User Manual: Melaquick 12+ Melaquick 12+ P

User Manual
Steam sterilizer
MELAquick® 12+
MELAquick® 12+ p
From software version 5.15
EN
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.
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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.
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: info@melag.com
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

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
Indicates a dangerous situation which if not avoided

Risk to health could entail slight to life-threatening injuries.
D a n g e r
Indicates a dangerous situation which if not avoided

Observe without could entail damage to the instruments, the practice
fail equipment or the steam sterilizer.
A t t e n t i o n
Important Draws your attention to important information.

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 MELAG devices are synonymous for long-term quality. When you
equipment eventually need to decommission your MELAG device, we offer a special
disposal service. Simply contact your stockist.
Accessories and Dispose of accessories and consumption media which you no longer
consumption media 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 and 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 the 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 environmentally sound
disposal of electric and electronic appliances.
Indication of the scale of the chamber volume
Opterating temperature of the device
Operating pressure of the device
Draws your attention to a hot surface. During operation the twist grip may
become hot. Let the steam sterilizer cool down after program completion.

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 ■ The power cable may not be replaced ba an inadequate measured
mains socket 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, ■ Only have the steam sterilizer set up, installed, and started up by
commissioning 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 ■ Follow the instructions of the instrument manufacturers for preparing
of instruments 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 the
steam sterilizer. If necessary, sterilize the affected →objects after
rewrapping.
Removal of the items to be ■ Never use force to open the door.
sterilized ■ 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.
Accessories and ■ Dispose of accessories and consumption media which you no longer
require in the appropriate manner. Comply with all relevant disposal
consumption media
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.

CONTENTS
CONTENTS
Chapter 1 – Performance Specifications ............ 8 Employing MELAflash as output medium ......... 36
Proper use .......................................................... 8 MELAnet Box as output medium....................... 37
User benefits ....................................................... 9 Computer as output medium ............................. 37
Overview of sterilization programs .................... 10 Automatic immediate log output ........................ 38
Subsequent log issue ........................................ 39
Chapter 2 – Device Description ......................... 11 Display protocol memory................................... 40
Reading logs correctly ...................................... 40
Scope of delivery .............................................. 11
Device views ..................................................... 12 Chapter 6 – Maintenance ................................... 42
Accessories....................................................... 13
Effective capacity .............................................. 14 Cleaning ............................................................ 42
Control panel..................................................... 14 Avoid formation of spots ................................... 43
Supply with feed water ...................................... 15 Use qualitatively high-grade feed water ............ 44
Exchange the door gasket ................................ 44
Chapter 3 – Initial Commissioning .................... 16 Maintenance ..................................................... 44
Pre-conditions for the set-up, installation and Chapter 7 – Operating pauses ........................... 45
commissioning .................................................. 16
Set-up location requirements ............................ 16 Sterilization frequency ....................................... 45
Establishing connections .................................. 17 Pause times ...................................................... 45
Installation examples for connecting a water Shut-down ......................................................... 45
treatment unit .................................................... 19 Transport........................................................... 45
Compressed air connection (only MELAquick Recommissioning after relocation ..................... 46
12+)................................................................... 21 Chapter 8 – Function test................................... 47
Electrical connection ......................................... 22
Preconditions for commissioning ...................... 22 Automatic function test...................................... 47
Record of installation and setting up ................. 22 Manual function test .......................................... 47
Switch on the steam sterilizer ........................... 23 Checks in daily operation .................................. 47
Opening the door .............................................. 23 Helix test body system ...................................... 47
Closing the door ................................................ 24 Display water quality ......................................... 48
Chapter 4 – Sterilization ..................................... 25 Chapter 9 – Malfunctions ................................... 49
Create prerequisites .......................................... 25 Warning messages ........................................... 49

Prepare items to be sterilized............................ 25 Malfunction message ........................................ 49
Loading the steam sterilizer .............................. 26 Before you call .................................................. 49
Selecting the program ....................................... 28 No display on the screen .................................. 56
Select automatic pre-heating ............................ 28 Poor drying results ............................................ 56
Select additional drying ..................................... 29 Open door in case of a power failure ................ 56
Starting the program ......................................... 29 Overview of programs ........................................ 57
Program run ...................................................... 29
Manual program termination ............................. 30 MAIN MENU ..................................................... 57
Sterilization phase is finished ............................ 31 Menu: Function ................................................. 58
Drying phase ..................................................... 31 Technical tables.................................................. 59
Program is finished ........................................... 32
Display batch number ....................................... 32 Pressure-time charts ......................................... 59
Remove sterilized items .................................... 32 Technical data..................................................... 62
Storage of sterilized items ................................. 33
Glossary .............................................................. 63
Chapter 5 – Logging ........................................... 34
Appendix A - Accessories ................................. 65
Batch documentation ........................................ 34
Setting the date and time .................................. 35
Use log printer as output medium ..................... 35

Chapter 1 – Performance Specifications
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 instruments, simple hollow items
(Hollow Body B) and dental transfer instruments 1. Large hollow bodies
such as hoses or similar may not be sterilized in the this steam sterilizer.
Observe the following instructions for using the steam sterilizer:

■ Do not sterilize any liquids with this steam sterilizer. It is not licensed
Danger of burning!
for the sterilization of liquids.
Failure to observe these instructions may lead to delayed boiling,
damage to the steam sterilizer and burns.
■ Use the steam sterilizer only for the intended purposes outlined in
the related technical documents and only in connection with the
Attention devices and components approved by MELAG.
■ The sterilization of instruments with this steam sterilizer, like the
foregoing instrument preparation, 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.

User benefits
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, To generate the sterilization steam, the steam sterilizer uses an →
overheating protection 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 The steam sterilizer works with the feed water one-way system. This
to DIN EN 13060, Appendix C means that fresh feed water is used for every sterilization run.
The quality of the feed water is constantly monitored via integrated
conductivity measurements. This prevents spots on instruments and
soiling of the steam sterilizer, provided the instruments have been carefully
prepared.
Optimal drying for wrapped The sterilized items are dried with the →pulsating overpressure drying
items to be sterilized method. This way you achieve optimal drying results for wrapped objects
as well.
Optimized total The steam sterilizer works with an electronic parameter control.
operating time This way the steam sterilizer optimizes the total operating time of a
program depending on the load.
High safety with The steam sterilizer verifies pressure and temperature in the sterilization
extensive chamber at all times and its door locking system does not permit opening
safety devices 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 With the →conductivity measurement, you can verify the water quality of
function check the feed water.
Effective batch The steam sterilizer has an internal log memory which can save up to 40
documentation 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.

Overview of sterilization programs

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 Type S Type S Type S

→DIN EN 13060
→Dynamic pressure test of the X X X

sterilization chamber
→Empty chamber test X X X
→Solid load X X X
→simple hollow items (hollow X X X

body B)
→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.
10

Chapter 2 – Device Description

 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 report
 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 cable for 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
11

Device views
Front side
(1) Twist grip
(1) (2) Operating and display field
(3) Mains switch
(2) (4) Suction fitting for drying air with insert (only
MELAquick 12+ p)
(4)
(3)
Rear side
(5) Device fuse
(6) Cable connection for water level monitoring in the
feed water container
(7) Cable connection for water level monitoring in the
waste water container
(5) (8) Serial interface (RS232)

(9) Sterile filter and compressed air connection
(only MELAquick 12+)
(6)
(7) (10) Mains supply for IEC plug
(11) Connection for external waste water container
(8) (11) (12) Slot for emergency release
(12)
(13) Safety valve
(9) (13)
(14) (14) Connection for external feed water container
(10)
Fig. 1: Device views
12

Top view, open
(1) Wiping rubber (under sliding door)

(2) Door gasket
(3) Sieve tray
Fig. 2: Top view
Accessories
Universal basket for up to 12 handpieces with The package holder for wrapped instruments can be
semicircular insert for universal use. Instruments removed from the steam sterilizer chamber using the
up to a length of 20 cm can be sterilized in the basket lifter by hooking into the upper holes.
basket.
Fig. 3: Universal basket with small parts insert (optional) Fig. 4: Package holder (optional)
For cooling down the instruments the universal The holding bow is hooked into the sideways venting
basket can be removed from the steam sterilizer slots of the steam sterilizer and is used to hold the
and placed on the frame. universal basket while cooling down the instruments.
Fig. 5: Frame (optional) Fig. 6: Holder (optional)
13

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.
2-line LED display

Chamber pressure (bar) and for program status display
(steam-) temperature (°C) Time (h:min:s) and parameter display
12:27:12
0.02 bar 25℃
Function key (-) and (+) Program selection button (P) Start – Stop button (S)
to select, set and display to select the sterilization programs/ test to start programs, terminate
special functions: programs programs / drying as well as
print, date/time, preheating, total batches, and select or set options control of the special functions
conductivity, acknowledge error, (+) KEY for (sub-menus) of the special functions
unlocking the door
14

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. MELAdem 40/MELAdem 47).
Feed water via the external If you employ the feed water container for the feed water supply, you must
feed water container 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 litres 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 A water treatment unit is connected to the domestic water supply. It
treatment system 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.
15

Chapter 3 – Initial Commissioning

 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 sterilizer set up, installed, and started up by
people →authorized by MELAG.
■ According to the currently valid VDE standards, this device is not

suitable for use in explosive areas.
Danger ■ 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.
■ Without fail, keep the specified distance free to the surrounding

surfaces at the sides and above the steam sterilizer.
Attention 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 The distance to the surrounding surfaces must be at least 5 centimetres
surrounding surfaces 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 guaranteed.
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.
16

Space requirements MELAquick 12+ MELAquick 12+ p
Width A= 19.5 cm A= 20.5 cm
Height B= 43 cm B= 43 cm
Depth C=47 cm C=46 cm
D= 29 cm D= 29 cm
E= 9 cm E= 9 cm
F= 5 cm F= 5 cm
G= 10 cm G= 10 cm
H= 22 cm H= 22 cm
Additional space for feed Other than for the steam sterilizer, the feed water and the waste water
water supply container require space.
Space requirement for water MELAdem 40
treatment unit
 The attachment can be next to the steam sterilizer or above or below
the steam sterilizer
MELAdem 47
 Attachment next to the steam sterilizer 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 accessible.
The length of the connection hoses and the cables amounts to 1.5 m.
During installation they can be cut to the desired length. 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 secured 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
17

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

couplings.
Danger 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.
Connection hoses
Cables for water level monitoring
Waste water container
Feed water container

Fig. 9: Connections
Requirements placed on All MELAG water treatment units comply with the following requirements:
the water treatment unit  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 If the steam sterilizer should receive feed water fully automatically from a
treatment unit 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.
18

Next, you must switch the feed water supply to External in the
"Function" menu.
Function:  Select the menu Function by simultaneous brief pressing of the
Feed water supply KEYS (+) and (-). The display shows Function: Last batch number.
 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
Purified water from the ion exchanger
(1) MELAdem 40
(2) Drain via waste water container
(3)
(4)
(11)
(8)
(5)
(10) (9) (6)
(7)
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
19

Example 2 – MELAdem 47
(1) Purified water from the reverse

(2) osmosis unit MELAdem 47
Drain via waste water container

(3)
(6)
(4) (7)
(18) (5) (8)
(10)
(13)
(17)
(12)
(11)
(15) (9)
(16) (14)
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
20

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 sterile 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 delivery of the steam sterilizer. Do not
remove the sterile filter pre-fitted to the steam sterilizer.
DIN EN 13060 prescribes that the steam sterilizer may not be operated
without the sterile filter integrated in the compressed air hose.
Danger
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).
If the steam sterilizer issues Error 42 "Drying - drying pump" or is a

Danger 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 performed five times
without a load (alternatively, three times with activated additional
drying). Drying may not be aborted. Only then is the steam sterilizer
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.
■ If the steam sterilizer is operated without a compressed air supply,
the stopper set to disable the drying (art.-no. 30986 included in the
Danger 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!
■ According to DIN EN ISO 7396-1, the steam sterilizer may not be

connected to the supply network for medical compressed air, e.g.
Attention medical air technology.
21

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
■ The connections for electrical provision and water supply and
discharge must be set-up by trained personnel.
Danger of injury 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:
■ Never splice or change the mains cable.
■ Never bend or twist the mains cable.
Danger of injury ■ 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)).
■ The IEC plug on the steam sterilizer or the mains socket must be
freely accessible after installation so that the steam sterilizer can be
Attention 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 setting up

PLEASE NOTE
As documentation of proper setting up, installation and commissioning 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.
22

Switch on the steam sterilizer

Switch on mains Turn the mains switch on to power the steam sterilizer (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.
Opening 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
perpendicular to the longitudinal axis. Only then the door can be opened
again using the (+) key. Otherwise the locking mechanism jams.
23

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.
 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
Attention
subsequent malfunction message.
24

Chapter 4 – Sterilization
 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 successful sterilization 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 materials according to the manufacturer's
instructions. Furthermore the materials, cleaning agents and processing
procedure employed are of significance.
25

Instruments Observe the following instructions for treating used and brand new
instruments:
■ Follow without fail the instructions of the instruments manufacturer

for treatment and sterilization, and observe the relevant standards
Danger of infection! 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 sterilizers
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 manufacturer:
 Ultrasonic units
 Maintenance appliances for hand pieces and angle pieces
 Washer-disinfectors
Loading the steam sterilizer

Only if the steam sterilizer is properly loaded can the sterilization be
effective and the drying deliver good results.
For loading the steam sterilizer:
■ Use the basket lifter to remove the universal basket.
Danger of burning! ■ 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 should
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 small part insert, which can be hooked into the universal
basket at a greater or lower height.
Wrapping The correct use of suitable wrapping is important for the success of the
sterilization.
Employ only packaging materials and -systems (sterile barrier

systems), which satisfy the DIN EN IS0 11607-1 Standard.
Attention
You can employ soft wrapping such as clear-plastic sterilization packages,

paper bags, sterilization paper or fleece.
26

Soft sterilization wrapping →Soft sterilization wrapping must always be sterilized using the
package holder. When using soft sterilization packages such as
MELAfol 1002. observe the following instructions:
■ Arrange →soft sterilization wrapping standing vertically in the

package holder to ensure that the paper side of the outer wrapping
Attention 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 packaging should 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.
27

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
sterilized.
Program Wrapping Especially Sterilization Operating Drying Load

suitable for at time1)
Universal- →single Solid instruments, 134 ˚C 13-15 min. ca. 7-10 1 kg unwrapped/
Program S wrapped simple hollow items, min. 270 g wrapped
dental transfer
instruments2)
Quick- unwrapped Simple solid 134 ˚C 6-8 min. ca. 1 min. 1 kg

Program S only instruments, simple
hollow items, dental
transfer instruments2)
Prion- →single Instruments where a 134 ˚C 28-30min. ca. 7-10 1 kg unwrapped/

Program S wrapped danger of infection by min. 270 g wrapped
pathologically-
modified proteins is
suspected (e.g.
Creutzfeld-Jacob,
BSE), dental transfer
instruments2)
1) Without drying and dependent on loading and installation conditions such as mains voltage, 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

Function: Using automatic pre-heating, the chamber of the steam sterilizer is heated
autom. Pre-heating 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.
28

Select additional drying

Additional drying For difficult drying tasks you can extend the drying time of a program by
selected 50% with the function Additional drying.
For this proceed as follows:
 When starting the program, simultaneously press the KEY (S)
AND KEY (+).
The display shows Additional drying selected. Then the program
sequence begins.
Starting the program

Universal-Program S If you selected a program with the program selection button (P), in addition
134℃ wrapped 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
1. Fractionation introduces saturated steam into the chamber.
0.69 bar 115°C
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.
Sterilization In alternation with pressure and temperature the remaining time of the
2 min., 12 s left 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.
Current-drying The regular drying time is approx. 1 minute for the Quick-Program S and
since 1’ 0.9 bar 85 °C approx. 10 minutes for all other programs.
29

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.
■ Take heed that when opening the door after terminating a running
program, hot water steam can escape out of the chamber, depending
Danger of burning! 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.
Manual termination before If you terminate a program before the beginning of drying, then the →items
beginning of drying 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 In the drying phase you can cancel the program without the steam
during drying 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 own
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:
Immediate removal
 Press the KEY (S).
Press STOP  Confirm the following prompt Immediate removal? Repeatedly
press "Stop" with the KEY (S).
The termination is confirmed with Drying stopped on the display.
30

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.
Last batch number 7 After the ventilation of the chamber with a corresponding display text the
Acknowl. with '+' 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 is finished

Sterilization phase You can recognize on the display whether the sterilization phase
successfully finished completed successfully.
Sterilization The remaining time of the sterilization phase is displayed in alternation

still 2 min, 12 s with the specification of the pressure and temperature.
Sterilization not successfully The sterilization is not successful if it was terminated by the operator or the
finished system in the event of a malfunction.
Program termination by the At a system abort, the system puts the chamber into a pressureless state.
system
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 “Additional
drying” on page 29.
31

Program is finished
Universal-Program S
At the end of a program run the chamber pressure is adapted to the
run successfully 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.
Last batch number
6 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.
Batch counter  Select the SETUP Menu Function by short simultaneous pressing of
367 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

After the end of a program observe the following instructions for removing
the →sterilized items:
Danger of burning! ■ 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.
■ Check the wrapping of the sterilized objects for damage when

removing them from the steam sterilizer.
Danger of infection! ■ 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.
32

Condensate residues on the If you remove the →sterilized items from the steam sterilizer directly after
sterilized items 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 plastic 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 items

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.
33

Chapter 5 – Logging
 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 sterilizer
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 stored in an internal 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 The capacity of the internal storage suffices for about 40 logs.
log memory 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.
34

Setting the date and time

Observe changing the clock Date and time of the steam sterilizer must be correctly set for proper batch
documentation. Observe the time re-settings in autumn and spring
("daylight saving time"), since this is not reset automatically Set date and
time as described below:
Function  Select the menu Function by simultaneous brief pressing of the
Date/Time KEYS (+) and (-).
 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 analogously.
 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 MELAprint 42/44 according to the pertinent operating
manual.
Initialisation of the In order to be able to print out logs on the connected log printer, you must
log printer initialise MELAprint 42/44 once by making the following setting at the
MELAprint 42/44 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 (-).
 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.
35

Output medium  Navigate with the KEY (+) or (-), until the display shows as output
MELAprint 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.
After renewed pressing of the KEY (S) the display again shows the initial
state.
Test outputs on the In order to verify the functional reliability of the log printer MELAprint 42/44
log printer and its communication with the steam sterilizer, a test output can be
MELAprint 42/44 carried out:
Test output  Select the menu Function by simultaneous brief pressing of the
KEYS (+) and (-).
Batch output is shown.
 Press the KEY (P). to select 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.
Employing MELAflash as output medium

The MELAflash CF card printer serves for storage of sterilization logs on
the MELAflash CF card. The readout of the logs from the CF card to the
practice computer is carried out with the MELAflash 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 card printer via the serial interface (similar to
the log printer MELAprint 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 MELAflash CF card printer.
36

MELAnet Box as output medium

Output medium The MELAnet Box enables the connection of the steam sterilizer to the
MELAnet+graphic data 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 MELAnet Box there runs a small web server program, which
displays status information of the connected steam sterilizer and settings
for the MELAnet Box via a web browser. Thus, you can display the current
progress of a program sequence or current measured values.
Connect the MELAflash CF card printer with the serial interface like the log
printer MELAprint 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 MELAnet Box.
Computer as output medium

Initialisation of the In order to be able to employ a computer as output medium, the computer
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.
Output medium In order to register the computer at the steam sterilizer, proceed as
Computer 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 endings 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:
37

 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 The following prerequisites must be satisfied for the immediate log output
automatic after the end of a program:
immediate output of the logs
after the end of the program  The computer, the log printer MELAprint 42/44 or the MELAflash CF
card printer must be connected and initiated as output medium.
Immediate output Proceed as follow in order to set the option for immediate log output after
YES program end:
 Switch on the steam sterilizer at the mains.
KEYS (+) and (-).
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
KEY (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.
38

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:
KEYS (+) and (-).
 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).
Last cycle  Press the KEY (P). The current report number blinks.
output: No. 25  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, press
the KEY (S).
 In order to leave the menu after the output, press the KEY (S).
The display shows the menu Function: Batch output.
back to the basic position of the display.
Output all saved logs In order to subsequently output all saved logs, proceed as follows:
KEYS (+) and (-).
 Navigate with the KEY (+) or (-), until the display Output stored
cycles is displayed.
Output  Press the KEY (P) in order to start the output of the selected program.
stored cycles 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 KEY (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.
39

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.
KEYS (+) and (-).
 Navigate with the KEY (+) or (-), up to the display
Function: Batch output is shown and press the KEY (P).
 Navigate with the KEY (+) or (-) until on the display All cycles
All cycles delete is shown.
delete
 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.
Display protocol memory

Allocated: 40 With a connected and initialised printer or another output medium you can
Free: 0 verify how many logs are already saved in the log memory of the steam
sterilizer.
Proceed as follows:
KEYS (+) and (-).
 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.
40

--------------------------------------- Header
MELAG MELAquick 12+
---------------------------------------
Program : Universal-Program S Started program
134°C wrapped
Date : 13.03.2015 Current date
Time of day : 12:16:14 (Start) Time at program start
Batch number: 2 Daily batch number
SN : 201512+p1017 Serial number
---------------------------------------
Preheating 133.5 °C Preheating temperature

AIN6: Conductivity 12 µS/cm
→conductivity of the →feed water
Preheating 133.5 °C Program step values
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
Program sequence phases with the accompanying values
Steam entry 1.72 129.7 01:27
Press. release 0.22 118.0 01:35 for pressure, temperature and time (relative to the
3.Fractionation program start)
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
------------------------------------------ Summary
PROGRAM PROPERLY EXECUTED! Control message
Temperature : 136.0 +0.3 /-0.2 °C Mean sterilization temperature with max. deviations
Pressure : 2.18 +0.02/-0.02 bar Mean sterilization pressure with max. deviations
Sterilizate time: 3 min 30 s
Sterilization time maintained
Time of day : 12:36:25 (End)
Time at the end of the program
---------------------------------------
58 20150101 5.15 5.05 Information with total-cycle counter, factory serial number
and device software version no.
Fig. 12: Example of a program log for a successful finished Universal-Program S
41

Chapter 6 – Maintenance
 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 Examine the chamber including door gasket and wiping rubber (page 26,
chamber and door gasket 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 cloth
soaked in alcohol (spirit). Clean the wiping rubber and the door gasket
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.
When cleaning chamber and door gasket, observe the following:

■ Switch the steam sterilizer off before cleaning and pull the power
Attention 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 gasket.
■ 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 an 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.
42

External waste water Only completely empty the waste water container for cleaning.
container During running operation, always ensure that the cooling hose is covered
with water when draining water.
Sterile filter Use a ph-neutral and chlorine-free cleaning fluid to remove soiling (e.g.
(only MELAquick 12+) 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.
Other colourings or dampness in the filter housing points to insufficient

treatment of the compressed air. In this case, the sterile filter must be
Danger of injury 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 Check the insulating plug on the sterile filter every four weeks. To do so,
filter (only MELAquick 12+ p) 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 Only if you properly clean the instruments before sterilization, you can
improperly cleaned avoid the detachment of residues resulting from loading or instrument
instruments preparation under steam pressure during the sterilization.
Detached dirt residues (e.g. residues of disinfectants) 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 All steam-conducting parts of the steam sterilizer are made of non-rusting
third-party rust 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 incorrectly 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 manufacturer for reconditioning.
Formation of spots due to The extent of the formation of spots on the instruments also depends on
inadequate quality the quality of the →feed water employed for steam production.
of the feed water
43

Use qualitatively high-grade feed water

Observe the following when using →feed water for the steam
sterilization:
Attention
■ Use only →demineralised or distilled water according to →DIN EN
13060, Appendix C.
In case of non-observance, stains or damage on the instruments
can arise and the functional readiness of the steam sterilizer can be
adversely affected.
PLEASE NOTE
→Feed water which you can inexpensively produce with the ion exchanger
MELAdem 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
■ Maintenance should only be performed by trained customer services
technicians, or stockist technicians. Consult your specialist dealer or
Attention 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 Regular maintenance is indispensable for the retention of value and the
functional reliability 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.
44

Chapter 7 – Operating pauses

 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 frequency
No pause times Pause times between individual programs are not necessary. After the
required 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 off at the mains switch.
 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
Observe the following when carrying the steam sterilizer:
■ Use the supplied carrying straps to transport the steam sterilizer and
Danger of injury attach them to the sides e.g. using package tape.
■ Never lift the steam sterilizer 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.
45

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

when moving or shipping the steam sterilizer or for the transport
Attention within the practice:
■ Empty the feed water and waste water container.
■ When using a water treatment unit, close the water feed and remove
the hose connections on the back of the device.
In case of non-observance, damages to the steam sterilizer 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).
46

Chapter 8 – Function test

 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 The interaction of the sterilization-relevant parameters of pressure,
monitoring systems 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 device
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, the 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.
47

Display water quality

AIN6: Conductivity The water quality can be displayed on the display of the switched on
7 µS/cm steam sterilizer at any time - even while a program is running.
To do this keep the KEY (-) pressed until the display shows the →
conductivity. The conductivity is stated in µS/ cm.
As soon as you release the (-) KEY, the display returns to its previous
status (e.g. initial state).
Pre-heating temperature of If you press the KEY (-) twice shortly and the second time keep it pressed,
the chamber the pre-heating temperature of the chamber is shown instead of the →
conductivity.
AIN4: Temp. Preheat.
120°C
48

Chapter 9 – Malfunctions
 Which type of messages exist

 How to react 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.
■ If a program is discontinued during the sterilization phase, the load is

unsterile. Repackage and repeat the sterilization for the respective →
Danger of infection! 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.
49

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/ Door switch is not closed on start Adjust the twist grip into the proper position
No start possible 90° perpendicular to the longitudinal axis.
Correct display: Door closed.
Warning: No feed water/ Only if feed water supply from Check feed water level in the feed water
Refill feed water – No start external feed water container: container, if necessary refill feed water.
possible Not enough feed water in the Check proper connection of the connection
container, hose / cable not properly hose / cable plug to the feed water
connected container.
Float switch blocked 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/ The warning message appears PLEASE NOTE
Check feed water quality after program start. The built-in flow At the first start-up or re-start-up, this
monitor doesn't close 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 installation.
Warning – Empty the waste Waste water container is full Empty the waste water container ensuring
water tank/No start possible that residual water (approx. 10 cm) will
remain in the container (see page 42,
Chapter 6 – Maintenance).
If the steam sterilizer does not start after the
acknowledgement, briefly switch the steam
sterilizer off and on.
50


Feed water quality bad/ Conductivity of the feed water too Still possible to start by repeatedly
Exchange cartridge/module high ≥ 40µS 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
MELAdem 40:
Mixed-bed resin pellets consumed Exchange the mixed-bed resin pellets (see
operating manual for the water treatment
unit MELAdem 40).
MELAdem 47:
Mixed-bed resin pellets in the after Exchange the mixed-bed resin pellets (see
ion exchanger (3rd cartridge) operating manual for the water treatment
consumed 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.
For different water treatment units:
Mixed-bed resin pellets in reverse Change the module/resin cartridge
osmosis unit consumed 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 Conductivity of the feed water too Start no longer possible:
insufficient/ No start high Conductivity ≥ 65 µS See warning message: Feed water quality
possible insufficient/Exchange cartridge/module
Please wait Message is displayed during The steam sterilizer starts automatically
Preheating chamber program start phase. The steam after reaching the starting temperature.
sterilizer has not reached the
starting temperature yet.
51


Output medium is not ready The steam sterilizer is operated Select the option in the menu Batch
without output medium although an output No output medium (see page
output medium is registered 35, Initialisation of the log printer).
Output medium is not correctly Check if the CF card of the CF card printer
connected and/or CF card is not is correctly inserted.
inserted Check the correct connection of the data
cable to the steam sterilizer and at the
output medium.
Electric power supply of the log Ensure electric power supply, the red LED
printer or the CF card printer is "P" at the log printer MELAprint 42/44 must
interrupted light red.
Log printer is "offline" 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 The message is shown at the start of a
allocated (capacity got up to 40 program.
logs). 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 Set printer to Immediate output YES
in the menu Batch output the (see page 38, Automatic immediate log
option Immediate output NO is output).
set. 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 message is shown after every program
the device has reached the start.
prescribed batch number 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 The battery must be exchanged by MELAG
battery voltage determined a too customer service or service of the specialist
low voltage value. dealer.
52

Malfunction message Possible cause What you can do

Fault 2: Steam generator Steam sterilizer is overloaded Pay attention to the correct loading
quantities (see page 26, Loading the
Decreased heating power, since steam sterilizer).
supply voltage too low Check building-side electrical installation;
operate steam sterilizer on a trial basis on
Loss of water as a result of leaks or another electric circuit.
of formation or collection of water Upon repeated occurrence, inform your
Steam generator overheated specialist dealer.
Switch steam sterilizer off and have it cool
down for 15 minutes.
Fault 4: Pressure release Sieve tray contaminated Clean sieve tray (see page 42, Cleaning).
Drain hose is blocked Check waste water hose for kinks.
On repeated occurrence notify your
specialist dealer.
Fault 8: Time base Maximum difference between the Upon repeated occurrence, inform your
program cycle time and the internal specialist dealer.
computer clock is exceeded
Fault 9: Door open! The twist grip was turned during a Adjust the twist grip into the proper
running program or was not properly position 90° perpendicular to the
closed, door contact opened during a longitudinal axis. Correct display: Door
program closed.
Upon repeated occurrence, inform your
specialist dealer.
Fault 10: Overheat. Steam Capillary tube regulator "level control" After program termination and immediate
generator is opened at program start start, this error message can be repeated;
(malfunction message immediately Repeat program start after a pause time of
after start) or during a program run two minutes.
(until the end of the sterilization) the Check feed water hose for kinks.
monitoring time until the capillary
tube regulator is switched back (with Upon repeated occurrence, inform your
water feed from feed water) is specialist dealer.
exceeded
Fault 12: Door locking Twist grip not 90° perpendicular to Properly turn twist grip until the stop into
the longitudinal axis of the steam the correct position.
sterilizer. 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 inspection of the Upon repeated occurrence, inform your
sensors for temperature, pressure or specialist dealer.
conductivity resulted in a too large
deviation, the message can occur
when the device is switched on or
during a program
Fault 21: Preheating The monitoring time from switching On repeated occurrence select option
on pre-heating until the achievement Automatic pre-heating NO ( see
of the respective pre-heating page 28, Select automatic pre-heating)
temperature was exceeded, e.g. due and inform your specialist dealer.
to a too low supply voltage
53


Fault 22: Overheat The maximum preheating On repeated occurrence select option
Preheating temperature was exceeded Automatic pre-heating No ( see
page 28, Select automatic pre-heating)
and inform your specialist dealers
Fault 23: Current Monitoring time for the pressure Clean sieve bottom and check waste water
release in the outflow procedure hose (see page 44).
during fractionations was exceeded Check installation of the waste water hose.
Sieve tray contaminated or dented Upon repeated occurrence, inform your
Waste water hose kinked specialist dealer.
Fault 26: A/D converting The maximum admissible deviation Upon repeated occurrence, inform your
of the computer-internal signal specialist dealer.
conditioning (A/D converting) was
exceeded
Fault 27: Temp.Sens. def The maximum admissible deviation Upon repeated occurrence, inform your
1.2 between the two temperature specialist dealer.
sensors for the steam temperature
was exceeded
Fault 32: Power The loss of the operating voltage The malfunction message occurs after the
loss/Sterilize sterile filter occurred after the start of a program operating voltage is again available.
Check building-side installation. If no
defects are detectable, notify MELAG
customer service
Disconnection of the steam sterilizer Only terminate a running program with KEY
during a running program (S), see also page 30.
Fault 33: Pressure drop The maximum switch-on time of the Check the door gasket.
steam generator for achieving the Upon repeated occurrence, inform your
control pressure was exceeded specialist dealer.
Fault 34: Sterilization TU1 Shortfall of minimum permissible Operate steam sterilizer with smaller load.
sterilization temperature (temperature Check door gasket for wear or damage,
sensor 1) exchange as needed (see page 44).
specialist dealer.
Clean sieve bottom and check waste water

hose (see page 44).
Fault 35: Sterilization TO1 Exceeding the maximum permissible Upon repeated occurrence, inform your
sterilization temperare (temperare specialist dealer.
sensor 1)
Fault 36: Sterilization PU Shortfall of the minimum sterilization Operate device with smaller load
pressure Check door gasket for wear or damage,
exchange as needed (see page 44).
specialist dealer.
Fault 37: Sterilization PO Exceeding the maximum permissible Upon repeated occurrence, inform your
sterilization pressure specialist dealer.
54


Fault 38: Sterilization TD1 Maximum permitted difference Upon repeated occurrence, inform your
between theoretical temperature specialist dealer.
calculated from the pressure signal,
and the temperature measured at
temperature sensor 1 was exceeded
Fault 41: Current-drying Sieve tray contaminated Clean sieve bottom and check waste water
hose (see page 44).
Drain hose is kinked Check waste water hose for kinks.
specialist dealer.
Fault 42: Drying press. MELAquick 12+: Check compressed air connection for
pump Compressed air supply not possible kinks and proper connection,
connected or is interrupted; inflow open inlet valve.
valve for the compressed air is
closed.
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.
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.
stockist.
Fault 51: Sterilization 2 Shortfall of minimum permissible Operate device with smaller load.
sterilization temperature (temperature Check door gasket for wear and damage.
sensor 2)
specialist dealer.
Clean sieve bottom and check waste water

hose (see page 44).
Fault 52: Sterilization TO2 Exceeding the maximum permissible Upon repeated occurrence, inform your
sterilization temperature (temperature specialist dealer.
sensor 2) Also see Fault 35
Fault 53: Sterilization TD2 Maximum permitted difference Upon repeated occurrence, inform your
between theoretical temperature specialist dealer.
calculated from the pressure signal, Also see Fault 38
and the temperature measured at
temperature sensor 2 was exceeded
55

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.
■ 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.
Electrical Shock Heavy injuries will be the consequences.
Hazard
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 steam sterilizer (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

Absolutely make sure that the pressure of the steam sterilizer is
completely released:
Attention ■ 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 off at the mains switch and pull 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.
56

Overview of programs
MAIN MENU
Main Menu
Function*
+
*see next page
1st time press
Initial state
hh:mm:ss h – AIN6: Conductivity
5 µS/cm
0.00 bar 89°C release
2nd time press

P
h – AIN4: Temp_preheat.
120°C
release
Quick-Program S
134°C unwrapped S +
Additional drying
selected
Manually terminate
P before drying
Program sequence
Stop program?
Press ‚Stop’
Universal-Program S START
134°C wrapped S
S
Only unwrapped
P instruments Programm
stopped
S
Pressure release
Prion-Program S 1.5 bar 112°C
Program runs
134°C wrapped 20’

Stop End
0.02 bar 88°C
Manually terminate Acknowledge

during drying with button ‚–’
Immediate removal?
Stop program Press ‚Stop’
Press ‚Stop’
S –
Quick-Program S Drying stopped Unlocking door

run successfully with button ‚+’
Last batch number x
Quit with button ’+’
+ – Press (+) and (–) simultaneously to select the

S + Press KEY ”Start/Stop” and (+) simultaneuously
Function menu
S KEY “Start/Stop“: Stop and terminate a program h – Select by keep pressing the KEY (-)
P KEY „Program“: "Enter/Confirm/Input“ + Unlocking door with KEY (+)
57

hh:mm:ss
Initial state
0,00 bar 89°C
Menu: Function
Press both keys
S + simultaneously
Function: *1) No output medium

MELAprint
MELAflash
MELAnet+graphic data
Computer
Last Batch counter Date/Time Batch output autom. Feed water

batch number Pre-heating supply
S P S P S P S P S P S P
Last batch number Batch counter. Date/Time P Output medium*1) P No Internal
xx xx Hour: xx

S + 
S +
–
– Yes External
P
P
Immediate output
Date/Time
Minute: xx = s. o.
Yes/No
 S
P P
P
+ Date/Time Last cycle output: P

Second: xx
= s. o. No. xx
S +
–
+
Date/Time P
Day: xx
= s. o.
Stored cycles

output
Date/Time S
Month: xx
= s. o.
P + – KEYS (+) and (-): (next/previous) in the menu
Allocated: xx
Date/Time P KEY “Program: “Enter/Confirm/Input”
= s. o. Free: xx
Year: xx
S KEY “Start/Stop”:”Terminate/Escape/Leave”
All cycles
+ delete
 S  S KEY “Start/Stop”: “Escape/Leave without saving”
Main and submenus can always be selected by KEY (+)
P „next“ and KEY (-) “previous” and you can always leave them
Test output with KEY (S).
 S
+ P
58

Technical tables
Technical tables
Nominal value tolerances
Quick-Progr. S Universal-Progr. S Prion-Progr. S ◄ same meaning as in Universal-Pr. S

Step Press. P Tolerance P Tol. P Tol. All values in mbar
2700 - 30/+160 ◄ ◄ ◄ ◄ Steam entry
1. F.
1250 -390/+ 30 ◄ ◄ ◄ ◄ Steam flow off
n. F. 2700 - 50/+110 ◄ ◄ ◄ ◄ Steam entry Fractio-
1250 -160/+ 50 ◄ ◄ ◄ ◄ Steam flow off nation
3050 - 50/+ 70 ◄ ◄ ◄ ◄ Heat up
Sterilization
3050 - 50/+ 70 ◄ ◄ ◄ ◄ start
3170 - 90/+ 90 ◄ ◄ ◄ ◄ Sterilization
1200 -140/+ 50 ◄ ◄ ◄ ◄ Pressure release
Pressure-time charts
Press. (mbar rel.)
Fig. 13: Pressure-time chart for Universal-Program S, 134 °C and 2.1 bar
59

Technical tables
Press. (mbar rel.)
Fig. 14: Pressure-time chart for Quick-Program S, 134 °C and 2.1 bar
Press. (mbar rel.)
Fig. 15: Pressure-time chart for Prion-Program S, 133 °C and 2.1 bar
60

Technical tables
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 ≤ 0.1 mg/l
above
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
61

Technical data
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 approx. 105 W
standby
Degree of soiling Category 2
Degree of protection IP20
(following IEC 60529)
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
62

Glossary
Glossary
aqua dem DIN EN 868-8
→demineralized water European standard: Packing materials and sytems for
medical devices to be sterilized
aqua dest
→distilled water DIN EN ISO 11140-1
European standard – Sterilization of products for health
Authorized persons care – chemical indicators – Part 1: General requirements
Medical specialist dealers, technician from depots or with
customer service designated by MELAG, who were trained DIN EN ISO 11607-1
by MELAG Standard – Requirements on materials, →sterile barrier
systems and packaging systems; this standard is a
Batch harmonization of the DIN EN 868 Part 1 and the
Collection of the →items to be sterilized that together international standard DIN EN ISO 11607.
passed through one and the same sterilization program
DIN EN 13060
BGV A1 European standard –Small steam sterilizers
Specifications from professional associations
(Berufsgenossenschaftliche Vorschriften) – the principles DIN EN 285
of prevention European standard – sterilization – steam sterilizers –
large sterilizers
CF card
Compact Flash card; Display
A memory card for digital data in compact form; Display panel on electronic devices for communicating
CF is a standardized term, i. e. these memory cards can information. Here: Graphic display of the control panel
be used in every device with a CF slot. The CF card can Distilled water
be read and possibly written by every device that supports From lat. aqua destillata; also designated as aqua dest;
the standard. water, which is largely freely of salts, organic materials and
Condensate microorganisms, is obtained by distillation (evaporation
A liquid (e.g. water), which forms upon cooling from the and subsequent condensation) from normal tap water or
vaporous state and thereby separates pre-cleaned water. It is employed here as →feed water
Conductivity Dynamic pressure test of the sterilization chamber

is the opposite of electrical resistance; measured in micro- Serves to verify that the rate of the change of pressure
Siemens / centimetre (µS/cm); the greater the amount of occurring in the sterilization chamber during a sterilization
dissolute matter in the water, the better it can conduct cycle does not exceed a certain value, which could lead to
electrical current and thus the higher its conductivity. damage of the wrapping material
→distilled water ideally has the conductivity zero [→DIN EN 13060]
Conductivity measurement Empty chamber test

Measurement of the →Conductivity Test without load; carried out in order to evaluate the
performance of the sterilizer without the influence of the
Corrosion load; permits checking the maintained temperatures and
Chemical change or destruction of metallic materials by pressures with respect to the intended settings
water and chemicals [→DIN EN 13060]
Delayed boiling Evacuation
This is the phenomenon that in certain conditions liquids Creation of a →vacuum in a chamber
can be heated beyond their boiling point without boiling;
this state is unstabile; a slight shock can cause a very Feed water
rapid formation of large gas bubble which expands like an is required for the creation of water steam for the
explosion sterilization; typical values for the water quality according
to →DIN EN 285 or →DIN EN 13060 – Appendix C
Demineralised water
Also designated as aqua dem; water to a large extent Flow-drying
without the minerals which occur in normal mineral or tap Drying, which removes moisture in the chamber using a
water; is obtained by ion exchange from normal tap water. mechanically generated air flow, is usually supported by
It is employed here as →feed water heat
DGSV Fractionated flow method
Deutsche Gesellschaft für Sterilgutversorgung (German Overpressure method in which the air is expelled from the
Association for the Sterilized Equipment Ordinance). The chamber and the items to be sterilized by alternating
DGSV training centres are specified in DIN 58946, part 6 between steam entry and steam outlet.
as "Requirements of personnel".
FTP
DIN 58953 (File Transfer Protocol) is a data transmission procedure
Norm – Sterilization, sterile goods supply serving to transport data from the internet. These data can
contain programs, files or information. Special FTP
DIN EN 867-5 programs (FTP clients) serve for uploading any data on a
European standard: non-biological systems for use in server.
sterilizers – Part 5: Stipulations of indicator systems and
testing bodies for performance tests of small sterilizers of Heating-up period
Type B and Type S After switching on the steam sterilizer or after starting a
sterilization program., it ist he time required for heating-up
63

Glossary
the steam generator before the sterilization process starts; Single wrapping
duration depends on the temperature of the sterilization Wrapped once, e.g. instruments sealed in a foil -
process contrasted to: →Multiple wrapping
Hollow body A
Simple hollow items
→Narrow lumen An article open on one side to which the following applies:
Hollow body B 1 ≤ L/D ≤ 5 and D ≥ 5 mm or an article with an opening
→Simple hollow items on both sides which is:
2 ≤ L/D ≤ 10 and D ≥ 5 L…length of hollow article
Initialization D…diameter of hollow article [DIN EN 13060
Creation of a certain initial state of the →software at start-
up Soft sterilization package
e.g. paper bags or clear-plastic sterilization packages
Integrated steam generation
The steam generator is located directly on the floor of the Software
sterilization chamber. non-material component of IT systems e.g. a computer
program
Items to be sterilized
Unsterile objects, materials still to be sterilized Solid load – Check of porous partial load
Serves to verify that for the values set on the control, the
Kontamination required sterilization conditions were achieved within the
here: Soiling of the sterilized load with unwanted or entire load. The load must reperesent the maximum
harmful materials measurements of solid instruments for whose sterilization
LED a sterilizer has been designed according to [→DIN EN
Light Emitting Diode: Semiconductor diode which lights up 13060]
when powered by current. LEDs are predominantly Stainless steel cleaning agent
employed for status displays in devices, for example to e.g. Sidol
display hard disk access.
Standards-compliant
Lubricants Conformity with all the relevant standards
Instrument oil or instrument milk
Sterile barrier systems
Massive Closed minimum packaging which prevent the occurrence
without hollows or cavities, compact, sealed closed of microorganisms, e.g. bags closed with sealing, closed
Mixed load reusable containers, folded sterilization cloths
Wrapped and unwrapped materials to be sterilized within Sterilization chamber
one load Interior of a sterilizer
MPBetreibV Accommodates the →items to be sterilized
Ordinance covering the installation, operation, application
Sterilized items
and maintenance of medical products according to § 3 of
the Medical Devices Directive with the exception of Also designated as →batch, if already successfully
medical products for clinical evaluation or performance sterilized: sterile goods
evaluation. TCP
Multiple wrapping (transmission control protocol) refers to a standard
e.g. instruments doubly sealed in foil or wrapped in foil are protocol for connecting computers and networks.
additionally found in one container or in a textile wrapped
VDE
container
Verband der Elektrotechnik, Elektronik und
Narrow lumen Informationstechnik e.V.
One-sided open bodies, for which applies: Association for Electrical, Electronic Information
1 = L/D = 750 and L = 1500 mm or Technologies
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 itself, 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
64

Appendix A - Accessories
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 instruments 00122
Support with round holders for 7 instruments 00123
Water treatment MELAdem 40 ion exchanger 01049

units
MELAdem 47 reverse-osmosis unit 01047
For documentation MELAflash CF card printer incl. MELAflash CF 01039
card and card reader
MELAnet Box 40296
Log printer MELAprint 44 01144
Other Cable for water level monitoring, 5 m 21353
Compressed air Hose coupling, T-piece 38600 --

connection
Y-piece 80220 --
Coupling 80230 --
Spare parts Device fuse 20 A gRL 21481
Door gasket 12550
*All specified articles are available through specialist dealers
65

Certificate of suitability
MELAquick®12+/MELAquick®12+ p
Manufacturer: MELAG Medizintechnik oHG
Address: Geneststraße 6-10
10829 Berlin
Country: Germany
Product: Steam sterilizer (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)
66

User Manual: Melaquick 12+ Melaquick 12+ P

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About these Instructions

Indicates a dangerous situation which if not avoided

Indicates a dangerous situation which if not avoided

Important Draws your attention to important information.

Example of emphasis Meaning Explanation

Universal-Program S Software citation Words or phrases appearing on the →display of the

Figure 1/(5) Cross reference Reference to a detail in a figure – in the example, to

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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.

Indication of the scale of the chamber volume

Opterating temperature of the device

Operating pressure of the device

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Chapter 4 – Sterilization ..................................... 25 Chapter 9 – Malfunctions ................................... 49

Create prerequisites .......................................... 25 Warning messages ........................................... 49

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Observe the following instructions for using the steam sterilizer:

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Overview of sterilization programs

Type tests Universal-Program S Quick-Program S Prion-Program S

Program type as per Type S Type S Type S

→Dynamic pressure test of the X X X

→Empty chamber test X X X

→simple hollow items (hollow X X X

→Single wrapping X --- X

Drying →solid load X X X

Sterilization temperature 134 °C 134 °C 134 °C

Sterilization pressure 2 bar 2 bar 2 bar

Sterilization time 5:30 min 3:30 min 20:30 min

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Chapter 2 – Device Description

 Which components are included in a standard scope of delivery

Only for MELAquick 12+

As option  Universal basket including small part insert

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(5) (8) Serial interface (RS232)

Fig. 1: Device views

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Top view, open

(1) Wiping rubber (under sliding door)

Fig. 2: Top view

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MELAquick 12+/12+ p ∅ 9 cm 20 cm 1.35 Litres

2-line LED display

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Supply with feed water

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