HEINE mini 3000 Instructions for Use Dec 2013

1. HEINE mini 3000 ® Battery Handle

2. HEINE mini 3000 ® Ophthalmoscope

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4. HEINE mini 3000 ® Tongue-blade holder

3. HEINE mini 3000 ® Focalux hand lamp

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5. HEINE mini 3000 ® F.O. Otoscope HEINE mini 3000 ® Otoscope 1

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6. H  EINE mini 3000 ® Cliplamp

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ENGLISH

HEINE mini 3000 ® Please read and follow these instructions for use and keep them for future reference.

General Conditions of Warranty Instead of the statutory warranty time period of 2 years, HEINE will grant a guarantee of 5 years from the date of the consignment of the goods ex works, concerning its equipment (excluding disposables, e.g. bulbs, singleuse articles, and rechargeable batteries). Date of consignment means that HEINE hands the goods over to the transport carrier, freight forwarder or any other person designated by the Customer for the transport of the goods without loading the collecting vehicle. The guarantee covers irreproachable workmanship, on condition of the proper use of the equipment and the observation of the operating instructions. During the warranty- and guarantee time period, errors and deficiencies arising on the equipment will be rectified free of charge, in so far as such are evidenced by defective materials, processing and/or constructional errors. Should buyer complain of a material deficiency during the warranty time period, then the onus of proof is always to be on the orderer, that the product was defective already upon receipt of the goods. The statutory warranty and the guarantee do not apply to loss or damage caused by wear and tear, negligent use, the non-employment of original HEINE components and/or spares (in particular bulbs, as these have been especially developed for HEINE instruments in accordance with the following criterions: colour temperature, useful service life, safety, optical quality and performance. The statutory warranty and the guarantee do not apply to interventions by persons not authorised by HEINE or when the operating instructions are not observed by the customer. Any modification of a HEINE product with parts or additional parts which do not conform to the original HEINE specification will invalidate the warranty for the correct function of the product and further invalidate any warranty claims which result from such a change or modification. Further claims, in particular claims for replacement of loss or damage, which are experienced otherwise than directly on the HEINE product itself, are hereby excluded. For U.S. only: Federal law restricts this device to sale by or on the order of a Physician or Practitioner! Warnings and Safety Information CAUTION! Indicates potential hazardous situations. Ignoring the corresponding instructions may lead to dangerous situations of mild to moderate extent. (Background color yellow; foreground color black). NOTE! Indicates valuable advice in terms of installation, operation, maintenance or repair. Notes are important, but not related to hazardous situations.

Intended Use 1. HEINE mini 3000® Battery Handle The HEINE mini 3000® battery handle should only be used for operation to power HEINE mini 3000® instruments.

2. HEINE mini 3000® Ophthalmoscope The HEINE mini 3000® ophthalmoscope is designed for examination of the eye. During examination, hold the instrument with your index finger on the lens wheel (1). You can also operate the aperture wheel (3) in this way. Window (2) shows the selected lens value. Minus lenses are shown red, plus lenses black.

3. HEINE mini 3000® Focalux hand lamp The HEINE mini 3000® Focalux hand lamp is designed for illuminating the oral cavity, the throat, nose, skin surface and for examining the anterior segment of the eye. When combined with an ophthalmoscopy lens it can be used for indirect ophthalmoscopy.

4. HEINE mini 3000® tongue-blade holder The HEINE mini 3000® tongue-blade holder should only be used to illuminate the oral cavity and throat.

5. HEINE mini 3000® otoscope HEINE mini 3000® F.O. otoscope The HEINE mini 3000® otoscopes should only be used to examine the external ear and for general non-invasive examination.

6. HEINE mini 3000® Cliplamp The HEINE mini 3000® Cliplamp is designed solely for the examination of the surface of the skin. med 3206

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Operate 1. HEINE mini 3000® Battery Handle Batteries: • 2 alkali cells (AA/ LR 6) • The HEINE mini 3000® battery handle can be charged in the HEINE® mini NT with the HEINE mini 2Z rechargeable battery 2,5V. Charging time: • The mini NT indicates when the rechargeable battery is fully-charged. The illuminated ring is lit continuously. • mini 2Z rechargeable battery (2,5V, NiMH) = ca. 4h (730mAh) Instrument connector: Internal thread in handle head (1). Switching on: Push switch (2) down. Switching off: Push switch up. If the handle is put back firmly into a coat pocket the handle is automatically switched off. Changing the batteries: Unscrew the end-cap (3) and shake out the old batteries / rechargeable battery. Insert new batteries / rechargeable battery with the plus contact facing the handle head.

2. HEINE mini 3000® Ophthalmoscope Changing the bulb: Unscrew the instrument from the handle and pull the bulb (4) downwards. Wipe the new bulb glass clean and insert it so that the locating pin (5) fits the slit.

3. HEINE mini 3000® Focalux hand lamp Method of operation: Attach the instrument to a handle. Switch on the illumination and direct the light emerging from the prism (7) onto a white surface. Using the slide (1) you can adjust the focusing of the light from parallel (slide at bottom) to convergent rays. Use of magnifying lens +3D: The lens is mounted on the cylindrical part (8) of the hand lamp. Ensure that the shoulder (5) of the lens ring (6) is pointing upward. The lens enables the presbyopic examiner to carry out examinations in comfort and produces a magnified fundus image. Always position the lens at the center of the hand lamp. Changing bulbs: Please note: The performance of this instrument can only be guaranteed if genuine HEINE bulbs are used. Remove the instrument from the handle. Grip the collar (4) of the bulb between your thumb and index finger nails and remove the bulb by pulling it downward. Wipe the dome of the new bulb on a clean cloth and then insert it so that the adjusting pin (4) fits into the recess (2).

4. HEINE mini 3000® tongue-blade holder Fitting and ejecting the tongue-blade: Push the HEINE disposable tongue-blade into the holder (3) until it clicks in. Press the trigger (4) to eject. Changing the bulb: Unscrew the cover (1) and pull out the bulb (2). Insert a new bulb and screw in the cover again.

5. HEINE mini 3000® Otoscope HEINE mini 3000® F.O. Otoskop Safety in use: The otoscope should only be used to examine the ear when a tip is fitted. The contact time (skin) has to be limited to max. 1 minute. Pressure should be applied with great care when doing pneumatic testing. Attaching a tip: The otoscope may only be inserted into the auditory canal when a disposable (grey) or reusable (black) tip is fitted. Push the tip onto the instrument so that the internal projection engages in the slit (1). Twist to the right to lock.

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Magnifying lens: The lens (2) magnifies ca. 3x and can be swivelled aside for instrumentation. Insufflation port: An insufflation bulb can be fitted to the port. General illumination: The otoscope can be used with or without a tip for general illumination of e.g. the oral cavity or skin. Avoid contact with sensitive or damaged skin. Changing the bulb: Swivel the lens (2) to one side and simply pull the bulb (3) backwards out of the head. Push in a new bulb. With the HEINE mini 3000® F.O. otoscope, first unscrew the head from the handle and pull the bulb (3) downwards. Push in the new bulb.

Hygienic Cleaning / Processing 1. HEINE mini 3000® Battery Handle The handle can be cleaned with a damp cloth (e.g. alkaline or pH- neutrale detergent). For cleaning disinfection of the outer surface we recommend the so called wipe disinfection by using detergents, which are released for Medical Devices made out of plastic. Disinfection by spraying or immersion as well as sterilisation is not allowed.

2. HEINE mini 3000® Ophthalmoscope The housing can be wiped clean with a cloth moistened with alcohol. Glass surfaces can be cleaned with a cotton wool bud in the same way.

3. HEINE mini 3000® Focalux hand lamp The instrument can be wiped with a cloth dipped in alcohol. Use a cotton wool bud with alcohol for the glass surfaces.

4. HEINE mini 3000® tongue-blade holder Wipe clean with cleaning or disinfectant solution. Do not soak or autoclave.

5. HEINE mini 3000® otoscope HEINE mini 3000® F.O. otoscope Otoscope head: Clean the outside with a soft cloth, inside with a cotton wool bud, if necessary soaked in alcohol. Gas sterilization is permitted. Do not soak. Reusable SANALON S tips: These can be cleaned, disinfected and sterilized or boiled by any conventional method. Autoclaving is permitted. AllSpec-Tips: Are for single use only. Do not attempt to clean them as the tip may be damaged and could injure the patient.

6. HEINE mini 3000® Cliplamp The Cliplamp can be cleaned with a damp cloth (e. g. alkaline or pH-neutral detergent). For cleaning disinfection of the outer surface we recommend the so-called wipe disinfection by using detergents, which are released for Medical Devices made out of plastic. Disinfection by spraying or immersion as well as sterilisation is not allowed. Maintenance This product does not require regular maintenance. Service This product does not require regular service. Disposal The product must be recycled as separated electrical and electronic devices. Please observe the relevant state-specific disposal regulations.

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General Notes and Warnings Check the correct operation of the product at regular intervals. Do not use the equipment if it shows visible signs of damage. Do not open the instrument / battery handle in the vicinity of the patient. This product is a precise optical instrument. Please handle this product with care and store it in a clean place. 1. HEINE mini 3000® Battery Handle Do not use alkali manganese batteries with lithium as bulb life will be reduced. - The performance of this instruments can only be guaranteed if genuine HEINE bulbs are used. - For repairs, please contact your supplier, who will return the goods to us or our authorized agent. This product is not allowed to be entered or used in strong magnetic fields like MRI scanners. Explanation of utilized symbols The following symbols are used on the device or on the packaging: The CE mark indicates that the product complies with the European medical device directive 93/42/EEC. REF

Catalogue- or reference number

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Humidity limitation for storage and transport

Manufacturer

Please read and follow the instructions for use and keep them for future reference (background color blue; foreground color white)

Date of manufacture

Fragile, handle with care!

Product bearing this symbol may not be disposed of together with general household waste, but instead requires separate disposal according to local provisions. (European Waste Electrical and Electronic Equipment Directive, WEEE)

Keep dry

Temperature limits in °C for storage and transport

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Temperature limits in °F for storage and transport

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Interference may occur in the vicinity of equipment marked with the following symbol “Grüner Punkt” (country-specific)

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