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Summary of Contents for Boscarol PAL32000
- Page 1 ED01_REV01-2021 IFU OB VENTI-BAG_ENG BOSCAROL MANUAL RESUSCITATORS OPERATING INSTRUCTIONS ____________________________________________________________________________________________________________ 1 - 16...
- Page 2 ED01_REV01-2021 IFU OB VENTI-BAG_ENG ____________________________________________________________________________________________________________ 2 - 16...
- Page 3 Information on manufacturer and medical device: • Oscar Boscarol applies a quality management system compliant with international standards ISO 13485 and ISO 9001. • The medical devices of category "Manual resuscitation" (in all their configurations) are compliant with MDD 93/42/EEC (as subsequently amended) and bear the CE marking (CE 0123 notified body TÜV SÜD PRODUCT SERVICE GmbH).
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Page 4: Table Of Contents
INFORMATION THAT IS IMPORTANT TO KNOW BEFORE USE ................7 CONTRAINDICATIONS (DO NOT USE FOR) ......................7 SIDE EFFECTS (POSSIBLE DURING ASPIRATION OPERATIONS)................7 OSCAR BOSCAROL RESUSCITATOR BAGS ......................7 OPERATING PRINCIPLE ............................8 CONFIGURATION OF THE DEVICE AND SPARE PARTS ..................8 Device structure .............................. -
Page 5: Meaning Of Symbols And Pictograms
ED01_REV01-2021 IFU OB VENTI-BAG_ENG MEANING OF SYMBOLS AND PICTOGRAMS Symbols used in these operating instructions to call the reader’s attention Danger: important safety-related information covering correct use of the resuscitator bag to prevent operator or patient injury and/or damage to unit itself Warnings: information requiring special attention Notes or information on preventing damage to the device or injury to others. -
Page 6: Warnings, Precautions And Important Information
• Only use original spare parts, provided by the manufacturer (Oscar Boscarol srl). The parts of the device must be disposed following national and local indications for the disposal of substances based on •... -
Page 7: Information That Is Important To Know Before Use
+39 0471 MAINTENANCE 932893. Boscarol resuscitator bags and ventilation masks have a lifespan of 5 years from the date of manufacture if stored and used in accordance with these operating instructions LIFESPAN • Boscarol resuscitator bag is designed for emergency medical service and must therefore be ready for use at any time and in any situation. -
Page 8: Operating Principle
The Boscarol resuscitator bag is a manual and portable device for the respiratory emergencies. The device ensures the administration of air or oxygen through the manual compression of the bag itself. It is recommended to use the device complete with Boscarol mask, choosing the proper size, to ensure a perfect grip the nose-mouth. - Page 9 ED01_REV01-2021 IFU OB VENTI-BAG_ENG Ref No. Description Material A. Patient valve Pop-off valve Polycarbonate Upper patient valve Polycarbonate One way valve Silicone Lower Patient valve with mask connector Polycarbonate Patient valve O ring Silicone B. Resuscitator bag Resuscitator Bag with connector Chosen material + Polycarbonate C.
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Page 10: Peep Positive Pressure Regulating Valve (Optional)
Optional accessories Auxiliary accessories for the device are available to facilitate the operations of emergency ventilation (e.g. helicoidal mouth/teeth opener, Guedel airway, oxygen tubes ready to use). Ask Oscar Boscarol srl for them. USE OF THE DEVICE Before using on patients Before starting to use the device on the patient it is necessary to ensure its full and proper functionality (both of resuscitator bag and of all the accessories included). -
Page 11: General Instruction For Use
A mask should be applied to the Boscarol resuscitator so to completely cover both nose and mouth. Make sure that the edge of the mask adheres perfectly to the face. If available, use suitable masks size for patient's face. -
Page 12: Functional Testing Of The Device
No parts/components of the device require periodic maintenance. Only standard functional testing is required, as described in this manual. In case of defects, malfunctions or tests failure, replace the device with a new one. In case of doubts please send an e-mail to the Boscarol technical service at info@boscarol.it or call +39 0471 932893. - Page 13 ED01_REV01-2021 IFU OB VENTI-BAG_ENG LIFETIME OF THE DEVICE: maximum 5 years if the device is tested and verified monthly! ATTENTION Technical characteristics of the device Adult (> 30 kg) Child (5÷30 Kg) Infant (< 5 Kg) Bag Volume (ml) 1800 Stroke Volume (ml) 1060 Reservoir Bag (ml)
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Page 14: Warranty
If, at any time during the entire 1-year warranty period, the product is found to be defective, before sending the device must be sent to Oscar Boscarol srl a specific request for authorization to return. In case of acceptance of the return, the Oscar Boscarol Srl (Ltd) will repair or replace the defective parts and/or the whole unit at its own discretion. - Page 15 ED01_REV01-2021 IFU OB VENTI-BAG_ENG ____________________________________________________________________________________________________________ 15 - 16...
- Page 16 ED01_REV01-2021 IFU OB VENTI-BAG_ENG Printed in Italy by Oscar Boscarol Srl (Ltd) ED01_REV01-2021 IFU OB VENTI-BAG_ENG Original language: Italian https://www.boscarol.it/ita/eifu.php MADE IN TAIWAN (R.O.C.) ____________________________________________________________________________________________________________ 16 - 16...
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