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Summary of Contents for Keeler Jazz Ultra
- Page 1 Jazz Ultra Instruments INSTRUCTIONS FOR USE A world without vision loss...
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Page 3: Table Of Contents
Jazz Ultra Instruments by KEELER CONTENTS INDICATIONS FOR USE ..................3 SAFETY ......................... 3 PHOTOTOXICITY ..........................3 WARNINGS AND CAUTIONS ......................4 CONTRAINDICATION ........................5 CLEANING AND DISINFECTION INSTRUCTIONS ............ 6 STERILISATION ..........................6 BATTERY HANDLES AND START-UP ............... 6 PURPOSE ............................6 START UP AND INSERTION AND REMOVAL OF BATTERIES ..............7 TURNING ON AND OFF ........................7... - Page 4 Catalogue number Serial number Translation Medical device The Keeler Jazz Ultra Instruments are designed and built in conformity with Directive 93/42/EEC, Regulation (EU) 2017/745 and ISO 13485 Medical Devices Quality Management Systems. Classifi cation: CE: Class I FDA: Class II The information contained within this manual must not be reproduced in whole or part without the manufacturer’s...
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Page 5: Indications For Use
Intended use / purpose of instrument Keeler Jazz Ultra Otoscopes are indicated for the examination of the health of the external auditory canal, the tympanic membrane, and the middle ear. Otoscopy can aid in the detection of ear conditions, including but not limited to earache, ear infection, hearing loss, ringing in the ears, infl ammation, and foreign bodies. -
Page 6: 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. -
Page 7: Contraindication
Jazz Ultra Instruments by KEELER • The product and the ear specula are supplied non-sterile. Do not use on injured tissue. • Use new or sanitised specula to limit the risk of cross-contamination. • The disposal of used ear specula must occur in accordance with current medical practices or local regulations regarding the disposal of infectious, biological medical waste. -
Page 8: Cleaning And Disinfection Instructions
7. The useful life of the device is determined by the wear and damage during use. Disposable Specula – use once only and dispose of safely. 4. BATTERY HANDLES AND START-UP 4.1 PURPOSE Keeler battery handles are fi tted to the Keeler Jazz Ultra Ophthalmoscope and Jazz Ultra Otoscope. -
Page 9: Start Up And Insertion And Removal Of Batteries
Jazz Ultra Instruments by KEELER 4.2 START UP AND INSERTION AND REMOVAL OF BATTERIES Unscrew the Jazz Ultra instrument head from the handle in an anti-clockwise direction. Insert one commercial type ‘AA’ alkaline battery of 1.5V (IEC standard reference LR6) into the case of the handle with the plus pole towards the upper section of the handle. -
Page 10: Replacement Of Led - Otoscope
Jazz Ultra Instruments by KEELER 5.3 REPLACEMENT OF LED – OTOSCOPE Remove instrument head from battery handle. The LED is in the bottom section of the instrument head. Remove LED from instrument head by using your thumb and forefi nger or a suitable tool. -
Page 11: Replacement Of Led - Ophthalmoscope
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: •... -
Page 12: Specifications And Electrical Ratings
Guidance and manufacturer’s declaration – electromagnetic immunity The Jazz Ultra Otoscope / Ophthalmoscope is intended for use in the electromagnetic environment specified below. The customer or the user of the Jazz Ultra Otoscope / Ophthalmoscope should assure that it is used in such an environment. - Page 13 Jazz Ultra Instruments by KEELER Immunity test IEC 60601 Compliance Electromagnetic Test level level environment – guidance Surge. ± 1 kV line(s) to Not Applicable Mains power quality should be line(s) that of a typical professional IEC 61000-4-5 healthcare facility environment.
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Page 14: Recommended Safe Distances
To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Jazz Ultra Otoscope / Ophthalmoscope is used exceeds the applicable RF compliance level above, the Jazz Ultra Otoscope / Ophthalmoscope should be observed to verify normal operation. -
Page 15: Technical Specifications
Jazz Ultra Instruments by KEELER For transmitters rated at a maximum output power not listed above, the recommended separation distance in metres (m) can be determined using the equation applicable to the frequency of the transmitter, where p is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. -
Page 16: Accessories And Spares
Jazz Ultra Instruments by KEELER TRANSPORT CONDITIONS 1060 hPa °C °C 500 hPa Vibration, sinusoidal 10 Hz to 500 Hz: 0.5g Shock 30 g, duration 6 ms Bump 10 g, duration 6 ms 11. ACCESSORIES AND SPARES Item Part Number Specula –... - Page 17 Jazz Ultra Instruments by KEELER...
- Page 20 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 China Office Keeler USA Halma China Group 3222 Phoenixville Pike 名称：沃迈（上海）机电有限公司 Building #50 地址：上海市闵行区金都路1165弄...
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