Tuttnauer Valueklave 1730 Manual

OPERATION
&
MAINTENANCE
MANUAL
Tabletop Autoclaves
Models
1730, 2340, 2540, 3140, 3850, 3870 M & MK
1730MK Valueklave
First time published; 28.02.2000
Cat. No. MAN205-0007000EN Rev. V
Tuttnauer Co. Ltd., Har Tuv Industrial zone B P.O. Box 170, Beit Shemesh 9910101, Israel
 Tel: [phone],  Fax: [phone]
 Tuttnauer U.S.A. Co, Ltd. 25 Power Drive Hauppauge, NY, 11788, USA.  Tel (631) 737
4850, [phone],  Fax: [phone]

1
TABLE OF CONTENTS
Paragraph Page No.
1GENERAL................................................................................................................3
1.1 Manufacturer and US Official Correspondence Information......................3
1.2 Intended Use..................................................................................................3
1.3 Intended Users ..............................................................................................3
1.4 Incoming Inspection .....................................................................................3
1.5 Warranty........................................................................................................3
1.6 Warranty Statement ......................................................................................4
2TECHNICAL DATA................................................................................................5
2.1 Introduction ..................................................................................................5
2.2 Storage Conditions........................................................................................6
2.3 Operating Conditions....................................................................................6
2.4 Construction..................................................................................................6
2.5 Directives and Standards ..............................................................................7
2.6 Utilities ..........................................................................................................8
2.7 Waste Water Disposal ...................................................................................8
2.8 Environment Emission Information.............................................................8
2.9 Dimensions, Models 1730 .............................................................................9
2.10 Dimensions, Models 2340, 2540 .................................................................10
2.11 Dimensions, Models 3140 ...........................................................................11
2.12 Dimensions, Models 3850, 3870 .................................................................12
2.13 Technical Specifications .............................................................................13
2.14 Electrical Data ............................................................................................14
2.15 Maximum Solid Load Sizes.........................................................................14
2.16 Symbols Description....................................................................................15
2.17 Water Quality ..............................................................................................17
3DESCRIPTION OF COMPONENTS....................................................................23
3.1 Control Panel ..............................................................................................23
3.2 Other Components ......................................................................................23
4INSTALLATION INSTRUCTIONS......................................................................24
4.1 Electrical .....................................................................................................24
4.2 Setup............................................................................................................24
4.3 Lifting and Carrying...................................................................................25
5PREPARATION BEFORE STERILIZATION .....................................................26
6OPERATION .........................................................................................................30
6.1 Loading and Unloading the Device ............................................................30
6.2 Fill the Water Reservoir..............................................................................30
6.3 Sterilization Time Table..............................................................................32
7SERVICE AND MAINTENANCE INSTRUCTIONS...........................................35
7.1 Preventive and Scheduled Maintenance.....................................................35
7.2 Draining the Reservoir................................................................................36
7.3 Cleaning the Air Jet....................................................................................37
7.4 Replacing the Door Gasket .........................................................................38
7.5 Checking the Safety Valve ..........................................................................39

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7.6 Unclogging the Multi-Purpose Valve or Fill Piping. .................................40
8CLEANING THE TABLETOP AUTOCLAVES WITH CHAMBER BRITE™ ...41
9TROUBLESHOOTING .........................................................................................42
10 LIST OF ACCESSORIES......................................................................................52

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1GENERAL
Read the Operating Instructions carefully, before beginning any operation
on the autoclave!
1.1 Manufacturer and US Official Correspondence Information
The Autoclave is manufactured by Tuttnauer Ltd., Located
Har-Tuv B Industrial Zone, P.O. Box 170, Beit Shemesh 9910101, Israel.
Tel: [phone]
The US Official Correspondence is:
Tuttnauer U.S.A Co, Ltd. 25 Power Drive Hauppauge, NY, 11788,
USA. Tel: [phone], Fax: [phone]
1.2 Intended Use
The autoclave is designed for the sterilization of medical and surgical
goods such as wrapped and unwrapped solid, hollow, and porous loads
used in healthcare facilities (e.g., hospitals, nursing homes, extended
care facilities, freestanding surgical centers, clinics, and medical &
dental clinics).
1.3 Intended Users
The autoclave is intended for use by hospital personnel and other medical
personnel.
All autoclave users must receive training in proper usage from an
experienced employee. Every new employee must undergo a training
period from an experienced employee.
1.4 Incoming Inspection
Upon receiving your Tuttnauer Autoclave carefully inspect the outside
of the shipping carton for signs of damage. If any damage to the carton
is found, note the location with respect to the autoclave and check that
area of the autoclave carefully once it is fully unpacked. 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 any damage is found, contact your dealer as soon as possible so
that they can file aclaim with the shipping carrier and notify
Tuttnauer.
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.
Note: Lifting and carrying should always be done by two people.
1.5 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.
This warranty does not include routine cleaning and preventive
maintenance to be performed according to instructions in
section 8.1 (Preventive and Scheduled Maintenance).

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Tuttnauer warranties all new Manual autoclaves for a period of one full
year, covering both parts and labor. This one year warranty covers
defects in materials and workmanship on every part in the autoclave
except door gaskets and HEPA filters (they are wear items).
Tuttnauer warranties all chambers for a period of ten (10) years against
defects in materials and workmanship. This chamber warranty went
into effect January 1997.
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 Tuttnauer.
Tuttnauer’s obligation is limited to the repair or replacement of parts
for the autoclave. This warranty will be void if the unit is not purchased
from an authorized Tuttnauer dealer. No other warranties or obligations
are expressed or implied.
The Autoclave should only be used in a manner described in this
manual!
1.6 Warranty Statement
To activate the warranty, the registration card must be completed and
returned to Tuttnauer within fourteen (14) days of purchase, or you
may call our customer service department at the number listed below.
No product will be received or accepted for repair without prior return
authorization from Tuttnauer. All transportation charges to and from
Tuttnauer must be paid by the owner of the autoclave. During the first
90 days after purchase of an autoclave, Tuttnauer will pay shipping
costs on an individually evaluated basis and ONLY with pre-approval.
Note:
If you have any questions or there are any difficulties with this
instrument and the solution is not covered in this manual, please
contact your dealer or our Technical Service Dept. at the address
below. Do not attempt to service this instrument yourself.
Tuttnauer USA Co., Ltd. 25 Power Drive Hauppauge, NY, 11788,
USA : [phone], [phone], Fax: [phone]
e-mail:[email protected]

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2TECHNICAL DATA
2.1 Introduction
This autoclave is an electrically heated sterilizer using steam as the
sterilizing agent. It is a manually operated device, with a control
system based upon steam pressure.
The operator can select a sterilization temperature from within a range
of 212ºF - 273ºF (100ºC - 134ºC). This allows for the sterilization of
heat sensitive material at a low sterilization temperature, as well as
providing for faster sterilization at higher temperatures for materials
able to withstand the higher sterilization temperatures.
All models feature an easy-to-use control panel. The machines are
ruggedly built using 316L stainless steel, copper, brass, and aluminum.
To guard against rusting, no iron components are used. All models
include a drying system for wrapped items.
2.1.1 Safety features
The safety features include adouble locking door
mechanism (door tightening bolt and locking bellows), a
mechanical pressure relief valve, over temperature
thermostats and a double pole circuit breaker.
Pressure Door Lock System (Door Bellow)
The Door Bellows is a safety device that prevents the door
from opening when the chamber is pressurized.
The system utilizes the buildup of pressure in the chamber
to expand a flexible Silicon-rubber bellows. The bellows
pushes a metal pin into a grove on the tightening bolt of the
Door Closing Device.
This prevents the operator from opening the door when
there is pressure in the chamber. When the steam is
released, this bellow returns to its original position, drawing
the pin with it and releasing the tightening bolt.
This manual is intended for the user and gives the user a general
understanding of the instrument and the best ways to operate and take
care of it, to obtain optimum effective results.
After reading this manual, operating the autoclave will be easy.
However, since this instrument is built with 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 and holding
technical documentation (including a technician manual) and
adequate information are authorized to service the apparatus.

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2.2 Storage Conditions
The packed or unpacked autoclave shall be stored in “indoor
conditions” (protected from rain and water).
2.3 Operating Conditions
This device is intended for indoor use.
This autoclave is intended for NORMAL environment conditions as
follows:
Altitude up to 2000m.
Minimum room temperature 41ºF (5ºC).
Installation Category II.
Pollution Degree 2.
Maximum relative humidity 80% for temperature up to 31ºC
decreasing linearly to 50% relative humidity at 40ºC.
Mains supply voltage fluctuations up to ±10% of nominal voltage.
The sterilizer should be loaded only with autoclavable material.
2.4 Construction
The main parts of the autoclave are made of materials as indicated
below:
Chamber is built of electro-polished stainless steel 316 L.
Door is made of stainless steel CF8.
Trays are made of stainless steel 304.
Door handle is made of hard plastic material that is safe to touch
and thermo-insulated.
Water reservoir is made of hard plastic material.

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2.5 Directives and Standards
Every autoclave meets the provisions of the following Directives and is in
compliance with the following Standards:
Medical Device Directive 93/42/EEC as amended by 2007/47/EC
Medical Device Single Audit Program –(MDSAP)
ISO 9001:
Quality Management System
EN ISO 13485:
Quality Management System –Medical Devices
ISO 14001:
Environmental management system
ISO 17025:
General requirements for the competence of testing and
calibration laboratories
EN ISO 14971:
Medical devices –Application of risk management for
medical devices
ASME Code
Section I and Section VIII. Div. I
PED
2014/68/EU
Chinese Regulations
Special Equipment Licensing Office
EN 13060:
Small Steam Sterilizers
ANSI/AAMI/ST55:
Table Top Steam Sterilizer
ISO 17665:
Sterilization of health care products –Moist heat
ANSI/AAMI/ST79:
Comprehensive guide to steam sterilization and sterility
assurance in health care facilities
IEC 61010-1 / UL 61010-1:
Safety requirements for electrical equipment for
measurement, control, and laboratory use –Part 1: General
requirements
IEC 61010-2-040:
Safety requirements for electrical equipment for
measurement, control, and laboratory use –Part 2-040:
Requirements for sterilizers and washer-disinfectors used to
treat medical materials
EN 613261-1:
EMC Requirements for Electrical Equipment
IEC 62304:
Medical Device Software –Software life cycle processes

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2.6 Utilities
Utilities
Unit
Value
Power supply (as appropriate)
V-A
1ph, 120V –16A,50/60 Hz
V-A
1ph, 230V –16A,50/60 Hz
Attention:
1. The electrical net must be protected with a current leakage safety
relay (GFI Receptical or Circuit Breaker).
2. The electrical network must comply with local rules or regulations.
3. The autoclave must be connected to a properly grounded outlet.
2.7 Waste Water Disposal
Caution !
Waste water must be brought into the public water piping in
accordance with the local rules or requirements, i.e. only non-
hazardous liquids may be disposed in public sewage!
2.8 Environment Emission Information
A. The peak sound level generated by the sterilizer is <70 / dBA with
background noise of 60 dB.
B. The total heat transmitted by the sterilizer is < 100 W/h for
1730/2340/2540 models and < 150 W/h for 3140/3850/3870
models.

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2.9 Dimensions, Models 1730
Model
Dimensions
1730
M, MK-Valueklave
in
mm
Overall Dimensions
A
17.4
440
B
12.0
305
C
17.9
455
Maximum Dimensions (door open)
D
29.5
750
E
22.0
560
Distance Between Supporting Legs
F1-front legs
F -rear legs
F1
13.7
347
F
13.4
339
G
2.0
50
H
12.4
315
Chamber Diameter
6.7
170
Chamber Depth
13.4
340