All Pupil Indirect Ophthalmoscope Instructions Issue C

Contents 1. 2. 3. 4.

5.

6.

Page Copyright and trademarks ... 3 Introduction ... 4 Symbols ... 5 Safety ... 6 • Device classification • Warnings • Cautions ... 7 • Safety considerations ... 8 Setting up and using the All Pupil II... 9 • Product description • Controls and components • Headband adjustment ... 10 • Ophthalmoscope alignment • Interpupillary distance setting control ... 11 • Obtaining a fused image • Mirror angle control • Head dimmer switch • Setting the aperture ... 12 • Selecting filters... 13 Wireless chargers ... 14 • Power supply • Standard lithium ... 15

Page • Slimline lithium ion ... 16 • Charging and charging cycle... 17 • Wall mounting ... 20 7. SmartPack and WallPack ... 22 • Parts list • Power conversion ... 23 • Wall mounting / charging ... 24 • LED displays ... 25 8. LED/bulb replacement... 26 9. Cleaning instructions ... 27 10. Specifications and electrical ratings ... 28 • Electrical specifications • Transport, storage and operation 11. Annex I – EMC statement and guidelines ... 29 12. Spare parts and accessories ... 34 • API II LED ... 35 • Teaching mirror ... 36 • Eyepiece Caps ... 37 • Plano Lenses • ExpressiOn Clip on Covers 13. Warranty ... 38 14. Contact and disposal information ... 39

Click on the headings above to go directly to that section. Use the buttons on the right to navigate the document. Clicking ‘Home’ from any page brings you back to this contents page.

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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. All Pupil II and All Pupil II LED are registered trademarks of Keeler Ltd 2012. Copyright © Keeler Limited 2012. Published in the UK 2012.

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2. Introduction Thank you for purchasing the Keeler All Pupil II Indirect Ophthalmoscope. We have taken the greatest care in the design, development and manufacture of this product to ensure that you get many years of trouble free service. However, it is important that you read the descriptions, installation and operating instructions carefully prior to installing or using your new indirect ophthalmoscope.

Please read and follow these instructions carefully.

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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 within the 93/42/EEC Medical Device Directive

Consult instructions for use

Double insulated

Trip hazard

Optical radiation hazard

Hot surface 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 market place after August 2005 and that this

Keep dry

product shall not be treated as Household Waste Fragile Type B protections against shock Material suitable Mandatory action sign

for recycling

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4. Safety Device classification

• Do not dispose of battery in fire, puncture or short circuit

CE Regulation 93/42 EEC: Class I

• Do not use a battery that is deformed, leaking, corroded or

FDA: Class II

visually damaged. Handle a damaged or leaking battery with care. If you come into contact with electrolyte, wash exposed

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 following information is intended to highlight potential safety hazards that can be associated with misuse, or damage.

Warnings and cautions Warning • Check your Keeler product for signs of transport / storage damage prior to use • Do not use if the product is visibly damaged, and periodically inspect for signs of damage • Do not use in the presence of flammable gases / liquids, or in an oxygen rich environment • This product should not be immersed in fluids • Do not disassemble or modify the battery. There are no serviceable parts inside

• US Federal law restricts this device to sale by or order of a physician or practitioner Do not fit mains power adapter into a damaged mains outlet socket Route power cords safely to eliminate risk of tripping or damage to equipment Bulbs / LED’s can reach high temperatures in use – allow to cool before handling Do not exceed maximum recommended exposure time After removal of the bulb / LED do not touch the bulb / LED contacts and the patient simultaneously

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4. Safety Caution • Use only genuine Keeler approved parts and accessories or device safety and performance may be compromised • Use only Keeler approved batteries, chargers and power supplies as per the accessories listed in section 12 • 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) • When replacing lithium battery pack, turn indirect off and attach new pack • Remove batteries when device may not be used for prolonged periods • Do not charge battery in any environment where the temperature may exceed 40˚C or fall below 0˚C

• Ensure battery orientation is correct, or personal injury / damage to equipment may occur • Care should be taken when handling halogen bulbs. Halogen bulbs can shatter if scratched or damaged • Ensure device is securely held in docking station to minimise risk of injury or damage to equipment • Follow guidance on cleaning / routine maintenance to prevent personal injury / damage to equipment Switch off the electrical supply and disconnect from the mains electrical supply before cleaning and inspection • Dispose of batteries in line with local environmental regulations • At product end of life dispose of in accordance with local environmental guidelines (WEEE) Note: Lithium Ion batteries contain no toxic heavy metals such as mercury, cadmium or lead

• There are no user serviceable parts inside. Contact authorised service representative for further information

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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

visualize ocular structure during delicate ophthalmic surgical

ocular damage. Exposure to light from this instrument when

procedure.

operated at maximum intensity will exceed the safety guideline after 17 minutes. The limit for the API II LED is 35 minutes.

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5. Setting up and using the All Pupil II Description of the Product

B

A Headband Size Adjuster

I

B Headband Height Adjuster

J Interpupillary Distance Setting Control

C Cushioned Padded Liners

K Mirror Angle Control

D Aperture Control Lever

L Optics Hinge Adjuster

E Headband Dimmer Switch

M Filter Selector Bar

Brow Bar

M F

L

F Brow Bar Adjuster G Front Window K

H Binocular Block J F

C

C D A I

E

G H

K

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5. Setting up and using the All Pupil II Headband Adjustment Comfortable Fit Adjust the Height and Size Adjusters (A and B) so that the indirect is supported comfortably, as shown in figs 1 and 2. Ophthalmoscope Angle Alignment Position the Brow Bar (I) such that the

fig.1

fig.2

fig.3

fig.4

Binocular Block (H) is set on the optical axis. The Brow Bar (I) may be correctly positioned by loosening the Brow Bar Adjusters (F). When in the correct position secure by tightening (F) as shown in fig 3. Position the All Pupil II as close to the eyes as possible for maximum field as shown in fig 4. by using the Optics Hinge Adjuster (L).

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5. Setting up and using the All Pupil II Interpupillary Distance Setting Control (J)

Mirror Angle Control (K)

Because the eyes are dissociated, particular care must be taken

The light is positioned vertically into the upper two thirds of the

to ensure the optics (eyepieces) are set properly in front of each

field of view by rotating the spindle (K) located on either side of

eye.

the binocular block.

Always set the Aperture Control Lever (D) to the large light patch for this exercise. Place an object, perhaps the thumb, approximately 40cm from the face and centre it horizontally in the light patch. Then, close one eye. Using the thumb and forefinger of the opposite hand, slide the Interpupillary Distance Setting Control (J) of the open eye (located directly under each eyepiece) so that your object

Head Dimmer Switch (E)

moves into the centre of the field, keeping the object in the

Turn the illumination on by rotating the headband dimmer

centre of the light patch. Repeat for the other eye.

switch (E) in an anti clockwise direction.

Obtaining a Fused Image Ensure that a singular, fused image is obtained as follows:

Separate images

Fused image

Overlapping images

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5. Setting up and using the All Pupil II Aperture Control Lever (D) The Aperture Control Lever (D) changes the aperture size to view through large, medium and small pupils. Select either the large, intermediate or small aperture by adjusting lever from left to right - small - intermediate - large.

Large The large, round homogenous patch is suitable for routine examinations through fully dilated pupils Intermediate The intermediate patch is designed to reduce reflections when entering a partially or poorly dilated pupil (3mm). It is also ideal for closer inspection of particular fundal areas. Small This light patch is ideal for small, undilated pupils.

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5. Setting up and using the All Pupil II Filter Selector Bar (M) The All Pupil II has two selectable filters built in to the head unit. Select the appropriate filter by sliding the Filter Selector Bar (M) either left or right from its mid position. The Filter Selector Bar is marked with dots to indicate in which direction to slide it for each filter.

Red Free Filter This filter reduces red light, so blood will appear black, silhouetted against a dark background. Diffuser This unique extra wide beam of diffused light permits a more relaxed technique during more challenging fundus examinations. Beginners may also find this aperture particularly helpful since, in order to achieve a full lens image, the alignment between the headset, the condensing lens and the pupil is not as critical as with the conventional beam. The instrument provides protection from UV/IR.

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6. Wireless chargers – 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

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6. Wireless chargers – Standard Lithium Inserting/replacing the Battery Pack

1

1. Release battery by pressing release button as shown and lift battery pack from cradle. 2. To insert new battery pack, place in cradle until fully engaged.

Press release button

2

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6. Wireless chargers – Slimline Lithium-ion 1

Inserting/replacing the Battery Pack

1

1. Release battery by pressing release button as shown and lift battery pack from cradle. 2. To insert new battery pack, place in cradle until fully engaged. 2

2

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Remove the blanking plate

6. Wireless chargers 1

Connect to charging/docking station

Charging 1. Replace the blanking plate with the

Replace with appropriate mains plug adapter

appropriate mains plug adapter, and connect plug on cable to power input

Power Supply

socket on charger. Spare battery

Switch on your Lithium Charger by 2

plugging it into a mains outlet. 2. Place your spare battery pack or

Press release button and push up

Charging/ docking station

headset into your Lithium

Power supply inlet

Charger as shown.

2 Spare battery Charging/ docking station

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Charging spare battery

6. Wireless chargers Headband Battery Holder Flashing LED – Battery requires charging.

Charging battery on headband

Slimline Lithium ion

Charging Station No indicator – Battery is fully charged. Flashing indicator – Top up Charge. Solid indicator – Rapid Charge. The battery pack can be used at any time during the charging cycle and will automatically resume charging when battery pack is placed back in the charger.

Charging spare battery only

Standard Lithium

Charging battery on headband

Direction arrow on charger indicates which battery is being charged.

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6. Wireless chargers Charging Cycle - Standard Lithium The battery attached to the indirect will take approximately 2 hours to fully charge. The battery will last approximately 2 hours on full power. The spare battery will take 4 hours to charge.

Charging Cycle - Slimline Lithium ion The battery attached to the indirect will take approximately 1½ hours to fully charge. The battery will last approximately 1 hour on full power. The spare battery will take 1½ hours to charge.

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6. Wireless chargers – wall mounting Use template document provided to mark position of charger and drill holes.

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