Keeler Spectra Plus User manual

Keeler Spectra Plus
Instructions
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Introduction
Thank you for purchasing the Keeler Spectra Plus
Indirect Ophthalmoscope.
We have taken the greatest care in the design,
development and manufacture of this product to
ensure that you get many years of trouble free
service. However, it is important that you read the
descriptions, installation and operating instructions
carefully prior to installing or using your new
indirect ophthalmoscope.
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Contents
1Symbols
2Warnings and Cautions
3Setting up and using the Spectra Plus
4 Power Supplies - Lithium Battery
5Accessories
6Cleaning Instructions
7Technical Information
8Warranty and Service Information
9Contact Information
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Please click on the contents to go straight to your chosen section or navigate by using the 'Next'
and 'Back' buttons to the right. Clicking on 'Home' will bring you back to this page.
As part of our policy for continued product development we reserve the right to amend specifications at any time without prior notice.
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Symbols
Read user instructions for Warnings, Cautions and
additional information.
The CE mark on this product indicates it has been tested
to and conforms with the provisions noted within the
93/42/EEC Medical Device Directive.
Double insulated.
Type B protection against shock.
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Warnings and Cautions
Warning
• Do not use if the product is damaged and periodically inspect
for signs of damage.
• Do not use in the presence of flammable gases.
• This product should not be immersed in fluids.
• Do not fit mains power adapter into a damaged mains
outlet socket.
• Route power cords safely to eliminate risk of tripping or
damage to user.
• Do not disassemble or modify the battery. There are no
serviceable parts inside.
• Do not dispose of battery in fire, puncture or short circuit.
• Do not use a battery that is deformed, leaking corroded or
visually damaged. Handle a damaged or leaking battery with
care. If you come into contact with electrolyte, wash exposed
area with soap and water. If it contacts the eye, seek medical
attention immediately. There are no user-serviceable parts
inside the device. Contact authorised Service representative
for further information.
• Federal law restricts this device to sale by or order of a
physician.
Caution
• The product has been designed to function safely when at an
ambient temperature between +10ºC and +35ºC.
• Use only Keeler charger supplied.
• Use correct Keeler power supply.
• Dispose of battery in line with local regulations on recycling
batteries.
• Keep out of the reach of children.
• To prevent condensation from forming, allow instrument to
come to room temperature before use.
• When replacing lithium battery pack, turn indirect off and
attach new pack.
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A
B
C
Setting up and using the Spectra Plus
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Description o the Product
AFrame
BFilter Selector
CMirror Angle
DHinge
EInterpupillary Distance Control
FMounting Holes
C
E
D
C
B
F
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Setting up and using the Spectra Plus
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Frame (A)
1. Fit the Spectra Plus
head unit to the frame (A)
via the pin mounting
system as shown.
2. The protective shield
is fitted by pushing
the shield into
position as shown.
Protective shield in
correct position
3. The Prescription Lens Frame is fitted
if required as shown.
Prescription Lens Frame in
correct position
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4. To adjust the Nose Bridge, turn the locking
cam to a position as shown above to
release the Nose Bridge. The Nose Bridge
can then be slid to the required position.
5. Lock the Nose Bridge in position by
turning the locking cam to a position as
shown above.
6. To securely fit the frame to the users
head, slid the toggle indicated to a
comfortable position.
Setting up and using the Spectra Plus
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Frame (A)
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Setting up and using the Spectra Plus
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Filter selection control (B)
By sliding the lever (B) in direction of arrows, different filters
may be selected.
Clear – Select the clear with no filter when inspecting a
specific pathology and a brighter, whiter light is desired.
Green – Red-free filter reduces the red light, so blood will
appear black, silhouetted against a dark background.
Blue – Cobalt blue for fluorescein angioscopy.
Mirror angle
control (C)
Mirror angle
control (C)
Filter selection (B)
Filter selection (B)
Mirror angle control (C)
The light is positioned vertically into the field of view
by rotation of the levers (C) located either side of the
binocular block.
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Setting up and using the Spectra Plus
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Interpupillary Distance Setting Control (E)
Because the eyes are dissociated, particular care must
be taken to ensure the optics (eyepieces) are set properly
in front of each eye.
Place an object, perhaps the thumb, approximately 40cm
from the face and centre it horizontally in the light patch.
Then, close one eye. Using the thumb and forefinger of
the opposite hand, slide the P.D.Control (E) of the open
eye (located directly under each eyepiece) so that your
object moves into the centre of the field, keeping the object
in the centre of the light patch. Repeat for the other eye.
Interpupillary
Distance Control (E)
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Power Supplies - Lithium Battery
Set Plug
Replace the blanking plate with the appropriate mains plug
adapter if required, or use IEC 60320 TYPE 7 connector
(not supplied).
IEC 60320 TYPE 7 connector
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Power Supplies - Lithium Battery
Charging the battery pack
Connect plug on cable to power input socket on side of
Charger.
Turn the battery pack off. The Green LED shows Charging
storage unit is powered.
Place the battery pack into the charging well as shown below.
A yellow LED indicates battery pack’s charge state as below:
Green LED Charging storage unit powered
No yellow LED Battery charged
Flashing yellow LED Top-up charge
Solid yellow LED Rapid charge
The battery pack can be used at any
time during the charging cycle and
will resume charging when battery
pack is placed back in the charger.
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Power Supplies - Lithium Battery
Charge time
The battery will take approximately 3 hours to fully charge.
The battery will last approximately 4 hours on full power.
Turn the illumination on by rotating the dimmer control knob in
an anti-clockwise direction.
A yellow LED indicates battery pack’s charge state as below:
Flashing yellow LED Battery requires charging
Insert connector into
socket as shown.
Belt Clip
The belt clip can be used
for those who prefer to
carry the unit on a belt.
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Accessories
3412-P-7002 Spectra Plus Carrying Case
EP39-33907 Lithium Battery
1201-P-6067 Large Thimble Depressor for Scleral Indentation
1201-P-6075 Small Thimble Depressor for Scleral Indentation
Contact Keeler who can supply a choice of Volk Lenses depending on
magnification and field of view.
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Cleaning Instructions
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Only manual non-immersion cleaning as described should be
used for this instrument. Do not autoclave or immerse in
cleaning fluids. Always disconnect power supply from source
before cleaning.
aWipe the external surface with a clean absorbent, non-
shedding cloth dampened with a water / detergent solution
(2% detergent by volume) or water / isopropyl alcohol
solution (70% IPA by volume). Avoid optical surfaces.
bEnsure that excess solution does not enter the instrument.
Use caution to ensure cloth is not saturated with solution.
cSurfaces must be carefully hand-dried using a clean non-
shedding cloth.
dSafely dispose of used cleaning materials.
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Technical In ormation
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It is well established that exposure of the eye to intense light
sources for extended periods of time poses a risk of retinal photic
injury. Many ophthalmic instruments illuminate the eye with
intense light. The decision about the intensity of the light level
to use in any procedure must be made on a case to case basis. In
each case, the clinician must take a risk benefit judgement about
the intensity of light to be used. Use of insufficient intensity may
result in inadequate visualization and in adverse effects more
serious than retinal photic damage. Further, despite all efforts
taken to minimise the risk of retinal damage, damage may still
occur. Retinal photic injury is a possible complication of the need
to use bright light to clearly visualize ocular structure during
delicate ophthalmic surgical procedure.
While no visible retinal lesions have been identified for
ophthalmic instruments, it is recommended that illumination
levels be set to the minimum level necessary to perform the
diagnostic function. Young children and persons with diseased
eyes may be at a higher risk. The risk may also be increased if the
person being examined has had any exposure with the same
instrument or any other ophthalmic instrument using an intense
visible light source during the previous 24 hours. This will apply
particularly if the eye has been exposed to retinal photography.
0
2
4
6
8
10
12
14
16
18
300 400 500 600 700 800 900 1000 1100
Wavelength / nm
Irradiance / mW m-2 nm-1
Spectral irradiance of Spectra Plus indirect ophthalmoscope at user plane.
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Technical In ormation
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Photochemical source
radiance (mW cm-2 sr-1)
Aphakic, LA(305-700nm) 3.26
Phakic, LB(380-700nm) 3.21
Calculated photochemical source radiances
Operating temperature: +10ºC to +35ºC
Transportation temperature: - 40ºC to +70ºC.10% to 95% RH
Input mains data: 100-240V – 50/60Hz
Power supply rating: 12V : 2.5amps
Operation: Continuous
Classification: Class II equipment
Type B protection against shock
Standards, tested to: IEC 60601-1 Electrical safety
IEC 60601-1-2 EMC
ISO 9022-2:1994 Optics and optical equipment-
Environmental test methods -
Cold, heat and humidity.
ISO 9022-3:1994 Optics and optical equipment -
Mechanical stress.
EN ISO 15004-1:2006 Ophthalmic Instruments -
Fundamental Requirements.
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Warranty and Service In ormation
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Your Keeler Instrument is guaranteed for 3 years and will be
replaced or repaired free of charge subject to the following:
1Any fault that is due to faulty manufacture.
2The instrument has been used in compliance with these
instructions.
3Proof of purchase accompanies any claim.
Please note that batteries are covered by this warranty
statement for I year only.
No user serviceable parts. All preventative maintenance and
servicing must be carried out by an authorised Keeler
representative.
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Contact In ormation
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Manu actured in the UK by:
Keeler Limited
Clewer Hill Road
Windsor
Berkshire SL4 4AA
Freephone: 0800 521251
Tel: [phone]
Fax: [phone]
Distributed by:
Keeler Instruments Inc.
456 Parkway
Broomall
PA 19008, USA
Toll Free: 1 800 523 5620
Tel: [phone]
Fax: [phone]
EP59 – 19148 Issue A
As part of our policy of continued product improvement we reserve the
right to alter and/ or amend specifications at any time without prior notice.
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