Summary of Contents for Boscarol CTS
- Page 1 ED01_REV02-2021 IFU CTS-EN BOSCAROL IMMOBILISATION DEVICES CHILDREN TRANSPORT SYSTEM OPERATING INSTRUCTIONS Medical devices compliant with European Medical Device Regulation 745/2017 1- 12...
- Page 2 +39 02 57760140 info@boscarol.it www.boscarol.it Information on the manufacturer and the medical device: Oscar Boscarol applies a quality management system in accordance with international standards • ISO 13485 and ISO 9001. • Medical devices in the "Immobilization" category (in all their configurations) comply with European Regulation MDR 2017/745 and bear the CE marking in accordance with risk class I (see Annex VIII of the Regulation).
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Page 3: Table Of Contents
DEMOLITION OF THE DEVICE ........................... 9 TECHNICAL SERVICE AND SPARE PARTS ......................9 TECHNICAL DATA AND CONFORMITY FORBOSCAROL CTS ................9 WARRANTY ..............................10 Note: From now on the word CTS will be used to indicate and refer to the medical device. 3- 12... -
Page 4: Meaning Of Symbols And Pictograms
0.1. Symbols used in these operating instructions to call the reader's attention Danger: important safety information on the correct use of the CTS to prevent injury to the operator or patient and/or damage to the device itself Warnings: information requiring special attention Notes or information for proper use and to prevent damage to the device or others. -
Page 5: Warnings, Precautions And Important Information
Short-term use (maximum 30 days of consecutive use) the same patient • CTS Boscarol can be used on all types of children and infants (up to a maximum weight of 15 kg) • Can be used in conjunction with cervical collar and other related medical devices •... -
Page 6: Contraindications (Do Not Use For )
CTS BOSCAROL The Boscarol CTS is sold "ready to use" and is complete with all functional parts. Upon receipt, it is necessary to check and, if necessary, to complain to the manufacturer if there are problems with the use or if some of the parts are missing. -
Page 7: Composition Of The Device
(see picture 3). How to use CTS Boscarol Lay the CTS on a stable and possibly clean surface. The device does not have a rigid bottom support and the fabric can be damaged by objects or debris (e.g. from the road surface). -
Page 8: Reuse Of Cts Boscarol
The CTS can be washed with water which must not exceed a temperature of 40° C. Never use abrasive metal brushes or very hard brushes, which could damage the fabric. If using a washing machine, avoid spinning. -
Page 9: Storage Of The Device
9. STORAGE OF THE DEVICE Boscarol CTS can be used and stored in the temperature range -10 to +50 °C. At very low or high temperatures, the material in contact with the patient may become extremely cold or hot, resulting in patient complications (hypothermia and hyperthermia). -
Page 10: Warranty
13. WARRANTY Oscar Boscarol warrants the CTS (all models) for a period of 1 year from the date of purchase from the original distributor or manufacturer. The company guarantees that the device is free from defective materials and/or defects due to manufacturing processes. - Page 11 ED01_REV02-2021 IFU CTS-EN NOTES BY THE USER TRAINING ON USE AND REUSE (by the user) 11- 12...
- Page 12 ED01_REV02-2021 IFU CTS-EN Printed in Italy by Oscar Boscarol Srl (Ltd) ED01_REV02-2021 IFU CTS - EN Language of editing: Italian https://www.boscarol.it/ita/eifu.php 12- 12...