Grafco 8617 Instructions For Use Manual

8617, FiberOptic OtOmeter:

8617

FiberOptic

Otoscope

bottom cap

battery handle

ON/OFF
switch

clip

magnification
lens

iNStrUctiONS FOr USe

pLeASe SAVe tHeSe iNStrUctiONS FOr FUtUre USe

SAFety gUideLiNeS - pLeASe reAd beFOre USe

WARNINGS that follow indicate potential hazard situations or unsafe practices that, if
not avoided, could result in death or serious injury.

Important! Read and understand these instructions before using the FiberOptic Otometer. If
you do not understand any part of these instructions, contact your medical supply distribu­tor for direction in the use of this product.

GF Health Products, Inc. assumes no responsibility for any damage or injury caused by im­proper installation or use of this product.

Do not use this device in the presence of ammable gases.

Do not use this device for nerve testing.

Turn this device OFF when not in use.

Use the otoscope very carefully to avoid perforation.

Before each use, check the outer surface of the ear speculum to ensure that there are no
unintended rough surfaces or sharp edges.

Use the otoscope for ear examination only with an ear speculum attached.

U.S. federal law restricts this device to sale by or on the order of a physician.

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CAUTIONS that follow indicate potential hazards or unsafe practices that, if not avoided,
could result in minor personal injury or product/property damage.

Do not immerse this device in fluid.

To minimize lamp housing temperatures, do not exceed one minute on-time, and allow no less
than five minutes off-time.

If the handle is too hot or the batteries leak, turn the device OFF immediately and take out the
batteries.

iNteNded USe

The Grafco 8617 FiberOptic Otoscope is intended to illuminate and ex­amine the auditory canal in conjunction with an ear speculum.

OperAtiON (See pictUre At rigHt)

Install the batteries: Unscrew the bottom cap from the battery handle.
Insert two AA alkaline batteries into the battery handle, ensuring that
the batteries are congured correctly. Screw the bottom cap onto the
battery handle.

Starting and stopping: Move the ON/OFF switch on the battery handle
clip down to turn the instrument on. Move the switch up to turn the
instrument off.

Magnification lens: The 2.5x lens can be swivelled laterally.

8617-INS-LAB-RevA07,

October 2007 1

Speculum insertion and removal: Position the selected speculum on the

bulb

battery

handle

socket

instrument

head

speculum

8617

FiberOptic

Otoscope

otoscope socket (speculum size is marked on its outside). Turn the specu­lum clockwise until you feel a resistance. To remove the speculum, turn it
counter-clockwise until it is free of the otoscope socket.

mAiNteNANce

Replacing the bulb: Unscrew the instrument head to remove it from the bat­tery handle. The bulb is in the bottom section of the instrument head. Re­move the bulb from the instrument head with your thumb and forenger or a
suitable tool. Insert the new bulb rmly.

Battery use and care: Use two AA alkaline batteries only. If the otoscope will
not be used for an extended period of time, remove the batteries. Dispose of
used batteries in accordance with all applicable laws and regulations.

Cleaning and sterilization: Dampen a clean cloth with a mild detergent and
water solution, a solution of 70% isopropyl alcohol and water solution, or a
10% bleach and water solution. Wring out the cloth to remove excess uid. Use the cloth to wipe
all external surfaces of the otoscope. Ensure that no fluid enters the otoscope. Clean the instru­ment glass with a cotton swab dipped in isopropyl alcohol. The reusable ear specula may be steril­ized in 134°C saturation steam for a dwell time of ten minutes.

SpeciFicAtiONS

Optical specications Illumination form Fiber optics transmit light

Ear specula specications Ear specula diameter 2.5mm, 4mm

Light port specications Light port Yes. An otoscope bulb can be tted to the port.

Electrical specications Bulb model T4954 2.5V, 1.6W

Environmental requirements Use Temperature 50°F — 95°F (10°C — 35°C)

Replacement parts Specula size 2.5mm (8617-1); Specula size 4.0mm (8617-2); Replacement bulb (8617-3)

WArrANty

GF Health Products, Inc. warrants the Grafco 8617 FiberOptic Otoscope (not including specula) for a
period of one year for defects in workmanship and materials. During the warranty period, defec­tive items will be repaired or replaced at manufacturer's option at no charge.

Lens magnication 2.5x

Otoscope port View tympanic membrane using the FiberOptic Otoscope bulb

Rated voltage Two AA alkaline batteries (included)

Operation mode On time Intermittent; ≤ one minute

Off time ≥ ve minutes

Electrical safety standard IEC60601-1, IEC60601-1-2

Relative humidity 30% — 75%

Atmospheric pressure 10.15 psi — 15.37 psi (70 kPa — 106 kPa)

Shipping and storage Temperature -40°F — 131°F (-40°C — 55°C)

Relative humidity 10% — 90%

Atmospheric pressure 7.25 psi — 15.37 psi (50 kPa — 106 kPa)

GF, Graham-Field, and Grafco are registered trademarks of GF Health Products, Inc.

© GF Health Products, Inc. • 2935 Northeast Parkway • Atlanta, GA 30360 • tel [phone] • fax [phone] • www.grahamfield.com

2 8617-INS-LAB-RevA07,

October 2007