Keeler LOUPES Instructions For Use Manual Download Page 5

 3

EN

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 fi tted 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 

fi tted.

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 fl uids.

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 

b10°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.

Summary of Contents for LOUPES

Page 1: ...A world without vision loss Keeler Loupes Magnification Systems INSTRUCTIONS FOR USE...

Page 2: ......

Page 3: ...UST 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 PROTECTI...

Page 4: ...eeler 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 in...

Page 5: ...re 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 Keele...

Page 6: ...r 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...

Page 7: ...and 1D caps should not be re used if visibly contaminated with uids or blood 6 Manually clean all surfaces of the units using a suitable brush and de ionised water detergent solution 2 detergent by v...

Page 8: ...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 circul...

Page 9: ...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 circumstan...

Page 10: ...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...

Page 11: ...d on a specially designed hinge permitting the telescopes to be ipped up out of view when not required Fig 10 To avoid touching the non sterile Loupes a sterilisable Loupe Flip Lever is provided with...

Page 12: ...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 repa...

Page 13: ...ps 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...

Page 14: ...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...

Page 15: ...act 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 inf...

Page 16: ...2021 USA Sales Office Keeler USA 3222 Phoenixville Pike Building 50 Malvern PA 19355 USA Toll Free 1 800 523 5620 Tel 1 610 353 4350 Fax 1 610 353 7814 India Office Keeler India Halma India Pvt Ltd P...

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