IMPORTANT: These specs are generic &may vary depending on Supplier. Description: Vacuum extractor system to assist vaginal deliveries in a delivery room setting. Hand-operated suction pump creates required vacuum. Vacuum range, adjustable: from 0 to -100kPa/-800mmHg. Gauge dial, minimal graduation: 5kPa/40mmHg. Accuracy vacuum gauge: ยฑ 2.5kPa. All parts of vacuum extractor can be disassembled, relevant parts can be autoclaved at 121 C. Requires no other than routine maintenance, manageable at level of delivery rooms. Supplied as a complete set consisting of: 2X Bird type anterior suction/extraction cup (1x 50mm & 1x 60mm diameter) rounded edges. 1X Bird type posterior suction/extraction cup (1x50 mm diameter) rounded edges. 2x Extraction handles for Bird type anterior suction/extraction cup. Suction/extraction cups & handle: stainless steel, Chrome nickel plated. 2x Soft suction/extraction cup (1x50 &1x60mm opening diameter). 1x Vacuum/collection bottle, plastic 500ml. 1x Cover plug for vacuum/collection bottle with 3 holes (2 connector + 1 vacuum gauge). 1x Connector angled, chrome plated. 1x Connector angled with screw valve (vacuum release), chrome plated, with cap & gasket. 1x Vacuum gauge with straight connector, chrome plated. 1x Basket, epoxy coated, supporting vacuum/collection bottle & suction pump, with large hook allowing to fit it to delivery table. 2x Tube, silicone, transparent, inner/outer diameter approx. 6/11mm, length 50 & 150cm. Intended use: Manual vacuum extractor system to assist vaginal deliveries in a delivery room setting with stainless steel anterior & posterior cups. Hospital equipment for delivery room. Vacuum extractor must be cleaned & disinfected after each use. Vacuum extractor is used in situations of acute need, it must always be readily available & in good working condition. Vacuum extractor must be operated by adequately trained staff only. It is recommended to follow the manufacturer's instructions at all times. Supplied with: 1x Spare vacuum/collection bottle, 500ml. 1x Spare tube, silicone, transparent, inner/outer diameter approx. 6/11mm, length 300cm. 1x Spare gasket for screw valve (vacuum release). 20x Polypropylene bottom plate, for stainless steel suction/extraction cup, 10 for each size, 50 and 60mm. 1x List of accessories and parts, each identified with their product reference. 1x Instructions for use and maintenance, and contact details for repair service, in English, French & Spanish. Accessories / Spare Parts / Consumables (available but not supplied): Vendor-specific. Packaging & labelling: Packaging: One (1) manual Bird vacuum system with accessories in protective packaging. Labels &: Name and/ or trade name, and address of manufacturer. Manufacturer's product code/reference. Lot number prefixed by the word "LOT" (or equivalent harmonized symbol). Expiry date: month and year. CE marking and Notified Body number. Symbols used accord. ISO 15223 & EN 980. Regulation & conformity requirements: CE mark (conforming to Medical Device Directive MDD 93/42/EEC, MDR 2017/745) or FDA 510k approved or equivalent. Declaration of Conformity according to ISO 17050. ISO 13485 certified. Classification: Class IIa - Rule 5: Invasive accessory device, short term use (MDD 93/42/EEC, MDR 2017/745) Safety & product Standards (current version of the following standards): ISO 14971: Medical Devices- Application of risk management to medical devices. ISO 10079-2: Medical suction equipment โ Part 2: Manually powered suction equipment. ISO 3529-1: Vacuum technology -Vocabulary โ Part 1: General terms. ISO 3529-2: Vacuum technology โ Vocabulary โ Part 2: Vacuum pumps and related terms. ISO 21360-1: Vacuum technology - Standard methods for measuring vacuum-pump performance - Part 1: General description. ISO 17664: Sterilization devices -- Information to be provided by manufacturer for processing of re-sterilizable medical devices. ISO 14001: Environmental management systems.
| Pack Size | Avg. Price |
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| Pack of 1 | $1,051.76 |
