Huvitz HT-5000 Manual de usuario

---------------------------------------------------------------- Applanation Tonometer HT-5000 1

User’s Manual

Applanation Tonometer HT-5000

2 Applanation Tonometer HT-5000 --------------------------------------------------------------

IMPORT 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. HUVITZ assumes no responsibility,

however, for possible errors or omissions, or for any consequences resulting from

the use of the information contained herein.

HUVITZ 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..

Ver 1.0

-689-3, Gumjeong-dong,Gunpoci, Gyeonggi-do

435-862,Republic of Korea

All rights are reserved. Under copyright laws, this manual may not be copied, in whole or

in part, without prior written consent of HUVITZ Co.,Ltd.

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Contents

1. Safety Infomation ....................................................................................................5

1.1. Introduction…………………………………………………………………………5

1.2. Safety symbols ………………………………………………………………6

1.3. Environmental Considerations.......................................................................8

1.4. Safety (Note for Use)...................................................................................10

2. Product Description ..............................................................................................14

2.1. Introduction.………………………………………………………………………14

2.2. Pressure Measurement Method………………………………………………..14

2.3. Operation and Storage Condition………………………………………………16

2.4. Configuration……………………………………………………………………..17

2.5. Basic Unit………………………………………………………………………....18

3. Installation.............................................................................................................19

3.1. Product Installation……………………………………………………………….19

4. Operation the Equipment......................................................................................21

4.1. Preparation before Using………………………………………………………..21

4.2. Equipment Control and Battery Replacement………………………………...23

4.3. Correct Measurement……………………………………………………………28

4.4. Tips for Measurement……………………………………………………………39

4.5. Astigmatism……………………………………………………………………….40

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5. Maintenance...........................................................................................................41

5.1. Applanation Tonometer HT-5000 Check……………………………………….42

6. Cleaning / Disinfection of Prism...........................................................................44

6.1. Disinfection of Prism……………………………………………………………..44

6.2. Accessories Disinfection…………………………………………………….......45

7. Technical Standard................................................................................................46

8. EMC information....................................................................................................48

9. Service Information..................................................................................................52

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1. Safety Information

1.1 Introduction

Safety is everyone’s responsibility. The safe use of this equipment is largely

dependent upon the installer, user, operator, and maintainer. It is imperative

that personnel study and become familiar with this entire manual before

attempting to install use, clean, service or adjust this equipment and any

associated accessories. It is paramount that the instructions contained in this

manual are fully understood and followed to enhance safety to the patient and

the user/operator. It is for this reason that the following safety notices have

been placed appropriately within the text of this manual to highlight safety

related information or information requiring special emphasis. All users,

operators, and maintainers must be familiar with and pay particular attention to

Cautions incorporated herein.

1. CAUTION

Please pay attention to this word.

CAUTION

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2. Product Classification

※This product is medical device

1) CE-

Regulatin MDD 93/42/EEC

; Class Im (measuring functions)

2) FDA –Class ll

3) KFDA –Class ll

3. Intended Use: Use for glaucoma diagnosis.

1.2 Safety Symbols

The International Electrotechnical Commission (IEC) has established a set of

symbols for medical electronic equipment which classify a connection or

warn of any potential hazards. The classifications and symbols are shown

below.

Type B Isolated patient connection.

This symbol identifies a safety note. Ensure you

understand the function of this control before

using it. Control function is described in the

appropriate User’s or Service Manual.

It indicates the year of manufacture and the

manufacturer.

Manufacturer

Authorised Representative in the European

Community

Identifies the point where the system safety

ground is fastened to the chassis. Protective

earth connected to conductive parts of Class I

equipment for safety purposes.

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Temperature Limitation

Keep DRY

UL60601-1

CAN/CSA

C22.2

NO.601.1

MEDICAL EUIPMENT

WITH RESPECT TO ELECTRIC SHOCK

FIRE AND MECHANICAL HAZARDS

ONLY IN ACCORDANCE WITH

UL 60601-1, AND

CAN/CSA C22.2 NO.601.1

Disposal of your old appliance

When this crossed-out wheeled bin symbol is

attached to a product it means the product is

covered by the European Directive 2002/96/EC.

All 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.

The correct disposal of your old appliance will

help prevent potential negative consequences

for the environment and human health.

4. For more detailed information about disposal

of your old appliance, please contact your city

office, waste disposal service or the shop where

you purchased the product.

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1.3 Environmental Considerations

Please avoid the environment below for the operation and storage of the

equipment.

Where the equipment is exposed to water vapor.

Don’t operate the equipment with wet hands.

Where the machine is exposed directly to the

sunlight.

Where the temperature changes frequently (Normal

temperature for operation of the machine is at the

range of 10C ~ 40C, and the humidity is at the

range of 30%~75%.

Where any heaters are at the close distance to the

machine.

Where the humidity is high and there are problems to

the heat dissipation and/or ventilation.

Where the equipment is subject to excessive shocks

Vibrations.

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Where the machine can be exposed to the chemical

or flammable substances.

Please keep the equipment out of dust and do not

let inserted any metal parts such as coins, clips, etc.

Do not disassemble or open the machine. The

manufacture shall have no responsibility for any

problems caused by these.

Do not close the thermal ventilation outlet.

10 Applanation Tonometer HT-5000 --------------------------------------------------------------

1.4 Safety (Note for Use)

1. This product can use only glaucoma diagnosis.

2. Applanation Tonometer must be used only through people to a medical

treatment relation occupation.

3. Applanation Tonometer could be Transfortation / Storage / Operation

from this environment.

4. Ambient condition

Transportation

Temperature : -40 °C ~ +70 °C

Air Pressure : 500 hPa ~ 1060 hPa

Humidity : 10% ~ 95%

Storage

Temperature : -10 °C ~ +55 °C

Air Pressure : 700 hPa ~ 1060 hPa

Humidity : 10% ~ 95%

Operation

Temperature : +10 °C ~ +40 °C

Air Pressure : 800 hPa ~1060 hPa

Humidity : 30% ~ 90%

5. Installation, Dispatch

-To avoid condensation, allow the instrument to adjust to

roomtemperature several hours before unpacking.

-The Applanation Tonometer should be verified for damage after

unpacking.

-The maintenance according to “After use custody and

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