Boscarol OB 2012 FA Operating Instructions Manual
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Boscarol OB 2012 FA Operating Instructions Manual

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ED01_REV01-2020 IFU OB2012_2P-ENG
MEDICAL SUCTION UNIT
OPERATING INSTRUCTIONS

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Summary of Contents for Boscarol OB 2012 FA

  • Page 1 ED01_REV01-2020 IFU OB2012_2P-ENG MEDICAL SUCTION UNIT OPERATING INSTRUCTIONS...
  • Page 2 Information on manufacturer and medical device: • Oscar Boscarol applies a quality management system compliant with international standards ISO 13485 and ISO 9001 • The medical device OB2012 (in all its configurations) is compliant with MDD 93/42/EEC (as subsequently amended) and bears the CE marking (CE 0123 notified body TÜV SÜD PRODUCT SERVICE GmbH)

  • Page 3: Table Of Contents

    ED01_REV01-2020 IFU OB2012-2P_ENG TABLE OF CONTENTS TABLE OF CONTENTS ..............................3 MEANING OF SYMBOLS AND PICTOGRAMS ..................... 4 0.1. Symbols used in these operating instructions to call the reader’s attention ........... 4 0.2. Symbols used on the device and accessories ....................4 0.3.

  • Page 4: Meaning Of Symbols And Pictograms

    ED01_REV01-2020 IFU OB2012-2P_ENG MEANING OF SYMBOLS AND PICTOGRAMS 0.1. Symbols used in these operating instructions to call the reader’s attention Danger: important safety-related information covering correct use of the suction unit 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 5: Symbols Used On Battery And Referred To In These Operating Instructions

    ED01_REV01-2020 IFU OB2012-2P_ENG Indicates that the user must consult these operating instructions for information, e.g. warnings and precautions that may not be displayed on the medical device in question CE marking in accordance with MDD 93/42/EEC for medical devices rated higher than class I Manufacturer Date of manufacture Suction units OB 2012 contain electrical and/or electronic equipment that must be recycled in...

  • Page 6: Intended Use

    Follow the European recycling plan Read the operating instructions Production batch number INTENDED USE Medical suction unit OB 2012 BOSCAROL Device name Suction unit designed to remove secretions, blood and other bodily fluids, solid pieces of Primary use...

  • Page 7: Warnings, Precautions And Important Informtion

    Phone +39 0471 93 28 93 info@boscarol.it • Read these instructions carefully before using the device. Careful, correct use of the device ensures smooth operation and will protect both patients and operators.
  • Page 8 WEEE (Waste Electrical and Electronic Equipment) directive, as this would result in a possible risk of infection (international law regarding worker protection must be applied, where applicable). • When in doubt, before sending a device in for repair, send an e-mail to the Boscarol technical service at info@boscarol.it or call +39 0471 932893 •...

  • Page 9: Information That Is Important To Know Before Use

    ED01_REV01-2020 IFU OB2012-2P_ENG INFORMATION THAT IS IMPORTANT TO KNOW BEFORE USE The suction unit has been designed and tested according to current law and the latest regulatory standards. If the suction unit is connected to a non-compliant electrical system and/or if the connection is not made by a professional installer, both the suction unit and the electrical system may be damaged.

  • Page 10: Contraindications (Do Not Use For)

    MEDICAL SUCTION UNITS OB 2012 After receiving the device, make certain that all parts are present. All Boscarol suction units come ready to use, fully assembled with everything except the antibacterial filter (in the version with reusable jar) which is not connected to the device (for transport and storage reasons).

  • Page 11: Description Of The Suction Unit

    90° connector Silicone tube with conical connector for filter connection For the accessories and options available, see the catalogue at www.boscarol.it or send an email to info@boscarol.it 6.2. Controls, operations and control panel All device operating controls are located on the front to facilitate its use, even when anchored to the wall bracket. To activate the device, press switch (4), which is protected against ingress of liquids and solids, splashes of water and cleansers.

  • Page 12: Indicator Lights

    ED01_REV01-2020 IFU OB2012-2P_ENG 6.3. Indicator lights All lights are placed on the front and display the operation of the device (see figure above): 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: SIGNALLING BATTERY POWER LEVEL 4 LEDS on...

  • Page 13: Six-Monthly/Yearly Test Of Suction Units Ob2012

    ED01_REV01-2020 IFU OB2012-2P_ENG Using the switch on the front panel, turn on the suction unit (0 - off, 1 - on). The suction unit • must operate smoothly, no fluctuations in internal pump speed must be heard. There should not be any unusual noise and/or vibrations.
  • Page 14 ED01_REV01-2020 IFU OB2012-2P_ENG • Replace the SERRES® disposable liner or antibacterial filter before performing these operations. Mechanical wall bracket function: check that it is secured properly (to the wall of the vehicle), that • it functions properly and that the upper red plastic button slides correctly (not hindered in any way).

  • Page 15: Periodic Safety Maintenance

    If even a single test fails, contact a service centre or the manufacturer. Do not use the device if it has not passed all tests. For any information, call 0471 932893 or send an e-mail to info@boscarol.it. 6.5. Periodic safety maintenance Depending on how the device is used, the OB2012 should be checked at least every 24 months even if not used.

  • Page 16: Autoclavable Jar Ob-J Fa

    The filter is disposable and must be replaced after each use. If contamination, discoloration and increased resistance to suction occurs, it must always be replaced. The filter isn’t manufactured by the Boscarol company. If the device is used on patients whose infectiousness is unknown, always replace the filter after use on that patient.

  • Page 17: Ob-J Liner: Jars For Serres® Disposable Liners

    When used in a home environment, the jar can be cleaned using a special detergent able to ensure medical device disinfection. Contact Boscarol for information about disinfectants. • Always keep at least three spare SERRES® liners on hand.

  • Page 18: Silicone Suction Tube And Sterile Fingertip Connection (Conical Connector)

    ED01_REV01-2020 IFU OB2012-2P_ENG 7.6. Silicone suction tube and sterile Fingertip connection (conical connector) Upon request, the device can be fit with a silicone patient tube (length: 130 cm) and a sterile conical Fingertip connector that makes it possible to use standard sterile catheters of appropriate size.

  • Page 19: Reuse Of Jar Ob-J Fa

    ED01_REV01-2020 IFU OB2012-2P_ENG 8.1. Reuse of jar OB-J FA The steps needed to separate the jar from the suction unit, dismantle it and re-assemble it after cleaning and disinfection are described below. Before starting, put on protective gloves that cover the forearms, and also wear mouth and eye protection.

  • Page 20: Cleaning, Disinfection And/Or Sterilization Of Jar Ob-J Fa And Silicone Tube

    ED01_REV01-2020 IFU OB2012-2P_ENG Separate all component parts. Parts that make up the lid: • Yellow polypropylene cage • Yellow polypropylene float Red silicone seal • • Red polypropylene lid Risk of infection due to the release of potentially contaminated substances when emptying secretions.

  • Page 21: Assembling The Jar And Connecting The Silicone Suction Tube

    ED01_REV01-2020 IFU OB2012-2P_ENG 8.3. Assembling the jar and connecting the silicone suction tube Place all components of the jar on a flat, stable surface. During assembly and disassembly, always check all parts for damage or deformation. The overflow valve has a float that slides on a plastic cage. Check that it moves unobstructed (by sliding it) and that the red silicone seal is intact.

  • Page 22: Cleaning The Jar With Serres® Disposable Liners

    ED01_REV01-2020 IFU OB2012-2P_ENG 8.5. Cleaning the jar with SERRES® disposable liners The jar OB-J LINER has a specific SERRES® brand disposable liner, approved for this type of application. Unlike the version OB-J FA, the antibacterial filter is located inside the liner and is automatically replaced after each liner change. Before removing the disposable liner, some safety precautions must be taken.

  • Page 23: Disinfection And/Or Sterilization Of Jar Ob-J And Silicone Tube

    ED01_REV01-2020 IFU OB2012-2P_ENG REUSABLE REUSABLE REUSABLE Unscrew the 90° connector by holding the screw inside the jar still with your hand. Be careful not to damage the O-ring. The jar must be replaced after 30 sterilization cycles or 5 years from the date of first use. Lifespan of jars OB-J and OB-J FA Risk of infection due to release of substances during the cleaning process.

  • Page 24: Assembly Of Jar With Serres® Disposable Liners

    8.8. Disposal of contaminated parts Always follow local regulations or hospital rules when disposing of contaminated wastes. Never store contaminated parts with new or sterile parts. Boscarol markets liners that are specifically designed for disposal of contaminated hospital wastes. 8.9. Suction unit cleaning and disinfection Disconnect the suction unit from any external power supply.
  • Page 25 To properly disinfect and decontaminate the suction unit, we recommend using specific, approved products. These disinfectants must be alcohol-free and contain no abrasive substances. Oscar Boscarol Srl (Ltd) can provide specific disinfectants suitable for medical equipment, including our suction units. These disinfectants, available in different formats (pre-soaked wipes,...

  • Page 26: Cleaning And Disinfection Plan

    ED01_REV01-2020 IFU OB2012-2P_ENG 8.10. Cleaning and disinfection plan Print this table and indicate the name of the operator who performed the process. Name of After each Operation Every patient/after operator who to be Cleaning Disinfection Sterilization HOW TO DO IT Daily each suction performed the...

  • Page 27: Internal Battery For Suction Units For Ob2012

    ED01_REV01-2020 IFU OB2012-2P_ENG Never tamper with and/or open the power supply. Risk of death. The adapter contains electronic parts which are connected to the mains voltage and can be fatal. DANGER Electric shock The suction unit lifespan is 10 years from the date of manufacture. The device must be replaced after 10 years.

  • Page 28: Accessories, Consumables And Spare Parts

    The suction unit is fully recyclable, contact the relevant specific law and all applicable guidelines You can request the procedure for cleaning and decontaminating the device before it is demolished from Boscarol (info@boscarol.it). DECONTAMINATION 13. ACCESSORIES, CONSUMABLES AND SPARE PARTS...

  • Page 29: Technical Service

    ED01_REV01-2020 IFU OB2012-2P_ENG To make technical improvements, the manufacturer can change the parts listed without prior notice. Contact the manufacturer for further information (info@boscarol.it). Code update 14. TECHNICAL SERVICE Suction units OB2012 have no electrical and/or mechanical parts that can be serviced by the retailer, customer and/or operator.

  • Page 30: Technical And Compliance Data For Ob2012

    ED01_REV01-2020 IFU OB2012-2P_ENG Never tamper with and/or open the suction unit and/or mains power supply. Risk of death. The power supply contains an electronic circuit running on the mains voltage. Contact with this voltage can be fatal. In case of failure, always contact only an authorized service centre or DANGER the manufacturer.

  • Page 31: Information On Electromagnetic Compatibility Emc For Suction Units Ob2012

    Sterile, disposable Silicone tube Reusable and sterilisable. Internal diameter: 6 mm. Length 1.3 m info@boscarol.it For further technical information, contact the manufacturer SERRES® products are factory-sterilised and must be stored in warm indoor locations. Protect the package from humidity, dirt and dust. Disposable products can be used over a period of 5 years after the date shown on the label.

  • Page 32: Methods To Prevent Electromagnetic Interference

    ED01_REV01-2020 IFU OB2012-2P_ENG Suction units OB2012 can be used with the approved power supply unit supplied by the manufacturer (accessory) Use with the power supply unit 16.2. METHODS TO PREVENT ELECTROMAGNETIC INTERFERENCE When there could be interference between this medical device and other electrical equipment in the vicinity, try changing the operating position or removing the sources of interference (cell phones, radio transceivers, mobile antennas).
  • Page 33 ED01_REV01-2020 IFU OB2012-2P_ENG 385 MHz; Pulse modulation: 18 Hz; 27 V/m Proximity fields form 450 MHz, FM + 5 Hz deviation: 1 kHz sine; 28 V/m Portable and mobile RF communications wireless RF 710, 745, 780 MHz; Pulse modulation: 217 Hz; 9 V/m equipment must not be used at a point that is communication 810, 870, 930 MHz;...

  • Page 34: Declaration Of Conformity

    OSCAR BOSCAROL SRL (LTD) The manufacturer: Via E. Ferrari, 29 – 39100 BOLZANO – ITALY Tel. +39 0471 932893 – Fax. +39 0257760140 Web: www.boscarol.it - Email: info@boscarol.it Certifies EN ISO 13485:2016 Certificate No. Q5 042208 0031 Certifies UNI EN ISO 9001:2015 Emission: TÜV–SÜD Product service (CE0123)

  • Page 35: Warranty

    ED01_REV01-2020 IFU OB2012-2P_ENG 18. WARRANTY Oscar Boscarol guarantees the suction units OB2012 for a period of 3 years from the date of purchase from the original distributor. The company guarantees that the suction unit is free of material and/or manufacturing defects.
  • Page 36 ED01_REV01-2020 IFU OB2012-2P_ENG Printed in Italy by Oscar Boscarol Srl (Ltd) ED01_REV01-2020 IFU OB2012-2P_ENG Original language: Italian https://www.boscarol.it/ita/eifu.php 36 - 36...

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