Tuttnauer EZ-Series User and maintenance manual (Rev.C)

OPERATION

&

MAINTENANCE

MANUAL

Electronic Table -Top Autoclaves

models EZ9, EZ10, EZ10K

Cat. No. MAN205-0263-001E Rev. C



Manufactured by:

Authorized Representative: Tuttnauer USA Co. 25 Power Drive Hauppauge, NY, 11788, USA, : [phone], [phone],



Fax: [phone], e-mail: [e-mail]

Tuttnauer Co. Ltd., Har Tuv Industrial zone B P.O.Box 170, Beit Shemesh 99000, IsraelTel: [phone], ¬Fax: [phone]

TABLE OF CONTENTS

PARAGRAPH PAGE NO.

1. GENERAL............................................................................................................. 4

1.1 Incoming Inspection.................................................................................. 4

1.2 Warranty .................................................................................................... 4

1.3 Warranty Statement...................................................................................4

2. TECHNICAL DATA.............................................................................................6

2.1 Introduction ...............................................................................................6

2.2 Stand – by heating mode ...........................................................................6

2.3 Environment Emission Information......................................................... 7

2.4 Operating Conditions ................................................................................7

2.5 Utilities .......................................................................................................7

2.6 Construction ..............................................................................................7

2.7 Symbol Description.................................................................................... 8

2.8 Electrical Data ...........................................................................................9

2.9 Specifications........................................................................................... 10

2.10 Technical Specifications .........................................................................11

(9.4 cu.ft.) ...........................................................................................................11

2.11 Directives and Standards......................................................................... 11

2.12 Water quality............................................................................................ 12

3. KEYBOARD (keys and display) .........................................................................15

3.1 Indicator Light Description..................................................................... 16

3.2 Description and Functions of the Control Panel Keyboard ..................17

3.3 Description of the Display Panel ............................................................19

3.4 Description of Displayed messages and Safety Measures .....................19

4. STERILIZATION PROGRAMS ........................................................................ 22

4.1 PROGRAM 1. Unwrapped Instruments ................................................. 22

4.2 PROGRAM 2 . Wrapped Instruments and Porous Loads ....................23

4.3 PROGRAM 3: Glassware........................................................................24

4.4 PROGRAM 4: Accessory (Dry Only).....................................................24

5. PRINTER (Optional) ..........................................................................................25

5.1 Printer Operation.....................................................................................25

5.2 Printer Handling .....................................................................................27

6. INSTALLATION INSTRUCTIONS .................................................................. 28

6.1 Electrical ..................................................................................................28

6.2 Water Filling............................................................................................ 29

6.3 Lifting and carrying ................................................................................30

6.4 Loading and unloading the Device......................................................... 30

6.5 Filling the Water Reservoir.....................................................................31

7. PREPARATION BEFORE STERILIZATION .................................................32

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TABLE OF CONTENT (Cont.)

PARAGRAPH PAGE NO.

8. OPERATING INSTRUCTIONS ........................................................................ 35

9. MAINTENANCE INSTRUCTIONS..................................................................38

9.1 Preventive and Scheduled Maintenance.................................................38

9.2 Replacing the Air Filter...........................................................................39

9.3 Draining the Reservoir ............................................................................40

9.4 Cleaning Air Jet....................................................................................... 41

9.5 Replacing the Door Gasket .....................................................................42

9.6 Checking the Safety Valve.......................................................................43

9.7 Replacing the Fuse ..................................................................................44

9.8 Cleaning water outlet strainer.................................................................45

9.9 Cleaning Table Top Autoclaves with Chamber Brite ™ .......................46

9.10 Water Sensor Cleaning............................................................................48

10. TROUBLESHOOTING FOR THE OPERATOR .............................................49

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TABLE OF CONTENT (Cont.)

DRAWINGS PAGE NO.

Front View...................................................................................................................13

Rear View ....................................................................................................................14

Front Panel Keyboard................................................................................................. 15

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1. GENERAL

Read the Operating Instructions carefully, before beginning any operation
on the autoclave!

1.1 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 a claim with the shipping carrier and also notify
Tuttnauer.

All Tuttnauer products are carefully inspected prior to shipment and all

reasonable precautions are taken in preparing them for shipment to

Note: Lifting and carrying should always be done by two people.

1.2 Warranty

We certify that this instrument is guaranteed to be free from defects in

This warranty does not include routine cleaning and preventive

section 9.1 (Preventive and Scheduled Maintenance).

Tuttnauer warrantees all new autoclaves for a period of two full years,

Tuttnauer warrantees all chambers for a period of ten (10) years against

This warranty does not apply to any instrument that has been subjected

Tuttnauer’s obligation is limited to the repair or replacement of parts

The Autoclave should only be used in a manner described in this

1.3 Warranty Statement

To activate the warranty, the registration card must be completed and

No product will be received or accepted for repair without prior return

assure safe arrival at their destination.

material and workmanship for two years against faulty components and
assembly.

maintenance to be performed according to instructions in

covering both parts and labor. This two year warranty covers defects in
materials and workmanship on every part in the autoclave.

defects in materials and workmanship. This chamber warranty went
into effect January 1997.

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.

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.

manual!

returned to Tuttnauer within fourteen (14) days of purchase or you may
call our customer service department at the number listed below.

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.

4

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 Tuttnauer USA Co.. Do not attempt to service
this instrument yourself.

 Tuttnauer USA Co. 25 Power Drive Hauppauge, NY, 11788, USA

: [phone], [phone], Fax: [phone]

e-mail:[e-mail]

5

2. TECHNICAL DATA

2.1 Introduction

This table-top 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.

This autoclave is an electrically - heated sterilizer using steam as the

sterilizing agent. A computerized control unit ensuring a fully
automatic sterilization cycle, control and monitoring of physical
parameters and a clear documentation of the sterilization cycle controls
the autoclave.

The autoclave has three automatic programs, according to the material

to be sterilized, and one auxiliary drying program. The autoclave is
equipped with an air compressor that during the drying stage draws air
through a HEPA filter (0.2µm.) and pushes that air through the heated
chamber to remove moisture and facilitate the drying operation. Drying
is performed with the door closed.

On all models, a water pump is installed between the water reservoir

and the chamber. This pump guarantees fast and accurate filling of the
chamber every time. Entry of water may be accompanied by a noise for
approximately 30 seconds. This is normal noise generated by regular
operation of the pump.

The control system provides adequate protection, to ensure the safety

of personnel and reliable operation with a minimum of shut down time.

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).

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 in order 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.

2.2 Stand – by heating mode

The autoclave provides an option of heating the chamber in stand-by

mode between cycles with a very low power in order to reduce total
cycle time (1.6% of the total power only). The autoclave turns off
automatically if the interval between the sterilization cycles is more
than 2 hours. This feature is standard on model EZ10K and optional on
EZ9 and EZ10 models.

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2.3 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 < 100 Wh for
all models.

2.4 Operating Conditions

This device is to be used for indoor use.

This autoclave is intended for NORMAL environment conditions as
follows:

● - Altitude up to 2000m.

● - Room temperature range 5ºC to 40ºC.

● - 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 the nominal voltage.

The sterilizer should be loaded only with autoclavable material.

Caution!
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!

2.5 Utilities

Utilities Unit Value

V-A 1ph, 120V – 16A,50/60 Hz

Power supply (as appropriate)

V-A 1ph, 230V – 16A,50/60 Hz

Attention:

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

2.6 Construction

The main parts of the autoclave are made of materials as indicated

below:

♦ Chamber is electro-polish and built of stainless steel 316 L.

♦ Door is made of stainless steel CF8.

♦ Trays are made of stainless steel 316.

♦ Water reservoir is made of hard plastic material.

♦ Door handle is made of hard plastic material, which is safe to touch

and thermo-insulated.

♦ Covers are made of aluminum sheet, coated with Epoxy paint.

7

2.7 Symbol Description

Caution! Consult accompanying documents

Caution! Hot surface.

Caution! Hot steam.

Protective earth (Ground)

Stand by

8

2.8 Electrical Data

EZ9 EZ10 EZ10K

Ampere (A) at 230/240V 6 6 9.6

Ampere (A) at 120V 11.7 11.7

Watts (W) 1400 1400 2200

Frequency 50 / 60 Hz

Degree of protection by enclosure IP31



AUTOCLAVE TYPE

DESCRIPTION

EZ9, EZ10 EZ10K

120V 230V 230V

Circuit breaker (A) 15 10 15

Air pump fuse (A) 2.0 1.25 1.25

Water pump fuse (A) 1.25 1.25 1.25

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2.9 Specifications

Overall Dimensions

Model

Dimensions

EZ9 EZ10, EZ10K

mm in mm in

A 510 20.0 510 20.0

Overall Dimensions

B 365 14.4 365 14.4

C 540 21.5 545 21.5

Maximum dimensions
(door open)

D 910 35.8 910 35.8

E 630 24.8 655 25.8

F 415 16.4 415 16.4

Distance between
supporting legs

F1 422 16.6 422 16.6

G 50 2.0 50 2.0

H 400 15.8 400 15.8

Reservoir volume 3 lit. 0.8 gal 3 lit. 0.8 gal
Minimum water vol. in

Reservoir
Max. Allowable Working
Pressure (MAWP)

0.8 lit. 0.21 gal 0.8 lit. 0.21 gal

2.76 bar (40 psi)

Load No. counter Counting from 0 to 250 and nullifies.

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2.10 Technical Specifications

Models EZ9 EZ10, EZ10K

Shipping Volume

Shipping Weight

Printer

No. of IMS Cassettes
(Optional)

Half

Full

No. of trays

Tray dimensions W X D X H

Volume of chamber

Chamber dimensions DIA x D

0.27m3

(9.4 cu.ft.)

36 kg.

(79 lbs.)

Yes Yes

2 3

2 3

3 4

17 x 41.5 x 2cm

(6.7" x 16.3" x 0.8")

19 l.

(5 US gal.)

23 x 47 cm

(9" x 18")

0.27m3

(9.4 cu. f.)

48 kg.

(106 lbs.)

17 x 41.5 x 2 cm

(6.7" x 16.3" x0.8")

23 l.

(6 US gal.)

25.4 x 47.5cm
(10" x 19")

2.11 Directives and Standards

Every autoclave meets the provisions of the following Directives and is

constructed in compliance with the following Standards:

2.11.1 Technical Directives

1. Medical device directive MDD/93/42/EEC.

2.11.2 Technical standards

1. A.S.M.E. Code, Section VIII div.1 for unfired pressure
vessels.

2. AAMI/ANSI ST-55:2001 Table-Top steam sterilizers.

3. UL61010-1 Safety for Electrical Equipment for Measurement,
Control, and Laboratory Use, General Requirements.

4. UL61010-2-041 Particular Safety for Autoclaves.

2.11.3 Quality standards

1. EN ISO 9001:2000– Quality System

2. ISO 13485 – Quality systems – Medical devices – Particular
requirements for the application of ISO 9001.

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2.12 Water quality

The distilled or mineral – free water supplied to the autoclave should

have the physical characteristics and maximum acceptable level of
contaminants indicated in the table below:

Physical characteristics and acceptable contaminants levels in

water, for sterilizers

Evaporate residue ≤ 15 mg/l

Silica ≤ 2 mg/l

Iron ≤ 0.2mg/l

Cadmium ≤ 0.005 mg/l

Lead ≤ 0.05 mg/l

Rest of heavy metals ≤ 0.1 mg/l

Chloride ≤ 3 mg/l

Phosphate ≤ 0.5 mg/l

Conductivity ≤ 50 µs/cm

pH 6.5 to 8

Appearance colorless, clean, without sediment

Hardness ≤ 0.1 mmol/l

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 does not comply with the table

above may have severe impact on the working life of the sterilizer and
can invalidate the manufacturer’s guarantee.

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FRONT VIEW

No. Description No. Description

1 Reservoir water drain valve 9 Air relief valve

2 Ring for drain valve 10 Panel base

3 Door closing device 11 Front panel key board

4 Door switch (under door) 12 Printer

5 Autoclave cover 13 Main switch

6 Water reservoir cover 14 RS232 port cover

7 Water reservoir – assembly 15 Completion to panel

8 Safety valve

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REAR VIEW

14

3. KEYBOARD (keys and display)

FRONT PANEL KEYBOARD

Note: See section 3.2 for a description of the Keyboard buttons

Note: See section 3.2 for a description of the Keyboard buttons

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3.1 Indicator Light Description

Programs

Indicators

START

HEAT

STE

EXH

DRY

FAIL

ADD WATER

DOOR
CLOSED

Shows the selected program

Shows the system is running a program

The system is currently in the Heating stage

The system is currently in the Sterilization stage.

The system is in the Exhaust stage.

The system is in the Dry stage.

Shows the system has failed as a result of either a
malfunction, or the STOP key was pressed. A
message is displayed on the screen; the reason for
failure.

This indicator lights if there is a lack of water in the
reservoir.

This indicator lights showing the door is in the
closed position.

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