Instruction Manual for Keeler models including: EP59, Loupe Frame, EP59 Loupe Frame
5EN 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
Index of / manuals/Loupes/Loupe Frame (EP59-19025-art-C)
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Keeler Loupe Frame INSTRUCTIONS FOR USE A world without vision loss 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 1 EN KEELER LOUPE FRAME Consult instructions for use General warning sign Date of manufacture Manufacturer's name and address Country of manufacture Waste Electrical and Electronic Equipment (WEEE) recycling Conformité Européene Temperature limit Authorised representative in the European Community Catalogue number This way up Keep dry Fragile Do not use if package is damaged Batch code Atmospheric pressure limitation Humidity limitation 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. EN 2 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. 3 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. EN Protective shield in correct position 4 3. The Prescription Lens Frame is fitted if required as shown. KEELER LOUPE FRAME 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. Protective shield in correct 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 5 EN KEELER LOUPE FRAME 4. TECHNICAL SPECIFICATIONS Environmental Conditions: USE 90% 35°C 1060 hPa 10°C 30% Shock (without packing) STORAGE CONDITIONS 55°C 800 hPa 10 g, duration 6 ms 95% 1060 hPa -10°C 10% TRANSPORT CONDITIONS 70°C 700 hPa 95% 1060 hPa -40°C 10% Vibration, sinusoidal Shock Bump 500 hPa 10 Hz to 500 Hz: 0.5g 30 g, duration 6 ms 10 g, duration 6 ms 5. SPARE PARTS AND ACCESSORIES Item Headband for surgical Loupes Head strap Hi-tech lens cloth in wallet Part Number 2199-P-7259 2199-P-7523 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: EN 6 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 (+44 1691 676124). (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. 7 EN Contact Manufacturer Keeler Limited Clewer Hill Road Windsor Berkshire SL4 4AA UK Freephone 0800 521251 Tel +44 (0) 1753 857177 Fax+44 (0) 1753 827145 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. Plot No. A0147, Road No. 24 Wagle Industrial Estate Thane West 400604, Maharashtra INDIA Tel +91 22 4124 8001 China Office Halma China Group 1165 12323B 021-6151 9025 Visiometrics, S. L., Vinyals, 131 08221 Terrassa, Spain EP59-19025 Issue C Date of Issue 12/05/2021 A world without vision lossAdobe PDF Library 15.0 Adobe InDesign 16.2 (Windows)