Manual Autoclave 2540e

7/31/2019 Manual Autoclave 2540e

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OPERATION

&MAINTENANCE

MANUAL

E-Type Electronic Table -Top Autoclaves

models 1730, 2340, 2540, 3140, 3850,3870

E, EK, EA & EKA

Cat. No. MAN205-0001 Rev. E

Tuttnauer Europe b.v., P.O. Box 7191, 4800GD Breda, The Netherlands. + 31/76-5423510Tuttnauer USA Co. 25 Power Drive Hauppauge, NY, 11788, USA (800) 624 5836, (631) 737 4850, Fax: (631) 737 07 20

Email: [email protected]


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TABLE OF CONTENTS

PARAGRAPH PAGE NO.

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

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

1.2 Warranty...................................................................................................41.3 Warranty Statement .................................................................................4

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

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

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

2.3 Operating Conditions...............................................................................7

2.4 Utilities......................................................................................................7

2.5 Environment Emission Information .......................................................7

2.6 Electrical Data: ........................................................................................7

2.7 Specifications ...........................................................................................8

2.8 Technical Specifications (for E, EK, EA, EKA models) ........................9

2.9 Construction...........................................................................................10

2.10 Directives and Standards .......................................................................10

2.11 Water quality ..........................................................................................11

2.12 Symbol Description ................................................................................12

3 STERILIZATION PROGRAMS ........................................................................15

3.1 Program 1 (134C with no drying).......................................................15

3.2 Program 2 (121C with no drying).......................................................16

3.3 Program 3 (134C with drying) ............................................................17

3.4 Program 4 (121C with drying) ............................................................18

3.5 Program 5 (121C with slow exhaust)..................................................19

4 KEYBOARD (keys and display) .........................................................................20

4.1 Description and Functions of the Front Panel Keyboard....................21

4.2 Description of the Operational Messages .............................................24

4.3 Description of Displayed Error Messages and Safety Measures .........26

5 PRINTER ............................................................................................................28

5.1 Printer Operation ...................................................................................285.2 Printer Handling....................................................................................30

6 INSTALLATION PLACING AND LEVELING INSTRUCTIONS.................31

6.1 leveling....................................................................................................31

6.2 Water quantity for a cycle......................................................................32

6.3 Lifting and carrying...............................................................................32

6.4 Loading and unloading the Device .......................................................32

6.5 Filling the Water Reservoir ...................................................................33

7 PREPARATION BEFORE STERILIZATION.................................................34

8 OPERATING INSTRUCTIONS ........................................................................38


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TABLE OF CONTENTS (Cont.)

PARAGRAPH PAGE NO.

9 MAINTENANCE INSTRUCTIONS..................................................................40

9.1 Preventive and Scheduled Maintenance...............................................40

9.2 Draining the Reservoir...........................................................................41

9.3 Cleaning Air Jet .....................................................................................42

9.4 Replacing the Door Gasket ....................................................................43

9.5 Replacing the Air Filter (models EA, EKA) .........................................44

9.6 Cleaning water outlet strainer ...............................................................45

9.7 Replacing the Cartridge Fuse................................................................46

9.8 Checking the Safety Valve .....................................................................47

9.9 Door Safety System ................................................................................48

9.10 Cleaning Table Top Autoclaves with Chamber Brite.......................4910 TROUBLESHOOTING..................................................................................51

11 ACSSESORIES LIST .....................................................................................57

12 SPARE PARTS LIST......................................................................................57


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TABLE OF CONTENT (Cont.)

DRAWINGS PAGE NO.

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

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

Front Panel Keyboard.................................................................................................20

Pouch Rack .................................................................................................................54

Tray..............................................................................................................................55

Tray handle CMT240-0001 ........................................................................................55

Tray holder ..................................................................................................................56

Alternative tray holder ................................................................................................56


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1 GENERALRead the Operating Instructions carefully, before beginning any operationon the autoclave!

1.1 Incoming InspectionThe autoclave should be unpacked and inspected for mechanicaldamage upon receipt. Observe packing method and retain packing

materials until the unit has been inspected. Mechanical inspectioninvolves 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 thatthey may notify the manufacturer and file a claim with the appropriatecarrier.All Tuttnauer products are carefully inspected prior to shipment andall reasonable precautions are taken in preparing them for shipment toassure safe arrival at their destination.

1.2 WarrantyWe certify that this instrument is guaranteed to be free from defects inmaterial and workmanship for one year against faulty components andassembly with the exception of glassware, lamps and heaters.The warranty does not include and does not replace routinetreatment and preventive maintenance to be performed accordingto instructions in paragraph 9.1 (Preventive and ScheduledMaintenance).

Our obligation is limited to replacing the instrument or parts, after ourexamination, 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 orapplication, nor shall it extend to autoclaves that have been repaired oraltered by an un-authorized person.The Autoclave should not be used in a manner not described in thismanual!

1.3 Warranty StatementThe warranty registration must be completed and returned to ourservice departments; within fourteen (14) days of purchase or thewarranty will be void.Our Technical Service Depts can be reached at: Tuttnauer Europe b.v., Paardeweide 36, P.C. Box 7191,

4800GDBreda, Netherlands. +31/76-5423510, Fax: +31/76-5423540, E-mail: [email protected]

Tuttnauer USA Co. 25 Power Drive Hauppauge, NY, 11788, USA (800) 624 5836, (631) 737 4850, Fax: (631) 737 07 20Email: [email protected]

Rudolf Gunz & Co. PTY LTD: Service Department, 26-34 Dunning Avenue, Ros, 2018, Sydney,Australia. Service Department, Locked bag 690, Beaconsfield, NSW 2014,Australia. +61-2-99356600Fax: +61-2-99356650


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Note:If there is any difficulty with this instrument, and the solution is notcovered in this manual, contact our representative or us first. Do notattempt to service this instrument yourself. Describe the difficulty asclearly as possible so we may be able to diagnose the problem and

provide a prompt solution.

If the autoclave is equipped with a printer, send along a copy of the lastprintout for our inspection. If replacement parts are needed, stipulatethe model and serial number of the machine.

No autoclaves will be accepted for repair without proper authorizationfrom us. All transportation charges must be paid both ways by theowner. This warranty will be void if the unit is not purchased from anauthorized full service Tuttnauer dealer.


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2 TECHNICAL DATA2.1 Introduction

This E-Type table-top autoclave is designed for the sterilization ofmedical and surgical solid instruments in dental, medical andveterinary clinics, first aid rooms, laboratories etc.Types E and EK are intended to sterilize non wrapped solid products.

Types EA and EKA are intended for sterilization of non-wrapped andwrapped solid products.The autoclave models E, EK, EA and EKA are electrically - heatedsterilizers of different dimensions, using steam as the sterilizing agent.A computerized control unit ensuring a fully automatic sterilizationcycle and precise control and monitoring of physical parameters and aclear documentation of the sterilization cycle controls the autoclave.

Five automatic programs are available, according to the material to besterilized. All sizes (except 1730) have a model that includes a dryingstage (EA and EKA). The difference between EK and EKA is the aircompressor that, during the drying stage, pushes filtered air (0.2m.)

through the chamber to pull out the humidity, the dry operation isperformed with the door closed.

On all models (except 1730), a water pump is installed between thewater reservoir and the chamber. This pump intensifies the water flowinto the chamber. Entry of water may be accompanied by a noise forapproximately 30 seconds. This is normal noise generated by regularoperation of the pump.

The control system provides adequate protection, to ensure the safetyof personnel and reliable operation with a minimum of shut down time.

All models (except 1730) are equipped with a pressure gauge that is

used as a guide only. Should there be a power failure during theoperation of the autoclave, the pressure gauge indicates to the operatorthat there is pressure in the chamber. The accuracy is 1.6%.On all models (except 1730), a printer is an optional addition to theautoclave. The printer prints the preset and actual parameters of thecycle (temperature, time and pressure/vacuum).

This manual is intended for the user and gives the user a generalunderstanding of the instrument and the best ways to operate and takecare 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 otherunauthorized person to repair or recalibrate it.Only technical personnel having proper qualifications and holdingtechnical documentation (including a technician manual) andadequate information are authorized to service the apparatus.

2.2 Stand by heating modeThe autoclave provides an option of heating the chamber in stand-bymode between cycles with a very low power in order to reduce totalcycle time (1.6% of the total power only). The autoclave turns offautomatically if the interval between the sterilization cycles is more

than 2 hours. The stand-by feature is activated, as default, on cycles 1,2, 3, 4 and not activated on cycle 5.


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The company qualified technician can cancel this feature on EK orEKA models, or activate it on E and EA models, according to customerrequirements.

2.3 Operating ConditionsThis device is for indoor use only!

The sterilizer should be loaded only with autoclavable material!The environment shall not exceed an ambient temperature of 40C anda relative humidity of 85% respectively.

Caution!Waste water should be brought into the public net inaccordance with the local rules or requirements i.e.ONLYNON-HAZARDOUSLIQUIDSSHALLBEDISPOSEDIN PUBLIC SEWAGE!

2.4 UtilitiesUtility Unit Value

V-A 1ph, 230/240V 16A, 50 HzPower supply (as appropriate)

V-A 1ph, 120V 16A, 60 Hz

Attention:The electrical net must be protected with a current leakage safetyrelay.

The electrical network must comply with local rules orregulations.

2.5 Environment Emission Information1. 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 Whfor all models.

2.6

Electrical Data:

1730 2340 2540 3140 3850 3870

E EK E, EA

EK,

EKAE, EA

EK,

EKAE, EA E, EA E, EA

Ampere (A)

at 230/240V4.6 5.9 6 9.6 6 9.6 10.4 10.4 13

Ampere (A)

at 120V8.8 11.2 11.7 11.7 20.0

Watts (W) 1050 1350 1400 2200 1400 2200 2400 2400 3000

Frequency 50 / 60 Hz

Protection against electrical shock Class I (IEC 60601-1)


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2.7 SpecificationsOverall Dimensions

1730 2340 2540 3140 3850 3870Model

Dimensions mm in mm in mm in mm in mm in mm in

A 440 17.4 510 20.0 510 20.0 590 23.2 660 26.0 660 26.0

B 305 12.0 365 14.4 365 14.4 450 17.7 525 20.7 525 20.7Overall

DimensionsC 455 17.9 545 21.5 545 21.5 566 21.9 695 27.5 875 34.5

D 750 29.5 900 35.8 900 35.8 990 39.0 1155 45.5 1335 53.0Maximum

dimensions

(door open) E 560 22.0 655 25.8 655 25.8 755 29.7 815 32.0 815 32.0

F 350 13.8 415 16.4 415 16.4 488 19.2 450 2.0 450 2.0

F1 339 13.4 422 16.6 422 16.6 371 14.6 564 22.2 564 22.2

G 50 2.0 50 2.0 50 2.0 50 2.0 50 2.0 50 2.0

Distance between

supporting legs

F1 - front legs

F - rear legs

H 315 12.4 400 15.8 400 15.8 400 15.8 555 2.0 725 2.0

Chamber diameter 170 6.7 230 9.1 254 10.0 312 12.3 384 15.1 384 15.1

Depth 340 13.4 470 18.5 475 18.7 475 15.4 580 22.8 760 29.9

Reservoir volume3.0

lit.

0.8

gal

3.0

lit.

0.8

gal

3.0

lit.

0.8

gal

3.0

lit.

0.8

gal

6.0

lit.

1.6

gal

6.0

lit.

1.6

gal

Minimum water

vol. in Reservoir

0.8

lit.

0.21

gal

0.8

lit.

0.21

gal

0.8

lit.

0.21

gal

0.8

lit.

0.21

gal

2.0

lit.

0.53

gal

2.0

lit.

0.53

galMax. Allowable

Working Pressure

(MAWP)2.76 bar (40 psi)

Load No. counter Counting from 0 to 3000 and nullifies.


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0.76m3

(26.8cu.f)

0.63m3

(22.2cu.f.)

0.35m3

(12.4cu.f.)

0.27m3

(9.4cu.f.)

0.27m3

(9.4cu.f.)

0.18m3

(6.35cu.f.)

Shipping

Volume

102kgs.

(225lbs.)

89kgs.

(196lbs.)

60kgs.

(132lbs.)

48kgs.

(106lbs.)

36kgs.

(79lbs.)

25kgs.

(55lbs.)

Shipping

Weight

Yes

Yes

Yes

Yes

Yes

N/A

Printer

432Full

15104322Half

No.ofstandard

Cassettes(Optional)

222433No.

oftrays

28x67x2.5cm

(11"x26"x1

")

35x67x2.5

(14"x26"x1

")

28x50x2.5

cm

(11"x20"x1")

35x50x2.5

cm

(14"x20"x

1")

25.6x40.8x

2.5

(10.1x16.1x1)

19.8x40.8x

2.2

(7.8x16.1x

1)

17x41.5x2

cm

(6.7"x16.3"x0.8")

17x41.5x2

cm

(6.7"x16.3"x

0.8")

12x29.5x2

cm

(4.7"x11.6"x0.8")

Traydimensions

WX

DXH

84liters

(22USgal)

65liters

(17USgal)

34.4liters

(7.8USgal.)

23l.

(6USgal.)

19liters

(5USgal.)

7.5liters

(2USgal.)

Volumeof

usable

space

38x76cm

(15"x30")

3858cm.

(15"23")

31.2x39.1

(2.3x15.4)

25.4x47.5cm

(10"x18.7")

23x47cm

(9"x18.5")

17x34cm

(6.7"x13.4")

Chamber

dimensions

DIAxD

3870

3850

3140

2540

2340

1730

Models2.

8

TechnicalSpecifications(forE,E

K,E

A,E

KA

models)


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2.9 ConstructionThe 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 totouch and thermo-insulated.

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

2.10 Directives and StandardsEvery autoclave meets the provisions of the following Directives and isconstructed in compliance with the following Standards:

2.10.1 Technical Directives1. Medical device directive MDD/93/42/EEC.

2.10.2 Technical Standards1. A.S.M.E. Code, section VIII division 1 for pressure

vessels.

2. EN 61010-1:93 Safety of electrical equipmentGeneral requirement.

3. EN 61010-2-041:97 Particular requirement for steamautoclaves.

4. EN 50081-1:92 (EMC) Emission compatibility

5. EN 50082-1:97 (EMC) Immunity compatibility.

6. prEN 13060-1:97-General requirements for all types ofsmall steam sterilizers.

7. prEN 13060-3 and 4:97-Particular requirements andtest method for type N and S sterilizers.

2.10.3 Quality standardsThe manufacturing plant meets the following qualitystandards:1. EN ISO 9002 (7.94) Quality System

2. EN 46002 (8.96) - Quality System - Medical device -Particular requirements.

3. ISO 13488 Quality systems Medical devices Particular requirements for the application of ISO9002.

The manufacturer retains all supporting documentation.


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2.11 Water quality2.11.1 Water for generation of steam

The distilled or mineral free water supplied to theautoclave should have the physical characteristics andmaximum acceptable level of contaminants indicated in thetable below:

Physical characteristics and acceptable contaminantslevels in water, for sterlizers

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

Documents

Manual Autoclave 2540e