WOSON TANDA COLOR Operation Manual

TANDA Color Steam Sterilizer Operation Manual

Woson Medical Instrument Co., Ltd

Technical
Publications

TANDA COLOR

TANDA Color Steam Sterilizer
Operation Manual

ASS090
REV-C

Operation Documentation

All rights reserved© 2017 By Ningbo Jiangbei Woson Medical Instrument Co.,Ltd.

TANDA Color Steam Sterilizer Operation Manual

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Regulatory Requirement

This product complies with regulatory requirements of the following European
Directive 93/42/EEC concerning medical devices.

Revision History

REV

ISSUE DATE

REASON FOR CHANGE

REV-A

2013.05.18

First Issue

REV-B

2015.11.27

Update

REV-C

2017.07.25

Update

Please verify that you are using the latest revision of this document. Information pertaining to
this document is maintained on manufactory. If you need to know the latest revision, please
contact your distributor, sales representative, or our service department.

Ningbo Jiangbei Woson Medical Instrument Co., Ltd

No.25, Lane 300, Jinshan Road, Jiangbei District, Ningbo

315032, China
Tel: [phone]

Fax:[phone]
Website:www.woson.com.cn
E-mail: [e-mail]

TANDA Color Steam Sterilizer Operation Manual

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Regulatory Requirement

Conformance Standard

The content of this manual is fit for the sterilizers.
Above sterilizer accords with the requirements of European Class N:
93/ 42/ EEC
97/ 23/ EC
EN 61010 -1
EN 61010 -2 -040
EN 13060
EN 61326 -1

European Authorized Representative

DTF Technology s.r.l.

Address: via Gressoney 9, 20137 Milan, Italy
Tel: [phone]
Fax: [phone]

This equipment complies with the regulatory requirements of the following:

• Council Directive 93/ 42/ EEC concerning medical devices:
The CE label affixed to the product testifies compliance to the Directive.
The location of the CE marking is shown in this manual.

Certification

Manufactory is certified with EN ISO 9001 and EN ISO 13485.

Original Documentation

The original document was written in English.

Declaration of Conformity

Council Directive 93/ 42/ EEC concerning medical devices:
The CE label affixed to the equipment testifies compliance to the Directive.
The location of the CE marking is shown in this manual. In this manual there are present the
CE certification and the Conformity, check appendixes.

TANDA Color Steam Sterilizer Operation Manual

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Table of Content

Regulatory Requirement .................................................................................. 1

Revision History ............................................................................................... 1

Regulatory Requirement .................................................................................. 2

Chapter 1 Introduction ..................................................................................... 4

1.1 Attention ............................................................................................... 4

1.2 Usage Indications ................................................................................ 4

1.3 Contraindication ................................................................................... 4

Chapter 2 Safety .............................................................................................. 5

2.1 Explanation Symbol ............................................................................. 5

2.2 General Safety Recommendation ........................................................ 6

2.3 Operation Risk ..................................................................................... 7

2.4 Protection Device ................................................................................. 7

Chapter 3 Receiving and Installation ............................................................... 8

3.1 Check the Package .............................................................................. 8

3.2 Unpack the Accessories ...................................................................... 8

3.3 Installation Environment ...................................................................... 9

Chapter 4 Description and Specification ........................................................ 10

4.1 Overview ............................................................................................ 10

4.2 Specification ...................................................................................... 10

Chapter 5 Panel and Function ....................................................................... 11

5.1 Function Panel ................................................................................... 11

5.2 Operation Process ............................................................................. 11

5.3 Drying Function Setting ..................................................................... 11

5.3 Sterilization Program ......................................................................... 11

Chapter 6 Error Code List .............................................................................. 15

Appendix Piping and Circuit Diagram ............................................................ 16

Piping Diagram ........................................................................................ 16

Circuit Diagram ........................................................................................ 17

TANDA Color Steam Sterilizer Operation Manual

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Chapter 1 Introduction

1.1 Attention

❖ This operation manual contains necessary and sufficient information to operate the

sterilizer safely, like optimal usage, safe and reliable operation, regular and correct
servicing requirements.

❖ Read and understand all instructions in this manual before attempting to use the product.

❖ Keep this manual with the sterilizer at all times. Periodically review the procedures for

operation and safety precautions.

1.2 Usage Indications

Application to all wrapped or non-wrapped, solid, hollow load products type A and porous
products or related articles.

This sterilizer can be used for dental clinic, laboratory, surgical room, emergency room,
ophthalmology, gynecology and steam, cosmetic hospital and so on, by doctors and
professionals.

1.3 Contraindication

There are no contraindications of this equipment.

TANDA Color Steam Sterilizer Operation Manual

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Chapter 2 Safety

2.1 Explanation Symbol

Device Icon Description

“ATTENTION” – Intended to alert the user to refer to the operation manual or
other instructions when complete information cannot be provided on the
label.

“ATTENTION” – Pay attention to the high temperature in the chamber, and
the sterilizer exterior when exhausting system is running.

“Protective Earth” - Indicates the protective earth (grounding) terminal.

“CAUTION” - Dangerous voltage” (the lightning flash with arrowhead) is used

to indicate electric shock hazards.

Label Icon Description

Symbol for "SERIAL
NUMBER"

Symbol for
"MANUFACTURER"

Symbol for "CATALOGUE
NUMBER"

Symbol for "AUTHORISED
REPRESENTATIVE IN
THE EUROPEAN
COMMUNITY

Symbol for "DATE OF
MANUFACTURE"

Symbol for "CAUTION"