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    IFU Otoscope

    Uploaded by

    shubhra jain
    The otoscope is intended for visual examination of the outer ear canal and eardrum. It requires cleaning and disinfection after each use to protect patients and users. The handles and instrument heads can be wiped clean with a moist cloth and disinfected with an approved product, but they should not be immersed in liquid. The manufacturer's instructions should be followed for proper cleaning, disinfection, and technical support.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd

    IFU Otoscope

    Uploaded by

    shubhra jain
    31 views2 pages
    The otoscope is intended for visual examination of the outer ear canal and eardrum. It requires cleaning and disinfection after each use to protect patients and users. The handles and instrument heads can be wiped clean with a moist cloth and disinfected with an approved product, but they should not be immersed in liquid. The manufacturer's instructions should be followed for proper cleaning, disinfection, and technical support.

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    © © All Rights Reserved

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    The otoscope is intended for visual examination of the outer ear canal and eardrum. It requires cleaning and disinfection after each use to protect patients and users. The handles and instrument heads can be wiped clean with a moist cloth and disinfected with an approved product, but they should not be immersed in liquid. The manufacturer's instructions should be followed for proper cleaning, disinfection, and technical support.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    31 views2 pages

    IFU Otoscope

    Uploaded by

    shubhra jain
    The otoscope is intended for visual examination of the outer ear canal and eardrum. It requires cleaning and disinfection after each use to protect patients and users. The handles and instrument heads can be wiped clean with a moist cloth and disinfected with an approved product, but they should not be immersed in liquid. The manufacturer's instructions should be followed for proper cleaning, disinfection, and technical support.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
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    Instruction for Use

    IFU/01, Rev 0, Date 12.10.2022

    Otoscope

    Intended for visual examination of the outer ear canal and tympanic membrane (eardrum) by direct viewing
    through the ear opening.

    CAUTION: • If you suspect that liquid or moisture could have entered the
    handle, it must not be charged under any circumstances. This
    • If you do not plan to use the device for a long time or if you
    travel with it, remove the rechargeable batteries from thecould lead to a life-threatening electric shock, especially in the
    handle. case of plug-in handles.
    •
    • New batteries should be inserted once the light intensity ofTothe
    extend the service life of the battery, the battery should
    instrument becomes weaker, even on a full charge. only be charged once the light intensity of the instrument has
    • To obtain the best possible light output we recommend always weaker.
    become
    fitting high quality batteries
    Instruction for Use
    IFU/01, Rev 0, Date 12.10.2022

    Otoscope

    with a moist cloth until visually clean. Wipe disinfection as


    specified by the disinfectant manufacturer. Only disinfectants
    CLEANING AND DISINFECTION with proven efficacy should be used, taking into account the
    Cleaning and disinfection of the medical devices serves tonational requirements. After disinfection, wipe the instrument
    protect the patient, the user and third parties and to preserve thedown with a moist cloth to remove possible disinfectant
    value of the medical devices. Due to the product design and theresidues. The components that come into contact with the skin
    materials used, no defined limit can be specified for thecan be rubbed down with alcohol or a suitable disinfectant.
    maximum number of reprocessing cycles that can be carriedPlease Note!
    out. The life span of the medical devices is determined by their
    • Never immerse the instrument heads and handles in
    function and by gentle handling of the devices. Defective
    products must undergo the reprocessing procedure described liquids! Take care to ensure that no liquids get inside
    before being returned for repair. the casing!
    Cleaning and Disinfection • This item is not approved for automated
    The instrument heads and handles can be cleaned externally reprocessing and sterilization.

    These instructions provided above have been validated by the medical device manufacturer as being CAPABLE of preparing a
    medical device for re-use. It remains the responsibility of the processor to ensure that the processing is actually performed
    using equipment, materials and personnel in the processing facility to achieve the desired result. This requires validation and
    routine monitoring of the process. Likewise, any deviation by the processor from the instructions provided should be properly
    evaluated for effectiveness and potential adverse consequences.
    Symbols
    Symbols may be used on some package labeling for easy identification.

    TECHNICAL SUPPORT:
     In case of defective and malfunctioning products, please inform to Asha Surgical Industries at 20,
    NEAR JAROUT CHOWNK, VILLAGE MANDAUR AMBALA CITY, HARYANA-134003, India.
     In case of adverse incident, inform competent authority of Member state in which the user or
    patient is established.
     Dispose these products as per Hospital Norms or Country Regulations.

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