Woson Medical Instrument Co., Ltd TANDA COLOR User 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]

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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.

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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

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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.

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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"

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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.

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❖During the transportation, the sterilizer should be carried by two people in case of turning
over.
❖Do not use the equipment for cooking.
2.3Operation 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.
2.4Protection Device
Device Name
Function
Rubber or fabric glove
Useful for loading and removing articles, avoid scald.

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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

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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.

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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

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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 Level
a
2、Turn the two fore pads counterclockwise and evenly elevate the equipment to tilt the device
backwards to add more distilled water.

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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、① Select 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.

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①
②③
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
"".

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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

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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 Air
Solenoid Valve
Jiggle Switch
Inside Temperature
Sensor
Outside Temperature
Sensor
Pressure
Sensor
Heating Stick
Exhausting Water
Solenoid Valve