Tuttnauer 5050 Manual de usuario

Operation and Maintenance

Manual

Electronic Laboratory Autoclaves

Models 5050, 5075 EL-MD/EL-D

EL-MD: standard autoclave (manual door)

EL-D: standard autoclave (automatic door)

C: optional system for fast cooling

PV: optional vacuum pump

BH: optional bio hazard filtration

F: optional fan for super-fast cooling

Cat. No. MAN205-0469000EN Rev. L

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

DOMINIQUE DUTSCHER SAS

Page 1

Table of content

Paragraph page no.

1General.................................................................................................... 4

1.1 Introduction...................................................................................... 4

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

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

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

2Safety Instructions.................................................................................... 8

3Technical Data....................................................................................... 10

3.1 Directives and Standards ............................................................... 10

3.2 Water quality.................................................................................. 11

3.3 Electrical Data................................................................................ 12

3.4 Stand –by heating mode ............................................................... 13

3.5 Operating Conditions ..................................................................... 13

3.6 Utilities........................................................................................... 14

3.7 Load on counter............................................................................. 14

3.8 Construction................................................................................... 15

3.9 Environment Emission Information................................................. 15

3.10 Overall Dimensions -- EL5050-MD/ EL5050-D ............................... 16

3.11 Overall Dimensions -- ELCPV 5050-MD/ ELCPV 5050-D............... 17

3.12 Overall Dimensions -- ELPRC 5075-MD/ ELPRC 5075-MD............ 18

3.13 Specifications................................................................................. 19

3.14 Stickers Description ....................................................................... 20

3.15 Front View...................................................................................... 21

3.16 Rear View...................................................................................... 22

4Control Panel ......................................................................................... 23

4.1 Control Panel Drawing ................................................................... 23

4.2 Description and Functions of the Front Panel Keyboard................. 24

4.3 Displayed Error Messages / Symbols............................................. 26

4.4 Displayed operational messages / Symbols ................................... 26

5Sterilization Programs ............................................................................ 28

5.1 Program 1: Glass........................................................................... 31

5.2 Program 2: Plastic.......................................................................... 32

5.3 Program 3: Liquid A ....................................................................... 33

5.4 Program 4: Liquid B –Waste.......................................................... 34

5.5 Program 5: Liquid A –Cooling (C –cooling models only)............... 35

5.6 Program 6: Liquid B –Waste Cooling (C –cooling models only).... 36

5.7 Program 7: Bio Hazard 1 (BH, bio-hazard models only) ................. 37

DOMINIQUE DUTSCHER SAS

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5.8 Program 8: Bio Hazard 2 (BH, bio-hazard models only) ................. 39

5.9 Program 9: Bio Hazard Liquids (BH, bio-hazard models only) ........ 40

5.10 Program 10: Vacuum Test (PV, pre-vacuum models only) ............. 42

5.11 Program 11: Warm-Up................................................................... 43

5.12 Program 12: Isothermal.................................................................. 44

5.13 Program 13: Air Mixture ................................................................. 45

5.14 Program 14: Glass Test ................................................................. 46

5.15 Program 15: Durham...................................................................... 48

6Screens.................................................................................................. 50

6.1 Screens following a completely successful cycle –"Cycle Ended".. 50

6.2 Screens following aborted cycles after complete sterilization stage 51

6.3 Screens following a fail cycle: ........................................................ 51

7Checking and Changing Parameters and other data .............................. 53

7.1 Browsing through the menus.......................................................... 53

7.2 Changing a Parameter................................................................... 54

7.3 Quick options screen...................................................................... 56

7.4 Logging in and entering the Main menu.......................................... 61

7.5 Changing parameters..................................................................... 62

7.6 System Parameters........................................................................ 63

7.7 Maintenance .................................................................................. 64

7.8Cycle parameters........................................................................... 66

8Printer.................................................................................................... 68

8.1 Printer Output................................................................................. 68

8.2 Printer Handling ............................................................................. 71

8.3 Treating the thermal papers: .......................................................... 72

9Preparation before Sterilization .............................................................. 74

9.1 Instruments.................................................................................... 74

9.2 Tubing............................................................................................ 76

9.3 Sterilization of Liquids.................................................................... 76

9.4 Filling the Water Reservoir............................................................. 77

10 Operating Instructions ............................................................................ 78

10.1 Turning on the autoclave................................................................ 78

10.2 Opening the door –MD models (mechanical door)......................... 78

10.3 Opening the door –D models (automatic door).............................. 79

10.4 Safety ............................................................................................ 80

10.5 Loading.......................................................................................... 80

10.6 Selecting the Program.................................................................... 80

10.7 Closing the door –MD models (mechanical door).......................... 81

10.8 Closing and locking the door –D models (automatic door)............. 81

10.9 Starting cycle ................................................................................. 83

DOMINIQUE DUTSCHER SAS

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10.10 Unloading.................................................................................. 83

10.11 Start Cycle by Clock mode......................................................... 84

11 Service and Maintenance Instructions.................................................... 85

11.1 Preventive and Scheduled Maintenance ........................................ 85

11.2 Draining the Reservoir ................................................................... 86

11.3 Cleaning water strainer .................................................................. 87

11.4 Checking the Safety Valve ............................................................. 89

11.5 Moving the Autoclave..................................................................... 91

12 Troubleshooting ..................................................................................... 92

13 Baskets and Containers ......................................................................... 96

14 Spare Parts List...................................................................................... 97

15 Acssesories List..................................................................................... 97

DOMINIQUE DUTSCHER SAS

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1General

Read the Operating Instructions carefully, before beginning any

operation on the autoclave!

1.1 Introduction

Model 5050/5075 EL-MD/EL-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.

MD models have a manual door with handle, and D models have an

automatic door equipped with an electrical cylinder. The automatic door

locks itself when closed and unlocks.by pressing a button.

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.

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

enables sterilizing bio-hazard load without contaminating the

surrounding.

There is a configuration equipped with fan that allows shortening the

cooling operation.

The temperature and pressure are controlled through sensors placed

inside and outside the media container or bottles.

The autoclave is equipped with A 9Kw generator that produces the

steam required for the sterilization.

DOMINIQUE DUTSCHER SAS

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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.

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.

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.

DOMINIQUE DUTSCHER SAS

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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 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 except for 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.

DOMINIQUE DUTSCHER SAS

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The Autoclave should not be used in a manner not described in

this manual!

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, Breda,

P.O. Box 7191, 4800 GD Breda, Netherlands. +31/76-5423510,

Fax: +31/76-5423540, 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.

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.

DOMINIQUE DUTSCHER SAS

Page 8

2Safety 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.

Never start using a new autoclave or a new steam generator, before

the safety, licensing and authorization department has approved it for

use.

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.

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.

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.

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.

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.

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

activating.

DOMINIQUE DUTSCHER SAS

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Before withdrawing trays, wear heat resistant gloves.

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

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

panel).

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

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

Once a month, ensure that the safety valves are functioning, and once

annually a certified tester must conduct pressure chamber safety tests.

Once annually, or more frequently, effective tests must be performed,

i.e., calibration and validation.

Examine the condition of assemblies on a regular basis. Make sure

there are no leaks, breaks, blockages, whistles, or strange noises.

It is required to conduct maintenance operations as instructed.

Immediately notify the person in charge of any deviation or risk for the

proper function of the device.

DOMINIQUE DUTSCHER SAS

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