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Summary of Contents for Boscarol IMM121640
- Page 1 ED01_REV03-2021 IFU HEAD IMMOBILIZER-ENG BOSCAROL IMMOBILIZATION DEVICES WIND AND OB HEAD IMMOBILIZER OPERATING INSTRUCTIONS WIND HEAD IMMOBILIZER OB HEAD IMMOBILIZER Medical devices compliant with the European Regulation on Medical Devices 745/2017 1 - 12...
- Page 2 Fax: +39 02 57760140 info@boscarol.it www.boscarol.it Manufacturer and medical device information: Oscar Boscarol applies a quality management system (QMS) according to international ISO 13485 • and ISO 9001 standards • Medical devices of the "Immobilization" category (in all their configurations) comply with the...
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Page 3: Table Of Contents
COMPOSITION OF DEVICES ..........................7 REUSE OF BOSCAROL HEAD IMMOBILIZER ....................... 8 DEVICE STORAGE ............................. 9 DEMOLITION OF THE DEVICE ........................... 9 TECHNICAL SERVICE AND SPARE PARTS ......................9 TECHNICAL DATA AND COMPLIANCE FOR BOSCAROL HEAD IMMOBILIZERS ............ 9 GUARANTEE ..............................10 3 - 12... -
Page 4: Meaning Of Symbols And Pictograms
(11) Date of production (20) Product variant (10) Lot number INTENDED USE Head Immobilizer Boscarol OB e WIND Device name Primary use Medical device intended for head immobilization in lifting and transport devices There are no known uses other than that for which it was designed Other uses Immobilization and stabilization of the patient's head before transport. -
Page 5: Warnings, Precautions And Important Information
"Short-term" use (maximum 30 days of consecutive use) the same patient • Boscarol head immobilizer (OB model and WIND model) can be used on all types of patients, excluding those under 25 kg in weight due to head size which may be too small •... -
Page 6: Contraindications (Do Not Use For)
FERMACAPO BOSCAROL Boscarol head immobilizers are marketed "ready to use" and are complete with all their functional parts. Upon receipt, problems relating to the use or lack of certain arts provided must be verified and possibly contested. The head immobilizers do not include accessories or spare parts. -
Page 7: Composition Of Devices
High-frequency welding of PVC guarantees stability and durability over time even in case of prolonged use. The BOSCAROL WIND head immobilizer is radio-transparent and translucent and ensuring radiological investigations without having to be removed from the patient. Inside the base of the device is inserted a recycled cardboard of appropriate thickness, coated with a thin layer of foam, that guarantees structural rigidity. -
Page 8: Reuse Of Boscarol Head Immobilizer
Do not use high pressure washers that could damage the surface layers of the head immobilizer and damage Velcro and polyethylene flaps Pressure washer Do not cut or change the structure and shape of Boscarol head immobilizer so as not to damage it irreparably Attention Remove the sheet that was placed between the patient's head and the device and discard it. -
Page 9: Device Storage
9. DEVICE STORAGE Boscarol head immobilizers can be used and stored in the temperature range between -10 and 50° C. With very low or too high values the material in contact with the patient could become extremely cold or hot causing complications to the patient (hypothermia and hyperthermia). -
Page 10: Guarantee
13. GUARANTEE Oscar Boscarol guarantees the head immobilizer (all models) for a period of 1 year or from the date of purchase from the original distributor or manufacturer. The company guarantees that the device is free of defective materials and/or other defects due to production processes. - Page 11 ED01_REV03-2021 IFU HEAD IMMOBILIZER-ENG 11 - 12...
- Page 12 ED01_REV03-2021 IFU HEAD IMMOBILIZER-ENG Printed in Italy by Oscar Boscarol Srl (Ltd) ED01_REV03-2021 IFU HEAD IMMOBILIZER – ENG Language of editing: English https://www.boscarol.it/ita/eifu.php 12 - 12...
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