Vacuklav 31B+ User Manual

User Manual
Autoclave
Vacuklav®23 B+
Vacuklav®31 B+
as of software version 4.06
Dear doctor,
We thank you for your confidence demonstrated by the purchase of this autoclave.
Since 1951, MELAG began as a medium-sized family-run enterprise to specialise in the manufacture of
sterilization equipment for medical practices. In the meantime our company has grown into one of the
world's leading producers of sterilization equipment. Verification of it success has been the sale of
more than 450,000 MELAG units worldwide, attesting to the high quality of our sterilizers, which are
exclusively made in Germany.
This autoclave has also been manufactured and tested according to the most stringent quality criteria.
Nevertheless, please read the User Manual carefully before the initial start-up of the device. The long-
term serviceability and the retention of value of your autoclave depend primarily on the careful
preparation of the instruments and the regular maintenance of the device.
MELAG - General Management and employees

For physicians, physician's assistants, and service personnel
Please read this User Manual before you start operation of the autoclave. The
instructions contain important safety precautions. Make sure to keep the User Manual
near to the autoclave. The instructions are a part of the product.
User Manual of Vacuklav®23 B+, Vacuklav®31 B+

® ®
Valid for Vacuklav 23 B+, Vacuklav 31 B+
as of software version 4.06
Responsible for the contents: Engineering Department

MELAG Medizintechnik oHG
Geneststraße 6-10
10829 Berlin
Germany
E-mail: [email protected]
www.melag.de
© 2013
Document: BA_2_GB_23B+_31B+_v9.docx/ Revision: 9 – 12/0426
Subject to technical changes
Foreword
Thank you for deciding to buy this Pro Class MELAG autoclave.
®
This User Manual describes both the autoclaves Vacuklav 23 B+ and
®
Vacuklav 31 B+. They are identical except for their chamber depth and
device depth.
Device name The device name "autoclave" is used in this User Manual to designate the
® ®
steam sterilizers Vacuklav 23 B+ and Vacuklav 31 B+.
User Manual The User Manual contains important safety instructions and information
which you need to operate the autoclave. Read these instructions carefully
and thoroughly in proper sequence.
Avoid dangers Please read all the safety instructions attentively before using the
autoclave.
About this manual

Symbol Meaning Explanation
Risk to health Indicates a dangerous situation which if not avoided

could entail slight to life-threatening injuries.
Danger!
Observe Indicates a dangerous situation which if not avoided

without fail could entail damage to the instruments, the practice
Warning! equipment or the autoclave.
Important Indicates important information.

information
Example of emphasis Meaning Explanation
→Conductivity Glossary entry Words or phrases marked with an arrow are

measurement explained in the glossary. The glossary is listed
alphabetically. It can be found at the end of this
manual.
Universal program Software Words or phrases appearing on the →display of the

citation autoclave are marked as software citations.
Chapter 6 – Logging Cross- Reference to another text section within this User
reference Manual.
Figure 1/(5) Cross- Reference to a detail in a figure – in the example, to

reference Part No. 5 in Figure 1.
Safety instructions
To operate the autoclave, pay attention to the following safety instructions
given below and in the individual chapters of this User Manual.
Instruction ■ Do not sterilize any liquids with this autoclave.
Mains cable and power ■ Never damage or change the mains cable or power plug.
plug ■ Never operate the autoclave if the mains cable or power plug are
damaged.
■ Never pull on the mains cable to take it out of the socket. Always take
hold of the power plug itself.
Setting up, installation, ■ Only have the autoclave set up, installed, and commissioned by
commissioning people authorised by MELAG.
■ Only operate the autoclave in areas which are not subject to
explosion hazards.
■ The electric connections and connections for feed water and used
water may only be completed by a specialist technician.
Preparation and ■ Follow the instructions of the textile and instrument manufacturers for
sterilization of textiles and preparing and sterilizing textiles and instruments.
instruments ■ Observe the relevant standards and directives for the preparation
and sterilization of textiles and 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 autoclave. If necessary, sterilize the affected →objects after
rewrapping.
Removal of the items to be ■ Never open the door by force.
sterilized ■ Use a tray lifter to remove the tray. Never touch the →sterilized
items, the chamber or the door with unprotected hands. The parts are
hot.
■ Check the wrapping of the sterilized objects for damage when
removing them from the autoclave. If a wrapping is damaged, wrap
the object again and re-sterilize it.
Maintenance ■ Have the maintenance done only by →authorized persons.
Carrying the autoclave ■ Two people are necessary to carry the autoclave.
■ Use a suitable carrying strap to transport the autoclave.
Errors ■ If repeated error messages occur while operating the autoclave, turn
the device off and notify your specialist dealer.
■ Only have the autoclave repaired by →authorized persons.
Contents
Chapter 1 – Performance Specification .............. 6 MELAnet Box as output medium .......................... 32
Proper use .............................................................. 6 Computer as output medium ................................ 32
User benefit ............................................................ 6 Automatic immediate log output ........................... 33
Overview of sterilization programs.......................... 8 Output the logs subsequently ............................... 33
Display protocol memory ...................................... 35
Read log files correctly ......................................... 35
Chapter 2 – Device Description ........................... 9
Scope of delivery .................................................... 9 Chapter 6 – Maintenance ................................... 37
Device views......................................................... 10
Effective capacity.................................................. 11 Cleaning ............................................................... 37
Mountings for the load .......................................... 11 Avoid formation of spots ....................................... 38
Control panel ........................................................ 12 Use qualitatively high-grade feed water................ 39
Supply with feed water ......................................... 12 Exchange the door seal ........................................ 39
Maintenance ......................................................... 39
Chapter 3 – Initial start-up ................................. 14

Chapter 7 – Operating pauses ........................... 41
Conditions for setting up, installing and starting up
............................................................................. 14 Sterilization frequency .......................................... 41
Set-up location requirements ................................ 14 Pause times .......................................................... 41
Connections required ........................................... 15 Shut-down ............................................................ 42
Prerequisites for initial start-up ............................. 17 Transport .............................................................. 42
Record of installation and setting up..................... 17 Re-startup after change of locality ........................ 42
Switch on autoclave.............................................. 17
Chapter 8 – Function test................................... 43
Chapter 4 – Sterilization ..................................... 18 Automatic function test ......................................... 43
Create prerequisites ............................................. 18 Manual function test ............................................. 43
Select feed water supply ...................................... 18 Testing in daily operation...................................... 44
Prepare items to be sterilized ............................... 19 Vacuum test.......................................................... 44
Load the autoclave ............................................... 20 Bowie & Dick test.................................................. 45
®
Close the door ...................................................... 22 Helix test body system MELAcontrol / PRO ........ 45
Select program ..................................................... 22 Display water quality............................................. 45
Select automatic pre-heating ................................ 23
Select additional drying ........................................ 24 Chapter 9 – Errors .............................................. 46
Start program........................................................ 24
A warning is not an error ...................................... 46
Program is running ............................................... 24
Warning messages ............................................... 46
Manually terminate program ................................. 25
Error message ...................................................... 46
Sterilization phase is finished ............................... 26
Before you call ...................................................... 47
Drying phase ........................................................ 26
No display on the screen ...................................... 53
Program is finished ............................................... 26
Too large feed water consumption ....................... 53
Display batch number ........................................... 27
Bad drying results ................................................. 53
Remove sterilized items ....................................... 27
Storage of sterilized items .................................... 28
Glossary .............................................................. 54
Chapter 5 – Logging ........................................... 29

Appendix A – Accessories................................. 57
Batch documentation ............................................ 29
Set date and time ................................................. 30
Use printer as output medium............................... 30 Appendix B – Symbols on the autoclave ......... 58
MELAflash as output medium ............................... 32
Chapter 1 – Performance Specification

In this chapter you learn
 Under which conditions and for which purpose you should use this autoclave
 What benefit you can achieve by using this autoclave
 Which sterilization programs you can use
Proper use
Application area The autoclave is intended for use in the medical field, e.g. in clinics, and
in physician and dental practices.
Sterilization tasks According to →DIN EN 13060 this autoclave is considered a Class B
sterilizer. It is suited as a universal autoclave for demanding sterilization
tasks. For instance, you can sterilize narrow-bore instruments and
transmission instruments – wrapped or unwrapped – and larger
quantities of textiles.
Observe the following instructions for using the autoclave:

■ Do not sterilize any liquids with this autoclave. It is not approved for
Danger of burning!
the sterilization of liquids.
In case of non-observance, the consequences could be →delayed
boiling, damage to the autoclave and burns.
■ Use the autoclave only for the intended purposes outlined in the
related technical documents and only in connection with the devices
Warning! and components approved by MELAG.
■ The sterilization of instruments and textiles with this autoclave, like
the foregoing instrument preparation, is only to be done by
competent personnel.
■ Only use instruments, wrappings and textiles which are suitable for
steam sterilization according to the manufacturer's information.
In case of non-observance the consequences can entail damage to
the autoclave and/or to the →items to be sterilized.
User benefit
Universal use The autoclave sterilizes on the basis of the →fractionated pre-vacuum
method. This ensures the complete and effective wetting or penetration
of the →items to be sterilized with saturated steam. This method makes it
possible to sterilize all kinds of loads which occur in a physician's medical
practice.
Large quantities To generate the sterilization steam, the autoclave uses a →separate
Low time expenditure steam generator. At program start, steam is generated and conducted
No pause times into the sterilization chamber. A defined pressure and a prescribed
Overheating protection temperature is thereby given. The sterilization chamber is protected from
overheating and you can consecutively sterilize large quantities of
instruments or textiles very rapidly and achieve excellent drying results.
Automatic pre-heating The cold chamber is preheated on activation of preheating or can be
maintained at a specific temperature between two sterilizations.
6
This shortens the program time periods and reduces the formation of
condensate to give improved drying results.
Clean feed water according The autoclave functions according to the feed water one-way system.
to VDE0510 This means that it uses fresh purified →feed water for every sterilization
run. The quality of the feed water is monitored via integrated
→conductivity measurement. This prevents stains on instruments and
soiling of the autoclave, assuming the instruments have been carefully
prepared.
Automatic feed water The →feed water for generating the steam is automatically supplied via
®
supply an internal water storage tank or a water treatment unit (e.g. MELAdem
®
40, MELAdem 47).
Optimal drying for The drying of the →sterilizing materials is carried out with the post-
wrapped items to be vacuum method (→vacuum drying). This way you achieve optimal drying
sterilized results for wrapped objects as well.
Optimized total operating The autoclave works with an →electronic parameter control. This way the
time autoclave optimizes the total operating time of a program depending on
the load.
High safety with The autoclave 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
autoclave. It monitors 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 autoclave outputs a warning or fault messages and, if
necessary, aborts the program. In the event of an automatic program
abort, observe the information on the display.
Additional With the help of the test programs, you can conduct an additional
function check function check at any time.
Use the vacuum test to check the autoclave for leaks in the steam
system.
With the →Bowie & Dick Test, you can verify the autoclave for sufficient
steam penetration of porous sterilizing materials (e.g. textiles).
With →Conductivity measurement, you can verify the water quality of the
feed water.
Effective batch The autoclave 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.
7
Overview of sterilization programs

Type tests Universal- Quick- Quick- Gentle- Prion-
Program Program B Program S Program Program
Program type as per Type B Type B Type S Type B Type B

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

sterilization chamber
→Air leak X X X X X
→Empty chamber test X X X X X
→Solid load X X X X X
→Porous partial load X X X
→Porous full load X X X
→Hollow body B X
→Hollow body A X X X X
→Simple wrapping X X X X
→Multiple wrapping X X X
Drying →solid load X X X X X
Drying →porous load X X X
Sterilization temperature 134°C 134°C 134°C 121°C 134°C
Sterilization pressure 2 bar 2 bar 2 bar 1 bar 2 bar
Sterilization time 5.5 min. 3.5 min. 3.5 min 20.5 min. 20.5 min.
X = Conformity with all applicable sections of the standard →DIN EN 13060
8
Chapter 2 – Device Description

 Which components are included in the standard scope of delivery

 Which components the autoclave contains
 What safety devices the autoclave 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 autoclave needs
Scope of delivery
® ®
Standard scope of delivery  Vacuklav 23 B+ or Vacuklav 31 B+
 User Manual
 Technical Manual
 Warranty certificate
 Manufacturer's inspection report
 Pressure device directive certificate
 Record of installation and setting up
 1 Mounting for trays or cassettes
 1 hose for draining the internal storage tank
 1 TORX wrench for removing the carrying strap
 1 lever for emergency unlocking of the door
 1 tank filter key
 2 replacement device fuses on the inside door of the autoclaves
As option  Trays
 Tray lifter
 Standard tray cassette and lifter
 Additional tray mounts
®
 Log printer MELAprint 42
 MELAflash CF card Printer with CF card and card reader
 MELAnet Box
9
Device views
Front side
(1) Operating and display field
(2) Door (pivots opens to the left)
(3) sliding closure grip
(4) Mains switch
(5) Front foot of the unit (adjustable)
Front side below with opened door

(6) Serial data and printer connection (RS232)*
(7) Device fuses – 2x 16A/ gRl
(8) Reset button for overheating protection

(9) Connection for emptying the storage tank feed water
(10) Connection for emptying the storage tank waste water
*hidden behind the white cover

Back side
(11) Tank cap
(12) Slot for optional upgrade with the safeguard combination

EN1717
(13) Sterile filter
(14) Safety valve
(15) One-way drain (optional)
(16) Emergency overflow hose
(17) Cooler
®
(18) Purified feed water inlet for MELAdem ,
fast screw connection for hose ∅ 8x1
(19) Power cable

Fig. 1: Device views
10
Interior view
(1) Chamber
(2) Mounting to hold trays/ cassettes
(3) Door locking pin
(4) Chamber sealing surface

(5) Blue door seal
(6) Door plate
Fig. 2: Interior view
Effective capacity
Device type Diameter Depth Volume
®
Vacuklav 23 B+ ∅25 cm 45 cm 22 litres
®
Vacuklav 31 B+ ∅ 25 cm 35 cm 18 litres
Mountings for the load

The autoclave is always delivered with a mounting to hold trays or
cassettes.
The mounting (A) is standard and can hold either five trays or three
standard tray cassettes rotated by 90°.
Fig. 3: Mounting A
The mounting (B) can hold four standard tray cassettes or four
trays.
Fig. 4: Mounting B
The mounting (D) can hold two high cassettes (e.g. for implant
cassettes) or four trays rotated by 90°.
Fig. 5: Mounting D
11
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 and
Time (h:min:s)
(steam)- temperature (°C) parameter display
Function KEY (-) and (+) Program selection button (P) Start – Stop button (S)
to select, set and display special functions: to select the sterilization programs/ test to start programs, terminate
print, date/time, preheating, total batches, programs and select or set options programs / drying as well as
conductivity, acknowledge error, (submenus) of the special functions control of the special functions
KEY (+) for unlocking the door
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 is displayed.
Supply with feed water

The autoclave requires →demineralized or →distilled →feed water for
steam production according to →VDE 0510. The feed water supply is
provided either by an external water storage tank or with a water
® ®
treatment unit (e.g. MELAdem 40/ MELAdem 47). The autoclave
automatically sucks in the feed water.
Feed water with internal If you employ the internal storage tank for the feed water supply, you
storage tank must fill it manually from time to time. At the given point in time, the
autoclave outputs an appropriate message. Only use water according to
→VDE 0510 as →feed water.
Internal storage tank The internal storage tank holds maximum 5 litres. This quantity of →feed
water suffices for up to 7 sterilizations.
® ®
Distilling unit MELAdest 65 With the MELAdest 65 distilling unit, you can produce →feed water in
the practice cost-effectively.
Feed water via 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
autoclave. The purified feed water connection for the autoclave is
directly connected to the water treatment unit.
If you use a water treatment unit, then there is always sufficient feed
water available. You no longer have to manually fill the water storage
tank.
The waste water can either be collected in an internal storage tank and
manually emptied or automatically drained via the one-way drain.
12
® ®
Water treatment units The water treatment units MELAdem 40 and MELAdem 47 produce the
®
MELAdem 40 and optimal purified feed water quality for the autoclave. The selection of the
®
MELAdem 47 respective unit depends on the number of sterilizations per day and the
respective loads. Both MELAG autoclaves can be supplemented with a
water treatment unit.
NOTICE:
Please first consult with MELAG if you would like to employ water
treatment units of other manufacturers.
13
Chapter 3 – Initial start-up

 Who may set up, install and start up the autoclave

 Which prerequisites you must create for setting up, installing and starting up the
autoclave
Conditions for setting up, installing and

starting up
■ Only have the autoclave 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 areas subject to explosion hazards.
Danger! ■ The autoclave is intended for use outside the patient environment.
The minimum distance to the treatment area must have a radius of
at least 1.5 metres.
Damages to the autoclave and/or injuries can occur in case this
precaution is not observed.
Set-up location requirements

Location Set up the autoclave in a dry and dustproof location. The air humidity
should be 30% to 60% and the ambient temperature 16° to 26 °C.
■ Without fail, keep the specified distance free to the surrounding

surfaces at the sides and above the autoclave.
Warning! Non-observance can lead to heat accumulation. This could
adversely affect the function of the autoclave and entail the
shortening of the vacuum pump's service life and result in extended
program times.
Distance to the surrounding The distance to the surrounding surfaces must be at least 5 centimetres
surfaces on both sides and 10 centimetres at the back side. The autoclave should
be freely accessible from above, so that the built-in storage tank can be
filled and a good ventilation is guaranteed.
14
® ®
Space requirements Vacuklav 23 B Vacuklav 31 B+
Width A= 42.5 cm A= 42.5 cm
Height B= 48.5 cm B= 48.5 cm
Depth C= 75.5 cm C= 63 cm
D= 49.5 cm D= 37 cm
E= 8.5 cm E= 8.5 cm
F= 5 cm F= 5 cm
G= 10 cm G= 10 cm
® ®
maximum acoustic power for Vacuklav 23 B+ and Vacuklav 31 B+: < 65db (A)
Additional space for Other than for the autoclave, the water treatment unit for the feed water
feed water supply supply require space.
NOTICE:
In no case may you subject the water storage tank to sunlight. This way
you avoid algae formation.
The maximum suction height from the external storage tank is 1.5 metres.
®
Space requirement for MELAdem 40
water treatment unit  can be directly hung on to the autoclave on the side
 The attachment can be next to the autoclave or above or below the
autoclave
®
MELAdem 47
 Attachment next to the autoclave or above or below the autoclave
(e.g. lower cabinet)
 delivered with water storage tank
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
Connections required
■ The electric connections and connections for feed water and used
water may only be completed by a specialist technician.
Danger of injury! Non-observance could lead to a short-circuit and/or fire and/or water
damage and/or electrical shock. Serious injuries could be the
consequence.
15
Electrical connection Provide the following electrical connections for the autoclave:
 Electric circuit with 220V - 240 V and 50/60 Hz
 16 A separate fuse protection – at least Automat Type B
 Protection from leakage current 30 mA
®
Connected load as software version 4.07 2100 W for Vacuklav 23 B+/ 31 B+
®
software version 4.06 2500 W for Vacuklav 23 B+
®
2400 W for Vacuklav 23 B+
NOTICE:
In order to prevent water damage, MELAG recommends the use of a
leak monitor, e.g. water stop valve from MELAG (Art. No. 01056).
Waste-water drain In order to attach the autoclave to the effluent pipe, you can order an
upgrade set (MELAG Art.-No. 26695) from MELAG. The waste water is
collected in the water storage tank (waste water side) and flows through
the one-way outflow hose into the flush siphon, using the MELAG
double-chamber siphon (Art. No. 266359. The drain must be located at
least 30 cm beneath the autoclave.
NOTICE:
The waste-water hose must be laid dip-free with continuous descent.
For waste-water paths which are longer than two metres we recommend
a fixed laying of HT (high temperature) piping by a specialised installation
firm.
Observe the following precautionary measures when handling the

mains cable and power plug:
■ Never splice or modify the mains cable.
■ Never bend or twist the mains cable.
Danger! ■ Never pull on the mains cable to take it out of the socket. Always
take hold of the power plug itself.
■ 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).
■ Do not run the mains cable along a heat source.
■ 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 autoclave.
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. Serious injuries could
be the consequence.
Insert power plug into the Plug the power plug into the socket.
socket
16
Prerequisites for initial start-up

The following prerequisites must be satisfied for initial start-up:
 The feed water supply must be secured.
 The power supply of the autoclave must be assured.
Record of installation and setting up
NOTICE:
As documentation of proper setting up, installation and setting up as well
as for your warranty claim, the record of installation must be filled out by
the person responsible and a copy sent to MELAG.
Switch on autoclave
Switch on mains Turn the mains switch on to power the autoclave (page 10, Fig. 1/(4).
After switching on  After switching on the autoclave with the mains switch, the →display
shows in alternation to the initial state the message Unlocking
door with button (+), if the door is closed.
Directly after having switched on the autoclave and before initial start-up,
remove the trays and accessories from the chamber.
 Press the KEY (+) to unlock the door. After pressing the key you can
open the door
17
Chapter 4 – Sterilization
 Which prerequisites should be created for a smoothly-running sterilization

 How to switch between internal and external feed water supply
 What you should observe when preparing the items to be sterilized
 How to correctly load the autoclave
 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 you use an internal storage tank for the feed water supply, fill this
with feed water of the respective quality (see page 36, Use
qualitatively high-grade water). You can use the removable funnel
insert to conveniently fill fresh feed water into the right chamber of
the storage tank up to the MAX mark. Simply remove the filter for
cleaning.
®
 If you employ a water treatment system, e.g. MELAdem 40,
®
MELAdem 47, and the water feed is closed, then open it up. If the
®
water storage tank of the MELAdem 47 is empty, turn the water feed
tap on at least one hour before the sterilization..
Switching on  If the autoclave is still not switched on, switch it at the mains switch
(page 10, Fig. 1/(4)). (See as of page 17, Switch on autoclave).
Select feed water supply

Depending on whether the feed water should be supplied from the
internal storage tank or whether you employ a water treatment unit for
the feed water supply, select the appropriate setting on the display.
 Select the setup menu function by simultaneous brief pressing of
the KEYS (+) and (-). The display shows Function: Last batch
number..
 Navigate with the KEY (+) or (-), up to the display
Function: Feed water–supply.
 Press the KEY (P). The currently set option appears on the display,
e.g. Feed water-supply – intern.
 To set the value to Feed water-supply – extern, press the
KEY (P) again.
18
 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 intern.
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.
NOTICE:
If possible, sterilize textiles and instruments separately from each other in
separate sterilization containers or sterilization packages.
This way you achieve improved drying results.
Textiles Observe the following instructions for treating textiles and putting
the textiles into sterilization containers:
■ Comply with the instructions of the textile manufacturer for treatment

and sterilization and observe relevant standards and directives.
Danger! ■ Adjust the folds of the textiles parallel to each other.
■ Stack the textiles in the sterilization containers vertically if possible,
and not too closely together, so that flow channels can form.
■ Retain the vertical stacking method when you pack the textiles in
sterilization containers.
■ If textile packages do not stay together, wrap the textiles in
sterilization paper.
■ Sterilize only dry textiles.
■ The textiles may have no direct contact to ground and walls of the
sterilization chamber, otherwise they absorb →condensate.
In case of non-observance, the steam penetration of the textiles can
be obstructed and/or bad drying results can result. Unsterile textiles
could be the consequence. This could mean endangering the health
of the patient and the practice team.
19
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.
■ Clean the instruments very thoroughly, for instance with the help of a
thermal 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. Rests of the
disinfection and cleaning agents lead to corrosion. Increased
maintenance requirements and impairment of the function of the
autoclaves 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
 Cleaning and disinfection devices (e.g. thermal disinfector)
Load the autoclave

Only if the autoclave is properly loaded can the sterilization be effective
and the drying deliver good results.
NOTICE:
Use perforated trays, such as the trays from MELAG. Only this way can
→condensate run off. If you use closed materials or shell halves to bear
the items to be sterilized, you risk bad drying results. Please note that the
use of tray insertions made of paper can perhaps likewise lead to worse
drying results.
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.
Warning!
You can employ reusable rigid packaging such as standard tray

cassettes or soft packaging such as clear-plastic sterilization packages,
paper bags, sterilization paper, textiles, fleece.
Closed sterilization - Preferably use sterilization containers made of aluminium. Aluminium
containers conducts heat well and thus accelerates drying.
20
When using closed sterilization containers, observe the following

instructions for holding the →sterilizing materials:
■ Closed sterilization containers must be equipped at least on one side
– possibly below – with perforations or valves.
Warning! Non-observance leads to insufficient steam penetration which could
make the sterilization ineffective. Furthermore the condensate
drainage is prevented, and bad drying results are the consequence.
This can ultimately lead to unsterile instruments and thereby to
endangering the health of the patient and the practice team.
The sterilization containers from MELAG satisfy all requirements

according to →DIN EN 868 for successful sterilization and drying. They
are perforated in the lid and floor and are equipped with disposable paper
filters.
Stack sterilization Stack on top of each other, if possible, only sterilization containers of the
containers same size, where the →condensate can run off on the side at the walls.
■ When stacking the sterilization containers, take care that the

perforations are not covered.
Danger! In case of non-observance, the condensate cannot drip off to the
vessel bottom. It would soak sterilizing materials lying underneath.
The consequence would be bad drying results. This can ultimately
lead to unsterile instruments and thereby to endangering the health
of the patient and the practice team.
Soft sterilization wrapping →Soft sterilization packages can be sterilized both in sterilization
containers on trays or standing when using a package holder. When
®
using soft sterilization packages such as MELAfol , observe the
following instructions:
■ Arrange the →soft sterilization packages standing vertically at small

intervals to each other.
Warning! ■ Do not place several soft sterilization packages flat on top of each
other on a tray or in a container.
■ If the welding 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 welding seam tears open during sterilization, extend the sealing
cycle of the package sealing device or weld a double seam.
Non-observance can ultimately lead to unsterile instruments and
thereby to endangering the health of the patient and practice team.
Multiple wrapping The autoclave functions on the →fractionated pre-vacuum method. This
permits the use of →multiple wrapping.
Mixed loads For sterilizing mixed loads, observe the following instructions:
 Always place textiles on the top
 Sterilization containers at the bottom
 Unwrapped instruments at the bottom
 Transparently wrapped sterilization packages and paper packaging
on the top – exception: in combination with textiles on the bottom
 The heaviest loads at the bottom
 Stack transparently wrapped sterilization packages if possible
edgewise in such a way that alternately paper side lies on paper side
and foil side on foil side; if this is not possible, then with the paper
side facing downwards.
21
® ®
Loading variants Vacuklav 23 B+ Vacuklav 31 B+
Instruments Textiles Instruments Textiles
Greatest weight per 2 kg 1.8 kg 2 kg 1.8 kg

single piece
Loading variant max. 5 trays, depth 420 mm max. 5 trays, depth 290 mm
mounting A* max. 6 sterilization containers 15K max. 3 sterilization containers 15K
max. 3 sterilization containers 15M
max. 2 sterilization containers 15G
max. 6 sterilization containers 17K max. 3 sterilization containers 17K
max. 1 sterilization containers 17G
max. 3 swab drums 17R max. 3 swab drums 17R
max. 1 sterilization container 23G
max. 2 swab drums 23R max. 2 swab drums 23R
max. 2 sterilization containers 28M max. 2 sterilization containers 28M
max. 1 sterilization containers 28G max. 1 sterilization container 28G
max. 3 standard tray cassettes max. 3 standard tray cassettes
Maximum total weight 5 kg 1.8 kg 5 kg 1.8 kg
*Mountings, trays, sterilization containers, norm-tray cassettes from MELAG, see Appendix A – Accessories
Close the door

When closing the door of the autoclave, observe the following
instructions:
 Close the door with light pressure against the chamber flange and
simultaneously press down the sliding-closure grip.
Select 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.
22
Programs Wrapping Especially Sterilization Operating Drying Load

suitable for at time* 23 B+/31 B+
Universal- →single and →Mixed loads;
Program →multiple long, narrow-bore 134 °C 30 min 20 min 5 kg
wrapping hollow bodies
Quick- only Simple →solid

Program S unwrapped instruments,
(no textiles) transmission 134 °C 15 min 5 min 5 kg
instruments; simple
hollow bodies
Quick- →single Narrow-bore hollow single wrapped

Program B wrapped and bodies 1.5 kg
unwrapped 134°C 28 min 10 min
(no textiles) unwrapped
5 kg
Gentle- →single and Larger quantities of Textiles

Program →multiple textiles 1.8 kg
wrapping
Thermo-instable goods
121 °C 45 min 20 min Thermo-
(e.g. plastic, rubber
articles) instable Goods
5 kg
→Mixed loads
Prion- →single and Instruments where a

Program →multiple danger of infection by
wrapping pathologically-modified
134 °C 45 min 20 min 5 kg
proteins is suspected
(e.g. Creutzfeld-Jacob,
BSE)
® ®
* without drying (full load in the Vacuklav 23 B+ und Vacuklav 31 B+: 5 kg) and depending on the load and
installation conditions (such as the supply voltage)
Select automatic pre-heating

With the automatic pre-heating, the chamber of the autoclave before a
program start is kept to the program-specific pre-heating temperature or
maintained at this temperature between two program runs.
Prerequisite is that the autoclave 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.
In order to change this setting if desired, proceed as follows:
 Select the SETUP Menu Function by brief simultaneous pressing
of the KEYS (+) and (-).
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.
NOTICE:
MELAG recommends the activation of automatic pre-heating.
23
Select additional drying

For difficult drying tasks you can extend the drying time of a program by
50% with the function Additional Drying.
For this proceed as follows:
 When starting the program, Simultaneously press the KEY (S) AND
KEY (+).
The display shows Supplement drying selected. Then the
program sequence begins.
Start program
Program Start-Stop
If you have selected a program with the program selection button, in
addition to the selected program the sterilization temperature is displayed
and whether the respective program for packaged or unpacked sterilizing
materials is suitable.
 Press the KEY (S), in order to start the program.
The autoclave 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 is running
After the start of the program you can track the program steps on the
→display. Chamber temperature and pressure as well as the duration
until the end of sterilization or the expired drying time is displayed.
Evacuation phase In the Evacuation Phase (fractionation) air is evacuated repeatedly until a
program-dependent pressure is reached. This occurs in alternation with
the inflow of steam up to a slight overpressure.
Program Start-Stop Depending on selected program and the current chamber temperature at
program start, additional →fractionations are connected.
Heating-up phase The heating-up phase follows after the evacuation phase. The pressure
and the temperature climb with continual steam introduction in the
chamber until the sterilization parameters are reached.
Sterilization phase After achieving the sterilization parameters of pressure and temperature,
the sterilization phase begins.
In alternation with pressure and temperature the remaining time of the
sterilization phase is also displayed.
A pressure discharge with a corresponding display is carried out at the
end of the sterilization phase.
Drying phase The drying phase begins after the pressure discharge.
The chamber is ventilated with simultaneous pressure compensation at
the end of the drying cycle.
The regular drying time is 5 minutes for the Quick-Program S, 10 minutes
for the Quick-Program B and 20 minutes for the other programs.
24
Manually terminate program

You manually terminate a running program in any of the phases.
IMPORTANT!
Do not interrupt a running program by disconnecting the power plug! In
case of non-observance, an error message of power loss is displayed
when the autoclave 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,
Danger of burning! depending on when the program was terminated.
■ Use a tray lifter to remove the tray. Never touch the →sterilized
items, the chamber or the door with unprotected hands. The parts
are hot.
■ To remove tray cassettes, use a tray-lifter or gloves. The parts are
hot.
In case of non-observance, you can suffer burns.
Manual termination before If you terminate a program before the beginning of drying, then the
beginning of drying →items to be sterilized are still unsterile.
Program Start-Stop
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).
NOTICE:
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 the termination, a pressure discharge

or ventilation of the instrument is carried out. An appropriate display is
shown on the screen.
After the pressure discharge or ventilation 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.
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 with the KEY (S).
during drying
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 autoclave.
In the drying phase, the expired drying time is shown in alternation with
25
the message Immed. Removal Press "Stop" is displayed.

To terminate the program, carry out the following steps:
 Press the KEY (S).
 Confirm the following prompt Stop program? Repeatedly press
"Stop" with the KEY (S).
The termination is confirmed with Drying stopped on the display.
NOTICE:
The confirmation prompt is shown for about 5 seconds on the display. If
the key is not repeatedly pressed, the program continues with the normal
process.
After the ventilation of the chamber with a corresponding display text the
message Universal-Program run successfully follows in
alternation with Last batch number. xx and quit with ’+’.
If a printer or another output medium is connected to the autoclave 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 has
successfully finished successfully completed.
The remaining time of the sterilization phase is displayed in alternation
with the specification of the pressure and temperature.
Sterilization not successfully The sterilization is not successful if it was terminated by the operator or
finished aborted by the system in the event of an error.
Program abort by the system At a system abort, the system puts the chamber into a pressureless
state.
NOTICE:
If the program is terminated by the operator, a warning text appears. If
the program is aborted by the system, an error message is displayed.
Drying phase
The autoclave 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  Load the autoclave correctly for drying. Place items wrapped in
sterilized clear plastic or paper upwards like filing cards.
Observe Section Load the autoclave on page 20. Possibly employ
the package holder.
 Activate the function Supplement Drying. Observe the Section
Select additional dryingon page 24.
Program is finished
The chamber pressure is adapted to the ambient pressure at the end of a
program. If the program was successfully finished, an appropriate
notification appears on the →display.
26
Immediate printout The report of the completed program is issued to the selected output
medium for activated immediate output (see page 29, 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. This is also shown if the program was
terminated by the operator or aborted by the system.
You can also allow the display of the last batch number whenever
necessary:
 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 allow the display of the number of total →batches.
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 open the door by force. The autoclave could be damaged
and/or hot steam could escape.
■ Use a tray lifter to remove the tray.
■ Never touch the →sterilized items, the chamber or the door with
unprotected hands. The parts are hot.
In case of non-observance, you can suffer burns.
■ Check the wrapping of the sterilized objects for damage when

removing them from the autoclave.
Danger ■ 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 patient and the practice team.
Open door After the end of a program, the request Quit with button ’+’ is
displayed. Press the KEY (+) to unlock the door. After unlocking the door
audible, you can open the door and remove the sterilized items.
For connected output medium and Immediate Output Yes a logging

printout is additionally carried out (see page 33, Automatic immediate
log output.
27
Condensate residues on the If you remove the →sterilized items from the autoclave directly after the
sterilized items end of the program, it can happen that slight quantities of condensate
moisture are found on the sterilized items.
Smaller quantities of water which may be are found on the upper side of
the paper bags and clear plastic sterilization packages are
unobjectionable if they dry out within 30 minutes after removal from the
autoclave.
Storage of sterilized items

Exclusively employ packaging which complies to 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 packaging 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.
28
Chapter 5 – Logging
 Why and how you document batches

 Which output media you can employ for the batch documentation in which way
 How to read the logs correctly
 How to set the date and time at the autoclave
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 type of program as well as →batch and process
parameters of the completed programs, are stored in an internal log
memory of the autoclave.
For the batch documentation you can transfer the internal log memory
readout and the data onto diverse output media. This can take place
immediately after every completed program or subsequently, e.g. at the
end of a work day in the practice.
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 report is automatically overwritten.
If you have connected a printer and additionally the option immediate
output is set to No (see also Page 33, Automatic immediate log
output), a confirmation prompt appears before the saved record is
overwritten. For additional information on connecting the printer, see
page 30, Connect printer.
Output media You can store the logs of the completed programs on the following output
media and archive them accordingly.
®
 Log printer MELAprint 42
 MELAflash CF card Printer on CF card
® ®
 Computer, e.g. with software MELAwin / MELAview
 MELAnet Box
 Modem
State on initial delivery No option for the output of the logs is set in the initial delivery state of the
autoclave. You can read below how to output the logs on the cited media.
29
Set date and time

Observe time re-settings Date and time of the autoclave 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:
 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 with the KEY (+)
or (-): 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) in to leave the menu
On the display, the Function: Date/Time are again displayed
By pressing the key (S) again you leave the menu completely and the
display again shows its starting position.
Use printer as output medium

®
If you want to employ the log printer MELAprint 42 as the output
medium, connect it to the autoclave as follows:
Data connection Open the white cover of the serial data- and printer connection (see page
from the autoclave 10, Fig. 1/ (6)):
(1)  Turn a coin by a quarter-revolution inserted in the locking slot (1) on
the white cover.
 Take cover off and fold the interior metal casing to the left.
(2)  Press the metal casing somewhat downwards until it engages and
no longer can automatically flip back.
 Connect the cables of the log printer to the printer connection at the
autoclave.
If the printer or a computer is continually connected to the autoclave, the
Connect printer
data connection cable of the log printer is laid in the cable ducts (2), the
metal casing retracted and the cover is closed again. This provides a
comfortable external cable connection to the printer.
®
Close the log printer MELAprint 42 according to the pertinent operating
manual.
Initialisation of the log In order to be able to print out logs on the connected log printer, you
®
printer must initialise MELAprint 42 once by making the following setting at the
30
®
MELAprint 42 autoclave:
 If the autoclave is still not switched on, switch it on.
 Wait until the display shows the basic settings (page 12, Control
Panel)
 Navigate with the KEY (+) or (-) until 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.
 Navigate with the KEY (+) or (-), until the display shows as output
medium MELAprint.
 For confirmation press the KEY (P). The display changes back to the
menu Batch output – Output medium.
 Press the KEY (S), in order to confirm and return to the menu
Function: Batch output.
 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
log printer and its communication with the autoclave, a test output can be carried
®
MELAprint 42 out:
of the keys (+) and (-).
 Navigate with the KEY (+) or (-) until on the display Function:
Batch output is shown.
 Press the KEY (P) to select the submenu Batch output –
Output medium is displayed and press the KEY (P) for
confirmation.
 Navigate with the KEY (+) or (-) until the display Test output is
shown.
 In order to start the output, press the KEY (P).
An appropriate display with Test output appears.
 In order to break cancel the test output or leave the menu after
finished printout, press the KEY (S). The display shows Function:
Batch output.
 By again pressing the KEY (S), you completely leave the menu and
31
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.
®
Additionally you can use the software MELAview for processing the
logged data.
TIP
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 with the serial interface like the
®
log printer MELAprint 42 (see page 30). and set at the autoclave as
output medium MELAflash in the SETUP Menu.
You will find detailed information in the operating manual for the
MELAflash CF card Printer itself.
NOTICE:
Naturally you can also allow the MELAflash CF card Printer to be
connected permanently to the autoclave like the log printer
®
MELAprint 42.
MELAnet Box as output medium

The MELAnet Box enables the connection of the autoclave with a real
ethernet interface to the computer network of the practice or clinic.
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 webserver program, which
displays status information of the connected autoclave and settings for
the MELAnet Box via a webbrowser. Thus you can allow the display of
the current progress of a program cycle or current measured values.
Connect the MELAnet Box with the serial interface like the log printer
®
MELAprint 42 (see page 30) and set at the autoclave as output medium
MELAnet in the SETUP Menu Function.
You will find detailed information in the operating manual for the
MELAnet Box itself.
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 with the serial interface to the autoclave.
®
Additionally the software MELAview can be installed for the log readout.
In order to register the computer at the autoclave, proceed as described
on page 30, Initialisation of the Log Printer.
Observe that for the output medium in the SETUP Menu Function you
must set at the autoclave as output medium Computer.
32
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  As output medium the computer, the log printer MELAprint 42 or
another output medium must be connected and initiated.
This sets the option for an immediate output of the logs after the end of
the program:
 Switch the autoclave on with the power switch.
batch number.
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.
NOTICE:
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.
Output the logs subsequently

You also have the option of outputting the logs subsequently and
independently from the time of the end of the program. You can select
whether selected or all saved logs (up to 40 logs) should be printed.
For this, use the connected output medium, e.g. the log printer.
Print selected logs In order to subsequently print selected logs of certain programs, proceed
as follows:
of the keys (+) or (-). The display shows Function: Last batch
number.
 The Menu Batch output – Output medium is displayed.
 Navigate with the KEY (+) or (-) until the display
Last cycle output: No. 40 is shown (as example No. 40).
 Press the KEY (P). The current report number blinks.
 In order to output a log of another cycle, navigate with the KEYS (+) or
33
(-) 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.
return back to the basic position of the display.
Print all saved logs In order to subsequently output all saved logs, proceed as follows:
of the keys (+) or (-). The display shows Function: Last batch
number.
 Navigate with the KEY (+) or (-), until the display Output stored
cycles is displayed.
 Press the KEY (P) in order to start the printout of the selected
program. The display shows Output.
After finishing the output the display again shows Output stored
cycles.
 In case you would like to leave the submenu without printing, press
the KEY (S).
NOTICE:
A termination during the output on the log printer is only possible by
disconnecting the instrument 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 setup menu Function: Batch output.
Delete stored 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.
of the keys (+) and (-).
Program Start-Stop
 Navigate with the KEY (+) or (-) until on the display All cycles
delete is shown.
 Press the KEY (P) in order to delete all logs now.
 In order to cancel the submenu without deleting, press the KEY (S).
 In order to leave the menu after deletion, press the KEY (P). The
display shows Function: Batch output.
34
Display protocol memory

Program Start-Stop
With a connected and initialised printer or another output medium you
can verify how many logs are already saved in the log memory of the
autoclave.
Proceed as follows:
batch number.
 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.
Read log files 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 autoclave type.
Values of the program steps 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.
35
------------------------------------------ Header
MELAG Vacuklav 31-B
------------------------------------------
Program : Universal program Started program
134°C wrapped
Date 07.10.2007 Current date
Time 21:34:07 (Start) time at program start
Batch No.: 100
daily batch number
Preheating 80.9 °C Preheating temperature

AIN6:Conductivity 7 µS/ cm
→conductivity of the →feed water
Program step Press. Temp. Time Values of the program steps

bar °C min.
Start 0.01 26.3 00:00

1. Fractionation
Evacuation -0.92 26.3 02:26
Steam entry 0.40 105.2 06:13
2. Fractionation
Evacuation -0.82 65.6 06:11
Steam entry 0.41 109.4 09:29
3. Fractionation
Program sequence phases with the accompanying
Evacuation -0.82 59.9 10:57
Steam entry 0.41 109.4 12:42 values for pressure, temperature and time (relative
Heat-up 2.04 134.1 14:52 to the program start)
Steriliz. begin 2.04 134.1 14:52
Steriliz. end 2.18 135.7 20:22
Press. release 0.20 105.2 21:03
Vacuum-drying
Drying begin -0.34 92.6 21:12
Drying pressure -0.92 52.9 23:10
Drying end -0.83 58.0 41:12
Ventilate -0.26 60.4 41:23
End 0.00 61.5 41:35
------------------------------------------ Summary
Program properly executed! Control message
Temperature : 135.7 +0.3 /-0.3 °C Mean sterilization temperature with max.
Pressure : 2.17 +0.03/-0.03 bar deviations
Sterilizate time: 5 min 30 s
Mean sterilization pressure with max. deviations
Time : 22:15:42 (End)
Sterilization time maintained
========================================== Time at the end of the program
67 200703066 4.06 4.06 Information with total-cycle counter, factory serial
CRC: 0xB3C5 V1.30A number and instrument software version no.
36
Chapter 6 – Maintenance
 How to clean the autoclave and which cleaning agents are suitable
 How to avoid the formation of spots
 How to exchange the door seal
 What to observe in autoclave maintenance
Cleaning
Weekly inspection of Examine the chamber including door seal and chamber sealing surface
chamber, door seal, and the mounting for loading (page 20, Load the Autoclave) once
mounting, chamber sealing weekly for contaminants, deposits or damage.
surface
In case of contaminations If you determine any contaminations, draw the existing trays or cassettes
and the associated mounting forwards out of the chamber. Clean the
contaminated parts.
Door seal The door seal must not be greased or oiled. It should be kept clean and
dry.
When cleaning the chamber, the loading mounting, the chamber

sealing surface and the door seal, observe the following:
Warning! ■ Switch the autoclave off before cleaning and pull the power plug from
the wall socket.
■ Make sure that the chamber is not hot.
■ Use a soft and lint-free cloth.
■ Use chlorine- and vinegar-free cleaning agents.
■ First drench the cloth with cleaning alcohol or methylated alcohol and
try to wipe off the contamination.
■ In case of persistent soiling of the chamber, mounting or chamber
sealing surface, employ only a mild →stainless steel cleaning agent
with a pH value between 5 and 8.
■ Employ neutral liquid cleaning agents to clean the door seal.
■ No cleaning agents may get into the piping system which exits the
autoclave 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.
Housing parts Clean the housing parts with neutral liquid cleaners or methylated
alcohol.
Internal storage tank for feed If you provide the feed water supply manually via the internal storage
water tank, check for soiling when you refill the feed water. If necessary, clean
the tank with a cloth and fresh feed water before refilling.
37
Notice:
Make sure to wipe up and remove any soiling or impurities from the tank
with a cloth without leaving any residues. If dirt particles are only
detached but not actually removed, they can get into the dirt particle filter
integrated into the drain hose while emptying the wastewater tank.
Non-observance could impair the service life of the dirt particle filter
and make it necessary to exchange the filter at short notice.
Clean the left side of the water storage tank ( waste water) every two
weeks.
The both chambers are emptied as follows:

 Attach the drain hose on a quick-fitting connection (left of the waste-
water tank, to the right of the feed-water tank), until this perceptibly
engages
 Drain off the water into a container with at least 5 litres holding
capacity.
To remove the drain hose again, press the grey release knob at the
quick-fitting connection. The hose detaches itself automatically from the
connection.
Please observe the following when removing the quick-fitting

connection:
Warning! ■ When draining the storage chambers, stand to the side of the
connection
■ Be sure to hold the hose tight with the other hand while pressing on
the grey release button of the quick-fitting connection in order to
arrest the spring tension of the connection.
Non-observance can lead to injuries.
 Repeat the procedure for the other chamber if necessary.
Avoid formation of spots

Formation of spots due to Only if you correctly clean the instruments before sterilization can you
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 autoclave and deposit as stains, spots or discolorations on
the instruments and in the chamber (see page 19, Prepare items to be
sterilized).
Formation of spots due to All steam-conducting parts of the autoclave are made of non-rusting
third-party rust materials. This excludes the formation of rust caused by the autoclave.
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 autoclave.
Remove third-party rust from the instruments with a chlorine-free
→stainless steel cleaning agent (see page 37, 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 of the the quality of the →feed water employed for steam production.
feed water
38
Use qualitatively high-grade feed water

Observe the following when using →feed water for the steam sterilization:
■ Use only →demineralized or distilled water according to →DIN EN
Warning! 13060, Appendix C (VDE 0510).
In case of non-observance, stains or damage on the instruments
can arise and the functional readiness of the autoclave can be
adversely affected.
Water according to VDE You can also use distilled or demineralized water from do-it-yourself
0510 markets, pharmacies or service stations as →feed water, if the →VDE
0510 is explicitly noted on the label of the packaging.
NOTICE:
→Feed water which you can inexpensively produce with the osmosis
® ®
processes with MELAdem 40 or with the ions exchanger MELAdem 47
®
or by distillation with MELAdest 65, satisfies the requirements on the
feed water.
Exchange the door seal

If the door seal shrinks or is wavy, it is necessary to exchange the door
seal.
The consequence can be poorly sealed areas which can lead to the
leakage of steam or cause a too high leakage rate in the vacuum test.
Open the door of the autoclave and take the old door seal out. The door
seal is only inserted in the groove of the door plate (page 11, Fig. 2/(5)).
Set the new door seal (Art.-No. 58510) in the groove in such a way, that
the wider sealing surface shows toward the chamber side.
IMPORTANT!
Observe without fail the different widths of the sealing surface. Only
with correct seating in the groove is a proper closing of the door
guaranteed and the chamber tight.
Maintenance
■ Have maintenance carried out only by trained field service
technicians or technicians of the specialist trade. Turn to your
Warning! specialist dealers or MELAG customer service in your vicinity.
■ Comply with the predetermined maintenance intervals.
Malfunctions at the autoclave can occur on continuation of
operation despite the servicing message.
39
For retention of value and Regular maintenance is indispensable for the retention of value and the
functional reliability reliable practice operation of the autoclave.
During maintenance, all functional and safety-relevant components and
electrical facilities are checked, and replaced if necessary. The
maintenance is carried out according to the maintenance instructions
which are relevant for this autoclave.
Maintenance intervals Regularly allow for maintenance after each 1000 program cycles or two
years.
NOTE:
National pressure vessel requirements may ask the user of pressure
vessel, such as autoclaves, to carry out safety inspections. Please check
the download area from our website and find our recommendation in
accordance with German requirements. For more information ask your
local authorities.
40
Chapter 7 – Operating pauses

 How quickly you can start sterilization programs in sequence

 What you must observe for longer operating pauses
 How to put the autoclave out of operation, transport it and re-start it
Sterilization frequency
No pause times Pause times between individual programs are not required, since the
required →sterilization chamber is permanently maintained at the required
temperature.
After the expiration or termination of the drying time and removal of the
→items to be sterilized, you can immediately re-load the autoclave and
start a program.
Pause times
Longer operating pauses Switch the autoclave off for longer operating pauses, e.g. overnight or on
the weekend, and leave the door ajar. The door seal is relieved and
protected from premature wear. Furthermore it prevents the sticking of
the door seal.
Close, if available, the water feed of the water treatment unit.
After operating pauses which last longer than two weeks, carry out a
vacuum test and thereafter an empty sterilization with the Quick Program
(see page 43, Chapter 8 – Function test)
The following situations can occur after longer pauses:
Event Possible cause What you can do

→conductivity too high Bad feed water Change the →feed water or the mixed-bed-
®
resin pellets for a MELAdem unit.
Door cannot be opened Door seal is sticking to the Switch the autoclave on and pull vigorously at
sealing surface the door to open it.
Function test after pauses After pauses, carry out the tests described in Chapter 8 – Functional
Tests, depending on the pause duration.
41
Shut-down
If you would like to shut down the autoclave (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 autoclave off at the mains switch.
 Pull the power plug from the wall socket.
 Empty both chambers of the storage tank
 Close, if available, the water feed of the water treatment unit.
Transport
Observe the following when carrying the autoclave:
■ Two people are necessary to carry the autoclave.
Danger of injury!
■ Use a suitable carrying strap to transport the autoclave.
Observe that the spacing between the underside of the housing floor
plate of the autoclave and the footprint is small.
In case of non-observance spine damage and contusions can result.
Observe the following when transporting the autoclave, e.g. when

moving or shipping the autoclave or for the transport within the
Warning! practice:
■ Empty both chambers of the storage tank
■ When using a water treatment unit, close the water feed and removal
the hose connections at the rear of the device.
■ If you would like to leave the mounting and the trays or cassettes in
the chamber during transport, protect the surface of the door plate.
Lay a piece of foam plastic or bubble wrap between the door plate
and mounting.
■ Close the door of the autoclave before you move the device.
In case of non-observance, damages to the autoclave and errors can
occur.
Re-startup after change of locality

At re-startup of the autoclave after a change of locality, proceed as for an
initial start-up (see page 14, Chapter 3 – Initial start-up)
42
Chapter 8 – Function test

 How the autoclave automatically carries out the function test

 Which possibilities you have for the manual function test
 Which function tests should be conducted in daily operation
 Why and how you should conduct a vacuum test
 Why and how you should conduct a Bowie & Dick test
 How you carry out batch-related tests
 How you display the water quality
Automatic function test

Process evaluation and The interaction of the sterilization-relevant parameters of pressure,
monitoring system temperature and time are continually automatically monitored by the
electronic parameter control.
The →process evaluation system of the autoclave compares the process
parameters with each other during the program and monitors them with
respect to their limit values.
The monitoring system of the autoclave checks the device components
with regard to their functional reliability and their plausible interaction. If
the parameters exceed defined limit values, the autoclave outputs
warning messages or error messages. If necessary, it aborts the
program with a corresponding notice.
If the program was successfully concluded, an appropriate message is
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
29, Chapter 5 – Logging)
43
Testing in daily operation
Vacuum test
Weekly in routine operation,  Conduct a vacuum test in the following situations:
at initial start-up, after  Once weekly in routine operations
pauses longer than two  At initial start-up
weeks and in case of error
 After longer operating pauses
 In case of a respective error (e.g. in the vacuum system)
The test serves to determine leaks in the autoclave.
The leakage rate is determined.
Conduct the vacuum test with a cold and dry autoclave as follows:
 Switch the device on at the mains switch. The display switches into
its initial state.
 Press the KEY (P) until the menu Vacuum test is shown in the
display.
 Close the door.
 Press the KEY (S), in order to start the vacuum test.
The chamber is →evacuated until the pressure for the vacuum test is
achieved. An equilibration time of five minutes and a measurement time
of ten minutes follow. The rise in pressure in the chamber is measured
within the measurement time.
The evacuation pressure and the equilibration time or measurement time
are shown on the display.
After the expiration of the measurement time, the chamber is ventilated
(appropriate display message).
Subsequently the message with specification of the leakage rate is
shown on the →display. If the leakage rate is too high, i.e. above 1.3
mbar, an appropriate message appears on the display.
Besides the display shows in alternation with the current batch number of
the day and Quit with button ’+’. After pressing the KEY (+) you
can open the door.
NOTICE:
For connected log printer or another output medium and the setting
Immediate output Yes logging is carried out with simultaneous
printout.
44
Bowie & Dick test

The →Bowie & Dick test serves the verification of the steam penetration
of porous materials such as textiles.
Diverse test systems are offered by specialist dealers for the →Bowie &
Dick test. Conduct the test according to the manufacturer's instructions
of the test system.
Start the program Bowie & Dick test as follows:
 Switch the device on at the mains switch. The display switches into
its initial state.
 Select the Bowie & Dick test with the KEY (P).
 Press the KEY (S) to start the Bowie & Dick test.
 After successful completion of the program the display shows in
alternation with the current batch number of the day and Quit with
button ’+’. After pressing the KEY (+) you can open the door.
Helix test body system MELAcontrol® / PRO

®
Batch-related tests The test body system MELAcontrol /PRO is an indicator and batch
monitoring system which satisfies the standard →DIN EN 867-5. It
consists of a test specimen, the helix, and an indicator strip.
®
If you sterilize instruments of the category "Critical B", the MELAcontrol
/PRO test specimen should be included as a batch control for every
sterilization cycle.
Independent of this you can at all times conduct a steam penetration test
®
with the MELAcontrol /PRO n the universal program.
The proper use of the Helix test body as directed can nevertheless result
in a discoloration of the plastic surface. However, this discoloration has
no influence on the functional capability of the Helix test body.
Display water quality

You can at all times have the display of water quality shown on the
switched on the autoclave, also during a running program.
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.
45
Chapter 9 – Errors
 Which type of messages exist

 What you should do in case of errors
 What you can do before calling the Hotline
 What you can do if no display appears
 What you can do when the feed water consumption is too high
 What you can do if there are bad drying results
A warning is not an error

Not all messages which appear on the →display are error messages.
Warning messages
Warning messages are displayed when necessary. Warning messages
are not error messages. They help to ensure smooth operation and to
recognize undesirable conditions. Observe these warning messages
promptly in order to avoid errors.
Error message
Error messages are displayed if safe operation or sterilization security is
not guaranteed.
These can appear on the →display shortly after switching on the
autoclave or while a program is running.
The program is aborted if a malfunction occurs during a program run.
■ If a program is aborted during the sterilization phase, the load is

unsterile. Repackage and repeat the sterilization for the respective
Danger of infection! →items to be sterilized.
Non-observance endangers the health of your patients and the
practice team.
The error message is then shown on the display. in alternation with the
current program phase (Pressure release, Ventilation or End)
After the program abort or termination, the error message is shown on
the display in alternation with the message acknowledge with
button
’-’and Stop/End. In order to delete the error message, press the
KEY (-).
46
Before you call

Follow the operating procedures shown in connection with a warning text
or an error message on the →display of the autoclave. You will find the
most important events in the following table. Possible causes and
appropriate operating instructions are listed for the events.
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 to help you, keep the
serial number of your autoclave and a detailed fault description of the
fault report ready.
Warning message Possible causes What you can do

Warning: Door open / Door switch is not closed on Push the sliding closure grip downwards until
No start possible start the stop. Correct display: Door closed.
Warning: No feed water/ Only if feed water supply from

Refill feed water – No start internal storage tank:
possible
Not enough feed water in the
internal storage tank Check feed water level in the internal storage
tank check, if necessary refill feed water.
Warning: No feed water/ The warning message appears Feed water supply from internal storage
Check feed water supply after program start. The built-in tank:
flow monitor doesn't close
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
®
Feed water-supply from MELdem 47
Check water treatment unit, possibly open
inflow to the unit. When the pressure reservoir
is empty about 1 h after restart and the
message is repeated, have the water treatment
Notice! At the first start-up or re-start-up, this
message can occur once since the piping
system is still not completely filled: restart.
Feed water quality bad/ Conductivity of the feed water Still possible to start by repeatedly pressing
exchange cartridge/ module too high the KEY (S):
Conductivity ≥ 40 µS Feed water-supply off
®
Mixed-bed resin pellets MELAdem 40:
consumed
Switch the mixed-bed resin pellets (Art. No.
61026), see Operating Manual for the water
®
treatment unit MELAdem 40.
47

Mixed-bed resin pellets in the ®
MELAdem 47:
after ion exchanger
(3rd cartridge) consumed Switch mixed-bed resin pellets (Art. No. 37470),
see Operating Manual for the water treatment
®
unit MELAdem 47 and examine the unit
On repeated occurrence, have maintenance
carried out by MELAG customer service or
service of the specialist trade. Possibly the pre-
and activated carbon filter must be exchanged
in addition.
Mixed-bed resin pellets in For another water treatment unit:

reverse osmosis facility
consumed Exchange module/ resin cartridge according to
the operating manual of the manufacturer
On repeated occurrence, carry out
maintenance.
NOTICE: 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 Start no longer possible:
insufficient/ No start too high
possible See warning message: Feed water quality bad/
Conductivity ≥ 65 µS switch cartridge/ module
Please wait Message is displayed during The autoclave starts automatically after
Preheating chamber program start phase. The reaching the starting temperature.
autoclave has not reached the
starting temperature yet.
Warning/ Exchange sterile Min. / Max. pressure on Exchange sterile filter (Art. No. 20160)
filter ventilation drying is too low/
NOTICE: Message comes at the end of the
high
program and in last row on logging printouts.
Sterile filter polluted or torn
Output medium is not ready The autoclave is operated Select the option in the menu Batch output
without output medium although No output medium ( see page 30,
a output medium is registered Initialization of the log printer)
Output medium is not correctly Correct connection of the data cable to the
connected autoclave and test at the output medium.
Electric power supply of the Ensure electric power supply, the red LED "P"
®
printer is interrupted at the log printer MELAprint 42 must light red
Printer is "offline" Set printer to "online" (press key "SEL" at the
®
MELAprint 42, LED "SEL" must light green)
Protocol memory full The device-internal log memory The message is shown at the start of a
is allocated (max. 40 logs program.
possible).
Repeatedly press the KEY (S) to delete the
message, and the program starts. The oldest
log is then deleted.
48

An output medium is registered Set autoclave to Immediate output Yes
and in the menu Batch (see page 33, Automatic immediate log
output the option Immediate output)
output No is set.
Delete protocol memory (see Delete stored
logfiles, possibly output all stored logs
beforehand (see page 34, Print all saved logs)
Log off the output medium in the menu batch
output output medium and set the option
no output medium.
Please carry out The maintenance message is The message is shown at program start.
maintenance activated, the device has
reached the prescribed batch Repeatedly press the KEY (S) to delete the
number message, and the program starts.
Retain the message: press the (S) key twice to
start
Carry out maintenance with MELAG customer
service or service of the specialist trade
NOTICE: Service counter is reset by the
customer service
Test not successful The leakage rate determined by

the vacuum test lies above the
Leakage rate: 3.2 maximum permissible value of
1.3 mbar.
Door seal, chamber flange is Check door seal and chamber flange for
contaminated cleanliness, possibly clean
Check door seal for damage, possibly
exchange, see page 11
Repeat vacuum test with completely cold
device
Door seal wrongly inserted Check door seal for correct seating
Repeat vacuum test with completely cold
device
Warning! Battery empty The monitoring of the device's The battery must be exchanged by MELAG
internal battery voltage has customer service or service of the specialist
determined a too low voltage trade
value.
49
Error message Possible causes What you can do

Error 1: Vacuum system Door seal, sealing surface at Check door seal and sealing surface at the
the chamber is polluted or chamber for contamination and clean it;
defective
Check door seal for defects, possibly
exchange, see page 11
Door seal wrongly inserted Check door seal for correct seating
Check the correct set-up of the autoclave.

Check the autoclave for fallen instruments, filter
paper etc. which might be lying on the chamber
floor
Error 2: Steam generator autoclave is overloaded Pay attention to the correct loading quantities
(see page 20, Load autoclave)
Decreased heating power, since Check building-side electrical Installation,
supply voltage too low operate device on a trial basis on another
electric circuit.
If problem persists, notify specialist dealers
Error 4: Pressure release Pressure release filter is soiled Check whether the pressure-release filter is
clogged (in chamber bottom in the rear area).
Beforehand, unscrew the filter.
On repeated occurrence notify your specialist
dealer
Error 6: Ventilation The sterile filter is soiled, Exchange sterile filter

appropriate warning text
appears beforehand
Error 8:Time-base Maximum difference between On repeated occurrence notify your specialist
the program cycle time and the dealer
internal computer clock is
exceeded
Error 9: Door open! The locking sliding handle was Push the sliding closure grip downwards until
pushed upwards during a the stop. Correct display: Door closed
running program
dealer
Error 10: Overheat Steam Capillary tube regulator "level After program termination and immediate start,
generator control" is opened at program this error message can be repeated after a
start (error message pause time of two minutes
immediately after start) or
during a program run (until the On repeated occurrence notify your specialist
end of the sterilization) the dealer
monitoring time until the
capillary tube regulator is
switched back (with water feed
from feed water) is exceeded
Error 12: Door locking Locking pin of the door is stiff Check the smooth running of the door locking
pin
dealer
50

Error 14: No feed water see warning text Warning no feed water,
however this error appears after the start of a
program
Error 18: Sensor: ...Input: The device-internal inspection On repeated occurrence notify your specialist
… of the sensors for temperature, dealer
pressure or conductivity
resulted in a too large deviation,
the message can occur when
the device is switched on or
during a program
Error 21: Preheating The monitoring time from On repeated occurrence select option
switching on the pre-heating Automatic pre-heating No ( see page
until the achievement of the 23) and notify specialist dealers
respective pre-heating
temperature was exceeded
Error 22: Overheat The maximum preheating On repeated occurrence select option
Preheating temperature was exceeded Automatic pre-heating No ( see page
23, Select automatic pre-heating) and notify
specialist dealers
Error 26: A/D converting The maximum admissible On repeated occurrence notify your specialist
deviation of the computer- dealer
internal signal conditioning (A/D
converting) was exceeded
Error 27: Temp.Sens. def The maximum admissible On repeated occurrence notify your specialist
1.2 deviation between the two dealer
temperature sensors for the
steam temperature was
exceeded
Error 31:System leak During the program vacuum Repeat vacuum test,
test the permitted pressure if renewed error message, notify specialist
maximum was exceeded (very dealers
large leak) after achieving the
evacuation pressure
Error 32: Power loss / The loss of the operating The error message occurs after the operating
voltage occurred after the start voltage is again available
Sterilize sterile filter of a program
Check building-side installation, If no defects
are detectable, notify MELAG customer service
In the event of power failure after a program
has been started in overpressure, an additional
request appears to sterilize the sterile filter,
since this has become damp and is possibly
contaminated with microbes.
Exchange sterile filter at the back side of the
autoclave,
sterilize the filter in the Quick Program,
after the expiration of the program, plug in the
filter again
Disconnection of the autoclave Only terminate a running program with KEY (S)
during a running program (see also page 25, Manually terminate
program)
51

Error 33: Pressure drop The maximum switch-on time of On repeated occurrence notify your specialist
the steam generator for dealer
achieving the control pressure
was exceeded
Error 34: Sterilization TU1 Shortfall of the minimum Operate device with smaller load, possibly
permissible sterilization carry out vacuum test
temperature (temperature
sensor 1) Check door seal for wear
dealer
Error 35: Sterilization TO1 Exceeding the maximum Carry out vacuum test
permissible sterilization
temperature (temperature On repeated occurrence notify your specialist
sensor 1) dealer
Error 36: Sterilization PU Shortfall of the minimum Operate device with smaller load, possibly
sterilization pressure carry out vacuum test
Check door seal for wear
dealer
Error 37: Sterilization PO Exceeding the maximum On repeated occurrence notify your specialist
permissible sterilization dealer
pressure
Error 38: Sterilization TD1 Maximum permitted difference On repeated occurrence notify your specialist
between theoretical dealer
temperature, quoted from the
pressure signal, and the
temperature measured at the
temperature senor 1 was
exceeded
Error 51: Sterilization TU2 Shortfall of minimum Operate device with smaller load, possibly
permissible sterilization carry out Vacuum test.
temperature (temperature
sensor 2) Check door seal for wear.
dealer.
Also see Error 34
Error 52: Sterilization TO2 Exceeding the maximum Carry out vacuum test
permissible sterilization
temperature (temperature On repeated occurrence notify your specialist
sensor 2) dealer.
Also see Error 35
Error 53: Sterilization TD2 Maximum permitted difference On repeated occurrence notify your specialist
between theoretical dealer.
temperature, quoted from the
pressure signal, and the Also see Error 38
temperature measured at the
temperature senor 2 was
exceeded
52
No display on the screen

After switching on the autoclave the display remains empty.
What you can do  Check whether the power plug is correctly in the socket.
 Check the supply voltage at the socket.
 If necessary, switch the device fuses at the lower front of the
autoclave (see page 10, Fig. 1/(7))off. Follow the instructions in the
technical manual in Exchange device fuses.
Too large feed water consumption

The feed water consumption is dependent upon the program and the
loading of the autoclave.
What you can do  Check the correct set-up of the autoclave.
 The floor of the vessel must be free. Where applicable, remove
fallen instruments, filter paper, etc.
Bad drying results

Apart from a proper device function, the drying process depends
decisively on the correct setting up and loading of the autoclave.
What you can do  Check the correct set-up of the autoclave. If necessary increase the
tilt by further screwing out the front feet of the unit of maximum 2
rotations.
 The floor of the vessel must be free. Where applicable, remove
fallen instruments, filter paper, etc.
 The tank filter is clogged. If necessary, check and clean it.
 Pay attention to the correct loading of the autoclave (see page 20
Load the autoclave).
 Do not overload the autoclave. Pay attention that textiles have no
direct contact with the chamber wall and floor.
 Activate the pre-heating (see page 23,Select automatic pre-
heating)
 Employ the function Additional Drying (see page 24, Additional
Drying).
53
Glossary
Glossary
Air leakage – checking the air leakage formation of a large gas bubble which expands like an
Air leakage is a poorly sealed location through which explosion
unwanted air can enter or escape;
Checking the air leakage serves to verify that the volume Demineralized water
of the air leak in the sterilization chamber during the Also designated as aqua dem; water to a large extent
vacuum stages does not exceed a value where it would without the minerals which occur in normal mineral or tap
prevents the intrusion of steam into the sterilizer load, and water; is obtained by ion exchange from normal tap water.
that the air leakage is not a possible cause of a renewed It is employed here as →feed water
→contamination of the sterilizer load during drying
DIN EN 867-5
aqua dem European standard: non-biological systems for use in
→demineralized water sterilizers – Part 5: Stipulations of indicator systems and
testing bodies for performance tests of small sterilizers of
aqua dest Type B and Type S
→distilled water
DIN EN 868
Authorized persons European standard: Packaging materials and systems for
Medical specialist dealers, technician from depots or with medical devices to be sterilized
customer service designated by MELAG, who were trained
by MELAG DIN EN ISO 11140-1
European standard – Sterilization of products for health
Batch care – chemical indicators – Part 1: General requirements
Collection of the →items to be sterilized that together
passed through one and the same sterilization program DIN EN ISO 11607-1
Standard – Requirements on materials, →sterile barrier
BGV A1 systems and packaging systems; this standard is a
Trade association regulations – Principles of Prevention harmonization of the DIN EN 868 Part 1 and the
international standard DIN EN ISO 11607.
Bowie & Dick test
Steam penetration test with standard testing packet; DIN EN 13060
described in →DIN EN 285; test is recognised for large- European standard –Small steam sterilizers
scale sterilizations
DIN EN 285
CF card European standard – sterilization – steam sterilizers –
Compact Flash Card; large sterilizers
Memory card for digital data of compact model size;
CF is a normed standard, i.e. this memory card can be
Display
Display device on electronic devices; here: Graphic display
employed in every device with a CF slot. The CF card can
of the control panel
be read and possibly written by every device that supports
the standard, Distilled water
From lat. aqua destillata; also designated as aqua dest;
Condensate water, which is largely freely of salts, organic materials and
A liquid (e.g. water), which forms upon cooling from the microorganisms, is obtained by distillation (evaporation
vaporous state and thereby separates and subsequent condensation) from normal tap water or
pre-cleaned water. It is employed here as →feed water
Conductivity
is the reciprocal value of the electrical resistance; unit of Dynamic pressure test of the sterilization
measurement in microsiemens/centimetre (µS/cm); the chamber
more materials are dissolved in water, the better it
Serves to verify that the rate of the change of pressure
conducts electrical current and the higher is its
occurring in the sterilization chamber during a sterilization
conductivity.
cycle does not exceed a certain value, which could lead to
→distilled water ideally has the conductivity zero
damage of the wrapping material
Conductivity measurement [→DIN EN 13060]
Measurement of the →conductivity Empty chamber test
Contamination Test without load; carried out in order to evaluate the
performance of the sterilizer without the influence of the
here: Soiling of the sterilized load with unwanted or
load; permits checking the maintained temperatures and
harmful materials
pressures with respect to the intended settings
Corrosion [→DIN EN 13060]
Chemical change or destruction of metallic materials by
water and chemicals
Evacuation
Creation of a →vacuum in a vessel
Delayed boiling
This is the phenomenon that in certain conditions liquids
Feed water
is required for the creation of water steam for the
can be heated beyond their boiling point without boiling;
sterilization; typical values for the water quality according
this state is unstable; a slight shock can cause a very rapid
54
Glossary
to →DIN EN 285 or →DIN EN 13060 – Appendix C, at sterilizer designed according to →DIN EN 13060
least however battery water according to →VDE 0510 [DIN EN 13060]
Fractionated pre-vacuum method Porous partial load – Check of porous

Technical methods of steam sterilization; partial load
the repeated →evacuation of the →sterilization chamber Serves to verify that for the values set on the control, the
alternating with steam intake steam quickly and uniformly penetrates into the defined
test packet
FTP [→DIN EN 13060]
(engl.: File Transfer Protocol) is a data communication
method which serves for the transmission of data from the Porous small parts
internet. These data can contain programs, files or Made of materials which can absorb fluids (e.g. liquids)
information. Special FTP programs (FTP clients) serve for
uploading any data on a server. Process evaluation system
Also self-monitoring system – observes itself, acts during
Heating-up period the programs, compares sensors with each other
After switching on the autoclave or after starting a
sterilization program, it is the time required for heating up RKI
the steam generator before the sterilization process starts; Robert Koch Institute
duration depends on the temperature of the sterilizing
process Self-Monitoring-system
→Process evaluation system
Hollow bodies A
One-sided open bodies, for which applies: Separate steam production
1 = L/D = 750 and L = 1500 mm or The steam generator is located outside the sterilization
a double-sided open body for which applies: chamber. The sterilization chamber is protected from
2 = L/D = 1500 and L = 3000 mm and which does not overheating in this way.
correspond to the hollow body B
L…hollow body length Simple wrapping
D…hollow body diam Wrapped once, e.g. instruments sealed in a foil. –
contrasted to: →Multiple wrapping
Hollow bodies B
One-sided open bodies, for which applies: Software
1 = L/D = 5 and L = 5 mm or non-material components of a EDP system; e.g. computer
a double-sided open body for which applies: programs
2 = L/D = 10 and D = 5
L…hollow body length Soft sterilization package
D…hollow body diameter e.g. paper bags or clear-plastic sterilization packages
[→DIN EN 13060]
Solid
Initialization Without hollows or spaces; firm, dense, closed
Creation of a certain initial state of the →software at start-
up Solid load – check of solid load
Serves to verify that for the values set on the control, the
Items to be sterilized required sterilization conditions were achieved within the
Unsterile objects, materials still to be sterilized entire load. The load must represent the maximum
measurements of solid instruments for whose sterilization
LED a sterilizer has been designed according to →DIN EN
Abbreviation for Light Emitting Diode; Semiconductor 13060
diode which lights up when powered by current. LEDs are [DIN EN 13060]
predominantly employed for status displays in devices, for
example to display hard disk access. Stainless steel cleaning agent
e.g. Sidol
Lubricants
Instrument oil or instrument milk Standards-compliant
Conformity with all the relevant standards
Mixed load
Wrapped and unwrapped materials to be sterilized within Sterile barrier systems
one load Closed minimum packaging which prevent the occurrence
of microorganisms, e.g. bags closed with sealing, closed
Multiple wrapping reusable containers, folded sterilization cloths
e.g. instruments doubly sealed in foil or wrapped in foil are
additionally found in one container or in a textile wrapped Sterilized items
container also designated as →batch, if already successfully
sterilized: sterile goods
Porous
Pervious to liquids and air, e.g. textiles Sterilization chamber
Interior of a sterilizer
Porous full load – Check of porous full load Takes up the →items to be sterilized
Serves to verify that for the values set on the control, the
required sterilization conditions are achieved in porous TCP
loads with the maximum mass for their sterilization in a (engl.: transmission control protocol) designates a
55
Glossary
standard-protocol for a connection between computers

and networks
Vacuum
colloquially: Space free of matter
in the technical sense: Volume with reduced gas pressure
(usually air pressure)
Vacuum drying
Gentle drying; the drying goods are exposed to an
underpressure which reduces the boiling point and thereby
also at low temperatures leads to a vaporizing of the water
VDE
Verband der Elektrotechnik, Elektronik und
Informationstechnik e.V. (Association of German
Electricians)
VDE 0510
Standard of the →VDE – Provisions for accumulators and
battery units
56
Appendix A – Accessories
Appendix A – Accessories
Article Order number*
® ®
Vacuklav 23 B+ Vacuklav 31 B+
Tray mounts A for 5 trays or 3 standard-tray cassette 40244 40233
B for 4 standard-tray cassettes 40224 40234
D for 2 high cassettes or 4 trays 46840
Sterilization 15K depth/ width/ height in cm: 18/ 12/ 4,5 01151
containers with
single-use paper 15M depth/ width/ height in cm. 35/ 12/ 4,5 01152
filters according to 15G depth/ width/ height in cm: 35/ 12/ 8 01153
DIN EN 868-8
17K depth/ width/ height in cm: 20/ 14/ 5 01171
17M Depth/ width/ height in cm: 41/ 14/ 5 01172
17G depth/ width/ height in cm: 14/ 14/ 9 01173
23M depth/ width/ height in cm: 42/ 16/ 6 01231
23G depth/ width/ height in cm: 42/ 16/ 12 01232
28M depth/ width/ height in mm: 32/ 16/ 6 01284
28G depth/ width/ height in mm: 32/ 16/ 12 01285
Swab drums with filter 17R diameter/ height in cm: 13/ 10,5 00174
cloth
23R diameter/height in mm: 18/ 14 00233
Package Holder for chamber ∅ 25 cm X 45 or 35 cm 22420 22410
Standard tray Perforated, depth/width/height in mm: 29/ 19/ 4
cassette
with filter cloth 00289
without filter cloth 00286
Trays tray 00230 00280
®
Test body system MELAcontrol consisting of helix test body and 01080
250 indicator strips
®
MELAcontrol PRO consisting of helix test body 01075
and 40 indicator strips
®
Water treatment units MELAdem 40 ion exchanger 01049
®
MELAdem 47 reverse-osmosis unit 01047
For the MELAflash CF card printer incl. MELAflash CF 01039
documentation card and card reader
MELAnet Box 40296
®
MELAprint 42 log printer 01042
Other Water stop valve 01056
Device fuses 16A/ gRl 57592
*All specified articles are available at the specialist dealers
57
Appendix B – Symbols on the autoclave
Appendix B – Symbols on the

autoclave
The manufacturer of the apparatus declares with the accompanying
sticker that the medical device corresponds to the basic requirements of
the European Standard EN1717 – "Protection of drinking water from
contaminants…."
The symbol of the struck out trashcan identifies a device that may not be
disposed with domestic waste. An appropriate and competent disposal
must be carried out by the marketing party.
With the designation of an apparatus with this symbol, the manufacturer
furthermore declares that he satisfies all requirements of the law
concerning the release, withdrawal and environmentally compatible
disposal of electric and electronic appliances.
With the CE sign, the manufacturer declares that the medical device
corresponds to the basic requirements of the German Medical Device
Guideline. The four-digit number means that an approved certification
body monitors the product certification.
With the CE sign, the manufacturer declares that the medical device
corresponds to the basic requirements of the German Printing Device
Guideline. The four-digit number means that an approved certification
body monitors the product certification.
58

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User Manual

MELAG - General Management and employees

User Manual of Vacuklav®23 B+, Vacuklav®31 B+

Responsible for the contents: Engineering Department

About this manual

Risk to health Indicates a dangerous situation which if not avoided

Observe Indicates a dangerous situation which if not avoided

Important Indicates important information.

Example of emphasis Meaning Explanation

→Conductivity Glossary entry Words or phrases marked with an arrow are

Universal program Software Words or phrases appearing on the →display of the

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

Chapter 3 – Initial start-up ................................. 14

Chapter 5 – Logging ........................................... 29

Chapter 1 – Performance Specification

Observe the following instructions for using the autoclave:

Overview of sterilization programs

Program type as per Type B Type B Type S Type B Type B

→Dynamic pressure test of the X X X X X

→Empty chamber test X X X X X

→Porous partial load X X X

→Porous full load X X X

Drying →solid load X X X X X

Drying →porous load X X X

Sterilization temperature 134°C 134°C 134°C 121°C 134°C

Sterilization pressure 2 bar 2 bar 2 bar 1 bar 2 bar

X = Conformity with all applicable sections of the standard →DIN EN 13060

Chapter 2 – Device Description

 Which components are included in the standard scope of delivery

(1) Operating and display field

(2) Door (pivots opens to the left)

(3) sliding closure grip

(4) Mains switch

(5) Front foot of the unit (adjustable)

Front side below with opened door

(7) Device fuses – 2x 16A/ gRl

(8) Reset button for overheating protection

*hidden behind the white cover

(12) Slot for optional upgrade with the safeguard combination

(19) Power cable

(3) Door locking pin

(4) Chamber sealing surface

(6) Door plate

Fig. 2: Interior view

Mountings for the load

Supply with feed water

Chapter 3 – Initial start-up

 Who may set up, install and start up the autoclave

Conditions for setting up, installing and

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

Set-up location requirements

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

Width A= 42.5 cm A= 42.5 cm

Height B= 48.5 cm B= 48.5 cm

Water treatment unit Width Height Depth Diameter

Observe the following precautionary measures when handling the

Prerequisites for initial start-up

Record of installation and setting up

 Which prerequisites should be created for a smoothly-running sterilization