Keeler Vantage Plus User manual

Vantage Plus and
Vantage Plus LED
Indirect Ophthalmoscope
INSTRUCTIONS FOR USE
A world without vision loss

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VANTAGE PLUS AND VANTAGE PLUS LED by KEELER
CONTENTS
1. INDICATIONS FOR USE ........................................................................................ 3
2. SAFETY................................................................................................................. 3
2.1 PHOTOTOXICITY ............................................................................................................................3
2.2 WARNINGS AND CAUTIONS..........................................................................................................3
2.3 CONTRAINDICATION.....................................................................................................................5
3. CLEANING AND DISINFECTION INSTRUCTIONS.................................................... 6
4. SETTING UP AND USING THE VANTAGE PLUS....................................................... 7
4.1 CONTROLS AND COMPONENTS.....................................................................................................7
4.2 HEADBAND ADJUSTMENT .............................................................................................................7
4.3 OPHTHALMOSCOPE ANGLE ALIGNMENT.......................................................................................8
4.4 INTERPUPILLARY DISTANCE SETTING CONTROL (S)........................................................................8
4.5 OBTAINING A FUSED IMAGE .........................................................................................................8
4.6 MIRROR ANGLE CONTROL (J)........................................................................................................9
4.7 HEADBAND DIMMER SWITCH (T) ..................................................................................................9
4.8 SETTING THE APERTURE ................................................................................................................9
4.9 SELECTING FILTERS......................................................................................................................10
5. WIRELESS CHARGERS ........................................................................................ 10
5.1 SET PLUG....................................................................................................................................10
5.2 STANDARD LITHIUM-ION.............................................................................................................10
5.3 STANDARD SLIMLINE LITHIUM-ION .............................................................................................11
5.4 CHARGING..................................................................................................................................11
5.5 CHARGING CYCLE.......................................................................................................................13
5.6 WALL MOUNTING.......................................................................................................................13
6. SMARTPACK AND WALLPACK ............................................................................. 14
6.1 PARTS LIST ..................................................................................................................................14
6.2 POWER CONVERSION .................................................................................................................15
6.3 FIXING THE WALL MOUNT...........................................................................................................15
6.4 LED DISPLAYS..............................................................................................................................16
7. BULB / LED REPLACEMENT................................................................................. 17
8. FITTING YOUR HIMAG™LENS (M) AND TEACHING MIRROR (N)........................ 18
9. SPECIFICATIONS AND ELECTRICAL RATINGS...................................................... 18
9.1 ELECTROMAGNETIC EMISSIONS..................................................................................................19
9.2 ELECTROMAGNETIC IMMUNITY ..................................................................................................19
9.3 RECOMMENDED SAFE DISTANCES ..............................................................................................21
9.4 TECHNICAL SPECIFICATIONS.......................................................................................................22
10. ACCESSORIES AND SPARES................................................................................ 23
11. PACKAGING AND DISPOSAL INFORMATION....................................................... 23
12. WARRANTY ........................................................................................................ 24

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VANTAGE PLUS AND VANTAGE PLUS LED by KEELER
Consult instructions for use General warning sign
Date of manufacture Warning: Electricity
Manufacturer’s name and
address Warning: Floor level obstacle
Country of manufacture Warning: Non-ionizing
radiation
Waste Electrical and Electronic
Equipment (WEEE) recycling Warning: Optical radiation
This way up Warning: Hot surface
Keep dry Conformité Européene
Fragile Type B applied part
Do not use if package is
damaged Class II equipment
Temperature limit Atmospheric pressure
limitation
Authorised representative in
the European Community Humidity limitation
Catalogue number Serial number
Translation Medical device
The Keeler Vantage Plus and Vantage Plus LED Instruments are designed and built in conformity with Directive
93/42/EEC, Regulation (EU) 2017/745 and ISO 13485 Medical Devices Quality Management Systems.
Classification: CE: Class I
FDA: Class II
The information contained within this manual must not be reproduced in whole or part without the manufacturer’s
prior written approval. As part of our policy for continued product development we the manufacturer reserve the right
to make changes to specifications and other information contained in this document without prior notice.
This IFU is also available on the Keeler UK and Keeler USA websites.
Copyright © Keeler Limited 2021. Published in the UK 2021.

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VANTAGE PLUS AND VANTAGE PLUS LED by KEELER
1. INDICATIONS FOR USE
NOTE: For users of the Vantage Plus Digital Indirect Ophthalmoscope, this instructions for use
document must be read in conjunction with the instructions for use document (part number
EP59-09863) for the Vantage Plus Digital.
These devices are intended to be used only by suitably trained and authorised healthcare
professionals.
CAUTION: Federal Law restricts this device to sale by or on the order of a
physician or practitioner.
Intended use / purpose of instrument
Indirect Ophthalmoscope is an AC or battery-powered device containing illumination and
viewing optics; and it is intended to be used to examine the cornea, aqueous, lens, vitreous
and retina of the eye. The device is intended for use by a trained healthcare professional and is
mounted on the user’s head.
2. SAFETY
2.1 PHOTOTOXICITY
CAUTION: The light emitted from this instrument is potentially hazardous.
The longer the duration of exposure, the greater the risk of ocular
damage. Exposure to light from this instrument when operated at
maximum intensity will exceed the safety guideline after 4.5 minutes.
Testing was completed with a 20D, 55mm diameter Volk lens.
While no acute optical radiation hazards have been identified for Indirect
Instruments, we recommend keeping the intensity of the light reaching
the patient’s retina to the minimum possible for the respective diagnosis.
Children, people with aphakia and people suffering from eye conditions
are most at risk. An increased risk may also occur if the retina is exposed
to the same or a similar device with a visible light source within 24 hours.
This applies, in particular, if the retina has been photographed with a
flashbulb in advance.
Keeler Ltd shall on request, provide the user with a graph showing the
relative spectral output of the instrument.
2.2 WARNINGS AND CAUTIONS
Please note that the proper and safe functioning of our instruments is only guaranteed if
both the instruments and their accessories are exclusively from Keeler Ltd. The use of other
accessories may result in increased electromagnetic emissions or reduced electromagnetic
immunity of the device and may lead to incorrect operation.

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VANTAGE PLUS AND VANTAGE PLUS LED by KEELER
Observe the following precautions in order to ensure safe operation of the instruments.
WARNINGS
• Never use the instrument if visibly damaged and periodically inspect it for signs of damage
or misuse.
• Check your Keeler product for signs of transport / storage damage prior to use.
• Do not use in the presence of flammable gases / liquids, or in an oxygen rich environment.
• US Federal Law restricts this device to sale by or on the order of a physician or practitioner.
• This device is intended to be used only by suitably trained and authorised healthcare
professionals.
• This product should not be immersed in fluid.
• 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.
• No modification to this equipment is allowed.
• The mains plug is the means of isolating the device from the mains supply. Ensure both the
power switch and mains plug are always accessible.
• 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.
• Before any cleaning of the instrument or the base unit ensure the power lead is
disconnected.
• Bulbs / LEDs can reach high temperatures in use – allow to cool before handling.
• Do not exceed maximum recommended exposure time.
Caution
• Refraction stand variants or adaptors should only be used in combination with EN/IEC
60601-1 and EN/IEC 60601-1-2 compliant power supplies and devices.
• Use only genuine Keeler approved parts and accessories or device safety and performance
may be compromised.

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VANTAGE PLUS AND VANTAGE PLUS LED by KEELER
• Use only Keeler approved batteries, chargers, and power supplies as per the accessories
listed in Accessories and Spares page 23.
• The product has been designed to function safely when at an ambient temperature
between +10°C and +35°C.
• Keep out of the reach of children.
• To prevent condensation from forming, allow instrument to come to room temperature
before use.
• For indoor use only (protect from moisture).
• When replacing lithium battery pack, turn indirect off and attach new pack.
• Remove batteries when device may not be used for prolonged periods.
• Do not charge battery in an environment where the temperature may exceed 40˚C or fall
below 0˚C.
• There are no user serviceable parts inside. Contact authorised service representative for
further information.
• Ensure battery orientation is correct, or personal injury / damage to equipment may occur.
• Care should be taken when handling halogen bulbs. Halogen bulbs can shatter if scratched
or damaged.
• Ensure device is securely held in docking station to minimise risk of injury or damage to
equipment.
• Follow guidance on cleaning / routine maintenance to prevent personal injury / damage to
equipment.
• Note: Lithium Ion contain no toxic heavy metals such as mercury, cadmium, or
lead.
• After removal of the battery do not touch the battery contacts and the patient
simultaneously.
• At product end of life dispose of in accordance with local environmental guidelines
(WEEE).
2.3 CONTRAINDICATION
There is no restriction to patient population this device can be used with other than those
outlined in the contra-indications stated below.
Whilst BIO using a head mount can be performed through an undiluted pupil, the field of view
and magnification can be greatly compromised; therefore, pupillary dilation using mydriatics
is recommended in practice. Optometrists regularly perform pupil dilation to comprehensively
examine the ocular fundus as part of a comprehensive eye health examination where clinically
indicated. Furthermore, in order to gain a more peripheral view of the retina, scleral indentation
is performed as an adjunct to BIO when using a head mount.

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VANTAGE PLUS AND VANTAGE PLUS LED by KEELER
3. CLEANING AND DISINFECTION INSTRUCTIONS
Before any cleaning of the instrument or the base unit, ensure the power
lead is disconnected.
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.
1. Wipe the external surface with a clean absorbent, non-shedding cloth dampened with
de-ionised water / detergent solution (2% detergent by volume) or water / isopropyl
alcohol solution (70% IPA by volume). Avoid optical surfaces.
2. Ensure that excess solution does not enter the instrument. Use caution to ensure cloth is
not saturated with solution.
3. Surfaces must be carefully hand-dried using a clean non-shedding cloth.
4. Safely dispose of used cleaning materials.
For re-useable depressor only
Re-useable depressor should not be re-used if visibly contaminated with
fluids or blood.
The cleaning and sterilization of reusable depressor, can be accomplished as follows:
1. Manually clean all surfaces of the units using a suitable brush and de-ionised water/
detergent solution (2% detergent by volume). Ensure all crevices are accessed and
cleaned. Solution can be heated to no more than 35°C.
2. Carefully examine to ensure that all visible contamination has been removed.
3. Safely dispose of used cleaning materials.
4. Sterilize using a validated steam sterilizer complying with BS 3970 or equivalent
standard. Operating cycle condition as below: 134-138°C sterilizing temperature at 2.25
bar operating pressure for minimum of 3 minutes hold time.
Following cleaning and/or sterilisation processes inspect the device
to ensure all visible soil has been removed and the device operates as
intended and is suitable for its intended use. Do not use if damaged.
Dispose of safely.
The useful life of the device is determined by the wear and damage during use.

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VANTAGE PLUS AND VANTAGE PLUS LED by KEELER
4. SETTING UP AND USING THE VANTAGE PLUS
4.1 CONTROLS AND COMPONENTS
4.2 HEADBAND ADJUSTMENT
Comfortable Fit
Adjust the size (A) fig.1 and the height (B) fig.2, so that the instrument is supported
comfortably around and on top of the head.
B
A
G
E
F
I
R
P
Q
O
S
I
H
K
J
T
L
M
N
C
A Headband Size Adjustment Knob
B Headband Height Adjustment Knob
C Metal Outer Brow Band
D Brow Band Tension Knob
E Ophthalmoscope Angle Knob
F Lithium Battery
G Hinge System
H Aperture Selection
I Filter Lever
J Mirror Angle Control
K Individual Eyepiece
L Front Window
M HiMag™ Lens
N Teaching Mirror
O Binocular Block
P Bulb or LED Cover
(Removed in Image)
Q Rubber Eyecaps
R Optics of Eyepiece
S Interpupillary Distance (PD) Control
T Headband Dimmer Switch

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4.3 OPHTHALMOSCOPE ANGLE ALIGNMENT
For vertical alignment of the eyepieces and binocular block (O), adjust the height of the
Metal Outer Brow Bar (C) if necessary by using the Brow Band Tension Knob (D) and/or the
Ophthalmoscope Angle Knob (E), located on the sides of the headset (fig 3).
Position the Binocular Block (O) as close to the eyes or spectacles as possible for maximum
field of view. Slightly loosen the Ophthalmoscope Angle Knob (E) to allow for adjustment and
tighten when in position as in (fig 4).
4.4 INTERPUPILLARY DISTANCE SETTING CONTROL (S)
Because the eyes are dissociated, particular care must be taken to ensure the optics (eyepieces)
are set properly in front of each eye.
Always set the Aperture Selection (H) to the large light patch for this exercise.
Place an object, approximately 40cm from the face and centre it horizontally in the light patch.
Then, close one eye. Slide the PD Control (S) 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.
4.5 OBTAINING A FUSED IMAGE
Ensure that a singular, fused image is obtained as follows:
Fused image Overlapping imagesSeparate images

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VANTAGE PLUS AND VANTAGE PLUS LED by KEELER
4.6 MIRROR ANGLE CONTROL (J)
The light is positioned vertically into the upper two thirds of the field of view by rotating the
spindle (J) located on either side of the Binocular Block.
4.7 HEADBAND DIMMER SWITCH (T)
Turn the illumination on by rotating the Headband Dimmer Switch (T) in a clockwise direction.
Turn the illumination off or dim by rotating the Headband Dimmer Switch (T) in an anti-
clockwise direction.
4.8 SETTING THE APERTURE
By rotating the knob (H) different apertures may be selected.
The Keeler Vantage Plus has 3 light apertures which offer maximum stereopsis. When you
select the aperture the illumination and viewing mirrors automatically adjust for maximum
stereopsis.
Large
The large, round homogenous patch is suitable for routine examinations through
fully dilated pupils.In this position the mirror remains in the forward position and the
optics are diverged.
Intermediate
The intermediate patch is designed to reduce reflections when entering a partially or
poorly dilated pupil (3mm). It is also ideal for closer inspection of particular fundal
areas. the mirror and optics stay in the mid position.
Small
This light patch is ideal for small, undilated pupils.The mirror moves back, and the
optics automatically converge.
Mirrors move forward / back
as apertures are selected
Illumination Angle
Adjustment
Aperture Selection Large /
Intermediate / Small
Aperture Lever
Selection (H)

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VANTAGE PLUS AND VANTAGE PLUS LED by KEELER
4.9 SELECTING FILTERS
By rotating the Lever (I), different filters may be selected.
Cobalt Blue filter
Used with fluorescein dye for the detection and
examination of corneal scars and abrasions.
White Circle
Clear light: select the clear with no filter when
inspecting a specific pathology and a brighter,
whiter light is desired.
Green filter
Red Free filter: this filter reduces the red light, so
blood will appear black,silhouted against a dark
background.
Diffuser
This extra wide beam of diffused light permits a
more relaxed technique during more challenging
fundus examinations.
5. WIRELESS CHARGERS
5.1 SET PLUG
Replace the Blanking Plate with the appropriate mains plug adaptor if required, or use IEC
60320 TYPE 7 connector (not supplied).
5.2 STANDARD LITHIUM-ION
Inserting / replacing the Battery Pack
1. Release battery by pressing release button and lift the Battery Pack from cradle.
2. To insert new Battery Pack, place in cradle until fully engaged.
Filter
Lever (I)
2
Press release button
1

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5.3 STANDARD SLIMLINE LITHIUM-ION
Inserting / replacing the Battery Pack
1. Release the battery by pressing release button and lift Battery Pack from cradle.
2. To insert new Battery Pack, place in the cradle until fully engaged.
5.4 CHARGING
1. Replace the Blanking Plate with the appropriate mains plug adapter, and connect the
plug on the cable to the power input socket on charger.
Switch on your Lithium Charger by plugging it into a mains outlet.
1 1
2 2
Connect to Charging
/ Docking Station
Power Supply
Remove the
blanking plate
Replace with
appropriate mains
plug adapter

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2. Place your spare Battery Pack or Headset into your Lithium Charger as shown.
Headband Battery Holder
Flashing LED – Battery requires charging.
Charging Station
No indicator – Battery is fully charged.
Flashing indicator – Top up Charge.
Solid indicator – Rapid Charge.
The Battery Pack can be used at any time during the charging cycle and will automatically
resume charging when Battery Pack is placed back in the Charger.
Direction arrow on Charger indicates which battery is being charged.
Spare Battery
Charging
/ Docking
Station
2Spare Battery
Press release
button and
push up
Charging
/ Docking
Station
Power
Supply
Inlet
2
Slimline Lithium Ion
Charging spare
battery
Charging battery
on headband
Charging spare
battery only
Charging battery
on headband
Standard Lithium

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5.5 CHARGING CYCLE
Slimline Lithium-Ion
The Battery attached to the Indirect will take approximately 2
hours to fully charge.
The Battery will last approximately 1 hour on full power. The
Spare Battery will take 2 hours to charge.
Standard Lithium-Ion
The Battery attached to the Indirect will take approximately 2
hours to fully charge.
The Battery will last approximately 2 hours on full power. The
Spare Battery will take 4 hours to charge.
5.6 WALL MOUNTING
Use template document provided to mark position of charger and drill holes.
1 2

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6. SMARTPACK AND WALLPACK
6.1 PARTS LIST
A Hex Key
B Screws
C Screws
D Wall Plugs
E Base Cap
F Wall Mount
G Adhesive Pads
H Rechargeable battery
Part No. EP39-22079
I Body
A
BC
D
F
E
H
I
I
G
3 4
Caution

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VANTAGE PLUS AND VANTAGE PLUS LED by KEELER
J Power Supply
K Australian Plug
L UK Plug
M Euro Plug
N USA Plug
6.2 POWER CONVERSION
Convert to either WallPack or SmartPack by following the illustration below.
6.3 FIXING THE WALL MOUNT
Use the wall plugs and screws to mount the WallPack unit, attach the adhesive pads to the
side of the case.
J
KL
NM
30mm
ø 6 x 50mm

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Connection
Insert the connectors into the sockets as shown. Before connecting
ensure that both the dimmer control and mains outlet are switched off.
Charge Time
Charge the battery for 12-14 hours before initial use. Note: The unit
becomes warm when charging, this is normal.
Recharging may take place while the Indirect is in use. Normal battery
life is 1.5 to 5 hours depending on setting with a recharge time of two
hours or on continuous trickle.
6.4 LED DISPLAYS
Power Supply Battery
Insert or remove the Indirect plug or switch the Indirect ON / OFF.
Power Supply Mains
• Switch the Indirect ON / OFF
• Insert or remove the mains plug
• Place on or off the cradle switch
• Green LED illuminates when Indirect is switched
on
Slow Pulse
Fast Pulse
LED On
LED Off
Charging
Trickle
Charging In Use
Battery
Low

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7. BULB / LED REPLACEMENT
Caution: Bulbs / LEDs can reach high temperatures in use – allow to cool
before handling.
Allow bulb / LED to cool and disconnect the instrument from the electrical supply. Remove the
bulb / LED from the back of the instrument and insert the new bulb / LED, ensuring that the
bulb / LED key is aligned with the aperture and securely pushed in.
Changing headband rheostat from Bulb to LED operation
Your Vantage Plus LED is already set to LED operation. If you want to change to Bulb operation,
please move the switch backwards as shown in diagram. To return to LED operation, please
move the switch forwards as shown in diagram.
LED Bulb
Bulb operation
Position – switch
pushed backwards
LED operation
Position – switch
pushed forwards

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8. FITTING YOUR HIMAG™LENS (M) AND TEACHING MIRROR (N)
To fit the HiMag™ lens simply push it onto the front of the window as shown in the diagram.
To remove simply reverse.
Rubber EyeCaps
Rubber eyecaps are provided to protect spectacles and have been manufactured in rubber to
avoid any abrasions. To use, simply fit over the eyecaps.
Plano Lenses
The Keeler Vantage Plus supplies as standard 2+ dioptre lenses.
Plano lenses, if preferred are available and can be fitted as
shown in fig.5.
Scleral Depressors
Scleral Depressors are avaiable to view the ora serrata.
9. SPECIFICATIONS AND ELECTRICAL RATINGS
The Keeler Vantage Plus and Vantage Plus LED are medical electrical instrument. The instrument
requires special care concerning electromagnetic compatibility (EMC). This section describes its
suitability in terms of electromagnetic compatibility of this instrument. When installing or using
this instrument, please read carefully and observe what is described here.
Portable or mobile-type radio frequency communication units may have an adverse effect on
this instrument, resulting in malfunctioning.
M
N