Hose assemblies for use with medical gas system.
REGULATIONS
• 21 CFR part 820
• 21 CFR Section 878.4780 pumps, portable aspiration (Powered).
• MHLW Ordinance no.169
• 34860010 Low pressure suction unit
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