WOSON C12L, C18L, C23L Operation Manual
Steam Sterilizer Operation Manual
TANZO Classic Model Page of 46
1
WOSON Medical System
Technical
Publications
TANZO Classic Steam Sterilizer
Operation Manual
ASS0011
REV-A
Operation Documentation
Copyright © 2016 By Ningbo Jiangbei Woson Medical Instrument Co., Ltd.
Steam Sterilizer Operation Manual
TANZO Classic Model Page of 46
2
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
No.25, Lane 300, Jinshan Road, Jiangbei District,
Ningbo 315032, China
Tel: 86-574-83022668
Fax:86-574-87639376
www.woson.com.cn
overseas@woson.com.cn
Steam Sterilizer Operation Manual
TANZO Classic Model Page of 46
3
Revision History
REV
ISSUE DATE
REASON FOR CHANGE
Rev-A
2015.09.06
First Issue
Rev-B
2016.07.22
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 dept.
Steam Sterilizer Operation Manual
TANZO Classic Model Page of 46
4
Regulatory Requirements
Conformity Standards
The content of this manual is used for sterilizer.
Above sterilizer accords with the requirements of European Class B:
93/42/EEC
97/23/EC
EN 61010-1:2001
EN 61010-2-040: 2005
EN 13060:2004
EN 61326-1:2006
European Authorized Representative
DTF Technology s.r.l.
Address: via Gressoney 9, 20137 Milano
Tel: +39.02.84893641
Fax: +39.02.84718594
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 has certified by 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 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.
Steam Sterilizer Operation Manual
TANZO Classic Model Page of 46
5
Table of Content
Regulatory Requirement ...................................................................................................... 2
Revision History ................................................................................................................... 3
Regulatory Requirements .................................................................................................... 4
Chapter 1 Introduction ......................................................................................................... 7
1.1 Attention .................................................................................................................. 7
1.2 Usage Indications ................................................................................................... 7
1.3 Contraindication ...................................................................................................... 7
Chapter 2 Safety .................................................................................................................. 8
2.1 Explanation Symbol ................................................................................................ 8
2.2 General Safety Recommendations ........................................................................ 9
2.3 Safety Parts .......................................................................................................... 10
2.4 Operation Risk ...................................................................................................... 11
2.5 Protection Device ................................................................................................. 11
Chapter 3 Receiving and Installation ................................................................................. 12
3.1 Check the Package .............................................................................................. 12
3.2 Unpack the Accessories ....................................................................................... 12
3.4 Set ........................................................................................................................ 13
3.5 Power Connection ................................................................................................ 14
3.6 Inspection Checklist.............................................................................................. 14
Chapter 4 Description and Specification ........................................................................... 15
4.1 Front View ............................................................................................................. 15
4.2 Rear View ............................................................................................................. 16
4.3 Open View ............................................................................................................ 17
4.4 Extemal Dimension............................................................................................... 17
4.5 Load Dimension .................................................................................................... 18
4.6 Specification ......................................................................................................... 18
4.7 Sterilization Cycle ................................................................................................. 20
Chapter 5 Panel and Functions ......................................................................................... 21
5.1 Function Panel ...................................................................................................... 21
5.2 Menu ..................................................................................................................... 22
5.3 Window of Sterilization Process ........................................................................... 25
Chapter 6 Operation Process ............................................................................................ 28
6.1 Switch On ............................................................................................................. 28
6.2 Distilled Water Adding .......................................................................................... 28
6.3 Alarm if Used Water Reservoir is Full................................................................... 29
Steam Sterilizer Operation Manual
TANZO Classic Model Page of 46
6
6.4 Select Program ..................................................................................................... 29
6.5 Load Articles ......................................................................................................... 29
6.6 Closing the Door ................................................................................................... 31
6.7 Starting a Program ................................................................................................ 31
6.8 End of the Sterilization Cycle................................................................................ 31
6.9 Power Off .............................................................................................................. 32
6.10 Abnormal Exiting ................................................................................................. 32
6.11 Suddenly Power Off ............................................................................................ 33
Chapter 7 Essential Information ........................................................................................ 34
7.1 Please Ensure the Following.... ............................................................................ 34
7.2 And Please Do Not.... ........................................................................................... 34
Chapter 8 Maintenance ..................................................................................................... 35
8.1 Maintenance Schedule Chart ............................................................................... 35
8.2 Daily Maintenance ................................................................................................ 35
8.3 Weekly Maintenance (More Often If Necessary) ................................................. 36
8.4 Monthly Maintenance ........................................................................................... 37
8.5 Other Maintenance ............................................................................................... 38
8.6 Service By the Approved Technician .................................................................... 39
Chapter 9 Transportation and Storage .............................................................................. 40
9.1 Preparation before Transportation and Storage ................................................... 40
9.2 Draining ................................................................................................................ 40
9.3 Conditions for Transportation and Storage .......................................................... 40
9.4 Package ................................................................................................................ 40
Appendix 1 Articles Preparation Procedure ....................................................................... 41
Appendix 2 Alarm Code ..................................................................................................... 42
Appendix 3 Electric and Pipeline Drawings ....................................................................... 43
Pipeline Drawing ......................................................................................................... 43
Electric Drawing .......................................................................................................... 44
Appendix 4 Inspection Checklist ........................................................................................ 45
Steam Sterilizer Operation Manual
TANZO Classic Model Page of 46
7
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 contraindications of this equipment.
Steam Sterilizer Operation Manual
TANZO Classic Model Page of 46
8
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"
Steam Sterilizer Operation Manual
TANZO Classic Model Page of 46
9
Manual Prompt
Note
Indicates that concerned information is easier or helpful in the operation.
Caution
Indicates that a potential hazard may exist through inappropriate conditions
or actions, which will or can cause:
• Minor injury;
• Property damage;
• Damage to machine.
Warning
Indicates that a specific hazard may exist through inappropriate conditions or
actions, which will or can cause:
• Severe personal injury;
• Substantial property damage;
• Substantial damage to machine.
NOTE: Indicates that precautions or recommendations should be used in the operation.
2.2 General Safety Recommendations
❖ The user is responsible for operating and servicing the sterilizer in accordance with
the instructions listed in this manual.
❖ The sterilizer cannot be used for liquids.
❖ 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 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 labels from the sterilizer.
❖ Do not pour water or any other liquids over the sterilizer.
❖ Do not fill the water tank with caustic liquids. .
❖ Do not place caustic matter in the chamber.
❖ Use only high quality distilled water.
Steam Sterilizer Operation Manual
TANZO Classic Model Page of 46
10
❖ Unplug the mains power supply before inspecting or servicing the machine.
❖ Only an approved technician using original spare parts can carry out repair and
maintenance.
❖ In case of transport, drain both water tanks completely, allow the sterilization chamber
to cool down and preferably pack the device in its original packaging.
❖ When the temperature is over 40℃, use the tools provided to remove articles from
the sterilizer.
❖ If the sterilizer needs to be moved or lifted, it should be done by two people.
❖ Do not cover the water tank cover while the sterilizer is running.
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
To ensure the door is closed completely for avoiding the risk of
safety
Tray Tong
Avoid scald when removing articles from the chamber
Control Part
Steam Sterilizer Operation Manual
TANZO Classic Model Page of 46
11
Part Name
Function
Temperature Sensor
(Internal)
To measure temperature inside the chamber
Temperature Sensor
(Heating Ring)
To 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 controlling 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 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.
2.5 Protection Device
Device Name
Function
Rubber or fabric glove
Useful for loading and removing articles, avoid scald.
Steam Sterilizer Operation Manual
TANZO Classic Model Page of 46
12
Chapter 3 Receiving and Installation
3.1 Check the Package
Please check package carefully when you receive the product.
Front
Flank
Item
C12L
C18L
C23L
Packing Size
655x560x495mm
655x560x495mm
765x560x495mm
Gross Weight
53kg
56kg
63kg
3.2 Unpack the Accessories
Open the door and take out all the accessories, items listed below:
No.
Part Name
Qty
1 2 4 3 7 5 6
1
Rack
1 piece
2
Tray
3 sets
3
Removal tool
1 piece
4
Draining tube
1 piece
5
Water filling tube
1 piece
6
Power supply cable
1 piece
7
Door seal
1 piece
Steam Sterilizer Operation Manual
TANZO Classic Model Page of 46
13
3.3 Installation Environment
The sterilizer should be set in a place where at least has 10cm distance with each side
(20cm from the top) as following:
NOTE:
The sterilizer should be set in a place with good ventilation.
The operation temperature: 5-40℃.
The humidity of environment: ≤85%.
The atmosphere pressure: 860Hpa～1060Hpa.
An earth connection is essential.
CAUTION
DO NOT PUT ANY STUFF WHICH EASILY MELTS NEAR THE STERILIZER.
3.4 Set
❖ The sterilizer should be set on level table or place; the front-end should be a little bit
higher than the back-end.
❖ The sterilizer cooling and vent area should not be jammed or blocked.
❖ Do not put any stuff on the top of the sterilizer.
Steam Sterilizer Operation Manual
TANZO Classic Model Page of 46
14
❖ Do not put any stuff in front of the door, avoid accidents when open the door.
❖ Do not put any caustic matter near the sterilizer, avoid accidents or risks.
3.5 Power Connection
❖ The sterilizer should be connected with a stable and individual 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 the sterilizer.
CAUTION
DO NOT BEND THE POWER CORD TO AVOID DAMAGE
DO NOT PUT ANY STUFF ON THE POWER CORD
DO NOT USE OTHER POWER CORD TO AVOID DAMAGE OF STERILIZER
DO NOT TRY TO ADD THE POWER CORD TO AVOID ACCIDENT OR RISK
WRONG
WRONG
RIGHT
3.6 Inspection Checklist
After installation, complete the checklist provided in Appendix 4 to ensure the equipment
is properly installed and can be operated safely and correctly.
Loading...