Potec PRK-8000 User manual

OPERATION MANUAL
AUTO REF-KERATOMETER PRK-8000
Revision1.0
www.potec.biz
2016.10 Before using the instrument, be sure to read this manual thoroughly.

- i -
IMPORTANT NOTICE
This product may malfunction due to electromagnetic waves caused by portable personal
telephones, transceivers, radio-controlled toys, etc. Be sure to avoid having objects such as,
which affect this product, brought near the product.
The information in this publication has been carefully checked and is believed to be entirely
accurate at the time of publication. POTEC assumes no responsibility, however, for possible
errors or omissions, or for any consequences resulting from the use of the information
contained herein.
Upon request, circuit diagrams, component part lists, descriptions, calibration instructions, or
other information will be provided to assist service personnel to repair parts of the equipment
that are designated by POTEC as repairable by service personnel.
POTEC reserves the right to make changes in its products or product specifications at any
time and without prior notice, and is not required to update this documentation to reflect such
changes.
© 2016 POTEC Co., Ltd.
40-4, Techno 2-ro, Yuseong-gu, Daejeon, 34015 Korea
All rights reserved.
Under copyright laws, this manual may not be copied, in whole or in part, without the prior written
consent of POTEC.

- ii -
SAFETY INFORMATION
Accessory equipment connected to the analog and digital interfaces must be certificated
according to the respective IEC standards (e.g. IEC 60950-1 for data processing equipment
and IEC 60601-1 for medical equipment). Furthermore all configurations shall comply with
the system standard EN 60601-1:2006, Clause 16. Everybody who connects additional
equipment to the signal input part or signal output part configures a medical system, and is
therefore responsible that the system complies with the requirements of the system standard
IEC 60601-1:2005, Clause 16. If in doubt, consult the technical service department or your
local representative.
For U.S.A
Do not make any changes or modifications to the equipment unless otherwise specified in the
manual.
If such changes or modifications should be made, you could be required to stop operation of
the equipment.
For EU Countries
The following mark, the name & address of the EU Representative shows compliance of the
instrument with Directive 93/42/EEC.
EU Representative:
Medical Device Safety Service GmbH
Schiffgraben 41, D-30175
Hannover, Germany

- iii -
Symbols marked on the Instrument
Symbol Description
TYPE BApplied Part
~ Alternating current
Protective earth (ground)
Refer to operating instructions
O Off (power: disconnect to the mains)
I On (power: connection to the mains)
Do not place your hand or fingers between the stage and base. Also
ensure that the examinee does not place his/her hand or fingers there
either. Otherwise, hand or fingers may be hurt.
Disposal of your old appliance
zWhen this crossed-out wheeled bin symbol is attached to a
product it means the product is covered by the European Directive
2002/96/EC.
zAll electrical and electronic products should be disposed of
separately from the municipal waste stream via designated
collection facilities appointed by the government or the local
authorities.
zThe correct disposal of your old appliance will help prevent
potential negative consequences for the environment and human
health.
zFor more detailed information about disposal of your old
appliance, please contact your city office, waste disposal service
or the shop where
y
ou purchased the product
General Safety Information
If you see any warnings or cautions printed on the warning labels, follow the safety
instructions in this manual. Ignoring such cautions or warnings while handling the product
may result in injury or accident. Be sure to read and fully understand the manual before using
this product.
Keep this manual in easy-to-access place.
Meaning of Caution Sign
Caution Sign Description
WARNING
This indicates a potentially hazardous situation which could results in
death or serious injury to you or others.
CAUTION
This indicates hazardous situations which may result in minor injury to
you or others, or may result in machine damage.
This is used to emphasize essential information. Be sure to read this
information to avoid incorrect operation.
NOTE

- iv -
WARNING
Only operate the instrument with the power supply indicated on the
rating plate. Otherwise, it may result in fire or electric shock.
WARNING
Be sure to turn OFF the power switch before connecting or
disconnecting the cables. Also, do not handle them with wet hands.
Otherwise, you may get an electric shock that may result in death or
serious injury.
WARNING
Never disassemble or modify this instrument because it may result in
fire or electric shock. Also, since this instrument incorporates high-
voltage parts and other hazardous parts, touching them may cause
death or serious injury.
WARNING
Should any of the following occur, immediately turn OFF the power
switch, unplug the power cable from the AC outlet, and contact the
dealer or the agent who/where you purchase this instrument.
zWhen there is smoke, strange odor or abnormal sound.
zWhen liquid has been spilled into the instrument or a metal object
has entered through an opening.
zWhen the product has been dropped or its housing damaged.
WARNING
To avoid the risk of electric shock, this equipment must only be
connected to supply mains with protective earth.
CAUTION
This instrument is shipped with a grounding type power cable.
To reduce the risk of electric shock, always plug the cable into a
grounded power outlet.
CAUTION
Ensure that the examinee has not placed his/her hand or fingers under
the chin rest. Otherwise, hand or fingers may be hurt.
CAUTION
Wipe the forehead rest with ethanol or glutaraldehyde solution to
disinfect it each time a different examinee uses it, in order to prevent
infection.
CAUTION
Change the chin rest paper each time the examinee changes in order
to keep the chin rest clean.
CAUTION
Do not place your hand or fingers between the stage and base. Also
ensure that the examinee does not place his/her hand or fingers there
either. Otherwise, hand or fingers may be hurt.
CAUTION
Do not use the device simultaneously with other electronic equipment
to avoid electromagnetic interference with the operation of the device.
CAUTION
Do not use the device near, on, or under other electronic equipment to
avoid electromagnetic interference with the operation of the device.
CAUTION
Do not use the device in the same room with other equipment such as
life-support equipment, other equipment that has major affects on the
life of patient an results of treatment , or other measurement or
treatment equipment that involve small electric current.
CAUTION
Do not use the device simultaneously with portable and mobile radio
frequency communication systems because it may have an adverse
effect on operation of the device.
CAUTION
Do not use cables and accessories that are not specified for the device
because that may increase the emission of electromagnetic waves
from the device or the system and decrease the immunity of the device
to electromagnetic disturbance.

- v -
CAUTION
Do not position the equipment to make it difficult to operate the
disconnection device. (Appliance coupler or separable plug)
CAUTION
Do not placed the multiple socket-outlet for PRK-8000 system on the
floor in order to prevent liquid penetration and damage to the product.
CAUTION
PRK-8000 system shall not be connected with additional multiple
socket-outlets or extension cords in addition to a designated single
multiple socket-outlet.
CAUTION
Maximum permissible load of each socket-outlet used for the PRK-
8000 system, shall not be less than 100VA.
CAUTION
If non-medical electrical equipments (e.g. Video monitor, IT equipment,
etc.) that are connected with the PRK-8000 are, directly connected to
the wall socket-outlets, high touch current may flow since the earth
continuity is not ensured.
CAUTION
Multiple socket-outlet should be a grounding-type . and complied with
IEC 60884-1.
CAUTION
Connection of the plug shall be possible only by using the tool.
(Refer to the figure below.)

PRK-8000 Operation Manual
CONTENTS
IMPORTANT NOTICE ····················································· ⅰ
SAFETY INFORMATION ················································· ⅱ
1. Features ··································································· 1
2. Notes for Using the Instrument ········································· 2
3. Description ································································3
3.1 Main Unit ···························································································· 3
3.2 Operation Panel ····················································································· 5
3.3 Rotating the Monitor ············································································· 6
4. Practicing through Model Eye ········································· 7
5. Measurement ······························································ 9
5.1 Continuous Keratometry and Refractometry [K/R Mode] ··································· 10
5.2 Refractometry [REF Mode] ······································································ 15
5.3 Keratometry [KER Mode] ········································································ 17
5.4 Contact Lens Base Curve Measurement [CLBC mode] ····································· 19
5.5 Peripheral Keratometry [K(P) Mode] ···························································· 20
6. Other Modes ································································23
6.1 Semi-Auto Eye Tracking ······································································· 23
6.2 Measuring Cornea Diameter [SIZE Mode] ···················································· 24
6.3 Observe image obtained by Retroillumination [ILLUM Mode] ··························· 27
6.4 DISPLAY Mode ·················································································· 30
6.5 SETUP Mode ······················································································· 31
7. Self Inspection and Maintenance ······································· 38
7.1 Before Calling a Service Person ································································· 38
7.2 Replacement ······················································································· 40
7.3 Cleaning ···························································································· 40
7.4 When Moving the Instrument ··································································· 40
7.5 Service Information ················································································ 41
8. Classifications and Specifications ····································· 42
8.1 Classifications ····················································································· 42
8.2 Specifications ······················································································· 43
9. Components ······························································ 44

PRK-8000 Operation Manual
- 1 -
1. Features
(1) Various Measurements Supported
Not only the usual refractometry and keratometry, but also corneal diameter and base
curve of contact lens can be measured with this one instrument. Thus, measurements
of eye and prescriptions for glasses and contact lenses can be made more efficiently.
(2) Wide Dioptric Measurement Range
Because the PRK-8000 covers a wide measurement range, from -30D to +25D, even an
examinee with strong myopia can be measured.
(3) More Accurate Measurement
You can measure more accurately because foggy method of the eye fixation target
makes the examinee’s eye comfortable.
(4) Pupil Distance(PD) can be measured.
(5) Customized Specifications
You can change the measurement modes, delete unnecessary modes, and/or change
order for printing results. By rotating the monitor, you can see the screen from multiple
directions.
(6) User-friendly operation features
You can easily operate the product with touch screen.
(7) Easy Connection with Other Equipments
This instrument is designed to connect other equipments using RS-232 or USB
communication..
(8) External VGA Monitor Display Supported
You can connect VGA monitor for the external display
(9) Economic printing mode
Letter size and arrangement, depending on the mode of printing adjusted to the paper,
can be saved.
(10) Eye image save function
Eye images (Identified in the ILLUM mode) are stored on your PC through USB
communication.
* Special PC application and USB drivers are provided.
(11) Semi-Auto Eye Tracking
Detect the pupil position of the patient and automatically adjusts the height of the
measuring head.

PRK-8000 Operation Manual
- 2 -
2. Notes for Using the Instrument
(1) Do not hit or drop the instrument. The instrument may be damaged if it receives a
strong impact. The impact can damage the function of this instrument. Handle with
care.
(2) Exposure to the direct sunlight or too bright indoor lights can influence on the result of
accurate measurement.
(3) If you want to connect this with other equipments, consult the dealer.
(4) Sudden heating of the room in cold areas will cause condensation on the protective
glass in the measurement window and on optical parts inside the instrument. In this
case, wait until condensation disappears before performing measurement.
(5) Keep clean the objective glass of the examinee side. If it is stained with other
substance, it may effect on error or inaccurate measurements.
(6) Don’t press the “TOUCH BUTTON” on LCD monitor by nail or sharp object. It may
make scratch on the surface of LCD.
(7) Disconnect the power supply and consult the dealer in case there is smoke, strange
odor or noise on working.
(8) Don’t use organic solution such as alcohol, thinner, benzene, etc. to clean the surface
of this instrument. It may damage the instrument.
(9) When moving this PRK-8000, fix the stage by using stage holding knob, always check
if the power supply is off, and then lift the bottom of the unit with both hands.
(10) If you leave PRK-8000 without using for certain period, disconnect the power supply
and protect the unit with dust cover.
(11) Giving an excessive force when rotating the monitor may cause a malfunction.

PRK-8000 Operation Manual
- 3 -
3. Description
3.1 Main Unit
Name Function
①Height Adjustment mark Align the height of the examinee’s eye with this mark by adjusting
the height of chin rest.
②Measurement Head Unit that performs measurement.
③Printer Print the measured result.
④Stage Holding Lever Holds the movement of stage (sliding table).
⑤Chinrest Lever Align the height of chin rest up and down.
⑥Monitor Monitor that displays Measurement and SET Modes displays.
⑦Measuring button Press this button for measurement.
⑧Operation Lever Use this lever for alignment and focusing.
⑨Clamping bolt Makes the system stage fixed.
②
③
①
⑤
④⑦
⑥
⑧
⑨

PRK-8000 Operation Manual
- 4 -
②③①⑤④
⑦
⑧
⑥
Name Function
①Power switch Switch for turning power ON and OFF
②USB USB connector for other instruments
③RS-232 RS-232 connector for other instruments
④Video Output Connector for the VGA monitor cable
⑤Power supply connector Connector for the power supply cable
⑥Forehead Rest rubber Place the examinee’s forehead against this rest
⑦Measurement window Window for the examinee to look into for measurement
⑧Chin Rest Place the examinee’s chin on this rest
If you want to connect the input / output signal ports and other devices that must meet IEC standards
(IEC60950 IT equipment, IEC60601 medical equipment)
If in doubt should contact POTEC or your authorized distributor.

PRK-8000 Operation Manual
- 5 -
3.2 Operation Panel
CHINREST LEVER Touch Button
CHINREST
LEVER This Lever is for raising/lowering the chin rest. Press “up” lever in order to raise and “down”
lever to lower the chin rest.
Press this button in order to change
measurement mode.
Press this button in order to enter
DISPLAY Mode, where you can
see measurement data stored in
memory
Press this button in order to start manual
or automatic measurement. - -
Press this button in order to OFF/ON
semi-automatic eye tracking Press this button in order to change
CYL form.
Press this button when the examinee’s
eye is difficult to measure due to cataract
or examinee with intraocular lens (IOL).
Press this button in order to enter
SIZE Mode, where you can measure
the diameter of cornea, etc.
Press this button in order to enter RET
(Retroillumination) Mode, where you can
observe the image obtained by
retroillumination. Press this button to clear all stored
data in memory.
Press this button in order to print or
transfer the measurement.
Press this button in order to enter
SETUP Mode, where you change all
the settings about measurements,
printouts etc.

PRK-8000 Operation Manual
- 6 -
3.3 Rotating the Monitor
By rotating the monitor, you can view the screen from various directions. When you rotate the
monitor, hold both sides of the monitor then rotate smoothly given the power. Forcibly
rotating may cause a malfunction.
Tilting: Up and Down Rotation: Left and right 90 degrees

PRK-8000 Operation Manual
- 7 -
4. Practicing through Model Eye
Practice measurement by using the accessory Test Model Eye before doing the actual
measurement.
(1) Turn ON the power
Turn ON the power switch of the instrument.
(2) Attach the model eye
Remove the chin rest paper and align the holes on the
base of the model eye with the holes on the chin rest. And
insert pins.
(3) Release stage lock
Turn the stage holding knob in counterclockwise direction to release the stage lock.
(4) Adjust height of Test Model Eye
Adjust the height of the chin rest by pressing “CHINREST LEVER” so
that the Test Model Eye is aligned with the “Height Adjustment
mark” on the face rest.
(5) Enter K/R or REF Mode.
If neither “K/R” nor “REF” is displayed on the monitor, press MODE button until either
one is displayed.

PRK-8000 Operation Manual
- 8 -
Mire Image
Outer Alignment Mark
Inner Alignment Mark
(6) Adjust the position and focus on the model eye
Looking at the monitor, incline the operation lever toward the model eye until a bright
dot appears near the Inner Alignment Mark. Place the Bright Dot in the center of
Inner Alignment Mark. If position cannot be adjusted just by inclining the operation lever,
slide the lever in the direction required.
Focus on the model eye by inclining the operation lever forward and backward so that
the Mire Ring image is displayed clearly on the monitor. The focus is correct, the color
of the aiming mark changes to yellow color.
zGuide image
In the focus away from
ÆTilt the lever to patient That closer focus ÆTilt the lever to operator
(7) Measurement
zManual measurement
(a) Adjust the position and focus on the model eye like the procedure (6).
(b) Press the Measuring button . At this point, if measurement is failed with
messages like ERROR, repeat the procedure (a) and press the Measuring
button again.
(c) Check whether diopter value is measured or not. Diopter value is recorded in
the bottom area of the model eye. If you are not satisfied with the measured
value, measure in the same way and check again.
zAutomatic measurement
Continuous measurement starts automatically and will be performed 3 times
or 5 times.
(a) Press the AUTO button on the operation panel.
(b) Adjust the position and focus on the model eye like the procedure (6) at
previous page.
(c) When the Bright Dot enters the Inner Alignment Mark and model eye is in focus
properly, measurement starts automatically.
(d) Execute the procedures (c) of manual measurement.

PRK-8000 Operation Manual
- 9 -
Power ON
DISPLAY Mode
DISP
button
EXIT
button
SETUP Mode
SETUP
button
EXIT
button
SIZE Mode
SIZE
button
EXIT
button
ILLUM Mode
ILLUM
button
EXIT
button
REF Mode
MODE
button
KER Mode
MODE
button
K/R Mode
MODE
button
CLBC Mode
MODE
button
K(P) Mode
MODE
button IOL Mode
IOL
button
EXIT
button
5. Measurement
WARNING
Should any of the following occur, immediately turn OFF the power
switch, unplug the power cable from the AC outlet, and contact the
dealer or the agent who/where you purchase this instrument.
zWhen there is smoke, strange odor or abnormal sound.
zWhen liquid has been spilled into the instrument or a metal object
has entered through an opening.
zWhen the product has been dropped or its housing damaged.
Relation between buttons and modes
NOTE: IOL button will be enabled at K/R mode and REF mode only. If IOL
button is pressed, IOL measurement will be performed and pressed
again to render the basic measurement.

PRK-8000 Operation Manual
- 10 -
5.1 Continuous Keratometry and Refractometry
[K/R Mode]
In the K/R mode, refractometry is automatically performed after keratometry.
(1) Enter K/R Mode
Press MODE button on the left side of the display, and then select “K/R”.
(2) Adjust height of examinee’s eye.
CAUTION
Ensure that the examinee has not placed his/her hand or fingers
under the chin rest. Otherwise, hand or fingers may be hurt.
CAUTION
Wipe the forehead rest with ethanol or glutaraldehyde solution to
disinfect it each time a different examinee uses it, in order to prevent
infection.
CAUTION
Change the chin rest paper each time the examinee changes in order
to keep the chin rest clean.
Have the examinee sit and place his/her chin and forehead against the chin rest and
forehead rest.
Adjust the height of the chin by pressing “CHINREST LEVER” so that the eye of the
examinee is aligned with the height adjustment mark on the face rest.

PRK-8000 Operation Manual
- 11 -
(3) Perform alignment and Focusing
CAUTION
Do not place your hand or fingers between the stage and base. Also
ensure that the examinee does not place his/her hand or fingers there
either. Otherwise, hand or fingers may be hurt.
Slide the operation lever to the left so that the right eye of the examinee is displayed on
the monitor.
Ask the examinee to look at the red roof in the center of the scene (eye fixation target).
Looking at the monitor, check that image of the mire ring is not obscured by the upper
eyelid. If it is covering the ring, instruct the examinee to keep his/her eye opened wide
until measurement ends. Or help them open the eye wider by lifting up his/her upper
eyelid lightly with your fingers.
Looking at the monitor, incline the operation lever to right or left, and turn the operation
lever so the pupil is concentric with the inner alignment mark. If the pupil is large, align it
with the outer alignment mark.
Focus on the mire image by inclining the operation lever forward and backward. The
focus is correct, the color of the aiming mark changes to yellow color.
NOTES:
①Slide stage to the forward/backward and right/left if you are unsatisfied with
the operation lever control.
②If the alignment marks and the pupil are not concentric, instruct the examinee
to look at the red roof at the center of the picture. Otherwise, measurement
error may occur due to aberration.

PRK-8000 Operation Manual
- 12 -
(4) Measurement
Press the Measuring button.
Measurement will be continuously performed when the Measuring button is kept
pressed.
zThe newest measured results will be displayed on the monitor.
zIn case of the continuous measurement, the result of previous measurement will be
displayed.
zIf you change setting for REF/KER of SETUP Mode, you can select the vertex
distance.
zIf you change setting for REF/KER of SETUP Mode, you can change display format
of CYL value.
zWhen measured results are displayed, changing for REF/KER of SETUP Mode
renders each cornea measured result of R1/R2/AX ÆK1/K2/AX ÆAR/CY/AX
displayed in turn.
NOTES:
①There can be error if the Outer Alignment Mark and the pupil is eccentric.
②There may be some aberration to the measurement value due to the
eccentricity or inclination of lens, or deformation of cornea after surgery.
③Reliability of the measurement with IOL switch turned ON may be low.