Keeler JAZZ SERIES, Jazz Ultra SERIES Instructions For Use Manual

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Jazz Instruments

Instructions for use

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Contents

1. Introduction ....................................................................p3

2. Symbols ...........................................................................p4

3. Safety

3.1 Device Classification

3.2 Warnings and cautions ............................................p5

4. Cleaning instructions

4.1 Sterilisation ...............................................................p6

5. Battery handles and start-up

5.1 Purpose

5.2 Start up and insertion and removal of batteries

5.3 Turning on and off

5.4 Changing the colour coded rings ............................p7

6. Otoscope and accessories

6.1 Purpose

6.2 Insertion and removal of ear speculum

6.3 Introduction of external instruments into the ear ..p8

6.4 Replacement of LED

6.5 Spare LEDs

6.6 Spare rings ................................................................p8

7. Ophthalmoscope and accessories

7.1 Purpose

7.2 Lens wheel and correcting lenses

7.3 Apertures and filters ................................................p9

7.4 Bulb/LED replacement

7.5 Spare Bulbs/LEDs

7.6 Spare rings ..............................................................p10

8. Maintenance .................................................................p11

9. Specifications and electrical ratings .......................p12-18

10. Warranty .......................................................................p19

11. Contact, packaging and disposal information ...........p20

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As part of our policy for continued product development we reserve the right to amend specifications at any time without prior notice.

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1. Introduction

Thank you for purchasing your Keeler Jazz Instruments.

Manufactured in compliance with Directive 93/42/EEC for

medical products.

Please read and follow these instructions carefully.

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2. Symbols

Read user instructions for Warnings, Cautions and

additional information

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

Manufacturers name and address

Keep dry

Type B protections against shock

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3. Safety

3.1 Device Classification

CE Regulation 93/42 EEC: Class 1

3.2 Warnings and cautions

Warning

• Please read these instructions carefully prior to use and keep

in a safe place. Should you have any queries, please contact

your supplier or your Keeler Agent who will be pleased to

assist you. For addresses please see the back page of these

instructions. The address of your authorised Keeler Agent can

be supplied on request.

• Please note that any instruments described in these

instructions are only suited for application by trained

operators.

• Correct and safe operation of instruments will only be

guaranteed when Keeler instruments and accessories are used

throughout.

• 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 or an oxygen

rich environment

• This product should not be immersed in fluids.

• Batteries must be inserted as per instructions - see section 5.2

• No modification to this equipment is allowed.

• Do not touch battery terminals and patient simultaneously.

• Instrument may become hot if used for extended periods

of time.

Caution

• The product has been designed to function safely when at an

ambient temperature between +10ºC and +35ºC.

• Keep out of the reach of children.

• To prevent condensation from forming, allow instrument to

come to room temperature before use.

• Bulbs/LEDs become hot during use, caution should be taken

when replacing bulbs/LEDs.

• The light emitted from this instrument is potentially

hazardous. The longer the duration of exposure, the

greater the risk of ocular damage. Exposure to light from this

instrument when operated at maximum

intensity will exceed the safety

guideline after 30 minutes.

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4. Cleaning instructions

Only manual non-immersion cleaning as described should

be used for this instrument. Do not autoclave or immerse in

cleaning fluids.

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.

4.1 Sterilisation

Keeler recommend that ear speculum are used once.

However, the ear speculum maybe sterilised at 134° for a dwell

time of 10 minutes in a steam steriliser.

Single use - repeated use could cause infection.

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5. Battery handles and start-up

5.1 Purpose

Keeler battery handles are fitted to the Keeler Jazz

Ophthalmoscope and Jazz Otoscope.

5.2 Start up and insertion and removal of batteries

Unscrew the Jazz instrument head from the handle in

an anti-clockwise direction. Insert two commercial type ‘AA’

alkaline batteries of 1.5V (IEC standard reference LR6) into the

case of the handle with the two plus poles towards the upper

section of the handle.

Warning:

• Should the unit not be used for an extended period of time

or whilst travelling, remove batteries from the handle.

• Insert new batteries when light intensity of the unit is

reduced, thus affecting examination.

• For maximum light yield it is recommended to always insert

new high-quality batteries on replacement.

• Never immerse handles in fluid. Ensure that no fluid or

condensation penetrates into the handle.

Disposal

Please note that batteries are subject to separate disposal.

For details ask your local authority and/or your environmental

officer.

5.3 Turning on and off

The handle is equipped with an

On/Off switch. When in the up position,

the unit is switched on, when in the

down position, the unit is off.

OFF

Unscrew

anti-clockwise

Screw on clockwise

5.4 Changing the colour coded rings

Unscrew the Jazz instrument head from the

handle in an anti-clockwise direction. Remove

the existing ring and replace with a new ring in

the colour of your choice. Screw the instrument

heads back on in a clockwise direction.

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6. Otoscope and accessories

6.1 Purpose

Keeler Jazz Otoscopes described in these instructions have been

produced for lighting and examination of the auditory canal,

combined with Keeler ear speculum.

6.2 Insertion and removal of ear speculum

Position the selected speculum on

the chromium plated metal cone

of the otoscope. Turn speculum to

the right until resistance is felt. The

size of the speculum is marked on the

outer surface.

6.3 Introduction of external instruments into the ear

When intending to introduce external

instruments into the ear (such as

forceps), turn magnifying lens (approx

2.5X enlargement) on otoscope head in

anti- clockwise direction. Replace cover

lens in reverse direction.

6.4 Replacement of LED

Remove instrument head from battery handle.

The LED is in the bottom section of the

instrument head. Remove LED, by using your

thumb and forefinger or a suitable tool,

from instrument head. Firmly insert new LED.

Caution:

• LED may be hot

• Speculum are Applied Parts

6.5 Spare LEDs

1015-P-5298 Jazz Otoscope LED

6.6 Spare rings

EP39-37051 Black

EP39-37342 Pink

EP39-37350 Blue

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7.1 Purpose

Keeler Jazz Ophthalmoscopes described in these instructions

have been designed for the examination of the eye and its

background.

7.2 Lens wheel and correcting lenses

The correcting lenses may be adjusted on

the lens wheel.

The following correcting lenses are available:

diopters 0 to +20 and 0 to -20. Readings will be

displayed on a lit panel. Plus values are displayed

in black digits and minus values in red digits.

7.3 Apertures and filters

The following apertures and/or filters may be

selected by the aperture and filter wheel:

7. Ophthalmoscope and accessories

Aperture Function

Small Circle Designed specifically for examination of the macular region of the fundus where a larger beam would create excessive papillary reaction or patient comfort

Semi-circle For reduction of reflexes of small pupils

Large Circle For standard fundus examination

Fixation Star For definition of central and eccentric

fixation

Red-free filter To increase contrast for assessment of changes in fine vessels, i.e. retinal haemorrhages

Cobalt Blue filter Used with fluorescein dye for the detection and examination of corneal scars and abrasions

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7.4 Bulb/LED replacement

Remove instrument head from battery handle.

The bulb/LED is located in the bottom section of

the instrument head. Remove bulb/LED from the

instrument head, by using your thumb and

forefinger. Insert new bulb/LED with the pin on

the bulb/LED fitted in the recess/slot provided

on the base of the instrument.

Warning:

• The bulb/LED may be hot

7.5 Spare Bulbs/LEDs

1011-P-5530 Jazz Ophthalmoscope Bulb

1011-P-5522 Jazz Ophthalmoscope LED (Not available in

Europe or USA)

7.6 Spare rings

EP39-37051 Black

EP39-37342 Pink

EP39-37350 Blue

7. Ophthalmoscope and accessories

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8. Maintenance

Jazz instruments and their accessories do not require

any specific maintenance. Should an instrument have

to be examined for any reason, please return it to

your supplier or an authorised dealer in

your area. Addresses can be supplied

on request or visit www.keeler.co.uk.

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9. Specifications and electrical ratings

Dimensions Otoscope - 18cm x 3cm x 7.5cm (H x D x W) (including handle and speculum) Ophthalmoscope - 18cm x 3cm x 3cm (H x D x W) (including handle)

Weight Otoscope - 96gm (including handle without batteries) Ophthalmoscope - 87gm (including handle without batteries)

Apertures Small Circle, Semi-circle, Large Circle, Fixation Star, Red-free filter, Cobalt Blue filter (see page 9)

Diopters 0 to +20 and 0 to -20 (see page 9)

Complies with Electrical Safety (Medical) BS EN 60601-1:2006

Electromagnetic compatibility EN 60601-1-2:2007 Ophthalmic instruments - fundamental requirements and test methods ISO 15004-1:2006 Optical radiation hazard ISO 15004-2:2007

Environment Temperature Humidity Pressure Use: +10°C to +35°C 30% to 90% 800 hpa to 1060 hpa

Storage: -10°C to +55°C 10% to 95% 700 hpa to 1060 hpa Transport: -40°C to +70°C 10% to 95% 500 hpa to 1060 hpa

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9. Specifications and electrical ratings

Caution

• PC-LED - The light emitted from this instrument is potentially

hazardous. The longer the duration of exposure, the greater the

risk of ocular damage. Exposure to light from this instrument

when operated at maximum intensity will exceed the safety

guideline after 30 minutes.

• Halogen bulb - The light emitted from this instrument is

potentially hazardous. The longer the duration of exposure, the

greater the risk of ocular damage. Exposure to light from this

instrument when operated at maximum intensity will exceed the

safety guideline after 30 minutes.

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9. Specifications and electrical ratings

Guidance and manufacturer’s declaration electromagnetic compatibility

The Jazz Otoscope and Ophthalmoscope have been tested regarding

their ability to operate in an environment containing other electrical/

electronic equipment (including other medical devices).

The purpose of this testing is to ensure the Jazz Otoscope and

Ophthalmoscope are not likely to adversely affect the normal

operation of other such equipment and that other such equipment

is not likely to adversely affect the normal operation of the Jazz

Otoscope and Ophthalmoscope.

Despite the testing of the Jazz Otoscope and Ophthalmoscope

that has been undertaken, normal operation of the Jazz Otoscope

and Ophthalmoscope can be affected by other electrical/electronic

equipment and portable and mobile RF communications equipment.

As the Jazz Otoscope and Ophthalmoscope are classed as medical

equipment, special precautions are needed regarding EMC

(electromagnetic compatibility).

It is important that the Jazz Otoscope and Ophthalmoscope are

configured and installed/put into service, in accordance with the

instructions/guidance provided herein and are used only in the

configuration as supplied.

The Jazz Otoscope and Ophthalmoscope have been tested (and should

be used only with) the Jazz battery handle and lamp supplied.

If the Jazz Otoscope and Ophthalmoscope are used with battery

handles other than the one supplied, or with lamps other than those

recommended, this may result in increased emissions or decreased

immunity of the Jazz Otoscope and Ophthalmoscope, in relation to

EMC performance.

It should be noted that the Jazz battery handle and lamps provided

with the Jazz Otoscope and Ophthalmoscope should not be used

on other equipment. To do so may result in increased emissions or

decreased immunity of the other equipment in relation to EMC

performance.

The Jazz Otoscope and Ophthalmoscope should not be used adjacent

to or stacked with other equipment. If adjacent or stacked use with

other equipment is necessary, the Jazz Otoscope and Ophthalmoscope

and the other equipment should be observed/monitored, to verify

normal operation in the configuration in which it will be used.

For the purposes of EN60601-1-2, the Jazz Otoscope and

Ophthalmoscope have an essential

performance. This essential performance

is that the light output should

remain on.

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9. Specifications and electrical ratings

Guidance and manufacturer’s declaration – electromagnetic emissions

The Jazz Otoscope / Ophthalmoscope is intended for use in the electromagnetic environment specified below. The customer or the user of the Jazz Otoscope / Ophthalmoscope should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment - guidance

RF emissions CISPR 11

Group 1 The Jazz Otoscope / Ophthalmoscope uses RF energy only for its internal

function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

RF emissions CISPR 11

Class B The Jazz Otoscope / Ophthalmoscope is suitable for use in all

establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Harmonic emissions IEC61000-3-2

Not Applicable

Voltage fluctuations / flicker emissions IEC61000-3-3

Not Applicable

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9. Specifications and electrical ratings

Guidance and manufacturer’s declaration – electromagnetic immunity

Immunity test IEC 60601 Test level Compliance level Electromagnetic environment - guidance

Electrostatic discharge (ESD) IEC61000-4-2

± 6 kV contact ± 8 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity

should be at least 30%.

Electrical fast transient / burst IEC61000-4-4

± 2 kV for power supply lines ± 1 kV for input / output lines

Not Applicable Mains power quality should be that of a typical

commercial or hospital environment.

Surge IEC61000-4-5

± 1 kV line(s) to line(s) ± 2 kV line(s) to earth

Not Applicable Mains power quality should be that of a typical

commercial or hospital environment.

Voltage dips, short interruptions and voltage variations on power supply input lines IEC61000-4-11

<5% U

(>95 % dip in UT) for 0.5 cycle

40% U

(60 % dip in UT) for 5 cycles

70 % U

(30 % dip in UT) for 25 cycles

<5% U

(>95 % dip in UT) for 5 s

Not Applicable Mains power quality should be that of a typical commercial

or hospital environment.

Power frequency (50/60 Hz) magnetic field IEC61000-4-8

3 A/m 3A/m If incorrect operation occurs, it may be necessary to

position the Jazz Otoscope / Ophthalmoscope further from sources of power frequency magnetic fields or to install magnetic shielding. The power frequency magnetic field should be measured in the intended installation location to assure that it is sufficiently low.

Note UT is the a. c. mains voltage prior to application of the test level.

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9. Specifications and electrical ratings

Guidance and manufacturer’s declaration – electromagnetic immunity

Immunity test IEC 60601 Test level Compliance level Electromagnetic environment - guidance

Conducted RF IEC61000-4-6

Radiated RF IEC61000-4-3

3 Vrms 150 kHz to 80 MHz

3 V/m 80 MHz to 2.5 GHz

Not Applicable

3 V/m

Portable and mobile RF communications equipment should be used no closer to any part of the Jazz Otoscope / Ophthalmoscope, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance (d)

d = 1.2 √ P

d = 1.2 √ P 80 MHz to 800 MHz

d = 2.3 √ P 800 MHz to 2.5 GHz

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).

Fields strengths from fixed RF transmitters, as determined by an electromagnetic site survey,

should be less than the compliance level in each

frequency range.

Interference may occur in the vicinity of equipment marked with the following symbol:

Note 1 At 80 MHz and 800 MHz, the higher frequency range applies. Note 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects

and people.

Field strengths from fixed transmitters, such as base stations for radio (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 Jazz Otoscope / Ophthalmoscope is used exceeds the applicable RF compliance level above, the Jazz Otoscope / Ophthalmoscope should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orientating or relocating the Jazz Otoscope / Ophthalmoscope.

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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9. Specifications and electrical ratings

Recommended separation distances between portable and mobile RF communications equipment and the Jazz Otoscope / Ophthalmoscope

The Jazz Otoscope / Ophthalmoscope is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Jazz Otoscope / Ophthalmoscope can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Jazz Otoscope / Ophthalmoscope as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of

transmitter

Separation distance according to frequency of transmitter

150 kHz to 80MHz

d = 1.2√ P

80MHz to 800MHz

d = 1.2√ P

800MHz to 2.5GHz

d = 2.3√ P

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23.3

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated 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.

Note 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. Note 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures objects

and people.

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10. 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 device has been used in compliance with

these instructions

• Proof of purchase accompanies any claim.

Bulbs/LEDs are guaranteed for 1 year from date of purchase.

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11. Contact, packaging and disposal information

EP59-33839 Issue 3

Disposal of old Electrical and Electronic Equipment

(Applicable in the European Union and other European Countries with

separate Collection Systems).

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 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).

Manufacturer

Keeler Limited Clewer Hill Road Windsor Berkshire SL4 4AA

Freephone: 0800 521251 Tel: +44 (0) 1753 857177 Fax: +44 (0) 1753 827145

USA Sales Office

Keeler Instruments Inc 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

Keeler JAZZ SERIES, Jazz Ultra SERIES Instructions For Use Manual

Specifications and Main Features

Frequently Asked Questions

User Manual