Tuttnauer 3840 ELVG-D Manuel

OPERATION

MAINTENANCE

MANUAL

Electronic Table–top Autoclave

models 3840, 3850, 3870

ELC-DStandard Autoclave

ELCPV-D Including Pre-Vacuum

ELCPVBH-D – Including Bio-Hazard

Cat. No. MAN205-0466001EN Rev J

Tuttnauer Europe B.V., Hoeksteen 11 4815 PR P.O. Box 7191 4800 GD Breda, The Netherlands

Tel: 31 (0) 765423510, Fax: 31 (0) 765423540

Page 1 of 110 Pages

TABLE OF CONTENTS

PARAGRAPH PAGE NO.

1. GENERAL ............................................................................................................5

1.1 Introduction .................................................................................................5

1.2 Incoming Inspection....................................................................................6

1.3 Warranty ......................................................................................................6

1.4 Warranty Statement .....................................................................................7

2. SAFETY INSTRUCTIONS ..................................................................................8

3. TECHNICAL DATA........................................................................................... 10

3.1 Introduction ...............................................................................................10

3.2 Storage Conditions.....................................................................................11

3.3 Operating Conditions.................................................................................11

3.4 Directives and Standards ...........................................................................11

3.5 Electrical Data ........................................................................................... 12

3.6 Specifications.............................................................................................12

3.7 Utilities.......................................................................................................15

3.8 Construction .............................................................................................. 16

3.9 Environment Emission Information .........................................................16

3.10 Safety Features ..........................................................................................16

3.11 Water Quality.............................................................................................16

3.12 Symbol Description....................................................................................18

4. CONTROL PANEL ............................................................................................24

4.1 Description and Functions of the Front Panel Keyboard .........................25

4.2 Displayed Error Messages / Symbols.........................................................27

4.3 Displayed operational messages / Symbols................................................28

5. DESCRIPTION OF PROGRAMS......................................................................29

5.1 Operations sequence ..................................................................................29

6. STERILIZATION PROGRAMS.........................................................................31

6.1 Program 1: Glass .......................................................................................33

6.2 Program 2: Plastic .....................................................................................34

6.3 Program 3: Liquid A..................................................................................35

6.4 Program 4: Liquid B – Waste ....................................................................36

6.5 Program 5: Liquid A – Cooling (ELC – cooling models only)..................37

6.6 Program 9: Vacuum Test (PV, pre-vacuum model only)..........................38

6.7 Optional Program 10: Bowie and Dick Test (PV, pre-vacuum model only)

....................................................................................................................39

6.8 Program 11: Bio Hazard Liquid Cooling (BH, bio-hazard models only) .40

6.9 Program 12: Bio Hazard Liquid (BH, bio-hazard models only)...............41

6.10 Program 13: Bio Hazard 1 (BH, Bio-Hazard models only) ......................42

6.11 Optional Program 14: Warm-Up...............................................................43

Page 2 of 110 Pages

6.12 Program 15: Isothermal ............................................................................44

7. SCREENS ...........................................................................................................45

7.1 Screens following a completely successful cycle – "Cycle Ended" ..........45

7.2 Screens following aborted cycles after complete sterilization stage ..........46

7.3 Screens following a fail cycle: ...................................................................47

8. PRINTER............................................................................................................48

8.1 Printer Output............................................................................................48

8.2 Printer Handling........................................................................................50

8.3 Filling the Water Reservoir .......................................................................53

8.4 Condense collecting tray............................................................................53

10. INSTALLATION ................................................................................................ 54

10.1 Placing .......................................................................................................54

10.2 Lifting and carrying...................................................................................54

11. PREPARATION BEFORE STERILIZATION..................................................55

11.1 Instruments ................................................................................................ 55

11.2 Wrapped Instruments ................................................................................56

11.3 Packs ..........................................................................................................57

11.4 Tubing........................................................................................................58

11.5 Liquids .......................................................................................................58

12. OPERATING INSTRUCTIONS.........................................................................60

12.1 Turning on the autoclave...........................................................................60

12.2 Opening the door .......................................................................................60

12.3 Safety..........................................................................................................61

12.4 Loading ......................................................................................................61

12.5 Operation ...................................................................................................61

12.6 Closing the door.........................................................................................61

12.7 Starting cycle ............................................................................................. 63

12.8 Unloading ..................................................................................................64

12.9 Stopping the process and cancelling the ERROR message.......................64

12.10Unloading ..................................................................................................65

12.11Cycle by Clock mode ..................................................................................65

13. CHECKING AND CHANGING PARAMETERS AND OTHER DATA ...........67

13.1 Quick options screen..................................................................................67

13.2 Entering the main menu............................................................................77

13.3 Directories and subdirectories ...................................................................79

13.4 Cycle Parameters (Custom program = duplicate cycle) ............................80

13.5 System Parameters.....................................................................................87

13.6 Maintenance ..............................................................................................89

14. DOOR SAFETY SYSTEM..................................................................................96

14.1 Electric door locking system ......................................................................96

14.2 Pressure switch ..........................................................................................96

Page 3 of 110 Pages

15. SERVICE AND MAINTENANCE INSTRUCTIONS .......................................97

15.1 Preventive and Scheduled Maintenance ...................................................97

15.2 Replacing the Air Filter.............................................................................99

15.3 Draining the Reservoir ............................................................................100

15.4 Cleaning water strainer ...........................................................................101

15.5 Checking the Safety Valve .......................................................................102

15.6 Cleaning the water sensor .......................................................................103

15.7 Moving the Autoclave ..............................................................................104

16. TROUBLESHOOTING ....................................................................................105

17. SPARE PARTS LIST........................................................................................ 110

18. ACCESSORIES LIST....................................................................................... 110

Page 4 of 110 Pages

TABLE OF CONTENT (Cont.)

DRAWINGS PAGE NO.

OVERALL DIMENSIONS , Models 3870...................................................................14

Models 3840 .................................................................................................................15

FRONT VIEW, Models EL/ELPV3870.......................................................................19

FRONT VIEW, Models EL/ELPV3840, EL/ELPV3850 .............................................20

REAR VIEW (MODELS WITHOUT BH) ..................................................................21

REAR VIEW (BH MODELS)......................................................................................22

REAR VIEW FOR THE FAN CONFIGURATION. ..................................................23

CONTROL PANEL DRAWING ..................................................................................24

BASKETS AND CONTAINERS ...............................................................................109

Page 5 of 110 Pages

1. GENERAL

1.1 Introduction

Model 3870 ELCPVGBH-D is a laboratory sterilizer designed especially

for the sterilization of instruments, liquids, and other materials in hospital

laboratories, medical laboratories (including the medical waste), research

institutes, food laboratories and pharmaceutical facilities.

The PV (pre-vacuum) models are equipped with a vacuum pump.

The advantages of the pre-vacuum sterilizer in comparison to the regular

gravity displacement steam sterilizer are as follows:

— Removal of air pockets from packs and porous loads 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.

— Better drying of materials with closed doors due to the vacuum

achieved in the chamber at the end of the sterilization cycle.

A special feature of the autoclave is fast cooling stage for liquids. In this

stage pressure in the chamber is increased by means of compressed air to

compensate the fast decreasing of pressure due to the fast cooling. The fast

cooling shortens the time required for safe handling of bottles.

In BH (bio-hazard) models, a bio-hazard filter installed in the chamber

enables sterilizing bio-hazard load without contaminating the surrounding.

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 or bottles.

The sterilizer is fully automatic with a choice of 15 programs, eliminating

any need for operator intervention during a cycle (programs 9-10 are for

vacuum testing only). A computerized control unit enables precise control

and monitoring of physical parameters and clear documentation of the

sterilization cycles.

The autoclave is equipped with a safety valve, which will discharge at an

overpressure of over 2.8 Bar (40 psi), which is located on the chamber

near the pressure switch and the steam pressure gauge. The control system

provides adequate protection, to ensure the safety of personnel and

reliable operation with a minimum of down time.

The sterilizer has multiple built - in safety devices, which provides

adequate protection to ensure the safety of operating personnel.

The printer prints the preset and actual parameters of the cycle

(temperature, time and pressure).

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

pressure gauge indicates to the operator that there is pressure in the

chamber.

Page 6 of 110 Pages

A deviation of +1.6% is accepted.

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.

1.2 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.

1.3 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 sec. 11.1 Preventive 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 products 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!

Page 7 of 110 Pages

1.4 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 P.O. Box 7191 4800

GD Breda, The Netherlands

Tel: 31 (0) 765423510, Fax: 31 (0) 765423540

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.

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 products 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.

Page 8 of 110 Pages

2. 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 instructions guidance provided by the manufacturer: how to operate 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.

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 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. 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. Liquids may be sterilized only with the “liquids” program. The container

must be covered but not sealed. Sealed bottles may only be sterilized using

a special program. The bottle must be either Pyrex or a Borosilicate glass

bottle.

5. 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.

6. Individual glass bottles may be placed within an appropriate container that

will be placed on a tray. Never place glass bottles on the floor of the

autoclave. Never fill more than 2/3 of the bottle volume.

7. On closing the autoclave's door, make sure it is properly locked before

activating.

8. Before withdrawing trays, wear heat resistant gloves.

9. Before opening the door, verify that there is no pressure in the chamber

(chamber pressure gauge is located on the autoclave's front panel).

10. Open the door slowly to allow steam to escape and wait 5 minutes before

you remove the load. When sterilizing liquids, wait 10 minutes.

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