Related Manuals for Boscarol OB OXIKIT PLUS
Summary of Contents for Boscarol OB OXIKIT PLUS
- Page 1 OB OXIKIT PLUS REV11-2021_EN Rev. 04-2010 USMAN2012-IT COMPLETE DISTRIBUTION OXYGEN KIT FOR AMBULANCE OB OXIKIT PLUS USER MANUAL PRODUCED BY 1 - 20...
- Page 2 OB OXIKIT PLUS REV11-2021_EN Rev. 04-2010 USMAN2012-IT 2 - 20...
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Page 3: Table Of Contents
OB OXIKIT PLUS REV11-2021_EN Rev. 04-2010 USMAN2012-IT INDEX INDEX ................................. 3 SYMBOLS ................................4 LIST OF OBLIGATIONS & PROHIBITIONS CONCERNING THE DEVICE ..............5 WARNINGS & PRECAUTIONS: READ CAREFULLY! ....................6 INTRODUCTION ..............................8 INTENDED USE .............................. 8 GENERAL INFORMATION & STRUCTURE OF THE DEVICE................8 USE CONTRAINDICATIONS .......................... -
Page 4: Symbols
SYMBOLS S.1 Symbols used on the device and referred to in the instruction manual Red carefully the user manual before using and/or install the OB OXIKIT PLUS Specific warnings for the device which must always be taken into consideration CE marking in accordance with Leg. 46/97 for medical devices of Class 1 and higher (European... -
Page 5: List Of Obligations & Prohibitions Concerning The Device
OB OXIKIT PLUS REV11-2021_EN Rev. 04-2010 USMAN2012-IT S.2 Symbols used in the instruction manual to alert the reader to specific issues Alert: important information how to use correct the device and avoidance of risk of injury to the operator, patient and/or damages to the device. -
Page 6: Warnings & Precautions: Read Carefully
The only assistance service authorized for repair, maintenance and technical inspection is the manufacturer (Oscar Boscarol Srl) or a service centre authorized by the manufacturer. Any intervention by anyone not directly authorized by the manufacturer is expressly prohibited and renders the warranty null and void. Any person that intervenes on the kit or its components is directly liable for any harm thus caused to persons and/or things. - Page 7 OB OXIKIT PLUS REV11-2021_EN Rev. 04-2010 USMAN2012-IT If the user or patient becomes aware of a user hazard, side effect, accident caused by the device or a criticality (operational and constructive) not addressed in these instructions for use, must immediately notify the manufacturer at the following e-mail address: raq@boscarol.it...
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Page 8: Introduction
To these terminals are to be attached medical devices capable of delivering the gas in the form and quantity required to meet therapeutic needs. The nominal pressure of the kit exercise is 400kPa (4 bar). OB OXIKIT PLUS is designed and manufactured in compliance with applicable legal requirements. -
Page 9: Use Contraindications
Oscar Boscarol Srl. The hoses are sold tested and with fittings included (straight, 90° or AFNOR). Authorized service centres can replace the fittings if they have specific equipment provided by the manufacturer. -
Page 10: Installation Of Connection Hoses
Oscar Boscarol Srl, in order to facilitate the installer's task, uses only hoses fully in accordance with reference standards and with specific fittings available for straight, 90°... -
Page 11: Functional Check On The Exchanger
OB OXIKIT PLUS REV11-2021_EN Rev. 04-2010 USMAN2012-IT Wiring colour Type of signal GREEN GND - GROUND WHITE (GRAY) OUTUT SIGNAL 0,5÷4,5 Vdc BROWN +VDC – Power supply WARNING! The wrong connection of the wires can damage the pressure transducer. In case of doubts please follow the identification marked on the body of the transducers. -
Page 12: Preparation & Operation
OB OXIKIT PLUS REV11-2021_EN Rev. 04-2010 USMAN2012-IT performed for both cylinder connections (whose valves have first been closed) by moving the knob of the exchanger to both positions 1 and 2. After emptying the kit, bring the exchanger knob back to its central, closed position. -
Page 13: Functional Checks
To disinfect the exterior of the device from contaminants (e.g. bodily secretions, blood), appropriate disinfectant materials, available in the form of disposable wipes, may be purchased separately from Oscar Boscarol Srl. These disinfectant wipes are laboratory tested to guarantee the neutralization of viruses, bacteria and microorganisms. Used periodically, they destroy and prevent the formation of hazardous bio-films (surface layers that easily accommodate bacteria, moulds, viruses and microorganisms). -
Page 14: Replacement Of Low Pressure Sealing Rings
OB OXIKIT PLUS REV11-2021_EN Rev. 04-2010 USMAN2012-IT regulators or not), it is necessary to document all replacements and conserve serial and/or lot numbers for backwards traceability. If a fault is due to the pressure regulator, it is necessary to send it to the manufacturer for repair. -
Page 15: Maintenance
The exchanger is subject to mechanical wear and tear caused by the movement of the control knob. Scheduled maintenance is required every five years after first installation and may only be performed by Oscar Boscarol Srl or one of its authorized service centres. The following table shows the various maintenance frequencies of the kit. -
Page 16: Disposal Of The Ob Oxikit Std/C Kit
The components can be purchased individually and are CE marked. These markings certify the conformity of individual parts, but do not alone indicate the conformity of the assembled kit. The conformity of kits supplied by Oscar Boscarol Srl. is declared following final testing and inspection of the complete device. -
Page 17: Technical Specifications & Reference Standards
Classification of the device in reference to Legislative Decree 46/97 (MDD93/42/EEC as amended) The OB OXIKIT PLUS kit is a medical device in accordance to Italian Legislative Decree 46/97 that transposes the European Directive 93/42/EEC (as amended). The kit includes all components necessary for the administration of therapeutic oxygen in emergency vehicles. - Page 18 OB OXIKIT PLUS REV11-2021_EN Rev. 04-2010 USMAN2012-IT Conversion formulas Below are several useful formulas for correct operation of the device: Calculation of the oxygen volume of the kit: OXYGEN VOLUME = CAPACITY OF THE CYLINDER X PRESSURE READING VALUE Conversion of pressure units: 1 bar = 100,000 Pa = 100 kPa = 1.0197 kg/cm²...
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Page 19: Warranty
WARRANTY Oscar Boscarol Srl. provides for a warranty on the OB OXIKIT PLUS of 24 months from the date of purchase. Oscar Boscarol Srl warrants that every new OB OXIKIT PLUS is free from defects in materials due to production processes. This warranty does not cover wear and tear arising from standard use, discoloration of external parts or discoloration and other cosmetic irregularities which do not in any case degrade the device from a technical or structural point of view. - Page 20 OB OXIKIT PLUS REV11-2021_EN Rev. 04-2010 USMAN2012-IT Printed in Italy by Oscar Boscarol srl OB OXIKIT PLUS REV11-2021_EN 20 - 20...
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