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Technical Manual
Autoclave
vitale 22B/17B
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
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.
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.
Instruction ■ 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.
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.
Program abort ■ 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
3
Content Chapter 1 Equipment Specification
Automatic Preheating 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
Time Optimization 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
Security Guarantee 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.
Additional Function 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)
UNIVERSAL B
Monolayer/ Mixed loads, long body, 134℃
5min 25min 15min 6kg
7
multilayer hollow body 2.1bar
134℃
B&D TEST Sterilizing effect tex 2.1bar 3.5min 23.5min
Product illustrations
Front view Internal structure
(2) Door
(1) cavity
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%
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.
(16) Filler
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
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.
10 11
Chapter 3 Initial Operation Chapter 3 Initial Operation
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.
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.
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.
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
Multiple package The sterilizer uses the multiple pre-vacuum methods and allows
sterilization of multiple packaged articles.
16 17
Chapter 4 Sterilization Chapter 4 Sterilization
Start program Manual stop before drying If things in cavity are still not sterilized,
when program stops before drying: press once, when the screen
Press once: begin shows “stop program”, check and press again.
Press twice: stop During the drying phase, you can press to stop the
sterilizer will check the supplement of water and its electric Stop during drying
Open the bags and dry things thoroughly. Good drying is the
phase program.
conductivity. If it does not fit start requirement, program will not work. 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.
Program execution
When the program begins, we can check the executive stage of During the drying phase, do as the following to stop program:
program. Cavity pressure, temperature, lasting time of pre-working, are Press with the screen “stop program?”, check and press again.
faction and working will be displayed. (Please check more details in the
Warning: The load can not be effectively sterilized if the program is
lists of LCD content).
terminated by manual operation.
During the pre-heating phase, the sterilization cavity will reach the Although manually terminated operation will not cause harm to the machine,
Pre-heating phase
terminate the program frequently might make the sterilization chamber
presupposed pre-heating temperature before the running of the serious ponding. On the one hand, there maybe danger of scalding by hot
program, or it should keep the due temperature during the sterilization. water when open the door, on the other hand, there may have a certain
It will not only shorten the working time, but also decrease the impact of time and effect to the next sterilization cycle. So it is strictly
prohibited to cause frequent termination procedure, if unavoidable, making
condensation product of the cavity body wall. a leaking test before the next sterilization cycle, so that the water in the
During the pre-vacuum phase, air in the cavity will be exhausted cavity can be pumped to ensure the reliability of the next sterilization cycle.
Pre-vacuum phase
repeatedly until it reaches the pre-supposed pressure parameter
values, and vacuum pump stops. During this process, steam goes in,
Sterilization completed
which makes the pressure a little higher than the barometric pressure. Sterilization completed It can check whether the sterilization program has finished from the
According to the different selected programs and cavity temperature, screen.
the remaining time and then temperature as well as pressure will be
pre-vacuum conditions will be different.
shown alternatively.
Pressed and heating phase After the pre-vacuum phase, it's heating phase, during which cavity Sterilization failed the sterilization fails when the operator stop it or when mistake comes
temperature and pressure will increase with steam's constant coming the system stops it.
until it reaches the pre-needed sterilization parameter. Program stopped by the system if stopped by the system, it will set the relative pressure of the cavity to
zero.
Sterilization phase The sterilization phase will start when the sterilization temperature and
pressure parameter. Pressure and temperature of the sterilization Attention:
Note: If the program is interrupted by the operator, the screen will
phase will be displayed, and at the same time its residual time will be
display a warning message.
displayed alternately. 。 If the program is interrupted by the system, the screen will display an
Drying phase After pressure released, it's the drying stage. At the end of drying stage, error message. It indicates the machine may malfunction, for example,
cavity ventilation and pressure balancing are taking place together. the pressure is too high, triggering the safety protection device, causing
Normally, drying time of FAST S/B is 10 minutes, UNIVERAL B and the high pressure protection exit. This is to ensure the effective
PRION B are 15 minutes, and while GENTLE B is 20 minutes. sterilization and the safety. Such safety protection error information
could be found in Chapter 9.
Manual terminator
Drying phase sterilizer can dry the sterilized things perfectly. But as to the difficult
It can abrogate program at any stage. Raise drying efficiency drying task, perhaps it is better to take the following measures to raise
Attention: drying efficiency:
Please don't unplug to stop program, or when it plug again, screen will to equip the sterilizer correctly, to locate things in plastic bags or paper
show misinformation.
bags like files, follow the locating part in p15 to locate it. If possible, it'd
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 better use shelf for take-off bags.
expel from the air, which will destroy air filter. And without immediate
exchange, it will cause a twice pollution. Program completed Program completed
at the last phase of the program, cavity pressure will reach atmosphere
■ When the program is out of operation, please be careful to the high- pressure. If the program completed successfully, the relevant warning
temperature when open the door, in case burn you. information will be displayed. The screen will show to check.
■ Get the tray with hand shank. Don't touch the sterilizer, cavity and after check the whole reporter will be printed though the external
door without any protection, or you will get burnt. printer.
Risk of burning
■ Get the tray with the hand shank or wearing gloves.
If the printer is not connected, the screen will show the corresponding
If you don't follow these rules, you may get burnt. prompt message.
18 19
Chapter 4 Sterilization Chapter 5 Program Records
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
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.
Condensed water in sterihzed 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
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.
|------------------------------------------------|
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 Chapter 6 Equipment Maintenance
Cleaning of Draining and Draining and Vacuuming Filter may be blogged with impurity after
Chapter 6 Equipment Maintenance 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
This chapter will introduce: with soft brush every three month.
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. 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.
External Lid of Device Use neutral liquid cleaner or denatured alcohol to clean the external lid
of device.
Note:
Water Tank Periodically clean water tank to avoid being stained by microorganism Distilled water produced by CRISTOFOLI distillation machine
and algae.
meets the requirements for sterilization water.
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 Replacement of Fuse
drain remaining water inside the tank.
■Use slotted screwdriver to pull out four screws on the lid of tank and ■ Power off supply.
remove the lid. ■ Use slotted screwdriver to counterclockwise rotate fuse holder.
■ Clean tank: Use alcohol-dampening cotton cloth below 50%
solubility, and wash it. After that, drain remaining water inside the tank ■ Take out fuse holder and pull out fuse.
via outlet. Dry the tank finally. ■ Install back fuse holder after replacement of fuse. Please align
■ Filter screen cleaning (changed if seriously blogged or worn on with fuse holder groove when lightly inserting fuse.
screen after long-time use). Be aware of putting the filter screen back to
■ Push the fuse holder inside and rotate clockwise to make the
the previous position after cleaning.
■ Cover water tank with lid and screw the four screws on the lid after holder stuck firmly.
cleaning.
24 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.
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).
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
Vacuum Test
Conducted as routine V acuum Test needs to be conducted in the following cases:
operation once a week ■ Conducted as routine operation once a week;
Conducted at initial installation ■ Conducted at initial installation;
Conducted when the device has not ■ Conducted when the device has not been used in a long period of
been used over two weeks time;
■ Conducted when error appears, such as vacuum overtime etc.;
Conducted when error appears
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
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
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
36 37