Ophthalmic and Diagnostic Instruments

Ophthalmoscope / Retinoscope / Otoscope

Instructions for use

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 Contents
Page Page
1. Copyright and trademarks.................................................... 3
• Upgrading to rechargeable handles............................. 20
2. Introduction............................................................................ 4 • Battery conditioning / charging.................................... 21
3. Symbols................................................................................... 5 7. GenMed Wall Unit................................................................ 22
4. Safety...................................................................................... 6
• Wall mounting

• Device classification • Wall mounting template............................................... 23
• Warnings • Power supply assembly.................................................. 24
• Cautions • Connecting / securing heads......................................... 25
• Safety considerations..................................................... 10 • Using the GenMed Wall Unit....................................... 26
5. Diagnostic Instrument heads • Dispos-A-Spec

• Ophthalmoscope models............................................... 11 8. Lithium Chargers.................................................................. 27
• Lens wheels.................................................................... 12
• Lithium Mini Charger
• Lens ranges • Lithium Double Charger
• Graticules and graticule control • Charging cycle
• Filters and filter control................................................. 13 9. Cleaning instructions........................................................... 28
• Retinoscope models....................................................... 14 10. Specifications and electrical ratings................................... 29
• Otoscope models............................................................ 15 • Electrical specifications
• Bulb replacement........................................................... 17 • Transport, storage and operation
6. Instrument handles.............................................................. 18 11. Annex I – EMC statement and guidelines.......................... 30

• Handle models 12. Spare parts and accessories................................................. 35
• Handle identification..................................................... 20 13. Warranty............................................................................... 36
• Inserting / replacing batteries 14. Contact and disposal information...................................... 37

Click on the headings above to go directly to that section.

Use the buttons on the right to navigate the document.
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1. Copyright and trademarks

The information contained within this manual must not be Ophthalmoscopes:

reproduced in whole or in part without the manufacturer’s Pocket, Professional, Practitioner, Specialist, Standard
prior written approval.
Retinoscopes:
As part of our policy for continued product development we Professional Combi, Spot, Streak
reserve the right to make changes to specifications and other
information contained in this document without prior notice. Otoscopes:
Deluxe, Fibre-Optic, Pocket, Professional, Standard
The products listed opposite are registered trademarks of
Keeler Ltd 2012 Handles:
C-size, Pocket, Slimline, GenMed Wall Unit
Copyright © Keeler Limited 2012
Chargers:
Published in the UK 2012 Lithium Duo Charger, Lithium Mini Charger, C-size NiCad Duo

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2. Introduction

Thank you for purchasing your Keeler diagnostic

instrument.

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
instrument.

Please read and follow these instructions carefully.

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3. Symbols

Read user instructions for warnings, cautions and Mandatory action sign Fragile
additional information

Follow instructions for use Material suitable

The CE mark on this product indicates it has been for recycling
tested to and conforms with the provisions noted
High voltage
within the 93/42/EEC Medical Device Directive
Symbol for
humidity limitation
Trip hazard
Consult instructions for use

Symbol for
Optical radiation hazard
Double insulated temperature limitation

Hot surface
Manufacturer's name and address RoHS Compliant

This Symbol on the product or on its packaging Non-ionizing radiation Do not use if
and instructions indicates that it was put on the package is damaged
market place after August 2005 and that this This way up
product shall not be treated as Household Waste

Keep dry
Type B protections against shock (otoscope only)

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4. Safety

Device classification • This product should not be immersed in fluids

CE Regulation 93/42 EEC: Class I • Do not position the device so access to the mains plug is
FDA: Class II limited or obscured

Ophthalmoscopes and retinoscopes are intended to illuminate Switch off the electrical supply and disconnect from the
the interior of the eye. Otoscopes are intended to illuminate the mains electrical supply before cleaning and inspection.
interior of the ear.
• If the product emits a strange odour, heat or smoke, stop use
Carefully read this Instruction Section before using your Keeler immediately. The continued use of a damaged product or part
product. For your own safety and that of your customers may cause injuries
observe all cautionary information provided in this section. The
• Do not touch the terminal contacts of the charging dock or
following information is intended to highlight potential safety
hand unit, or the terminal contacts and the patient
hazards that can be associated with misuse, or damage.
simultaneously

Warnings and cautions - General

Caution

Warning • Use only genuine Keeler approved parts and accessories or

• Check your Keeler product for signs of transport / storage device safety and performance may be compromised

damage prior to use • Use only Keeler approved batteries, chargers and power

• Do not use if the product is visibly damaged, and periodically supplies as per the accessories listed in section 12

inspect for signs of damage • Backwards compatibility of the

• Do not use in the presence of flammable gases / liquids, or in LED module has not

an oxygen rich environment been tested Home Back Next 6

4. Safety

Warnings and cautions – General (cont’d) • At product end of life dispose of in accordance with local
environmental guidelines (WEEE)
• The product has been designed to function safely when at an
ambient temperature between +10°C and +35°C • To isolate the equipment, disconnect from the mains or switch
off at the mains
• Keep out of the reach of children

• To prevent condensation from forming, allow instrument to Chargers

come to room temperature before use
Do not fit mains power adapter into a damaged mains
• For indoor use only (protect from moisture)
outlet socket.
• There are no user serviceable parts inside. Contact authorised
service representative for further information Route power cords safely to eliminate risk of tripping
or damage to equipment.
• Ensure device is securely held in docking station to minimise
risk of injury or damage to equipment
Only Keeler handles with a red base can be used in the Keeler
• Follow guidance on cleaning / routine maintenance to prevent Lithium Chargers. Do not try to insert a Keeler handle with a
personal injury / damage to equipment blue base into the Keeler Lithium Chargers. Refer to Keeler
handle and bulb identification.
• Failure to carry out recommended routine maintenance as per
the instructions in this IFU may reduce the operational lifetime
of the product

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4. Safety

Diagnostic Instruments • Plastic reusable Speculae will degrade if exposed to ultra-

violet light, dry heat or gamma irradiation. These methods of
• When connecting instrument heads to handles please check
sterilization must not be used
that the voltage of the bulb in the instrument corresponds
with the voltage of the handle • This device must only be used by clinicians trained in the use
of ophthalmic devices
• Care should be taken when fitting heads to handles not to
trap skin between parts
Batteries and bulbs
• Please ensure that the control is in the off position when the • Do not use a battery that is deformed, leaking, corroded or
examination has been completed visually damaged. Handle a damaged or leaking battery with

• Keeler Professional Retinoscopes contain strong magnets. care. If you come into contact with electrolyte, wash exposed

Pacemakers and magnetically stored data will be affected or area with soap and water. If it contacts the eye, seek medical

damaged by magnets attention immediately

• Strong magnetic fields may influence or distort sensitive • Ensure battery orientation is correct, or personal injury /

electronic or mechanical test instruments. Very sensitive damage to equipment may occur

devices may even be destroyed. Always keep magnets at a • Do not mix battery types
safe distance from such devices
• Do not attempt to charge Non-Rechargeable batteries
• Do not use Keeler Retinoscopes in ambient temperatures
above 30°C • Do not charge battery in an environment
where the temperature may exceed
• Disposable speculae should not be used for insufflation 40˚C or fall below 0˚C
testing
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4. Safety

Batteries and bulbs (cont’d)

• When replacing rechargeable cell, turn handle off and insert Note: Lithium Ion batteries contain no toxic heavy metals
new cell. Replace bottom cap, and place handle into charging such as mercury, cadmium or lead.
well
Do not exceed maximum recommended exposure time.
• If a short circuit occurs, reactivate the battery by placing the
• Always ensure that the handle rheostat is turned off before
handle in the charger until the LED flashes. This is a built in
fitting an instrument head or changing a bulb
protection device to protect the battery from damage
Bulbs / LED’s can reach high temperatures in use – allow
• Dry cell batteries should be removed if your instrument is not
to cool before handling. If the ophthalmoscope has been
to be used for long periods
in the charging position for over 15 minutes, it must be
• Do not disassemble or modify the battery. There are no left to cool for at least 10 minutes before use.
serviceable parts inside
• Care should be taken when handling halogen bulbs. Halogen
• Do not dispose of battery in fire, puncture or short circuit bulbs can shatter if scratched or damaged

• Dispose of batteries in line with local environmental After removal of the bulb / LED do not touch the bulb /
regulations LED contacts and the patient simultaneously.

• Tape over battery contacts to avoid short circuiting during Refer to the instructions on page 17 for bulb replacement.
disposal

After removal of the battery do not touch the battery

contacts and the patient simultaneously.

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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 CAUTION - The light emitted from this instrument is potentially
possible complication of the need to use bright light to clearly hazardous. The longer the duration of exposure, the greater the
visualize ocular structure during delicate ophthalmic surgical risk of ocular damage. Exposure to light from this instrument
procedures. when operated at maximum intensity will exceed the safety
guideline after 3 minutes. The ophthalmoscope should not be
continuously switched on for more than 15 minutes. If it is left
on for 15 minutes or longer then it must be switched off and
left to cool for at least 10 minutes before the next use.

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5. Instrument heads - Ophthalmoscopes

Specialist Standard
Graticule and Auxiliary Lens
Filter Control Wheel

Lens Wheel

Lens Wheel

Practitioner / Professional
Pupilometer

Filter Control

Pocket
Graticule
Lens Wheel Auxiliary Lens Control
Wheel

Graticule and
Filter Control
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5. Instrument heads - Ophthalmoscopes

Lens Wheel Graticule Control

The lens wheel is rotated to select the required lens. Lens The graticule control is used to select the required beam for
powers are displayed in the viewing window as follows: examination. The choice of graticules is as follows.
Black = (+) power lenses
Wide Angle
Red = (-) power lenses
Illuminates the largest area of fundus for the best
possible general diagnosis through a dilated pupil.
Auxiliary lens wheel
Swings in +/- 20 in one Dioptre step* (*Professional only). Intermediate
Permits easier access through an undilated pupil in

Specialist Auxiliary lens wheel peripheral examination. Particularly useful in paediatric

examination.
Rotate to align +10, +15, +30/ -10, -15, -30 Dioptre lenses.
Macular
Lens ranges Designed specifically for viewing the macular area of
Specialist the fundus. Reduces pupillary reaction and improves
+44D to –45D in single Dioptre steps patient comfort.

Professional Slit
+29D to –30D in single Dioptre steps Used primarily to determine retinal elevations and
depressions but may also be used to assess anterior
Practitioner and Standard
chamber depth.
+40D to –25D

Pocket
+20D to –20D Home Back Next 12
5. Instrument heads - Ophthalmoscopes

Graticule Control (cont’d) Filter Control*

Glaucoma The filter control is used to select the required filter.
Projects a graticule onto the retina to assess the optic (*Professional/Practitioner/Standard only.)
disc/cup ratio as an aid to glaucoma diagnosis and
monitoring. Filter Applications
Fixation Cross Red Free (Green filter)

Projects a graticule on to the retina for assessment of Is used to examine the blood vessels in fine detail. The

the degree and direction of eccentric fixation. This is green filter blocks red rays showing blood vessels as

particularly useful when examining children. black against a dark green background. This filter is particularly
useful for diabetic retinopathy.

The Graticule Range for each ophthalmoscope is as follows: Cobalt Blue*

Is used in conjunction with flourescein dye for the
Specialist detection and examination of corneal scars and abrasions.
(*Practitioner and Specialist only).
Professional
Pupillometer*
Practitioner Hold the pupillometer adjacent to the patients eye to
estimate pupil size. 1=1mm. The range is 1mm to 8mm.
(*Applies to Specialist only.)
Standard

Pocket
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5. Instrument heads - Retinoscopes

Professional Combi Retinoscope Focussing and axis control (Spot)

Brow Rest
The vergence is altered by sliding the focussing control up and
Aperture
Control down as indicated. For all positions the effect is a plane mirror
effect.

Brow Rest
The Keeler retinoscope is supplied with a choice of brow rests to
accommodate spectacle wearers. To interchange the brow rest
Focussing
and Axis disconnect and attach as indicated.
Control

Aperture Control
The aperture control has two positions. To change from the
large to the small aperture slide the control from left to right as
indicated.
Focussing and axis control (Streak)
The vergence is altered by sliding the focussing control up and
Note: Handheld diagnostic instruments can become hot
down as indicated. In the top position the effect is a concave
during use and charging.
mirror. Mid position produces a streak behind the patient. The
mid position is used to determine the presence and axis of any
astigmatism. In the bottom position the effect is a divergent
plane mirror effect. Refraction is normally performed between
the mid position and the bottom position. The focussing and
axis control can be rotated continuously in any direction. Home Back Next 14
5. Instrument heads - Otoscopes
Five permanent Speculae are provided with each Otoscope/Set. Practitioner
The diameters are as follows: 2.5, 3.5, 4.5, 5.5 & 8mm. These are
attached to the Otoscope head as shown in the following
diagrams.

Standard / Pocket

Fibre Optic Deluxe

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5. Instrument heads - Otoscopes

Disposable Speculae* Minor surgical Procedures

Disposable speculae can be fitted to the Standard, Practitioner, Should you wish to use surgical instruments such for minor
Fibre Optic and Pocket Otoscopes. procedures the following notes may be of assistance.

The disposable speculae is attached as shown on the previous Standard and Pocket Otoscopes
page. The magnifier can be removed to allow the introduction of
surgical instruments.
Pneumatic Testing*
An insufflation tube can be fitted to your Otoscope to enable Fibre Optic/Practitioner
you to carry out pneumatic testing. The Fibre Optic magnifier can be moved to one side or removed
completely to aid the introduction of surgical instruments.
For Practitioner, Standard, Pocket & Fibre Optic Otoscopes attach
the insufflation adaptor into port. The insufflation tube can Deluxe Otoscope
then be attached to this.
The Deluxe magnifier may be swung to the side to aid the
introduction of surgical instruments. The magnifier can also be
An Insufflation adaptor is also available for Practitioner as
rotated clockwise to bring the focus closer to the end of the
shown on the previous page.
specula.

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5. Instrument heads

Bulb replacement
Bulbs / LED’s can reach high temperatures in use – allow • Loosen the set screw securing the instrument

to cool before handling. head to the handle (GenMed Wall Unit only)

• Always ensure that the handle rheostat is turned off before

fitting an instrument head or changing a bulb • Remove the head by holding it horizontally with one hand

• Care should be taken when handling halogen bulbs. Halogen while rotating the handle counterclockwise with the other

bulbs can shatter if scratched or damaged • Take care to ensure the battery / bulb does not drop out when

• After removal of the bulb / LED do not touch the bulb / LED the head and handle are separated

contacts and the patient simultaneously • Remove the faulty bulb and dispose of in accordance with

• Keeler bulbs can only be used in the instrument for which local environmental regulations

they are designed – refer to part number list in section 12 • Replace the bulb with one of the correct voltage and type.

• Ensure the replacement bulb is the correct voltage. See base Ensure that the location key is aligned with the aperture in

of bulb the instrument head

• Refit the handle to the head by rotating it clockwise while

horizontal. If required, secure the head in
place with the set screw provided
• Blue = 2.8v for dry cell battery handles (GenMed Wall Unit only)
• Red = 3.6v for rechargeable handles
• Black = LED Home Back Next 17

 6. Instrument handles

Slimline Pocket C-size

Rechargeable 2 x AA or 2x AA or Rechargeable 2 x C or
Battery MN1500 MN1500 Battery MN 1500
(Red Cap) (Blue Cap) (Blue Cap)

(Blue Cap)

(Red Cap)

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6. Instrument handles

Connection of the instrument heads On / Off brightness control

to the handle To switch the instrument on, rotate the brightness control as
The connection between the instrument indicated to the right.
head to the handle is a screw thread. To
connect our instrument head connect as shown To switch off the instrument, rotate the brightness control as
and rotate in clockwise direction. Ensure the indicated to the left.
connection between the head and handle
is positive. Keeler C sizes Handles have a power indicator. This will show if
the instrument is on or off.

Compatibility Silver = off Red = on

The Keeler Specialist, Professional,

Standard and Practitioner Ophthalmoscopes and
Keeler Retinoscopes are compatible with Keeler 2.8v and 3.6v
Keeler handles.

The Keeler LED module is only compatible with Keeler 2.8V

Off Half On On
and 3.6V slimline handles.

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6. Instrument handles

Handle Identification Please note Keeler rechargeable handles are normally supplied
complete with a rechargeable battery (3.6v - 0.7Ah Ni-Cd).
Keeler C size and pocket handles are colour coded to allow you
to distinguish between a dry cell battery handle (2.8v) and a
rechargeable handle (3.6v). Dry cell batteries
The following dry cell batteries should be used:
The handles and Keeler bulbs are colour coded as follows:
• Keeler Pocket Handle – 2 x AA size dry cell batteries –
Blue base = 2.8v for dry cell batteries. Duracell MN 1500 or equivalent.
Red base = 3.6v for rechargeable batteries. • Keeler C size handle – 2 x 1.5v C size batteries. – Duracell MN
Black base = LED for dry cell and rechargeable batteries. 1400 or equivalent.

Upgrade from Battery to Rechargeable Handles

Your Keeler 2.8 v C Size Handle (blue base) dry cell battery
Please ensure when replacing batteries and bulbs that the handle can be upgraded to a 3.6v (red base) rechargeable
voltage corresponds to the handle. handle. Refer to section 12 for details of part numbers required.

Disconnect from charger prior to removing instrument head. Please note the bulb in your instrument will also need to be
upgraded from 2.8v to 3.6v.
Dispose of old batteries safely.
Contact Keeler for details:
Inserting/Replacing Batteries Tel: +44 (0) 1753 857177
Unscrew battery cap, insert batteries and replace battery cap Fax: +44 (0) 1753 827145.
as shown on page 18.
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6. Instrument handles

Battery charging Repeat steps 1, 2 and 3 three times, i.e. fully charge and
discharge the battery three times to complete the conditioning
Do not attempt to charge non-rechargeable
process. Once you have conditioned your batteries as described
batteries.
above you may place your instrument in the charger when not
in use between examinations.
Battery Conditioning
Your Keeler rechargeable batteries need to be conditioned to
Charger Compatibility
ensure you achieve the maximum life from the product. Follow
Keeler Rechargeable Handles can be used in the
the conditioning instructions as indicated.
following Keeler chargers only:
Step 1
• Keeler Mini charger
Fully charge your new Keeler rechargeable battery. This will take
• Keeler Duo charger
approximately 15 hours.

Step 2 Note: Handheld diagnostic instruments can become hot

Use the instrument WITHOUT RECHARGING UNTIL THE BATTERY during use and charging.
IS COMPLETELY EMPTY.

Step 3
Once empty recharge the battery until full. This will take
approximately 15 hours.

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7. GenMed Wall Unit – wall mounting

Wall mounting
1.8m MAX
Check the distance Secure the GenMed Wall Unit and Dispenser Unit as
from the wall socket to shown below:
the intended mounting
position.

For the Gen Med Wall Units drill two holes Ø6mm x 55mm deep
and 110mm apart.

ø6mm

55mm

ø6mm

For the Dispenser Unit drill an additional two holes 249mm below
the existing holes using the template on the following page. Home Back Next 22
 7. GenMed Wall Unit and Dispenser mounting template
249mm

WALL UNIT AND

Scale 1:1 Do not scale

DISPENSER
TEMPLATE

THIS
WAY
UP
110mm

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7. GenMed Wall Unit – 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).

Connect to
GenMed
Wall Unit IEC 60320 TYPE 7 connector

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7. GenMed Wall Unit

Connecting your instrument head

to the wall unit handle
The instrument head should be screwed
positively onto the handle as shown.

As an additional security measure,

instrument heads may be locked onto
Please note:
Keeler cord handles by tightening
This equipment may be affected by electromagnetic
the built in screw with the hexagonal
interference.
key provided.

Other electrical equipment in the close vicinity may also

be affected by the GenMed Wall Unit.

If such effects are suspected, switch off the offending

equipment.
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7. GenMed Wall Unit
To use the required instrument, remove the relevant handle from
its cradle as shown.

A yellow light (LED) will illuminate when a cord handle is

removed from its cradle. This will occur whether or not an
instrument head is fitted.

When the instrument is no longer required always ensure that

the handle is returned correctly to its cradle and that the LED
goes out.

Only one handle can be used at a time. Replace the handle

before using the other instrument.

Refer to the instructions in section 5 for information on the

controls and operation of Ophthalmoscope, Otoscope and
Retinoscope heads.

Dispos-A-Spec PULL

To dispense a speculum, simply grasp the end of the required

speculum and gently pull vertically. When a dispenser tube is
empty, reorder speculum using the order form EP59-48483.
Remove the lid from the unit and refill the required tube.
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8. Chargers

Lithium Mini Charger and Lithium Double Charger Charging

No LED Battery is fully charged
Power supply Flashing LED Top up charge
Assemble the power supply as per the instructions in section 7, Solid LED Battery is charging
and connect the lead to the power input port on the charger.
The handle can be used at any time during the charging cycle and
will automatically resume charging when handle is placed back in
the charging well.

When using the Mini charger the handle can be left in place.

The instrument must not be used while charging.

Charging cycle
Lithium Double Charger The battery will take approximately 2-3 hours to fully charge.
The battery will last approximately 2-3 hours on full power.

Lithium Mini Charger

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9. Cleaning
Only manual non-immersion cleaning as described should be used The cleaning and sterilization of reusable speculum, metal tongue
for this instrument. depressor, nasal dilator, laryngeal and post natal mirrors can be
accomplished as follows:
Do not autoclave or immerse in cleaning fluids. a Manually clean all surfaces of the units using a suitable brush
and water/detergent solution (2% detergent by volume).
Always disconnect power supply from source before Ensure that hinged versions of specula are cleaned in both
cleaning. open and closed positions. Ensure all crevices are accessed.

a Wipe the external surface with a clean absorbent, non- Solution can be heated to no more than 35°C.

shedding cloth dampened with a water / detergent solution b Carefully examine to ensure that all visible contamination has
(2% detergent by volume) or water / isopropyl alcohol solution been removed.
(70% IPA by volume). Avoid optical surfaces.
c Safely dispose of used cleaning materials.
b Ensure that excess solution does not enter the instrument. Use d Sterilize using a validated steam sterilizer complying with BS 3970
caution to ensure cloth is not saturated with solution. or equivalent standard. Operating cycle condition as below:
134 - 138°C sterilizing temperature at 2.25 bar operating
c Surfaces must be carefully hand-dried using a clean non-
pressure for minimum of 3 minutes hold time.
shedding cloth.
e Inspect for any visible damage prior to use.
d Safely dispose of used cleaning materials.
f Nominal life of 400 sterilization cycles for
reusable Speculum.
Sterilization
Plastic reusable Speculae will degrade if exposed to ultra-violet Disposable Speculae - use once only

light, dry heat or gamma irradiation. These methods of and dispose of safely.

sterilization must not be used.

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10. Specifications and electrical ratings
The ophthalmoscope/retinoscope/otoscope, the power
Transport, storage and operating conditions
supply (EP29-32777) with its charging dock (1941-P-5289
and 1941-P-5326) together constitute a Medical Electrical Transport Storage Operation

System as defined in EN 60601-1. Temperature -40°C +10°C +10°C

range to +70°C to +55°C to +35°C

Input mains data: 100-240V – 50/60Hz Relative

10% to 95% 10% to 95% 30% to 75%
Power supply rating: 12V : 2.5amps humidity

Operation: Maximum 15 minutes ON Atmospheric 500hPa 700hPa 700hPa

Minimum 10 minutes OFF pressure to 1060hPa to 1060hPa to 1060hPa

Classification: Class II equipment

Type B protection against shock

Instrument heads and handles

Input voltage (DC): 3V 2xAA Alkaline Batteries - BLUE
3.75V Lithium Ion Rechargeable Battery - RED (EP39-18918)

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11. Annex I – EMC statement and guidelines
Keeler Diagnostic Instruments and associated power systems are
medical electrical instruments. These instruments require special care
concerning electromagnetic compatibility (EMC). This section describes
the suitability in terms of electromagnetic compatibility of these
instruments. When installing or using these instruments, please read
carefully and observe what is described here.

Portable or mobile-type radio frequency communication units may

have an adverse effect on these instruments, resulting in
malfunctioning.

Instrument heads and handles are considered to be inherently EMC

benign¹, with the exception of the GenMed Wall Unit, to which the
following table refers, in addition to the Lithium Chargers.

¹ Refer to section 1.1.4 of the Guide for the EMC Directive 2004/108/EC (21st May 2007).

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11. Annex I – EMC statement and guidelines
Guidance and manufacturer’s declaration – electromagnetic immunity

Keeler Diagnostic Instruments are intended for use in the electromagnetic environment specified below. The customer or the user should assure
that they are 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 N/A or hospital environment.
IEC 61000-4-4 *± 1 kV for input/output lines *GenMed Wall Unit only
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 N/A or hospital environment.
Voltage dips, short <5% UT <5% UT Mains power quality should be that of a typical commercial or
interruptions and (> 95% dip in UT) for 0.5 cycles (> 95% dip in UT) for 0.5 cycles hospital environment.
voltage variations on 40% UT 40% UT
power supply input If the user of the Keeler Diagnostic Instruments requires
(60% dip in UT ) for 5 cycles (60% dip in UT ) for 5 cycles
lines. continued operation during power mains interruptions, it is
IEC 61000-4-11 70% UT 70% UT recommended that the charger be powered from an
(30% dip in UT ) for 25 cycles (30% dip in UT ) for 25 cycles uninterruptible power supply.
<5% UT <5% UT
(>95% dip in UT) for 5 s (>95% dip in UT) for 5 s
Power frequency 3 A/m 3 A/m Power frequency magnetic fields should be at a level
(50/60 Hz) magnetic characteristic of a typical location in a typical commercial or
field. IEC 61000-4-8 hospital environment.

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

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11. Annex I – EMC statement and guidelines
Guidance and manufacturer’s declaration – electromagnetic emissions

Keeler Diagnostic Instruments are intended for use in the electromagnetic environment specified below. The customer or the user should assure
that they are used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions Group 1 Keeler chargers and power systems use RF energy only for their internal
Chargers and CISPR 11 function. Therefore, the RF emissions are very low and are not likely to
GenMed Wall Unit cause any interference in nearby electronic equipment.
only RF emissions Class B Keeler chargers and power systems are suitable for use in all
CISPR 11 establishments, including domestic establishments and those directly
connected to the public low-voltage power supply network that supplies
Harmonic emissions Class A
buildings used for domestic purposes.
IEC 61000-3-2
Voltage fluctuations / Complies
flicker emissions
IEC 61000-3-3

Battery operated Keeler Diagnostic Instruments are considered to be inherently EMC benign¹, and therefore
are not covered by the statements in this section.

¹ Refer to section 1.1.4 of the Guide for the EMC Directive 2004/108/EC (published 21st May 2007).

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11. Annex I – EMC statement and guidelines
Guidance and manufacturer’s declaration – electromagnetic immunity

Keeler Diagnostic Instruments are intended for use in the electromagnetic environment specified below. The customer or the user should assure
that they are used in such an environment.
Immunity test IEC 60601 Test level Compliance level Electromagnetic environment - guidance
Portable and mobile RF communications equipment should be used no closer to
any part of the Keeler Diagnostic Instruments, 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 3V
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 survey2, should be less than the compliance level in each frequency range.3
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.
2 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 Diagnostic
Instruments are used exceeds the applicable RF compliance level above, the instruments should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as re-orientating or relocating the instruments.
3 Over the frequency range 150kHz to 80 MHz, field strengths should be less than 3 V/m. Home Back Next 33
11. Annex I – EMC statement and guidelines
Recommended separation distances between portable and mobile RF communications equipment and Keeler Diagnostic Instruments

Keeler Diagnostic Instruments are intended for the use in an electromagnetic environment in which radiated RF disturbances are controlled. The
customer or the user of Keeler Diagnostic Instruments can help prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and the Keeler instruments as recommended below, according to the maximum
output power of the communications equipment.
Rated maximum Separation distance according to frequency of transmitter
output power of m
transmitter
150 kHz to 80MHz 80MHz to 800MHz 800MHz to 2.5GHz
W
d = 1.2√ p d = 1.2√ p d = 2.3√ p
0.01 0.12 0.12 0.23
0.1 0.37 0.37 0.74
1 1.2 1.2 2.3

10 3.7 3.7 7.4

100 12 12 23
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.

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.

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12. Spare parts and accessories
The following replacement bulbs are available for Keeler In addition the following accessories are available from the
diagnostic instruments: distributor:

Part Number Description Part Number Description

1011-P-7050 2x 2.8v Halogen Pocket ophthalmoscope bulbs EP29-32777 Power supply
1011-P-7106 2x 2.8v Xenon ophthalmoscope bulbs EP39-18918 Slimline 3.6v Lithium battery
1011-P-7114 2x 3.6v Xenon ophthalmoscope bulbs Airtight Chamber with Lens for Pocket and
1501-P-7117
1011-P-7210 1x Ophthalmoscope LED Standard otoscopes
1011-P-7229 1x Specialist LED Pneumatic Testing Adaptor for ‘old type’
1501-P-7133
1013-P-7006 2x 2.8v Professional Spot retinoscope bulbs Standard and Pocket otoscopes
1013-P-7007 2x 3.6v Professional Spot retinoscope bulbs 1513-P-7034 Viewing lens for Practitioner otoscope
1013-P-7008 2x 2.8v Professional Streak retinoscope bulbs Pneumatic Testing Adaptor for Practitioner,
1514-P-7028
Fibre Optic, Standard and Pocket otoscope
1013-P-7009 2x 3.6v Professional Streak retinoscope bulbs
1531-P-5016 3x Magnifier for Deluxe otoscope
1305-P-7000 1x Professional Streak retinoscope LED
Bulb extractor for Deluxe, Standard and Pocket
1015-P-7023 2x 3.6v Halogen Standard/Deluxe otoscope bulbs 1599-P-7237
otoscope
1015-P-7031 2x 2.8v Halogen Standard/Deluxe otoscope bulbs
1599-P-7245 Insufflator bulb for all otoscopes
1015-P-7058 2x 3.6v Practitioner/Fibre Optic otoscope bulbs
1941-P-1341 Lithium Mini Charger
1015-P-7066 2x 2.8v Practitioner/Fibre Optic otoscope bulbs
1941-P-1368 Lithium Double Charger
Upgrading your C-size handle from dry cell to rechargeable:
Replace 2.8v bulb with correct 3.6v version as per table above

Part Number Description

1911-P-5229 Battery cap (red)
1919-P-7069 3.6v NiCad battery
1941-P-5246 Double charger
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13. Warranty
Warning: Do not modify this equipment without
authorization of Keeler.

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 bulbs and batteries are not covered by this
warranty statement.

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14. Contact and disposal information

Keeler Limited Keeler Instruments Inc

Clewer Hill Road 3222 Phoenixville Pike
Windsor Building #50
Berkshire SL4 4AA Malvern, PA 19355
UK USA
Freephone: 0800 521 251 Toll Free: 1 800 523 5620
Tel: +44 (0)1753 857177 Tel: +1 610 353 4350
Fax: +44 (0)1753 827145 Fax: +1 610 353 7814

Disposal of old Electrical and Electronic Equipment

(Applicable in the European Union and other European Countries with To reduce the environmental impact of WEEE (Waste Electrical Electronic
separate Collection Systems). Equipment) and minimise the volume of WEEE entering landfills we
encourage at product end of life that this equipment is recycled and reused.
This symbol on the product or on its packaging and instructions
indicates that it was put on the market place after August 2005 and If you need more information on the collection reuse and recycling then
that this product shall not be treated as Household Waste. please contact B2B Compliance on 01691 676124 (+44 1691 676124).

EP59-11234 Issue 5 October 2017

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