Related Manuals for Keeler Spectra Iris
Summary of Contents for Keeler Spectra Iris
- Page 1 Spectra Iris Spectra Iris Indirect Ophthalmoscope Indirect Ophthalmoscope Instructions for use Instructions for use Next Next Next...
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Page 2: Table Of Contents
Contents Page Page 1. Copyright and trademarks ........... 3 6. Chargers, battery packs and power supply 14 • Power supply assembly 2. Introduction ................4 • Charging the battery pack ........... 15 3. Symbols .................. 5 • Charge time / belt clip ..........16 4. Safety ..................6 7. Cleaning instructions ............17 • Device classification 8. Specifications and electrical ratings ........18 • Warnings • Electrical specifications • Cautions . -
Page 3: Copyright And Trademarks
1. Copyright and trademarks The information contained within this manual must not be reproduced in whole or in part without the manufacturer’s prior written approval. As part of our policy for continued product development we reserve the right to make changes to specifications and other information contained in this document without prior notice. Spectra Iris is a registered trademark of Keeler Ltd 2012. Copyright © Keeler Limited 2012. Published in the UK 2012. Home Back Next... -
Page 4: Introduction
2. Introduction 2. Introduction Thank you for purchasing the Keeler Spectra Iris Indirect Thank you for purchasing the Keeler Spectra Iris Indirect Ophthalmoscope. We have taken the greatest care in the design, We have taken the greatest care in the design, development and manufacture of development and manufacture of this product to ensure that you get this product to ensure that you get many years of trouble free service. many years of trouble free service. However, it is important that you read However, it is important that you read the descriptions, installation and operating the descriptions, installation and operating instructions carefully prior to installing or instructions carefully prior to installing or using your new indirect ophthalmoscope. using your new indirect ophthalmoscope. Please read and follow these instructions carefully. Home Back Next... -
Page 5: Symbols
3. Symbols Read user instructions for warnings, cautions and Follow instructions for use additional information High voltage The CE mark on this product indicates it has been tested to and conforms with the provisions noted Trip hazard within the 93/42/EEC Medical Device Directive Optical radiation hazard Consult instructions for use Hot surface Double insulated Non-ionizing radiation Manufacturer's name and address This way up This Symbol on the product or on its packaging and instructions indicates that it was put on the Keep dry Keep dry market place after August 2005 and that this product shall not be treated as Household Waste Fragile Type B protections against shock Material suitable Material suitable for recycling for recycling Home Back Next Mandatory action sign... -
Page 6: Safety
Carefully read this Instruction Section before using your Keeler area with soap and water. If it contacts the eye, seek medical product. For your own safety and that of your customers attention immediately observe all cautionary information provided in this section. The • US Federal law restricts this device to sale by or order of a following information is intended to highlight potential safety physician or practitioner hazards that can be associated with misuse, or damage. Do not fit mains power adapter into a damaged mains Warnings and cautions outlet socket Route power cords safely to eliminate risk of tripping or Warning damage to equipment • Check your Keeler product for signs of transport / storage damage prior to use Bulbs / LED’s can reach high temperatures in use – allow to cool before handling • Do not use if the product is visibly damaged, and periodically inspect for signs of damage Do not exceed maximum recommended exposure time • Do not use in the presence of flammable gases / liquids, or in After removal of the bulb / LED do not touch the bulb / an oxygen rich environment LED contacts and the patient simultaneously • This product should not be immersed in fluids Home Back Next • Do not disassemble or modify the battery. There are no... -
Page 7: Cautions
4. Safety Caution • Use only genuine Keeler approved parts and accessories or • Ensure battery orientation is correct, or personal injury / device safety and performance may be compromised damage to equipment may occur • Use only Keeler approved batteries, chargers and power • Care should be taken when handling halogen bulbs. Halogen supplies as per the accessories listed in section 10 bulbs can shatter if scratched or damaged • The product has been designed to function safely when at an • Ensure device is securely held in docking station to minimise ambient temperature between +10°C and +35°C risk of injury or damage to equipment • Keep out of the reach of children • Follow guidance on cleaning / routine maintenance to prevent personal injury / damage to equipment • To prevent condensation from forming, allow instrument to come to room temperature before use Switch off the electrical supply and disconnect from the mains electrical supply before cleaning and inspection • For indoor use only (protect from moisture) • Dispose of batteries in line with local environmental • When replacing lithium battery pack, turn indirect off and regulations attach new pack • At product end of life dispose of in accordance with local • Remove batteries when device may not be used for prolonged... -
Page 8: Safety Considerations
4. Safety Safety considerations It is well established that exposure of the eye to intense light While no visible retinal lesions have been identified for sources for extended periods of time poses a risk of retinal ophthalmic instruments, it is recommended that illumination photic injury. Many ophthalmic instruments illuminate the eye levels be set to the minimum level necessary to perform the with intense light. The decision about the intensity of the light diagnostic function. Young children and persons with diseased level to use in any procedure must be made on a case to case eyes may be at a higher risk. The risk may also be increased if basis. In each case, the clinician must take a risk benefit the person being examined has had any exposure with the same judgement about the intensity of light to be used. Use of instrument or any other ophthalmic instrument using an intense insufficient intensity may result in inadequate visualization and visible light source during the previous 24 hours. This will apply in adverse effects more serious than retinal photic damage. particularly if the eye has been exposed to retinal photography. Further, despite all efforts taken to minimise the risk of retinal damage, damage may still occur. Retinal photic injury is a The light emitted from this instrument is potentially hazardous. possible complication of the need to use bright light clearly The longer the duration of exposure, the greater the risk of ocular damage. Exposure to light from this instrument when visualize ocular structure during delicate ophthalmic surgical procedure. operated at maximum intensity will exceed the safety guidelines after 27 minutes. Home Back Next... -
Page 9: Setting Up And Using The Spectra Iris
5. Setting up and using the Spectra Iris Description of the Product A Frame B Hinge C Aperture Lever D Filter Selector E Mirror Angle F Interpupillary Distance Control G Mounting Holes Home Back Next... -
Page 10: Fitting The Spectra Iris To The Frame
5. Setting up and using the Spectra Iris Frame (A) 2. The prescription lens frame (if required) 1. Fit the Spectra Iris head unit into the frame (A) is fitted as shown. via the pin mounting system as shown. Prescription lens frame in correct position Home Back Next... -
Page 11: Frame Adjustments
5. Setting up and using the Spectra Iris Frame (A) 4. As the nose bridge slides 5. Once the desired position has been into the slot a sprung catch confirmed this can be locked more will engage with the dimples securely in position by gently on the nose bridge. This is to tightening the screws circled. allow a range of adjustment to suit the users requirements. Please note: Care must be taken not to overtighten the screws during this process, or the equipment 3. The nose bridge is fitted by sliding into the slot as shown. may be damaged. Home Back Next... -
Page 12: Aperture Lever
5. Setting up and using the Spectra Iris Filter selection control (D) By sliding the lever (D) in direction of the arrows, different filters may be selected. Clear – Select the clear with no filter when inspecting a specific pathology and a brighter, whiter light is desired. Green – Red-free filter reduces the red light, so blood will appear black, silhouetted against a dark background. Blue – Cobalt blue for fluorescein angioscopy. 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. Aperture lever (C) By sliding the lever (C) in direction of the arrows, the size of the aperture can be adjusted. Slide to the right to increase aperture size, to the left to decrease. Refer to the white Home Back Next dots located on the top of the lever, as per image right. -
Page 13: Interpupillary Distance Setting Control
5. Setting up and using the Spectra Iris Interpupillary Distance Setting Control (F) Because the eyes are dissociated, particular care must be taken to ensure the optics (eyepieces) are set properly in front of each eye. Place an object, perhaps the thumb, approximately 40cm from the face and centre it horizontally in the light patch. - Page 14 6. Charger – power supply assembly Set Plug Replace the blanking plate with the appropriate mains plug adaptor if required, or use IEC 60320 TYPE 7 connector (not supplied). IEC 60320 TYPE 7 connector Home Back Next...
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Page 15: Charging The Battery Pack
6. Charger – lithium battery Charging the battery pack Place the battery pack into the charging well as shown below. A yellow LED indicates battery pack’s charge state as below: Connect plug on cable to power input socket on side of Charger. Green LED Charging storage unit powered No yellow LED Battery charged Flashing yellow LED Top-up charge Solid yellow LED Rapid charge The battery pack can be used at any Turn the battery pack off. The Green LED shows Charging time during the charging cycle and storage unit is powered. will resume charging when battery pack is placed back in the charger. Home Back Next... -
Page 16: Charge Time / Belt Clip
6. Charger – lithium battery Charge time A yellow LED indicates battery pack’s charge state as below: The battery will take approximately 3 hours to fully charge. Flashing yellow LED Battery requires charging The battery will last approximately 4 hours on full power. Turn the illumination on by rotating the dimmer control knob in an anti-clockwise direction. Insert connector into socket as shown. Belt Clip The belt clip can be used for those who prefer to carry the unit on a belt. Home Back Next... -
Page 17: Cleaning Instructions
7. Cleaning • Only manual non-immersion cleaning as described should be used for this instrument • Do not autoclave or immerse in cleaning fluids Always disconnect power supply from source before cleaning a Wipe the external surface with a clean absorbent, non- shedding cloth dampened with a water / detergent solution (2% detergent by volume) or water / isopropyl alcohol solution (70% IPA by volume). Avoid optical surfaces b Ensure that excess solution does not enter the instrument. Use caution to ensure cloth is not saturated with solution c Surfaces must be carefully hand-dried using a clean non- shedding cloth d Safely dispose of used cleaning materials Home Back Next... -
Page 18: Specifications And Electrical Ratings
8. Specifications and electrical ratings Input mains data: 100-240V – 50/60Hz Power supply rating: 12V : 2.5amps Operation: Continuous Classification: Class II equipment Type B protection against shock Transport, storage and operating conditions Transport Storage Operation Temperature -40°C -10°C +10°C range to +70°C to +35°C to +35°C Relative 10% to 95% 10% to 95% 30% to 75% humidity Home Back Next... -
Page 19: Annex I - Emc Statement And Guidelines
9. Annex I – EMC statement and guidelines 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. Portable or mobile-type radio frequency communication units may have an adverse effect on this instrument, resulting in malfunctioning. Home Back Next... - Page 20 9. Annex I – EMC statement and guidelines Guidance and manufacturer’s declaration – electromagnetic immunity The Keeler Spectra Iris is intended for use in the electromagnetic environment specified below. The customer or the user should assure that it is used in such an environment. Immunity test IEC 60601 Test level Compliance level Electromagnetic environment - guidance Electrostatic ± 6 kV contact ± 6 kV contact Floors should be wood, concrete or ceramic tile. discharge (ESD). ± 8 kV air ± 8 kV air If floors are covered with synthetic material, the relative IEC 61000-4-2 humidity should be at least 30%. Electrical fast ± 2 kV for power supply lines ± 2 kV for power supply lines Mains power quality should be that of a typical commercial transient/burst. ± 1 kV for input/output lines or hospital environment. IEC 61000-4-4 Surge. ± 1 kV line(s) to line(s) ± 1 kV line(s) to line(s) Mains power quality should be that of a typical commercial IEC 61000-4-5 ± 2 kV line(s) to earth or hospital environment.
- Page 21 9. Annex I – EMC statement and guidelines Guidance and manufacturer’s declaration – electromagnetic emissions The Keeler Spectra Iris is intended for use in the electromagnetic environment specified below. The customer or user should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance RF emissions Group 1 The Keeler Spectra Iris uses RF energy only for its internal function. CISPR 11 Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. Charger only RF emissions Class B The Keeler Spectra Iris is suitable for use in all establishments, including CISPR 11 domestic establishments and those directly connected to the public low- voltage power supply network that supplies buildings used for domestic Harmonic emissions Class A purposes. IEC 61000-3-2 Voltage fluctuations / Complies flicker emissions IEC 61000-3-3 Indirect RF emissions Complies The Keeler Spectra Iris is not suitable for interconnection with other Ophthalmoscope CISPR 15 equipment.
- Page 22 Electromagnetic environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of the Keeler Spectra Iris, including cables, than the recommended separation distances calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance Conducted RF 3 Vrms d = 1.2 √ p IEC 61000-4-6 150 kHz to 80 MHz d = 1.2 √ p 80MHz to 800 MHz Radiated RF 3 V/m 3 V/m d = 2.3 √ p 800MHz to 2.5GHz IEC 61000-4-3 80MHz to 2.5GHz Where p is the maximum output power rating of the transmitter in watts(W) according to the transmitter manufacturer and d is the recommended separation distance in metres(m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey¹, should be less than the compliance level in each frequency range.² Interference may occur in the vicinity of equipment marked with the following symbol: Note 1 At 80MHz and 800MHz, the higher frequency range applies. Note 2 These guide lines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. ¹ Field strengths from fixed transmitters, such as base stations ( cellular / cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. 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. Home Back Next ² Over the frequency range 150kHz to 80 MHz, field strengths should be less than 3 V/m.
- Page 23 Recommended separation distances between portable and mobile RF communications equipment and the Keeler Spectra Iris The Keeler Spectra Iris is intended for the use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Keeler Spectra Iris can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Keeler Spectra Iris as recommended below, according to the maximum output power of the communications equipment.
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Page 24: Spare Parts And Accessories
Small thimble depressor for Scleral 1201-P-6075 Indentation 1205-P-7000 Spectra teaching mirror 1941-P-5350 KLED / Spectra double charger 3412-P-7002 Spectra carrying case Contact Keeler, who can supply a choice of Volk Lenses depending on magnification and field of view. Home Back Next... -
Page 25: Warranty
11. 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:- • Any fault due to faulty manufacture • The instrument and accessories have been used in compliance with these instructions • Proof of purchase accompanies any claim Please note that batteries are covered by this warranty statement for 1 year only. Home Back Next... -
Page 26: Contact And Disposal Information
12. Contact and disposal information Keeler Limited Keeler Instruments Inc Clewer Hill Road 3222 Phoenixville Pike Windsor Building #50 Berkshire SL4 4AA Malvern, PA 19355 England Freephone: 0800 521 251 Toll Free: 1 800 523 5620 Tel: +44 (0)1753 857177...
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