Operation & Maintenance Manual: Model 3870 HSG-D

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OPERATION

&
MAINTENANCE
MANUAL
Model 3870 HSG-D

Cat. No. MAN205-0458001EN Rev E


 Tuttnauer Europe b.v., Hoeksteen 11, 4815 PR, Breda, P.O. Box 7191, 4800 GD Breda, Netherlands.  +31/76-5423510,
Fax: +31/76-5423540
TABLE OF CONTENT
PARAGRAPH PAGE NO.
1 GENERAL ............................................................................................................4
1.1 Incoming Inspection ....................................................................................4
1.2 Warranty ......................................................................................................4
1.3 Warranty Statement .....................................................................................4
1.4 Safety Instructions .......................................................................................5
1.5 Operating Safety ..........................................................................................5
1.6 Safety features .............................................................................................6
2 TECHNICAL DATA.............................................................................................7
2.1 Introduction .................................................................................................7
2.2 Operating Conditions...................................................................................8
2.3 Construction ................................................................................................9
2.4 Environment Emission Information ...........................................................9
2.5 Directives and Standards .............................................................................9
2.6 Technical Specifications............................................................................10
2.7 Autoclave's Electrical data ........................................................................12
2.8 Utilities.......................................................................................................12
2.9 Stickers Symbol Description ......................................................................13
2.10 Water Quality.............................................................................................15
3 CONTROL PANEL ............................................................................................18
3.1 Description and Functions of the Front Panel Keyboard .........................19
3.2 Displayed Error Messages / Symbols.........................................................21
3.3 Displayed operational messages / Symbols................................................22
4 STERILIZATION PROGRAMS.........................................................................23
4.1 Program 1: Unwrapped instruments .........................................................24
4.2 Program 2 - Wrapped instruments ............................................................25
4.3 Program 3 - Wrapped pouches ..................................................................26
4.4 Program 4 - Unwrapped delicate instruments...........................................27
4.5 Program 5 - Wrapped delicate instruments...............................................28
4.6 TEST 1 – LEAK TEST ..............................................................................29
4.7 TEST 2 – B&D TEST ................................................................................31
5 SCREENS ...........................................................................................................32
5.1 Screens following a complete successfully cycle – "Cycle Ended" ..........32
5.2 Screens following aborted cycles after complete sterilization stage..........33
5.3 Screens following a fail cycle: ...................................................................34
6 PRINTER............................................................................................................35
6.1 Printer Output............................................................................................35
6.2 Printer Handling........................................................................................37
6.3 Treating the thermal papers: .....................................................................39
7 PREPARATION BEFORE STERILIZATION ..................................................40
Page 1 of 56 Pages
7.1 Instruments ................................................................................................ 41
7.2 Packs ..........................................................................................................41
7.3 Tubing........................................................................................................42
8 OPERATING INSTRUCTIONS ........................................................................43
8.1 Operating the autoclave.............................................................................43
8.2 Turning on the autoclave ..........................................................................43
8.3 Opening the door .......................................................................................43
8.4 Loading ......................................................................................................44
8.5 Selecting the program ...............................................................................44
8.6 Closing the door.........................................................................................45
8.7 Starting cycle .............................................................................................46
8.8 Unloading ..................................................................................................47
8.9 Stopping the process and cancelling the ERROR message.......................47
8.10 Start Cycle by Clock mode .........................................................................48
9 SERVICE AND MAINTENANCE .....................................................................48
9.1 Preventive and Scheduled Maintenance ...................................................48
9.2 Cleaning water strainer .............................................................................49
9.3 Checking the Safety Valve .........................................................................50
10 TROUBLESHOOTING ......................................................................................53
11 SPARE PARTS LIST..........................................................................................56
12 ACSSESORIES LIST .........................................................................................56

Page 2 of 56 Pages
TABLE OF CONTENT (Cont.)

DRAWINGS PAGE NO.

FRONT VIEW .............................................................................................................16


REAR VIEW ................................................................................................................17

Page 3 of 56 Pages
1 GENERAL
Read the Operating Instructions carefully, before beginning any operation on
the autoclave!
1.1 Incoming Inspection
The autoclave should be unpacked and inspected for mechanical damage
upon receipt. Observe packing method and retain packing materials until
the unit has been inspected. Mechanical inspection involves checking for
signs of physical damage such as: scratched panel surfaces, broken knobs,
etc.
If damage is apparent, contact your dealer or point of purchase, so that they
may notify the manufacturer and file a claim with the appropriate carrier.
All Tuttnauer products are carefully inspected prior to shipment and all
reasonable precautions are taken in preparing them for shipment to assure
safe arrival at their destination.

1.2 Warranty
We certify that this instrument is guaranteed to be free from defects in
material and workmanship for one year against faulty components and
assembly with the exception of glassware, lamps and heaters.
The warranty does not include and does not replace routine treatment
and preventive maintenance to be performed according to instructions
in paragraph 9.1 (Preventive and Scheduled Maintenance).
Our obligation is limited to replacing the instrument or parts, after our
examination, if within one year after the date of shipment they prove to be
defective. This warranty does not apply to any instrument that has been
subjected to misuse, neglect, accident or improper installation or
application, nor shall it extend to autoclaves that have been repaired or
altered outside the factory without prior authorization from us.
The Autoclave should not be used in a manner not described in this
manual!

1.3 Warranty Statement


The warranty registration must be completed and returned to our service
departments; within fourteen (14) days of purchase or the warranty will be
void.
Our Technical Service Depts can be reached at:
 Tuttnauer Europe b.v., Hoeksteen 11, 4815 PR, Breda,
P.O. Box 7191, 4800 GD Breda, Netherlands. +31/76-5423510,
Fax: +31/76-5423540, E-mail: info@tuttnauer.nl
Note:
If there is any difficulty with this instrument, and the solution is not
covered in this manual, contact our representative or us first. Do not
attempt to service this instrument yourself. Describe the difficulty as
clearly as possible so we may be able to diagnose the problem and provide
a prompt solution.

Page 4 of 56 Pages
If the autoclave is equipped with a printer, send along a copy of the last
printout for our inspection. If replacement parts are needed, stipulate the
model and serial number of the machine.
No autoclaves will be accepted for repair without proper authorization
from us. All transportation charges must be paid both ways by the owner.
This warranty will be void if the unit is not purchased from an authorized
full service Tuttnauer dealer.

1.4 Safety Instructions

The autoclave has unique characteristics. Please read and understand the operation
instructions before first operation of the autoclave. The following issues may
require guidance provided by the manufacturer: operation of the autoclave, the
door safety mechanism, the dangers involved in circumventing safety means, how
to ensure that the door is closed, and how to select a correct sterilization program.
Make sure that you know where the main power switch is, where the water cut-off
valve is and where the steam and compressed air disconnection valves are located.
Protective equipment and clothes and other safety instructions should be
implemented in accordance with local and national regulations and/or rules!
Autoclave maintenance is crucial for the correct and efficient function of the
device. We enclose a log booklet that includes maintenance recommendations,
with every device.
The daily B&D test and the weekly spore test is part of the preventive
maintenance plan, along with the annual validation of the sterilization processes
that ensures appropriate temperature dispersion within the chamber.
Never use the autoclave to sterilize corrosive products, such as: acids, bases and
phenols, volatile compounds or solutions such ethanol, methanol or chloroform
nor radioactive substances.
1.5 Operating Safety

1. Never start using a new autoclave or a new steam generator, before the
safety, licensing and authorization department has approved it for use.
2. All autoclave users must receive training in proper usage from an
experienced employee. Every new employee must undergo a training
period under an experienced employee.
3. A written procedure must be established for autoclave operation,
including: daily safety tests, seal inspection and door hinge inspection,
smooth action of the closing mechanism, chamber cleaning, prevention of
clogging and preservation from corrosion, what is permitted and what is
prohibited for sterilization and choosing a sterilization program.
4. Clean the steam generator daily.
5. Before use, check inside the autoclave chamber to ensure that no items
have been left from the previous cycle.
6. Load trays in such a way as to allow steam to move freely among all
items.

Page 5 of 56 Pages
7. Only autoclavable products shall be used. Please refer to the manufacturer
instructions for sterilization of unknown materials or instruments.
8. When sterilizing plastic materials, make sure that the item can withstand
sterilization temperature. Plastic that melts in the chamber is liable to
cause a great deal of damage.
9. On closing the autoclave's door, make sure it is properly locked before
activating.
10. Verify once again that you have chosen the appropriate sterilization
program.
11. Before withdrawing trays, wear heat resistant gloves.
12. Before opening the door, verify that there is no pressure in the chamber
(chamber pressure gauge is located on the autoclave's front panel).
13. Open the door slowly to allow steam to escape and wait 5 minutes before
you remove the load.
14. Once a month, ensure that the safety valves are functioning, and once
annually a certified tester must conduct pressure chamber safety tests.
15. Once annually, or more frequently, effective tests must be performed, i.e.,
calibration and validation.
16. Examine the condition of assemblies on a regular basis. Make sure there
are no leaks, breaks, blockages, whistles or strange noises.
17. It is required to conduct maintenance operations as instructed.
18. Immediately notify the person in charge of any deviation or risk for the
proper function of the device.
19. This autoclave equipped with rear and front wheels, when moving the
autoclave all utilities must be disconnected, at least 2 persons shall move
the autoclave with caution. When the autoclave located in the required
place the Wheels has to be locked for further information see
FRONT/REAR VIEW OF THE AUTOCLAVE.

1.6 Safety features

Steam generator located inside the autoclave has the following


features for hazard protection:

1. Cut-off pressure switch


2. Cut-off thermostat
3. Water level protection

The main power of the generator is shut off if there is leak of water
or the pressure is above the safe level.

The pressure vessel chamber door has the following features


protecting personnel from hazards

1. Two door switches that indicate that the door is closed and
locked. Without this indication steam is not introduced to the
chamber.
2. A control that blocks door opening if the pressure is higher than
20% above the ambient pressure.

Page 6 of 56 Pages
2 TECHNICAL DATA
2.1 Introduction

This Horizontal autoclave is designed for the sterilization of wrapped and


unwrapped instruments and related items found in dental, medical and
veterinary clinics, first aid rooms, hospitals, laboratories, etc.
The instrument is a steam-heated sterilizer, using steam as sterilizing agent.
Its control unit ensures a fully automatic sterilization cycle, precise control and
monitoring of physical parameters and clear documentation of the sterilization
cycle. Five automatic programs are available, according to the material to be
sterilized + two test programs.
` This autoclave is equipped with a vacuum system and steam generator..
The advantages of the prevacuum sterilizer in comparison to the regular
gravity displacement steam sterilizer are as follows:
— Removal of air pockets from packs and porous load and most kinds of
tubes (rubber, plastic etc.) by vacuum at the first stage of the cycle.
— Better steam penetration into the load; resulting in effective
sterilization.
— Better temperature uniformity.

This manual is intended to give the user a general understanding of how the
instrument works and indicate the best ways to operate and take care of it in
order to obtain optimum results and a trouble-free operation. After reading this
manual, operating the autoclave will be an easy job. However, since the
instrument is built using high technology sensitive components, no attempt
should be made by the user or any other unauthorized person to repair or re-
calibrate it.
Only technical personnel having the proper qualifications, and holding technical
documentation and adequate instrumentation are authorized to service the
instruments.

Model 3870 HSG-D are table-top sterilizers designedespecially for the


sterilization of instruments, and other materials inhospital
laboratories, medical laboratories, research institutes, foodlaboratories and
pharmaceutical facilities.
A computerized control unit ensuring a fully automatic sterilization cycle
controls the autoclave.
The temperature and pressure are controlled through sensors placed inside
and outside the media container.
The sterilizer has multiple built - in safety devices, which provides
adequate protection to ensure the safety of operating personnel.
On all models, a printer is an optional addition to the autoclave. The
printer prints the preset and actual parameters of the cycle (temperature,
time and pressure/vacuum).
The autoclave is provided with a pressure gauge that is used as guide only.
Should there be a power failure during the operation of the autoclave, the

Page 7 of 56 Pages
pressure gauge indicates to the operator that there is pressure in the
chamber.
A deviation of +1.6% is accepted.
The pressure scale, printer option can be set up at any time by a technician.
NOTE:
After operating the sterilizer, brown stains might appear on the bottom of
the chamber. These stains are a result of the heating elements that are
located at the lower external part of the chamber. The brown color is a
common phenomenon, can easily be removed, and will not have any effect
on the sterilized goods.
This manual is intended to give the user a general understanding of how
the autoclave works and indicates the best ways to operate and take care of
it in order to obtain optimum results and a trouble-free operation. After
reading this manual, operating the autoclave should be straightforward.
However, since the autoclave is built using high technology sensitive
components, no attempt should be made by the user or any other
unauthorized person to repair or recalibrate it.
Only technical personnel having proper qualifications, holding
technical documentation and adequate test instrumentation are
authorized to undertake repair or service.
2.2 Operating Conditions

 Only autoclavable materials shall be used.


 The ambient temperature shall be 5ºC to 40ºC and a relative
humidity respectively up to 85%
 Operate the autoclave only in the manner specified in the manual. If
the equipment is used in a manner not specified by the manufacturer,
the protection provided by the equipment may be impaired.
Cautions!
Waste water should be brought into the public net in accordance
with the local rules or requirements i.e.
ONLY NON-HAZARDOUS LIQUIDS SHALL BE DISPOSED IN
PUBLIC SEWAGE!
The sterilizer should be loaded only with autoclavable material!
The environment shall not exceed an ambient temperature of 40ºC
and a relative humidity of 85% respectively.

 The operation altitude shall not be over 2000 meters (6561 feet)
(ambient pressure shall not be lower than 80 kPa (11.6 psi)).
 The autoclave shall not be used in a manner not specified in this
manual!
 Do not use the autoclave in the presence of dangerous gases.
 The packed or unpacked device shall be stored in ‘indoor’ conditions.

Page 8 of 56 Pages
2.3 Construction
The main parts of the autoclave are made of materials as indicated below:

 Chamber is built of stainless steel 316 L.


 Door is made of stainless steel 304.
 Pressure vessel is made of stainless steel 316L.
 Cabinet is made of stainless steel 304.
 Trays are made of stainless steel 316L.
 Generator's vessel is made of carbon steel.
 Door closing handle is made of aluminum material, which is safe to
touch and thermo-insulated.

2.4 Environment Emission Information


1. The peak sound level generated by the autoclave is less than 70 dBa
with background noise of 60 dBa.
2. The total heat per hour transmitted by the autoclave is < 300 W/h for
all models.

2.5 Directives and Standards


Every autoclave meets the provisions of the following Directives and is
constructed in compliance with the following Standards:

2.5.1 Technical Directives


1. Pressure Equipment Directive 97/23/EC.
2. Council Directive for low voltage equipment 73/23/EEC.
3. Electromagnetic Compatibility Requirements Directive
89/336/EC.
2.5.2 Technical Standards
1. ASME code
2. IEC-61010-1 & IEC-61010-2-040 - Safety requirements for
medical device.
3. EN 61326 – EMC Requirements .
2.5.3 Quality standards
The manufacturing plant meets the following quality standards:
1. EN ISO 9001:2008– Quality System
2. ISO 13485:2003 – Quality systems – Medical devices.

Page 9 of 56 Pages
2.6 Technical Specifications
(See drawing on next page)

Property Value
Diam. 38 cm
Chamber
Depth 76 cm
Chamber volume 84 liters. (22 US gal.)
Width (72.1 cm)
External dimensions Height (137.5 cm)
Length (118.1 cm)
Maximum dimensions Width (91.0 cm)
(door open) Length (166.9 cm)
Max. Allowable Working
2.8Bar
pressure (MAWP)
Overall weight 340Kg
According to the Overall weight and
Floor loading requirements
floor requirements
Max load 30 kg solid load or 10 kg textile
Maximum load per tray Unwrapped 5 kg (11 lbs.)
Maximum solid load Unwrapped 10 kg (22 lbs.)
Big 35 x 67 x 2.5 cm (14" x 26" x 1")
Tray dimensions
Small 28 x 67 x 2.5 cm (11" x 26" x 1")
No. of trays 2
IMS cassettes (optional) 15
Load No. counter Counting from 0 to 9999 and nullifies.

Page 10 of 56 Pages
OVERALL DIMENSIONS

Page 11 of 56 Pages
2.7 Autoclave's Electrical data

380-400V
PROPERTIES
3PH version
Ampere (A) 15 each phase
Voltage (V) 400/3ph
Hertz (Hz) 50/60
Heaters power (W) 9000
Protection against electrical shock Class I
Degree of protection by enclosure X0

2.8 Utilities

Water inlet (to generator) 1.5-2.5 Bar


Water connection(to generator) 1/2 NPT
Steam outlet 1/2 NPT
2" or bigger Withstanding
Drain
temp. of 80°C
Attention:

Attention:
The electrical net must be protected with a current leakage safety relay.
The electrical network must comply with local rules or regulations.

 A circuit-breaker of 3 ph. 16A must be included in the building


installation. This switch or circuit-breaker shall be in close proximity
to the equipment, within easy reach of the operator; and marked as the
disconnecting device for the equipment.
 The electrical net must be protected with a current leakage safety
relay.
 The electrical network must comply with local rules or regulations.
 Verify that there is an easy access to the main power switch, to the
water cut-off valve and to the current leakage safety relay.
 Make sure while placing the autoclave, to leave space around the
machine, to give the technician access to service the machine.
 All water connections to autoclave must be performed through
"BACK FLOW PREVENTION SYSTEM" only, as per IEC 61770.
 The cable cord has to fit the electrical requirement rating.
 Only locally qualified electrician can connect the autoclave to the
power.

Page 12 of 56 Pages
2.9 Stickers Symbol Description

Symbol Meaning Part Number Location


Caution! Consult LAB048-0024 Near the cut-off a5
accompanying
documents
Caution! Hot LAB048-0058 Near the safety valve
steam.

Protective earth LAB048-0020 Near the on/off switch


(Ground)

ON On-Off LAB048-0018 Near the Power switch

OFF

Page 13 of 56 Pages
Stickers map

ON

OFF

Page 14 of 56 Pages
2.10 Water Quality

The distilled or mineral-free water supply shall be according to the table below:
Physical Characteristics and Maximum acceptable contaminants levels in water or
steam, for steam generator and sterilizers
(According to EN 285:2006).

Contaminants in Contaminants in
water supplied to condensate at steam
generator inlet to sterilizer
Evaporate residue ≤ 10 mg/l N/A
Silicate (SiO2) ≤ 1 mg/l ≤ 0.1 mg/l
Iron ≤ 0.2mg/l ≤ 0.1mg/l
Cadmium ≤ 0.005 mg/l ≤ 0.005 mg/l
Lead ≤ 0.05 mg/l ≤ 0.05 mg/l
Rest of heavy metals
except iron, cadmium, ≤ 0.1 mg/l ≤ 0.1 mg/l
lead
Chloride (Cl) ≤ 2 mg/l ≤ 0.1 mg/l
Phosphate (P2O5) ≤ 0.5 mg/l ≤ 0.1 mg/l
Conductivity (at 25°C) ≤ 5 µs/cm ≤ 3 µs/cm
pH value (degree of
5 to 7.5 5 to 7
acidity)
Hardness (Σ ions of
≤ 0.02 mmol/l ≤ 0.02 mmol/l
alkaline earth)
Appearance Colorless, clean, without sediments

Compliance with the above data should be tested in accordance with acknowledged
analytical methods, by an authorized laboratory.

Attention:

The use of water for autoclaves that do not comply with the table above may have severe
impact on the working life of the sterilizer and can invalidate the manufacturer’s
guarantee.

Tap Water supply


Maximum hardness value 0.7-2.0 mmol/l

Caution: The use of soft water is strictly forbidden!


Please consult a water specialist!

Page 15 of 56 Pages
FRONT VIEW

1 6

2
7
3

10
12
11

No. Description No. Description


1 Chamber pressure gauge 7 Left service door latch
2 Control panel display 8 USB socket
3 Control panel keypad 9 Printer
4 Printer compartment door 10 RJ45 socket
5 Generator pressure gauge 11 On/ Off Switch
6 Ventilation grills 12 Wheels

Page 16 of 56 Pages
REAR VIEW

1 9

2 10

3 11

7 12

4 5 6 4 5 6

13

14 14

No. Description No. Description


1 Fan 8 Wheels
2 Circuit breaker 9 Chamber Safety Valve
3 Power input socket 10 Generator Safety Valve
4 Mineral-Free Water Overflow 11 Chamber Strainer
(WS configuration only) Manual
5 12 Mineral-Free Water Inlet
water fill inlet
(WS configuration only) Glass tube
6 Mechanic water level indicator 13
water level indicator
(WS configuration only) Water
7 Generator Drain 14
reservoir drain valve
15 Overflow drain

Page 17 of 56 Pages
3 CONTROL PANEL

No. Description
1 Display
2 Keypad: Up Button
3 Keypad: Start/Stop Button
4 Keypad: Down Button
5 Printer

Page 18 of 56 Pages
3.1 Description and Functions of the Front Panel Keyboard
The front panel is composed of 3 sections:
1. Display screen.
2. Keypad.
3. Printer

3.1.1 Display screen


The display is a LCD panel used to display the current status of
the autoclave while using Operational Messages and Error
Messages.

Program description:
 Program icon and name

 Sterilization temperature
 Sterilization time
 Drying time
Chamber temperature

Chamber pressure

Jacket temperature
 System status
 Name of stage
 Error and operational
messages

Page 19 of 56 Pages
3.1.2 Keypad
The keypad consists of three keys as described below:

UP key
This key has the following functions:
 In the main screen:
o This key enables the operator to browse
through the cycles.
 In the directories available:
o When the cursor is blinking on a number,
the UP ▲ key increases its value.
o When the cursor is blinking on a word, the
UP ▲ key enables to move ahead or to
browse through the directories.
DOWN key
This key has the following functions:
 In the main screen:
o This key enables the operator to browse
through the cycles.
 In the directories available:
o When the cursor is blinking on a number,
the DOWN ▼ key decreases its value.
o When the cursor is blinking on a word, the
DOWN ▼ key enables to move ahead or
to browse through the directories.
START/STOP key
This key has the following functions:
 In the main screen:
o Starts the process when the required
program was chosen.
o Stops the current process.
o Cancels the ERROR message displayed on
the screen to open the electric door
locking.
 In the directories available:
o When the cursor is blinking on a number,
the START/STOP key enables to
move ahead.
o When the cursor is blinking on a word, the
START/STOP key enables to enter in
the selected directory.

Page 20 of 56 Pages
3.1.3 Printer
The printer is an optional device.
It prints the detailed history of each cycle performed by the
autoclave. The printing is on thermal paper with 24 characters
per line and records the sterilization cycle information for
subsequent consideration.

3.2 Displayed Error Messages / Symbols


The failures are divided into two categories.
a. Failure that occur before completing the sterilization stage, which in
this case will leave the load unsterilized
b. Failure that occur after completing the sterilization stage, which in
this case will leave the load sterilized
For the list of Displayed Error Messages / Symbols
see sec. 12. TROUBLESHOOTING

Page 21 of 56 Pages
3.3 Displayed operational messages / Symbols
Message /
Message / Symbol
Symbol Required Action
Description
Name
This symbol is displayed
Close the door.
when the door is open.
This message is displayed
Door is open
when the door is opened: In Close the door to perform a
(during stand
standby - if START/STOP new cycle.
by)
is preset.
This message is displayed
Press START/STOP in
Cycle Ended when the cycle ended
order to perform a new cycle.
successfully.
This message is displayed Press START/STOP in
Test Ended
when the test ended. order to perform a new test
Enter the Admin menu as
This symbol is displayed
described in this manual to
when Cycle by Clock mode
change the time or to cancel
is performed.
this option.
This symbol is displayed
Wait until the temperature in
when the temperature in the
the jacket reaches the preset
jacket did not reach the
value
preset value
This message is displayed if
Enter the Admin menu as
the user presses
Cycle by described in this manual to
START/STOP key while
clock change the time or to cancel
the "cycle by clock" mode
this option.
is active.
This message id displayed
Atmospheric in order to set the Open the door for 5 minutes
pressure not atmosphere pressure by in order to set the
set opening the door for 5 Atmospheric pressure.
minutes.
Critical
settings have
been updated,
If a change of the autoclave Restart the autoclave in
Please restart
setting was made, a restart order for changes to be
machine in
operation is required. updated.
order for
changes to be
updated

Page 22 of 56 Pages
4 STERILIZATION PROGRAMS
The autoclave offers five sterilization programs and two test programs as follows:

Sterilization Programs Sterilization


Dry time
Temp time
Program Description (minutes)
(minutes)
Unwrapped 134°C
1 4 1
instruments (273°F)
Wrapped 134°C 20
2 4
instruments (273°F)

134°C
3 Wrapped pouches 7 30
(273°F)
Unwrapped delicate 121°C
4 20 0
instruments (250°F)
Wrapped delicate 121°C
5 20 20
instruments (250°F)

Test Programs Sterilization


Dry time
Temp time
Test Description (minutes)
(minutes)
5 + 10 min test
1 Leak test
time
2 B&D test 134°C 4 2

During the process, the stages of the cycle will be displayed on the screen:

The stages names are as follows:


Start
Pulse H
Pulse L
Keep Heat (*option)
Heating
Sterilization
Exhaust
Drying (**option)
Ending

* Can be changed only by an authorized technician.


** Can be changed by the operator.

Page 23 of 56 Pages
4.1 Program 1: Unwrapped instruments
For unwrapped instruments and materials, when the manufacturer
recommends autoclaving at temperatures of 134C (273F) no preset
drying stage required.

Nominal parameters default settings


 Sterilization temperature: 134C (273F)
 Sterilization time: 4 minutes.
 Drying time: 1 minute

Operations Sequence
 Air-removal stage; vacuum pulses are performed.
 Heating stage: steam is inserted into the chamber until the sterilization
temperature is reached.
 Sterilization stage; temperature and pressure are maintained constant at
the pre-set level for the sterilization time.
 Fast exhaust stage; steam is exhausted out of the chamber at a fast rate
until pressure decreases to ambient pressure.
 Dry stage; heating of chamber followed by a vacuum break (air inlet) to
remove leftover moisture from the instruments and wraps.

Note:
The sterility of instruments processed in unwrapped cycles cannot be
maintained if exposed to non-sterile environment.

Page 24 of 56 Pages
4.2 Program 2 - Wrapped instruments

For wrapped instruments and materials, when the manufacturer


recommends autoclaving at temperatures of 134C (273F) with a drying
stage.

Nominal parameters default settings


 Sterilization temperature: 134C (273F)
 Sterilization time : 4 minutes
 Drying time: 20 minutes (may be altered by the operator).

Operations sequence:
 Air-removal stage; vacuum pulses are performed.
 Heating stage: steam is inserted into the chamber until the sterilization
temperature is reached.
 Sterilization stage; temperature and pressure are maintained constant at
the pre-set level for the sterilization time.
 Fast exhaust stage; steam is exhausted out of the chamber at a fast rate
until pressure decreases to ambient pressure.
 Dry stage; heating of chamber followed by a vacuum break (air inlet) to
remove leftover moisture from the instruments and wraps.

Page 25 of 56 Pages
4.3 Program 3 - Wrapped pouches

For wrapped pouches and materials, when the manufacturer recommends


autoclaving at temperatures of 134C (273F) with a drying stage.

Nominal parameters default settings


 Sterilization temperature: 134C (273F)
 Sterilization time: 7 minutes.
 Drying time: 30 minutes (may be altered by the operator)

Operations Sequence
 Air-removal stage; vacuum pulses are performed.
 Heating stage: steam is inserted into the chamber until the sterilization
temperature is reached.
 Sterilization stage; temperature and pressure are maintained constant at
the pre-set level for the sterilization time.
 Fast exhaust stage; steam is exhausted out of the chamber at a fast rate
until pressure decreases to ambient pressure.
 Dry stage; heating of chamber followed by a vacuum break (air inlet) to
remove leftover moisture from the instruments and wraps.

Page 26 of 56 Pages
4.4 Program 4 - Unwrapped delicate instruments

For unwrapped delicate instruments, when the manufacturer recommends


autoclaving at temperatures of 121C (250F) with a drying stage.

Nominal parameters default settings


 Sterilization temperature: 121C (250F)
 Sterilization time : 20 minutes

Operations sequence:
 Air-removal stage; vacuum pulses are performed.
 Heating stage: steam is inserted into the chamber until the sterilization
temperature is reached.
 Sterilization stage; temperature and pressure are maintained constant at
the pre-set level for the sterilization time.
 Slow exhaust phase; steam is slowly exhausted from the chamber by
pulses of the exhaust valve, until the chamber pressure equals
atmospheric pressure.

Note:
The sterility of instruments processed in unwrapped cycles cannot be
maintained if exposed to non-sterile environment.

Page 27 of 56 Pages
4.5 Program 5 - Wrapped delicate instruments

For wrapped delicate instruments, when the manufacturer recommends


autoclaving at a temperature of 121C (250F).

Nominal parameters default settings


 Sterilization temperature: 121C (250F).
 Sterilization time: 20 minutes.
 Drying time: 20 minutes (may be altered by the operator).

Operations sequence:
 Air-removal stage; vacuum pulses are performed.
 Heating stage: steam is inserted into the chamber until the sterilization
temperature is reached.
 Sterilization stage; temperature and pressure are maintained constant at
the pre-set level for the sterilization time.
 Fast exhaust stage; steam is exhausted out of the chamber at a fast rate
until pressure decreases to ambient pressure.
 Dry stage; heating of chamber followed by a vacuum break (air inlet) to
remove leftover moisture from the instruments and wraps.

Page 28 of 56 Pages
4.6 TEST 1 – LEAK TEST

Vacuum is produced in the chamber down to P 1=17 kPa. At this stage all the
valves close. The autoclave remains in this stage for 5 minutes. This period
enables the condition in the chamber to reach equilibrium. After the 5 minutes
have elapsed the printer records the pressure that is referred to as P 2. At this
point the test begins and lasts 10 minutes. At the end of the test, the printer
records the results. The pressure at the end of the test is referred to as P 3.
Operations Sequence
 Vacuum is produced into the chamber down to 17kPa.
 The vacuum pump stops.

Note: During the test period the autoclave is not heated.


Note: During the test period the screen color is purple.
If the vacuum test failed, the screen color changes from purple to yellow
If the vacuum test is completed, the screen color will remain purple
Even if the vacuum test is completed, the operator shall check the test results
and consider whether the test results are acceptable or not

Page 29 of 56 Pages
PRESSURE (kPa)

Ambient Pressure

TIME
P3
P2
P1=17
kPa
t1 t2 t3

P1 = lowest pressure level, which is equal to or lower than


the level set for the cycle, during the air removal and t1 = Approx. 20 minutes
steam penetration stage t2 = 5 minutes
p2 = pressure after a period of 300 s t3 = 10 minutes
p3 = pressure after a leakage time of 600 s

Page 30 of 56 Pages
4.7 TEST 2 – B&D TEST

Bowie & Dick test program, with fixed sterilization parameters 134ºC and
3.5 minutes, which cannot be modified by the operator or the technician.

Nominal parameters default settings


 Sterilization temperature: 134ºC
 Sterilization time: 3.5 minutes.
 Dry time: 2 minutes.

Operations Sequence
 Air-removal stage; four vacuum pulses are performed.
 Heating stage: steam is inserted into the chamber until the sterilization
temperature is reached.
 Sterilization phase; temperature and pressure are maintained constant at
the pre-set level 134ºC for sterilization time 3.5 minutes.
 Fast exhaust stage; steam is exhausted out of the chamber at a fast rate
until pressure decreases to ambient pressure.
 Dry stage; heating of chamber followed by a vacuum break (air inlet) to
remove leftover moisture from the instruments and wraps.

If the B&D test cycle failed, the screen color changed from purple to yellow
If the B&D test cycle ended successfully "Test Ended" message will display and
the screen color will remain purple

Page 31 of 56 Pages
5 SCREENS
5.1 Screens following a complete successfully cycle – "Cycle Ended"

1. System Ready 2. Starting 3. Pulse L

4. Pulse H 5. Keep Heat* 6. Heat

7. Sterilization 8. Exhaust 9. Drying (option)

10. Ending 11. Cycle Ended (successfully cycle)

Note: “Jacket” line is configuration-dependant.

* Display can be activated only by an authorized person.


In order to open the door press START / STOP key

Page 32 of 56 Pages
5.2 Screens following aborted cycles after complete sterilization stage
The sterilization phase ended successfully – cycle ended and the reason of
failure is displayed
For example the next two scenarios:

5.2.1 Canceled by user after complete sterilization stage


The cycle ended successfully, the reason for aborted cycle is
displayed.

5.2.2 Door is open after sterilization stage has finished


The cycle ended successfully, the reason for aborted cycle is
displayed.

5.2.3 Screens following a Failure occurrence after complete


sterilization stage

The cycle ended successfully, the reason of failure is displayed.

Page 33 of 56 Pages
5.3 Screens following a fail cycle:

In this case, the display becomes yellow, a warning sign and the
reason of failure will be displayed.
For example the next two scenarios:

7.3.1 Failure according to Pressure Time Error

7.3.2 Failure according to Cancellation by user before complete


sterilization stage

When "Cycle Failed" appears on the screen, the user shall press
START/STOP key in order to delete the "Cycle Failed"
message.

An example for all displayed warnings according to Cycle Failed:

Cycle Failed
message

Reason of failure
The screen color changed
Warning symbol from white to yellow

An example for all displayed warnings according to Test Failed:

Test Failed message

Reason of failure
The screen color changed
Warning symbol from purple to yellow

Page 34 of 56 Pages
6 PRINTER
6.1 Printer Output
The printing is on thermal paper with 24 characters per line and contains
the following information:

 Date:
 Time:
 Ser. Num:
 Model:
 Version:
 Cycle Num:
 Cycle:
 Dry Time:
 Ster Temp:
 Ster Time:

When the sterilization cycle begins the printer starts printing the above
data.

After the preliminary printing, the autoclave starts performing the


sequence of operations of the cycle. The measured values of temperature
and pressure are printed at fixed time intervals, according to the phase of
the process, as shown in the table on the next page.
The data is printed from the bottom up, beginning with the date and
ending with "Cycle Ended". For an aborted cycle, "Cycle Failed" and the
Error message are printed (refer to "Displayed Error Messages/Symbols").
For an example of a typical printout, see next page.

Note: Please note that the print out goes from the bottom upwards.

Page 35 of 56 Pages
PRINTER OUTPUT DESCRIPTION
Operator: ____________ To be filled in manually by operator
Time: 12:14:47 Time sterilization cycle ended
Status: Cycle Ended
00:24:43 101.3 099.7 Cycle finished time
D 00:27:40 107.0 107.4 The time, temperature and pressure during Drying Stage
D 00:35:12 107.0 107.4 The time, temperature and pressure during Drying Stage
D 00:32:32 107.0 107.4 The time, temperature and pressure during Drying Stage
D 00:28:22 107.0 107.4 The time, temperature and pressure during Drying Stage
D 00:26:45 107.0 107.4 The time, temperature and pressure during Drying Stage
D 00:23:01 107.0 107.4 The time, temperature and pressure during Drying Stage
E 00:23:43 107.0 107.4 The time, temperature and pressure during exhaust
E 00:22:08 134.5 311.9 The time, temperature and pressure during exhaust
CLK 2: 12:12:10:00
Sterilization Process End time as registered by two clocks
CLK 1: 12:12:10:00
S 00:22:07 134.5 311.6 The time, temperature and pressure during sterilization
S 00:22:06 134.5 311.6 The time, temperature and pressure during sterilization
S 00:21:06 134.6 311.0 The time, temperature and pressure during sterilization
S 00:20:06 134.5 310.1 The time, temperature and pressure during sterilization
S 00:19:06 134.8 311.1 The time, temperature and pressure during sterilization
S 00:18:06 134.5 315.8 The time, temperature and pressure during sterilization
CLK 2: 12:08:08:00
Sterilization Process Start time as registered by two clocks
CLK 1: 12:08:08:00
H 00:18:04 134.4 315.1 The time, temperature and pressure during heating
H 00:16:35 128.9 268.4 The time, temperature and pressure during heating

H 00:13:35 116.3 180.9 The time, temperature and pressure during heating

K 00:13:04 107.0 162.9 The time, temperature and pressure during Keep Heat
K 00:12:22 115.1 200.4 The time, temperature and pressure during Keep Heat
K 00:11:10 113.7 162.5 The time, temperature and pressure during Keep Heat
A 00:11:04 107.0 162.9 The time, temperature and pressure during Air removal
A 00:10:22 115.1 200.4 The time, temperature and pressure during Air removal
A 00:10:00 113.7 162.5 The time, temperature and pressure during Air removal
A 00:07:00 098.7 200.5 The time, temperature and pressure during Air removal
A 00:06:45 097.6 165.4 The time, temperature and pressure during Air removal
A 00:03:45 080.2 200.4 The time, temperature and pressure during Air removal
A 00:00:45 053.7 154.4 The time, temperature and pressure during Air removal
A 00:00:04 046.5 097.0 The time, temperature and pressure during Air removal
F 00:10:18 092.8 096.6 The time, temperature and pressure during Steam Flush
F 00:07:18 074.7 096.4 The time, temperature and pressure during Steam Flush
F 00:04:18 047.4 096.3 The time, temperature and pressure during Steam Flush
F 00:01:18 025.4 101.4 The time, temperature and pressure during Steam Flush
W 00:00:05 029.3 096.0 The time, temperature and pressure during Water inlet
TIME °C kPa
End Temp: 120.0 °C
Ster Time: 4.0min Sterilization time for selected program
Ster Temp: 134.0°C Sterilization temperature in chamber for selected program
Cycle: Unwrapped instru Cycle name
Cycle Num: 000001 Cycle number
Version A.B.CC.DD = 1.0.00.00
A: Door Type: Single Manual = 1
Version: 1.0.00.00 B: Vacuum Type = 0
C: Total number of Input/Output functionality that are not as default = 00
D: Total number of parameters values that are not as default = 00
Model: 3870HSG Model name
Ser. Num: 000000000001 Model Serial number
Time: 11:50:05 Time sterilization cycle started

Page 36 of 56 Pages
Date: 9/FEB/2010 Date sterilization cycle started
-----------------------
Time: 08:51:39 Time of turning on
Date: 9/FEB/2010 Date of turning on
POWER ON The device is turned on
Time: 00:00:00 Time of turning off
Date: 9/FEB/2010 Date of turning off
POWER OFF The device is turned off

Legend
A Air removal stage (Pulse L & Pulse H) D Drying stage
H Heating stage CLK 1 Real Time Clock
S Sterilization stage CLK 2 Software clock
E Exhaust stage

6.2 Printer Handling


6.2.1 Maintenance
Wipe off the soiling on the printer surface with a dry soft cloth
with a weak neutral detergent. After that, wipe the printer with a
dry cloth.
6.2.2 Setting paper
PLUS II Front view
1-Paper mouth
2-STATUS Led
3-OPEN key (for paper roll compartment
opening)
4-FEED key
5-Paper roll compartment
6-Paper end sensor

Fig. 1 Fig. 1
Page 37 of 56 Pages
1. Open the printer's cover door (1) by pulling it up (see Fig.
2).

Fig. 2
2. Press the OPEN key to open the printer cover as shown
(see Fig. 3/1). Handle the paper cutter carefully not to cut
your hand.
3. Place the paper roll making sure it unrolls in the proper
direction as shown (see Fig. 3/2).
4. Take out the paper and re-close the cover as shown (see
Fig. 3/3) the printer cover is locked.
5. Tear off the exceeding paper using the jagged edge (see
Fig. 3/4).

Fig. 3

6. Close the printer's cover door (see Fig. 2/7) by pulling it


down, with the tip end of the paper emerging from the slot
(see Fig. 2/8).

Page 38 of 56 Pages
6.3 Treating the thermal papers:
 Store the papers in a dry, cool and dark place.
 Do not rub the papers with hard substance.
 Keep the papers away from organic solvent.
Cautions
Never disassemble the printer. Failure to follow this
instruction may cause overheating or burning of the printer
or the AC adapter. Or an electric shock, which may lead to
fires or accidents.

Never use the printer in a place of extreme humidity or any


place where it can possibly be splashed by any liquids. If
any liquids get into the printer, it could lead to fire, electric
shock, or other serious accidents.

Never touch the thermal head immediately after printing


because it becomes very hot. Make sure that the thermal
head is cool before setting papers or cleaning the thermal
head.

Power OFF the printer in any of the following cases:


 The printer does not recover from an error.
 Smoke, strange noise or smells erupt from the printer.
 A piece of metal or any liquid touches the internal parts or
slot of the printer.

Page 39 of 56 Pages
7 PREPARATION BEFORE STERILIZATION
The purpose of packaging and wrapping of items for sterilization is to provide an
effective barrier against sources of potential contamination in order to maintain
sterility and to permit aseptic removal of the contents of the pack. Packaging and
wrapping materials should permit the removal of air from the pack, penetration of
the sterilizing water vapor into the pack and removal of the sterilizing vapor.
The basic principle determining the size, mass and contents of instrument and
hollowware packs is that the contents are sterile and dry immediately on
completion of the drying cycle and removal of the pack from the sterilizer
chamber.
Instruments to be sterilized must be clean, free from any residual matter, such as
debris, blood, pads or any other material. Such substances may cause damage to
the contents being sterilized and to the sterilizer.
1. Before use, check inside the autoclave chamber to ensure that no items have
been left from the previous cycle.
2. Immediately after use, clean instruments thoroughly to dispose of any
residue.
3. It is recommended to wash instruments with an ultrasonic cleaner, using
detergent and mineral-free water.
4. Launder textile wraps prior to reuse.
5. After cleaning, rinse instruments for 30 seconds. (Follow manufacturer’s
instructions on the use of products for cleaning and lubricating instruments
after using the ultrasonic cleaner).
6. Materials, including materials used for inner wraps, shall be compatible
with the item being packed and the sterilizing method selected.
7. Do not place materials to be sterilized directly on the chamber’s wall. Place
the material only on trays, rack, etc.
8. Before placing an instrument into the sterilizer tray, make sure that
instruments which are not of the same metal, (stainless steel, carbon steel,
etc.) are separated and placed on different trays.
Note:
Check manufacturer’s instructions for the sterilization of each item.
7. In case carbon steel instruments are placed on stainless steel trays, the trays
should be lined with a towel or paper wrap before placing the instruments
on the trays. There should be no direct contact between the carbon steel and
the stainless steel trays.

Page 40 of 56 Pages
7.1 Instruments

9. Place empty containers upside down to prevent accumulation of water.

10. All instruments must be sterilized in an open position.


11. Use single-use wraps once only and discard after use.
12. Place a sterilization indicator strip on the tray.
13. Place instruments with ratchets opened and unlocked or clipped on the first
ratchet position.
14. Disassemble or sufficiently loosen multiple-part instruments prior to
packaging to permit the sterilizing agent to come into contact with all parts
of the instrument.
15. Tilt on edge items prone to entrap air and moisture, e.g. hollowware, so that
only minimal resistance to removal of air, the passage of steam and
condensate will be met.
16. Load items within the boundaries of the tray so that they do not touch the
chamber walls.
17. The operator may use racks to allow for adequate separation of packaged
instruments.
18. Allow a distance of approximately 2.5 cm (1”) between trays to permit
steam circulation.
19. Once a week, use a biological spore test indicator in any load to make sure
sterilization is performed efficiently.
20. Make sure that all instruments remain apart during the sterilization cycle.
21. Empty canisters should be placed upside-down, in order to prevent
accumulation of water.
7.2 Packs
22. Place packs upright on trays, side by side.
23. Packs should not touch the chamber walls.
24. Pack instrument sets in a manner that prevents damage to delicate items.
25. Pack hollowware sets so that all openings face the same direction and so
that the contents cannot move inside the pack.
26. Load packs of folded operating room drapes with layers vertical, allowing
air to be removed from the packs rapidly.

Page 41 of 56 Pages
27. Do not place packs of hollowware and trays of instruments above textile
packs or soft goods in order to avoid wetting caused by condensation from
items above.

28. Load items packed in flexible packaging materials on edge with paper to
laminate, or flat with the paper surface downwards.
Note:
The manufacturer’s recommendations shall be observed, concerning
the sterilization data for each type of material.

7.3 Tubing
Rinse tubing after cleaning with pyrogen free water. When placing in
a tray, Make sure that both ends are open, without sharp bends or
twists.

Page 42 of 56 Pages
8 OPERATING INSTRUCTIONS

Note: For operating the generator, refer to the operating instruction in the
generator manual.
8.1 Operating the autoclave

1. Open the manual tap to the water supply network.

8.2 Turning on the autoclave


 To start the system, turn on the main switch (1), located under the
printer cover.

The door is equipped with an electrical cylinder. This electrical cylinder


performs the automatic opening and closing of the door.

8.3 Opening the door


In order to open the door, follow the next steps:

When the door is closed the screen below will be displayed:

Page 43 of 56 Pages
Press the Key in order to open the door

The following screen will be displayed:

If the door has opened successfully, the following screen will be


displayed:

8.4 Loading
 Load the autoclave properly according to instructions in sec. 9.
PREPARATION BEFORE STERILIZATION.
8.5 Selecting the program

1. Select the program.


 Pressing the UP key selects the next program.
 Pressing the DOWN key selects the previous program.
2. Make sure Verify that you chose the required program.
3. If the autoclave is equipped with a printer verify that a paper roll is
inserted in the printer. If not - insert as per para. 5.2.
Attention:
Selecting a program is possible only when the door is open.

Page 44 of 56 Pages
8.6 Closing the door
In order to close the door, follow the next steps:
When the door is open, the screen below will be displayed:

In order to close the door push the door to the wall of the autoclave
chamber for at least 5 seconds as shown in the picture below:

While closing the door the following screen will be displayed:

Page 45 of 56 Pages
When the door is properly closed, open door symbol is replaced
by the message "System Ready" and the following screen will be
displayed:

8.7 Starting cycle

1. Start the cycle by pressing the START/STOP key.


The autoclave starts performing sequence of operations. The actual
measured values of pressure and temperature are displayed
continuously and printed every minute at STE stage, and every 5
minutes at the other stages. The phase in progress is displayed at the
right side of the upper line as WATER, HEAT, STER., EXH., and DRY.
If the operator presses the START key and the door is not completely
closed, the process will not start and the DOOR indicator will flash
twice then turn off and the buzzer will sound four times.
Caution!
Do not touch the strainer’s cover, mounted on the exhaust line,
during and short after operation.
Touching the hot strainer’s cover may cause severe injuries.

Page 46 of 56 Pages
8.8 Unloading

1. When the cycle ended, press START/STOP key to verify the status.
Message "Cycle Ended" (and the relevant failure message, if
applicable) is displayed on the screen.
2. Verify that there is no pressure in the chamber, according to the
reading on the display. Only then you may open the door.
3. Open the autoclave. (see sec. 11.2 Opening the door)

Warning!
To avoid severe injuries from hot steam when opening the door:
It is strictly forbidden to lean on the autoclave.
It is strictly forbidden to place your hand or any part of your
body over the door.
Wear heat-resistant gloves or use the tray handle to remove the
load from the autoclave
To avoid severe injuries from hot steam when opening the door:
It is strictly forbidden to lean on the autoclave.
It is strictly forbidden to place your hand or any part of your
body over the door.
Wear heat-resistant gloves or use the tray handle to remove the load
from the autoclave
On completion of the cycle, the load shall be visual inspected to
ascertain that the load is dry, and that the colour of the sterilization
indicators turned to the required colour.

8.9 Stopping the process and cancelling the ERROR message


It is possible to stop the program while the autoclave is operating.
Pressing the START/STOP key at any stage of the process stops the
operation. If the cycle was aborted before completing the
sterilization stage, it will leave the load unsterilized.
At the end of the aborted process (before completing the sterilization
stage), "Cycle Failed" message, error message and a warning symbol
are displayed on the screen. Refer to "Displayed Error
Messages/Symbols".
Pressing the START/STOP key cancels the displayed message and
enables opening the door.
If the door is not opened, the vacuum pump will stop automatically
after 30 minutes.

Warning
The load has not completed a sterilization cycle, therefore it is not
sterile. Handle it as contaminated load.

Page 47 of 56 Pages
8.10 Start Cycle by Clock mode
This mode enables the operator to define the time of the beginning of
the cycle. The maximum possible delay is 24 hours. For further
information see sec. 6.8.1. “Start Cycle by Clock”.

9 SERVICE AND MAINTENANCE


9.1 Preventive and Scheduled Maintenance
The maintenance operations described in this chapter have to be fulfilled
periodically to keep the device in good condition and to reduce the
breakdown time to a minimum.
The user maintenance personnel can easily execute these operations in
accordance with further instructions.
The owner of the autoclave is responsible to order an authorized technician
to perform the periodical tests and preventive maintenance operations, as
specified in the technician manual.
Use only mineral-free water as detailed in para. 2.13 (water quality).
Warning!
Before carrying out any preventive maintenance operation, ensure that
the electrical cord is disconnected and that there is no pressure in the
autoclave.
9.1.1 Daily
Clean door gasket with a soft cloth. The gasket should be clean
and smooth.
9.1.2 Weekly
1. Take out the tray holder and trays. Clean the tray holder,
trays and chamber's interior (especially its bottom part) with
a commercial cleaning agent & water. Wipe off the sediments
from the chamber bottom with a sponge. Immediately after
cleaning, rinse the tray holder, trays and chamber's interior
with water to avoid stains on the metal.
Caution
Do not use steel wool or steel brush as this can damage
the chamber!
2. Put a few oil drops on the 2 door pins and door tightening bolt.
3. Clean the outer parts of the autoclave with a soft cloth.
Clean the water strainers once a month as per sec. 11.2,
Cleaning frequency may be reduced according to
experience.

9.1.3 Periodically
1. Replace the air filter, every 6 months (to be performed by a
technician).
1. In hard water areas, blowdown is necessary at least once a
day. In soft water areas, once a week. See blowdown
instruction in the generator's manual.

Page 48 of 56 Pages
2. Check the door gasket every 12 months and replace it if
required (see para. 9.5). Replacing the gasket shall be done
by a technician.
3. Once a year check and tighten the piping joints to avoid
leakage.
4. Once a year check and tighten all screw connections in the
control box, heaters and valves and instrumentation.
5. Once a month clean the strainer as per para. 9.3. Cleaning
frequency may be reduced according to experience.
6. Once every six months clean the fan grid, from the inside
outward, with a vacuum cleaner.

9.1.4 Periodical Tests


1. Once every month activate the safety valve (see para. 9.4).
9.2 Cleaning water strainer
Caution!
Before proceeding, Make sure that the electric cord is disconnected
and there is no pressure in the autoclave.

1. Open the strainer cover (see "Rear view of the autoclave").


2. Remove the strainer element.
3. Rinse the strainer with water. Use a brush if necessary.
4. Reinstall the strainer element.
5. Close the strainer cover.

Teflon Strainer Strainer


Cap gasket element Housing

Caution!
Page 49 of 56 Pages
Do not touch the strainer’s cover, mounted on the exhaust line, during
and short after operation.
Touching the hot strainer’s cover may cause severe injuries.

9.3 Checking the Safety Valve


Both safety valves, the chamber safety valve (2) and the generator safety
valve (3), are located on the top rear of the autoclave (see Rear View, 14
and 15).
They are protected by a safety shield.
In order to prevent the safety valve from a blockage, operate it once a
month.
Attention:
Use protective gloves in order to prevent hot steam burns to hands

9.3.1 PED-approved type safety valve

1. For the autoclave safety valve, operate the sterilization


cycle; for the generator safety valve, operate the generator.
2. Allow a pressure of approximately 200 kPa (29 psi) to
build up in the chamber.
3. Turn the safety valve pressure-regulating nut clockwise
for 2 seconds.
Caution: Be careful not to burn your hands.
4. Return the nut to its original position.
5. Press the STOP/STOP key to interrupt the operation, and
exhaust steam from chamber.
6. Wait until the pressure decreases to zero, only then can the
door be opened.
Pressure-Regulating Nut

Rear Wall

Page 50 of 56 Pages
9.3.2 ASME-approved type safety valve

1. For the autoclave safety valve, operate the sterilization


cycle; for the generator safety valve, operate the
generator.
2. Allow a pressure of approximately 200 kPa (29-psi) to
build up in the chamber.
3. Operate the safety valve by pulling the ring of the safety
valve using a tool, i.e. screwdriver, hook etc and lift the
safety valve ring for 2 seconds. Be careful not to burn
your hands.
4. Press the STOP/STOP key to interrupt the operation,
and exhaust steam from chamber.
5. Wait until pressure goes down to zero, only then can the
door be opened.
Attention:
Use protective gloves in order not to burn your hands with the
hot steam.

Safety valve ring

Page 51 of 56 Pages
9.3.3 Replacing the Air Filter
In order to “break” the vacuum, at the end of the dry phase, filtered
atmospheric air enters the chamber via a solenoid valve. The filtration of
the air is performed by the bacteriological filter that is placed at the inlet
of the chamber, through a solenoid valve.
The filter is mounted near an opening on the left sidewall of the autoclave
enclosure, to ease access for replacing it.
To replace the filter proceed as follows:
1. Open the left service door.
2. Remove the filter cover (2), by turning the cover counterclockwise until it
is released.
3. Remove the filter (3) from the filter cover by pulling the filter apart from
the filter cover.
4. Cut the tie wrap (4) fixing the flexible tubing (5) connecting the filter to
the copper pipe, and pull off the filter.
5. Replace the filter with a new one. Connect the filter (3) to the flexible
tubing (5) and tightening it with a tie wrap (4).
6. Connect the filter to the filter cover by pressing the filter (3) into the hole
in the cover (1).
7. Insert the filter to its place inside the autoclave and reassemble the filter
cover by turning it a ¼ turn clockwise. Verify that the cover is fastened
well in its place.

2
1

5 4 3 2
Page 52 of 56 Pages
10 TROUBLESHOOTING
This troubleshooting chart enables the user to solve minor malfunctions, prior to
contacting our service department.
Only technical personnel having proper qualifications and holding technical
documentation (including a technician manual) and adequate information are
authorized to service the apparatus.
Problem /
Failure Message / Symbol Description Corrective Action
message
1. Turn the main switch is to the
‘On’ position.
1. The main switch is in ‘OFF’ position. (see front view drawing).
The machine
2. The power cord is disconnected from the 2. Make sure the power cord is
is not
machine or the mains. connected properly to the
responding.
3. The circuit breaker has tripped. machine and the mains.
(see rear view drawing)
3. Lift the circuit breaker lever.
The printer
1. Install the paper roll in the
prints, but
1. The Paper roll is not installed in the right right way. Only one side of the
nothing is
way. (see sec. 8.2, Printer handling) paper is printable.
printed on the
(see sec. 8.2, Printer handling)
paper.

1. Make sure the paper roll


1. No paper is inserted in the printer.
is inserted in the printer.
The printer (see sec. 8.2, Printer handling)
(see sec. 8.2, Printer handling)
does not print. 2. No obvious reason.
2. Switch off the machine and
switch it back on for restart

1. Door is not tightened enough. 1. Hand tighten the door.


The machine
2. The door gasket is damaged. 2. Replace the door gasket.
is leaking at
(see sec. 11.1.1 daily maintenance and (see sec. 11.1.3 Periodically
the door.
11.1.3 Periodically maintenance) maintenance)
Water does
1. Clean strainer according to
not exit 1. Outlet strainer is clogged.
instructions.
chamber.
"Low Temp" Temperature dropped for more than 1
Perform a new cycle.
message is second below the sterilization temperature
displayed. during sterilization cycle.
The temperature raised 7°F (4°C) above
"High Temp"
sterilization temperature during the
message is Perform a new cycle.
sterilization stage for 2 seconds during
displayed.
sterilization cycle.

Page 53 of 56 Pages
"Heat Time The system cannot reach the required
Check that the autoclave is not
Error" is temperature, in the chamber, within the
overloaded.
displayed. preset time.
Pressure drops below the sterilization
"Low
pressure (134°C = 304 kPa, 121°C = 205
Pressure" is Perform a new cycle.
kPa) for 2 seconds during the sterilization
displayed.
stage.
Chamber Pressure raised 4.2 psi-29 kPa
"High
above sterilization pressure (134°C = 304
Pressure" is Perform a new cycle.
kPa, 121°C = 205 kPa) for 2 seconds during
displayed.
the sterilization stage.
"Pressure Time The system cannot reach the required Check that the autoclave is not
Error" is pressure conditions in the chamber, after overloaded.
displayed. preset time, during the air removal stage.
"RTC Error -
Please Set Set Current Date And Time.
Current Date Date and the time are not set. If the problem persists, call the
and Time" is technician.
displayed.
"Time Error"
The real time clock is faulty. Call the technician.
is displayed.
"Door is open
Close the door to perform a new
(During the
The door is open: During the cycle. cycle.
cycle)" is
displayed.
Wait until "cycle failed –
"Canceled By
The START/STOP key is pressed and cycle canceled by user" or "cycle end –
User" is
aborted. canceled by user" is displayed.
displayed.
Perform a new cycle.
"Cycle Failed"
and the An error occurred before sterilization cycle
Perform a new cycle.
following is completed.
symbol are
displayed.
"Air Error" is
Wait until the autoclave reaches
displayed at The autoclave does not reach the
the atmospheric pressure and
the end of the atmospheric pressure after 10 minutes.
perform a new cycle.
cycle.
This message is displayed if I/O card is
I/O Card
faulty or disconnected (both while cycle is Call the technician.
Failed
running or not).
Turn on the autoclave and wait
"Power power down occurred during the cycle. (this
until the autoclave is ready
Down" is message will be printed by the printer after
(reaches the safe condition) and
displayed. the autoclave will turn on).
perform a new cycle.
If the problem is not covered by this section or if the problem persists,
contact your dealer or point of purchase for further assistance.

Page 54 of 56 Pages
POUCH RACK TRH387-0006

TRAY

TRAY CAT. NO.


Big TRY387-0001
Small TRY387-0003

TRAY HOLDER TRH387-0001

Page 55 of 56 Pages
11 SPARE PARTS LIST

PART NUMBER DESCRIPTION


FIL175-0046 Strainer element, 400µ
FIL175-0027 Cap for¼” strainer
GAS082-0008 Teflon gasket 4mm

12 ACSSESORIES LIST

PART NUMBER Description

ACS215-0008 Pouch rack (available upon request)


THE002-0052 Printer paper
TRY387-0005 Tray
BSK387-0006 Basket
BSK387-0004 Container (available upon request)

Page 56 of 56 Pages

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