Otoscope
Coax Ophthalmoscope
Dermascope
Throat Illuminator
Power Handles
Instruction Manual
Questions?
Call ADC toll free:
1-800-232-2670
1
Diagnostix
TM
EENT Instruments
Table of Contents
1. A Special Thank You 4
2. Introduction - Intended Use 4
3. Warnings and Precautions 4-5
4. Battery Handles and Initial Use 6-8
5. Instrument Heads 9
6. Diagnostix®Otoscope 9-10
7. Diagnostix®Ophthalmoscope 10-12
8. Diagnostix®Dermascope 12-13
9. Diagnostix®Throat Illuminator 13
10. Replacing the Lamp 13
11. Spare Parts and Accessories 13
12. Cleaning and Disinfection 14
13. Technical Specifications 15
14. Maintenance 15
15. Electromagnetic Compatibility 15-19
16. Warranty 19
17. Quality Standards 20
18. How to Contact Us 20
2
Diagnostix
Otoscope
TM
DiagnostixTMPMV
Otoscope
Diagnostix
TM
Coax Ophthalmoscope
Diagnostix
TM
Dermascope
DiagnostixTMCoax Plus
Ophthalmoscope
Diagnostix
TM
Throat Illuminator
3
1. A SPECIAL THANK YOU
Congratulations on your purchase of an ADC
®
Diagnostix™Physical Exam
instrument.
®
ADC
professional diagnostic products are the instruments of choice where
accuracy and dependability are critical.
This feature rich instrument was designed to simplify physical exams and non-
invasive diagnostics, and with proper use and care these instruments will provide
many years of dependable service.
Read this booklet thoroughly before attempting to use your new ADC
®
Diagnostix™EENT instrument.
2. INTRODUCTION - INTENDED USE
These instruments are designed to facilitate examination of the eye, ear,
nose, throat, and skin.
If you have any questions call our toll-free number or visit our website.
Note: Only use ADC
®
instruments and accessories to ensure safe and
functional use of this product.
3. WARNINGS AND PRECAUTIONS
You have purchased a high quality ADC®DiagnostixTMinstrument which has been
manufactured to the highest global standards and is subjected to rigorous quality control.
Read these instructions for use carefully before putting the unit into operation and keep
them in a safe place.
If you should have any questions, call our toll-free number or visit our website. Our
address can be found on the last page of this booklet.
Please note that all instruments described in these instructions for use are only to be used
by suitably trained personnel.
The performance and efficency of these instruments are only guaranteed when genuine
®
parts and accessories are used.
ADC
Attention: There may be a risk of gases igniting when the instrument is used in the
presence of flammable or combustible gases. Working in areas with good
ventilation is recommended.
4
Never attempt to take the instrument apart! There is a danger of life-threatening
electrical shock. Unplug the instrument before cleaning or when disinfecting.
Warning:Do not use batteries, electrical cords other than those included with this product or
replacement parts supplied by the manufacturer.
Warning:Because prolonged intense light exposure can damage the retina, the use of the
device for ocular examination should not be unnecessarily prolonged, and the brightness setting
should not exceed what is needed to provide clear visualization of the target structures. This
device should be used with filters that eliminate UV radiation (<400 nm) and, whenever
possible, filters that eliminate short-wavelength blue light (<420 nm).
The retinal exposure dose for a photochemical hazard is a product of the radiance and the
exposure time. If the value of radiance were reduced in half, twice the time would be needed to
reach the maximum exposure limit.
While no acute optical radiation hazards have been identified for direct or indirect
ophthalmoscopes, it is recommended that the intensity of light directed into the patient’s eye be
limited to the minimum level which is necessary for diagnosis. Infants, aphakes and persons
with diseased eyes will be at greater risk. The risk may also be increased if the person being
examined has had any exposure with the same instrument or any other ophthalmic instrument
using a visible light source during the previous 24 hours. This will apply particularly if the eye
has been exposed to retinal photography.
Warning: Otoscope MUST be used with included disposable specula.
Warning: This product may contain a chemical known to the state of California to
cause cancer, birth defects, or other reproductive harm.
Caution: Not made with natural rubber latex.
Attention: Make sure to charge wall plug-in handles for at least 12 hours before
first use and for all subsequent charges to ensure optimal capacity and battery life.
TM
NOTE:To obtain the greatest performance from your Diagnostix
Instrument, it is
recommended that the instrument be used within a temperature range of 50°F (10°C) to
104°F (40°C), with a 10-95% relative humidity.
Caution: Observe the Operating Instructions
Device double-earthed
Classification
Type-B applied part - Otoscope head with speculum
To learn more, visit our website at: www.adctoday.com.
5
4. BATTERY HANDLES AND INITIAL USE
4.1. Function
The ADC
®
battery handles described in these Operating Instructions serve
to supply the instrument heads with power (the lamps are contained in
their respective instrument heads).
4.2. Battery Handle Options
All the instrument heads described in these Operating Instructions fit on
the following battery handles and can therefore be individually combined.
For Otoscopes, Ophthalmoscopes, Dermascope, Throat Illuminator,
Power Handles.
Wall Mounted Handle
(with extension unit)
Rechargeable Handle
(requires desk charger)
Plug-In Rechargeable Handle
Note: These handles are compatible with ADC
#
5660E 3.5v, 230v or 120v
#
5560 3.5v
#
5460 3.5v, 230v or 120v
®
, Riester*, and Welch Allyn*
3.5v instrument heads.
* Welch Allyn is a registered trademark.
* Riester is a registered trademark
4.3. Inserting and Removing Rechargeable
Batteries
Screw off the battery cap on the lower part of the
handle. Depending on which handle you have
purchased and for what voltage (Fig. 1), insert the
rechargeable battery into the casing such that the
positive end points toward the top of the handle. There
(Fig. 1)
is also an arrow next to the plus symbol on the
rechargeable battery, which shows you the direction to insert into the
handle. Screw the battery cap onto the handle to secure.
6
Plug-in Handle
Prior to initial use of the plug-in handle,
it should be charged for up to 24 hours
in the mains socket.
To charge Diagnostix
TM
standard
rechargeable handles, desk charger base
(# 5500) is required. Follow “Instructions
for Use” supplied with desk charger.
To change plug-in handle, remove top
portion by unscrewing counter-
Rechargable
Plug-in Handle
Recharger Base
sold separately
clockwise to reveal 2 prong plug in lower portion. Plug into electrical outlet.
CAUTION:
• If you do not plan to use the device for a long time or if you travel with it,
remove the rechargeable batteries from the handle.
• New batteries should be inserted once the light intensity of the
instrument becomes weaker, even on a full charge.
• To obtain the best possible light output we recommend always fitting
high quality batteries (as described in 4.3).
• If you suspect that liquid or moisture could have entered the handle, it
must not be charged under any circumstances. This could lead to a
life-threatening electric shock, especially in the case of plug-in handles.
• To extend the service life of the battery, the battery should only be
charged once the light intensity of the instrument has become weaker.
• Plug-in handle should be charged overnight (12 hours) to ensure
uninterrupted power supply.
NOTE for #5460: 3.5 V for charging in a 120 or 230 V wall socket.
When using the new 5460BAT, care must be taken to ensure that no
insulation is affixed to the spring of the battery-handle cap. If the old
5460BAT is used, an insulation must be affixed to the spring to avoid
short circuit.
New Old
7
Waste Disposal:
Please note that rechargeable batteries must be disposed of as special
waste. You can obtain the relevant information from your local authority
or from your local environmental agency.
4.4. Fitting Instrument Heads
Fit the required instrument head on the receptacle on the
upper part of the handle such that the two recesses of the
lower part of the instrument head fit on the two protruding
guide studs on the battery handle. Press the instrument head
lightly on to the battery handle and twist the handle
clockwise until securely locked (Fig. 2). The head is removed
by reversing the process.
4.5 Locking Instrument Head
(Fig. 2)
Instrument heads are equipped with a security feature. Use enclosed hex
key to lock head onto power handle. To secure, insert hex key into slot on
head and tighten by turning clockwise. Keep the hex key in a convenient
place in case the head must be removed for cleaning or service.
NOTE: Locking the head is recommended on wall mounted systems only.
4.6 Adjusting the Light Intensity
®
With the ADC
AdtronicTMelectronic rheostat, it is possible to modulate the
light intensity. Smoothly control the applied power by holding the easy grip
dial either turn clockwise or counter-clockwise, varying the light intensity stronger or weaker.
ATTENTION: At every switch-on of the battery handle the light intensity
is at 100%. Automatic safety switch-off after 180 seconds.
Explanation of the symbol on the plug-in handle:
Caution: Observe the Operating Instructions!
8
5. INSTRUMENT HEADS
All ADC
®
3.5v instrument heads are compatible with Riester and Welch
Allyn power handles equipped with bayonet style mount.
6. DIAGNOSTIX®OTOSCOPE
6.1. Purpose
The ADC
®
DiagnostixTMOtoscope described in these Operating
Instructions is produced for illumination and examination of the auditory
canal in combination with the ear specula. The ADC
®
Diagnostix
TM
Otoscopes are compatible with Riester, or Welch Allyn speculum.
6.2. Fitting and Removing Ear Specula
Screw the speculum clockwise until noticeable resistance is felt. To
remove the speculum, twist the speculum counter-clockwise.
6.3 Swivel Lens for Magnification
Standard Series: The swivel lens (3x max.) is fixed to
the device and can be swiveled 360° (Fig. 3).
PMV Series: The focusing wheel allows you to adjust
the focusing range. The adjustment wheel moves up
and down to focus the lens (Fig. 4).
6.4 Insertion of External Instruments into the Ear
(Fig. 3)
Standard Series only: If you wish to insert external
instruments into the ear (e.g. tweezers), you have to
rotate the swivel lens located on the otoscope head by
180°.
6.5 Pneumatic Test
To perform the pneumatic test (examination of the
eardrum), an insufflator is required to be connected (sold
separately (
#
5122N). The tube for the insufflator is
(Fig. 4)
attached to the connector port on the right side of the
instrument head (Fig. 5). Now you can carefully insert the
necessary volume of air into the ear canal.
(Fig. 5)
9
6.6 Technical Data of the Lamp
Otoscope XL 3.5 V 3.5 V 720 mA mean life span 15h
Otoscope LED 3.5 V 3.5 V 28 mA mean life span 100,000h
7. DIAGNOSTIX®OPHTHALMOSCOPE
7.1. Purpose
The ADC
®
DiagnostixTMOphthalmoscope described in
these Operating Instructions is produced for the
examination of the eye.
7.2. Lens Wheel with Correction Lens The
correction lens can be adjusted on the lens wheel. The
following correction lenses are available:
Standard Head
(Fig. 6)
Coax 3.5v Ophthalmoscope (Fig. 6).
Plus: 1-10, 12, 15, 20, 40
Minus: 1-10, 15, 20, 25, 30, 35
Coax Plus 3.5v Ophthalmoscope (Fig. 7).
Plus: 1-45 in single steps
Minus: 1-44 in single steps
The values can be read off in the illuminated field
of view. Plus values are displayed in green numbers,
Premium Head
(Fig.7)
minus values with red numbers.
7.3. Apertures
The following apertures can be selected with
the aperture hand-wheel (Fig. 8).
10
Switching Aperture
(Fig.8
Coax Ophthalmoscope:
Semi-circle, small/medium/large circular aperture, fixation star and slit.
Coax Plus Ophthalmoscope:
Semi-circle, small/medium/large circular aperture, fixation star, slit and grid.
Aperture Function Model(s)
Half Moon For examinations with turbid lenses Coax/Coax Plus
Micro Spot Allows quick entry into small, undilated pupils Coax/Coax Plus
Small Circle Excellent view of fundus through an undilated pupil Coax/Coax Plus
Large Circle For a dilated pupil and general examination Coax/Coax Plus
Karo (Grid) For topographic determination of retina changes Coax Plus Only
Slit To help determine levels of tumors and lesions Coax/Coax Plus
Fixation star Measuring eccentric fixation or locating lesions Coax/Coax Plus
7.4. Changing Filters
Using the filter wheel, the following filters can be switched for each aperture.
Coax & Coax Plus Ophthalmoscope:
Red-free filter, blue filter, and polarisation filter.
Filter Function
Red-free filter: Contrast enhancing to assess fine
vascular changes, e.g. retinal bleeding.
Polarisation filter: For precise assessment of tissue colors
and to minimize retinal reflections.
11
Blue filter: For improving recognition of vascular
abnormalities or bleeding, for fluorescence
ophthalmology.
7.5. Focusing Device (Coax Plus)
Fast fine adjustment of the examination area to be
observed is achieved from various distances by
turning the focusing daisywheel (Fig. 9).
(Fig 9)
7.6. Technical Data on the Lamp
Coax 3.5 V ophthalmoscope: 3.5v / 690 mA / average service life 15 h
Coax Plus 3.5 V ophthalmoscope: 3.5v / 29 mA / average service life 100,000 h
8. DIAGNOSTIXTMDERMASCOPE
8.1. Purpose
The Diagnostix
®
Dermascope described in these Operating Instructions is
produced for early identification of changes of skin pigmentation
(malignant melanomas).
8.2. Focusing
Focus the magnifying glass by rotating the eyepiece
ring (Fig. 10).
8.3. Contact Plates
(Fig. 10)
Two contact plates are supplied:
1) Without a scale.
2) Including a scale of 0 - 10 mm for measuring melanotic skin changes,
such as malignant melanoma.
12
8.4. Technical Data of Lamp
Dermascope LED: 3.5 V 28 mA / mean life span 100,000h
9. DIAGNOSTIXTMTHROAT ILLUMINATOR
9.1. Purpose
The throat illuminator described in these Operating Instructions is
produced for examination of the oral cavity and pharynx in combination
with commercial wooden and plastic blades.
9.2. Technical Data of Lamp
Illuminator XL 3.5 V 720 mA mean life span 15h
Illuminator LED 3.5 V 28 mA mean life span 100,000h
10. REPLACING THE LAMP
All Instrument Heads
Remove the instrument head off the battery handle. The lamp is located
at the base of the instrument head. Pull the lamp out of the instrument
head with thumb and forefinger or a suitable tool. Insert a new lamp.
CAUTION: The pin on the ophthalmoscope lamp must be inserted into
the guide groove on the instrument head.
*Use only ADC
®
, or Riester lamps.
11. SPARE PARTS AND ACCESSORIES
For a complete list of our physical exam instrument spare parts and
accessories, please visit our website at www.adctoday.com.
13
12. CLEANING AND DISINFECTION
Cleaning and disinfection of the medical devices serves to protect the
patient, the user and third parties and to preserve the value of the medical
devices. Due to the product design and the materials used, no defined
limit can be specified for the maximum number of reprocessing cycles that
can be carried out. The life span of the medical devices is determined by
their function and by gentle handling of the devices. Defective products
must undergo the reprocessing procedure described before being returned
for repair.
Cleaning and Disinfection The instrument heads and handles can be
cleaned externally with a moist cloth until visually clean. Wipe
disinfection as specified by the disinfectant manufacturer. Only
disinfectants with proven efficacy should be used, taking into account the
national requirements. After disinfection, wipe the instrument down with a
moist cloth to remove possible disinfectant residues. The components that
come into contact with the skin can be rubbed down with alcohol or a
suitable disinfectant.
Please Note!
• Never immerse the instrument heads and handles in liquids!
Take care to ensure that no liquids get inside the casing!
• This item is not approved for automated reprocessing and sterilization.
Single-Use Ear Specula
For single Use Only
WARNING: Repeated use can cause infections.
14
13. TECHNICAL SPECIFICATIONS
Ambient Temperature: 32°F-104°F (0°C to +40°C)
Relative Humidity: 30% to 70% non-condensing
Transport and Storage
Temperature: 14°F-131°F (-10°C to +55°C)
Relative Humidity: 10% to 95% non-condensing
14. MAINTENANCE
These instruments and their accessories do not require any specific
maintenance. Should an instrument have to be examined for any specific
reason whatsoever, please return it to ADC
®
.
15. ELECTROMAGNETIC COMPATIBILITY
Medical electrical equipment is subject to special precautionary measures
with regard to electromagnetic compatibility (EMC).
Portable and mobile high-frequency communication equipment can
influence medical electrical equipment. This ME device is intended for
operation in an electromagnetic environment as specified below. The user
of the device should ensure that it is operated in such an environment.
The ME device must not be used directly next to or arranged in a stack
with other devices. If the device has to be operated near to or in a
stacked arrangement with other devices, then the ME device should be
monitored in order to verify that it operates as intended in this
arrangement. This ME device is intended exclusively for use by
professional medical staff. This device can cause radio interference and
can disrupt the operation of equipment nearby. Suitable remedial
measures, such as for instance re-alignment, re-arrangement of the ME
device or shielding, can become necessary.
15
Guidelines and manufacturer's declaration - electromagnetic emissions
The Diagnostix
TM
insrument is intended for operation in an electromagnetic
environment as specified below. The customer or the user of the Diagnostix
instrument should ensure that it is used in such an environment.
Emission
Measurements
HF emissions according
to CISPR 11
Compliance
Group 1
Electromagnetic Environment
Guidelines
The Diagnostix
TM
instrument employs HF
energy solely for an internal function. Its
HF emission is therefore very low and it
is unlikely that neighboring electronic
devices will be affected by interference.
TM
HF emissions according
to CISPR 11
Class B
The Diagnostix
for use in all facilities, including living
instrument is intended
quarters and such as are directly
Harmonics emissions
according to
EC61000-3-2
Not applicable
connected to a public power supply that
also supplies buildings that are used for
residential purposes.
TM
Voltage fluctuation /
flicker emissions
according to
IEC61000-3-3
Not applicable
16
Guidelines and manufacturer's declaration - electromagnetic emissions
The Diagnostix
The customer or the user of the Diagnostix
Electrostatic discharge
(ESD) according to
Fast transient electrical
interference/bursts
Voltage dips, short-time
interruptions and
fluctuations in the
supply voltage according
to IEC61000-4-11
TM
Immunity
Tests
IEC61000-4-2
according to
IEC61000-4-4
Surges
IEC61000-4-5
instrument is intended for operation in an electromagnetic environment as specified below.
IEC 60601
Test Level
± 6 kV contact
discharge
± 8 kV air discharge
± 2 kV for power
lines
± 1 kV for input and
output lines
± 1 kV voltage
phase-to-phase
± 2 kV voltage
phase-to-earth
<5% UT (>95 % drop
in UT) for 0.5 cycles
40% UT (60 % drop
in UT) for 5 cycles
70 % UT (30 % drop
in UT) for 25 cycles
<5% UT (>95 % drop
in UT) for 5 s
Magnetic field at the
3 A/m 3 A/m
mains frequency (50Hz)
according to IEC61000-4-8
TM
instrument should ensure that it is used in such an environment.
Compliance
Level
± 6 kV contact
discharge
± 8 kV air
discharge
Electromagnetic
Environment Guidelines
Floors should be made of wood or
concrete or be covered with
ceramic tiles. If the floor is
covered with a synthetic material,
the relative air humidity must be
at least 30%.
The quality of the supply voltage
Not applicable
should correspond to that of a
typical business or hospital
environment.
The quality of the supply voltage
Not applicable
should correspond to that of a
typical business or hospital
environment.
The quality of the supply voltage
should correspond to that of a
typical business or hospital
Not applicable
environment.
If image disturbances occur, the
TM
Diagnostix
instrument may have
to be placed further away from the
sources of mains-frequency
magnetic fields, or magnetic
shielding may have to be installed:
the mains-frequency magnetic
field should be measured at the
intended set-up site in order to
ensure that it is small enough.
Note - UT is the alternating supply voltage prior to application of the test level.
17
Guidelines and manufacturer's declaration - electromagnetic immunity
This
TM
Diagnostix
Instrument model is intended for operation in the electromagnetic environment specified below.
The customer or the user of this
Immunity
Tests
Conducted HF
interference
according to
IEC61000-4-6
Radiated HF
rerference cording
to C61000-4-3
TM
Diagnostix
instrument should ensure that it is used in such an environment.
IEC 60601
Test Level
3 Vrms
150 kHz to 80MHz
3 V/m
80 MHz to 2.5GHz
Compliance
Level
Not applicable
10 V/m
3 V/m
Electromagnetic
Environment Guidelines
Portable and mobile radio
equipment should not be used
within a distance from the
TM
Diagnostix
instrument, including
cables, that is less than the
recommended safety distance as
calculated by the equation that is
appropriate for the transmission
frequency.
Recommended safety distance:
d = 1.2ìP
d = 1.2ìP 80 MHz to 1000 MHz
d = 2.3ìP 1400 MHz to 2.5 GHz
Where P is the nominal power of
the transmitter in Watts (W) as
specified by the manufacturer of
the transmitter, and d is the
recommended safety distance in
meters (m).
The field strength of stationary
radio transmitters should be less
than the compliance level at all
frequencies as verified by an on-
a
site test
Interference is possible in the
vicinity of equipment marked with
the following symbol
Note 1: At 80 MHz and 800 MHz, the higher value applies.
Note 2: These guidelines may not apply in all situations. The propagation of electromagnetic waves is influencedby reflection and absorption by
buildings, objects and people.
a. The field strength of stationary transmitters, such as base stations of wireless telephones and mobile field radio services, amateur radio
stations, AM and FM radio and television transmitters cannot be precisely determined theoretically in advance. In order to determine the
electromagnetic environment due to stationary HF transmitters, an investigation of the location is advisable. If the field strength determined
at the location of the Diagnostix
monitored with regard to its normal operation at each place where it is used. If unusual performance characteristics are observed, additional
measures such as re-alignment of the Diagnostix
b. In the frequency range of 150 kHz to 80 MHz, the field strength should be smaller than 3 V/m.
TM
Instrument exceeds the compliance level indicated above, then the Diagnostix
TM
Instrument or its removal to another place may be necessary.
18
TM
Instrument must be
Recommended safety distances between portable and mobile HF communication devices and the Diagnotix®L
This Diagnostix
minimum distances between portable and mobile HF communication equipment (transmitters) and this Diagnostix
For transmitters whose nominal power is not indicated in the table above, the distance can be determined using the equation belonging to
the respective column, where P is the nominal power of the transmitter in Watts (W) as specified by the manufacturer of the transmitter.
Note 1: At 80 MHz and 1400 MHz, the distance for the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. The propagation of electromagnetic waves is influenced by reflection and absorption
by buildings, objects and people.
TM
monitored. The customer or user of this Diagnostix
instrument is intended for operation in an electromagnetic environment in which the radiated HF interference is
as recommended below, depending on the maximum output power of the communication equipment.
Nominal power of
the transmitter
W
0.01 0.12 0.23
0.01 0.38 0.73
1 1.2 2.3
10 3.8 7.3
100 12 23
150 kHz to 80 MHz
TM
instrument can help prevent electromagnetic interference by observing
Safety distance that applies to the transmitter frequency m
80 MHz to 1000 MHz 1400 MHz to 2.5GHz
Not applicable
d = 1.2ìP d = 2.3ìP
TM
instrument
16. WARRANTY
This DiagnostixTMInstrument is warranted for 2 years on instruments
and Lifetime on LED lamps, from date of purchase. This warranty
includes the instrument. The warranty does not apply to damage
caused by improper handling, accidents, improper use, or alterations
made to the instrument by third parties. The warranty is only valid after
the product is registered online at www.adctoday.com.
19
17. QUALITY STANDARDS
Device standard:
This device is manufactured to meet the European and United States
standards for:
ISO 62471:2008, ISO 15004, ISO 10942, ISO 15004-1, and ISO 15004-2
Electromagnetic compatibility:
Device fulfills the stipulations of the International standard IEC60601-1-2
18. HOW TO CONTACT US
To register your product and obtain further detailed user
information about our products and services visit us at:
www.adctoday.com
and follow the links.
For questions, comments, or suggestions call us toll free at:
1-800-232-2670
ADC
55 Commerce Drive
Hauppauge, NY 11788
ADC (UK) Ltd.
Unit 6, PO14 1TH
United Kingdom
Type BF applied part
IB p/n 93-5400-00 rev 2
Consult instructions
for use
Inspected and Packaged in the U.S.A.
Made in Germany
tel: 631-273-9600
toll free: 1-800-232-2670
fax: 631-273-9659
www.adctoday.com
email: info@adctoday.com
Printed in U.S.A.
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