ITALECO FEDMED11 User manual

INSTRUCTION MANUAL
MANUALE D’ISTRUZIONI
DM 93/42/CEE (MODIFIED BY DIRECTIVE 2007/47/CE)
MEDICAL DEVICE IN CLASS 1 WITH MEASUREMENT FUNCTIONS
COMPLIANCE WITH UNI EN ISO 1041:1998
MODELS
FEDMED11 FEDMEDM1500 FEDMED700U1 FEDMEDM7500PLD FEDMED1500LD
FEDMED100 FEDMEDM1500LD FEDMED700U2 FEDMED100PLD FEDMEDM100
FEDMED100M FEDMEDM1500P FEDMED700IR FEDMED1500PLD FEDMEDM100M
FEDMED100LD FEDMED100LD40 FEDMED700UW FEDMEDM100PLD FEDMEDM100LD
FEDMED100UWLD FEDMED600 FEDMEDM700 FEDMEDM1500PLD FEDMEDM100UWLD
FEDMED100P FEDMED600P FEDMEDM700P FEDMED1500UW FEDMEDM600IR
FEDMED100IR FEDMED600LD FEDMEDM700LD FEDMEDM1500UW FEDMEDM600UW
FEDMED100U1 FEDMED600U1 FEDMEDM700U1 FEDMED1500U2 FEDMED700
FEDMED100U2 FEDMED600U2 FEDMEDM700U2 FEDMEDM1500U2 FEDMED700P
FEDMED100UW FEDMED600IR FEDMEDM700IR FEDMED1500U1 FEDMED700LD
FEDMED100N FEDMED600UW FEDMEDM700UW FEDMEDM1500U1 FEDMED2500P
FEDMED1500 FEDMEDM600 FEDMED100P4 FEDMED100UW2 FEDMEDM7500
FEDMED1500P FEDMEDM600P FEDMEDM100P FEDMED1500UW2 FEDMEDM7500P
FEDMED21 FEDMEDM600LD FEDMEDM100UW FEDMEDM100UW2 FEDMEDM7500LD
FEDMED200 FEDMEDM600U1 FEDMEDM100P4 FEDMEDM1500UW2 FEDMEDM1500N
FEDMED300 FEDMEDM600U2 FEDMED2500 FEDMED1500N FEDMEDM100N
FEDMEDM700PLD FEDMED1500IRU
0068
Copyright 2008, ITALECO S.R.L. All rights reserved.
Copies, whole or partial duplication, in any form, of this manual is forbidden without the written authorisation by ITALECO S.R.L.
S/N: 0001 Rev. 3 printed in 2011

2
WARNING
!
THE USERS
SHOULD READ THIS MAN
UAL
VERY
CAREFULLY BEFORE USING THE DEVICE
ITALECO S.R.L. will not be held responsible in case of damages or injuries due to an
illegal or improper use of the product resulting from failure to follow instructions, warnings,
notices or indications for use published in this book.
DinoCapture © software provided with this device is under Anmo Electonics Corporation
Copyright or its suppliers.
All rights are reserved. The software is protected by copyright law and the provisions of
applicable international treaties. In accordance with these laws, the licensee is permitted to
use a copy of the software embedded in it in the manner provided for the operation of the
product in which it is incorporated. The software can not be copied, decompiled, reversed,
disassembled or reduced in any form.
The software or copies of the software are not for sale, all right, title and ownership of the
software belongs to Anmo Electonics Corporation or its suppliers.
For further information about the device, please contact:
MANUFACTURER:
ANMO ELECTRONICS CORPORATION
5F-1, No.76, Sec. 2, Dung-Da Road, Hsinchu 300, Taiwan
Tel:[phone]
Fax:[phone]
http://www.anmo.com.tw
OFFICIAL AND AUTHORISED DISTRIBUTOR:
ITAL
ECO SRL
Via Giulio Pastore 8, 10024, Moncalieri (To), Italy
Tel: [phone]
Fax: [phone]
http://www.dinolitemedical.com
Manufactured in: 2011

3
Summary
1. UNPACKING...................................................................................................................................... 4
2. PACKAGE CONTENTS .................................................................................................................... 4
3. SYMBOLS .......................................................................................................................................... 5
4. WARNINGS ....................................................................................................................................... 7
5. INTRODUCTION ............................................................................................................................... 9
6. DESTINATION OF USE ..................................................................................................................10
7. GENERAL GUIDELINES FOR HANDLING ...................................................................................11
8. GENERAL MAINTENANCE ............................................................................................................12
9. INSTRUCTION FOR THE THREE CONFIGURATIONS OF USE ..............................................13
9.1 COMMON PROCEDURES FOR THE THREE CONFIGURATIONS ......................................13
9.2 HOW TO USE THE DERMATOSCOPE.....................................................................................14
9.3 HOW TO USE EARSCOPE ........................................................................................................15
9.4 HOW TO USE THE MICROSCOPE WITH DENTAL MIRROR HOLDER ..............................16
10 MEASUREMENT FUNCTION .....................................................................................................18
11 CALIBRATION FUNCTION .........................................................................................................20
12 FREQUENCY OF CALIBRATION...............................................................................................22
13 INSTALLATION ............................................................................................................................23
13.1 MINIMUM SYSTEM REQUIREMENTS ......................................................................................23
13.2 DINO CAPTURE SOFTWARE INSTALLATION ........................................................................23
14 ACCESSORIES ............................................................................................................................27
15 CLEANING THE MICROSCOPE ................................................................................................28
16 CLEANING SPECULUM..............................................................................................................28
17 CLEANING CONTACT CAPS .....................................................................................................28
18 CLEANING THE DENTAL MIRROR HOLDER..........................................................................28
19 DISPOSAL ....................................................................................................................................29
20 WARRANTY..................................................................................................................................30

4
1. UNPACKING
Please handle with care, to avoid risk of injury.
It is the owners responsibility to ensure that all the necessary components are present.
2. PACKAGE CONTENTS
A Dino-Lite digital microscope
DinoCapture software on CD
A protective soft case
An Instruction Manual
Depending on the intended use of the digital microscope the package will also contain:
•Contact transparent caps (Small and Large) for dermatological surveys
•A “speculum“ pack for otoscopical surveys
•A dental mirror holder
•A stand on which you can put the device after its use
•A rack with P/N “Amita”

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3. SYMBOLS
The symbols shown in the following pages can be found on DINO-LITE DIGITAL
MICROSCOPE packaging, or in this book
WARNING SYMBOLS
WARNING in this manual indicates the conditions and procedures that if not
met could cause injury or damage to the user, the patient or improper use of
the device
ATTENTION on the product means "see the documentation attached"
SYMBOLS FOR STORAGE, TRANSPORT, THE ENVIRONMENT
High
Fragile Keep dry
CERTIFICATION SYMBOLS
0068 Indicates that the product meets
the essential requirements of the
Directive 93/42/EEC on medical
devices
Indicates a Type
B applied,
because the
microscope must
be in contact with
the patient
ANMO
ELECTRONIC
CORPORATION
Indicates the name of
the Manufacturer
ITALECO SRL
Via G. Pastore,8
10024 Moncalieri
(TO), ITALY
Indicates the
name and
address of the
entity responsible
for the products
according to
European
standards
5F-1, No.76, Sec. 2, Dung-Da
Road, Hsinchu 300, Taiwan IDENTIFICATION SYMBOLS

6
Followed by an
alphanumeric code is
the lot code
Followed by an
alphanumeric
code and a date
indicates the
serial number
and year of
manufacture
FURTHER SYMBOLS
Indicates that the product complies with Directive 2002/95/EC on the
reduction of hazardous substances in electrical and electronic
equipment
Indicates that the product at the end of its useful life must be collected
separately from other waste
It must be disposed of in accordance with local WEEE regulations
Federal Telecommunications Commission (FCC, Federal
Communications Commission)
An U.S. commission, indicates that the product does not cause
interference with other devices commonly found in the office or at
home

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4. WARNINGS
Read these instructions carefully before using the Digital Microscope Dino-Lite
The following warnings are related to the use of generic Digital Microscope Dino-Lite.
The warnings for specific procedures, such as measurement, calibration, connecting
accessories are included in the relevant sections of the manual.
A different use of the Dino-Lite than as described in this manual, can endanger the health
of the patient and the person using the microscope.
The device is suitable for external use only and non-invasive measurements
The device does not make diagnoses, but only measurements. The results of
the measurements must be read and interpreted by a doctor
.
Do not put Dino-Lite microscope in human or animal apertures. RISK OF
SERIOUS INJURY!
Do not put your fingers or other objects in the cavity containing the LED light
Keep out of reach of children
Do not use the microscope without accessories
Always make sure that the accessories have been regularly cleaned and
disinfected before and after use
Before handling the microscope and accessories wear disposable gloves to
maintain a high level of cleanliness and hygiene
Do not direct the beam of light toward the eyes
Not to be used to capture images of or to video the eye
Do not use the device in contact with areas of the body that have injuries or
wounds that are inflamed, swollen or painful

8
Do not use the microscope on wet skin or sweat
Using Dino-Lite, its accessories and devices associated with it without the
presence of properly trained personnel can cause irreparable damage such as
(just an example) the eardrum injury, injuries and skin irritation
Do not use the device simultaneously with other transactions that could
penetrate to dust, water or other substances into the device such as (just an
example) cleaning teeth, descaling
Do not use the device in close proximity to high heat, magnetic fields
Do not use the device in contact with lenses, glasses or other surfaces that can
change the perceptions of the images
Place the Amita stand only on a flat surface

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5. INTRODUCTION
Thank you for purchasing a DINO-LITE DIGITAL MICROSCOPE.
This product is designed to assist in improving the accuracy of diagnosis.
Only a well-documented image allows the examiners to compare their analysis with the
result of other forms of investigation. In addition, a series of images derived from
comparative tests repeated in a certain period of time allows an assessment of possible
diseases and a more timely verification of the effectiveness of treatment prescribed or
implemented to the patient. The Dino-Lite microscope is capable of attaching to the visual
image (magnification, photos, video) a detailed metrology verification.
.
Dino-lite despite being extremely easy to use is a medical device, and we
therefore recommend reading this book before using the equipment
WARNING! The measurement results are provided only as a guide for users
and should not be used for the formulation of a diagnosis

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6. DESTINATION OF USE
The DINO-LITE DIGITAL MICROSCOPE is a medical device that is used in conjunction
with supplied accessories in three different configurations and can allow you to observe
the skin, the hearing canal and the oral cavity.
The DINO-LITE DIGITAL MICROSCOPE allows you to make measurements through the
analysis of digital images captured using the software DinoCapture.
The technology also allows the device to display in real time on a PC monitor video
captured during the operation.
The device has a LED embedded light source used to illuminate the skin, the inside of the
hearing canal, or the oral cavity.
The LED lights are switchable (ON/OFF) by software (except the model AM311H).
A PC is required for the DinoCapture software to run (please see minimum requirements).
The device is powered via the USB connection to the PC.
The image can be captured by using the mouse or Microtouch placed on the handle of the
microscope.
The device can be used in three specific configurations based on the type of accessories
used:
A – DERMATOSCOPE CONFIGURATION
B – OTOSCOPE CONFIGURATION
C – MICROSCOPE CONFIGURATION WITH DENTAL MIRROR HOLDER
Before being used, and accordingly to the specific purpose, the microscope must have the
relevant attachment fitted to it:
•The contact caps for using the device as a dermatoscope
•The hearing speculum (measurements 3mm, 4mm, 5mm) for using the device as an
otoscope
•The dental mirror holder for mouth and teeth inspection
WARNING! THE DEVICE IS NOT INTENDED FOR CLINICAL
INVESTIGATIONS

11
7. GENERAL GUIDELINES FOR HANDLING
We would always recommend wearing disposable gloves when using the microscope,
however this can reduce the sensitivity of touch when operating the device.
Do not use the microscope with wet hands
Do not use the microscope if damaged or if it does not work correctly
Always ensure that the device is properly connected to the hardware on which
you installed the software supplied
Do not twist the usb cable when using the device
Do not subject the microscope to sudden shocks

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8. GENERAL MAINTENANCE
Check the product and accessories before use, even after it has been cleaned.
Disinfection of the instrument is needed before use (the assessment has to be performed
by the doctor).
The product is made of materials resistant to corrosion and environmental conditions
provided for normal use, and does not require specific attention, but it must be kept in a
closed environment, clean and dry, avoiding exposure to light and protecting it from dust in
order to ensure the hygiene conditions.
Do not place the device and accessories in direct sunlight, high temperatures or
in humid or dusty places
After using the microscope always separate from accessories and specula,
cleaning them with a mild disinfectant solution, then proceed with the
procedures for cleaning and disinfection the rest of the equipment, put headsets
and specula in the case provided, taking care to disconnect the Dino-Lite from
power supply or USB port
Do not immerse the microscope in liquids
DO NOT EVER DISASSEMBLE the microscope

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9. INSTRUCTION FOR THE THREE CONFIGURATIONS OF USE
9.1 COMMON PROCEDURES FOR THE THREE CONFIGURATIONS
a) Put the part to be observed below and in the center of the illuminated area of your
Dino-Lite microscope
b) It is advisable to start working at minimum magnification (turn the wheel of the
microscope until the arrow matches 20x). Place the microscope at a distance
greater than 3cm from the subject to enlarge
c) Slide under the cover/optic the subject you wish to see in order to visualise the area
d) Turn the wheel of focus to maximise viewing and have a sharper image
e) To use the microscope at a magnification between 20x and 50x, move progressively
the cover closer to the surface of the subject and proceed to enlarge the focus as in
the preceding paragraph
f) To use the microscope at a magnification of 200x it is necessary to bring the cover
of the microscope in contact with the subject, then using the wheel to focus on the
object
g) Always use the procedures described above, being careful that the lenses are not in
direct contact with the part to be observed
h) Click on "capture" and then on "image" or "video" from DinoCapture software to
take the picture that interests you or to start recording video
N.B. For optimal use of the microscope without support grip the device between thumb
and index accommodating it in the palm of the hand and using your thumb to rotate the
wheel of focus. The tool can be rotated on its axis in order to achieve the rotation of the
image on the screen.
Find below the instructions for the use of the three configurations:
•DERMATOSCOPE (in combination with contact caps)
•EARSCOPE (in combination with hearing speculums)
•MICROSCOPE WITH DENTAL MIRROR HOLDER
The user is reminded that for each configuration, the appropriate accessories
have to be used.
The device can’t be used for different applications from its purpose!
Do not use the microscope without the accessories!
Picture 1 Picture 2 Picture 3
Please note the images shown are for illustration purposes only.
Pictures 1, 2, 3 were taken with the dermatoscope configuration, however the steps are the
same for all models.

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9.2 HOW TO USE THE DERMATOSCOPE
In dermatology this medical device must be used in conjunction with small plates in
contact with the skin (for this configuration). This allows you to observe the skin and make
measurements by analysis of photos or digital video captured by the device.
Contact caps are designed and suitable for use in digital photos.
For the documentation of images in dermatological practice, you must have some
experience in the field of dermatology and a basic knowledge of photography. It is
important to establish a pattern of systematic workflow to ensure the best management of
the pictures, in the event of subsequent tests and visits of the patient the search of the file
related to the picture has to be very fast and easy.
In this configuration the Dino-Lite provides the dermatologist a valuable method for
improving the accuracy of the analysis. The device is able to measure the length (including
the calculation of areas) and the amplitude of plane angle.
The measurements are made by DinoCapture software previously installed on a personal
computer.
Put the contact cap on the microscope (simply push to fit) request the patient to take a
comfortable position and hold still for the duration of the examination:
•Connect the microscope to the computer
•Start the software DinoCapture (previously installed)
•moisten the contact cap and the skin of the patient with disinfectant or oil for
dermatoscopy
•Put the contact cap on the skin of the patient
•Choose image or video to capture
•Use the focus wheel to obtain the required size of the picture
•Verify on the focus wheel the current magnification
•Capture the pictures or videos using microtouch
•Move the device from the patient
•Place the device on the Amita support (if present)
•The patient can now relax
•Move your mouse cursor on the picture to preview the photo on the left side
of the screen (Picture 1)
•On the top of the screen you can enter the patient information and other
notes deemed necessary (Picture 2)
•Click on Save as choosing the desired resolution (Picture 3)
•Save in your computer using the coding system of the patient deemed
necessary (Picture 2)
•To make measurements see Chapter 10
Dermatoscope investigations must be achieved by keeping the device perpendicular to the
surface inspected in order to minimize the distortion of perspective of the captured image.
The device is intended for external use only
Do not use the device in contact with areas of the body showing wounds,
injuries, body parts inflamed, swollen or painful

15
9.3 HOW TO USE EARSCOPE
This medical device is used in conjunction with a speculum (sizes 3, 4, 5mm) which allows
you to perform visual examinations of the hearing canal outside of the walls of the eardrum
through direct analysis of otoscopic photos or digital video caught by the device.
The speculum is made of reusable polypropylene.
In this configuration the device offers doctors a valuable method for improving the
accuracy of the visual analysis.
The measurements are made by DinoCapture software previously installed on a personal
computer.
To be used as otoscope the Dino-Lite requires the deployment of a speculum CE marked
made of reusable polypropylene. The speculum requires a special procedure for cleaning
and disinfection as described in the special paragraph.
Put the speculum on the device before capturing pictures or video (simple joint) and ask
the patient to take a comfortable position and to remain immobile for the duration of the
visit.
•Connect the microscope to the computer
•Start the software DinoCapture (previously installed)
•Moisten the contact cap and the skin of the patient with disinfectant or oil for
dermatoscopy
•Put the contact cap on the skin of the patient
•Choose image or video to capture
•Zoom acting on the wheel to obtain the required size of the picture see
previous page amendments
•Verify on the focus wheel the current magnification
•Captures pictures or videos using microtouch
•Move the device from the patient
•Place the device on the Amita support (if present)
•Tell the patient is able to move again
•Move your mouse cursor on the picture preview just took the photo on the left
side of the screen (Picture 1)
•On the top of the screen you can enter patient information and other notes
deemed necessary (Picture 2)
•Click on Save as choosing the desired resolution (Picture 3)
•Save in your computer using the coding system of the patient deemed
necessary (Picture 2)
•To make measurements see Chapter 10
Earscopic investigations must be achieved by keeping the device parallel to the
floor of the room in order to minimize the risk of eardrum perforation caused by
the fall of the microscope or speculum
The device is intended for external use only.
Measurement or visual surveys of the ear and the hearing canal must be
conducted exclusively by using a speculum (CE marked)
Make sure that the Dino-lite has been regularly connected to the PC prior to the
application of the speculum on the body of the device

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9.4 HOW TO USE THE MICROSCOPE WITH DENTAL MIRROR HOLDER
In the dental field the device with the appropriate accessories holder for dental mirror may
be used to perform visual examinations of the oral cavity, through direct analysis in real
time on the monitor or later through the analysis of the video and images captured and
stored via software.
In this configuration the microscope facilitates the dentist during the inspection of the oral
cavity allowing a better view and a better working posture and ergonomics.
Put the mirror into the holder microscope as described in Figures 4, 5, 6, ask the patient to
take a comfortable position and to remain immobile for the duration of the visit
•Connect the microscope to the computer
•Start the software DinoCapture (previously installed)
•Choose image or video to capture
•Zoom acting on the wheel to obtain the required size of the picture
•Verify on the focus wheel the current magnification
•Captures pictures or videos using microtouch
•Move the device from the patient
•Place the device on the support Amita (if present)
•Tell the patient is able to move again
•Move your mouse cursor on the picture preview just took the photo on the left
side of the screen (Picture 1)
•On the top of the screen you can enter patient information and other notes
deemed necessary (Picture 2)
•Click on Save as choosing the desired resolution (Picture 3)
•Save in your computer using the coding system of the patient deemed
necessary (Picture 2)
•To make measurements see Chapter 10
The device is intended for external use only
Do not enter the microscope in the oral cavity
Make sure that the holder has been regularly cleaned and disinfected before use
Do not to use the microscope simultaneously with the cleaning and dental
descaling
Do not make measurements in configuration with the support of the holder of
dental mirror as the reflection in the mirror is a projection of the real image.
Therefore, the measurements made on reflected images will be inaccurate

17
Picture
4
Fill the dental mirror
in the proper support
(holder)
Picture
5
Position the mirror in
line with the lens of
the microscope
Picture
6
Screw closely
Picture
7
Pressing the button
placed on the holder
you can rotate 90
degrees the dental
mirror around the
microscope

18
10 MEASUREMENT FUNCTION
The uncertainty of the measurements following the procedures and conditions operation
outlined in this manual is ± 3%
During the measurement is essential to keep the microscope perpendicular to the
surface to be examined

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Measurement function with DinoCapture 2.0
1. Click on the measure icon on the top right corner of the image or live video
you want to measure.
2. You would be prompted to input a magnification. Input the magnification
3. value located on the Dino-Lite in the box that says “Mag”.
3. Start measuring by selecting a measure tool.
For example select the distance measurement.
4. Left click your mouse once to start the measurement.
5. Left click you mouse once more to end the
measurement.
Hint: For more accurate measurements, click on the magnify icon located
at the top right corner of the child window after selecting a measurement tool.

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11 CALIBRATION FUNCTION