Frey TN-100 User manual

TN-100
NON-CONTACT TONOMETER
OPERATION MANUAL
All specifications are subject to changes without notice.
September 2018.
24-24 04.04
1434 FREY S.J.
05-502 Piaseczno
ul. Wołodyjowskiego 38
POLAND
Tel:[phone]
E-mail: [e-mail]
www.freymedical.eu

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Operation Manual 24-24 04.04
TABLE OF CONTENTS
1 INTRODUCTION....................................................................................... 5
2 SYMBOLS ............................................................................................... 6
SYSTEM DESCRIPTION ................................................................................... 7
3 SAFETY PRECAUTIONS........................................................................... 8
Intended use............................................................................................. 8
Installation................................................................................................ 8
Precautions during operation....................................................................... 9
Interferences .......................................................................................... 11
4 PACKAGE CONTENT ............................................................................. 12
5 GLOSSARY ........................................................................................... 13
6 DEVICE DESCRIPTION........................................................................... 14
6.1 Ope ato 's side view ..................................................................... 14
6.2 Patient's side view........................................................................ 15
6.3 Bottom side view.......................................................................... 16
6.4 Cont ol panel ............................................................................... 17
6.5 Display ........................................................................................ 18
6.5.1 Main screen .............................................................................. 18
6.5.2 Common settings ....................................................................... 20
6.5.3 Tonometer settings..................................................................... 22
6.5.4 Printer settings........................................................................... 24
6.5.5 Storage settings......................................................................... 26
6.5.6 Device info................................................................................ 28
6.5.7 Patients list ............................................................................... 29
6.5.8 Adding a patient......................................................................... 30
6.5. Detailed view of patient ............................................................... 31
6.5.10 On screen keyboard ................................................................... 33
7 OPERATING THE DEVICE....................................................................... 34
7.1 P epa ation fo the measu ement................................................... 34
7.1.1 Starting tonometer...................................................................... 34
7.1.2 Settings.................................................................................... 34
7.1.3 Checking the paper in printer ....................................................... 34
7.2 Measu ement ............................................................................... 35
7.2.1 Setting the patient's position......................................................... 36
7.2.2 Conducting the measurement....................................................... 37
7.2.3 High / Normal IOP selection dialog................................................ 41
7.2.4 Saving unrelaible results dialog .................................................... 41
7.2.5 Error messages during measurement............................................ 42
7.3 P inting........................................................................................ 44
7.3.1 Printing the results from the main screen........................................ 44
7.3.2 Printing from the database........................................................... 45

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7.3.3 Printout format........................................................................... 45
7.4 Database ope ations..................................................................... 47
7.4.1 Browsing the patient list .............................................................. 47
7.4.2 Searching for patient................................................................... 47
7.4.3 Detailed view of patient ............................................................... 47
7.4.4 Adding patient to database .......................................................... 47
7.4.5 Removing patient from database .................................................. 48
7.4.6 Setting patient's central corneal thickness (CCT)............................. 48
7.4.7 Selecting a patient...................................................................... 48
7.4.8 Deselecting current patient .......................................................... 48
7.4. Saving the results for currently selected patient............................... 48
7.4.10 Appending the results, when no patient selected ............................. 49
7.5 Database expo t ........................................................................... 49
7.5.1 Export to SD card....................................................................... 49
7.5.2 Export using a Wi-Fi card ............................................................ 49
8 TECHNICAL DATA................................................................................. 50
8.1 Ene gy of visible light and inf a ed light......................................... 51
8.2 Ope ating envi onment ................................................................. 51
8.3 Confo ming standa ds .................................................................. 52
9 MAINTENANCE AND SERVICE................................................................ 53
9.1 Du able yea s............................................................................... 53
9.2 Cont ol of the accu acy of the measu ement .................................. 53
9.3 Maintenance................................................................................. 53
.3.1 Outlet of the measuring head ....................................................... 53
.3.2 Chin rest and forehead support .................................................... 54
.3.3 The surface of the housing .......................................................... 54
.3.4 LCD Display.............................................................................. 54
9.4 Replacing consumables................................................................ 55
.4.1 Printer paper ............................................................................. 55
9.5 Sto ing and t anspo tation ............................................................ 56
.5.1 Packaging................................................................................. 56
.5.2 Disposal ................................................................................... 57

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1 INTRODUCTION
This OPERATION MANUAL describes the purpose, overall view and user maintenance
of the TN-100 Non-contact Tonometer. This manual is intended for medical personnel
and who will perform measurements on patients using TN-100 device. This instruction
provides information concerning cleaning and basic user maintenance that should be
very precisely presented to the cleaning and technical personnel of the clinic in order to
decrease the probability to harm the equipment.
If you have encountered problems when using your TN-100 Tonometer which you
cannot solve, or the Tonometer parameters are changed, please, in all these cases
contact the Manufacturer or his authorized representative.
MEDICAL RESPONSIBILITY - The manual does not provide
guidance or interpretation of the results of measurement. The
operator must ensure that he or she has received an
appropriate medical training in such interpretation. For the same
reason, FREY can not be held responsible for misdiagnosis of
results.
The right to repair or set up the TN-100 Tonmeter or to carry out
periodical part replacements is reserved only to the
Manufacturer or to persons authorized by the Manufacturer.
TN-100 Non-contact Tonometer is to be used only in
accordance with this Operation Manual.
If you have questions regarding the use, please contact the
manufacturer or distributor.
During the lifetime of the device, this manual should be kept in
an easily accessible place for the user to at any time it is
available.
In case of loss of this manual, please contact your authorized
distributor.

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2 SYMBOLS
Manufacturer
Date manufacture
Follow Instructions for Use
The CE mark - indicates conformity with the provisions of
3/42/EEC Medical Device Directive
Separate collection of Waste Electrical and Electronic Equipment -
Indicates that this device should be disposed of for EU member
countries in accordance with Directive 2002/ 6/EC (WEEE).
Type B Applied Part
Temeperature limit during transportation and storage.
Humidity limitation during transportation and storage.
Warnings – Observe these prescriptions in order to ensure safe
operation of the the device and safety of Patients and Operators!
Notes and hints - Useful functions to know. Paying attention to these
will prevent the noted problems..

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SYSTEM DESCRIPTION
TN-100 Non-contact Tonometer is a modern diagnostic device for fast end precise
measuring of the intraocular pressure of patient's eye.
The measurement is carried out without coming into contact with the patient's eye.
TN-100 allows to conduct measurement both in automatic or manual mode. The device
has an option to make an automatic correction of the intraocular pressure value
obtained by the thickness of the patient's cornea.
TN-100 is equipped with a color 7" touch screen display, with which can be controlled all
the operations. The friendly and easy user interface allows intuitive navigate through
available options. Additionally, the device has the control panel with keys, located on the
unit housing.
TN-100 has a built-in printer, which allows to print out of the results of intraocular
pressure measurements.
The position of the measuring head of the device is electrically adjustable in three
dimensions, using the multi-function joystick.
General outline of operation of TN-100:
 The patient places their chin on the chinrest and looks into the sight-fixing LED in
the measurement head.
 The physician observes the patient's eye on the screen and roughly aligns the
measuring position. After the onscreen indicators confirm that correct initial position
has been reached, he presses the 'Auto' button, what initialize an automatic fine
alignment of measuring position, and then the conduct of the measurement.
 When measurement has started, air blows from the nozzle in the outlet of the
measurement head. When the cornea becomes flat due to blown air, corneal
reflect light from the light source is received by the light receiving element. Then
the instrument calculates the intraocular pressure by analyzing changes in air
pressure in the device's measurement circuit, and shows the result on the screen.

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3 SAFETY PRECAUTIONS
Intended use
TN-100 Non-contact Tonometer is medical device designed to
calculate intraocular pressure of patient's eye. Do not use
tonometer for any other purpose!
Installation
Do not lift device by holding the measuring head, chin rest, or
joystick. These elements can disconnect from the device, causing it
to fall, and as a result cause injury!
Do not install the device in a place exposed to water or chemicals.
Any water or chemicals entering the instrument may cause electric
shock or failure!
Do not install the device in a place where chemicals are stored or
gases may occur. Spilt chemicals or vapor my enter the device and
ignite!
Install the device in a location not subject to direct sunlight, high
temperature and humid, or air with significant dust, salt and/or sulfur
content. This may cause failure or malfunction of the device!
Install the device in a location that is sufficiently clear of any other
equipment that may interfere with the examination when using the
device.
Powe connections
To power the Tonometer may be used ONLY the power supply
supplied with the unit!

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Powe connections
Check the frequency, voltage and allowable current (or power
consumption) of the power source before connecting the power
supply. Connecting to inappropriate power source may cause fire or
an electric shock!
Connect the power plug only to a grounded 3P-outlet. Otherwise a
short circuit due to failure of the device may result in electric shock.
Use an intact power cord. Replace the cord if it is cracked, frayed,
broken or otherwise damaged.
Do not apply tension to the power cord., do not place any heavy
object on the power cord or squash the cord,. This may cause fire
or electric shock!
Do not use extension cords or adapters of any type.
Device is designed for continuous use.
Exte nal connections:
Do not connect any external devices to the device other than those
specified by manufacturer.
P ecautions du ing ope ation
When moving the measurement head and/or chinrest of the device,
pay attention to the position of the patient's face, hands and fingers.
The patient may be injured by the moving section of the device.
Do not allow any person to place their hands or fingers in the
clearance under the measuring head or the section under the
chinrest. Their hands or finger may be injured!
Never touch the cutter in the printer, it may cause the injury!
If any smoke, offensive odor, or abnormal sound occurs, turn off the
device immediately, disconnect the power plug from the outlet, and
contact local distributor or the manufacturer!

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If any device failure occurs, stop operation immediately, indicate the
failure, and contact local distributor to request repair.
Do not attempt to repair device yourself!
Never modify the device! Doing so may cause electric shock or
failure of the device!
Sto ing and t anspo tation
The device must be properly prepared for transport to prevent
damage. To do this, press button on the control panel for 3
seconds to lower the measuring head to the lowest position. Not
lowering the measuring head may cause damage of the device
during transport!
For more information on storage and transport of the device refer to the chapter .5.
Cleaning and maintenance
Do not perform any service or maintenance activities on the device
during examination of the patient!
Turn of the device and disconnect the power cord from the outlet
before attempting any maintenance or cleaning activities on the
device. Before reconnecting the power, wipe dry all parts of the
device
Do not use ammonia-, phenol-, or acetone-based cleaners. Get rid
of moisture completely before reconnecting to the mains outlet.
Do not immerse the device in any liquid. Do not allow liquid to
enter the device.
Do not sterilize the device.
For more information on storage and transport of the Tonometer refer to the chapter .3.

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Inte fe ences
This device emits a certain level of electromagnetic radiation that is
within the levels specified by applicable standards.
This instrument has been tested against the effects of external
interference including high energy frequency emission, magnetic
fields and electrostatic discharge (for example large motors,
portable radios, cellular phones, etc.). It has been tested according
to the requirements of applicable standards.
Excessive interference may affect the device operation. If it occurs
the failure cause shall be removed.
The Manufactu e is esponsible fo the safety, eliability and
pe fo mance of the TN-100 Tonomete only if:
 All operations of assembly extensions, adjustment,
modification or repairs have been carried out by people
authorized by manufacturer.
 The electric setting of the room complies with the electric
standards.
 The instrument is used in compliance with Operation Manual.
The Manufacturer accepts no responsibility for any modifications
made to the TN-100 Non-contact Tonometer outside the factory.

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4 PACKAGE CONTENT
Open the package and check that the specified amount of the following
items are included in the package and are not damaged. If any item is
missing or damaged, contact local distributor as soon as possible.
It is recommended to keep the box and packaging materials for use when
moving or transporting the device.
When taking the device out of the box, be careful not to lift the device up
by directly holding the measuring head, chinrest, forehead support, or
joystick. The device may be damaged!
Package contents: :
 Main unit
 External Power Supply
 Operation Manual
 Power cord
 Built-in printer paper - 2 pcs.
 Dust cover
 SD card

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5 GLOSSARY
[CCT]: Central cornea thickness
[IOP]: Intraocular pressure

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6 DEVICE DESCRIPTION
6.1 Ope ato 's side view
1. Eye level mark - a reference mark when aligning the patient's eye.
2. LCD Touch screen - displays the measurement screen and various settings
screens. Touch the touch panel buttons shown on the screen to make various
settings and operate the device.
3. Measuring head.
4. Control Panel - refer to chapter 6.4
5. Three-axis joystick with a button. Joystick movement in the horizontal plane causes
the corresponding movement of the measuring head (in axis X or Z). Height control
of measuring head position (movement in the Y-axis) is done by turning the knob of
the joystick clockwise or counterclockwise.
6. Built-in printer flap.
7. Button for opening the printer flap.
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6.2 Patient's side view
1. Forehead support.
2. The outlet of the measuring head.
3. Chin rest.
4. Power switch.
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6.3 Bottom side view
1. DC Input.
1

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6.4 Cont ol panel
1. LED Power indicator.
2. Chin rest 'Up' button.
3. Chin rest 'Down' button.
4. 'Sleep' button - to switch the device in the sleep mode - it turns off the display.
5. 'Packing' button - pressing this button for 3 seconds moves the measuring head to
the lowest position for packing.
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5

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6.5 Display
6.5.1 Main sc een
1. 'New Exam' - prepares the device for examination by clearing the previous results.
2. 'Patients' - go to the list of patients (7.5.7).
3. 'Print' - allows to save and/or print the results.
4. 'Single measurement'/'Triple measurement' - toggles between two available
measurement modes: triple and single measurement.
5. 'Settings' - go to the device setup screen.
6. 'Auto' - triggers the automatic measurement.
7. Intraocular pressure mode Indicator / Switch -
Shows in which mode: High Intraocular Pressure (HIOP) mode (icon with red
arrow) or normal mode (grey icon) device is currently working. By touching this
button you can also toggle between these two modes manually.
8. This icon indicates that WiFi card is in use. If the icon is silver and keeps turning -
database synchronization is being in progress. The green icon indicates that
internal database synchronization is completed.
. This icon indicates that the 'Eye to close!' warning is disabled by the user.
10. This icon indicates that the SD card is inserted into the device.
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11. In this place on the screen patient's name is displayed, if he was selected from the
database.
12. These buttons allow to choose the eye which will be examined.
13. Inside this circle, during the examination in a manual mode, the reflection of the
fixation LED on the eye should be placed.
14. These circles are used to set the correct initial position of the measuring head
relating to patient's eye, to start examination in an auto mode. Before triggering the
auto mode measurement, the operator should reach the eye in such a way that the
two white reflection markers were inside the yellow circles.

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6.5.2 Common settings
1. 'Common' - go to the common settings screen.
2. 'Tonometer' - go to the tonometer settings (7.5.3).
3. 'Printer' - go to the printer settings (7.5.4).
4. 'Storage' - go to the storage settings (7.5.5).
5. 'Info' - go to the info screen (7.5.6).
6. 'Back' - return to the main screen.
7. Pin Password - enable / disable access to the database with a PIN code.
To enable / disable code protection, press the key (7), the window for entering the
code will appear:
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