WIN-TEC-ATB01-037-V1.

Technical Manual
Autoclave

vitale 22B/17B

Dear CRISTOFOLI users,

Thank you very much for your confidence in our product!

CRISTOFOLI, founded in 1990, is headquartered in Parana, Brazil, with more than

220 headquarters staff. It is a global oral medical device enterprise engaged in research
and development, production and sale. The company has passed ISO 13485:2003 system
certification and ISO 14001:2004 Environmental Management System Certification.
CRISTOFOLI is the first company to develop its own dental sterilizer independently in
South America, with the largest production and sales in this market. So far, it has sold

Cristofoli (China) Medical Equipment Co., Ltd. more than 100,000 sterilizers to thirty five countries all over the world.
sterilizer is produced and tested according to the quality criterion strictly like other
Address: Block 2-2F, No. 1177, Lingyun Road, Ningbo National Hi-Tech Zone, 315103, Zhejiang, China.
CRISTOFOLI products, which comply with the latest European standards.
Tel: 0086-574-87913737 Fax: 0086-574-87913735
Web: www.cristofoli.cn
Please carefully read all safety and operating instructions before using, and take
No:WIN-TEC-ATB01-037 Issued in February 2013, version V1.0
proper maintenance according to the rules strictly when you use.
Europen Representative:Shanghai International Holding Corp.GMBH(Europe)
Address:Eiffestrasse 80,20537 Hamburg,Germany
All colleagues of CRISTOFOLI
Tel:+49-40-2513175 Fax:+49-40-255726

Instruction
The main power cord and plug
Installation and commissioning
Preparation and sterilization of
the fabric and instrument
Program abort
Preface Preface
Taking out the sterilization articles ■ Do not open the door with strong force. You can lift the door just by
Preface pushing the switch behind the door gently.
Thanks for buying this sterilizer.
■ Remove the tray with the handle. Do not touch the sterilized
device, cavity and door without wearing gloves so as not to burn.
This Manual is designed for Class B sterilizer. All models are
the same except for the cavity and external depth.
Maintenance
The Manual concludes important safety information. Please ■ The job is conducted by professional staff.
read all safety and operating instructions carefully before operating
the sterilizer. sterilizer moving
Please carefully read all safety instructions in this manual ■ Two persons are needed when moving the sterilizer.
before operating the sterilizer, this manual will help you to fully Choose suitable bag.
share various functions of the sterilizer
Intended use:Use saturated steam as the heat transfer ■ Cut off the power after pressure relief if error message reappears.
medium, and deliver heat to all parts of the instrument quickly, in
order to kill spores and viruses and other microorganisms. It is an ■ Maintenance of equipment can be only conducted by
efficient sterilization. Mainly used to high temperature high professional staff.
pressure steam sterilization, applied in various departments of
medical institutions, laboratories and bio-medical research
institutions. About This Manual
Safety Introduction Symbol Meaning Introduction
Please carefully read the following safety instructions and those in Dangerous situations.The property and the
each chapter before operating the sterilizer. security risk security of people’s life will be threatened
Dangerous! if the situations are not avoided.
■ The sterilizer can not sterilize any liquid.
■ Equipment Protection Level :Ordinary protection. Dangeroussituations.The equipment,
■ The sterilizer is sensitive equipment, ensure not use under Be sure to keep device or the sterilizer will be damaged
strong electromagnetic environment Warning! if the situations are not avoided.
■ Operations should be carried out by professionals, training each
piece of content according to the instructions before operating
Important information Important information
the sterilizer, especially the training of safety-related Highlight!
information, daily maintenance, etc. To ensure the safety of
operators and sterilization effect of the sterilizer.
CE MARKING
■ Do not damage or change the main power cord and plug.
■ If they are damage, the device is out of use.
■ Unplug the power plug itself to cut off the power instead of
WEEE MARKING
pulling the power cord to unplug the power plug.
■This will be conducted by professional staff.
■ The sterilizer should be used in environment with no explosive Manufacturer
dangers.
■ The connection of the electrical and water should be done by
professional staff.
Manufacturer date
■ Make preparation and sterilize the fabric and instrument
according to manufacturers' requirements.
■ Follow related regulations and instructions of sterilization. Consult operation instructions
■ Use packing material and device suitable for steam.
■ Be careful when you open the door if the program aborts. Hot
EC REP Authorised representative in the European community.
water vapor may escape from the cavity, which depends on when
the program aborts.
■ The device may have not sterilized when the program aborts.
Please repack the material and device and operate according to
the display hints.
SN: Number
■ Do not try to abort the program by cutting off the power.
Otherwise, hot water vapor spurting from the air filter will cause
Earthing
dangers and the container filter will be damaged.
3

Content
Chapter 1 Equipment Specification
Correct way of using the sterilizer..........................5
Efficacy...............................................................5
Overview of the sterilization program.....................6
Chapter 2 Equipment Description
Random delivery of goods.....................................7
Product illustrations..............................................8
Effective volume...................................................9
Tray rack.............................................................9
Control panel......................................................10
Chapter 3 Initial Operation
Conditions for equipment installation.....................11
Site requirements of installation............................11
Connectivity requirements....................................12
Conditions of initial operation...............................13
Open the power switch of the sterilizer...................13
Chapter 4 Sterilization
Prerequisites to smooth running
of sterilizing program...........................................14
Preparations for articles to be sterilized.................14
Correct way of sterilizer installation.......................15
Door closing........................................................17
Program selection...............................................17
Start program......................................................18
Program execution..............................................18
Manual terminator................................................18
Sterilization completed........................................19
Drying phase.......................................................19
Program completed.............................................19
Display of total running times...............................20
Fetch-out of the sterilized articles.........................20
Sterile storage...................................................20
Chapter 5 Program Records
Programming document records...................21
Date and time setting...................................21
Use printer as output media.........................22
Use USB Connector as output media............22
Output of program records...........................22
Correctly understand programming
document records.......................................23
4 5
Content
Chapter 6 Equipment Maintenance
Cleaning...............................................................24
Avoid the formation of stains...................................24
High water quality..................................................25
Replacement of fuse..............................................25
Change door seal ring............................................26
Maintenance.........................................................26
Chapter 7 Operation Interval
Sterilization frequency .......................................27
Operation interval ..............................................27
Terminate equipment .........................................28
Removal .............................................................28
Re-installation after change of position ............28
Chapter 8 Function Test
Auto function test...................................................29
Manual function test...............................................29
Conduct test in daily operation................................29
Vacuum test..........................................................29
B&D test...............................................................30
Water quality display..............................................30
Chapter 9 Error Information
Warnings are not meant to be error information........31
Warning................................................................31
Error information...................................................31
Before calling user helpline....................................32
No display on screen.............................................34
Too great water consumption of sterilizer ................34
Non-thorough drying..............................................34
APPENDIX
Contaminants of condesate and feed water .......... 35
Electrical schematics .........................................36
Each program graph ..........................................37
Large capacity, short program
time, sterilization program without
Chapter 1 Equipment Specification
Chapter 1 Equipment Specification
The chapter will introduce
Conditions and purposes of using the sterilizer
Efficacy of the sterilizer
The available sterilization procedures
Correct way of using the sterilizer
Application Range Suitable for medical field such as clinical department and oral
department
Sterilization Task Suitable for various demanding requirements, such as
sterilization of packing or unpacking small cavity equipment and
transmission equipment as well as a lot of fabric
Instruction of using the sterilizer
■ The sterilizer can not sterilize any kind of liquid. It is forbidden to
Danger of burns! sterilize any kind of liquid. Otherwise, the liquid may boil, damaging the
sterilizer and burning people.
■ Please use the sterilizer according to description of ccorresponding
technical documents.
Warning! ■ The sterilization process can only be conducted by qualified personnel.
■ Only if the manufacturers of the equipment and fabric allow for steam
sterilization, can the sterilizer be used.
Efficacy
General purpose The VITALE sterilizer adopts three pre-vacuum, advanced
technologies of vacuum drying and independent steam generator,
which can guarantee completely effective wetness and soakage of
the sterilization articles and then help to sterilize with high
efficiency in clinical application.
At the beginning of the program, water vapor generates and is lead
into the sterilization cavity to hit corresponding pressure and
interval, overheating/ temperature, so the sterilizer can sterilize the equipment or fabric
overpressure protection quickly. The sterilizer applies microprocessor intelligent control
and man-machine interface, which are simple to use. Various
parameters and states are displayed dynamically. Automatic fault
diagnosis and overheat/ overpressure protection can ensure the
reliability of sterilization and disinfection.
Use of water The sterilizer adopts independent water supply system,
guaranteeing the sterilizing water fresh and pure in each cycle.
The water quality will be monitored by the built-in electrical
conductivity testing device, which avoids the appearance of spots
on the sterilization equipment and stain in the sterilizer.
 Chapter 1 Equipment Specification Chapter 2 Equipment Description

Automatic Preheating
Time Optimization
Security Guarantee
Additional Function
The cold cavity can preheat by activating the automatic preheating
function and maintain certain temperature between two sterilization
Chapter 2 Equipment Description
procedures, which guarantee short term of program running and
reduce formation of condensation water so as to improve the drying
effect.
This chapter will introduce
The sterilizer adopts electronic parameter control, optimizing the
running time according to different amount of load.
delivery configuration and optional items when the sterilizer is delivered
The temperature and pressure are monitored frequently and the components of the sterilizer
door is not allowed to open when pressure exists in the cavity. The the menu of the user interface
sterilizer integrates process evaluation system, which monitors the contents of the LCD display
parameters such as temperature, time and pressure, in the process
of procedure running, and meanwhile controls the parameter values
under the limiting ones so as to guarantee effective sterilization. If
any parameter value is higher or lower than the limiting ones, the
sterilizer will give an alarm to prompt the error information and abort
the procedure. The operation then can be conducted by touching Components
the screen.
Standard configuration Vitale22B/17B
B&D testing program can be used to monitor the soakage of porous
sterilization articles such as fabric. Vacuum testing procedure can Operation manual
monitor the leakage of steam system. Conductivity testing Information on means of production
procedure can inspect the quality of sterilizing water.

The built-in storage can save two hundred and forty records at Tray rack: 1
Program Records
Tray: 3
most. All parameter data in each program can be saved
Handle: 1
automatically. The records can be typed out when the program Wrench: 1 (used for fixing the well adjusted door)
stops running or later, or be written in USB flash disk and read from Spare insurance: 2 (on the door of the sterilizer)
the computer. Drain-pipe: 1 (1 meters, silica gel material)

Optional items Additional tray

Overview of the sterilization program Thermal printer

Program Packaging Special Scope Sterilization Program Drying

Parameter Time Load
Time Time

UNIVERSAL B
Monolayer/ Mixed loads, long body, 134℃
5min 25min 15min 6kg
7
multilayer hollow body 2.1bar

No packaging Simple solid equipment,

134℃
FAST S non-woven transmission equipment,
2.1bar 3.5min 17.5min 10min 6kg
fabric and simple hollow equipment
No packaging Simple solid equipment,
134℃
FAST B non-woven transmission equipment,
2.1bar 3.5min 23.5min 10min 6kg
fabric and simple hollow equipment

A large number of fabric, Fabric:2.5kg

Monolayer/ 121℃
GENTLE B
multilayer
non-resistant fabric such as
1.1bar 20min 40min 20min Heat-intolerant
plastic, and rubber good fabric: 6kg

Monolayer/ Suspected that the equipment

134℃
PRION B is infected by lesions protein 20min 40min 15min 6kg
multilayer such as creutzfeld- Jacob, BSE
2.1bar

134℃
B&D TEST Sterilizing effect tex 2.1bar 3.5min 23.5min

Leaking test ≤1.3mbar

LEAKING TEST
/min 20min

* Note:A. Conform to standards of EN13060

B. Maximum load of each package: 1Kg Maximum load of each tray: 2Kg
C. Each program graph in annex 3
6
 Chapter 2 Equipment Description Chapter 2 Equipment Description

Product illustrations
Front view Internal structure

(1) Control Panel

(2) Door

(1) cavity

(2) tray rack

(3) safe lock

(3) Adjustable Door Mat
Side view (4) Water interface

(4) Chute Door Switch (5) Cavity ring

(5) Power Switch (6) Door cover

(6) Printer Interface

Sterilization
Internal cavity: torage tank Environment Relatice humidity
Power Rating temperature/ use
(7) USB Interface diameter ×depth volume temperature Range
pressure
(8) Fixed Mat
Rear View 121℃/1.1bar
25X47cm 230V,2000VA
134℃/2.1bar
16A 4L +5℃~+40℃ 30%-70%

(10) Air Filter

(11) Security Gateway

(12) Outlet Tray Rack

(13) Drainage Filter
A tray rack used for holding trays or boxes is delivered.

The tray rack can hold 3 trays under standard configuration and 5
trays after rotating 90 degrees.

The tray rack can hold two high boxes such as planting box.

Top View (14) Fuse

(15) Power Supply

(16) Filler

(17) Radiator Cap

8 9
 Chapter 2 Equipment Description Chapter 3 Initial Operation

Control Panel
Chapter 3 Initial Operation
Left side is LOGO, middle is LCD display, right side are 4buttons,
buttons function as below:
This chapter will introduce

Test run after equipment installation

Prepare for equipment installation

Starting conditions for equipment installation

■ Equipment installation should be conducted by the authorized
1、" " :Program or menu forward flip over button professional personnel.
2、" ":Program or menu back flip over button, Pan wall
temperature check button, Enter
3、" ":Function button, Door Lock/open button ■ The equipment is not intended for areas where there is a risk of
4、" ":Enter, Cancel, Function return explosion or areas with patients nearby.
■ The distance between the equipment and the treated area is at least
Danger!
1.5 meters.
LCD display content The distance between the equipment and the treated area is at least 1.5
meters.
Stage Display Remark

Start PRESS BALANCE +0.01bar Display pressure balance after startup

PRESS KEY,OPEN THE DOOR Site requirements of installation

Cycle3,4 switch after startup,
PRESS KEY or KEY,SELECT A PROGRAM ■ Dry and free of dust; Humidity range: 30%-70%;
Stand by After 30 seconds lock switch，
2012-01-02 09:27:14 atmospheric pressure:70-106KPa;
Lock tight; cycle 2,3,4 switch display
T:76℃ P:+0.03 bar
Storage Temperature range: 5℃-40℃.
Long press cycle display
Pre-heating HEATING UP 00:01 work Temperature range: 5℃-40℃.
T:105℃ P:+0.00 bar PARAMTER CHECK PREHEAT:101.7℃
PARAMTER CHECK CORDUCT:OUS/CM
■ Make sure there is free place above the sterilizer. Otherwise, the
Pre-vacuum VACUUM 1 01:30 According to the different program, gathering heat will influence functions of the sterilizer, shorten
T:67℃ P:-0.50 bar there is two pre-vacuum and three pre-vacuum
Warning! service life of the vacuum pump, and lengthen operation time of the
program.
Press PRESSURIZING 1 06:02 According to the different program,
T:110.8℃ P:+0.40 bar there is two pressing and three pressing
Electric protection:class I(PE conneted)
Sterilizing STERILIZING 14:02 According to the different program,
T:134.5℃ P:+2.15 bar there are 121℃,1.1BAR and 134℃, 2.1BAR

Press release PRESS.RELEASE 24:50 From sterilizing stage the press depress to
T:113.9℃ P:+1.23 bar +0.40bar stage
Requirements of space distance
DRYING 28:19
Drying T:87.0℃ P:-0.39 bar
TIME REMAINS 5MIN 48S
■ At least 10 cm distance is needed around the sterilizer so as to help
to dissipate heat.
Air filling AIR FILLING 34:07
T:70.0℃ P:-0.80 bar ■ At least 50 cm distance is needed above the sterilizer to facilitate
regular cleaning and water filling.
CYCLE FINISHED 34:07 The sterilizer is suggested to be placed in ventilated environment. No
Cycle finished Program finished, press Printing
CYCLE FINISHED PRESS TO CONFIRM foreign matter is allowed at the cooling window.

Printing PRINTING NOW Printing

10 11
 Chapter 3 Initial Operation Chapter 3 Initial Operation

Please following the below precautions of power cord connection

Placing requirements ■ Observe the following precautions.

May hurt person ■ Do not change or cut off power cord randomly.
■ The sterilizer is placed with left and right balance and the front-end ■ Do not twist the power cord.
higher than the back-end. ■ Do not unplug the power plug by pulling power cord.
■ The sterilizer is fixed by four screw holes at bottom during transport. ■ Do not place heavy objects on the power cord.
Four fixed feet are needed to be installed for the first installation, with
■ Do not place the power cord through window or door, where may
the back two rotated to the end and the front two keeping a certain
cause power cord extrusion.
height.
■ Do not place the power cord near heat source.
■ Vacuum drying is not complete if the front-end is lower than the back-
end. The door mat can be adjusted to modify the height
(counterclockwise rotation stands for increasing of the height) If the power cord or plug is damaged,turn off the sterilizer,
The power cord or plug should be replaced by professional persons.

If you do not perform according to the requiiements above,the

power cord or plug may be domaged ,and may cause as frre or
electric shock,resulting in serious personal injury
Space Requirements Vitale 22 B+

Width A=465mm
G

Length B=465mm

Depth C=730mm

D=530mm
B

E=70mm Sewage Disposal One pressure resistant silicone tube is configured randomly. Do not
bend it.
F=100mm
H G=500
D E Clean Water Discharge One silicone tube with quick connector is configured
F A C H=100
randomly, which can be connected to the quick connector in
the lower right corner of the sterilizer (page 9, (4)) after the
water tank being washed.

Connectivity Requirements Conditions of Initial Operation

Initial operation must meet the following conditions precedent:
Sterilizing water supply
■ The equipment need to be connected by professional personnel.
Power supply
Otherwise, it may lead to short circuit, fire, water leakage, and
May get hurt! electric shock and cause serious injury.

Electrical Connection The equipment need to be connected by professional personnel.

Otherwise, it may lead to short circuit, fire, water leakage, and
electric shock and cause serious injury.
Open the power switch of Open the power switch of the sterilizer
230V,50Hz
the sterilizer Open the power switch (page 8, side view (5)) and supply power for
Fuse:F16AL250V
Input power: 2000VA the sterilizer.
The screen displays the following information “PRESS BALANCE
+0.01bar (Pressure balance)” and then switch to the initial state.
Take the tray and other accessories out of the cavity before initial
operation.

12 13
 Chapter 4 Sterilization Chapter 4 Sterilization

Fabric: Please take the precautions when treat the fabric and put the fabric into
Chapter 4 Sterilization sterilizing cavity.

■ Treat the fabric complying with sterilization requirements proposed

This chapter will introduce by the fabric manufacturers and relevant standards and requirements.
Warning! ■ Adjust the folding way of the fabric and make them keep parallel to
Prerequisites to smooth running of sterilizing program each other.
Precautions when preparing for sterilizing materials ■ Place the fabric vertically in the cavity and leave certain space
Correct way of sterilizer installation among them so as to ensure optimal airflow.
Intended use of the programs ■ Vertical placement is still applied if the sterilization window is used.

How to begin to run the program? ■ The fabric can be packed by sterilization paper bag.
■ The fabric to be sterilized must be dry.
Phases of program running
■ The fabric can not contact the cavity, avoiding absorption of
How to cancel the program?
condensate.
How to identify if the sterilization program successfully runs or not?
How to improve the drying effect?
Otherwise, the effect of steam penetrating or the effect of dry will be
Precautions of taking out the sterilizing materials
affected so that the fabric can not be sterilized completely which will
endanger the patients and medical staff.
Create prerequisites
Successful sterilization needs:
Equipment Follow the instructions below when handling old equipments
Sterilizing water please add water to the top water tank if water is lower than the lowest
level. Otherwise, the program will give a prompt “Not enough water, ■ Comply strictly with sterilization requirements proposed by

check your device press to confirm” manufacturers and relevant local standards and requirements
Risk of infedction ■ Wash the equipment completely, by using of devices such as
"NOT ENOUGH WATER,CHECK YOUR DEVICE PRESS TO
CONFIRM" ultrasonic wave cleaner
■ Wash the equipment with distilled water and then dry it with non-dust
To ensure the quality of feed water meets the requirement, reduce the cloth after it being washed and sterilized.
condensate exceed, the following table shows the reference values of ■ Sterilize the equipment only suitable for steam sterilization.
contaminants of condensate and feed water. Making a comparison ■ The fabric can be packed by sterilization paper bag.
between the values provided in the table and the values worked out by
Otherwise, the dropped residual dirt under the steam pressure and the
testing and analyzing, judging whether the feed water meets the
corrosive cleaning agent will increase equipment maintenance and
requirement and whether the condensate is excessive.(See Page35)
affect functions of the sterilizer, which will endanger the patients and
medical staff.
Please rotate open the top lid anticlockwise and add distilled water. You
Attention
can inspect whether it hits the highest water level by checking warning
tone, the liquid crystal display (LCD) or the mark MAX on the filter (rear Use of materials that are not suitable for cleaning, such as non-
view (10) on page 8). water-soluble substances or oil that can not be penetrated by
steam, will cause the sterilizer unable to sterilize, which will
Minimum water supply tank: 640ml, ensure to complete the entire endanger the patients and medical staff.
sterilization process when water is not enough
water consumption of one single cycle 450ml Please comply strictly with requirements proposed by manufacturers
Attention: for their equipment preparation when using the following equipments:
Make sure to use distilled water to avoid damage caused by using Ultrasonic equipment
of water. Dental handpiece maintenance equipment
Cleaning and sterilization equipment
Do not dump the sterilizer when the storage water tank is full.
Open the power switch Please open the power switch if it is off (see page 13, open the power
switch) Installation
Only correct installation can sterilize effectively and get better
Preparations for materials to be sterilized drying.
Correct preparation is one important prerequisite for safe and effective
sterilization of the materials.
Attention
Attention:
Make use of perforated tray, such as that provided by CRISTOFOLI,
sterilize the fabric and equipment separately by using of sterilization
to discharge the condensed water. Otherwise, the drying effect will
box or container if possible to improve dry effect.z
be affected.
14 15
 Chapter 4 Sterilization Chapter 4 Sterilization

Packaging It is of vital importance to package right. Mixed loads Following the principles below
Put the fabric on the top
■ Packaging materials and packaging equipment only up to the ISO Put the sterilization container on the bottom.
11607-1 standard can be used. Put the unpackaged equipments on the bottom.
Warning! Warning! Put the transparent sterilization packaging and paper packaging bag on
the top. If fabric exists, put them on the top of the bag.
Reusable rigid packaging such as the tray box and flexible packaging
such as transparent plastic wrapping and fabric can be used. If possible, put the transparent plastic sterilization packaging bag
vertically and let it face to the principal plane and the plastic plane face
Aluminum sterilization container boxes are better to accelerate the to the the plastic plane. If impossible, making the principal plane faces
drying because of aluminum heat conduction. downward is ok.

The closed sterile container Please follow the following instructions.

Door Closing
Push the door slightly in the direction of the sterilization container,
■ The closed sterile container must be set aside, at the bottom if
meanwhile, lift the chute switch. Lock the door by pressing down on the
possible, with holes and valves. door switch.
Warning! The program can not start if the door is not locked.
The sterilization box must meet all requirements of EN 868 for
successfully sterilizing and drying. There are holes at bottom and on
the lid as well as a paper filter.

The size of the sterilization containers could be the same if possible

Program Selection
with one up on the other one and all door mats keeping the same height, press or select program，then press to start.
Select program according to physical properties, especially the
so that the condensed water can flow away from the edge of the wall.
heat resistance, of the sterilization articles.
Otherwise, the steam can not penetrate the sterilization articles
completely to sterilize effectively. The drying effect is also affected by
the condensed water inside. The sterilizer can not sterilize completely
Program Packaging Special Scope Sterilization Program Drying
and thus endangers the patients and medical staff. Parameter Time Load
Time * Time

Monolayer/ Mixed loads, long body, 134℃

UNIVERSAL B 2.1bar 5min 25min 15min 6kg
stacking the sterilization box multilayer hollow body
■ Keep the holes uncovered when stacking the sterilization box.
No packaging Simple solid equipment,
Otherwise, the condensed water can not flow away and will soak the 134℃
FAST S non-woven transmission equipment, 2.1bar 3.5min 17.5min 10min 6kg
sterilization articles at the bottom, affecting the drying effect and fabric and simple hollow equipment

Danger! causing the equipment unable to sterilize. The sterilizer can not No packaging Simple solid equipment,
134℃
FAST B non-woven transmission equipment, 2.1bar 3.5min 23.5min 10min 6kg
sterilize completely and thus endangers the patients and medical staff. fabric and simple hollow equipment

A large number of fabric, Fabric:2.5kg

Monolayer/ 121℃
GENTLE B
multilayer
non-resistant fabric such as 1.1bar 20min 40min 20min Heat-intolerant
Flexible sterile packaging plastic, and rubber good fabric: 6kg
Flexible sterile packaging can be sterilized on the tray of the sterilizer.
It can also be put on the holder vertically. Please follow the instructions
Monolayer/ Suspected that the equipment
below when using the flexible packaging. 134℃
PRION B is infected by lesions protein 2.1bar 20min 40min 15min 6kg
multilayer such as creutzfeld- Jacob, BSE
■ The flexible packages should be placed vertically, with a certain
134℃
space among them. B&D TEST Sterilizing effect tex 2.1bar 3.5min 23.5min
■ Do not overlay one flat flexible package on another one.
Danger! Leaking test ≤1.3mbar
■ Please repack and begin to sterilize again if the seals of the LEAKING TEST /min 20min

packaging bags open during the sterilization. It is better to fill three-

quarters of the bags, or to leave three centimeter space between the
seal and the articles.
■ Prolong the seal time or seal twice if the packaging bags open during
sterilization.
Otherwise, the sterilizer can not sterilize completely and thus
endangers the patients and medical staff.

Multiple package The sterilizer uses the multiple pre-vacuum methods and allows
sterilization of multiple packaged articles.
16 17
 Chapter 4 Sterilization
Start program
Press once: begin
Press twice: stop
sterilizer will check the supplement of water and its electric
conductivity. If it does not fit start requirement, program will not work.
Program execution
When the program begins, we can check the executive stage of
program. Cavity pressure, temperature, lasting time of pre-working, are
faction and working will be displayed. (Please check more details in the
lists of LCD content).
During the pre-heating phase, the sterilization cavity will reach the
Pre-heating phase
presupposed pre-heating temperature before the running of the
program, or it should keep the due temperature during the sterilization.
It will not only shorten the working time, but also decrease the
condensation product of the cavity body wall.
During the pre-vacuum phase, air in the cavity will be exhausted
Pre-vacuum phase
repeatedly until it reaches the pre-supposed pressure parameter
values, and vacuum pump stops. During this process, steam goes in,
which makes the pressure a little higher than the barometric pressure.
According to the different selected programs and cavity temperature,
pre-vacuum conditions will be different.
Pressed and heating phase After the pre-vacuum phase, it's heating phase, during which cavity
temperature and pressure will increase with steam's constant coming
until it reaches the pre-needed sterilization parameter.
Sterilization phase The sterilization phase will start when the sterilization temperature and
pressure parameter. Pressure and temperature of the sterilization
phase will be displayed, and at the same time its residual time will be
displayed alternately. 。
Drying phase After pressure released, it's the drying stage. At the end of drying stage,
cavity ventilation and pressure balancing are taking place together.
Normally, drying time of FAST S/B is 10 minutes, UNIVERAL B and
PRION B are 15 minutes, and while GENTLE B is 20 minutes.
Manual terminator
It can abrogate program at any stage.
Attention:
Please don't unplug to stop program, or when it plug again, screen will
show misinformation.
If it stops, the cavity is in high-pressure condition. When it's out of
electricity, high-temperature and high-pressure steam will filter and
expel from the air, which will destroy air filter. And without immediate
exchange, it will cause a twice pollution.
■ When the program is out of operation, please be careful to the high-
temperature when open the door, in case burn you.
■ Get the tray with hand shank. Don't touch the sterilizer, cavity and
door without any protection, or you will get burnt.
Risk of burning
■ Get the tray with the hand shank or wearing gloves.
If you don't follow these rules, you may get burnt.
18
Chapter 4 Sterilization
Manual stop before drying If things in cavity are still not sterilized,
when program stops before drying: press once, when the screen
shows “stop program”, check and press again.
During the drying phase, you can press to stop the
Stop during drying
Open the bags and dry things thoroughly. Good drying is the
phase program.
prerequisite of sterile preservation. Therefore, if possible, make sure
the sterile program of the take-out lasts until the end of the drying
phase. FAST S/B, sterile equipment taken out of the sterilizer can dried
with the waste heat.
During the drying phase, do as the following to stop program:
Press with the screen “stop program?”, check and press again.
Warning: The load can not be effectively sterilized if the program is
terminated by manual operation.
Although manually terminated operation will not cause harm to the machine,
terminate the program frequently might make the sterilization chamber
serious ponding. On the one hand, there maybe danger of scalding by hot
water when open the door, on the other hand, there may have a certain
impact of time and effect to the next sterilization cycle. So it is strictly
prohibited to cause frequent termination procedure, if unavoidable, making
a leaking test before the next sterilization cycle, so that the water in the
cavity can be pumped to ensure the reliability of the next sterilization cycle.
Sterilization completed
Sterilization completed It can check whether the sterilization program has finished from the
screen.
the remaining time and then temperature as well as pressure will be
shown alternatively.
Sterilization failed the sterilization fails when the operator stop it or when mistake comes
the system stops it.
Program stopped by the system if stopped by the system, it will set the relative pressure of the cavity to
zero.
Attention:
Note: If the program is interrupted by the operator, the screen will
display a warning message.
If the program is interrupted by the system, the screen will display an
error message. It indicates the machine may malfunction, for example,
the pressure is too high, triggering the safety protection device, causing
the high pressure protection exit. This is to ensure the effective
sterilization and the safety. Such safety protection error information
could be found in Chapter 9.
Drying phase sterilizer can dry the sterilized things perfectly. But as to the difficult
Raise drying efficiency drying task, perhaps it is better to take the following measures to raise
drying efficiency:
to equip the sterilizer correctly, to locate things in plastic bags or paper
bags like files, follow the locating part in p15 to locate it. If possible, it'd
better use shelf for take-off bags.
Program completed Program completed
at the last phase of the program, cavity pressure will reach atmosphere
pressure. If the program completed successfully, the relevant warning
information will be displayed. The screen will show to check.
after check the whole reporter will be printed though the external
printer.
If the printer is not connected, the screen will show the corresponding
prompt message.
19
 Chapter 4 Sterilization Chapter 5 Program Records

Display of total running times

The total software running times can be checked at any time
Chapter 5 Program Records
Keep pressing button, the screen will display the current total
running times
Keep pressing button again to return to the initial position This chapter aims to provide:

Fetch-out of the sterilized articles What kind of medium can be employed to conduct programming
document records?
Please follow the next instructions when fetching out the sterilized How to correctly read log records?
articles after the process ends
Risk of burning! How to set date and time of sterilizer?
■ Don't open the door too violently. It might damage the sterilizer, and
the steam might evaporate
■ Use the handle to fetch out the tray
programming document records
■ Don't touch the sterilized articles\storage box and the door without
Programming document records are indispensable as they function as
the glove. They are very hot!
records of successfully operated sterilization process and mandatory
The operator would be burned if failed to obey the instructions
devices of quality assurance.
Procedure selected, operation times and processing parameters in the
whole program etc. will all be stored in the log reservoir inside the
■ Remember to check the sterilized goods when fetching out sterilizer.
■ If damaged, repack and re-sterilize it Programming document records can be read through various output
Danger!
Failure to obey the instructions above would lead to unsuccessful medium, which can be conducted not only at the termination of each
procedure, but also after the end of operation.
sterilization, bringing danger to the medicals and patients

Condensed water in sterihzed
Storage for Inner Log Inner storage is capable to store 240 programs.
The screen will prompt when the process ends. Then press button it If the storage is full, the previous program stored will be covered by the
would prompt printing process. next program when it is started. Covering information will be displayed
on the screen.
If the sterilized articles are fetched out right after the end of the
sterilization process, there might be some condensed water on the Output Medium Program records can be stored and documented via following output
package. medium:
Program record printer (Selected by CRISTOFOLI)
It might be found on a paper wrapper or transparent plastic bags. The USB
sterilized articles would dry in half an hour.
Factory Setting of Sterilizer Setting about program record output for sterilizer is printer. Read the
following contents carefully and set on the basis of current output
medium.

Sterile storage

Storage conditions of Storage conditions: the sterilized articles must be stored by using of Date and Time Setting
the sterilized articles related sterilization standard packaging. Re-set according to Time and date of sterilizer must be correctly set for the sake of
Current time accurately recording program.
Do not pack sterilized articles in the instrument package room.
Please set date and time as follows:
Please follow the instructions when packing the sterilized articles
■ Dust-free sealed: the articles should be placed in closed cabinet
■ Prevent damage of the smooth surface FUNCTION
■ Ambient temperature fluctuations SET DATE & Time
■ Prevent moisture such as alcohol and disinfectant. Press conformation button and proceed into this setting
。 2012-01-01
At the first, At first, cursor will show on “Year”. Press to add
“year”,press to decrese “year”.Press and the cursor will move to
the next setting option—“Month”setting,the rest can be done in the
Storage time Storage time is related with packaging type. same manner.
Press to return to the previous menu.
Maximum storage is connected with packaging type and storage
conditions. It can reach 6 months if the sterilized articles are packed
with respect to relevant standards under free-dust environment.

20 21
 Chapter 5 Program Records Chapter 5 Program Records

Use Printer as output Media Correctly Understand programming document

The connection
records
If CRISTOFOLI printer is selected as output media, please connect
of printer and sterilizer the printer as follows:
Title
Title of program list includes general information of complete
2 ①The two ends of wire respectively connect with the holes marked procedures, such as current date and time, name of selected
③ and ⑤.
procedure, serial number of the procedure, as well as the sterilizer
②One end of adapter connects with power supply, and the other
1 end connects with the hole④. type.

Note: The screws should be tightened when connecting two data TitleVarious Numerical Various stages of program processing are recorded via
cable plugs to prevent prolapse, to ensure reliable connection; Values in Procedure
5⑥ corresponding steam pressure, temp and time.
3 4 when disassembly, first unscrew the screw then set aside
Summary
The summary presents whether the program is successfully
Use USB Connector as output media
recorded.
USB output If USB is selected as output media, please connect the printer as In addition, the screen will display required sterilizing time, temp,
follows:
External connector is connected with USB joint ?, without need for
installation of any software.
|------------------------------------------------|

Output of programrecords | CRISTOFOLI | Title

| VITALE 22-B |
| 2012-01-01 00:27:28 (START) | Current Date and Time
|------------------------------------------------| Program Start time
SERIAL #: VITALE-0000000
Print the selected You can choose to output records at a time after the termination of CYCLE #: 000004
application record PROGRAM: FAST S PROGRAM Serial number
program. You can also choose to output a certain selected program 134 3.5MIN
BATCH #: 003 Cycle in Total
or all the stored program records (at most 240). Current connected |------------------------------------------------| Program Name
PREHEATING: 124.2 C
output media is applicable, such as program printer. CONDUCTIVITY: 14 S/cm
Please output program record according to the following steps: Batch of that day
STAGE TIME TEMP PRESS
C BAR
Pre-heating Temp
START 00:00 56.4 +0.05
Long press to confirm to enter function setting menu. VACUUM 1 04:52 50.7 -0.87 Water Conductivity
Press or until the appearance of FUNCTION:PRINT PRESS. 1 08:36 106.6 +0.40
VACUUM 2 12:50 60.1 -0.82
RECORDS on the screen. PRESS. 2 18:25 134.0 +2.19 Numerical Values in Sterilizing Procedures
STER. BEGIN 18:25 134.0 +2.19
Press to confirm to enter printing interface, with the screen STER. END 21:55 134.1 +2.16
showing: PRESS. REL. 24:03 87.0 -0.40
DRYING BEGIN 24:03 86.8 -0.41
RECORD NO.XXX DRYING END 34:04 68.7 -0.83
First Vacuuming
PRESS TO PRINT END 34:16 71.4 -0.07 First Pressure Rising
|------------------------------------------------|
Press or to review the menu, and select the program wanted PROGRAM COMPLETED SUCCESSFULLY Second Vacuuming
to be printed, with the screen displaying: Second Pressure Rising
TEMP. PREV.: 134.1 +-0.1
RECORD NO.066 (as an example) PRESS. PREV.: +2.26 +0.01bar Sterilization Started
PRESS TO PRINT Sterilization Terminated
TEMP. MIN/MAX: 134.0/134.6℃
PRESS TO CONFIRM PRINT PRESS. MIN/MAX: +2.14/+2.21 bar Pressure Released
If the print is wrongly connected or unconnected, the screen shows: Drying Started
PRINTING ERROR END TIME: 01:01:51
|------------------------------------------------| Drying Finished
CHECK PRINT VERSION 1.00 Program Completed

Program State
Note: Current Temp
Printing can not be realized during programming cycle. Current Pressure
If printing needs to be suspended during its running, please cut off Highest Temp and Lowest Temp during Program
power supply. Cycling
Highest Pressure and Lowest Pressure during
Program Cycling
Termination Time
If you need to leave the following menu, press and the screen
displays: Program Version
FUNCTION:PRINT
Press again and leave setting menu for inntial state.
22 23

Chapter 6 Equipment Maintenance
This chapter will introduce:
How to clean sterilizer with appropriate detergent?
How to avoid smudginess?
How to replace door seal ring?
Different purposes of different procedures
What should be noted during sterilizer maintenance?
Check chamber, door seal ring, joint
shaft between chamber and door seal
ring, as well as tray track whether there
is smudginess, deposits and damage
on them every week.
If there is smudginess…
Door seal ring
Warning!
External Lid of Device
Water Tank
24
Chapter 6 Equipment Maintenance
Cleaning
Check chamber, door seal ring, joint shaft between chamber and door
seal ring, as well as tray rack whether there is smudginess, deposits
and damage on them once a week.
Tray and tray rack inside chamber should be taken out when cleaning
the smudginess. Clean the parts with smudginess.
Door seal ring does need to be coated with oil. It needs to be kept clean.
When cleaning chamber, tray rack, door seal ring and sealing surface of
chamber, please pay attention to the following tips:
■ Power off and make sure chamber is not hot.
■ Use soft cloth which will not fluff.
■ Dampen the cloth with alcohol or denatured alcohol and use the
cloth to wipe off smudginess.
■ Use stainless pan cleaner (with PH ranging from 5 to 8) to clean
stubborn stains on chamber, tray rack and sealing surface of chamber.
■ Use neutral detergent to clean door seal ring.
■ Make sure detergent will not flow into the tubes through chamber.
■ Do not use tough objects such as metal or stainless brushes.
Your not abiding by the above tips will result into scratches on the
cleaned surface, loose seal, and faster stain deposits in the chamber
and faster rust of sterilizer.
Your not abiding by the above tips will result into scratches on the
cleaned surface, loose seal, and faster stain deposits in the chamber
and faster rust of sterilizer.
Use neutral liquid cleaner or denatured alcohol to clean the external lid
of device.
Periodically clean water tank to avoid being stained by microorganism
and algae.
The tank should be cleaned once every two month.
■Connect one end of the incidental tube with quick connector, and joint
quick connector with water outlet connector (Figure (4), Page 9), then
drain remaining water inside the tank.
■Use slotted screwdriver to pull out four screws on the lid of tank and
remove the lid.
■ Clean tank: Use alcohol-dampening cotton cloth below 50%
solubility, and wash it. After that, drain remaining water inside the tank
via outlet. Dry the tank finally.
■ Filter screen cleaning (changed if seriously blogged or worn on
screen after long-time use). Be aware of putting the filter screen back to
the previous position after cleaning.
■ Cover water tank with lid and screw the four screws on the lid after
cleaning.
Chapter 6 Equipment Maintenance
Cleaning of Draining and Draining and Vacuuming Filter may be blogged with impurity after
Vacuuming Filter being used for a period of time, which may affect the effect of pre-
vacuuming, draining and drying. Those impurities come from the
grease and dust brought by items to be sterilized as well as
calcification in water. For the sake of prolonging the service life of
draining and vacuuming filter, it is better to take off filter and clean it
with soft brush every three month.
Note:
Maintenance can only be conducted when power is off and the
device is fully cooling down.
Warning!
Avoid the Formation of Stains
Stains formed by Incorrect The only way to avoid stripping off of residue produced by loadings or
Cleaning instruments under high steam pressure is correctly cleaning the
equipment before sterilization. Stripped impurities (Such as detergent
residue) may blog filter screen, holes and valves of sterilizer, and
deposit in the instruments and chamber in the form of stain,
smudginess, or blots
All the steam conduction components are made of stainless material,
Stains formed by Embedded which expel the possibility of rust formation. If rust forms, it should be
Rust defined as embedded rust. Without correct preparation, even stainless
devices produced by well-known manufacturers may form rust. In
generally, only one component which is easy to rust can arise
embedded rust in the other components or chamber.
Use stainless pan cleanser (containing no Chlorine)to remove
embedded rust from the equipment or send the damaged device back to
manufacturer for better treatment.
Stains formed by Low Water Seriousness of stains formed on the device also depends on quality of
Quality
feed water used to produce steam.
High Water Quality:
Only the water meets the requirements of EN13060 is available.
Warning!
Your not abiding with the above principle may result into stain
formation on the device or damage to the device, meantime damage
to the functions of sterilizer.
sterilization water conforms De-ionized water made in market or sold in pharmacy, or distilled
with VDE 510 Standard
water, with definite indication of VDE 510) are available.
Note:
Distilled water produced by CRISTOFOLI distillation machine
meets the requirements for sterilization water.
Replacement of Fuse
■ Power off supply.
■ Use slotted screwdriver to counterclockwise rotate fuse holder.
■ Take out fuse holder and pull out fuse.
■ Install back fuse holder after replacement of fuse. Please align
with fuse holder groove when lightly inserting fuse.
■ Push the fuse holder inside and rotate clockwise to make the
holder stuck firmly.
25
 Chapter 6 Equipment Maintenance Chapter 7 Operation Interval

Change Door Seal Ring C. The function and installation of safety device
It is necessary to change seal ring if it is too small or it wrinkles. 1. The circuit board itself has safety protection system, program
runs automatically terminate when the pressure exceeds the
Low quality seal may lead to: leaking of steam or high leakage rate rated value. If the program is out of action, when the pressure
during Vacuum Test. continue to increase exceeds the rated value, the safety valve
Open the door and take out old seal ring.
open which is paced at the back of the equipment, discharge
Replace with the new door seal ring and guarantee that any position
of the seal ring is closely contacted with the door lid. pressure and prevent danger.
Clean the seal every two months and replace the seal per year. 2. There are two safety devices around the door switch, ensure
the door has been locked to prevent danger if the door opening
under high pressure.
Note:
D. Technical service location directory:
Danger! Carefully observe the different width on the surface of seal ring.
Eiffestrasse 80,20537 Hamburg,Germany
Door can not be firmly closed and chamber can not be airproof
Tel.+49-40-2513175 Fax: +49-40-255726
without correct installation of seal ring.

Chapter 7 Operation Interval

Warning!
To keep the value and
using reliability of ster ilizer
Maintenance
This chapter will introduce:
Shortest Operation Interval of Sterilizer
■ Maintenance can not be conducted by persons who are not
trained field technical personnel or related experts.
What should be noted when operation interval lasts for a long time?
■Conduct interval maintenance according the requirements.
How to lay aside, remove and re-use sterilizer?
Your ignoring service information and continuous using sterilizer
may result into failure. Sterilization Frequency
Regular maintenance is indispensable to keeping the value as well
as using reliability of sterilizer. No need for Operation There is no need for operation interval among procedures as the
During maintenance, all the functions and safety-related Interval sterilizing chamber keeps the temp required for running program
components and electrical equipment will be examined, and if permanently.
Take out sterilized items when drying stage normally completes or
necessary, replaced. Maintenance should be conducted according is terminated manually. After that, sterilizer can be re-started with a
to sterilizer-related instructions. new sterilization immediately.

Maintenance Sterilizer should be maintained after being used for 1000 times or Operation Interval
two years. When there is a need for maintenance, sterilizer will Long-time Operation If Operation Interval last for a long time, such as overnight or
display hints on the screen. Interval weekends, sterilizer should be powered off and the door should be
slightly open. Therefore, door seal ring can be kept in a relaxing
state with the purpose of avoiding adhesion of seal ring and
A. Spare part list: 2pcs fuses: F16AL250V
premature wear of the door.
B. Electrical schematics (page 36)
If operation interval exceeds two weeks, run vacuum test first, and
then run another fast sterilizing procedure of no-load (Refer to
Chapter 8 Function Test, Page 29).

A long-time interval may result into:

Cases Possible Causes Solutions

Replace feed water, such as water purified

High Conductivity Low Feed Water Quality by CRISTOFOLI Distillation Machine
Door can not Door seal ring adheres to the
be Open sealing surface of the chamber Power off and Pull the door.

Function Test after Interval Conduct function test according to the lasting period of interval.

26 27
 Chapter 7 Operation Interval Chapter 8 Function Test

Terminate Equipment
Chapter 8 Function Test
Operate as following if the sterilizer is put into rest for a long time,
such as vacation or device removal:
Power off the device
Pull off power plug This chapter aims to provide:
Clean the water tank and guarantees no water inside

How sterilizer conduct auto function test

Removal Forms of Manual Function Test
What function tests should be conducted in daily operation?
Sterilizer removal should abide by following instructions:
■ Under two persons' handling; Why and how to conduct Vacuum Test?
■ Use appropriate handling belt to carry sterilizer
Be careful! Why and how to conduct Bowie & Dick Test？
Note: The bottom of sterilizer is only a short distance from the
ground.
How to conduct tests on each sterilization procedure?
Your not abiding by the above instructions might lead to hurts. How to display water quality?

Pay attention to the following tips when removing sterilizer on

highway, by sea carriage or in working place:
Warning! ■ Drain the water in the tank;
■ You'd better put a sheet of foam plastic or bag between the door
disc and tray rack if tray, tray rack and tray box are not removed
from the chamber of sterilizer during removal.
■ Your not abiding by the above instructions may damage the
sterilizer.
Re-installation after Change of Position
After removal and re-installation of sterilizer, the device is re-
started up and operated according to initial setting (Refer to
Chapter 3, initial operation, Page 11)
Auto Function Test
Process evaluation With incidental Process evaluation
and Detection System and Detection System
During the running of sterilizer, electronic parameter controller
continuously automatically detects and racks interaction among
parameters relater with sterilization, such as pressure, temp, and
time.
Process evaluation of sterilizer compares and supervises
parameter during sterilizer operation process, and guarantees that
they will not exceed respective limits. Detection System of sterilizer
examines reliability of device components and possible interactive
effects among those components. If the parameters exceed their
limits, sterilizer will give warnings or error information. If necessary,
the program will be suspended with corresponding hints. If the
program successfully finishes, there will appear corresponding
information on the screen.
Manual Function Test
Rack the progression of program by the values displayed on the
screen. Reasonably deduce whether the program runs successfully
according to each program record (Details in Program Record).

Conduct test in daily operation

Conducted as routine
operation once a week
Conducted at initial installation
Conducted when the device has not
been used over two weeks
Conducted when error appears
Vacuum Test
V acuum Test needs to be conducted in the following cases:
■ Conducted as routine operation once a week;
■ Conducted at initial installation;
■ Conducted when the device has not been used in a long period of
time;
■ Conducted when error appears, such as vacuum overtime etc.;
Test whether there is leakage in sterilizer, with the final rate
<1,3mbar/min being acceptable.

28 29
 Chapter 8 Function Test Chapter 9 Error Information

Conduct Vacuum Test when sterilizer is cooling down and dry :

Power on, press to select LEAKING TEST, and press to start
VACUMM　Test.
From then on, air in the chamber of sterilizer will be evacuated to
reach the pressure required in Vacuum Test.
Chapter 9 Error Information
After 5-miu balancing time, there comes 10-miu testing time.
Rising value of Pressure inside the chamber will be measured
during test. This Chapter aims to provide:
Pressure after air evacuation, balancing time and testing time will
be displayed on the screen. Types of Error Information
In the end, leakage rate will be displayed.
What should do when error appears?
If leakage rate exceeds 1.3mbar, vacuum test fails (displayed on
the screen), or vacuum test succeeds. What should do Before Calling User Helpline?
Press to confirm, print operation records, and open the door after What should do if No Display on Screen?
pressing . What should do if Water Consumption of Sterilizer is too great?
What should do if drying is not thorough?
B&D Test
As function inspection, B&D Test aims to test the penetrability of
steam into fabric.
B&D Test can be used to permeability of steam. Warnings are not meant to be error information.
Not all the information on the screen is error information.
Professional agency provides various testing system to test B&D
Test. Please conduct this test according to the testing system
Warning:
selected.
Warnings will appear of necessary. But warnings are not meant to
be error information, functioning to help smoothly run program and
Conduct B&D Test as followings: recognize unfavorable conditions. Act according to warnings can
Power on, press twice to select B&D Test and press to start
the test. avoid errors.
Helix Test, a specimen test system, is an indicator and supervision
system which meets DIN EN 967-5 standard.
Error Information
It includes testing specimen, helix tube and indicator strips. This
Error information will appear when the reliability or safety of
test should be used to supervise each sterilization procedure if the
items to be sterilized are tagged as “Critical B”. Helix Test can also sterilizer operation can not be guaranteed. It may arise at the time
be used to test permeability of steam in general procedure. of powering on sterilizer or during operation of sterilizer.
Fading on the surface of plastic will be caused by Helix Test even in
correct using way, however, which will not affect the testing effect. Error information emerged during operation process will result into
the termination of program.
Risk of infection!
Water Quality Display ■ If the program is interrupted during the stage of sterilization, then
the loadings to be sterilized are not thoroughly sterilized which

Feed Water quality of sterilizer can be showed after turning on the should be re-packaged and re-sterilized.
sterilizer or during the running of sterilizer.
Your not abiding by the above principle will put patients and medical
Long press and the screen displays: workers into danger.
PARAMETER CHECK
CONDUCT: OuS/cm PREHEAT: 134℃ (SCAN of Water quality and
Temp)
Long press and return to previous interface. Error information will be displayed alternately with the
simultaneous operation stage (pressure release, ventilation or
termination)

30 31
 Chapter 9 Error Information Chapter 9 Error Information

Before Calling User Helpline

Warnings Possible Causes Solutions
Please operate sterilize according to the hints related wit error or CYCLE CANCELLED
warning information offered by the device.The following figure lists T:38.0℃ P:+0.00Bar Program closed due to heating Contact agency when the
HEATING TIME LIMIT time limit exceeded. problem repeats.
several error and warning information of importance with EXCEEDED
corresponding causes and solutions.
If you can not find corresponding information hints, or you can not CYCLE CANCELLED
solve the problem according to the hints, please contact after-sale T:124.0℃ P:+0.97Bar Program closed due to low Fill into the tank with
NOT ENOUGH FEED water level. purified water.
s e r v i c e c e n t e r a u t h o r i z e d b y C R I S TO F O L I . N o t e : B e f o r e WATER
contacting, please prepare the serial number of sterilizer and
CYCLE CANCELLED
detailed error description with the purpose of solving the problem T:124.0℃ P:+0.97Bar Program closed due to steam Shutdown the devices for
earlier. STEAM GENERATOR generator overheating. two minutes and re-try.
OVERHEATING

Check whether seal ring is aging or

CYCLE CANCELLED correctly installed; Conduct
Warnings Possible Causes Solutions T:124.0℃ P:+0.97Bar Cycle cancelled due to low Vacuum Test.
LOW PRESSURE pressure. Reduce loadings of sterilizer.
DETECTED Contact agency when the problem
Close the door, switch down repeats.
DOOR OPEN Door unclosed. to the maximum.
Check whether seal ring is aging or
CYCLE CANCELLED correctly installed; Conduct
CYCLE CANELLED T:124.0℃ P:+1.10Bar Cycle cancelled due to high Vacuum Test.
T: 30℃ P:+0. 00Bar No enough water. Fill water into the tank. HIGH PRESSURE pressure. Reduce loadings of sterilizer.
NOT ENOUGH FEED WAYTER DETECTED Contact agency when the problem
repeats.
Program fails when water quality Check whether seal ring is aging or
exceeds 65uS/cm. Improve water CYCLE CANCELLED correctly installed; Conduct
Low Water Quality Cycle cancelled due to high Vacuum Test.
quality in the tank, such as purified T:124.0℃ P:+1.10Bar
water. HIGH TEMPERATURE temp. Reduce loadings of sterilizer.
DETECTED Contact agency when the problem
repeats.
PRINTING ERROR
CHECK PRINTER Make the printer well-connected Check whether seal ring is aging or
TRY AGAIN?PRESS Printer is not well-connected. or change the setting CYCLE CANCELLED correctly installed; Conduct
“react immediately” into “No” T:124.0℃ P:+1.10Bar Vacuum Test.
CANCLELLED?PRESS Cycle cancelled due to low temp. Reduce loadings of sterilizer.
LOW TEMPERATURE
DETECTED Contact agency when the problem
repeats.
Full Internal Storage of Printer Check whether seal ring is aging or
CYCLE CANCELLED correctly installed; Conduct acuum
T:124.0℃ P:+1.10Bar Test.
Pre-heating time limit exceeded.
Check whether the seal rings and PRE-HEATING TIME Reduce loadings of sterilizer.
chamber margins are smudged, LIMIT EXCEEDED Contact agency when the problem
If vacuum Test Value exceeds the clean them if necessary; check repeats.
LEAKING TEST FAILED maximum 1.3bar, door seal ring w h e t h e r t h e s e a l r i n g s a r e CYCLE CANCELLED Check whether seal ring is aging or
108 mbar/ min and chamber margins may be d a m a g e d , r e p l a c e t h e m i f T:124.0℃ P:+1.10Bar correctly installed; Conduct
smudged. necessary; check whether door VACUUMING TIME Vacuuming time limit exceeded. Vacuum Test.
seal ring is correctly installed; LIMIT EXCEEDED
Conduct Vacuum Test when the Reduce loadings of sterilizer.
sterilizer is fully cooling down. Contact agency when the problem
repeats.
CYCLE CANCELLED
HOT STEAM Steam over-heats, press to Shut down and open the door. Re- T:124.0℃ P:+1.10Bar Terminate it manually. Contact
BE CAREFUL
Pressurizing Time Limited
confirm. test after cooling down. PRESSURIZING TIME Exceeded agency when the problem repeats.
HTO STEAM LIMIT EXCEEDED
TO CONFIRM

CYCLE CANCELLED
CYCLE CANCELLED T:124.0℃ P:+1.10Bar Re-start. Contact agency when
T:124.0℃ P:+0.9Bar Internal Temp Sensor 1 error
User closes the program. Re-sterilization TEMP SENSOR1 the problem repeats.
CANCELLED BY USER FAILURE

32 33
 Chapter 9 Error Information APPENDIX

Table— Contaminants of condensate and feed water

Warnings Possible Causes Solutions Feed water Condensate

CYCLE CANCELLED Evaporate residue ≤ 10 mg/l ≤ 1,0 mg/kg

T:124.0℃ P:+1.10Bar Restart, if error repeats,
Internal Temp Sensor2 Error
TEMP SENSOR2 please contact agency. Silicium oxide, SiO2 ≤ 1 mg/l ≤ 0,1 mg/kg
DETECTED
Iron ≤ 0,2 mg/l ≤ 0,1 mg/kg
CYCLE CANCELLED
T:124.0℃ P:+1.10Bar Restart, if error repeats,
External Temp Sensor3 Error Cadmium ≤ 0,005 mg/l
TEMP SENSOR3 please contact agency. ≤ 0,005 mg/kg
LIMIT EXCEEDED
Lead ≤ 0,05 mg/l ≤ 0,05 mg/kg
CYCLE CANCELLED
T:124.0℃ P:+1.10Bar Restart, if error repeats, Rest of heavy metals, excluding
PRESSURE SENSOR
Pressure Sensor Error please contact agency. ≤ 0,1 mg/l ≤ 0,1 mg/kg
LIMIT EXCEEDED iron, cadmium, lead
CYCLE CANCELLED Chloride ≤ 2 mg/l ≤ 0,1 mg/kg
PRESS TO CONFIRM
DOOR OPEN Door Open Re-sterilization after door closed Phosphate ≤ 0,5 mg/l
DETECTED
CYCLE CANCLELLED
≤ 0,1 mg/kg
T:124. 0℃ P: +1.10Bar
≤ 3 μs/cm
Conductivity (at 20 °C) ≤ 15 μs/cm
POWER LOSS Voltmeter Lost after Press to confirm after
Programming starting up
pH value 5 to 7,5 5 to 7

Appearance colourless, clean, colourless, clean,

Solution Solution: No display on screen
without sediment without sediment
No display on screen when powering on the sterilizer.
Check whether the power plug is correctly put into the socket.
Hardness ≤ 0,02 mmol/l ≤ 0,02 mmol/l
Check voltage of power socket.
NOTE 1 The use of water for steam generation with contaminants at levels exceeding those
Check and replace main power insurance components.
given in this Table can greatly
shorten the working life of a sterilizer and can invalidate the manufacturer's warranty of
Solution: Water Consumption of Sterilizer is too guarantee.
great. NOTE2 The condensate is produced from steam that has been taken from the empty sterilizer
Water consumption of sterilizer depends on the program selected chamber.
and load.
Solution Check whether the sterilizer is correctly installed and set; if
necessary, raise the foreleg of the device.
Check whether the return path at the bottom of sterilizer chamber is
blogged by instruments or filter paper which should removed.

Solution: Non-thorough drying

Drying quality depends on whether the equipment is correctly
installed and whether the sterilizing items are correctly loaded.
Solution Check whether the sterilizer is correctly installed and set; if
necessary, raise the foreleg of the device.
Clean the left over instruments and paper.
Check and clean filter in the chamber.
Correctly install and set up sterilizer. (Refer to Page X, Sterilizer
Installation)
No over-loading on sterilizer. Pay attention that fabric are forbidden
to be directly contacted with chamber.
Turn on pre-heating function. (Refer to Page X and set pre-heating
function)
Select extra drying function. (Refer to Page X and set extra drying
function)
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 APPENDIX APPENDIX

Electrical schematics Each program graph

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