MELAG MELAquick 12+ p, MELAquick 12+ User Manual

Dear doctor,
we thank you for your confidence demonstrated by the purchase of this MELAG product.

As an owner-run and operated family concern founded in 1951, we have a long history of successful
specialization in hygiene products for practice-based use. Our focus on innovation, quality and the highest
standards of operational reliability has established MELAG as the world’s leading manufacturer in the instrument
treatment and hygiene field.

You, our customer are justified in your demand for the best products, quality and reliability. Providing
"competence in hygiene" and "Quality – made in Germany", we guarantee that these demands will be met. Our
certified quality

management system is subject to close monitoring: one instrument to this end is our annual multi-day audit
conducted in accordance with ISO 13485 and ISO 9001. This guarantees that all MELAG products are
manufactured and tested in accordance with strict quality criteria.

The MELAG management and team.

User Manual

Steam sterilizer

MELAquick® 12+
MELAquick

®

12+ p

From software version 5.15

EN

User manual MELAquick® 12+/12+ p

Valid MELAquick® 12+/12+ p

From software version 5.15

Responsible for content:

MELAG Medizintechnik oHG

Geneststraße 6 – 10

10829 Berlin

Germany

Email: [e-mail]

www.melag.com

© 2017

Document: BA_quick12+_12+p_EN_v12.docx / Rev.: 12 – 17/2441

Date of update: 2017-12-13

We reserve the right to technical alterations

For doctors, physicians assistants and service personnel

Please read this User Manual before you start operation of the

steam sterilizer.

The
instructions include important safety information. Make sure to keep the User Manual
near to the steam sterilizer. It represents a component of the product.

Foreword

Thank you for deciding to buy this MELAG steam sterilizer.

Device description

The device name "steam sterilizer" is used in this User Manual to
designate the steam sterilizer

MELAquick 12+/12+ p.

User Manual

The User Manual contains important safety instructions and information
which you need to operate the

steam sterilizer. Read these instructions

carefully and thoroughly in proper sequence.

Avoid dangers

Please read all the safety instructions attentively before using the steam
sterilizer.

About these Instructions

Symbol

Meaning

Explanation

Danger

Risk to health

Indicates a dangerous situation which if not avoided

could entail slight to life-threatening injuries.

Attention

Observe without
fail

Indicates a dangerous situation which if not avoided

could entail damage to the instruments, the prac tic e
equipment or the steam sterilizer.

Important

information

Draws your attention to important information.

Table 1: Meaning of the symbols used in this User Manual

Example of emphasis

Meaning

Explanation

→

Conductivity measurement

Glossary entry

Words or phrases marked with an arrow are explained

in the

glossary. The glossary is listed alphabetically. It

can be found at the end of this manual.

Universal-Program S

Software citation

Words or phrases appearing on the →display of the

steam sterilizer are marked as software citations.

Chapter 6 – Logging

Cross reference

Reference to another text section within this manual.

Figure 1/(5)

Cross reference

Reference to a detail in a figure – in the example, to

part no. 5 in figure 1.

Table 2: Meaning of the emphasized text within this User Manual

Disposal

Electrical and electronic

equipment

MELAG devices are synonymous for long-term quality. When you

eventually need to decommission your MELAG device, we offer a special
disposal service. Simply contact your stockist.

Accessories and

consumption media

Dispose of accessories and consumption media which you no longer

require in the appropriate manner. Comply with all relevant disposal
specification in terms of possibly contaminated waste.

Packaging

The packaging protects the device against transport damage. The

packaging materials have been selected for their environmentally-friendly
and recycling properties and can be recycled. Returning the packaging to
the material flow reduces the amount of waste and saves raw materials.
Dispose of all non-required packaging materials at the collection points of
the dual system.

Symbols on the steam sterilizer

In affixing this CE mark, the manufacturer declares that this medical
product fulfils the basic

requirements of the medical device directive. The

four

-digit number confirms that this is monitored by an approved

certification agency.

Manufacturer of the medical device
date of manufacture

of the medical device

Serial

number of the medical device by the manufacturer

This User Manual contains important safety informations.
Failure to comply of the safety instructions could result in human and

material damage.

Please read this user manual carefully before commissioning the device.
The manual includes important safety information. The functionality and
value-retention of this sterilizer depends on the care accorded to it. Please
store this user manual carefully a

nd in close proximity to your sterilizer. It

represents a component of the product.

The symbol of the struck out waste bin identifies a device that may not be
disposed in the domestic waste. The vendor is responsible for appropriate
disposal of th

e device - it must be delivered to the vendor to be disposed

of. With the designation of an apparatus with this symbol, the
manufacturer furthermore declares that he satisfies all requirements of the
law concerning the release, redemption and environmental

ly sound

disposal of electric and electronic appliances.

Indication of the scale of the chamber volume

Opterating temperature

of the device

Operating pressure

of the devic e

Draws your attention to a hot surface. During o peration the twist grip may
become hot. Let the steam sterilizer cool down after progr am comple tion .

Safety Instructions

To operate the steam sterilizer, pay attention to the following safety
instructions

given below and in the individual chapters of this Operating

Manual.

Appropriate use

■ Do not sterilize any liquids with this steam sterilizer.

Power cable and

mains socket

■ The power cable may not be replaced ba an inadequate measured

power cable.

■

Never damage or alter the plug or mains cable.

■

Never operate the steam sterilizer if the mains cable or power plug are

damaged.

■

Never unplug by pulling on the power cable. Always take a grip on the

plug.

Setting up, installation,

commissioning

■ Only have the steam steriliz er set up, installed, and started up by

people →authorized by MELAG.

■

Only operate the steam sterilizer in areas which are not subject to

explosion hazards.

■

The connections for electrical provision and water supply and discharge

must be set-up by trained personnel.

■

Documentation media (computer, CF card reader, etc.) must be placed

in such a way that they cannot come into contact with liquids.

Preparation and sterilization

of instruments

■ Follow the instructions of the instrument manufacturers for preparing

and sterilizing instruments.

■

Observe the relevant standards and directives for the preparation and

sterilization of instruments, e.g.

→RKI [Robert Koch Institute] and →

DGSV [German Society for Sterile Supply].

■

Only use wrapping materials and systems which are suitable for steam

sterilization according to the manufacturer's information.

Program termination

■ Take heed that when opening the door after terminating a running

program, hot water steam can escape out of the chamber, depending
on when the program was terminated.

■

Depending on the time of the program termination, the load might not

be sterile. Observe the clear instructions shown on the

→display of t he
steam sterilizer. If necessary, sterilize the affected →objects after
rewrapping.

Removal of the items to be

sterilized

■ Never use force to open the door.

■

Use the basket lifter to remove the insert basket and the package

holder. Never touch the

→sterilized

items, the chamber or the door with

unprotected hands. The elements are hot.

■

After removal, place the insert basket and the package holder on a dry,

disinfected surface or use the holder and the frame as an alternative.

■

Check the wrapping of the sterilized objects for damage when removing

them from the steam sterilizer. If a wrapping is damaged, wrap the
object again and re-sterilize it.

Maintenance and repair

■ Have the maintenance and repair done only by →authorized persons.

■

When exchanging spare parts, you may use only the original MELAG

components.

Carrying the steam sterilizer

■ Use the supplied carrying straps to transport the steam sterilizer and

attach them to the sides e.g. using package tape.

Malfunctions

■ If repeated error messages occur while operating the steam sterilizer,

turn the device off, unplug the power plug and notify your specialist
dealer.

Disposal

■ MELAG devices are synonymous for long-term quality. When you

eventually need to decommission your MELAG device, we offer a
special disposal service.

Simply contact your stockist.

■

Dispose of accessories and consumption media which you no longer

require in the appropriate manner. Comply with all relevant disposal
specification in terms of possibly contaminated waste.

Accessories and

consumption media

Packaging

■ The packaging protects the device against transport damage. The

packaging materials have been selected for their environmentally­friendly and recycling properties and can be recycled. Returning the
packaging to the material flow reduces the amount of waste and saves
raw materials. Dispose of all non-required packaging materials at the
collection points of the dual system.

CONTENTS

CONTENTS

Chapter 1 – Performance Specifications ............ 8

Proper use .......................................................... 8

User benefits ....................................................... 9

Overview of sterilization programs .................... 10

Chapter 2 – Device Description ......................... 11

Scope of delivery .............................................. 11

Device views ..................................................... 12

Accessories ....................................................... 13

Effective capacity .............................................. 14

Control panel ..................................................... 14

Supply with feed water ...................................... 15

Chapter 3 – Initial Commissioning .................... 16

Pre-conditions for the set-up, installation and

commissioning .................................................. 16

Set-up location requirements ............................ 16

Establishing connections .................................. 17

Installation examples for connecting a water

treatment unit .................................................... 19

Compressed air connection (only MELAquick

12+) ................................................................... 21

Electrical connection ......................................... 22

Preconditions for commissioning ...................... 22

Record of installation and setting up ................. 22

Switch on the steam sterilizer ........................... 23

Opening the door .............................................. 23

Closing the door ................................................ 24

Chapter 4 – Sterilization ..................................... 25

Create prerequisites .......................................... 25

Prepare items to be sterilized ............................ 25

Loading the steam sterilizer .............................. 26

Selecting the program ....................................... 28

Select automatic pre-heating ............................ 28

Select additional drying ..................................... 29

Starting the program ......................................... 29

Program run ...................................................... 29

Manual program termination ............................. 30

Sterilization phase is finished ............................ 31

Drying phase ..................................................... 31

Program is finished ........................................... 32

Display batch number ....................................... 32

Remove sterilized items .................................... 32

Storage of sterilized items ................................. 33

Chapter 5 – Logging ........................................... 34

Batch documentation ........................................ 34

Setting the date and time .................................. 35

Use log printer as output medium ..................... 35

Employing MELAflash as output mediu m ......... 36

MELAnet Box as output medium ....................... 37

Computer as output medium ............................. 37

Automatic immediate log output ........................ 38

Subsequent log issue ........................................ 39

Display protocol memory................................... 40

Reading logs correctly ...................................... 40

Chapter 6 – Maintenance ................................... 42

Cleaning ............................................................ 42

Avoid formation of spots ................................... 43

Use qualitatively high-grade feed water ............ 44

Exchange the door gasket ................................ 44

Maintenance ..................................................... 44

Chapter 7 – Operating pauses ........................... 45

Sterilization frequency ....................................... 45

Pause times ...................................................... 45

Shut-down ......................................................... 45

Transport........................................................... 45

Recommissioning after relocat ion ..................... 46

Chapter 8 – Function test................................... 47

Automatic function test ...................................... 47

Manual function test .......................................... 47

Checks in daily operation .................................. 47

Helix test body system ...................................... 47

Display water quality ......................................... 48

Chapter 9 – Malfunctions ................................... 49

Warning messages ........................................... 49

Malfunction message ........................................ 49

Before you call .................................................. 49

No display on the screen .................................. 56

Poor drying results ............................................ 56

Open door in case of a power failure ................ 56

Overview of programs ........................................ 57

MAIN MENU ..................................................... 57

Menu: Function ................................................. 58

Technical tables .................................................. 59

Pressure-time charts ......................................... 59

Technical data ..................................................... 62

Glossary .............................................................. 63

Appendix A - Accessories ................................. 65

Chapter 1 – Performance Specifications

8

Chapter 1 – Performance

Specifications

In this chapter you learn
 Under which conditions and for which purpose you should use this steam

sterilizer

 What benefit you can achieve by using this steam sterilizer
 Which sterilization programs you can use

Proper use

Application area

The steam sterilizer is intended for use in every kind of general medical
area where no Class B

steam sterilizer

is required for the instruments used

and their type of packaging.

Sterilisation tasks

According to →DIN EN 13060 this steam sterilizer is considered a Class S
sterilizer. As a universal

steam sterilizer, it is suited for sterilizing

wrapped

/unwrapped solid instrumen ts, simple hollow items

(Hollow Body B)

and dental transfer instruments1. Large hollow bodies

such as hoses or similar may not be sterilized in the

this steam sterilizer.

Danger of burning!

Observe the following instructions for using the steam sterilizer:

■ Do not sterilize any liquids with this steam sterilizer. It is not licensed
for the sterilization of liquids.

Failure to observe these instructions may lead to delayed boiling,
damage to the steam sterilizer and burns.

Attention

■ Use the steam sterilizer only for the intended purposes outlined in

the related technical documents and only in connection with the
devices and components approved by MELAG.

■ The sterilization of instruments with this ste am ster iliz er, like the
foregoing instrument preparati on, is only to be done by competent
personnel.

■ Only use instruments and wrappings which are suitable for steam
sterilization according to the manufacturer's information.

Failure to observe these provisions could result in damage and/or
can compromise safety.

1

For further information please refer to the certificate of suitability in the appendix.

Chapter 1 – Performance Specifications

9

User b

enefits

Universal use

The steam sterilizer sterilizes on the basis of the →fractionated flow
method. This method ensures the complete and effective wetting or
penetration of the items to be sterilized with saturated steam.
The procedure can also be used to safely and quickly sterilize wrapped
instruments.

Low time expenditure,

overheating protection

To generate the sterilization steam, the steam ster iliz er uses an

→

integrated steam generator. The sterilizer chamber is protected from
overheating and you can sterilize instruments in a short time.

Automatic pre-heating

The cold chamber is preheated on activation of preheating or can be
maintained at a specific temperature between two sterilizations. This
shortens the program time periods and reduces the formation of
condensate to give improved drying results.

Clean feed water according

to DIN EN 13060, Appendix C

The steam sterilizer works with the feed water one-way system. Th is
means that fresh feed water is used for every sterilization run.
The quality of the feed water is constantly monitored via integrated
conductivity mea

surements. This prevents spots on instruments and

soiling of the

steam sterilizer

, provided the instruments have been careful ly

prepared.

Optimal drying for wrapped

items to be sterilized

The sterilized items are dried with the →pulsating overpressure drying
method. This way you achieve optimal drying results for wrapped objects
as well.

Optimized total

operating time

The steam sterilizer works with an electronic parameter control.
This way the

steam sterilizer optimizes the total operating time of a

program depending on the load.

High safety with

extensive

safety devices

The steam sterilizer verifies pressure and temperature in the sterilization
chamber at all times and its door locking system does not permit opening
the door when there is overpressure in the chamber. A

→process

evaluation system is integrated in the electronics of the

steam sterilizer. It

compares the process parameters such as temperature, time and
pressure during a program.
It monitors the parameters with respect to their limit values at activation
and control, and guarantees a safe and successful sterilization.
If one or

more parameters are above or fall below the determined limit

values, the

steam sterilizer outputs a warning or fault messages and, if

necessary, aborts the program. In the event of an automatic program
termination, observe the information on the display.

Additional

function check

With the →conductivity measurement, you can verify the water quality of
the feed water.

Effective batch

documentation

The steam sterilizer has an internal log memory which can save up to 40
program cycles. All data of the completed programs are automatically
stored here.
You can read out the internal log memory immediately after the end of the
program, or at a later time.

Chapter 1 – Performance Specifications

10

Overview of sterilization pr ograms

The results of this chart

indicate which tests were performed at the steam

sterilizer

. The marked fields show compliance with all applicable sections of the

Standard

→ DIN EN 13060.

Type tests

Universal-Program S

Quick-Program S

Prion-Program S

Program type as per

→DIN EN 13060

Type S

Type S

Type S

→

Dynamic pressure test of the

sterilization chamber

X X X

→

Empty chamber test

X X X

→

Solid load

X X X

→

simple hollow items (hollow

body B)

X X X

→

Dental transfer instruments1)

X X X

→

Single wrapping

X

---

X

Drying →solid load

X X X

Sterilization temperature

134 °C

134 °C

134 °C

Sterilization temperature band

134.5 ... 136.5 °C

134.5 ... 136.5 °C

134.5 ... 136.5 °C

Sterilization pressure

2 bar

2 bar

2 bar

Sterilization time

5:30 min

3:30 min

20:30 min

1) For further information please refer to the certificate of suitability in the appendix.

Chapter 2 – Device Des cription

11

Chapter 2 – Device Description

In this chapter you learn

 Which components are included in a standard scope of delivery
 Which components the steam sterilizer contains
 What safety devices the steam sterilizer has
 How the operating elements are designed and how you should use them
 How the menus of the user interface are structured
 What kind of water supply the steam sterilizer needs

Scope of delivery

Standard scope of delivery

 MELAquick 12+/12+ p



User Manual



Warranty certificate



Manufacturer's inspection repo r t



Record of installation and setting up



1 Basket lifter



1 Sieve tray



1 Support plate



1 Feed water container with connecting hose and cable

for water level

monitoring



1 Waste water container with connecting hose and cab le f or water

level monitoring



2 Replacement device fuses

Only for MELAquick 12+



Hose for compressed air 5 m



Coupling connector (DN 7.2)



Stopper Set to disable the drying

As option

 Universal basket including small part insert



Package Holder for wrapped instruments



Frame



Holding bow



Support with ISO adapters



Support with round holders



Log printer MELAprint 42/44



MELAnet Box



MELAflash CF card printer with CF card and card reader

Chapter 2 – Device Des cription

12

Device views

Front side

(2)

(3)

(1)

(4)

(1) Twist grip
(2) Operating and display field
(3) Mains switch
(4)

Suction fitting for drying air with insert (only
MELAquick 12+ p)

Rear side

(5)

(12)

(14)

(6)

(7)

(8)

(9)

(10)

(13

)

(11)

(5) Device fuse
(

6) Cable c

onnection for water level monitoring in the

feed water container

(

7) Cable c

onnection for water level monitoring in the

waste water container

(

8) Serial interface (RS232)

(

9) Sterile filter and compre ss e d air connec tion
(only MELAquick 12+)

(1

0) Mains supply for IEC plug

(

11) Connection for external waste water container

(

12) Slot for emergency release

(

13) Safety valve

(

14) Connection for external feed water container

Fig. 1: Device views

Chapter 2 – Device Des cription

13

Top view, open

(1)
(2)
(3)

Wiping rubber (under sliding

door)

Door

gasket

Sieve

tray

Fig. 2: Top view

Accessories

Universal basket for up to 12 handpieces with
semicircular insert for universal use. Instruments
up to a length of 20 cm can be sterilized in the
basket.

The package holder for wrapped instruments can be
removed from the steam sterilizer chamber usi ng t he
basket lifter by hooking into the upper holes.

Fig. 3: Universal basket with small parts insert (optional) Fig. 4: Package holder (optional)

For cooling down the instruments the universal
basket can be removed from the steam sterilizer
and placed on the frame.

The holding bow is hooked into the sideways venting
slots of the steam sterilizer and is used to hold the
universal basket while cooling down the instruments.

Fig. 5: Frame (optional) Fig. 6: Holder (optional)

Chapter 2 – Device Des cription

14

Support with round holders for 7 handpieces

Support with ISO adapters 7 handpieces

Fig. 7: Support with round holders (optional) Fig. 8: Support with ISO adapters (optional)

Effective capacity



Device type

Diameter

Depth

Volume

MELAquick 12+/12+ p

∅ 9 cm

20 cm

1.35 Litres

Control panel

The control panel consists of a two-line alphanumerical LED display and
four membrane keys.

Function key (-) and (+)

to select, set and display
special functions:
print, date/time, preheating, total batches,
conductivity, acknowledge error, (+)

KEY for

unlocking the door

Program selection button (P)

to select the sterilization programs/ test

programs

and select or set options

(sub-

menus) of the special functions

Start – Stop button (S)

to

start programs, terminate

programs / drying as well as
control of the special functions

2-line LED display

for program status display
and parameter display

Time (h:min:s)

Chamber pressure (bar) and

(steam-) temperature (°C)

12:27:12

0.02 bar 25℃

Chapter 2 – Device Des cription

15

Initial state

The display switches to the initial state after every switch-on, where the
current time and the chamber pressure in bar and the (steam) temperature
in °C are displayed.

Supply with feed water

The steam sterilizer requires →demineralised or →distilled →feed water
for steam production according to →DIN EN 13060, Appendix C. The feed
water supply is provided either by an external feed water container or with

a water treatment unit (e.g. MELA

dem 40/MELAdem 47).

Feed water via the external

feed water container

If you employ the feed water container for the feed water supply, you must
from time to time fill it manually.
At the given point in time, the

steam sterilizer outputs an appropriate

message.
The external feed water container holds 5 litr

es and suffices for approx.

20

sterilizations depending on the selected program.

The maximum water

demand for a program run is 280 ml.

Feed water via the water

treatment system

A water treatment unit is connected to the domestic water supply. It
produces the

→feed water required for generating the steam for the

steam

sterilizer

.

If you use a water treatment unit, then there is always sufficient feed water
available. You no longer have to manually fill the feed water container.

Chapter 3 – Initial Commissioning

16

Chapter 3 – Initial Commissioning

In this chapter you learn

 Who may set up, install and start up the steam sterilizer
 Which prerequisites you must create for setting up, installing and starting up the

steam sterilizer

 How to turn the steam sterilizer on

Pre

-conditions for the set-up, installation

and commissioning

■ Only have the steam steriliz er set up, installed, and started up by

people →authorized by MELAG.

Danger

■ According to the currently valid VDE standards, this device is not

suitable for use in explosive areas.

■ The steam sterilizer is intended for use outside the patient
environment. The device should be located a minimum of 1.5 m
radius away from the treatment area.

Damages to the steam sterilizer and/or injuries can occur in case
this precaution is not observed.

Set

-up location requirements

Location

Set up the steam sterilizer in a dry and dustproof location on a horizontal
surface.

The relative humidity should amount to

max. 80% at 31 °C, decreasing in

a linear fashion up to a relative humidity of

max. 50% at 40 °C. We

recommend an ambient temperature of between 5

-40 °C (recommended

max. 25 °C).
The load capacity of the installation surface of a steam sterilizer must

amount to

a minimum of 25 kg. The containers for the feed water and

waste water exert max. 5 kg on the installation surface.

Attention

■ Without fail, keep the specified distance free to the surrounding

surfaces at the sides and above the steam sterilizer.

Non-observance can lead to heat accumulation. This could
adversely affect the function of the steam sterilizer and entail the
shortening of the components' service life and result in extended
program times.

Distance to the

surrounding surfaces

The distance to the surrounding surfaces must be at least 5 centimetres
on both sides and 10 centimetres at the

rear side. The steam sterilizer

should be freely accessible from above, so that the

steam sterilizer

can be

filled and good ventilation is guara

nteed.

The setup location must be selected so that the temperature in the area of
the sterile filter and along the compressed air hose cannot exceed 40°C.

Chapter 3 – Initial Commissioning

17

Space requirements

MELAquick 12+

MELAquick 12+ p

Width

Height
Depth

A= 19.5 cm

B= 43 cm
C=47 cm
D= 29 cm
E= 9 cm
F= 5 cm
G= 10 cm
H= 22 cm

A= 20.5 cm

B= 43 cm
C=46 cm
D= 29 cm
E= 9 cm
F= 5 cm
G= 10 cm
H= 22 cm

Additional space for feed

water supply

Other than for the steam sterilizer, the feed water and the waste water
container require space.

Space requirement for water

treatment unit

MELAdem 40



The attachment can be next to the steam sterilizer or above or below

the steam sterilizer

MELA

dem 47



Attachment next to the steam steriliz er or above or below the steam

sterilizer (e.g. lower cabinet)

Water treatment unit

Width

Height

Depth

Diameter

MELAdem 40

32 cm

35 cm

15 cm

MELAdem 47 module housing

39 cm

47 cm

15 cm

MELAdem 47 water storage tank

51 cm

∅ 24 cm

Establishing connections

The feed water and waste water container should be installed in
immediate proximity, below the

steam sterilizer and easily access ibl e.

The length of the connection hoses

and the cables amounts to 1.5 m.

During installation they can be cut to the desired l

ength. If needed, hose

lengths

and cables up to a maximum of 5 m may be ordered and used.

The mains socket must be freely accessible after installation so that the
device can be taken from the electricity supply at any time.

Connection of feed water

The feed water connection hose (Ø 6 mm) is inserted to the end into the
feed water connector (

Fig. 1/(14)) on the rear side of the steam sterilizer

and se

cured with the union nut. In order to enquiry the water level in the

container, the cable is connected on the

rear side of the steam sterilizer

(

Fig. 1/(6)) as well.

Waste water connection

The waste water connection hose (Ø 8 mm) is inserted to the end into the
waste water connector (

Fig. 1/(11)) on the rear side of the steam sterilizer

and secured with the union nut. In order to enquiry the water level in the

Chapter 3 – Initial Commissioning

18

container, the cable is connected on the rear side of the steam sterilizer
(

Fig. 1(7)) as well.

If the connection for feed and waste water enquiry were mixed up by
mistake, the information on the display for container filling and/or emptying
will be incorrectly displayed.

PLEASE NOTE

The waste

-water hose must be laid dip-free with continuous descent.

Danger

■ It is absolutely necessary to insert both hoses to the end into the

couplings.

In case of non-observance there is danger of burns, as hot steam
may escape on the rear side and/or air may enter the lines when
sucking feed water and impact the functionality of the steam
sterilizer.

After the connection fill in tap water (approx. 10 cm high) into the waste
water container in order to cool the condensate coil and add commercially
available

instrument disinfectant to prevent germ formation in the waste

water container.

Use half of the amount recommended by the

manufacturer in order to preserve the material of the condensate coil.
This is required during initial commissioning and after every emptying of
the waste water container.

Fig.

9: Connections

Connection hoses
Cables for water level monitoring

Waste water container

Feed water container

Requirements placed on

the water treatment unit

All MELAG water treatment units comply with the following requirements:

 The water pressure at the output of the water treatment unit amounts

to min. 0.5 and max. 10 bar.

 The temperature of the feed water reaches max. 40 °C.


At 0.5 bar, the flow rate reaches min. 0.8 l/min for a short time and

then an average of 0.025 l/min (= 1.5 l/h).

Connection to a water

treatment unit

If the steam sterilizer should receive feed water fully automatically from a
water treatment unit, the

steam sterilizer is connected using a

PTFE hose

with exterior diameter Ø 6 mm to

the water treatment unit. It is also

possible to connect the

steam sterilizer

in parallel to a different unit, using

a T

-piece, to an already existing water treatment unit of sufficient

capacity.

Chapter 3 – Initial Commissioning

19

Next, you must switch the feed water supply to External in the
"Function" menu.

 Select the menu Function by simultaneous brief pressing of the

KEYS (+) and (-). The display shows Function: Last batch numb er.



Navigate with the KEY (+) or (-) until on the display Function:

Feed water–supply.



Press the KEY (P). The currently set option appears on the display,

e.g. Feed water-supply – internal.



To set the value to Feed water-supply – External, press the

KEY (P) again.



In order to save the setting and to leave the menu, press the KEY (S).

By again pressing the

KEY (S), you completely leave the menu and return

to the starting position of the display.
At initial delivery, the

Feed water-supply is set to Internal.

Installation examples for connecting a
water treatment unit

Example 1 – MELAdem 40

(1)

(7)

(2)

(4)

(6)

(8)

(11)

(3)

(5)

(9)

(10)

Purified water from the ion exchanger
MELAdem

40

Drain via waste water container

Fig.10: Feed water-supply from the ion exchanger MELdem 40

(1)

Safeguard combination according to EN1717, consisting of return flow inhibitor and pipe aerator

(2)

Tap water adapter (reduction from 3/4“ to 1/4“)

(3)

Input side MELAdem 40, Ø 6 mm inlet hose

(4)

Ion exchanger MELAdem 40

(5)

Water tap (available on-site)

(6)

Waste water hose (Ø 8 mm)

(7)

Waste water container

(8)

Waste water connection

(9)

Feed water filter MELAdem

(10)

Connection of feed water
(11)

Connection for water level monitoring in the waste water container

Function:

Feed water supply

Chapter 3 – Initial Commissioning

20

Example 2 – MELAdem 47

(1)

(14)

(6)

(10)

(9)

(2)

(7)

(8)

(15)

(16)

(17)

(5)

(4)

(11)

(3)

(1

3)

(18)

(12)

Purified water from the reverse
osmosis unit MELAdem

47

Drain via waste water container

Fig. 11: Feed water supply from the reverse osmosis unit MELAdem 47

(1)

Rear view Vacuklav 40 B+

(2)

Safeguard combination, consisting of return flow inhibitor and pipe aerator according to EN 1717

(3)

Y piece 3/4” (Art. No. 37300)

(4)

Cooling water inflow fitting

(5)

Leak monitor with shut-off valve and probe (Art.-No. 01056 – optional), recommended with fixed water
connection

(6)

Connection for water level monitoring in the waste water container

(7)

Waste water connection

(8)

Connection of feed water

(9)

Waste water container

(10)

Water tap (available on-site)

(11)

T-piece with hose (Art.-No. 38605)

(12)

Feed water filter MELAdem

(13)

Cooling water outlet fitting

(14)

Reverse-osmosis unit MELAdem 47

(15)

Double hose nozzle with anti-flooding flap (Art. No. 37400)

(16)

Double-chamber trap (Art. No. 26635)

(17)

Water tap DN40 (available on-site)

(18)

Electrical connection

Chapter 3 – Initial Commissioning

21

Compressed air connection

(only MELAquick 12+)

A compressed air connection is intended for MELAquick 12+.
Connect a free end of the compressed air hose (Ø 6 mm) to the quick
coupling piece of the steril e filter pre

-fitted to the steam sterilizer

and the

other end to the on-site compressed air supply. A coupling connector (NW

7.2) is included in the scope of de

livery of the steam sterilizer

. Do not

remove the sterile filter pre

-fitted to the steam steri liz er .

Danger

DIN EN 13060 prescribes that the steam sterilizer may not be operated

without the sterile filter integrated in the compressed air hose.

The

externally provided compressed air must meet the following

conditions:



Dried, condensate free, oil-free and filtered with a filter fineness

≤ 2 µm



Pressure range 3 ... 8 bar (43.5 ... 116 PSI)



For hose lengths greater than 4 m the minimum pressure must be



4 bar (58 PSI).



Standard volume flow 10 l/min. This is taken from the supply only

during drying.

For the connection of the compressed air hose, different manifolds and
coupling plugs are available as optional accessories (see

Appendix A -

Accessories

).

Danger

If the steam sterilizer issues Error 42 "Drying -

drying pump" or is a
program is aborted without the compressed air supply having been
completed at this point, the program is viewed as not having been

completed successfully.

■ In such a case, the Universal-Program must be perform

ed five times

without a load (alternatively, three times with activated additional

drying). Drying may not be aborted. Only then is the

steam st erilizer

ready for operation.

■ The steam sterilizer

can only be operated correctly with a

permanently-connected compressed air supply.

■ Ensure that the compressed air supply shut-

off valve is open before

every program start.

Danger

■ If the steam sterilizer is operat ed w ithout a compr es sed air s upply ,

the stopper set to disable the drying (art.-no. 30986 included in the
scope of delivery of the steam sterilizer) must have been installed
before commissioning the steam sterilizer.

■ To install, follow the "Instructions for deactivating the drying
function".

■ If the steam sterilizer is operated without a compressed air supply, in
lacking a drying function, it does not conform to DIN EN 13060. The

steam sterilizer

no longer corresponds with the intended use

described in the operating manual!

Attention

■ According to DIN EN ISO 7396-1, the steam sterilizer may not be

connected to the supply network for medical compressed air, e.g.
medical air technology.

Chapter 3 – Initial Commissioning

22

Electrical connection

Provide the following electrical connections for the steam sterilizer:



Electric circuit with 220-240 V (max. voltage range 207 - 253 V) and

50/60 Hz (MELAquick 12+) and 50 Hz (MELAquick 12+ p, see name
plate)



10 A separate fuse protection – at least Automat Type B



Protection from leakage current 30 mA

Danger of injury

■ The connections for electrical provision and water supply and

discharge must be set-up by trained personnel.

Non-observance could lead to a short-

circuit and/or fire and/or water

damage and/or electrical shock. This could result in serious injury.

Observe the following precautionary measures when handling the
mains cable and power plug:

Danger of injury

■ Never splice or change the mains cable.

■ Never bend or twist the mains cable.

■ Never unplug by pulling on the power cable (socket and steam

sterilizer). Always take a grip on the plug.

■ Never place any heavy objects on the mains cable.

■ Never run the mains cable over places where it could be squeezed

(e.g. doors or windows).

■ Never lead the cable along a source of heat.

■ Do not use any nails, staples or similar objects to fixate a cable.

■ If the mains cable or the power plug is damaged, turn off the steam

sterilizer. Mains cables or power plugs may only be replaced by →
authorised persons.

If these points are not observed, the cable or plug can be damaged
and/or a fire or electrical shock might occur. This could result in

serious injury.

Connecting the mains cable

Plug the mains plug into the socket and the IEC plug into the mains
connector (see Fig. 1/(10)).

Attention

■ The IEC plug on the steam sterilizer or the mains socket must be

freely accessible after installation so that the steam sterilizer can be
taken from the electricity supply at any time.

Preconditions for commissioning

The following prerequisites must be satisfied for initial start-up:



The feed water supply must be connected and filled with fresh feed

water of the appropriate quality and/or a water treatment unit must be
connected as alternative.



The waste water container must be connected.



The compressed air line must be connected.

 The power supply of the steam sterilizer must be assured.

Record of installation and s e t ti ng

up

PLEASE NOTE

As docu

mentation of proper setting up, installati on and comm iss ion ing as

well as for your warranty claim, the record of installation

and set up must

be filled out by the person responsible and a copy sent to MELAG.

Chapter 3 – Initial Commissioning

23

Switch on the

steam sterilizer

Switch on mains

Turn the mains switch on to power the steam steriliz er (see Fig. 1/(3)).

After switching on

 After switching on the steam sterilizer with the mains switch, the

→

display shows in alternation to the initial state the message

Unlocking door with button (+)

, if the door is closed.

PLEASE NOTE

In case of insufficiently filled and/or empty containers or not connected
water treatment unit, a signal tone sounds and a respective message is
shown on the

display.

After switching the steam sterilizer on, it require approx. 15 minutes to
reach operational readiness, if the "autom. preheating" option is activated.

Open

ing the door

After the end of a program

After the end of a program, the request Acknowledge with
button ’+’

is displayed. Press the KEY (+) to unlock the door. After

unlocking the door you can open the door and remove the sterilized items.



Turn the twist grip 90° counter-clockwise in order to open the sliding

door – minor resistance can be perceived just prior to the stop. Now
slide the door completely to the back.

For connected output medium and

Immediate output Yes a logging

printout is additionally carried out (see page

38, Automatic immediate

log output

.)

PLEASE NOTE

Only if the twist grip is completely turned by 90°, the door can be opened:

If it was unintentionally attempted to open the door while the door was still
locked, the twist grip must first be turned back until the groove is
perpendicula

r to the longitudinal axis. Only then the door can be opened

again using the (+) key. Otherwise the locking mechanism jams.

Chapter 3 – Initial Commissioning

24

Closing the door

When closing the door of the steam sterilizer, observe the following
instructions:



Pull the sliding door on the twist grip forward to the end and lock the

door by turning the twist grip 90° clockwise.

In correctly locked condition, the groove in the door grip must be
perpendicular to the longitudinal axis.

Attention

 Never push the sliding door downwards while pulling it shut.

Otherwise, the door gasket could fold over or become damaged.

The result may be a leaking sterilization chamber as well as a
subsequent malfunction message.

Chapter 4 – Sterilization

25

Chapter 4 – Sterilization

In this chapter you learn

 Which prerequisites should be created for a smoothly-running sterilization
 What you should observe when preparing the items to be sterilized
 How to correctly load the steam sterilizer
 Which programs you should use for what
 How you start a program
 Which stages a program runs through
 How to cancel a program
 How to recognise when the sterilization is successfully finished
 What you can do to improve the drying results
 What you must consider when removing the items to be sterilized

Create prerequisites

Create the prerequisites for a smooth and successf ul ster ilization process
as follows:

Provide feed water

 If feed water is supplied from the feed water container, then fill the

container with fresh feed water of appropriate quality (see page 44,

Use qualitatively high-grade feed water).



If you employ a water treatment unit, e.g. MELAdem 40, MELAdem

47, and the water feed is closed, then open it up. If the MELAdem 47
storage container should be empty, open the water feed tap at least
an hour before sterilization begins.

Connect compressed air line

 Make sure that the compressed air supply is ensured. This means

that the compressed air line is connected and that the shut-off valve

is

opened.

Switching on

If the steam sterilizer is still not switched on, switch it on at the mains
switch.
For this purpose see page

23, Switch on the steam sterilizer.

Prepare items to be sterilized

A significant prerequisite for safe disinfection and sterilization of

→

sterilizing

materials is the appropriate preparation, i.e. cleaning and

maintenance of the sterilizing mater ial s accor din g to the manufa ctur er' s
instructions. Furthermore the materials, cleaning agents and processing
procedure employed are of significan ce.

Chapter 4 – Sterilization

26

Instruments

Observe the following instructions for treating used and brand new
instruments:

Danger of infection!

■ Follow without fail the instructions of the instruments manufacturer

for treatment and sterilization, and observe the relevant standards
and directives of your country (in Germany, e.g. →BGV A1, →RKI

und →DGSV).

■

Clean the instruments very thoroughly, for instance with the help of a

washer -disinfector.

■ After disinfection and cleaning, rinse the instruments if possible with
→demineralized or →

distilled

water and subsequently thoroughly dry

the instruments with a clean, non-fuzzing cloth.

■ Employ only cleaning materials which are suitable for steam
sterilization. Ask the manufacturer about the cleaning materials.

In case of non-observance, residual dirt can possibly be loosened
up during sterilization in the steam pressure. Disinfection and
cleaning agent residue lead to corrosion. Increased maintenance
requirements and impairment of the function of the steam sterilizer

s

can be the consequence.
Unsuitable cleaning materials, e.g. water-rejecting cleaning

materials or steam-impermeable oils, can result in unsterile
instruments. This endangers your health and the health of your
patients.

When using the following devices, observe without fail the preparation
instructions of the instrument manufact urer:



Ultrasonic units



Maintenance appliances for hand pieces and angle pieces



Washer-disinfectors

Loading the

steam st erilizer

Only if the steam sterilizer is properly loaded can the sterilization be
effective and the drying deliver good results.

Danger of burn

ing!

For loading the steam sterilizer:

■

Use the basket lifter to remove the universal basket.

■

Never touch the chamber or the door with unprotected hands. The

elements may be hot.

Failure to observe this requirement can result in burns.

Unwrapped instruments

Always use the universal basket for unwrapped instruments. It is possible
to sterilize approx. 12 handpieces, turbines or other instruments up to a
length of maximum 20 cm in this basket.

Unless specified differently by the manufacturer, hand pieces shoul

d

always be inserted into the steam sterilizer with the shaft, hence the drive
side, pointing upwards.

For the sterilization of very small objects to be sterilized, e.g. in the
endodontic area (e.g. Hedström files, Reamer, K files), use the
semicircular sm

all part insert, which can be hooked into the universa l

basket at a greater or lower height.

Wrapping

The correct use of suitable wrapping is important for the success of the
sterilization.

Attention

Employ only packaging materials and -systems (sterile barrier

systems), which satisfy the DIN EN IS0 11607-1 Standard.

You can employ soft wrapping such as clear-plastic sterilization packages,
paper bags, sterilization paper or fleece.

Chapter 4 – Sterilization

27

Soft sterilization wrapping

→Soft sterilization wrapping must always be sterilized using the
package holder. When using soft sterilization packages such as
MELA

fol 1002. observe the following instructions:

Attention

■ Arrange →soft sterilization wrapping standing vertically in the

package holder to ensure that the paper side of the outer wrapping
points to the outside.

■ The sterilizing wrappings must be clamped on both sides into the
slots of the package holder. Only use respectively wide sterilizing
wrapping (a width of 10 cm is recommended).

■ Wrapping may not be jammed between door gasket and sliding door

.

Fold the upper end of the wrapping overas needed (film side to the
outside).

■ If the seal seam tears open during sterilization, then it might be that
the wrapping was too small. If this is the case, re-wrap the
instruments and sterilize them once again. The pac kag ing sh ould be
filled to ¾ or the spacing for the sealing seam at 3 cm.

■ If the seal seam tears open during sterilization, extend the sealing
impulse of the package sealing device or seal the wrappings with a
double seam.

■ If the sterilizing wrappings are increasingly damaged when using the
Prion-Program, you can reinforce the industrial seams of the
packaging via sealing prior to sterilization.

Non-observance can ultimately lead to unsterile instruments and
thereby to endangering the health of the patient and practice team.

Multiple wrapping

The steam sterilizer functions on the →fractionated flow method.
The use of

→multiple wrapping is not possible.

Mixed loads

Sterilization of mixed loads is not permitted.

Chapter 4 – Sterilization

28

Selecting the program

Select by rotating between the initial state and the desired program with
the program selection button (P).

Select the sterilization program according to how the

→items to be

sterilized are wrapped. Furthermore, consider the resistance to high
temperature of the items to be sterilized.

The following table shows which program to use for which items to be
steriliz

ed.

Program

Wrapping

Especially
suitable for

Sterilization
at

Operating
time1)

Drying

Load

Universal­Program S

→

single

wrapped

Solid instruments,

simple hollow items,
dental transfer
instruments

2)

134 ˚C

13-15 min.

ca. 7-10

min.

1 kg unwrapped/

270 g wrapped

Quick­Program S

unwrapped

only

Simple solid

instruments, simple
hollow items, dental
transfer instruments

2)

134 ˚C

6-8 min.

ca. 1 min.

1 kg

Prion­Program S

→

single

wrapped

Instruments where a

danger of infection by
pathologically­modified proteins is
suspected (e.g.
Creutzfeld-Jacob,
BSE), dental transfer
instruments

2)

134 ˚C

28-30min.

ca. 7-10

min.

1 kg unwrapped/

270 g wrapped

1) Without drying and dependent on loading and insta lla tion cond itio ns su ch as mains volt a ge , air pressure, feed
water supply

for example. We reserve the right to technical modifications. After a cold start, this can take up to 2

min longer.
2

) For further information please refer to the certificate of suitability in the appendix.

Select automatic pre-heating

Using automatic pre-heating, the chamber of the steam steril iz er is heat ed
up to the program

-specific pre-heating temperature before a program start

or maintained at this temperature between two program runs.
Prerequisite is that the

steam sterilizer remains continuously switched on.

The condensate formation at the chamber wall is reduced and drying is
supported. The cycle times shorten.

The automatic pre

-heating is activated in the factory settings.

To alter this setting proceed as follows:



Select the Function

menu by short simultaneous pressing of the (+)

and (-) KEYS.
The display shows Function: Last batch number..



Navigate with the KEY (+) or (-), up to the display

Function: autom. Pre-heating is displayed.



For confirmation press the KEY (P). The display shows the current

preset option, e.g. Pre-heating YES.



Press the KEY (P) once again, switch the display to Pre-heating

NO. The pre-heating is deactivated.



In order to end the menu Function: autom. Pre-heating

and return to the initial state, press the KEY (S) twice.

PLEASE NOTE

MELAG recommends the activation of automatic pre

-heating.

Function:

autom. Pre-heating

Chapter 4 – Sterilization

29

Select additional drying

For difficult drying tasks you can extend the drying time of a program by
50% with the function Additional drying.

For this proceed as follows:



When starting the program, simultaneous ly press the KEY (S)

AND KEY (+).

The display shows

Additional drying selected. Then the program

sequence begins.

Starting the program

If you selected a program with the program selection button (P), in addition
to the selected program, the sterilization temperature is displayed and
whether the respective program is

suitable for wrapped or unwrapped

sterilizing materials.

 Press the KEY (S), in order to start the program.

The steam sterilizer checks the transport of the →feed water and its

→

conductivity.
If the Quick

-Program S is started, the warning text Warning only

unwrapped instruments

is shown on the display.



If the load exclusively contains unwrapped instruments, press the KEY

(S) once again to confirm and start the program.

Program run

After starting the program, you can follow the program run in the →display.
Chamber temperature and pressure as well as the remaining duration until
end of sterilization respectively the expired drying time is displayed.

Evacuation phase

In the evacuation phase the →fractionated flow method with pulsating,
repeated steam entry and discharge, sucks the air out of the chamber and
introduces saturated steam into the chambe r.

Depending on selected program and the current chamber temperature at
program start, additional

→fractionations follow.

Heating-up phase

The heating-up phase follows after the evacuation phase. A pressure
discharge with a corresponding display is carried out at the end of the
sterilization phase.

Sterilization phase

After achieving the sterilization parameters of pressure and temperature,
the sterilization phase begins.

In alternation with pressure and temperature the remaining time of the
sterilization phase is also displayed.

A pressure discharge with a corresponding display is carried out at the end
of the sterilization phase.

Drying phase

The drying phase begins after the pressure discharge.
The regular drying time is approx. 1

minute for the Quick-Pro gram S and

approx. 10 minutes for all other programs.

Additional drying

selected

Universal-Program S

134℃ wrapped

1. Fractionation

0.69 bar 115°C

Sterilization

2 min., 12 s left

Current-drying

since 1’ 0.9 bar 85 °C

Chapter 4 – Sterilization

30

Manual program termination

You can manually terminate a running program in any of the phases.

PLEASE NOTE

Do not interrupt a running program by switching off the mains switch! In
case of non

-observance, an malfunction message of power loss is

displayed when the

steam sterilizer is switched back on.

Danger of burning!

■ Take heed that when opening the door after terminating a running
program, hot water steam can escape out of the chamber, depending

on when the program was terminated.

■ Use the basket lifter to remove the insert basket and the package
holder. Never touch the →sterilized items, the chamber or the door
with unprotected hands. The elements are hot.

Failure to observe this requirement can result in burns.

Manual termination before

beginning of drying

If you terminate a program before the beginning of drying, then the →items
to be sterilized are still unsterile.

To terminate the program, carry out the following steps:



Press the KEY (S).



Confirm the following prompt Stop program? Repeatedly press

"Stop" with the KEY (S).

PLEASE NOTE

The confirmation prompt is

shown for about 5 seconds on the display. If

the key is not pressed again, the program continues with the normal
process.

Depending on the point in time of termination, a pressure release of the
device is carried out. An appropiate display is shown on the screen.

After the pressure

release is carried out, there is a request for an

acknowledgement of the program termination.
The screen alternately displays

Stop End and Acknowledge with

button ’

–’.



Press the KEY (-).

The message

Unlocking door with button ’+’ is displayed in

alternation with the previously

-selected program.

After pressing the

KEY

(+) you can open the door. If the door is not opened

within 40 seconds, the (+)

KEY must be pressed again.

A reference to

“Program stopped/load not sterile” is issued to the logging

printout.

Manual termination

during drying

In the drying phase you can cancel the program without the steam
sterilizer

reporting a malfunction.

You must then expect insufficient drying, especially for wrapped

→

sterilized

items. Sufficient drying is a prerequisite for sterile storage.

Therefore, if possible, always let sterilization programs with wrapped items
continue up to the end of the drying phase.
In a Quick program, sterilized unwrapped instruments dry from their ow

n

heat after removal from the

steam sterilizer.

In the drying phase, the expired drying time is shown in alternation with the
message

Immed. Removal Press "Stop" is displayed.

To terminate the program, carry out the following steps:



Press the KEY (S).



Confirm the following prompt Immediate removal? Repeatedly

press "Stop" with the KEY (S).

The termination is confirmed with

Drying stopped on the display.

Immediate removal

Press STOP

Chapter 4 – Sterilization

31

PLEASE NOTE

The confirmation prompt is shown for about 5 seconds on the display. If
the key is not

pressed again, the program continues with the normal

process.

After the ventilation of the chamber with a corresponding display text the
message

Universal-Program run successfully follows in

alternation with

Last batch number. xx and quit with ’+’.

If a printer or another output medium is connected to the

steam sterilizer

and the

Immed. Output is set to YES, a reference to Drying stopped

is issued to the logging printout.

Sterilization phase i s finished

Sterilization phase

successfully finished

You can recognize on the display whether the sterilization phase
completed successfully.

The remaining time of the sterilization phase is displayed in alternation
with the

specification of the pressure and temperature.

Sterilization not successfully

finished

The sterilization is not successful if it was terminated by the operator or the
system in the event of a malfunction.

Program termination by the

system

At a system abort, the system puts the chamber into a press urele ss stat e.

PLEASE NOTE

If the program is terminated by the operator, a warning text appears. If the
program is aborted by the system, a malfunction message is displayed.

Drying phase

The steam sterilizer does an excellent job of drying the items to be
sterilized. In the event of difficult drying tasks it might however be
necessary to take the following measures to further improve drying:

Improve drying results

 Always use the package holder for wrapped instruments.



Activate the additional drying function. Observe the section “A

dditional

drying” on page 29.

Sterilization

still 2 min, 12 s

Last batch number 7

Acknowl. with '+'

Chapter 4 – Sterilization

32

Program is finished

At the end of a program run the chamber pressure is adapted to the
ambient pressure. If the program was successfully finished, an appropriate

notification appears on the →display.

Immediate output

The report of the completed program is issued to the selected output
medium for activated immediate output (see page

34, Chapter 5 –

Logging

).

Display batch number

Display last batch number

After every completed program you automatically see on the display the
last batch number of the day.

You can also manually

display the last batch number:



Select the SETUP Menu Function

by short simultaneous pressing of

the KEYS (+) and (-). The display shows Function: Last batch
number.



Press the KEY (P) to display the current batch number of the day.

In order to reach the starting position again, press the

KEY (S) twice.

Display total batch number

You can display the total number of →batches.

 Select the SETUP Menu Function by short simul tane ous pressing of

the KEYS (+) and (-). The display shows Function: Last batch
number.



Navigate with the KEY (+) or (-), up to the display where the submenu

Batch counter is shown.



Press the KEY (P).

You see the current counter reading of the total batch number on the
display.



In order to reach the starting position again, press the KEY (S) twice.

Remove sterilized items

Danger of burning!

After the end of a program observe the following instructions for removing

the →sterilized items:

■ Never use force to open the door. The steam sterilizer could be

damaged and/or hot steam could escape.

■ Use the basket lifter to remove the universal basket.

■ Never touch the sterilized items, the chamber or the door with

unprotected hands. The elements are hot.

Failure to observe this requirement can result in burns.

Danger of infection!

■ Check the wrapping of the sterilized objects for damage when

removing them from the steam sterilizer.

■ If a wrapping is damaged, wrap the object again and re-sterilize it.

Non-observance can result in unsterile instruments.
This endangers the health of the patients and the practice team.

Universal-Program S

run successfully

Last batch number

6

Batch counter

367

Chapter 4 – Sterilization

33

Condensate residues on the

sterilized items

If you remove the →sterilized items from the steam sterilizer directly after
the end of the program, it can happen that slight quantities of condensate
moisture are found on the sterilized items.

According to →DIN 58953, Part 7: Smaller quantities of water which

are

found on the upper side of paper bags and clear pl

astic sterilization

packages are unobjectionable if they dry out within 30 minutes after
removal from the

steam sterilizer.

PLEASE NOTE

Residual moisture dries especially quickly in the warm sterilization
chamber. Thus, let wrapped instruments dry in the opened

steam sterilizer

for approx. 1 to 3 minutes.

Storage of sterilized it ems

Exclusively employ packaging which complies with standards for the
sterilized materials. Do not store sterilized items in the preparation room.
For the storage of the sterilized items, observe the criteria mentioned
below.

Storage conditions

■ Sealed against dust e.g. in a closed instrument cabinet

■

Protected from damage on smooth surfaces

■

Protected from excessive fluctuations in temperature

■

Protected from moisture (e.g. alcohol, disinfectant)

■

Storage duration in accordance with the type of package wrapping

Storage time

The maximum storage life depends on the wrapping and the storage
conditions. For

→sterilized items which have been wrapped in compliance

with the standards (dust

-protected storage is assumed) – this time period

is up to six months.

Chapter 5 – Logging

34

Chapter 5 – Logging

In this chapter you learn



Why and how you document batches



Which output media you can employ for the batch documentation



How to read logs correctly



How to set the date and time at the steam steriliz er

Batch documentation

The batch documentation is indispensable as documentation for the
successfully completed sterilization process and as an obligatory measure
of quality assurance

(→Medical Devices Operator Ordinance).

The data, such as e.g. type of program as well as

→batch and process

parameters of the completed programs, is store d in an inter n al log memory
of the

steam sterilizer.

For the batch documentation you can transfer the internal log memory
readout and the data onto diverse output media. This can be performed at
the end of every program or at a later point, such as at the end of the day.

Capacity of the internal

log memory

The capacity of the internal storage suffices for about 40 logs.
If the internal log memory is full, when starting the next program the
respectively oldest log is automatically overwritten.

If a printer is connected and option

Immed. output "NO" is adjusted

(see page

38, Automatic immediate log output as well), a confirmation

prompt is issued prior to overwriting the saved record.

Output media

You can store the logs of the completed programs on the following output
media and

archive them accordingly.

 Log printer MELAprint 42/44



MELAflash CF card printer on CF card



Computer with the software MELAview/MELAtrace

(from software version 3)



MELAnet Box

PLEASE NOTE

For further information of the protocoll printer (for

example for the duration

of for he log prinouts) please refer to the respective operating instructions.

State of delivery

No option for the output of the logs is set in the initial delivery state of the
steam sterilizer

. You can read below how to output the logs on the cited

media.

Chapter 5 – Logging

35

Setting the date and time

Observe changing the clock

Date and time of the steam sterilizer must be correctly set for proper bat ch
documentation. Observe the time re

-settings in autumn and spring

("daylight saving time"), since this is not reset automa tic ally S et date and
time as described below:

 Select the menu Function by simultaneous brief pressing of the

KEYS (+) and (-).
The display shows Function: Last batch number..



Navigate with the KEY (+) or (-) in the Menu Function, up to the

display Function: Date/Time are displayed.



Press the KEY (P) in order to confirm. The current hour is displayed.



Select between the following setting possibilities using the (+) or (-)

Key: Hour, minute, second, day, month, year



In order to adjust the hour parameter, press the KEY (P) for the

confirmation.

The current value on the

display blinks.



The value can be increased or reduced with the KEYS (+) and (-).



In order to store the value, confirm with the KEY (P).

The current preset value on the display no longer blinks.
In order to adjust the other parameters, proceed ana log ous ly .



After finishing the settings, press the KEY (S) to leave the menu.

On the display, the

Function: Date/Time are again displayed.

By pressing the (S)

KEY again you leave the menu completely and the

display shows its starting position again.

Use log printer as output medium

If you want to employ the log printer MELAprint 42/44 as the output
medium, connect it to the

steam sterilizer as follows:

Connect printer

 Connect the cables of the log printer to the printer connection (RS232

interface) on the rear side of the steam sterilizer.

Close the log printer MELA

print 42/44 according to the pertinent operating

manual.

Initialisation of the

log printer

MELAprint 42/44

In order to be able to print out logs on the connected log printer, you must
initialise MELA

print 42/44 once by making the following setting at the

steam sterilizer

:



If the steam sterilizer is still not switched on, switch it on.



Wait until the display shows the basic settings (page 14, Control

panel).



Select the menu Function by simultaneous brief pressing of the

KEYS (+) and (-).
The display shows Function: Last batch number..



Navigate with the KEY (+) or (-) in the Menu Function, up to the

display Function: Batch output is shown.



Press the KEY (P) to select the submenu Batch output –

Output

medium.



Press the KEY (P) again. The display shows Output medium – No

Output medium

, in case no printer was yet selected.

Function

Date/Time

Chapter 5 – Logging

36

 Navigate with the KEY (+) or (-), until the display shows as output

medium MELAprint.



For confirmation press the KEY (P). The display changes back to the

menu Batch output – Output medium.



Press the Key (S), in order to confirm and return to the menu

Function: Batch output.

Af

ter renewed pressing of the KEY (S) the display again shows the initial

state.

Test outputs on the

log printer

MELAprint 42/44

In order to verify the functional reliability of the log printer MELAprint 42/44
and its communication with the

steam sterilizer, a test output can be

carried out:

 Select the menu Function by simultaneous brief pressing of the

KEYS (+) and (-).
The display shows Function: Last batch number..



Navigate with the KEY (+) or (-) until on the display Function:

Batch output is shown.



Press the KEY (P). to sel ect the submenu Batch output –

Output

medium.



Press the KEY (P) in order to confirm.



Navigate with the KEY (+) or (-) until the display Test output is

shown.



In order to start the output, press the (P) KEY.

An appropriate display with Test output appears.



In order to cancel the test output or leave the menu after finished

printout, press the KEY (S). The display shows Function: Batch
output.

By again pressing t

he KEY (S), you completely leave the menu and return

to the starting position of the display.

Employing MELA

flash as output medium

The MELAflash CF card printer serves for storage of sterilization logs on
the MELA

flash CF card. The readout of the logs from the CF card to the

practice computer is carried out with the MELA

flash card reader.

In addition, you can use the

software MELAview/MELAtrace (from

software version 3)

software to read out log data.

PLEASE NOTE

You can download a current version of the software on the internet page of
MELAG on www.melag.de in the download area.

Connect the MELAflash CF c

ard printer via the serial interface (similar to

the log printer MELA

print 42/44, see page 35).

On the

steam sterilizer, set the output media in the Function menu to

MELAflash. Detailed information can be found in the operating manual for
the MELA

flash CF card printer.

Output medium

MELAprint

Test output

Chapter 5 – Logging

37

MELAnet Box as output medium

The MELAnet Box enables the connection of the steam sterilizer to the
computer network of the practice or clinic via an Ethernet interface.

The logs which are created during a program run can be saved by means
of a

→FTP server or over →TCP via the MELAnet Box on the computer.

In the MELA

net Box there runs a small web server program, which

displays status information of the connecte d

steam sterilizer and settings

for the MELA

net

Box via a web browser. Thus, you can display the current

progress of a program sequence or current measured value s .

Connect the MELAflash CF card printer with the serial interface like the log
printer MELA

print 42/44 (see page 35) and set at the steam sterilizer as

output medium

MELAflash in the SETUP menu. On the steam sterilizer,

set the output media in the

Function menu to MELAnet. Detailed

information can be found in the operating manual for the MELA

net Box.

Computer as output medium

Initialisation of the

computer

In order to be able to employ a computer as output medium, the computer
must be connected via the serial interface to the

steam sterilizer. The

software

MELAview/MELAtrace (from software version 3) can be installed

for the log readout.

In order to register the computer at the steam sterilizer, proceed as
described under

Use log printer as output medium on page 35.

Observe that for the output medium in the SETUP

menu Function you

must set at the

steam sterilizer as output medium Computer.

Reading out a text log on the computer

All text logs can be opened and printed out using a text editor, a word
processing program or a spreadsheet program

. Graphic logs can only be

displayed with the MELAtrace/MELAview documentation software

.

Each text log (e.g. PRO, .STR, .STB etc.) must be linked with the text
editor to enable the computer

to open them automatically with a text editor

.

The meanings of the e

ndings are outlined in the section Subsequent log

issue

(page 39). The following examples show how you can link the

Windows 7

editor with a specific text log.



Working in Windows Explorer, double click on the log file.



If the file ending is unfamiliar, Windows 7 will display the following

message:

Output medium

MELAnet+graphic data

Output medium

Computer

Chapter 5 – Logging

38

 Select "Select a program from a list of installed programs" and confirm

with "OK".



You can then open files with this ending via a double-

click in Windows

Editor.

Automatic immediate log output

If you immediately would like to output the associated report automatically
on an output medium after the end of a program, use the function

Immediate output YES

. This is not preset in the initial delivery state.

Prerequisite for

automatic

immediate out

put of the logs

after the end of the program

The following prerequisites must be satisfied for the immediate log output
after the end of a program:



The computer, the log printer MELAprint 42/44 or the MELAflash CF

card printer must be connected and initiated as output medium.

Proceed as follow in order to set the option for immediate log output after
program end:



Switch on the steam sterilizer at the mains.



Select the menu Function by simultaneous brief pressing of the

KEYS (+) and (-).
The display shows Function: Last batch number..



Navigate with the KEY (+) or (-) until on the display Function:

Batch output is shown and press the KEY (P).



Navigate with the KEY (+) or (-) until on the display the submenu

Immediate output YES/NO is shown.



Press the Key (P), in order to switch between Immediate output

NO and Immediate output YES.

In order to output logs immediately,

Immediate printout YES

must be

set.



In order to save the setting and to leave the menu again, press the

K

EY (S). The display shows Function: Batch output.



By again pressing the KEY (S), you leave the menu completely and

return back to the initial state.

PLEASE NOTE

If it is not possible to output a log report for the immediate output because
for example the

activated output medium is not connected, a warning

message appears. MELAG recommends that you employ the immediate
output of logs.

Immediate output

YES

Chapter 5 – Logging

39

Subsequent log issue

You also have the option of outputting the logs subsequently and
independently from the time of

program end. You can select whether

selected or all saved logs (up to 40 logs) should be printed.
For this purpose the connected output medium is used, e.g. the log printer.

Output selected logs

In order to subsequently print selected logs of certain programs, proceed
as follows:



Select the menu Function by simultaneous brief pressing of the

KEYS (+) and (-).
The display shows Function: Last batch number..



Navigate with the KEY (+) or (-) until on the display Function:

Batch output is shown and press the KEY (P).



The Menu Batch output – Output medium is displayed.



Navigate with the KEY (+) or (-) until the display

Last cycle output: No. 40 is shown (as example No. 40).



Press the KEY (P). The current report number blinks.



In order to output a log of another cycle, navigate with the KEYS (+) or

(-) up to the desired number, here e.g. 25.



Press the KEY (P) in order to start the output of the selected program.

The display shows Output.

After finished printout, the display changes again to its previous setting

Last cycle output: No. 25

.

In order to output additional logs, repeat the last three steps.



In order to leave the submenu without outputting, pres s

the K

EY (S).



In order to leave the menu after the output, press the KEY (S).

The display shows the menu Function: Batch output.

By again pressing the

KEY (S), you completely leave the menu and return

back to the basic position of the display.

Output all saved logs

In order to subsequently output all saved logs, proceed as follows:



Select the menu Function by simultaneous brief pressing of the

KEYS (+) and (-).
The display shows Function: Last batch number..



Navigate with the KEY (+) or (-) until on the display Function:

Batch output

is shown and press the KEY (P).



Navigate with the KEY (+) or (-), until the display Output stored

cycles is displayed.



Press the KEY (P) in order to start the output of the selected program.

The display shows Output.



After finishing the output the display again shows Output stored

cycles.



In case you would like to leave the submenu without printing, press

the K

EY (S).

PLEASE NOTE

A termination during the output on the log printer is only possible by
disconnecting the unit at the mains switch or interrupting the power supply
of the printer.

 In order to leave the menu, likewise press the KEY (S). The display

shows the menu Function: Batch output.

By again pressing the

KEY (S), you completely leave the menu and return

to the starting position of the display.

Last cycle

output: No. 25

Output

stored cycles

Chapter 5 – Logging

40

Delete saved logs

In order e.g. to suppress the warning text Protocol memory full for
preset option

Immediate output No, the saved logs can be manually

deleted.
In

the following example you can read how you can delete all saved logs.

 Select the menu Function by simultaneous brief pressing of the

KEYS (+) and (-).
The display shows Function: Last batch number..



Navigate with the KEY (+) or (-), up to the display

Function: Batch output is shown and press the K

EY (P).



Navigate with the KEY (+) or (-) until on the display All cycles

delete is shown.



Press the KEY (P) in order to delete all logs now.



In order to cancel the submenu without deleting, press the KEY (S).



In order to leave the menu after deletion, press the KEY (P). The

display shows Function: Batch output.



By again pressing the KEY (S), you completely leave the menu and

return to the starting position of the display.

Disp

lay protocol memory

With a connected and initialised printer or another output medium you can
verify how many logs are already saved in the log memory of the steam
sterilizer.

Proceed as follows:



Select the menu Function by simultaneous brief pressing of the

KEYS (+) and (-).
The display shows Function: Last batch number..



Navigate with the KEY (+) or (-) until on the display Function:

Batch output is shown and press the KEY (P).



Navigate with the KEY (+) or (-), up to the display for the storage

occupancy (see left display figure) are shown.



In order to leave the menu again, press the KEY (S) twice.

Reading logs correctly

Header

The head of the program listing includes the general fundamental
information for the

completed program such as for example current date,

the selected program, the daily batch number and the steam sterilizer
type.

Program step values

During the program the program sequence phases are recorded with the
accompanying values for steam

pressure, temperature and time (relative

to the program start).

Summary

The summary states whether the program was successfully concluded.
Furthermore the values of the required sterilization time, the sterilization
temperature and the pressure including

its maximum deviations are

displayed.

All cycles

delete

Allocated: 40

Free: 0

Chapter 5 – Logging

41

---------------------------------------

MELAG MELAquick 12+

---------------------------------------

Header

Program : Universal-Program S

134°C wrapped
Date : 13.03.2015
Time of day : 12:16:14 (Start)
Batch number: 2
SN : 201512+p1017

---------------------------------------

Started program

Current date
Time at program start
Daily batch number
Serial number

Preheating 133.5 °C
AIN6: Conductivity 12 µS/cm

Preheating temperature
→conductivity of the →feed water

Preheating 133.5 °C

AIN6: Conductivity 12 µS/cm

Program step Press. Temp. Time
bar °C min

Start 0.02 127.6 00:00

1.Fractionation
Steam entry 1.75 128.6 00:54
Press. release 0.19 127.4 01:00

2.Fractionation
Steam entry 1.72 129.7 01:27
Press. release 0.22 118.0 01:35

3.Fractionation
Steam entry 1.71 129.8 02:04
Press. release 0.25 108.7 02:14

4.Fractionation
Steam entry 1.71 129.8 02:45
Press. release 0.25 108.7 02:58

5.Fractionation
Steam entry 1.72 130.1 03:33
Press. release 0.24 108.2 03:49

6.Fractionation
Steam entry 1.72 130.1 04:25
Press. release 0.23 107.3 04:42

7.Fractionation
Steam entry 1.71 130.0 05:20
Press. release 0.25 108.2 05:36

8.Fractionation
Steam entry 1.72 130.0 06:13
Press. release 0.24 108.8 06:30

9.Fractionation
Steam entry 1.71 130.0 07:08
Press. release 0.23 108.5 07:26
Heat up 2.04 134.3 08:26
Steriliz.begin. 2.04 134.3 08:26
Steriliz.end 2.18 136.1 11:56
Press. release 0.16 108.7 12:10
Flow drying
Drying begin. 0.16 108.7 12:10
Drying flow 0.12 103.1 12:16
Drying pumping 1.20 107.1 12:29
Drying end 1.21 123.1 20:06

End 0.02 123.0 20:11

Program step values

Program sequence phases with the accompanying values
for pressure, temperature and time (relative to the
program start)

------------------------------------------

Summary

PROGRAM PROPERLY EXECUTED!

Control message

Temperature : 136.0 +0.3 /-0.2 °C

Pressure : 2.18 +0.02/-0.02 bar
Sterilizate time: 3 min 30 s
Time of day : 12:36:25 (End)

---------------------------------------

Mean sterilization temperature with max. deviations

Mean sterilization pressure with max. deviations
Sterilization time maintained
Time at the end of the program

58 20150101 5.15 5.05

Information with total-cyc le co unter , fact or y ser ial number

and device software version n o.

Fig. 12: Example of a program log for a successful finished Universal-Program S

Chapter 6 – Maintenance

42

Chapter 6 – Maintenance

In this chapter you learn

 How to clean the steam sterilizer and which cleaning agents are suitable
 How to avoid the formation of spots
 How to exchange the door gasket
 What to observe in steam sterilizer maintenance

Cleaning

Weekly inspection of

chamber and

door gasket

Examine the chamber including door gasket and wiping rubber (page 26,

Loading the steam sterilizer

) once weekly for contaminants, deposits or

damage.

In case of contaminations

If you detect contaminations, clean the chamber with a soft, lint-free cl oth
soaked in alcohol (spirit). Clean the wiping rubber and the

door gaske t

using a commercially available, gentle liquid cleaning agent.
Check if the entire

door gasket is properly inserted in the groove. The

door

gasket

may not show any waves, otherwise push it back into the groove

using a rounded object.
Next, start a sterilization program without loading.

Attention

When cleaning chamber and door gasket, observe the following:

■ Switch the steam sterilizer off before cleaning and pull the power
plug from the wall socket.

■ Make sure that the chamber is not hot.

■ Use a soft and lint-free cloth.

■ Use chlorine- and vinegar-free cleaning agents.

■ Employ neutral liquid cleaning agents to clean the door gas k et.

■ No cleaning agents may get into the piping system which exits the

steam sterilizer chamber.

■ Do not use any rough objects such as pot cleaners made of metal or
steel brushes.

In case of non-observance the cleaned surface could become
scratched or damaged and the sealing surfaces not tight. This
would promote dirt deposits and corrosion in the sterilization
chamber.

Sieve tray of the chamber

The Sieve tray may only be removed and cleaned in case of coarse
contaminations. The

sieve tray prevents dirt particles from depositing in

the bores of the

steam sterilizer

chamber and clogging them. Thus, ensure

that the

steam sterilizer chamber is clean prior to removing the sieve tray.

You can use a

n adhesive tape to remove the sieve tray.

A

strongly-soiled sieve tray can trigger malfunction messages

(see

Chapter 9 – Malfunctions).

Housing parts

Clean the housing parts with neutral liquid cleaners or spirit.

External feed water container

If you provide the feed water supply manually via the external feed water
container, check for contamination when you refill the feed water. If
necessary, clean the container with a cloth and fresh feed water

before

refilling.

Chapter 6 – Maintenance

43

External waste water

container

Only completely empty the waste water container for cleaning.
During running operation, always ensure that the cooling hose is covered
with water when draining water.

Sterile filter

(only MELAquick 12

+)

Use a ph-neutral and chlorine-free cleaning fluid to remove soiling (e.g.
dust) from the surface of sterile filter and the compressed air hose.

Check the filter medium regularly for discolouration. A light grey colouring
of the filter medium does not influence the filter performance.

Danger

of injury

Other colourings or dampness in the filter housing points to insufficient

treatment of the compressed air. In this case, the sterile filter must be
replaced immediately. Check whether the quality of the compressed air
available corresponds to the requirements (see

Chapter 3 – Initial

Commissioning).

Insulating plug on the sterile

filter (only

MELAquick 12+ p)

Check the insulating plug on the sterile filter every four weeks. To do so,
you can remove this using the plastic bracket and then remove

it from the

bracket. If necessary, clean the insulating plug in the sterile filter with clean
water and allow it to dry before inserting.



Push the insulating plug some 2 mm over the rim of the passage into

the plastic bracket while rotating it slightly.



Place the plastic bracket in the opening in the side wall and turn it by

a full rotation so that the insulating plug sits securely in the opening of

the sterile filter.

Avoid formation of spots

Formation of spots due to

improperly cleaned

instruments

Only if you properly clean the instruments before sterilization, you can
avoid the detachment of residues resulting from loading or instrument
preparation under steam pressure dur ing the ster iliz ation.
Detached dirt residues (e.g. residues of disinfectant

s) can clog the filter,

nozzles and valves of the

steam sterilizer and deposit as stains, spots or

discolorations on the instruments and in the chamber (see page

25,

Prepare items to be sterilized

).

Formation of spots due to

third-party rust

All steam-conducting parts of the steam sterilizer are made of non-rusting
materials. This excludes the formation of rust caused by the

steam

sterilizer

. Should rust stains occur, then we are dealing with third-party

rust.
If the instruments have been inco

rrectly prepared, rust can form even on

stainless steel instruments of leading manufacturers. Often a single rust

-

producing instrument already suffices for third

-party rust to form on the

other instruments or in the

steam sterilizer.

Remove third

-party rust from the instruments with a chlorine -free →

stainless steel cleaning agent (see page

42, Cleaning) or send the

damaged instruments to the manufactur er for reco ndi tion ing.

Formation of spots due to

inadequate quality

of the feed water

The extent of the formation of spots on the instruments also depends on
the quality of the

→feed water employed for steam production.

Chapter 6 – Maintenance

44

Use qualitativel y high-grade feed water

Attention

Observe the following when using →feed water for the steam

sterilization:

■ Use only →demineralised or distilled water according to →DIN EN
13060, Appendix C.

In case of non-observance, stains o r damage o n the inst ru ments
can arise and the functional readiness of the st eam ster ilizer can be
adversely affected.

PLEASE NOTE

→Feed water which you can inexpensively produce with the ion exchanger
MELA

dem 40 or with the revers osmosis process with MELAdem 47,

satisfies the requirements on the feed water.

Exchange the door

gasket

If the door gasket shrinks, is very wavy or shows cracks in the sealing lip,
it is necessary to exchange the door

gasket.

The consequence can be leaks which can lead to the leakage of steam.
Safe and successful sterilization may be impacted.

PLEASE NOTE

For

inserting the door gasket it is mandatory to observe the instructions

provided with the door

gasket spare part with the article no. 12550.



Remove the worn door gasket from the groove.



Insert the new door gasket in accordance with the instructions for

fitting the door gasket.

Maintenance

Attention

■ Maintenance should only be performed by trained customer services

technicians, or stockist technicians. Consult your specialist dealer or
the nearest MELAG customer services point.

■ Maintain the specified servicing intervals.

Malfunctions at the steam sterilizer can occur on continuation of
operation despite the servicing message.

For retention of value and

functional reliability

Regular maintenance is indispensable for the retention of value and the
reliable practice operation of the

steam sterilizer.

All function and safety

-relevant components and electrical units are

checked during maintenance and replaced where necessary. Maintenance
is carried out according to the maintenance instructions relevant for this
steam sterilizer

.

Maintenance intervals

Regularly allow for maintenance every 3000 program cycles or every two
years.

Chapter 7 – Operating pauses

45

Chapter 7 – Operating pauses

In this chapter you learn

 How quickly you can start sterilization programs in sequence
 What you must observe with longer operating pauses
 How to put the steam sterilizer out of operation, transport it and re-start it

Sterilization fre quency

No pause times

required

Pause times between individual programs are not necessary. After the
expiration or termination of drying and removal of the items to be sterilized,
you can immediately re-load the steam sterilizer and start a program.

Pause times

Longer operating pauses

Close the sliding door, but do not lock the door by turning the twist grip by
90°, in order to preserve the

door gasket. Switch the steam sterilizer

off for
longer operating pauses, e.g. overnight or on the weekend. Close, if
available, the water feed

of the water treatment unit and the compressed

air supply.

Shut

-down

If you would like to shut down the steam sterilizer (put it out of operation)
for a longer period of time, for instance because of holidays or a planned
transport, proceed as follows:



Switch the steam sterilizer of f at the mains sw itch.



Pull the power plug from the wall socket.



Empty the feed water and waste water container.



Close, if available, the water feed of the water treatment unit and the

compressed air supply.

Transport

Danger of injury

Observe the following when carrying the steam sterilizer:

■ Use the supplied carrying straps to transport the steam sterilizer and
attach them to the sides e.g. using package tape.

■ Never lift the steam steriliz er on the twist grip. Otherwise the locking
mechanism will be damaged and functionality is not ensured any
more.

■

Observe that the spacing between the underside of the housing floor

plate of the steam sterilizer and the installation surface is small.

Chapter 7 – Operating pauses

46

Attention

Observe the following when transporting the steam sterilizer, e.g.

when moving or shipping the steam sterilizer or for the transport
within the practice:

■ Empty the feed water and waste water container.

■ When using a water treatment unit, close the water feed and remov e

the hose connections on the back of the device.

In case of non-observance, damages to the steam sterili zer and
errors may occur.

Recommissioning after relocation

At re-startup of the steam sterilizer after a change of locality, proceed as
for an initial start

-up (see page 16, Chapter 3 – Initial Commissioning).

Chapter 8 – Function test

47

Chapter 8 – Function test

In this chapter you learn

 How the steam sterilizer automatically carries out the function test
 Which possibilities you have for the manual function test
 Which function tests should be conducted in daily operation
 How to display the water quality

Automatic function test

Process evaluation and

monitoring systems

The interaction of the sterilization-relevant parameters of pressure,
temperature and time are continually automatically monitored by the
electronic parameter control.
The

→process evaluation system of the steam sterilizer compares the

process parameters with each other during the program and monitors
them with respect to their limit values.
The monitoring system of the

steam sterilizer checks the dev ice

components with regard to their functional reliability and their plausible
interaction. If the parameters exceed defined limit values, the

steam

sterilizer

outputs warning messages or malfunction messages. If

necessary, it interrupts the

program with a corresponding message.

When the program has ended successfully, the corresponding message
will be issued on the

→display.

Manual function test

You can track the program sequence based on the values shown on the

→

display. Furthermore on the basis of logs made for every program, you

can logically reconstruct whether a program was successful (see page

34,

Chapter

5 – Logging).

Checks in daily operation

Helix test body system

Batch-related tests

We recommend testing functional reliability of the steam sterilizer using a
Helix test body system at least once a month.

For this purpose, specialist dealers offer specific dental test body systems
as indicator and batch monitoring systems, e.g. Dental BMS (batch
monitoring system) by GKE.

This consists of a test body, t

he Helix, and an

indicator strip,

and is used with the MELAquick 12+/MELAquick 12+ p in

the Universal

-Program S.

Prior to program start the

door gasket should be cleaned.

Chapter 8 – Function test

48

Display water quality

The water quality can be displayed on the display of the switched on
steam sterilizer

at any time - even while a program is running.

To do this keep the

KEY (-) pressed until the display shows the →

c

onductivity. The conductivity is stated in µS/ cm.

As soo

n as you release the (-) KEY, the display returns to its previous

status (e.g. initial state).

Pre-heating temperature of

the chamber

If you press the KEY (-) twice shortly and the second time keep it pressed,
the pre

-heating temperature of the chamber is shown instead of the →

conductivity.

AIN6: Conductivity

7 µS/cm

AIN4: Temp. Preheat.

120°C

Chapter 9 – Malfunctions

49

Chapter 9 – Malfunctions

In this chapter you learn

 Which type of messages exist
 How to rea ct to errors
 What you can do before calling the hotline
 What you can do if no display appears
 What you can do in case of poor drying results

Warning messages

Warning messages are displayed when necessary. Warning messages
are not malfunction messages. They help to ensure malfunction

-free

operation and to recognize undesirable situations. Observe these
warnings early in order to avoid

malfunctions.

Malfunction message

Malfunction messages are displayed if safe operation or sterilization safety
is not guaranteed.
These can appear on the

→display shortly after switching on the steam

sterilizer

or while a program is running.

If a malfunction occurs during a program run, the program will be
interrupted.

Danger of infection!

■ If a program is discontinued during the sterilization phase, the load is

unsterile. Repackage and repeat the sterilization for the respective

→

items to be sterilized, as needed.

Failure to observe these provisions can endanger the health of your
patients and practice team.

The error message is then shown on the display in alternation with the
current program phase. After the program abort or termination, the error
message is shown on the display in alternation with the message

Acknowledge with button "

-" and Program stopped. In order to

delete the error message, press the

KEY (-).

Before you call

Follow the operating procedures shown in connection with a warning text
or an

malfunction message on the →display of the steam sterilizer. You

will find the most important

events in the following table. Possible causes

and appropriate operating instructions are listed for the events.

Chapter 9 – Malfunctions

50

If you do not find the event in the table below or your efforts do not lead to
success, turn to your specialist dealer or the

→authorised MELAG

customer service centre in your vicinity. In order for us to help you, keep
the serial number of your

steam sterilizer and a detailed error description

of the malfunction message ready.

Warning message

Possible cause

What you can do

Warning: Door open/

No start possible

Door switch is not closed on start

Adjust the twist grip into the proper position

90° perpendicular to the longitudinal axis.

Correct display: Door closed.

Warning: No feed water/

Refill feed water – No start
possible

Only if feed water supply from

external feed water container:
Not enough feed water in the

container, hose / cable not properly
connected

Float switch blocke d

Check feed water level in the feed water

container, if necessary refill feed water.
Check proper connection of the connection

hose / cable plug to the feed water
container.

Check if float switch is blocked or jammed in
the feed water container.

Check filter insert in the feed water container

for blockages.

Warning: No feed water/

Check feed water quality

The warning message appears

after program start. The built-in flow
monitor doesn't close

PLEASE NOTE

At the first start-up or re-start-up, this
message can occur once since the piping
system is still not completely filled: restart.

Feed water supply from the feed water
container

If the message appears repeatedly, have the
unit checked by the MELAG customer
service.

Feed water supply from MELAdem

40

Check water treatment unit, possibly open
inflow to the unit.

If the message appears repeatedly, have the
unit checked by the MELAG customer
service.

Feed water-supply from MELdem

47

Check water treatment unit, possibly open
inflow to the unit. When the storage tank is
empty, restart after about 1 h.

If the message is repeated, have the water
treatment unit checked by the MELAG

customer service.

Hose not correctly connected

Check hose for correct connection to the

steam sterilizer and the feed water container

and for kink-free installati on.

Warning – Empty the waste

water tank/No start possible

Waste water container is full

Empty the waste water container ensuring

that residual water (approx. 10 cm) will
remain in the container (see page

42,

Chapter 6 – Maintenance).

If the steam sterilizer does not start af ter the
acknowledgement, briefly switch the steam

sterilizer off and on.

Chapter 9 – Malfunctions

51

Warning message

Possible cause

What you can do

Feed water quality bad/

Exchange cartridge/module

Conductivity of the feed water too

high ≥ 40µS

Still possible to start by repeatedly

pressing the KEY (S):
Feed water supply from the feed water

container

Empty the feed water container, clean, rinse
with fresh feed water and fill fresh feed
water of the respective quality into the
container.

Feed water supply from water treatment

unit

Mixed-bed resin pellets consumed

MELAdem 40:

Exchange the mixed-bed resin pellets (see
operating manual for the water treatment

unit MELAdem 40).

Mixed-bed resin pellets in the after
ion exchanger (3

rd

cartridge)

consumed

MELAdem 47:

Exchange the mixed-bed resin pellets (see
operating manual for the water treatment
unit MELAdem

47) and examine the water

treatment unit.
On repeated occurrence, have maintenance

carried out by MELAG customer service or
service of the specialist dealer. Possibly the
pre- and activated carbon filter must also be

exchanged.

Mixed-bed resin pellets in reverse
osmosis unit consu med

For different water treatment units:

Change the module/resin cartridge
according to the manufacturer’s instructions.

On repeated occurrence, carry out
maintenance.

PLEASE NOTE

Initiate program start after completion of the
above-mentioned work. On the first start
after maintenance of the water treatment
unit, this warning text can appear once
again since the inlet hose/measuring cell are
still not completely flushed with fresh water.

Feed water quality

insufficient/ No start
possible

Conductivity of the feed water too

high Conductivity ≥ 65 µS

Start no longer possible:

See warning message: Feed water quality
insufficient/Exchange cartr idg e/module

Please wait

Preheating chamber

Message is displayed during

program start phase. The steam
sterilizer has not reached the
starting temperature yet.

The steam sterilizer starts automatically

after reaching the starting temperature.

Chapter 9 – Malfunctions

52

Warning message

Possible cause

What you can do

Output medium is not ready

The steam sterilizer is operated

without output medium although an
output medium is registered

Select the option in the menu Batch

output No output medium (see page
35, Initialisation of the log printer).

Output medium is not correctly

connected and/or CF card is not
inserted

Check if the CF card of the CF card printer

is correctly inserted.
Check the correct connection of the data
cable to the steam sterilizer and at the

output medium.

Electric power supply of the log

printer or the CF card printer is
interrupted

Log printer is "offline"

Ensure electric power supply, the red LED

"P" at the log printer MELAprint 42/44 must
light red.

Set printer to "online" (press key "SEL" at
the MELAprint

42/44, LED "SEL" must light

green).

Protocol memory full

The device-internal log memory is

allocated (capacity got up to 40
logs).

The message is shown at the start of a

program.
Repeatedly press the KEY (S) to delete the

message, and the program starts. The

oldest log is then deleted.

An output medium is registered and

in the menu Batch output the
option Immediate output NO is
set.

Set printer to Immediate output YES

(see page 38, Automatic immediate log
output).
Delete internal log memory (see page 40 ,

Delete saved logs

In orde
preset
deleted
In the f

), possibly output all saved logs beforehand
(see page 39, Output all saved logs).
Log off the output medium in the menu
batch output output medium and

set the option no output medium.

Execute Service

The servicing message is activated,

the device has reached the
prescribed batch number

The message is shown after every program

start.
Repeatedly press the KEY (S) to delete the

message, and the program starts.
Retain the message: press the (S) KEY twice

to start.
Have maintenance carried out by MELAG

customer service or service of the specialist
dealer.

PLEASE NOTE

Service counter is reset by customer
service.

Warning/Battery empty

Monitoring of the device's internal

battery voltage determined a too

low voltage value.

The battery must be exchanged by MELAG

customer service or service of the specialist

dealer.

Chapter 9 – Malfunctions

53

Malfunction message

Possible cause

What you can do

Fault 2: Steam generator

Steam sterilizer is overloa ded

Decreased heating power, since
supply voltage too low

Loss of water as a result of leaks or
of formation or collection of water

Steam generator overheated

Pay attention to the correct loading

quantities (see page 26, Loading the

steam sterilizer).

Check building-side electrical installation;
operate steam sterilizer on a trial basis on
another electric circuit.

Upon repeated occurrence, inform your
specialist dealer.

Switch steam sterilizer off and have it cool
down for 15 minutes.

Fault 4: Pressure release

Sieve tray contaminated

Drain hose is blocked

Clean sieve tray (see page 42, Cleaning).

Check waste water hose for kinks.
On repeated occurrence notify your

specialist dealer.

Fault 8: Time bas e

Maximum difference between the

program cycle time and the internal
computer clock is exceeded

Upon repeated occurrence, inform your

specialist dealer.

Fault 9: Door open!

The twist grip was turned during a

running program or was not properly
closed, door contact opened during a
program

Adjust the twist grip into the proper

position 90° perpendicular to the
longitudinal axis. Correct display: Door
closed.

Upon repeated occurrence, inform your
specialist dealer.

Fault 10: Overheat. Steam

generator

Capillary tube regulator "level control"

is opened at program start
(malfunction message immediat ely
after start) or during a program run
(until the end of the sterilization) the
monitoring time until the capillary
tube regulator is switched back (with
water feed from feed water) is
exceeded

After program termination and immediate

start, this error message can be repeated;
Repeat program start after a pause time of
two minutes.

Check feed water hose for kinks.
Upon repeated occurrence, inform your

specialist dealer.

Fault 12: Door locking

Twist grip not 90° perpendicular to

the longitudinal axis of the steam
sterilizer.

Properly turn twist grip until the stop into

the correct position.
Upon repeated occurrence, inform your

specialist dealer.

Fault 14: No feed water

See warning text Warning no feed

water, however this error appears after
the start of a program.

Fault 18: Sensor: ...Input: …

The device-internal inspectio n of the

sensors for temperature, pressure or
conductivity resulted in a too large
deviation, the message can occur
when the device is switched on or
during a program

Upon repeated occurrence, inform your

specialist dealer.

Fault 21: Preheating

The monitoring time from switching

on pre-heating until the achievement
of the respective pre-heating
temperature was exceeded, e.g. due
to a too low supply voltage

On repeated occurrence selec t option

Automatic pre-heating NO ( see
page

28, Select automatic pre-heating)

and inform your specialist dealer.

Chapter 9 – Malfunctions

54

Malfunction message

Possible cause

What you can do

Fault 22: Overheat

Preheating

The maximum preheating

temperature was exceeded

On repeated occurrence select option

Automatic pre-heating No ( see
page

28, Select automatic pre-heating)

and inform your specialist deal er s

Fault 23: Current

Monitoring time for the pressure

release in the outflow procedure
during fractionations was exceeded

Sieve tray contaminated or de nted
Waste water hose kinked

Clean sieve bottom and check waste water

hose (see page 44).
Check installation of the waste water hose.
Upon repeated occurrence, inform your

specialist dealer.

Fault 26: A/D converting

The maximum admissible deviation

of the computer-internal signal
conditioning (A/D converting) was
exceeded

Upon repeated occurrence, inform your

specialist dealer.

Fault 27: Temp.Sens. def

1.2

The maximum admissible deviation

between the two temperature
sensors for the steam temperature
was exceeded

Upon repeated occurrence, inform your

specialist dealer.

Fault 32: Power

loss/Sterilize sterile f ilt er

The loss of the operating voltage

occurred after the start of a program

The malfunction message occurs after the

operating voltage is again available.
Check building-side installation. If no

defects are detectable, notify MELAG

customer service

Disconnection of the ste am st eriliz er

during a running program

Only terminate a running program with KEY

(S), see also page 30.

Fault 33: Pressure drop

The maximum switch -on tim e of the

steam generator for achieving the
control pressure was exceeded

Check the door gasket.

Upon repeated occurrence, inform your

specialist dealer.

Fault 34: Sterilization TU1

Shortfall of minimum permissible
sterilization temperature (temperature

sensor 1)

Operate steam sterilizer with smaller load.

Check door gasket for wear or damage,
exchange as needed (see page 44).

Upon repeated occurrence, inform your
specialist dealer.

Clean sieve bottom and check waste water
hose (see page 44).

Fault 35: Sterilization TO1

Exceeding the maximum permissible

sterilization temperare (temperare

sensor 1)

Upon repeated occurrence, inform your

specialist dealer.

Fault 36: Sterilization PU

Shortfall of the minimum sterilization

pressure

Operate device with smaller load

Check door gasket for wear or damage,
exchange as needed (see page 44).

Upon repeated occurrence, inform your

specialist dealer.

Fault 37: Sterilization PO

Exceeding the maximum permissible
sterilization pressure

Upon repeated occurren ce, inf orm your
specialist dealer.

Chapter 9 – Malfunctions

55

Malfunction message

Possible cause

What you can do

Fault 38: Sterilization TD1

Maximum permitted difference

between theoretical temperature
calculated from the pressure signal,
and the temperature measured at

temperature sensor 1 was exceeded

Upon repeated occurrence, inform your

specialist dealer.

Fault 41: Current-drying

Sieve tray contaminated

Drain hose is kinked

Clean sieve bottom and check waste water

hose (see page 44).
Check waste water hose for kinks.
Upon repeated occurrence, inform your

specialist dealer.

Fault 42: Drying press.

pump

MELAquick 12+:

Compressed air supply not
connected or is interrupted; inflow
valve for the compressed air is
closed.

Check compressed air connection for

possible kinks and proper connection,
open inlet valve.

The steam sterilizer is ready for operation

only after the Universal-

Program has been
run 5 times (or 3 times with activated
additional drying) without a load and after

re-

connection of the compressed air

supply.

Upon repeated occurrence, inform your

stockist.

MELAquick 12+ p:

Check the insulating plug on the sterile

filter; if necessary clean the insulating plug
in the sterile filter with clean water and
allow it to dry before inserting.

Upon repeated occurrence, inform your
stockist.

Fault 51: Sterilization 2

Shortfall of minimum permissible
sterilization temperature (temperature

sensor 2)

Operate device with smaller load.

Check door gasket for wear and damage.
Upon repeated occurrence, inform your

specialist dealer.
Clean sieve bottom and check waste water

hose (see page 44).

Fault 52: Sterilization TO2

Exceeding the maximum permissible
sterilization temperature (temperature

sensor 2)

Upon repeated occurrence, inform your

specialist dealer.

Also see Fault 35

Fault 53: Sterilization TD2

Maximum permitted difference

between theoretical temperature
calculated from the pressure signal,
and the temperature measured at

temperature sensor 2 was exceeded

Upon repeated occurrence, inform your

specialist dealer.
Also see Fault 38

Chapter 9 – Malfunctions

56

No display on the screen

After switching on the steam sterilizer the display remains empty.

What you can do

 Check whether the power plug is correctly plugged in the socket and

the IEC plug on the steam sterilizer.



Check the supply voltage at the socket.



If necessary, exchange the device fuses on the rear side of the

steam

sterilizer.

Electrical Shock

Hazard

■ Pull the power plug from the power socket on the rear of the device

before replacing the device fuses.

■ Non-compliance can cause electric shock.

Heavy injuries will be the consequences.

Poor drying results

Apart from a proper device function, the drying process depends decisively
on the correct setting up and loading of the

steam sterilizer.

What you can do

 Do not overload the ste am ste riliz er (max. 1 kg load).



Activate the pre-heating (see page 28, Select automatic pre-

heating)



Employ the function Additional Drying (see page 29, Select

additional drying).

Open door in case of a power failure

Attention

Absolutely make sure that the pressure of the st eam ste r ilizer is

completely released:

■ No steam may escape the steam sterilizer.

■ Let the steam sterilizer absolutely cool down. Metal parts such as

door and chamber may be hot.

Non-observance may result in severe scalding/burns.

In the case that the door cannot be opened due to e.g. a

power failure,

proceed as follows taking into account the safety information mentioned
above:



Switch the steam sterilizer of f at the mains sw itch and pul l the power

plug from the wall socket.



Insert a flat rounded object into the sideways slots of the steam

sterilizer (see

Fig. 1/12)) and push the object down.



Hold the object down and unlock the sliding door at the same time by

turning the twist grip counter-clockwise by 90° and opening the

sliding

door towards the back.

Overview of programs

57

Overview of programs

MAIN MENU

hh:mm:ss

0.00 bar 89°C

Initial state

Quick-Program S

134°C unwrapped

Universal-Program S

134°C wrapped

Prion-Program S

134°C wrapped 20’

P P P

Function*

release

1st time press

*see next page

–

h

AIN6: Conductivity

5 µS/cm

+

2nd time press

–

h

AIN4: Temp_preheat.

120°C

release

Program sequence

START

Quick-Program S

run successfully

Last batch number x

Quit with button ’+’

Stop program

Press ‚Stop’

Program runs

Manually terminate

during drying

Immediate removal?

Press ‚Stop’

Drying stopped

S

Manually terminate

before drying

Acknowledge

with button ‚–’

Unlocking door

with button ‚+’

–

Stop End

0.02 bar 88°C

Pressure release

1.5 bar 112°C

Programm

stopped

S

Stop program?

Press ‚Stop’

S

Additional drying

selected

Main Menu

Press K

EY

”Start/Stop” and (+) simultaneuously

K

EY “Start/Stop“: Stop and terminate a program

K

EY „Program“: "Enter/Confirm/Input“

S

P

Press (+) and (–) simultaneously to select the
Function

menu

Select by keep pressing the

KEY (-)

Unlocking door with

KEY (+)

h

–

+

– S +

S

Only unwrapped

instruments

S

Overview of programs

58

Menu: Function

K

EYS

(+) and (-): (next/previous) in the menu

K

EY “Program: “Enter/Confirm/Input”

K

EY “Start/Stop”:”Terminate/Escape/Leave”

K

EY “Start/Stop”: “Escape/Leave without saving”

No

Yes

Press both keys
simultaneously

autom.

Pre-heating

hh:mm:ss

0,00 bar 89°C

Function:

+

Initial state

S

Feed water

supply

+

+

Internal

External



S

S

P

–

+



S

P

Batch counter

S

Batch counter.

xx

Last

batch number

S

Last batch number

xx

P

P

+

–



S

Date/Time

Month: xx

Date/Time

Minute: xx

Date/Time

Second: xx

Date/Time

Day: xx

Date/Time

Year: xx

Date/Time

= s. o.

= s. o.

= s. o.

= s. o.

= s. o.

Date/Time

Hour: xx

Allocated: xx

Free: xx

Immediate output

Yes/No

Batch output

P P

+

–



S

P

Output medium*1)

P

+

–



S

P

Last cycle output:

No. xx



S

Stored cycles

output

P



S

All cycles

delete

P



S

P

Test output

+

*1) No output medium

MELAprint
MELAflash
MELAnet+graphic data

Computer

S P S P S P S

+

Main and submenus can always be selected by KEY (+)
„next“ and

KEY (-) “previous” and you can always leave them

with

KEY (S).

P

P P P

Technical tables

59

Technical tables

Nominal value tolerance s

Step

Press. P

Tolerance P Tol. P Tol.

2700 - 30/+160 ◄ ◄ ◄ ◄ Steam entry
1250 -390/+ 30 ◄ ◄ ◄ ◄ Steam flow off

n. F.

2700 - 50/+110 ◄ ◄ ◄ ◄ Steam entry
1250 -160/+ 50 ◄ ◄ ◄ ◄ Steam flow off
3050 - 50/+ 70 ◄ ◄ ◄ ◄ Heat up

3050 - 50/+ 70 ◄ ◄ ◄ ◄

Sterilization

start

3170

- 90/+ 90

◄ ◄

◄

◄ Sterilization

1200 -140/+ 50 ◄ ◄ ◄ ◄ Pressure release

Quick-Progr. S

Universal-Progr. S

Prion-Progr. S

Fractio-

nation

1. F.

◄ same meaning as in Universal-Pr. S

All values in mbar

Pressure-time charts

Fig. 13: Pressure-time chart for Universal-Program S, 134 °C and 2.1 bar

Press. (mbar rel.)

Technical tables

60

Fig. 14: Pressure-time chart for Quick-Program S, 134 ° C and 2.1 bar

Fig. 15: Pressure-time chart for Prion-Program S, 133 °C and 2.1 bar

Press. (mbar rel.)

Press. (mbar rel.)

Technical tables

61

Feed water quality

Evaporation residue

≤

10

mg/l

Silicon oxide, SiO2

≤

1

mg/l

Iron

≤

0.2

mg/l

Cadmium

≤

0.005

mg/l

Lead

≤

0.05

mg/l

Heavy metals except for those named

above

≤

0.1

mg/l
Chloride

≤

2

mg/l

Phosphate

≤

0.5

mg/l

pH value

5 – 7

Appearance

colourless; clean; without sediment

Hardness

≤

0.02

mmol/l

Table 3: Minimum requirements to the feed water following the EN 13060, Appendix C

Technical data

62

Technical data

Model name

MELAquick 12+

MELAquick 12+ p

Device dimensions (WxHxD)

19,5 x 43 x 47 cm

20,5 x 43 x 46 cm

Chamber (Ø x T)

∅ 9 x 20 cm

Volume (chamber)

1.35 l

Weight (empty)

23 kg

24 kg

Electrical connection

220-240V*, 50/60Hz, 9.5A 2050 W

220-240 V*, 50 Hz, 9.5 A 2050 W

Max. sound pressure level

66 dB(A) @1 m

69 dB(A) @ 1 m

Heat emission

c. 0.48 kW/h (1.74 MJ/h)

Surrounding temperature

5-40 °C (recommended max. 25 °C)

Relative humidity

max. 80 % with temperatures up to 31 °C

max. 50 % at 40 °C (in between decreasing in a linear fashion)

Max. altitutde

height to 2000 m

Installation category

II

Feed water quality

demineralised and/or distilled water according to DIN EN 13060,

Appendix C

Maximum load

1 kg unwrapped, 270 g single wrapped

Energy consumption during

standby

approx. 105 W
Degree of soiling

Category 2

Degree of protection

(following IEC 60529)

IP20

EMC

Emitted interference and interference resistance according to EN 61326,

EN 60601-1 and -2 at 3 V/m

CE mark

CE 0197

*Observe the maximum voltage range of 207-253V

Glossary

63

Glossary

aqua dem

→demineralized water
aqua dest

→

distilled water

Authorized persons

Medical specialist dealers, technician from depots or with
customer service designated by MELAG, who were trained
by MELAG

Batch

Collection of the →items to be sterilized that together
passed through one and the same sterilization program

BGV A1

Specifications from professional associations
(Berufsgenossenschaftliche Vorschriften) – the pri ncipl es
of prevention

CF card

Compact Flash card;
A memory card for digital data in compact form;
CF is a standardized term, i. e. these memory cards can
be used in every device with a CF slot. The CF card can
be read and possibly written by every device that supports
the standard.

Condensate
A liquid (e.g. water), which forms upon cooling from the
vaporous state and thereby separates

Conductivity

is the opposite of electrical resistance; measured in micro­Siemens / centimetre (µS/cm); the greater the amount of
dissolute matter in the water, the better it can conduct
electrical current and thus the higher its conductivity.
→distilled water ideally has the conductivity zero

Conductivity measurement
Measurement of the →Conductivity

Corrosion
Chemical change or destruction of metallic materials by
water and chemicals

Delayed boiling

This is the phenomenon that in certain conditions liquids
can be heated beyond their boiling point without boiling;
this state is unstabile; a slight shock can cause a very
rapid formation of large gas bubble which expands like an
explosion

Demineralised water
Also designated as aqua dem; water to a large extent
without the minerals which occur in normal mineral or tap
water; is obtained by ion exchange from normal tap water.
It is employed here as →feed water

DGSV

Deutsche Gesellschaft für Sterilgutversorgung (German
Association for the Sterilized Equipment Ordinance). The
DGSV training centres are specified in DIN 58946, part 6
as "Requirements of personnel".

DIN 58953
Norm – Sterilization, sterile goods supply

DIN EN 867-5
European standard: non-biological systems for use in
sterilizers – Part 5: Stipulations of indicator systems and
testing bodies for performance tests of small sterilizers of
Type B and Type S

DIN EN 868-8
European standard: Packing materials and sytems for
medical devices to be sterilized

DIN EN ISO 11140-1
European standard – Sterilization of products for health
care – chemical indicators – Part 1: General requirements

DIN EN ISO 11607-1

Standard – Requirements on materials, →sterile barrier
systems and packaging systems; this standard is a
harmonization of the DIN EN 868 Part 1 and the
international standard DIN EN ISO 11607.

DIN EN 13060
European standard –Small steam sterilizers

DIN EN 285
European standard – sterilization – steam sterilizers –
large sterilizers

Display
Display panel on electronic devices for communicating
information. Here: Graphic display of the control panel

Distilled water
From lat. aqua destillata; also designated as aqua dest;
water, which is largely freely of salts, organic materials and
microorganisms, is obtained by distillation (evaporation
and subsequent condensation) from normal tap water or
pre-cleaned water. It is employed here as →feed water

Dynamic pressure test of the sterilization chamber
Serves to verify that the rate of the change of pressure
occurring in the sterilization chamber during a sterilization
cycle does not exceed a certain value, which could lead to
damage of the wrapping material
[→DIN EN 13060]

Empty chamber test

Test without load; carried out in order to evaluate the
performance of the sterilizer without the influence of the
load; permits checking the maintained temperatures and
pressures with respect to the intended settings
[→DIN EN 13060]

Evacuation
Creation of a →vacuum in a chamber

Feed water
is required for the creation of water steam for the
sterilization; typical values for the water quality according
to →DIN EN 285 or →DIN EN 13060 – Appendix C

Flow-drying
Drying, which removes moisture in the chamber using a
mechanically generated air flow, is usually supported by
heat

Fractionated flow method
Overpressure method in which the air is expelled from the
chamber and the items to be sterilized by alternating
between steam entry and steam outlet.

FTP
(File Transfer Protocol) is a data transmission procedure
serving to transport data from the internet. These data can
contain programs, files or information. Special FTP
programs (FTP clients) serve for uploading any data on a
server.

Heating-up period
After switching on the steam sterilizer or after starting a
sterilization program., it ist he time required for heating-up

Glossary

64

the steam generator before the sterilization process starts;
duration depends on the temperature of the sterilization
process

Hollow body A

→Narrow lumen

Hollow body B

→Simple hollow items

Initialization

Creation of a certain initial state of the →software at start­up

Integrated steam generation
The steam generator is located directly on the floor of the
sterilization chamber.

Items to be sterilized
Unsterile objects, materials still to be sterilized

Kontamination
here: Soiling of the sterilized load with unwanted or
harmful materials

LED

Light Emitting Diode: Semiconductor diode which lights up
when powered by current. LEDs are predominantly
employed for status displays in devices, for example to
display hard disk access.

Lubricants

Instrument oil or instrument milk

Massive

without hollows or cavities, compact, sealed closed
Mixed load

Wrapped and unwrapped materials to be sterilized within
one load

MPBetreibV

Ordinance covering the installation, operation, application
and maintenance of medical products according to § 3 of
the Medical Devices Directive with the exception of
medical products for clinical evaluation or performance
evaluation.

Multiple wrapping
e.g. instruments doubly sealed in foil or wrapped in foil are
additionally found in one container or in a textile wrapped
container

Narrow lumen
One-sided open bodies, for which applies:
1 = L/D = 750 and L = 1500 mm or
a double-sided open body for which applies:
2 = L/D = 1500 and L = 3000 mm and which does not
correspond to the hollow body B
L…hollow body length
D…hollow body diam

Porous

Pervious to liquids and air, e.g. textiles

Process evaluation system

Also self-monitoring system – observes itsel f, acts during
the programs, compares sensors with each other

Pulsating overpressure drying
Drying method which removes moisture from the chamber
and the items to be sterilized by alternating between air
entry and discharge.

RKI
Robert Koch Institute

Self-Monitoring-system

→Process evaluation system

Single wrapping
Wrapped once, e.g. instruments sealed in a foil ­contrasted to: →Multiple wrapping

Simple hollow items

An article open on one side to which the following applies:
1 ≤ L/D ≤ 5 and D ≥ 5 mm or an article with an opening
on both sides which is:
2 ≤ L/D ≤ 10 and D ≥ 5 L…length of hollow article
D…diameter of hollow article [DIN EN 13060

Soft sterilization package
e.g. paper bags or clear-plastic sterilization packages

Software
non-material component of IT systems e.g. a computer
program

Solid load – Check of porous partial load
Serves to verify that for the values set on the control, the
required sterilization conditions were achieved within the
entire load. The load must reperesent the maximum
measurements of solid instruments for whose sterilization
a sterilizer has been designed according to [→DIN EN
13060]

Stainless steel cleaning agent
e.g. Sidol

Standards-compliant

Conformity with all the relevant standards

Sterile barrier systems

Closed minimum packaging which prevent the occurrence
of microorganisms, e.g. bags closed with sealing, closed
reusable containers, folded sterilization cloths

Sterilization chamber
Interior of a sterilizer
Accommodates the →items to be sterilized

Sterilized ite ms
Also designated as →batch, if already successfully
sterilized: sterile goods

TCP

(transmission control protocol) refers to a standard
protocol for connecting computers and networks.

VDE
Verband der Elektrotechnik, Elektronik und
Informationstechnik e.V.
Association for Electrical, Electronic Information
Technologies

Appendix A - Accessories

65

Appendix A - Accessories

Article

Article number*

MELAquick 12+

MELAquick 12+ p

Accessories

Universal basket including small part insert

00125

Package Holder

00126

Basket lifter

10003

Holder

00127

Frame

00128

Support with ISO adapters for 7 instru ment s

00122

Support with round holders for 7 instruments

00123

Water treatment

units

MELAdem 40 ion exchanger

01049

MELAdem 47 reverse-osmosis unit

01047

For documentation

MELAflash CF card printer incl. MELAflash CF

card and card reader

01039

MELAnet Box

40296

Log printer MELAprint 44

01144

Other

Cable for water level monitor in g, 5 m

21353

Compressed air

connection

Hose coupling, T-piece

38600

--

Y-piece

80220

--

Coupling

80230

--

Spare parts

Device fuse 20 A gRL

21481

Door gasket

12550

*All specified articles are available through specialist dealers

66

Certificate of suitability

MELAquick®12+/MELAquick®12+ p

Manufacturer: MELAG Medizintechnik oHG
Address: Geneststraße 6-10
10829 Berlin
Country: Germany
Product: St ea m s terilizer (steam sterilizer)
Type of device: MELAquick

®

12+/12+ p

Classification: Class IIb medical device

We declare that the sterilizer specified above is suitable for the steam sterilization of the
following instruments (wrapped and unwrapped) in accordance with DIN EN 13060 class S:

- W & H Synea WA-99LT

- W & H Alegra WE-99 LED G

- KaVo GentleSilence LUX 8000B

- KaVo IntraCompact 25 LHC

- Sirona T1 Line

- Sirona T1 Control

- Handpieces with comparable qualities (material, weight, geometry)

References to loading quantities and loading variations are outlined in the user manual and
must be observed.

Manufacturer instructions regarding the medical devices stipulated for sterilization in
accordance with DIN EN ISO 17664 must be observed.

Berlin, 08/01/2016

--------------------------------------------

Dr. Steffen Gebauer

(General Management)