Keeler Jazz Ultra SERIES User manual

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Jazz Ultra Instruments
Instructions for use

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2
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 LED replacement
7.5 Spare LEDs
7.6 Spare rings ..............................................................p10
8. Maintenance .................................................................p11
9. Specifications and electrical ratings .......................p12-17
10. Warranty .......................................................................p18
11. Contact, packaging and disposal information ...........p19
Please click on the contents to go straight to your chosen section or navigate by using the 'Next'
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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 Ultra 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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5
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.
• LEDs become hot during use, caution should be taken
when replacing 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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6
4. Cleaning instructions
Only manual non-immersion cleaning as described should
be used for this instrument. Do not autoclave or immerse in
cleaning fluids.
aWipe 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.
bEnsure that excess solution does not enter the instrument.
Use caution to ensure cloth is not saturated with solution.
cSurfaces must be carefully hand-dried using a clean non-
shedding cloth.
dSafely 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 Ultra
Ophthalmoscope and Jazz Ultra Otoscope.
5.2 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.
Warning:
• Should the unit not be used for an extended period of time
or whilst travelling, remove batteries from the handles.
• 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.
ON
OFF
ON
OFF
Unscrew
anti-clockwise
Screw on
clockwise
5.4 Changing the colour coded rings
Unscrew the Jazz Ultra 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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8
6. Otoscope and accessories
6.1 Purpose
Keeler Jazz Ultra 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-7074 Jazz Ultra Otoscope LED
6.6 Spare rings
EP39-37051 Black
EP39-37342 Pink
EP39-37350 Blue

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9
7.1 Purpose
Keeler Jazz Ultra 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 LED replacement
Remove instrument head from battery handle.
The LED is located in the bottom section of
the instrument head. Remove LED from the
instrument head, by using your thumb and
forefinger. Insert new LED with the pin on
the LED fitted in the recess/slot provided
on the base of the instrument.
Warning:
• The LED may be hot
7.5 Spare LEDs
1011-P-7122 Jazz Ultra Ophthalmoscope LED
7.6 Spare rings
EP39-37051 Black
EP39-37342 Pink
EP39-37350 Blue
7. Ophthalmoscope and accessories

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8. Maintenance
Jazz Ultra 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 - 12cm x 3cm x 7.5cm (H x D x W) (including handle and speculum)
Ophthalmoscope - 13cm x 3cm x 3cm (H x D x W) (including handle)
Weight Otoscope - 68gm (including handle without battery)
Ophthalmoscope - 59gm (including handle without battery)
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
Guidance and manufacturer’s declaration -
electromagnetic compatibility
The Jazz Ultra 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 Ultra 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 Ultra
Otoscope and Ophthalmoscope.
Despite the testing of the Jazz Ultra Otoscope and Ophthalmoscope
that has been undertaken, normal operation of the Jazz Ultra
Otoscope and Ophthalmoscope can be affected by other electrical/
electronic equipment and portable and mobile RF communications
equipment.
As the Jazz Ultra Otoscope and Ophthalmoscope are classed as
medical equipment, special precautions are needed regarding EMC
(electromagnetic compatibility).
It is important that the Jazz Ultra 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 Ultra Otoscope and Ophthalmoscope have been tested (and
should be used only with) the Jazz Ultra battery handle and lamp
supplied.
If the Jazz Ultra 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 Ultra Otoscope and Ophthalmoscope, in relation
to EMC performance.
It should be noted that the Jazz Ultra battery handle and lamps provided
with the Jazz Ultra 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 Ultra 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 Ultra 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
Ultra 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 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.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1 The Jazz Ultra 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 Ultra 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
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.
Immunity test IEC 60601 Test level Compliance level Electromagnetic environment - guidance
Electrostatic
discharge (ESD)
IEC61000-4-2
± 6 kV contact
± 8 kV air
± 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% UT(>95 % dip in UT) for 0.5 cycle
40% UT(60 % dip in UT) for 5 cycles
70 % UT(30 % dip in UT) for 25 cycles
<5% UT(>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 Ultra 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 UTis the a. c. mains voltage prior to application of the test level.

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16
9. 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.
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 Ultra 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,ashould be less than the compliance level in each
frequency range.b
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.
aField 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 Ultra Otoscope /
Ophthalmoscope is used exceeds the applicable RF compliance level above, the Jazz Ultra 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 Ultra
Otoscope / Ophthalmoscope.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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17
9. Specifications and electrical ratings
Recommended separation distances between portable and mobile RF communications equipment and the Jazz Ultra Otoscope / Ophthalmoscope
The Jazz Ultra 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 Ultra Otoscope / Ophthalmoscope can help prevent electromagnetic interference by maintaining
a minimum distance between portable and mobile RF communications equipment (transmitters) and the Jazz Ultra Otoscope / Ophthalmoscope as
recommended below, according to the maximum output power of the communications equipment.
Rated maximum
output power of
transmitter
W
Separation distance according to frequency of transmitter
m
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.
LEDs are guaranteed for 1 year from date of purchase.

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11. Contact, packaging and disposal information
EP59-33847 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 ([phone]).
Manufacturer
Keeler Limited
Clewer Hill Road
Windsor
Berkshire
SL4 4AA
Freephone: 0800 521251
Tel: [phone]
Fax: [phone]
USA Sales Office
Keeler Instruments Inc
3222 Phoenixville Pike
Building #50
Malvern, PA 19355
USA
Toll Free: 1 800 523 5620
Tel: [phone]
Fax: [phone]