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TANZO Touch
(HSV 23-A)
ASS00032
REV-C
R1.0 software version
Operating Instructions:
All rights reserved 2014 By Woson Medical Instrument Co.,Ltd.
Regulatory Requirement
This product complies with regulatory requirements of the following European Directive
93/42/EEC concerning medical devices.
Revision History
REV
ISSUE DATE
Rev-A
2014.07
First Issue
Rev-B
2014.12
Version Update
Rev-C
2015.07
Version 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.
Page 1 of 54
Regulatory Requirements
Conformance Standards
The content of this instruction is fit for sterilizers.
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
Certifications
Manufactory has certified with ISO 9001 and 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.
Touch18 Touch23 REV-C
Page 2 of 54
Catalogue
Regulatory Requirement................................................................................................................. 1
Revision History................................................................................................................................ 1
Regulatory Requirements............................................................................................................... 2
Chapter 1 Product Scope and Structure...................................................................................... 5
1.1 Attention.............................................................................................................................. 5
1.2 Usage Indications.............................................................................................................. 5
1.3 Contraindication................................................................................................................. 5
Chapter 2 Product Features........................................................................................................... 6
2.1 Sign Explanation................................................................................................................ 6
2.2 General Safety Recommendations.................................................................................7
2.3 Safety Parts........................................................................................................................ 8
2.4 Operation Risk....................................................................................................................9
2.5 Protection Device...............................................................................................................9
Chapter 3 Receiving and Installation.......................................................................................... 10
3.1 Check the Package......................................................................................................... 10
3.2 Unpacking the Accessories........................................................................................... 10
3.3 Installation Environment................................................................................................. 11
3.4 Set...................................................................................................................................... 11
3.5 Power Connection........................................................................................................... 11
Chapter 4 Description and Specification.................................................................................... 13
4.1 Front View.........................................................................................................................13
4.2 Rear View......................................................................................................................... 14
4.3 Open View........................................................................................................................ 14
4.4 Exterior Size..................................................................................................................... 15
4.5 Loading Size.....................................................................................................................15
4.6 Specification..................................................................................................................... 15
4.7 Sterilization Cycle............................................................................................................ 17
Chapter 5 Panel and Functions................................................................................................... 20
5.1 Function Panel................................................................................................................. 20
5.2 Menu.................................................................................................................................. 20
5.3 Window of Sterilization Process....................................................................................33
Chapter 6 Operation Process.......................................................................................................35
Page 3 of 54
Page 4 of 54
1.3 Contraindication
There is no any contraindication of this equipment.
Page 5 of 54
Label Description
Symbol for
Symbol for
"SERIAL NUMBER"
"MANUFACTURER"
Symbol for
"CATALOGUE NUMBER"
Symbol
for
"AUTHORISED
REPRESENTATIVE IN
Symbol for
Symbol for
"DATE OF MANUFACTURE"
"CAUTION"
THE
EUROPEAN COMMUNITY"
Page 6 of 54
Operation Prompt
Note
Caution
Minor injury;
Property damage;
Damage to machine.
Indicates that a specific hazard may exists, which through inappropriate
conditions or operation, will or can cause:
Warning
NOTE
The user is responsible for proper operation and maintenance of the sterilizer in
accordance with the instructions listed in this manual.
The trays and the load will still be hot at the end of each cycle. Use the removal tool 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.
Page 7 of 54
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 cant be put on the place that is not easy to cut off power supply.
Function
Temperature Protector
(Steam Generator)
high.
Temperature Protector
Cut off current when the heating ring temperature is too high.
(Heating Ring)
Electricity Protection
Part Name
Double Fuse
Function
Cut off current when the connected power is too high or
unstable.
Electronic Filter
Mechanical Protection
Part Name
Jiggle Switch
Tray Tong
Function
Ensure the door closed completely, avoiding safety risk.
Avoid scald when removing articles from the chamber
Control Part
Part Name
Temperature Sensor
Function
Measure temperature inside the chamber
(Internal)
Touch18 Touch23 REV-C
Page 8 of 54
Temperature Sensor
(Heating Ring)
Temperature Sensor
(Steam Generator)
Pressure Sensor
PCB Control
CAUTION
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.
Function
Page 9 of 54
Front
Flank
Item
18L Model
23L Model
Packing Size
633500437
743500437
56kg
63kg
Packing
Weight
Part Name
Qty
Rack
1 piece
Tray
3 sets
Removal tool
1 piece
Draining tube
1 piece
1 piece
1 piece
Door seal
1 piece
1 2
Page 10 of 54
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 then back-end.
The sterilizer cooling and vent area should not be jammed or blocked.
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.
The sterilizer should be connected with a stable and separated power source.
Please confirm the connection power is complied with specification of nameplate at the
back of sterilizer.
DO NOT BEND THE POWER WIRE TO AVOID DAMAGE OF POWER WIRE.
DO NOT PUT ANY HEAVY STUFF ON THE POWER WIRE TO AVOID DAMGE
CAUTION
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.
Page 11 of 54
Wrong
Wrong
Right
Page 12 of 54
7
6
5
4
Name
3
Description
1. Door Handle
5. USB/SD Port
6. Power Switch
7. Printer (optional)
8. LED Screen
Page 13 of 54
12
11
13
10
9
14
Name
Description
9. Power socket
10. Fuse
Vent steam
14. Nameplate
16
18
Page 14 of 54
Item
18L Model
23L Model
557471401
667471401
827471401
987471401
18L Model
23L Model
4.6 Specification
Basic Specification
Rated voltage: a.c.220V-230V, 50Hz
Rated power: 18L 1500VA, 23L 1700VA
Fuse: T10A
Operation temperature: 540
The board affording weight: 4000 N/m2
Noise: < 50db
The maximum capacity of a plate: 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.
Touch18 Touch23 REV-C
Page 15 of 54
Sterilizer Chamber:
Material: stainless steel (for medical)
Max. work pressure: 2.5 bar
Min. work pressure: -0.9 bar
Max. temperature: 145
Chamber volume: 18L (245320mm) 23L (245450mm)
Loading size: 18L (3.14232325mm) 23 L(3.14232425mm)
Max. loading weight: 18L (3.07kg/cm2)
23L (3.21kg/cm2)
CAUTION
23L (4L)
Test Method
Vacuum Test
B&D Test
Helix Test
Page 16 of 54
1-2 pre-heating
2-3 pre-vacuum
3-4 sterilizing
4-5 air-discharging
5-6 drying
6-7 stabilizing
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
NOTE 2
Page 17 of 54
5.1.2 Up Choosing
Button
Up choosing has the functions that are used for setting down the cycle program and filling in
water pump, Press this button you can choose the following programs, and if press button for 3
seconds, the machine would enter into filling in water automatically program.
Button
Down choosing has the cycle program, press this button you can also choose the following
programs.
5.1.4
Button
It will enter into the cycle program choice menu, and then please press
or
button to
5.1.5
Button
This button is used for confirmation on the start or end the cycle and removing the malfunction
of program. After choosing a certain program, please press this button to confirm it. Press the
button again will start a working cycle. Keep pressing it for 5 seconds during a program any
time, the cycle will be terminated.
CAUTION
5.2 Menu
5.2.1 Main Menu
Turn on power switch, enter the Loading interface, wait for 10 seconds, automatically jump into
Touch18 Touch23 REV-C
Page 18 of 54
or
process, Press
or
Page 19 of 54
Custom Programs
sterilization program options select Custom Programs, press
Programs interface, press
decrease, press
or
interface, Press
or
Page 20 of 54
or
button to confirm,
Automatic into the system setting interface. The interface showed as followed:
or
button to confirm, Automatic into the system setting interface. The interface showed
as followed:
or
button to confirm.
Automatic into the system setting interface. The interface showed as followed:
Page 21 of 54
When the printer closing, logo on the main screen is dotted line shows constantly
When the printer opening, logo on the main screen is solid line shows constantly
When the printer opening without device, logo on the main screen is solid line
flicker
When the printer open, but print module damage, logo on the main screen is dotted line
flicker
or
to select on or
button to confirm. Automatic into the system setting interface. The interface
showed as followed:
Page 22 of 54
When close the USB, logo on the main screen is dotted line shows constantly
When open the USB, logo on the main screen is solid line shows constantly
When open the USB without device, logo on the main screen is solid line flicker
When open the USB, but print module damage, logo on the main screen is dotted line
flicker
or
to
When insulation standby time opening, logo on the main screen is solid line shows
constantly
When insulation standby time opening, logo on the main screen is dotted line shows
constantly
Page 23 of 54
or
or
to
to save the user name, automatic into the system setting interface. The
or
to switch, Press
as followed:
to perform this
Page 24 of 54
to perform this
to perform this
Page 25 of 54
or
to switch,
back to the
or
to switch, Short
press
confirmation tick, again to cancel, choose the sterilization record need to print, long
press
Page 26 of 54
or
or
to switch,
or
the interface.
5.2.5.1 HELIX/B&D Test
Test & Maintenance options select HELIX/B&D Test, press
Test interface. Press
to start the
program. Until the test over. HELIX/B&D Test interface showed as followed:
Page 27 of 54
Page 28 of 54
or
button to switch
or
button to
Rese and Cancel options, select Reset residual circulation automatic reset or select
Cancel back to the Maintenance info interface. Maintenance info interface showed as
followed:
or
Page 29 of 54
Page 30 of 54
14
13
No
Description
No
Description
Sterilization Program
11
Temperature
12
Sterilization time
13
Vacuum times
14
Drying time
15
Printer icon
Sterilization curve
16
USB icon
17
Total time
18
Cycle no.
Real-time temperature
19
Standard time
Real-time pressure
20
Operation instructions
10
Page 31 of 54
Page 32 of 54
(Figure 6-2-1)
You can fill in water automatically or by manual on the top of the machine;
Automatically: Connect the water tube with the machine right lower corner inlet connector as
Page 33 of 54
Figure 6-2-2 arrow marked, please see the picture, and press
By manual: open up the top cover, to fill in water according to the Figure 6-2-3, stop filling in
water again when you hear beep sound. Press
(Figur 6-2-2)
(Figur 6-2-3)
If the water shortage alarmed during the sterilizing, you should not worry about it, the water will
not influence this process. The water that had been left in the tank is adequate for the
operating cycle, but you need to add water in time, so as to ensure the next operation.
CAUTION
This product has the function of water quality detection, please use the distilled water,
water quality not up to standard will show E17---storage tank water quality exceeding
alarm!
When water quality detection is enabled, the water quality is normal, the logo on main
When water quality detection is enabled, the water quality is not normal, the logo on main
When water quality detection closing, the logo on main screen is dotted line shows
constantly
Page 34 of 54
(Figure 6-3-1)
Connect the water tube to the machine right lower corner inlet connector as Figure 6-3-2 arrow
marked, please see picture.
Generally, the maximum temperature of drained water should be under 70. If it is higher, you
need to check whether the fan operates normally, or contact the local distributor immediately,
we will offer our best service to you in no time.
(Figure 6-3-2)
or
to confirm.
Page 35 of 54
(Figure 6-5)
Read the following instructions for proper usage and maintenance of articles and material.
Make sure that the articles of different materials are separated and placed on different
trays.
In case of carbon steel articles, place a towel or paper-wrap between the tray and the
articles in order to avoid a direct contact.
Make sure that the articles remain apart during the sterilization cycle.
Drawings explain:
RIGHT
WRONG
CAUTION
ATTENTION
Page 36 of 54
(Figure 6-6-1)
If the door not close well, the screen will show warning as Figure 6-6-2, reminding you the door
open,
is flicker.
flicker
(Figur 6-6-2)
start program
Page 37 of 54
When you run the sterilization process, the LCD screen will show as below:
Sterilization end:
When the entire sterilization process is over, the machine will give you a beep.
CAUTION
Page 38 of 54
WARNING
When the door of sterilizer opened, the program will return to the initial state, heat-preserving
and waiting for next sterilizing cycle, before start a new program it will be kept in a
heat-preserving condition all the while.
AFTER STERILIZING HAS BEEN FINISHED, PLEASE USE THE
CAUTION
or
out
directly, if need to dry, choose Dry and exit, then return to the normal display interface.
WARNING
Page 39 of 54
Page 40 of 54
The load has been rinsed thoroughly in clean water before sterilization to avoid any
chemical residues left after cleaning contaminating the sterilizer.
When placing instruments on trays, ensure that they are placed on the ribs of the tray (to
help drainage), they must not touch each other and must not interfere with other trays or
the chamber above.
attempt to sterilize volatile substances, toxic materials or other unsuitable loads. Refer
to your Authorized Person for advice.
Page 41 of 54
Chapter 8 Maintenance
Service is essential to effective sterilization and continued running.
We suggest general servicing by an approved technician per 2-year, or 2500 cycles. Every 3
months replace the bacteriological filter, every year replace the door seal.
Person Responsible
Daily
Clean Door Gasket
User
Clean Chamber
User
Weekly
Clean Chamber, Trays and Rack
User
User
Monthly
Clean Reservoir
User
Yearly
Performance Verification and maintenance
As Required
Change Door Gasket
User
Cleaning function
User
Refer to qualified personnel for servicing Never use a wire brush, steel
wool, abrasive material, or chloride-containing products to clean door and
chamber assembly. Caution hot surface. Avoid contact." ensure that the
sterilizer is cooled down fully before cleaning to avoid burns.
Page 42 of 54
WARNING
Failure to keep the interior of the stainless steel chamber free of mineral
deposits and debris can cause premature failure of the sterilizer.
WARNING
(Pic 8-1)
(Pic 8-2)
Water draining filter might has been jammed by some dust because of use for a long-term, so
effect of vacuum and drying would be influenced. Some tiny impurity might be deposited on the
filter after a long-term use, blocking the filter, so as to influence the effect of the vacuuming and
water discharging. The kinds of impurity come from smeary dust on the instruments being
sterilized or some calcification in the water.
Touch18 Touch23 REV-C
Page 43 of 54
Keep cleaning of the inside chamber in order to make life-time of filter much longer; please
take the following advice for consideration:
The instruments should be cleaned before placing in; it is good to use specified packing
for the instruments with oil or other impurity, dont forget to seal up.
Rotate the water filter which composed by filter net tube(A) and filter holder(B) inside the
chamber. Cleaning the part A and B, ensure that there is no any dirty thing on it.( We
suggest you to clean by ultrasonic cleaning machine). Then set it back and rotate to the
hold bottom of the chamber.
(pic 8-2)
pic 8-3
BE SURE THAT USE DISTILLED WATER PROPERLY IN ORDER TO
ATTENTION
Page 44 of 54
Hold verge of the seal by one hand softly, and another hand should be inserted the
screwdriver into the gap between gasket and door, take out the seal slowly.
2)
Once you take out one part of the seal, you can draw out the whole seal slowly. After
taking out the seal, please check and clean the groove of gasket, so does the gasket,
please replace it if there is some damage.
3)
Fix the clean gasket in initial door groove. At first, embed 4 spots equably into groove
when fix the gasket, and then embed the other parts. Next, press the gasket equably by
hands.
Attention: The gasket should be embedded in the groove equably.
4)
Attention: The inner edge of gasket may be ectropion during embedding it in the door
groove. Youd better to tight it back to the groove by using screwdriver carefully.
Page 45 of 54
Page 46 of 54
9.2 Draining
Drain water from reservoir and the condensate collector completely: insert the joint end of the
attached tube to drain connection. (The spout on the left is the water spout used for the
used-water out, the one on the right is used for the clean-water drain spout)
Used-Water out
Clean-Water out
9.4 Package
Package is used in transportation for protecting product, conveniently delivery and sales.
The sterilizer package requirement should as followed:
1) Product can not over 3/4 volume of package
2) Product should be fix inside the package
3) Package bag should be higher than product 6mm
Page 47 of 54
CAUTION
CAUTION
Page 48 of 54
Alarm code
Error Information
E01
Heat up Slow
E02
Over Pressure
E03
E04
Pressure Low
E05
E06
E07
E08
Micro-switch 1
E09
Micro-switch 2
10
E10
11
E11
Over Temperature
12
E12
Temperature Low
13
E13
Auto-filling abnormal
14
E17
15
E23
16
E24
No sufficient water
17
E25
18
E27
Steam leak
19
E31
Temp.sensor1 abnormal
20
E32
Temp.sensor2 abnormal
21
E33
Temp.sensor3 abnormal
22
E34
Temp.sensor4 abnormal
23
E51
24
E52
25
E53
Page 49 of 54
26
E54
27
E71
28
E72
Page 50 of 54
RV
AF
P1
EV4
EV1
CC
TS1
SM
VP
EV2
EV3
WP1
R3
R2
R1
AF
DWT
WP2
Air Filter
WP1
UMT
WP2
DWT
SM
Steam Maker
EV1
VP
Vacuum Pump
EV2
RV
Relief Valve
EV3
Vacuum Valve
R1
EV4
R2
P1
Pressure sensor
R3
P2
Pressure sensor
TS1
Temperature Sensor
CC
Condensate Collector
UWT
Page 51 of 54
Electric Drawing
AC12V
2AFuse
2A
Fuse
Valve(normal open)
AC21V
AC8V
AC220V
Yellow
Bule
Bule
Yellow
&
Bule
&
Bule
Bule
Yellow
Yellow
Brown
Brown
White
White
Black
Black
Bule
Bule
Jiggle SWitch
Black
Black
Red
Red
Yellow
Yellow
Green
Green
White
White
Bule
Fan
Steam Generator
Display
Connection Port
Heating Ring
Line No.4(Black)
Line No.1(Red)
N(Black)
Fuse
L(Red)
Power
ower Switch
Inside Temperature Sensor
Connection Port
Outside Temperature Sensor
Steam Generator Temperature
Sensor
Page 52 of 54
Power Socket
Testing item
Request of standards
Exterior
Cover Plate
Cover Plate
Electroplate
Components
Printer Components
Chamber Pressure
Safety Valve
Sterilizing Program
10
Controlling System
temperature
value
accords
with
the
pressure
controlling value.
Able to timing control of the sterilization and drying, and
11
Timing Control
12
13
14
Leakage Forbidden
15
Leakage Forbidden
16
Protective Earthing
Impedance
17
18
Successional Leakage
Current under the Work
Temperature
19
Empty Load
20
Hollow Load
21
Page 54 of 54