Keeler LOUPES User manual

A world without vision loss
Keeler Loupes
Magnification Systems
INSTRUCTIONS FOR USE

1 EN
KEELER LOUPES
CONTENTS
1. INDICATIONS FOR USE ........................................................................................ 3
1.1 WARNINGS AND CAUTIONS ..........................................................................................................3
1.2 CONTRAINDICATION.....................................................................................................................4
2. CLEANING AND STERILISATION INSTRUCTIONS .................................................. 5
3. YOUR LOUPE SPECIFICATION ............................................................................... 6
4. SETTING UP AND USING YOUR LOUPES ............................................................... 6
4.1 HOW TO ADJUST LOUPES FITTED TO A HEADBAND ........................................................................8
4.2 HOW TO FIT AND REMOVE LOUPES FROM A FRAME OR HEADBAND .............................................8
4.3 HOW TO FIT THE LOUPE ‘FLIP UP’ LEVER........................................................................................9
4.4 THE LOUPE HEAD STRAP.............................................................................................................10
4.5 FRAME ADJUSTMENTS ................................................................................................................10
4.6 PROTECTIVE AND +1D CAPS .......................................................................................................10
5. WARRANTY ........................................................................................................ 10
6. ENVIRONMENTAL CONDITIONS: ........................................................................ 10
7. ACCESSORIES AND SPARES................................................................................ 11
8. OPTICIAN GUIDANCE NOTES.............................................................................. 11
8.1 PRESCRIPTION FITTING ...............................................................................................................12
8.2 CORRECT FITTING OF KEELER LOUPES.........................................................................................12
9. PACKAGING AND DISPOSAL INFORMATION....................................................... 13

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KEELER LOUPES
Consult instructions for use General warning sign
Date of manufacture Conformité Européene
Manufacturer’s name and
address Temperature limit
Country of manufacture Authorised representative in
the European Community
Waste Electrical and Electronic
Equipment (WEEE) recycling Catalogue number
This way up Batch code
Keep dry Atmospheric pressure
limitation
Fragile Humidity limitation
Do not use if package is
damaged Translation
The Keeler Loupes 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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KEELER LOUPES
1. INDICATIONS FOR USE
Intended use / purpose of instrument
The Keeler Loupes and Frames are intended for use in various clinical settings including but
not limited to users in dental practices, ophthalmology clinics, operating theatres, hospitals,
veterinary practices, private consulting rooms and surgical environments and used by trained
students and experienced professionals.
It is important that if you normally wear spectacles, your prescription is fitted into the Loupe
frames. Guidance notes for your optician are included, see Optician guidance notes, page 11.
Please take these notes with you to your optician should you require prescription lenses to be
fitted.
1.1 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.
Observe the following precautions in order to ensure safe operation of the Loupes.
WARNINGS
• 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 .
• Check your Keeler product for signs of transport / storage damage prior to use.
• Do not use if the product if visibly damaged and periodically inspect it for signs of damage
or misuse.
• 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 fluids.
CAUTION
• Use only genuine Keeler approved parts and accessories or device safety and performance
may be compromised.
• 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).
• There are no user serviceable parts inside. Contact authorised service representative for
further information.

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KEELER LOUPES
• Failure to carry out recommended routine maintenance as per the instructions in this IFU
may reduce the operational lifetime of the product.
• At product end of life dispose of in accordance with local environmental guidelines
(WEEE).
• Correctly fitted Loupe can help reduce back and neck pain. Spend a few moments ensuring
your Loupes are at the optimal angle to suit you.
1.2 CONTRAINDICATION
There is no restriction to patient population this device can be used with other than those
outlined in the contraindications stated below.
The Keeler Loupe and Frame restrict the user’s field and depth of view, forcing them to adopt
awkward head-neck postures in order to see clearly.
Fit the Loupe unit
to the frame via
the pin mounting
system as shown
A Nose Pads
B Telescope Locking Knobs
C Telescope
D PD Bar
E Hinge
F Hinge Pins
G Hinge Tightening Screws
A
B
C
D
E
F
G

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KEELER LOUPES
2. CLEANING AND STERILISATION INSTRUCTIONS
Under no circumstances should the telescopes be autoclaved or immersed
in any form of cleaning fluid.
Only non-immersion cleaning as described below should be used for Keeler Loupes.
1. Wipe the external surface with a clean absorbent, non-shedding cloth dampened with
a 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.
5. The optical surfaces of the Loupes are treated with an anti-reflective coating and should
only be cleaned with the lens cloth provided.
The cleaning and sterilisation of the Loupe Flip Lever, protective and 1D caps, can be
accomplished as follows:
Re-useable flip lever, protective and 1D caps should not be re-used if
visibly contaminated with fluids or blood.
6. 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. The
glass lens may need to be carefully removed from the silicone rubber holder to achieve
cleaning. Solution can be heated to no more than 35°C.
7. Carefully examine to ensure that all visible contamination has been removed.
8. Safely dispose of used cleaning materials.
9. Sterilize using a validated steam sterilizer complying with BS 3970 or equivalent
standard. Operating cycle conditions 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.
For more extensive cleaning, service or repair, the Loupes may be returned to your authorised
Keeler distributor or to Keeler directly.

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KEELER LOUPES
3. YOUR LOUPE SPECIFICATION
When you receive your new Keeler Surgical Loupes please check that the contents are as
ordered:
• The magnification and working distance of the Loupes is marked on the Loupe bar (e.g.
3.5x 42cm /16”).
• The frame size is marked on the inside of the frame arm.
• As well as a pair of Loupes and a Frame, a full loupe outfit will comprise of the following
additional components:
• Loupe Flip Lever, Head Strap
• Lens cloth
• Case
4. SETTING UP AND USING YOUR LOUPES
The aim in using Keeler Surgical Loupes is to achieve a clear, circular, binocular view (Fig. 1) at
your chosen magnification and working distance without any shadows or double images.
To achieve the best from your Keeler Loupes, they must be correctly aligned both horizontally
and vertically with your visual axis (Figs. 2 and 3).
To obtain this, your Loupes may require some minor adjustments.The most common are:
Fig.1
Fig.2 Fig.3

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KEELER LOUPES
Adjustment Method
Vertical alignment (height)
(Fig 4 & 5)
= Pinch or open frame pads
Fig.4 Fig.5
Horizontal alignment (PD)
Fig.6
= Slightly loosen locking knobs
(interpupillary distance) and slide
telescope along bar (Fig. 6)
Look through your Loupes at a target that is the correct working distance away. Look through
first with one eye closed and adjust the alignment until a perfect image appears. Repeat this
with the other eye. Alternate closing the left and right eye to check binocularity and make
fine adjustments. Once you are satisfied that you have the best possible image, tighten the
telescope locking knobs.
Important: All Keeler Surgical Loupes are accurately aligned and set for precise binocular
vision. Under no circumstances should adjustment be made by rotating or holding the
telescopes, as this may cause the telescopes to misalign and create double vision.
The corrective actions outlined below should be followed for poorly aligned Loupes.
Image
Quality
Telescope
Position
Action
Too high Open frame pads
Too low Pinch frame pads
Too far left Slide telescope to the right in
the direction of the shadow
Too far
right
Slide telescope to the left In
the direction of the shadow
Adjust the angle and height of your Loupes by adjusting the hinge (Fig. 7).
Fig.7

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KEELER LOUPES
4.1 HOW TO ADJUST LOUPES FITTED TO A HEADBAND
If you have ordered your Keeler Loupes for fitting to a Headband, the following notes will help
you to set up the Loupes correctly.
• Put the Headband on and position centrally
on your head with the padded band just
above your eyebrows, adjusting both top and
back bands for security and comfort.
• Position the telescopes in approximately the
correct position in front of your eyes. Slightly
loosen both adjustment knobs so that the
telescopes can be moved easily. Vertically
align each telescope. (Fig. 8).
• Align each telescope as outlined earlier by
sliding along the bar. (Fig. 6)
Note: If you are using your Loupes in conjunction
with a fiber-optic headlamp, first adjust the
Loupes as described above. The light may then be
adjusted to illuminate the specific area you are
viewing through your Loupes.
4.2 HOW TO FIT AND REMOVE LOUPES FROM A FRAME OR HEADBAND
Keeler Loupes allow you to easily fit or remove them from a Frame or Headband. This allows
you to switch between Loupes of different magnifications without having to purchase an
additional Frame.
• To fit Keeler Loupes to the hinge, hold the Loupe PD bar and push the Loupes onto the
hinge pins through the holes on the PD bar. To remove, hold the Loupe PD bar and hinge
and wriggle the Loupes away from the pins. (Fig. 9)
Fig.9
Fit the Loupe unit to the
frame via the pin mounting
system as shown
Fig.8

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KEELER LOUPES
UNDER NO CIRCUMSTANCES SHOULD THIS BE DONE BY HOLDING THE
TELESCOPES.
• If your Loupe Frames are fitted with prescription lenses, you may find it necessary to
position your Loupes on the front stop of the Loupe pins to prevent the telescope from
touching the lenses, particularly when the curvature of high-powered lenses prevent the
Loupes from being angled fully downward.
4.3 HOW TO FIT THE LOUPE ‘FLIP UP’ LEVER
Keeler Surgical Loupes are mounted on a specially designed hinge, permitting the telescopes to
be flipped up out of view when not required (Fig. 10).
To avoid touching the non-sterile Loupes, a sterilisable Loupe Flip Lever is provided with each
pair of Loupes (spares are also available). When magnification is required again, the Loupes
may be returned to their original preset working angle. The Loupe Flip Lever is fitted by pushing
onto the Loupe bar (Fig. 11) and removed by twisting off.
Over a period of time the hinge tension may slacken slightly and require adjustment. Using
a small crosshead or Phillips screwdriver, adjust the hinge screw to the required tension as
shown (Fig. 12).
Fig.10
Fig.11
Fig.12

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KEELER LOUPES
4.4 THE LOUPE HEAD STRAP
Keeler Surgical Loupes are supplied with the Head Strap already fitted (spares are available).
The use of the Head Strap is strongly recommended for added security and to ensure that the
Loupes are close to your eyes for the widest field of view. Simply fit the Head Strap over the
ends of the Loupe side arms. When wearing the Loupes use the toggle to tighten the strap.
4.5 FRAME ADJUSTMENTS
The length of the Loupe side arms may be altered by bending the end section to provide a
comfortable fit. A qualified optician should do any other adjustments required to the Frame.
4.6 PROTECTIVE AND +1D CAPS
All Keeler Loupes are supplied with protective caps.These are designed to be a push fit. We
recommend these be worn at all times to help protect the lenses.
+1D lens caps can be ordered separately. They reduce the working distance and are useful if
you need to work in two different positions. They are also a push fit.
5. WARRANTY
Your Keeler product is guaranteed for 3 years and will be replaced, or repaired free of charge
subject to the following:
• Any fault due to faulty manufacture.
• The instrument and accessories have been used in compliance with these instructions.
• Proof of purchase accompanies any claim.
The manufacturer declines any and all responsibility and warranty
coverage should the instrument be tampered with in any manner or
should routine maintenance be omitted or performed in manners not in
accordance with these manufacturer’s instructions.
There are no user serviceable parts in this instrument. Any servicing or
repairs should only be carried out by Keeler Ltd. or by suitably trained and
authorised distributors. Service manuals will be available to authorised
Keeler service centres and Keeler trained service personnel.
6. ENVIRONMENTAL CONDITIONS:
USE
35°C
10°C
90%
30%
1060 hPa
800 hPa
Shock (without packing) 10 g, duration 6 ms

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KEELER LOUPES
USE
STORAGE CONDITIONS
55°C
-10°C
95%
10%
1060 hPa
700 hPa
TRANSPORT CONDITIONS
70°C
-40°C
95%
10%
1060 hPa
500 hPa
Vibration, sinusoidal 10 Hz to 500 Hz: 0.5g
Shock 30 g, duration 6 ms
Bump 10 g, duration 6 ms
7. ACCESSORIES AND SPARES
Item Part Number
+1D lens cap for Galilean Loupes (pair) 2112-P-8057
Protective caps for Galilean Loupes (pair) 2112-P-8049
+1D lens cap for Hi Res Galilean Loupes (pair) 2112-P-8073
Protective caps for Hi Res Galilean Loupes (pair) 2112-P-8065
+1D lens cap for Panoramic Loupes (pair) 2113-P-7001
Protective caps for Panoramic Loupes (pair) 2113-P-7000
Loupe Flip Lever (pack of 7) 2199-P-7216
8. OPTICIAN GUIDANCE NOTES
The set of Keeler Surgical Loupes have been supplied to your customer with Plano lenses fitted.
We hope that the following notes on lens fitting and frame adjustments will help you, help
your customer obtain the best from their Loupes.
There are two types of binocular telescopes used in Keeler Loupes:
• Galilean based on a Galilean optical system.
• Panoramic based on a Keplerian telescope system incorporating a roof prism.

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KEELER LOUPES
8.1 PRESCRIPTION FITTING
First establish the following facts:
1. The type of Loupe (i.e., Galilean, or Panoramic).
2. The magnification.
3. The working distance or focal length (noted on the loupes).
4. Your customers interpupillary distance, taking the working distance / focal length of the
Loupe into consideration.
It is important to fit the frame as close as possible to the eyes so that your customer can obtain
the widest field of view.
Any distance prescription should be fitted with centers to coincide with the Loupe IPD setting.
If fitting bifocals, care should be taken to fit the bifocal segment either below or above the
rim of the telescope (Fig.12, page 9) never in between. If the near vision ADD is more
than +2D the bifocal segment should be fitted below the lower rim of the telescopes to avoid
shortening the focal length of the telescopes and causing double vision.
Note: Varifocals are not suitable for fitting to Keeler Loupes.
In most cases the Bifocal ADD should be the same as the normal prescription. However, some
surgeons prefer the ADD to be of a power that produces a working distance similar to that of
the Loupe telescopes. This avoids constant accommodation as they alternatively look through
the Loupe and alongside for orientation. Others prefer a weaker ADD for easier focusing onto
surgical instruments outside the operative area. Discuss this matter with your customer to
ascertain which option is best suited to their needs.
Note: All lenses should be plastic.
Once your customers Loupes have been glazed, it may be necessary to place the Loupes on the
front stop of the Loupe pins to prevent the telescopes from touching the lenses, particularly
where the curvature of high-powered lenses prevent the Loupes from being angled fully
downwards.
8.2 CORRECT FITTING OF KEELER LOUPES
When you have glazed your customers correction into the Loupe Frame, we would be grateful
if you could offer further assistance to help them ‘set up’ the Loupes correctly so that they
can obtain the best from them. Full fitting instructions are given on Setting up and using your
Loupes, page 6.

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KEELER LOUPES
9. PACKAGING AND DISPOSAL INFORMATION
Disposal of old electrical and electronic equipment
This symbol on the product or on its packaging and instructions indicates
that this product shall not be treated as household waste.
To reduce the environmental impact of WEEE (Waste Electrical Electronic
Equipment) and minimise the volume of WEEE entering landfills we
encourage at product end of life that this equipment is recycled and reused.
If you need more information on the collection reuse and recycling then please
contact B2B Compliance on 01691 676124 ([phone]). (UK only).
Any serious incident that has occurred in relation to the device must be reported to
the manufacturer and the competent authority of your Member State.

A world without vision loss
Contact
Manufacturer
Keeler Limited
Clewer Hill Road
Windsor
Berkshire
SL4 4AA UK
Freephone 0800 521251
Tel [phone]
Fax[phone]
EP59-33759 Issue C Date of Issue 12/05/2021
USA Sales Office
Keeler USA
3222 Phoenixville Pike
Building #50
Malvern, PA 19355 USA
Toll Free 1 800 523 5620
Tel [phone]
Fax [phone]
India Office
Keeler India
Halma India Pvt. Ltd.
Plot No. A0147, Road No. 24
Wagle Industrial Estate
Thane West – 400604,
Maharashtra
INDIA
Tel [phone]
China Office
Halma China Group
名称：沃迈（上海）机电有
限公司
地址：上海市闵行区金都路
1165弄123号23幢一号厂房
三层B座
电话：[phone]
Visiometrics, S. L., Vinyals, 131
08221 Terrassa, Spain