Keeler Loupe Frame User manual

A world without vision loss
Keeler Loupe
Frame
INSTRUCTIONS FOR USE

1 EN
KEELER LOUPE FRAME
CONTENTS
1. INDICATIONS FOR USE ........................................................................................ 2
1.1 WARNINGS AND CAUTIONS ..........................................................................................................2
1.2 CONTRAINDICATION.....................................................................................................................3
2. CLEANING AND DISINFECTION INSTRUCTIONS ................................................... 4
3. SETTING UP AND USING THE LOUPE FRAME........................................................ 4
4. TECHNICAL SPECIFICATIONS................................................................................ 6
5. SPARE PARTS AND ACCESSORIES ......................................................................... 6
6. WARRANTY .......................................................................................................... 6
7. PACKAGING AND DISPOSAL INFORMATION......................................................... 7

2
EN
KEELER LOUPE FRAME
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 Loupe Frame is 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.
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.
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.

3 EN
KEELER LOUPE FRAME
Observe the following precautions in order to ensure safe operation of the Loupe Frame.
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.
• 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).
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.

4
EN
KEELER LOUPE FRAME
2. CLEANING AND DISINFECTION INSTRUCTIONS
Only manual non-immersion cleaning as described should be used for this instrument. Do not
autoclave or immerse in cleaning fluids.
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.
3. SETTING UP AND USING THE LOUPE FRAME
1. Fit the Loupe unit to the frame 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

5 EN
KEELER LOUPE FRAME
3. The Prescription Lens Frame is fitted if required as shown.
4. To adjust the nose bridge, turn the
locking cam to a position as shown 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.
6. To securely fit the frame to the user’s head, slide the toggle indicated to a comfortable
position
Protective shield in correct position

6
EN
KEELER LOUPE FRAME
4. TECHNICAL SPECIFICATIONS
Environmental Conditions:
USE
35°C
10°C
90%
30%
1060 hPa
800 hPa
Shock (without packing) 10 g, duration 6 ms
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
5. SPARE PARTS AND ACCESSORIES
Item Part Number
Headband for surgical Loupes 2199-P-7259
Head strap 2199-P-7523
Hi-tech lens cloth in wallet 2199-P-7136
6. WARRANTY
No user serviceable parts – all preventative maintenance and servicing must only be performed
by authorised Keeler representatives.
Your Keeler product is guaranteed for 3 years and will be replaced, or repaired free of charge
subject to the following:

7 EN
KEELER LOUPE FRAME
• Any fault due to faulty manufacture.
• The instrument and accessories have been used in compliance with these instructions.
• Proof of purchase accompanies any claim.
7. 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]
EP59-19025 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