Topcon KR-1W Manual de usuario

USER MANUAL

WAVE-FRONT ANALYZER

KR-1W

INTRODUCTION

Thank you for purchasing the TOPCON Wave-front Analyzer KR-1W.

This instrument has the following features:

• The refractive power of the eye, the curvature radius of the cornea and the pupil diame-

ter can be determined by simple operations.

• By displaying the Hartmann image and Mire image, wavefront aberration measurement

of the eye can be done.

•

Auto alignment and auto start functions enabling quick measurement under best conditions

This text outlines the TOPCON Wave-front Analyzer KR-1W and describes basic opera-

tions, troubleshooting, checking, maintenance and cleaning.

To encourage the safe, efficient use of this instrument, carefully read "DISPLAYS FOR

SAFE USE" and "GENERAL SAFETY INFORMATION."

Also, keep this User Manual in a convenient location for your future reference.

PRECAUTIONS

• The patient who undergoes an examination by this instrument must maintain concentration for a

few minutes and keep to the following instructions:

• To fix the face to the chinrest, forehead rest, etc.

• To keep the eye open.

• To understand and follow instructions when undergoing an examination.

• To ensure smooth operation, install the instrument on a leveled stand free of vibrations. Also, do

not place any objects on the instrument.

• Connect all cables according to Preparation instructions on page 30.

• Use the specified source voltage.

• When not in use, turn off the power and put the measuring window cap and dust cover on.

• To ensure the correct reading, do not mar the measuring window with finger prints, dust, etc.

• Use this machine in a darkroom.

CAUTION : Federal laws restricts this device to the sale by or on the order of a physician.

DISPOSAL

When disposing the instrument and/or parts, follow the local regulations for disposal and recy-

cling.

STORING PLACE, USAGE PERIOD

1. When storing the instrument, ensure that the following conditions are met:

(1) The instrument must not be splashed with water.

(2) Store the instrument away from environments where air pressure, temperature, humidity,

ventilation, sunlight, dust, salty/sulfurous air, etc. could cause damage.

(3) Do not store or transport the instrument on a slanted or uneven surface or in an area

where it is subject to vibrations or instability.

(4) Do not store the instrument where chemicals are stored or gas is generated.

2. Normal life span of the instrument:

8 years from delivery providing regular maintenance is performed [TOPCON data]

USER MAINTENANCE

1.Regularly maintain and check the equipment and parts.

2.When resuming the use after a long storage time, verify that the instrument operates cor-

rectly and safely.

3.To ensure the correct reading, do not soil the measuring window with finger prints or dust.

4.If the measuring window is soiled, clean it following the "CLEANING THE INSTRUMENT"

instructions on page 180.

This symbol is applicable for EU member countries only.

To avoid potential damage to the environment and possibly human health, this instrument should be

disposed of (i) for EU member countries - in accordance with WEEE (Directive on Waste Electrical and

Electronic Equipment), or (ii) for all other countries, in accordance with local disposal and recycling

laws.

[WARNING]

Handling the cord on this product or cords associated with accessories sold with this product, will expose you to lead, a

chemical known to the State of California to cause birth detects or other reproductive harm. Wash hands after han-

dling.

This Product Contains Mercury in the backlighting of the LCD display. Prior to disposal remove of otherwise ensure that

this is disposed of in accordance with Local, State and Federal Laws. This information is applicable in U.S.A only.

This product contains a CRL Litium Battery which contains Perchlorate Material-special handling may apply.

See http://www.dtsc.ca.gov/hazardouswaste/perchlorate/

Note; This is applicable to California, U.S.A. only

HOW TO READ THIS MANUAL

• Read the instructions on pages 1to 8before using the machine.

• Regarding connection to various devices, see "PREPARATIONS" on page 30.

• If you need to see how the machine works first of all, read "BASIC OPERATIONS"(page 37)

first.

• For setting various functions, see "FUNCTION SETTING USING SETTINGS SCREEN" on

page 111.

SYMBOL IN THE TEXT

Note: contains the information of useful features to know and cautions to prevent

any problems.

DISPLAYS FOR SAFE USE

In order to encourage the safe use of the machine and prevent any danger to the operator and

others or damage to properties, important warnings are placed on the product and inserted in the

user manual.

We suggest that everyone understand the meaning of the following displays and icons before

reading the "GENERAL SAFETY INFORMATION" and the main text.

DISPLAYS

Display Meaning

Ignoring or disregarding this display may lead to death or

serious injury.

Ignoring or disregarding this display may lead to personal injury

or physical damage.

• Injury refers to cuts, bruises, sprains, fractures, burn, electric

shock, etc.

• Physical damage refers to extensive damage to buildings or

equipment and furniture.

WARNINGS

CAUTIONS

NOTES

GENERAL SAFETY INFORMATION

Ensuring the Safety of Patients and Operators

When operating the instrument, be not touch the patient's eye or nose.

[Inform the patient accordingly]

The safety and effectiveness of the Wave-front Analyzer KR-1W has not been established for

use of the device as an accessory interfaced to the refractive laser for the treatments of the

higher order aberrations of the eye by photorefractive keratectomy (PRK), phototherapeutic

keratectomy (PTK), or laser assisted in situ keratomileusis (LASIK).

Preventing Electric Shocks and Fires.

To avoid fire and electric shock, install the instrument in a dry place free of water and other liq-

uids.

To avoid fire and electric shock, do not put cups or other containers with liquids near the instru-

ment.

To avoid electric shocks, do not insert metal objects into the instrument body through the vent

holes or gaps.

To avoid fire in the event of an instrument malfunction, immediately turn OFF the power switch

"" and disconnect the power cord from the instrument if you see smoke coming from the

instrument, etc.

Don't install the instrument where it is difficult to disconnect the power cord from the instru-

ment. Ask your dealer for service.

WARNINGS

Ensuring the Safety of Patients and Operators

To avoid injury in changing the measurement mode, do not place fingers into the measuring

opening.

To avoid electric shock, do not open cover. For repair, ask a certified Topcon Service Engineer.

When changing the fuse, turn off the power, and disconnect the power cable. Use the properly

rated fuse.

Preventing Electric Shocks and burn.

To avoid injury, when moving the chinrest up/down, keep fingers away from moving parts.

When operating the instrument, be careful not to touch the patient's eye or nose.

Electromagnetic Compatibility (EMC)

This instrument has been tested (with 100/120/230V) and found to comply with IEC60601-1-2:

Ed.3.0: 2007.

This instrument may emit a radio frequency energy (within the standard) and cause an

adverse effect on the devices located nearby.

When such effect is confirmed by the ON/OFF operation, a proper treatment as to change the

direction, use another outlet, etc. is recommended. If the problem remains unsolved, call your

dealer.

CAUTIONS

USAGE AND MAINTENANCE

PURPOSE

USER MAINTENANCE

To ensure the safety and performance of the instrument, all maintenance work, unless speci-

fied in this manual, shall be conducted by trained service engineers.

The following maintenance tasks may be done by the user.

For details, see the relevant part of this manual.

CHANGING THE FUSE

The primary fuses for the main body may be changed by a non-trained service technician.

For details, refer to "REPLACING THE FUSE" on page 181.

DISCLAIMERS

The Wave-front Analyzer KR-1W is a precision electrical instrument for medical use

which must be used under the guidance and instructions of a doctor.

• TOPCON is not responsible for damage due to fire, earthquakes, actions or inactions of third

persons or other accidents, or damage due to negligence and misuse by the user and any

use under unusual conditions.

• TOPCON is not responsible for damage derived from inability to properly use this equip-

ment, such as loss of business profits and suspension of business.

• TOPCON is not responsible for damage caused by operations other than those described in

this User Manual.

• The device does not provide a diagnose of any condition or lack thereof or any recommen-

dations for appropriate treatment. The relevant healthcare provider is fully responsible for all

diagnose and treatment decisions and recommendations.

WARNING INDICATIONS AND POSITIONS

To ensure the safety, this machine provides warning displays.

Use the instrument correctly by observing the display instructions. If any of the following dis-

play labels are missing, contact your TOPCON dealer at the address listed on the back cover.

No. Label Meaning

WARNING

To avoid injury caused by electric shock, do not open the cover.

Ask your dealer for service.

WARNING

Electric shock may cause burns or a possible fire. Turn the power

switch OFF and unplug the power cord before replacing the fuses.

Replace only with fuses of the correct rating.

CAUTION

When operating the chinrest up/down switch, be careful not to

pinch the patient's hand.

The patient may be injured.

CAUTION

Be careful not to hit the patient's eyes or nose with the instrument

during operation.

5Degree of protection against electric shock:

TYPE B EQUIPMENT

1 3 4 2 5

CLASS

LASER PRODUCTS

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