Woson TANDA User manual

Steam Sterilizer Operation Manual
Ningbo Jiangbei Woson Medical Instrument Co., Ltd
Technical
Publications
TANDA Steam Sterilizer
Operation Manual
ASS0007
REV-E
Operation Documentation
All rights reserved © 2016 By Ningbo Jiangbei Woson Medical Instrument Co.,Ltd.

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Regulatory Requirement
This product complies with regulatory requirements of the following European Directive
93/42/EEC concerning medical devices.
Ningbo Jiangbei Woson Medical Instrument Co., Ltd
Address: No.25, Lane 300, Jinshan Road, Jiangbei District,
Ningbo 315032, China
Tel: [phone]
Fax: [phone]
Website: www.woson.com.cn
E-mail: [email protected]

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Revision History
REV
ISSUE DATE
REASON FOR CHANGE
Rev-A
2009.02.01
First Issue
Rev-B
2009.09.08
Version Change
Rev-C
2010.04.26
Version Change
Rev-D
2012.07.29
Version Change
Rev-E
2016.06.25
Version Change
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 dept.

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Regulatory Requirements
Conformance Standards
The content of this instruction is fit for sterilizers.
Above sterilizer accord with the requirements of European Class B:
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 Milano
Tel: [phone]
Fax: [phone]
This product complies with the regulatory requirement 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.
Certifications
Manufactory is EN ISO 9001 and EN ISO 13485 certified.
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 product 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 Requirements.................................................................................................1
Revision History.................................................................................................................2
Regulatory Requirements.................................................................................................3
Chapter 1 Introduction......................................................................................................6
Chapter 2 Safety.................................................................................................................7
2.1 Sign Explanation.....................................................................................................7
2.2 General Safety Recommendations........................................................................8
2.3 Safety Parts............................................................................................................9
2.4 Operation Risk......................................................................................................10
2.5 Protection Device .................................................................................................10
Chapter 3 Receiving and Installation............................................................................. 11
3.1 Check the Package..............................................................................................11
3.2 Unpack the Accessories.......................................................................................11
3.3 Optional Accessories............................................................................................12
3.4 Installation Environment.......................................................................................12
3.5 Installation.............................................................................................................13
3.6 Power Connection................................................................................................13
Chapter 4 Description and Specification......................................................................14
4.1 Front View.............................................................................................................14
4.2 Rear View.............................................................................................................15
4.3 Open View............................................................................................................15
4.4 External Size ........................................................................................................16
4.5 Loading Size.........................................................................................................16
4.6 Specification .........................................................................................................16
4.7 Sterilization Cycle.................................................................................................18
Chapter 5 Panel and Functions......................................................................................19
5.1 Display Panel........................................................................................................19
5.2 Controlling Button.................................................................................................19
5.3 Sterilization Program............................................................................................21
5.4 Window of Sterilization Cycle...............................................................................21

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Chapter 6 Operation Process.........................................................................................23
6.1 Switching On ........................................................................................................23
6.2 Distilled Water Adding ..........................................................................................23
6.3 Alarming if Used Water Reservoir is Full..............................................................24
6.4 Selecting Sterilizing Program ...............................................................................24
6.5 Loading Articles....................................................................................................24
6.6 Closing the Door...................................................................................................25
6.7 Starting a Program................................................................................................26
6.8 End of the Sterilization Working Cycle.................................................................28
6.9 Power Off..............................................................................................................28
6.10 Abnormal Exiting.................................................................................................29
Chapter 7 Essential Information ....................................................................................32
Chapter 8 Maintenance ...................................................................................................32
8.1 Maintenance Schedule Chart...............................................................................32
8.2 Daily Maintenance................................................................................................32
8.3 Weekly Maintenance............................................................................................33
8.4 Monthly Maintenance...........................................................................................34
8.5 Other Maintenance...............................................................................................35
8.6 Servicing by the Approved Technician .................................................................36
Chapter 9 Transportation and Storage..........................................................................37
Appendix 1 Instruments Preparation Procedure .........................................................38
Appendix 2 Error Code List............................................................................................39
Appendix 3 Piping and Circuit Diagram........................................................................40
Piping Diagram...........................................................................................................40
Circuit Diagram...........................................................................................................41
Appendix 4 The Standards of Testing...........................................................................42

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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 is no any contraindication of this equipment.

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Chapter 2 Safety
2.1 Sign Explanation
Device Sign Description
“ATTENTION” – Refer to this Operation Manual” is 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 temperatures in the chamber, and
to 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 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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Operation Prompt
Note
Indicates that concerned information is easier or helpful in operation
Caution
Indicates that a potential hazard may exist which, through inappropriate
conditions or operation, will or can cause:
• Minor injury
• Property damage.
• Damage to machine
Warning
Indicates that a specific hazard exists which, through inappropriate conditions
or operation, may cause:
• Severe personal injury
• Substantial property damage
• Substantial damage to machine
NOTE: Indicates precautions or recommendations that should be used in the operation.
2.2 General Safety Recommendations
❖The user is responsible for proper operation and maintenance of the sterilizer in
accordance with the instructions listed in this manual.
❖The sterilizer could not be used for liquid.
❖The sterilizer could not be used for gas.
❖The trays and the load will still be hot at the end of each cycle. Use the tray holder to
remove each tray from the chamber.
❖Do not open the door of the chamber during the sterilization programs.
❖Do not put you hands or face on the cover of the water tank when the sterilizer is running.
❖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 liquid into the water tank.
❖Do not fill the caustic matter in the chamber.
❖Use only high quality distilled water.
❖Unplug the mains lead before inspecting or servicing the machine.

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❖Only an approved technician using original spare parts can carry out repairs and
maintenance.
❖In case of transportation, drain both water tanks completely, allow the sterilization
chamber to cool down and preferably use the original packaging.
❖The articles under sterilization should be removed by special tools when the temperature
over 40℃.
❖Picking-up the sterilizing trays should use the special tools provided.
❖During the transportation, the sterilizer should be carried by two people in case of turning
over.
❖Notice! This product can’t be put on the place that is not easy to cut off power supply.
❖Prohibit covering the lid of water tank during usage.
2.3 Safety Parts
Temperature Protection
Part Name
Function
Temperature Protector
(Steam Generator)
Cut off current when the steam generator temperature is too high.
Temperature Protector
(Heating Ring)
Cut off current when the heating ring temperature is too high.
Electricity Protection
Part Name
Function
Double Fuse
Cut off current when the connected power is too high or unstable.
Electronic Filter
Filter the electromagnetic interference during working.
Mechanical Protection
Part Name
Function
Jiggle Switch
Ensure the door closed completely, avoiding safety risk.
Tray Tong
Avoid scald when removing articles from the chamber

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Control Part
Part Name
Function
Temperature Sensor
(Internal)
Measure temperature inside the chamber
Temperature Sensor
(Heating Ring)
Measure temperature of the heating ring
Temperature Sensor
(Steam Generator)
To measure temperature of the steam generator
Pressure Sensor
To measure pressure of the chamber
PCB Control
Control system for all the process of sterilization
CAUTION: Manufacturer is not held responsible for any arbitrary disassembly,
amendment with the unit, by unauthorized person or unprofessional
technician.
2.4 Operation Risk
Please take attention on avoid operation risk during operation.
Scald risk
❖Every time opening the door after sterilization cycle, please keep an appropriate distance,
because the chamber still has rudimental steam with high temperature.
❖Every time open the door after sterilization cycle, please not touch the main door and
chamber, because of high temperature, and avoid to be scalded.
Pollution risk
Please clean the chamber after every time use to avoid rudimental contamination left inside
chamber.
2.5 Protection Device
Device Name
Function
Plastic or fabric glove
Useful during load and remove 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 product.
Front
Side
3.2 Unpack the Accessories
Open the package and take the product out, remove the plastic bag then open the door to take
all the accessories and check as following:
No.
Part Name
Qty
1 2 6 4 3 5
1
Rack
1 piece
2
Tray
3 sets
3
Removal Tool
1 piece
4
Draining Tube
1 piece
5
Power Supply Cable
1 piece
6
Door Gasket
1 piece
Item
TANDA 18
TANDA 23
Packing Size
(mm)
660x525x495
770x530x495
Gross Weight
(Kg)
52
58

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3.3 Optional Accessories
Name
Model
QTY
Picture
USB Reader
1G
1
Thermal Printer
PINTER20 (SP-POS58VTH)
1
3.4 Installation Environment
The sterilizer should be set in a place which at least has 10cm distance against each side
(20cm to the top) as following:
❖The sterilizer should be set in a place with good ventilation.
❖The temperature of enviroment: 5-40℃
❖The humidity of environment: ≤85%
❖Atmosphere pressure: 860Hpa～1060Hpa
❖An earth connection is essential.
CAUTION: Do not place any stuff which easily melts near the sterilizer.

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3.5 Installation
❖The sterilizer should be set on level table or place; the front-end should be a little bit
higher then back-end(via front pads).
❖The sterilizer cooling and vent area should not be jammed or blocked.
❖Do not put any stuff on the top of the sterilizer.
❖Do not put any stuff in front of the door, to avoid accident when open the door.
❖Do not put any corrosive stuff near the sterilizer to avoid accident or risk.
3.6 Power Connection
❖The sterilizer should be connected with a stable and separated power source.
❖Power socket is at the back of the sterilizer.
❖Please confirm the connection power is complied with specification of nameplate at the
back of sterilizer.
WRONG
WRONG
RIGHT
CAUTION: Do not bend the power wire to avoid damage of power wire.
Do not put any heavy stuff on the power wire to avoid damage of power wire.
Do not use other power wire to avoid damage of sterilizer.
Do not try to add the power wire to avoid accident and risk.

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Chapter 4 Description and Specification
4.1 Front View
No.
Name
Description
1
Water Filling Port
Manually filling water
2
Drainage Port
Connected to used water tank
3
Drainage Port
Connected to main water tank
4
Fuse
Protect product when the power is not stable
5
Power Supply Switch
Standard green power switch
6
Displaying Window
Show temperature, pressure or other sterilization information
on the window, easy to operate during the working
7
Door Handle
Door handle with safe door locker to open and close the door

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4.2 Rear View
No.
Name
Description
8
Power socket
Connected with power source
9
Printer out port
Connect a mini printer and output sterilization record
10
Relief Valve
Leak pressure automatically when over working pressure
11
Nameplate
Basic information of manufacturer
12
Vent area
Output heat from this vent area by condenser
4.3 Open View
No.
Name
Description
13
Air Filter
Filter the air and ensure air into chamber is clean
14
Door Seal
For sealing the door
15
Water level sensor
For used water tank
16
Tray & Rack
To load the articles

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4.4 External Size
Item
18L
23L
Size of Closed Door(A×B×C)
445×400×560
445×400×670
Size of Opened Door(A×B×D)
445×400×830
445×400×940
4.5 Loading Size
The loading size of sterilizer as followed:
18L
23L
4.6 Specification
Basic Specification
Rated voltage: a.c.220V-230V, 50Hz
Rated power: 18L/ 1500VA, 23L/ 1700VA
Fuse: T10A
Operation temperature: 5～40℃
The board affording weight: 4000 N/m2
Noise: < 50db

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Maximum capacity of one tray: 1000g
The frequency of water draining: once a day, drain the water once you find “waster water over”
during operation.
The maximum duration of using loading test: 90mins
The maximum thermal radiation energy under the condition of 20℃~26℃: <2000J
Sterilizer Chamber
Material: stainless steel (for medical)
Max. work pressure: 2.5bar
Min. work pressure: -0.9bar
Max. temperature: 145℃
Chamber volume: 18L(Φ245×352mm) 23L(Φ245×450mm)
Loading size: 18L (198×204×285mm) 23L(198×204×385mm)
Max. loading weight: 18L (3.07kg/cm2) 23L (3.21kg/cm2)
Working pressure/temperature: 1.10~1.30bar/121℃~122℃; 2.10~2.30bar/134℃~135℃
Water volume for one cycle: 0.16L~ 0.18L
Sterilizer Steam Safety Valve
Safety release pressure: 2.45bar
Max. working temperature: 160℃
Water Tank
Main water tank volume: 18L (3.5L) 23L (4L)
CAUTION: Water added into main water tank must be distilled water!
Water temperature must be under 40℃.
Test Method
❖Vacuum Test
❖B&D Test
❖Helix Test

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4.7 Sterilization Cycle
-0.8
-1.0
123 4 5 6 7
kPA
Time
0.8
2.0
Pressure
END
1-7 Entire duration
1-2 Pre-heating
2-3 Pre-vacuum
3-4 Sterilizing
4-5 Air-discharging
5-6 Drying
6-7 Stabilizing
Table—Types of sterilization cycles
Type
Purpose description
B
The sterilization of all wrapped or non-wrapped, solid, hollow load products type
A and porous products as represented by the test loads in this standard.
S
The sterilization of products as specified by the manufacturer of the sterilizer
including non-wrapped solid products and at least one of the following: porous
products, small porous items, hollow load products type A, hollow load products
B, single wrapped products, multiple-layer wrapped products.
NOTE 1
The description identifies ranges of products and test loads.
NOTE 2
Non wrapped sterilized instruments are intended either for immediate use or for
non sterile storage, transport and application (e.g. to prevent cross infection).

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Chapter 5 Panel and Functions
5.1 Display Panel
5.1.1 Temperature display
Indicate real time in-chamber temperature.
Unit: ℃
5.1.2 Pressure display
Indicate real time in-chamber pressure.
Unit: kPa
5.1.3 Cycle status/ Error cord display
Indicate sterilization status, referring to the “window of sterilization cycle”.
When the sterilizer alarms, a corresponding error code will be displayed. Check the
malfunction parts according to the error code list (please contact the local dealer or our service
dept).
5.2 Controlling Button
5.2.1 “UNPACKED”
Used for unwrapped instruments at 134℃, 210kPa, 1 time vacuum.
5.2.2 “PACKED”
Used for packed instruments, handpieces etc. at 134℃, 210kPa, 3 time vacuum.
5.2.3 “PRION”
Used for prion, bacteria and virus etc. at 134℃, 210Kpa, 3 time vacuum.
5.2.4 “POROUS”
Used for cotton yarn and similar articles at 121℃,110Kpa, 3 time vacuum.
5.2.5 TEST
Choose Vacuum Test or BD Test.