TECHNICAL DATASHEET TV12
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TECHNICAL DATASHEET TV12
Product catalog summary
Technical Specifications
The document provides detailed specifications for a Vacuum Therapy Device classified as a Class IIA and Class II medical device. It complies with ISO 13485 and various international standards including Annex IX rules 9 93/42 CEE, Schedule I rules 9(1) SOR/98-282, and 21 CFR part 870 § 870.5800.
Device Specifications
Operating Conditions
Storage Conditions
Power Supply
Indications and Contraindications
Materials and Accessories
Innovations
Additional Information
The document provides detailed specifications for a Vacuum Therapy Device classified as a Class IIA and Class II medical device. It complies with ISO 13485 and various international standards including Annex IX rules 9 93/42 CEE, Schedule I rules 9(1) SOR/98-282, and 21 CFR part 870 § 870.5800.
Device Specifications
- Weight: 4 kg
- Dimensions: 30 x 28 x 18 cm
- Power: 30 W
- Voltage/Frequency: 100 - 240 V / 47 - 63 Hz
- Sound Level: 43 dB to 46 dB
- Pressure Range: Vacuum from -50 to -900 mBar
- Pressure Control: Manual
- Suction Mode: Continuous or Alternative
Operating Conditions
- Temperature: 0°C to 40°C
- Relative Humidity: 30% to 80%
- Atmospheric Pressure: 70 kPa to 106 kPa
Storage Conditions
- Temperature: -5°C to 45°C
- Relative Humidity: 30% to 80%
- Atmospheric Pressure: 70 kPa to 106 kPa
Power Supply
- Medical Grade: GSM90A24-PIM Meanwell
- Compliance: IEC 60601-1
Indications and Contraindications
- Indications: Traumatic or burn scars, muscular or tendinous injuries, face and body contouring
- Contraindications: Inflammatory or infectious disease in acute phase, skin tumor, open wound, hematoma, erythema, bruises
Materials and Accessories
- Materials: PVC, PMMA, PET
- Accessories: Standard and flexible round suction cups, oval and roller connectors, straight or Y-shape connection tubes
Innovations
- High efficiency through precise manual control combined with the safety of transparent suction cups
- Direct control and pressure regulation with continuous or alternate suction modes
Additional Information
- Device Type: Class II, Type BF, IP20
- Various sizes and reference numbers for accessories
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Catalog excerpts
VACUUM THERAPY DEVICE Medical Device Medical Device Medical Device 19, rue de Clairefontaine - 78120 RAMBOUILLET - FRANCE Tel.: +33 (0)1 34 61 01 61 - Email: [email protected]
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TECHNICAL SPECIFICATIONS Weight Voltage / Frequency Sound level
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ACCESSORIES Description Rigid PMMA Rigid PMMA Y-Shaped Connecting Tube PVC Flexible Support Mobile Stand with Flexible Support 19, rue de Clairefontaine - 78120 RAMBOUILLET - FRANCE Tel.: +33 (0)1 34 61 01 61 - Email: [email protected]
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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.