Tuttnauer 3870 HSG-D Manual

OPERATION
&
MAINTENANCE
MANUAL
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: [phone]
Model 3870 HSG-D

Page 1 of 56 Pages
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 2 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 3 of 56 Pages
TABLE OF CONTENT (Cont.)
DRAWINGS PAGE NO.
FRONT VIEW .............................................................................................................16
REAR VIEW................................................................................................................17

Page 4 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: [phone], E-mail: [email protected]
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 5 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 6 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 7 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.
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
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.

Page 8 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 9 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 10 of 56 Pages
2.6 Technical Specifications
(See drawing on next page)
Property
Value
Chamber
Diam.
38 cm
Depth
76 cm
Chamber volume
84 liters. (22 US gal.)
External dimensions
Width
(72.1 cm)
Height
(137.5 cm)
Length
(118.1 cm)
Maximum dimensions
(door open)
Width
(91.0 cm)
Length
(166.9 cm)
Max. Allowable Working
pressure (MAWP)
2.8Bar
Overall weight
340Kg
Floor loading requirements
According to the Overall weight and
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.)
Tray dimensions
Big
35 x 67 x 2.5 cm (14" x 26" x 1")
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 11 of 56 Pages
OVERALL DIMENSIONS

Page 12 of 56 Pages
2.7 Autoclave's Electrical data
PROPERTIES
380-400V
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
Drain
2" or bigger Withstanding
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 13 of 56 Pages
2.9 Stickers Symbol Description
Symbol
Meaning
Part Number
Location
Caution! Consult
accompanying
documents
LAB048-0024
Near the cut-off a5
Caution! Hot
steam.
LAB048-0058
Near the safety valve
Protective earth
(Ground)
LAB048-0020
Near the on/off switch
ON
OFF
On-Off
LAB048-0018
Near the Power switch

Page 14 of 56 Pages
Stickers map
ON
OFF

Page 15 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
water supplied to
generator
Contaminants in
condensate at steam
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,
lead
≤ 0.1 mg/l
≤ 0.1 mg/l
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
acidity)
5 to 7.5
5 to 7
Hardness (Σ ions of
alkaline earth)
≤ 0.02 mmol/l
≤ 0.02 mmol/l
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 16 of 56 Pages
FRONT VIEW
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
3
4
5
2
1
7
6
8
9
10
11
12

Page 17 of 56 Pages
REAR VIEW
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
5
(WS configuration only) Manual
water fill inlet
12
Mineral-Free Water Inlet
6
Mechanic water level indicator
13
(WS configuration only) Glass tube
water level indicator
7
Generator Drain
14
(WS configuration only) Water
reservoir drain valve
15
Overflow drain
4
9
11
14
10
6
3
2
1
5
7
8
12
13
4
6
5
14

Page 18 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
3
5
1
2
4