Boscarol OB 2012 FA User Manual
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Boscarol OB 2012 FA User Manual

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Rev. 08-2016 USMAN2012 - EN
MEDICAL SUCTION UNIT
OB2012 FA
OB2012 LINER
USER MANUAL
:
MANUFACTURED BY

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Summary of Contents for Boscarol OB 2012 FA

  • Page 1 Rev. 08-2016 USMAN2012 - EN MEDICAL SUCTION UNIT OB2012 FA OB2012 LINER USER MANUAL MANUFACTURED BY...
  • Page 2 Rev. 08-2016 USMAN2012 - EN Rev. 04-2010 USMAN2012-IT 2 - 28...

  • Page 3: Table Of Contents

    Rev. 08-2016 USMAN2012 - EN Rev. 04-2010 USMAN2012-IT INDEX SYMBOLS ..................................... 4 WARNINGS, PRECAUTIONS AND IMPORTANT INFORMATION ................... 6 IMPORTANT INFORMATION ............................... 7 OB2012 SUCTION UNIT ............................... 8 □ DESCRIPTION AND INTENDED USE STATEMENT....................8 □ CONTRA INDICATION FOR USE ..........................8 □...

  • Page 4: Symbols

    Rev. 08-2016 USMAN2012 - EN Rev. 04-2010 USMAN2012-IT SYMBOLS S.1 Symbols used on the device and recalled in the user manual Double insulation. The device is doubly electrically isolated from the user and the work environment (there is no ground conductor or connection equipotential point). Applied part type BF Only use the device in the indicated temperature range.
  • Page 5 Rev. 08-2016 USMAN2012 - EN Rev. 04-2010 USMAN2012-IT Authorized Representative in the European Community, if the manufacturer is not resident therein. Expiration date Do not use if the packaging is not intact Catalogue ID code Sterile device. Sterilization method: ethylene oxide Sterile device.

  • Page 6: Warnings, Precautions And Important Information

    WARNINGS, PRECAUTIONS AND IMPORTANT INFORMATION Read carefully This User Manual has been prepared using simple, easy-to-understand language. If you have difficulty interpreting the above, contact the manufacturer for further clarification info@boscarol.it Tel.: +39 0471 932893 raq@boscarol.it  Read all instructions carefully before using the unit. Careful, proper use will ensure smooth operation and protect both patients and operators alike.

  • Page 7: Important Information

    If the substances aspirated have entered the suction unit, it must be discarded. For Oscar Boscarol srl, the safety of its employees and authorized service centre staff is important. The suction units will not be demolished according to the WEEE Directive (Waste Electrical and Electronic Equipment) if the suction unit is contaminated and there is the risk of infection (application of It.

  • Page 8: Ob2012 Suction Unit

    Conical connector Silicone tube for filter connection Conical connector NOTE For accessories and options available, see the catalogue at www.boscarol.it or send an email to info@boscarol.it. □ Description and intended use statement The OB2012 is a portable electrical medical suction device designed to remove fluids and substances obstructing the upper airways and restore spontaneous and/or assisted respiration.

  • Page 9: Indicator Lights

    Rev. 08-2016 USMAN2012 - EN Rev. 04-2010 USMAN2012-IT Fig.1 Fig.2 □ Indicator lights All lights are placed on the front and display the operation of the device (see Fig1): the autonomy of the battery (3) and the recharge state (2). The table below indicates the condition of the LEDs and the relative power of the battery: LEDS STATUS BATTERY POWER LEVEL 4 LEDS on...

  • Page 10: Collection Jar

    Rev. 08-2016 USMAN2012 - EN Rev. 04-2010 USMAN2012-IT reading on the vacuum gauge should reach maximum value (about -800 mbar, -80 kPa, -600 mmHg) in a few seconds.;  While keeping your finger over the silicone tubing, turn the vacuum regulator counter-clockwise and check the reading on the instrument to ensure that suction drops to nearly 0 (40-50 mbar);...

  • Page 11: Jankauer Suction Tube And Finger-Typ End-Piece

    Rev. 08-2016 USMAN2012 - EN Rev. 04-2010 USMAN2012-IT In case of possible contamination, discolouration and increased resistance to suction replace the filter Warnings and precautions on the use of protection filter If the suction unit is used on a patient whose medical condition is not known, always replace the filter after use.

  • Page 12: Accessories & Optionals

    Rev. 08-2016 USMAN2012 - EN Rev. 04-2010 USMAN2012-IT □ Accessories & Optionals The suction unit has a rechargeable internal battery (which cannot be replaced by the operator). The maximum battery charging time (depending on residual charge) is about 15 consecutive hours. A fully charged battery will provide approximately 45-60 minutes of continuous operation (at open flow).

  • Page 13: Reusable Collection Jar Ob-J Fa

    Rev. 08-2016 USMAN2012 - EN Rev. 04-2010 USMAN2012-IT □ Occupational safety and health and PPE (Current legislation concerning workplace safety and health) The decontamination process is always a delicate process, which implies specific training, especially in the emergency field where the patient’s medical condition and degree of contamination are mostly unknown. For this reason, the operator must always wear personal protective equipment (PPE) to protect himself and others.

  • Page 14: Decontamination/Sterilisation Of The Collection Jar

    Rev. 08-2016 USMAN2012 - EN Rev. 04-2010 USMAN2012-IT □ Decontamination/sterilisation of the collection jar The collection jar and silicone tubing can be disinfected with any mild, non-abrasive chemical cleanser. Alcohol or solvent-based detergents cannot be used. Do not use any coloured disinfectants as these may damage the plastic of the jar and stain the silicone tubing, reducing its transparency (e.g.

  • Page 15: Disposal Of Contaminated Parts

    Rev. 08-2016 USMAN2012 - EN Rev. 04-2010 USMAN2012-IT Dispose of the single-use parts and, after disassembling the collection jar, set the reusable parts under cold running water and rinse thoroughly. Then dip the same parts in hot water (temperature not higher than 60°C) containing a mild, non-alcoholic detergent.

  • Page 16: Suction Unit Safety

    To correctly disinfect and decontaminate the suction unit, we recommend using specific, approved products. These disinfectants must be free of alcoholic and/or abrasive substances. Oscar Boscarol srl can provide specific materials for disinfection of medical equipment, including our suction units. These disinfectants, available in different formats (wipes, spray, liquids), have been laboratory tested and guaranteed to deactivate viruses, bacteria and microorganisms.

  • Page 17: Accessories, Consumables And Spare Parts

    Silicone tube 18 cm with conical connector for OB-J BSU834 Red carrying bag ZMA3000 User manual NOTE To make technical improvements, the parts listed may be changed by the manufacturer without prior notice. Contact the manufacturer for additional information (info@boscarol.it). 17 - 28...

  • Page 18: Technical Service

    Unauthorized access to the suction unit can jeopardize its conformity with the applicable laws and reduce safety for both operators and patients. Contact Oscar Boscarol srl for a list of authorized service centres by sending an e-mail to info@boscarol.it.

  • Page 19: Technical Data And Conformity To International Law

    Rev. 08-2016 USMAN2012 - EN Rev. 04-2010 USMAN2012-IT   Vacuum is always at maximum even if the Fault on the internal pneumatic Contact an authorised service centre jar is removed. circuit.   Contact an authorised service centre High noise, low suction, high vibration. Internal pump damaged.
  • Page 20 100÷240 Vac 50/60Hz, 600mA Output: 24 Vcc 1 A max Manufacturer: GLOBTEK DEUTSCHLAND GMBH - HAFENWEG, 26/A – 48155 MÜNSTER Technical and product conformity specifications available from Oscar Boscarol srl Symbology Vac = Voltage (alternating current) unit for pressure and vacuum...

  • Page 21: The Risks Of Reciprocal Interference With Other Devices

    Rev. 08-2016 USMAN2012 - EN Rev. 04-2010 USMAN2012-IT THE RISKS OF RECIPROCAL INTERFERENCE WITH OTHER DEVICES The OB2012 suction unit does not create interferences with other medical devices that are operating in the same area during the conduct of investigations and clinical treatments. The unit must not be connected to other equipment for its operation and has an internal power source.
  • Page 22 Rev. 08-2016 USMAN2012 - EN Rev. 04-2010 USMAN2012-IT GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY The OB2012 suction unit is intended for use in the electromagnetic environment specified below. The user of the OB2012 suction unit should assure that it’s used in such an environment. Electromagnetic environment - IMMUNITY test IEC 60601 test level...
  • Page 23 Rev. 08-2016 USMAN2012 - EN Rev. 04-2010 USMAN2012-IT GUIDELINES AND DECLARATION OF COMPLIANCE FOR MEDICAL DEVICES TEST OF CONDUCTED AND RADIATED ELECTROMAGNETIC IMMUNITY For the purposes of conducting the tests using test levels IEC60601, V =3 and E The BSU suction units are intended for use in the electromagnetic environment specified below. The user of the OB2012 suction unit should assure that it’s used in such an electromagnetic environment.

  • Page 24: Guarantee

    The product that during the 36 months’ warranty is found defective, should be sent to Oscar Boscarol srl with a note describing the defect. The Oscar Boscarol Company will, at their discretion, arrange for repairs or complete replacement within the terms of this guarantee.

  • Page 25: Declaration Of Conformity

    Rev. 08-2016 USMAN2012 - EN Rev. 04-2010 USMAN2012-IT DECLARATION OF CONFORMITY OSCAR BOSCAROL SRL We, the manufacturer: Via E. Ferrari , 29 – 39100 BOLZANO – ITALY Il produttore: Tel. +39 0471 932893 – Fax. +39 0257760140 Web: www.boscarol.it - Email : info@boscarol.it...
  • Page 26 Rev. 08-2016 USMAN2012 - EN Rev. 04-2010 USMAN2012-IT 26 - 28...
  • Page 27 Rev. 08-2016 USMAN2012 - EN Rev. 04-2010 USMAN2012-IT 27 - 28...
  • Page 28 Rev. 08-2016 USMAN2012 - EN Rev. 04-2010 USMAN2012-IT Printed in Italy by Oscar Boscarol Company Rev. 08-2016 USMAN2012 - EN 28 - 28...

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