Keeler All Pupil 2 User manual

All Pupil II
Indirect Ophthalmoscope
INSTRUCTIONS FOR USE
A world without vision loss

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ALL PUPIL II 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 DESCRIPTION OF THE PRODUCT....................................................................................................7
4.2 HEADBAND ADJUSTMENT .............................................................................................................8
5. WIRELESS CHARGERS ........................................................................................ 10
5.1 POWER SUPPLY ASSEMBLY ..........................................................................................................10
5.2 STANDARD LITHIUM-ION.............................................................................................................10
5.3 STANDARD SLIMLINE LITHIUM-ION .............................................................................................11
5.4 CHARGING..................................................................................................................................11
5.5 CHARGING CYCLE.......................................................................................................................13
6. WIRELESS CHARGERS – WALL MOUNTING.........................................................13
7. SMARTPACK AND WALLPACK ............................................................................. 14
7.1 PARTS LIST ..................................................................................................................................14
7.2 POWER CONVERSION .................................................................................................................15
7.3 FIXING THE WALL MOUNT...........................................................................................................15
8. BULB / LED REPLACEMENT................................................................................. 17
8.1 ALL PUPIL II LED..........................................................................................................................17
9. TEACHING MIRROR ............................................................................................ 18
9.1 EYEPIECE CAPS...........................................................................................................................18
9.2 PLANO LENSES............................................................................................................................19
10. SPECIFICATIONS AND ELECTRICAL RATINGS...................................................... 19
10.1 ELECTROMAGNETIC EMISSIONS..................................................................................................19
10.2 ELECTROMAGNETIC IMMUNITY ..................................................................................................19
10.3 RECOMMENDED SAFE DISTANCES ..............................................................................................21
10.4 TECHNICAL SPECIFICATIONS.......................................................................................................22
11. ACCESSORIES AND SPARES................................................................................ 23
12. WARRANTY ........................................................................................................ 24
13. PACKAGING AND DISPOSAL INFORMATION....................................................... 24

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ALL PUPIL II 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 All Pupil II 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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ALL PUPIL II by KEELER
1. INDICATIONS FOR USE
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 35 minutes.
Testing was completed with a 20D, 55mm diameter Volk lens.
While no acute optical radiation hazards have been identified for Indirect
Ophthalmoscopes, 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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ALL PUPIL II 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.
• After removal of the bulb / LED do not touch the bulb / LED contacts and the
patient simultaneously.
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.

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ALL PUPIL II by KEELER
• Use only genuine Keeler approved parts and accessories or device safety and performance
may be compromised.
• 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 contraindications 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 the BIO when using a head mount.

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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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ALL PUPIL II by KEELER
4. SETTING UP AND USING THE VANTAGE PLUS
4.1 DESCRIPTION OF THE PRODUCT
C
D
E
G
H
I
C
A
B
F
J
K
L
M
F
A Headband Size Adjuster
B Headband Height Adjuster
C Cushioned Padded Liners
D Aperture Control Lever
E Headband Dimmer Switch
F Brow Bar Adjuster
G Front Window
H Binocular Block
I Brow Bar
J Interpupillary Distance Setting Control
K Mirror Angle Control
L Optics Hinge Adjuster
M Filter Selector Bar

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ALL PUPIL II by KEELER
4.2 HEADBAND ADJUSTMENT
Comfortable Fit
Adjust the Height and Size Adjusters (A and B) so that the Indirect is supported comfortably, as
shown in figs 1 and 2.
Ophthalmoscope Angle Alignment
Position the Brow Bar (I) such that the Binocular Block (H) is set on the optical axis.
The Brow Bar (I) may be correctly positioned by loosening the Brow Bar Adjusters (F). When in
the correct position secure by tightening (F) as shown in fig 3.
Position the All Pupil II as close to the eyes as possible for maximum field as shown in fig 4. by
using the Optics Hinge Adjuster (L).
Interpupillary Distance Setting Control (J)
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 Control Lever (D) 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 Interpupillary Distance Setting Control (J) 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.

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ALL PUPIL II by KEELER
Obtaining a fused image
Ensure that a singular, fused image is obtained as follows:
Mirror Angle Control (K)
The light is positioned vertically into
the upper two thirds of the field of
view by rotating the spindle (K) located
on either side of the Binocular Block.
Headband Dimmer Switch (E)
Turn the illumination on by rotating the headband
dimmer switch (E) in a clockwise direction.
Aperture Control Lever (D)
The Aperture Control Lever (D) changes the aperture size to view through large, medium and
small pupils.
Select either the large, intermediate, or small aperture by adjusting lever from left to right
-small -intermediate -large.
Large
The large, round homogenous patch is suitable
for routine examinations through fully dilated
pupils.
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.
Small
This light patch is ideal for small, undilated
pupils.
√
Fused image Overlapping imagesSeparate images

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ALL PUPIL II by KEELER
Filter Selector Bar (M)
The All Pupil II has three selectable filters built into the head unit. Select the appropriate filter
by sliding the Filter Selector Bar (M) either left or right from its mid position, using the marked
dots to indicate in which direction to slide for each filter.
Red-free filter
To increase contrast for assessment of changes
in fine vessels, i.e. retinal haemorrhages.
Cobalt Blue filter
Used with fluorescein dye for the detection and
examination of corneal scars and abrasions.
Diffuser
This extra wide beam of diffused light permits
a more relaxed technique during more
challenging fundus examinations.
The instrument provides protection from UV / IR.
5. WIRELESS CHARGERS
5.1 POWER SUPPLY ASSEMBLY
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.
2
Press release button
1

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ALL PUPIL II by KEELER
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 Bblanking Plate with the appropriate mains plug adapter and connect the
plug on cable to 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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ALL PUPIL II by KEELER
2. Place your spare Battery Pack or Headset into your Lithium Charger.
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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ALL PUPIL II by KEELER
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.
6. WIRELESS CHARGERS – WALL MOUNTING
Use template document provided to mark position of charger and drill holes.
1 2

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ALL PUPIL II by KEELER
7. SMARTPACK AND WALLPACK
7.1 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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ALL PUPIL II by KEELER
J Power Supply
K Australian Plug
L UK Plug
M Euro Plug
N USA Plug
7.2 POWER CONVERSION
Convert to either WallPack or SmartPack by following the illustration below.
7.3 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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ALL PUPIL II by KEELER
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.
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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ALL PUPIL II by KEELER
8. BULB / LED REPLACEMENT
Caution: Bulbs / LEDs can reach high temperatures in use – allow to cool
before handling.
Disconnect the instrument from the electrical supply. Remove the bulb / LED from the back of
the instrument and insert the replacement, ensuring that the bulb / LED key is aligned with the
aperture and securely pushed in.
8.1 ALL PUPIL II LED
All PupiI II bulbs can be replaced with an LED light source if required. Follow fitting instructions
as for bulbs.

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9. TEACHING MIRROR
1. Remove the screws from the panel
beneath the front window with the
screwdriver supplied.
2. Fit the mounting bar with the pin pointing
to the right and secure with the screws
removed in step (1). Slide the Teaching
Mirror onto the pin on the mounting bar.
The Teaching Mirror can now be swivelled
up and down.
To remove, slide the Teaching Mirror to the right of the pin and return to its case leaving
mounting bar in position.
To make the Teaching Mirror non-removable for security purposes proceed as follows:
3. Remove the screws as in step (1). Position the mounting bar and replace the screw on
left side only. Fit the Teaching Mirror as in step (2).
4. Fold the Teaching Mirror down and slide it to the right to reveal fixing hole. Then secure
the mounting bar with the special washer and pan head screw provided.
5. Return the Teaching Mirror to its central position.
The Teaching Mirror can now be demounted only by removing the screw. Retain the
screwdriver for future use.
9.1 EYEPIECE CAPS
Eyepiece Caps are provided to protect spectacles and have rubber surrounds to prevent
scratching.To use, simply fit over the eyepieces. Replacements are available from the distributor.