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Summary of Contents for Keeler Spectra Iris
- Page 1 Spectra Iris Indirect Ophthalmoscope INSTRUCTIONS FOR USE A world without vision loss...
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Page 3: Table Of Contents
PHOTOTOXICITY ..........................3 WARNINGS AND CAUTIONS ......................3 CONTRAINDICATION ........................5 CLEANING AND DISINFECTION INSTRUCTIONS ........... 5 SETTING UP AND USING THE SPECTRA IRIS ............6 FRAME (A), NOSE BRIDGE (B) ......................6 APERTURE LEVER (C) ........................7 FILTER SELECTION CONTROL (D) ....................7 MIRROR ANGLE CONTROL (E)......................8 INTERPUPILLARY DISTANCE SETTING CONTROL (F) ................8... - Page 4 Use-by date Serial number Catalogue number Medical device Translation The Keeler Spectra Iris is 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 The Spectra Iris is indicated for examining the fundus; specifi cally the posterior segment where a wider fi eld of view is needed in order to aid in the screening and diagnosis of retinal... - Page 6 Do not use if the product if visibly damaged and periodically inspect it for signs of damage or misuse. • Check your Keeler product for signs of transport / storage damage prior to use. • Do not use in the presence of fl ammable gases / liquids, or in an oxygen rich environment.
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Page 7: Contraindication
SPECTRA IRIS by KEELER • For indoor use only (protect from moisture). • When replacing lithium battery pack, turn Spectra Iris off and attach new pack. • Remove battery pack when device may not be used for prolonged periods. •... -
Page 8: Setting Up And Using The Spectra Iris
3. Surfaces must be carefully hand-dried using a clean non-shedding cloth. 4. Safely dispose of used cleaning materials. 4. SETTING UP AND USING THE SPECTRA IRIS 4.1 FRAME (A), NOSE BRIDGE (B) 1. The nose bridge is fitted by sliding into 2. -
Page 9: Aperture Lever (C)
SPECTRA IRIS by KEELER 5. Fit the Spectra Iris head unit into the 6. Once the desired position has frame (A) via the pin mounting system. been confi rmed this can be locked more securely in position by gently tightening the screws circled. -
Page 10: Mirror Angle Control (E)
SPECTRA IRIS by KEELER 4.4 MIRROR ANGLE CONTROL (E) The light is positioned vertically into the field of view by rotation of the levers (E) located either side of the binocular block. 4.5 INTERPUPILLARY DISTANCE SETTING CONTROL (F) Place an object approximately 40cm from the face and centre it horizontally in the light patch. -
Page 11: Charging Time
SPECTRA IRIS by KEELER Charging the battery pack Green LED Charging storage unit powered No LED light Battery charged Flashing yellow LED Top-up charge Solid yellow LED Rapid charge The battery pack can be used at any time during the charging cycle and will resume charging when battery pack is placed back in the charger. -
Page 12: Specifications And Electrical Ratings
SPECTRA IRIS by KEELER 7. SPECIFICATIONS AND ELECTRICAL RATINGS The Keeler Spectra Iris is a medical electrical instrument. The instrument requires special care concerning electromagnetic compatibility (EMC). This Section describes its suitability in terms of electromagnetic compatibility of this instrument. When installing or using this instrument, please read carefully and observe what is described here. - Page 13 Test level level – guidance Charger only Portable and mobile RF communications equipment should be used no closer to any part of the Keeler Conducted 3 Vrms Spectra Iris, including cables, than the recommended RF IEC 150 kHz to...
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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 Keeler Spectra Iris is used exceeds the applicable RF compliance level above, the Keeler Spectra Iris should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orientating or relocating the Keeler Spectra Iris. -
Page 15: Technical Specifications
SPECTRA IRIS by KEELER For transmitters rated at a maximum output power not listed above, the recommended separation distance d 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: Spare Parts And Accessories
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 17: Packaging And Disposal Information
SPECTRA IRIS by KEELER 10. 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. - Page 18 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 Building #50 限公司...
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