TANDA COLOR - Woson Latam · 2020. 1. 10. · TANDA Color Steam Sterilizer Operation Manual Rev-C...

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.


Rev-C Page 1 of 17

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: 86-574-83022668 Fax:86-574-87639376 Website:www.woson.com.cn E-mail: [email protected]


Rev-C Page 2 of 17

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: 390284893641

Fax: 39 02 84718594

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.


Rev-C Page 3 of 17

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


Rev-C Page 4 of 17

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.


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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"


Rev-C Page 6 of 17

Manual Prompt

Note Indicates that concerning information which easier or helpful in the

operation.

Caution

Indicates that a potential hazard may exist which through inappropriate

conditions or actions will or can cause:

• Minor injury;

• Property damage;

• Damage to machine.

Warning

Indicates that a specific hazard may exist which through inappropriate

conditions or actions will or can cause:

• Severe personal injury;

• Substantial property damage;

• Substantial damage to equipment.

CAUTION INDICATES PRECAUTIONS OR RECOMMENDATIONS THAT SHOULD BE

USED IN THE OPERATION.

2.2 General Safety Recommendation

❖ The user is responsible for operation and servicing the sterilizer in accordance with the

instructions listed in this manual.

❖ The sterilizer could not be used for liquid.

❖ The sterilizer has not been designed to operate in the presence of gas or explosive vapors.

❖ The trays and the load will still be hot at the end of each cycle. Use the tray holder provided

to remove each tray from the chamber.

❖ Do not open the door of the chamber during the sterilization programs. Do not open the

door until the pressure inside chamber is getting to 0bar.

❖ Do not put your hands or face on the cover of the sterilizer during the sterilization programs.

❖ Do not remove the instruction plate or any label from the sterilizer.

❖ Do not pour water or any other liquid over the sterilizer.

❖ Do not fill the caustic matter in the chamber.

❖ Use only high quality distilled water.

❖ Unplug the main lead before inspecting or servicing the machine.

❖ Only an approved technician using original spare parts can carry out repairs and

maintenance.


Rev-C Page 7 of 17

❖ During the transportation, the sterilizer should be carried by two people in case of turning

over.

❖ Do not use the equipment for cooking.

2.3 Operation Risk

Please take attention on avoiding operation risks during operation.

Scald risk

❖ Every time open the door after the sterilizer finishes the cycle, please keep an appropriate

distance, because the chamber still has rudimental steam with high temperature, avoid to

be scalded.

❖ Every time open the door after the sterilizer finishes the cycle, please do not touch the

main door and chamber, because of high temperature, avoid to be scalded.

Pollution risk

Please clean the chamber after every time using, avoid rudimental contamination left inside the

chamber.

2.4 Protection Device

Device Name Function

Rubber or fabric glove Useful for loading and removing articles, avoid scald.


Rev-C Page 8 of 17

Chapter 3 Receiving and Installation

3.1 Check the Package

Please check package carefully when you receive the equipment.

Front Flank

Item 18 L 23 L

Packing Size 660x525x495 mm 770x530x495mm

N./G. Weight 25/28 KGs 30/33 KGs

3.2 Unpack the Accessories

Open the door and take out all the accessories, item listed below:

No. Part Name Qty

1 Tray rack 1 piece

2 Tray 3 pcs

3 Removal tool 1 piece

4 Draining tube 1 piece

5 Power supply cable 1 piece

6 Door gasket 1 piece

7 Operation manual 1 piece


Rev-C Page 9 of 17

3.3 Installation Environment

After remove the package, the sterilizer should be set in a level place which at least has 10

cm distance with each side (20cm of the top) as followed:

The sterilizer should be set in a place with

good ventilation;

The temperature of environment: 5-40℃;

The humidity of environment: ≤85%;

Atmosphere pressure: 860Hpa～1060Hpa;

An earth connection is essential.


Rev-C Page 10 of 17

Chapter 4 Description and Specification

4.1 Overview

4.2 Specification

Basic specification

Sterilizer Chamber Material: stainless steel 304

Chamber Volume: 18L(Φ245×320mm) 23L(Φ245×450mm)

Rated Voltage and Rated Power: AC110V /1600W/ 8A AC220V/1800W/4A

NO. Item Description

1 Door Handle Open or close the door

2 Function Panel Show sterilization information for control and operation

3 Safety Valve Leak pressure automatically when over working pressure

4 Discharge Port Output heat and wasted water (Attention! High temperature!)

5 Power Cable Connected with power source

6 Power Supply Switch To switch on or switch off

7 Fuse Protect product when the power is not stable

8 Fore Pad Regulate the oblique angle of the equipment

1 2 3

4 5 6 7 8


Rev-C Page 11 of 17

Chapter 5 Panel and Function

5.1 Function Panel

Display Description

1．Press. Real time in-chamber pressure

2．Temp. Real time in-chamber temperature and error code

3．Start lamp Flash when the program starts

4．Sterilize lamp Flash in the process of sterilization

5．End lamp Lighted up when the program ends

6．121℃ lamp 121℃ sterilizing temperature indicator

7．134℃ lamp 134℃ sterilizing temperature indicator

8．Open lamp Lighted up when the release valve is open

manually

9．Close lamp Lighted up when the release valve is closed

manually

10．Dry lamp Flash when you choose drying process, Lighted up

when it ends

Controlling Button Description

℃ Choose sterilizing temp. 121℃/134℃

Release Open or close the release valve

DRY Choose drying program

START Start sterilizer program

5.2 Operation Process

1、Connect one end of the draining tube to the equipment and put the other end into the waste

water tank. Attention: In the drying process, in the chamber there may be a thermal vacuum, to

avoid the back-flow of the water in the waste water tank which will affect the drying effect, please

assure that the drain outlet is higher than the used water’s level in the waste water tank, a>5cm.

Used Water Levela

2、Turn the two fore pads counterclockwise and evenly elevate the equipment to tilt the device

backwards to add more distilled water.


Rev-C Page 12 of 17

3、Open the door and fill 1000ml distilled water into the chamber until the water immerse the

heating stick.

4、Put the instruments which need to be sterilized in the chamber, ①Turn on the power switch；

②Turn the handle clockwise until it is tightened.

①

②

5、①Select sterilizing temperature； ②Press the DRY key to start the automatic drying function

as needed. If you do not need the drying function, skip this step；③Press the START key, light

of “start” begins to flash, the program starts.


Rev-C Page 13 of 17

①

② ③

6、Light of “END” will be lighted up when the program ends, when it releases automatically to

the safe pressure below 0.1 bar,

①Manually press the release button to open, or rotate the handle to the door-opened position,

the program will automatically open the exhaust valve；

②Wait for about 2-3min, then open the door；

③Press the Dry key to start the drying function, dry light flashes, when the drying indicator light

turns to be always bright, drying process finished；

④Please take the instruments out with tools and then turn off the power switch.

5.3 Drying Function Setting

1. If you have not pressed DRY button to start the automatic drying function before you start

the program, there will not be a drying process. After the process of exhaust, the END light is

always on, the pressure window shows the real-time pressure, the temperature window

alternately displays the real-time temperature and " ", indicating the end of the program.

You can open the release valve, wait for 2-3 minutes, then open the door to take out the items.

2. Before starting the sterilization, if the DRY button is pressed in advance to start the automatic

drying function, the program will automatically complete 20 min of drying process after the end

of sterilization. In the drying stage, DRY lights flashes, END light flashes, and pressure window

displays real-time pressure, temperature window alternately displays real-time temperature and

" ".


Rev-C Page 14 of 17

3. During drying stage, the DRY button can be pressed to stop the drying process.

4. If you need to dry with the door opened, you only need to open the door, then press the DRY

lamp light to start manually the door-opened drying function, manual drying time is 20min by

default and it can be adjusted. When the manual drying time arrives, the program closes the

drying function automatically.

5. Press the "DRY" key for 3 seconds to set the drying time, press the temperature selection

key "℃" and dry key "DRY" for time adjustment, press the release key "Release" for drying time

adjustment between 1, 2. Drying time 1 refers to the automatic running drying time, drying time

2 refers to the manual running drying time, press the enter key to save and exit.

5.4 Sterilization Program

Program Sterilizing time Cycle time

(without drying)

Default drying time

(if request)

121℃ 20min approx.35min +20min

134℃ 5min approx.25min +20min

When the program is running and the display window shows（134℃）：

：means alternate display

Preheating 1st pressurize 1st Exhaust 2nd pressurize 2nd Exhaust

3rd pressurize Sterilizing 3rd Exhaust Dry (if request) End

0.0

34

Pr.0

0.2

100

Pr.1

1.0

110

rE1

0.0

100

Pr.2

1.8

130

rE2

0.0

100

Pr.3

2.2

134

5

1.3

123

rE3

0.0

100

dry

0.0

100

End


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Chapter 6 Error Code List

The sterilizer will show Error information when malfunctions happen.

Example

Error Code: E01

Error Code List

No. Error Code Description

1 Er01 Sensor of the chamber defective

2 Er02 In-chamber sensor defective

3 Er03 Sterilization fail (high temperature)

4 Er04 Sterilization fail (low temperature)

5 Er05 Chamber over temperature

6 Er06 Chamber over pressure

7 Er07 Pressurizing over time

8 Er08 Door open during cycle

9 Er98 Out of power during cycle

10 Er99 Forced Exit

1.0

E01


Rev-C Page 16 of 17

Appendix Piping and Circuit Diagram

Piping Diagram

RV

PR

EV1

TS1

EV1

PR

排气电磁阀（常闭）

蒸汽温度压力表

RV

TS1

安全阀

温度传感器(PT100)

AD

AD 排气接头

EV2

EV2 排水电磁阀（常闭）

Code Name Code Name

RV Safety Valve EV2 Drain valve (Normal-Close)

AD Pressure Exhausting Port PR Pressure sensor

EV1 Air Release Valve (Normal-Close) TS1 Temperature Sensor（PT1000）


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Circuit Diagram

AC10V

AC20V

AC220V Transformer

L

N

L

N

L(1）

Heating Ring

Power Socket

Fuse

Ground

Exhausting AirSolenoid Valve

Jig

gle

Sw

itch

Insid

e T

em

pera

ture

Sensor

Outs

ide T

em

pera

ture

Sensor

Pressure

Sensor

Heating Stick

Exhausting WaterSolenoid Valve

TANDA COLOR - Woson Latam · 2020. 1. 10. · TANDA Color Steam Sterilizer Operation Manual Rev-C...

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