User Manual Owner manual

Symbols
Attention. Read Operating Manual for Cautions and Instructions for
Use.
TYPE BF – Indicates this is a product with Type BF applied parts (the
patient eyecup).
The CE mark on this product indicates it has been tested to and con-
forms with the provisions noted within the 93/42/EEC Medical Device
Directive.
European Regulatory Manager
Welch Allyn Ltd.
Navan Business Park
Dublin Road
Navan, County Meath, Republic of Ireland
Tel: [phone] • Fax: [phone]
Warnings and Cautions
CAUTION: To minimize lamp housing temperatures, on-time should not exceed
2 minutes with off-time not less than 10 minutes.
CAUTION: No acute optical radiation hazards are identified for
ophthalmoscopes. However, Welch Allyn recommends limiting the intensity of
the light directed into the patient’s eye to the minimum level that is necessary
for diagnosis. Infants, aphakes, and persons with diseased eyes are at a
greater risk. The risk is also increased if the examined person has had any
exposure with the same instrument or any other ophthalmic instrument using
a visible light source within the previous 24 hours. This will apply particularly
if the eye has had exposure to retinal photography. The intended use of this
device is for routine ophthalmic exams on the order of typically less than 60
seconds per eye. Although there is a benefit versus risk factor in any medical
procedure, these more complicated exams should not exceed a three minute
exam time in 24 hours. Significant use of this device beyond its intended use
is not recommended; it may cause harm to the eyes.
Use only PanOptic Patient Eyecups (part number 118092) with this product.
CAUTION: Federal Law restricts this device to sale by or order of a
physician.
CAUTION: Spectrally weighted photochemical radiance L
B
and L
A
give a
measure of the potential hazard that exists for a beam of light to cause
photochemical damage to the retina. L
B
gives the measure for eyes in which a
crystalline lens is not in place. L
A
gives this measure either for eyes in which
the crystalline lens has been removed (aphakes) and has not been replaced by
a UV-blocking lens or for the eyes of very young children.
The value stated for this ophthalmoscope gives a measure of hazard potential
when the instrument is operated at maximum intensity and maximum
aperture. Values of L
B
or L
A
over 684 mW/(cm
2
*sr) are considered high.
The retinal exposure dose for a photochemical hazard is a product of the radiance and
the exposure time. For instance, at a radiance level of 684 mW/(cm
2
*sr), a 3-minute
exposure would produce a retinal exposure dose level at the recommended limit. If the
value of radiance were reduced to 342 mW/(cm
2
*sr), twice that time (i.e. 6 minutes) is
needed to reach the recommended limit. The recommended exposure dose is based on
calculations using the American Conference of Governmental Industrial Hygienists
(ACGIH) Threshold Limit Values for Chemical Substances and Physical Agents (1995-
1996 Edition).
The 118 Series Ophthalmoscope has spectrally weighted photochemical radi-
ances at maximum intensity and maximum aperture of .281 W/(cm
2
*sr) for L
B
and.300 W/(cm
2
*sr) for L
A
(aphake). The relative spectral output of the device
is shown.
The PanOptic™ Ophthalmoscope
Transparency of the cornea, lens and vitreous humor permits the practitioner to directly
view arteries, veins, and the optic nerve of the retina.
Direct observation of the structures of the fundus through a PanOptic Ophthalmoscope
may show disease of the eye itself or may reveal abnormalities indicative of disease
elsewhere in the body. Among the most important of these are vascular changes due to
diabetes or hypertension and swelling of the optic nerve head due to papilledema or
optic neuritis. In this sense, the eye serves as a window through which many valuable
clinical evaluations may be made.
When a preliminary diagnosis of an imminently dangerous eye condition, such as acute
(angle-closure) glaucoma or retinal detachment, is made by the examiner, prompt
referral to an eye specialist may prevent irreversible damage. Or, when distressing but
less urgent conditions, such as visual impairment due to cataract or vitreous floaters,
are recognized, the patient can be reassured and referred.
Set-up Instructions
Attaching the PanOptic
Ophthalmoscope head to a
Welch Allyn Power Source
Align cutouts in the PanOptic Ophthalmo-
scope base with lugs on power source.
(The PanOptic Ophthalmoscope fits all 3.5v
Welch Allyn power sources.) Push in
slightly and turn 90 degrees.
Attaching the Patient Eyecup
to
PanOptic
Use only PanOptic Patient Eyecups (part number 118092) with this product.
Insert eyecup into the patient’s side of
the instrument. Push and twist in one motion
until you feel the two “lock” together.
See Accessory and Replacement Parts List to
reorder new PanOptic Patient Eyecups.
Attaching Corneal Viewing Lens to PanOptic (Model
11820 only)
Insert Corneal Viewing Lens into patient’s side of the instrument. Push and twist in one
motion until you feel the two “lock” together as shown, except replacing Patient Eyecup
with the Corneal Viewing Lens. Verify that the line on the lens housing is aligned with
the top seam of the PanOptic instrument.
Apertures and Filters
There is a wide range of practical apertures and filters to select from: small spot, large
spot, micro spot, slit aperture, red-free filter, cobalt blue filter (optional), and half-moon
aperture (optional).
1. Small Aperture: Provides easy view of the fundus through an undilated
pupil. Always start the examination with this aperture and proceed to
micro aperture if pupil is particularly small and/or sensitive to light. This
position is the “Home” position on the aperture dial and is denoted by
the green marking.
2. Large Aperture: Standard aperture for dilated pupil examination of the
eye.
3. Micro Spot Aperture: Allows easy entry in very small, undilated
pupils.
4. Slit Aperture (Models 11810, 11820 only): Helpful in determining
various elevations of lesions, particularly tumors and edematous discs.
5. Red-Free Filter (Model 11810, 11820 only): This filter excludes red
rays from the examination field: this is superior to ordinary light in
viewing slight alterations in vessels, minute retinal hemorrhages, ill-
defined exudates and obscure changes in the macula. The nerve fibers
become visible and the observer may note the disappearance of such
fibers, as in optic nerve atrophy. The background appears gray, the disc
appears white, the macula appears yellow, the fundus reflex is intense
and the vessels appear almost black. This filter is also used to help
distinguish veins from arteries; veins stay relatively blue, but
oxygenated arterial blood makes arteries appear blacker. This greater
contrast makes differentiation easier for the examiner.
6. Cobalt Blue Filter (Model 11820 only): In conjunction with
fluorescein dye applied topically to the cornea and an add-on magnifying
lens (included), this filter is helpful in detecting corneal abrasions and
foreign bodies. In this way, it can be used as a surrogate to a Woods
Light.
7. Half-Moon Aperture (11810 Only): Provides a combination of depth
perception and field-of view.
Lamp Replacement Instructions
Lamp Replacement Caution: Halogen lamps are pressurized to provide maximum effi-
ciency and illumination. Mistreatment may cause shattering. Protect lamp surface
against abrasion and scratches. Verify power is off when replacing lamp. Dispose of
lamp with care.
Cleaning and Repair Instructions
Cleaning and repairs (with exception of the lamp replacement) beyond what is specified
in the “general cleaning instructions” section should be performed at the factory.
General Cleaning Instructions
NOTE: Excess solution entering the optical assembly could damage internal compo-
nents. Use caution to ensure cloth is not saturated with solution.
This is a precision optical instrument. Please follow these specific cleaning
requirements:
• Do not use any solvent based cleaners on the lenses. Use only a clean/soft optical
grade cleaning cloth on the lenses.
• The PanOptic Ophthalmoscope is Non-sterilizable.
• Disinfect housing using soft cloth moistened with alcohol.
• Clean the Patient Eyecup with soft cloth/cotton swab moistened with alcohol.
1. Soft cloth/cotton swab moistened with alcohol.
2. Soaking in gluteraldehyde based solutions (i.e. Cidex OPA).
NOTE: For disinfection time / procedure requirements it is recommneded that you
follow the directions of the specific brand you are using.
3. Autoclaving.
• Do not use acetone based products or other harsh chemicals.
No other preventative maintenance is necessary for this product.
Troubleshooting
PanOptic™
Ophthalmoscope
118 Series
118088VET Rev. A
Printed in the U.S.A.
A
B
C
D
E
F
A Patient Eyecup D Aperture/Filter Dial
B Patient’s Side E Focusing Wheel
C Soft Grip Handle F Practitioner’s Side Brow Rest
TURN HANDLE
COUNTER-
CLOCKWISE
Twist
CAUTION: Lamps may be hot. Lamp should be allowed to cool before
removal. Use only Welch Allyn model 03800 lamp with this product
Use your fingernail or a small prying
instrument to remove the lamp from the
ophthalmoscope head base.
To insert the new lamp, align tab on
lamp with notch in the base of the
ophthalmoscope head and push inward
until firmly seated.
Align Tab
Trouble Area Possible Cause Corrective Action
No Light output
Aperture dial is in-
between positions
Rotate the aperture dial.
Lamp burned out. Replace the lamp using
Welch Allyn part number
03800.
Wrong lamp/ incorrect
Welch Allyn lamp/non-
Welch Allyn lamp.
Replace lamp using Welch
Allyn part number 03800.
The battery handle has
completely discharged.
Charge the handle, check the
battery, and/or the charger.
Spot is not centered. The aperture dial is not
centered.
Move aperture dial to the full
detent position.
Not achieving full or
expected view.
Unit is not in proper
operating position.
Ensure that the eyecup is
slightly compressed during
the procedure.
Can not obtain sharp
focus/hazy view.
The lenses are dirty. Clean the lenses with a
clean/soft optical grade
cleaning cloth.
Dim Light Output
Lamp pin not engaged in
slot
Insert the lamp with pin
firmly seated in slot.
Film on Optics Clean the lenses with a
clean/soft optical grade
cleaning cloth.
The handle is not fully
charged.
Charge the handle, check the
battery and/or the charger.
Glare in view Fingerprints or dirt on the
objective (Patient’s Side)
lens
Clean the objective (Patient’s
Side) lens with a clean/soft
optical grade cleaning cloth.
Cannot attach to power
handle.
Lamp is not fully
inserted.
Insert the lamp with pin
firmly seated in slot.