BA Evo 41B+ 43B+ enUser Manual Vacuklav 41 B+ Evolution Vacuklav 43 B+ Evolution Steam sterilizer as of software version v3.218 EN Dear doctor, We thank you for your confidence demonstrated

User ManualVacuklav 41 B+ EvolutionVacuklav 43 B+ EvolutionSteam sterilizeras of software version v3.218

ENDear doctor,

We thank you for your confidence demonstrated by the purchase of this MELAG product. As an owner-run and operatedfamily concern founded in 1951, we have a long history of successful specialization in hygiene products for practice-based use. Our focus on innovation, quality and the highest standards of operational reliability has established MELAGas the world’s leading manufacturer in the instrument treatment and hygiene field.

You, our customer are justified in your demand for the best products, quality and reliability. Providing "competence inhygiene" and "Quality – made in Germany", we guarantee that these demands will be met. Our certified qualitymanagement system in accordance with ISO 13485 and ISO 9001 is subject to close monitoring e.g. through our annualmulti-day audit conducted conducted by a specified independent certification agency. This guarantees that all MELAGproducts are manufactured and tested in accordance with strict quality criteria.

The MELAG management and team.

Contents

Contents1 General Guidelines............................................................................................................................................................... 5

Symbols used....................................................................................................................................................................... 5

Formatting rules ................................................................................................................................................................... 5

Symbols on the device ......................................................................................................................................................... 5

2 Safety..................................................................................................................................................................................... 7

3 Performance specifications ................................................................................................................................................ 9Intended use ........................................................................................................................................................................ 9

Sterilization procedure ......................................................................................................................................................... 9

Type of the feed water supply .............................................................................................................................................. 9

Safety equipment ................................................................................................................................................................. 9

Overview of sterilization programs (class B) ...................................................................................................................... 11

Program sequences ........................................................................................................................................................... 12

4 Description of the device................................................................................................................................................... 13Scope of delivery................................................................................................................................................................ 13

Views of the device ............................................................................................................................................................ 14

Energy-saving key.............................................................................................................................................................. 15

Load mounts ...................................................................................................................................................................... 15

Colour-touch display .......................................................................................................................................................... 16

LED status bar ................................................................................................................................................................... 17

5 First steps ........................................................................................................................................................................... 18Setup and Installation......................................................................................................................................................... 18

Feed water supply.............................................................................................................................................................. 18

Switching on the steam sterilizer........................................................................................................................................ 19

Opening and closing the door ............................................................................................................................................ 19

6 Loading the steam sterilizer .............................................................................................................................................. 21Preparing the sterilization material..................................................................................................................................... 21

Loading the steam sterilizer ............................................................................................................................................... 22

7 Sterilization ......................................................................................................................................................................... 24Important information regarding routine operation ............................................................................................................. 24

Selecting the program........................................................................................................................................................ 25

Additional program options ................................................................................................................................................ 26

Starting the program .......................................................................................................................................................... 27

Program run ....................................................................................................................................................................... 27

Manual program abort........................................................................................................................................................ 28

Program end ...................................................................................................................................................................... 30

Removing the sterilized equipment .................................................................................................................................... 31

Storing sterile instruments.................................................................................................................................................. 32

8 Logging ............................................................................................................................................................................... 33Batch documentation ......................................................................................................................................................... 33

Output media...................................................................................................................................................................... 33

Outputting text logs automatically after program end (immediate output).......................................................................... 35

Subsequent log output ....................................................................................................................................................... 36

Finding a log....................................................................................................................................................................... 38

Contents

9 Functional checks .............................................................................................................................................................. 40Vacuum test ....................................................................................................................................................................... 40

Bowie & Dick test ............................................................................................................................................................... 41

10 Settings ............................................................................................................................................................................. 42Logging .............................................................................................................................................................................. 42

User administration ............................................................................................................................................................ 46

Formatting the CF card ...................................................................................................................................................... 48

Additional drying................................................................................................................................................................. 48

Intelligent drying ................................................................................................................................................................. 49

Water supply ...................................................................................................................................................................... 49

Date & time ........................................................................................................................................................................ 50

Brightness .......................................................................................................................................................................... 50

Volume............................................................................................................................................................................... 51

Key tone ............................................................................................................................................................................. 51

Screensaver ....................................................................................................................................................................... 52

Log printer MELAprint 42 ................................................................................................................................................... 53

Label printer MELAprint 60 ................................................................................................................................................ 53

Sensitivity ........................................................................................................................................................................... 53

Energy-saving mode .......................................................................................................................................................... 53

11 Maintenance...................................................................................................................................................................... 55Servicing intervals .............................................................................................................................................................. 55

Cleaning ............................................................................................................................................................................. 55

Avoiding staining ................................................................................................................................................................ 57

Oiling the door spindle ....................................................................................................................................................... 57

Maintenance....................................................................................................................................................................... 58

12 Pause times ...................................................................................................................................................................... 59Frequency of sterilization ................................................................................................................................................... 59

Decommissioning............................................................................................................................................................... 59

Emptying the double jacket ................................................................................................................................................ 59

Transport............................................................................................................................................................................ 60

Recommissioning after relocation ...................................................................................................................................... 61

13 Malfunctions ..................................................................................................................................................................... 62Messages........................................................................................................................................................................... 62

Warnings ............................................................................................................................................................................ 63

Malfunction messages ....................................................................................................................................................... 63

14 Technical data .................................................................................................................................................................. 65

15 Accessories and spare parts .......................................................................................................................................... 66

Glossary ................................................................................................................................................................................. 67

1 General Guidelines

5


Please read this user manual carefully before commissioning the device. The user manual includesimportant safety information. The functionality and value-retention of this device depends on the careaccorded to it. Please store these user manual carefully and in close proximity to your device. It representsa component of the product.

Should the user manual no longer be legible, damaged or lost, please obtain a new copy from MELAG.State the device type and your address in an e-mail.

The device type is specified on the type plate on the rear of the device.

Symbols usedSymbol Explanation

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

Draws your attention to a situation, which if not avoided, could result in damage to theinstruments, the practice fittings or the device.

Draws your attention to important information.

Formatting rulesExample Explanationsee Chapter 2 Reference to another text section within this documentSettings Words or phrases appearing on the display of the device are marked as display text.

Symbols on the device

Manufacturer of the medical device

Date of manufacture of the medical device

Medical device serial number from the manufacturer

Article number of the medical device

Information about the chamber volume

Operating temperature of the device

Operating pressure of the device


6

The user manual includes important safety information. Failure to comply with theseinstructions can result in injury and material damage.

Please read this user manual carefully before commissioning the device.

In affixing this CE mark, the manufacturer declares that this medical product fulfils thebasic requirements of the Medical products directive. The four-digit number confirms thatthis is monitored by an approved certification agency.

In affixing this CE mark, the manufacturer declares that this medical product fulfils thebasic requirements of the Pressure equipment directive. The four-digit number confirmsthat this is monitored by an approved certification agency.

Draws your attention to a hot surface. Should the fan fail, the cooling unit fins canbecome hot.

The device may not be disposed as domestic waste. The vendor is responsible forappropriate disposal of the device - it must be delivered to the vendor to be disposed of.In affixing this symbol, the manufacturer furthermore declares that he has satisfied all thelegal requirements pertaining to the release, redemption and environmentally sounddisposal of electric and electronic appliances.MELAG devices are synonymous for long-term quality. When you eventually need todecommission your MELAG device, we offer a special disposal service. Simply contactyour stockist.

2 Safety

7

2 Safety

When operating the device, comply with the following safety instructions as well as thosecontained in subsequent chapters. Use the device only for the purpose specified in theseinstructions. Failure to comply with the specifications of the safety instructions can result ininjury and/or damage to the device.

Qualified personnel

n As with the preceding instrument decontamination, the sterilization of instruments and textiles usingthis steam sterilizer may only be carried out by competent personnel.

Set-up installation and commissioning

n Check the device for any damage suffered during transport after unpacking.

n Only have the device set up, installed, and started up by people authorized by MELAG.

n The connections for electrical provision and water supply and discharge must be set-up by trained per-sonnel.

n In accordance with current VDE specifications, the device is unsuitable for operation in explosive at-mospheres.

n The device is conceived for use outside patient surroundings. The device should be located at least1.5 m away (radius) from the treatment area.

n The documentation media (computer, CF card reader etc.) must be placed in such a way that theycannot come into contact with liquids.

n Observe all the information contained in the technical manual during commissioning.

Power cable and power plug

n Only the power cable included in the scope of delivery may be connected to the device.

n The power cable may not be replaced by a cable determined to be insufficient.

n Comply with all legal requirements and locally-specified connection conditions.

n Never operate the device if the plug or power cable are damaged.

n The power cable and plug should only be replaced by authorized personnel.

n Never damage or alter the power plug or cable.

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

n Ensure that the power cable does not become jammed in.

n Never lead the cable along a source of heat.

n Never fix the power cable with sharp objects.

Double-jacket steam generator

n The steam sterilzer remains pressurized for a long time after being switched-off. Check the pressuredisplay of the manometer below on the front of the device.

Decontamination and sterilization

n Follow the manufacturer instructions of your textile articles and instruments regarding their decontam-ination and sterilization.

n Observe the relevant standards and directives for the decontamination and sterilization of textiles andinstruments, e.g. RKI [Robert Koch Institute] and DGSV [German Society for Sterile Supply].

n Only ever use packaging material and systems which have been approved by their manufacturer forsteam sterilization (consult the manufacturer’s instructions).

Program termination

n Please observe that depending on the time of the program abort, opening the door following a pro-gram abort can lead to hot steam leaving the chamber.

2 Safety

8

n Depending on the time of the program abort, it is possible that the load is unsterile. Observe the clearinstructions shown on the display of the steam sterilizer. If necessary, sterilize the affected objectsafter rewrapping.

Removing the sterilized equipment

n Never use force to open the door.

n Use a tray jack to remove the tray. Never touch the sterilized items, the chamber or the door with un-protected hands. The components are hot.

n Check the packaging on the sterilized equipment for damage when removing it from the steam steril-izer. Should the packaging be damaged, re-pack the sterilization material and re-sterilize it.

Transport and storage

n Install and operate the device in a frost-free environment.

n The device should always be carried by two people.

n Use suitable carrying straps to carry the device.

Maintenance

n Have the maintenance done only by authorized persons.

n Maintain the specified servicing intervals.

n Only original MELAG spare parts may be used.

Malfunctions

n Should the device issue the same malfunction message repeatedly, turn off the deviceand if necessary, inform your stockist.

n Only have the device repaired by authorized persons.

3 Performance specifications

9


Intended useThis steam sterilizer is designed for application in a medical context, e.g. General Practitioners and dentalpractices. According to DIN EN 13060, this steam sterilizer is a Class B sterilizer. As a universal steamsterilizer, it is suited to highly-demanding sterilization tasks. It can be used to sterilize instruments with anarrow lumen and transfer instruments - both wrapped or unwrapped - and large quantities of textiles.

WARNINGAny attempt to sterilize liquids can result in a delay in boiling. This can result in damageof the steam sterilizer and burns.n Never use this steam sterilizer to sterilize any fluids. It is not licensed for the sterilization of

fluids.

Sterilization procedureThe steam sterilizer sterilizes on the basis of the fractionated vacuum procedure. This guarantees thecomplete and effective wetting/penetration of the sterilization material with saturated steam.

This procedure enables the sterilization of loads common to a doctor's practice.

The steam sterilizer uses the double-jacket technology to generate the sterilization steam, i.e. the steamsterilizer is fitted with a separate steam generator combined with a double-walled sterilization chamber.After heating, steam is held constantly available in the double-jacket. This gives the walls of thesterilization chamber a defined temperature and protects the sterilization chamber from overheating. Thisespecially effective procedure supports the quick evacuation of the air from the sterilization chamber, thesterilization packaging and instrument cavities. This permits the sterilization of large quantities ofinstruments or textiles directly one after each other, thereby achieving excellent drying results.

Type of the feed water supplyThe steam sterilizer works with a one-way feed water system. This means that it uses fresh feed water (i.e.demineralized or distilled water) for every sterilization procedure. The quality of the feed water is subject topermanent monitoring via integrated conductivity measurement. If combined with careful preparation of theinstruments, this serves largely to prevent stain accretion on the instruments and soiling of the steamsterilizer.

Safety equipment

Internal process monitoringAn process evaluation system is integrated in the electronics of the steam sterilizer. It compares theprocess parameters (such as temperature, time and pressure) during a program run. It monitors theparameters in terms of their threshold values during control and regulation and guarantees safe andsuccessful sterilization. A monitoring system checks the device components of the steam sterilizer for theirfunctionality and their plausible interaction. If one or more parameters exceeds pre-determined thresholdvalues, the steam sterilizer issues warning or malfunction messages and if necessary, aborts the program.In the case of a program abort, follow the instructions on the display.

The steam sterilizer uses an electronic parameter control. This enables the steam sterilizer to optimize thetotal operating time of a program in dependence on the load.

Door mechanismThe steam sterilizer constantly checks pressure and temperature in the sterilization chamber and preventsthe door from being opened when over-pressure has built up in the chamber. The motor-driven automaticdoor locking mechanism opens the door slowly by turning the locking spindle. This also holds the door


10

whilst it opens. Pressure compensation will have been performed by the time that the door is completelyopen, even following pressure differences.

Quantity and quality of the feed waterThe quantity and quality of the feed water is automatically checked before every program start.

Automatic emergency shutdownThe steam sterilizer is equipped with an emergency shut-down mechanism; i.e. the steam sterilizer shutsdown automatically if the internal process evaluation system registers a fault which represents a particularhazard situation. Reactivation of the steam sterilizer is only possible after the malfunction has beenremedied.


11

Overview of sterilization programs (class B)The results in this table show which inspections were performed on the steam sterilizer. The marked fieldshows compliance with all the applicable sections of the standard DIN EN 13060.

Type tests Universal-Program

Quick-Program B

Quick-Program S

Gentle-Program

Prion-Program

Program type inaccordance with DIN EN13060

Type B Type B Type S Type B Type B

Dynamic pressure test ofthe sterilization chamber

X X X X X

Air leakage X X X X XEmpty chamber test X X X X XSolid load X X X X XPorous partial load X -- -- X XPorous full load X -- -- X XSimple hollow body(Hollow body B)

X X X X X

Product with narrowlumen (Hollow body A)

X X -- X X

Single wrapping X X -- X XMultiple wrapping X -- -- X XDrying solid load X X X X XDrying, porous load X -- -- X XSterilization temperature 134 °C 134 °C 134 °C 121 °C 134 °CSterilization pressure 2.1 bar 2.1 bar 2.1 bar 1.1 bar 2.1 barSterilization time 5:30 min. 5:30 min. 03:30 min. 20:30 min. 20:30 min.X = Complies with all applicable sections of the standard DIN EN 13060


12

Program sequences

Regular sterilization programA program runs in three phases, the air removal; sterilization; and drying phase. After program start, youcan follow the program run on the display. It shows the chamber temperature and pressure as well as thetime until the end of sterilization / the drying.

Program phase Description1. The air removalphase (fractionation)

The air removal phase comprizes the conditioning and the evacuation phase.During conditioning, steam is repeatedly injected into the sterilization chamber togenerate over-pressure. The mixture of air and steam is then removedrepeatedly (evacuation). This procedure is also called the fractionated pre-vacuum procedure.

2. Heating phase The heating phase follows the air removal phase. The continued steamadmittance into the chamber leads to an increase in pressure and temperaturewhich continues until the program-specific sterilization parameters have beenreached.

3. Sterilization phase If the pressure and temperature correspond to the program-dependent nominalvalues, the sterilization phase begins. The sterilization time is indicated on thedisplay.

4. Pressure release The end of the sterilization phase is followed by pressure release withsimultaneous emptying of the steam generator.

5. Drying phase The sterilization material is dried using a vacuum (vacuum drying). The dryingphase begins after the pressure release. Upon program end, the chamber isfilled with sterile air via the air filter and adjusted to the ambient pressure.

6. Ventilation Once the program has come to an end, the chamber pressure is adapted to theambient pressure. The corresponding display notification "ventilation" isdisplayed.

Vacuum testThe vacuum test serves measurement of the leakage rate. No real sterilization is performed. The test isperformed with a cold, dry and unloaded device.

Program phase Description1. Air removal phase(evacuation)

The chamber is evacuated until the pressure for the vacuum test has beenreached.

2. Equilibration time An equilibration time of five minutes will follow.3. Measurement time The measurement time amounts to ten minutes. The pressure increase within

the chamber is measured during the measurement time. The evacuationpressure and the equilibration time or measuring times are shown on thedisplay.

4. Test end The display shows the test results, the batch number, the total number ofbatches and the leakage rate

4 Description of the device

13


Scope of delivery

Standard scope of delivery▪ Vacuklav 41 B+ or Vacuklav 43 B+

▪ User manual

▪ Usage instructions for the mounts

▪ Manufacturer's inspection report including declarations of conformity

▪ Guarantee

▪ Technical manual

▪ Record of installation and setup

▪ Mounts for trays and cassettes

▪ Tray lifter

▪ Power cable

▪ 2x cover caps for the fore device feet

▪ 2x mounts for the water treatment unit MELAdem

▪ 4x cover caps for niches for mounts in the side wall

▪ Allen key to open the door in an emergency

▪ TORX key for removing the carrying strap

▪ 1x hose for emptying the interior water storage tank

▪ Oil for door lock bushing

Optional▪ Trays

▪ Standard tray cassettes and lifter

▪ MELAstore-Trays

▪ MELAstore-Boxes

▪ Additional mounts

▪ MELAflash CF card

▪ MELAflash CF card reader

▪ Wall bracket for Flex display


14

Views of the device

8

14 13 10 9

7

4

3

2

5

12 11

6

1

Fig. 1: View from front

1 Tank lid of the internal storagetank

2 CF card slot3 Colour touch-display4 LED status bar5 Energy-saving key6 Door (swings open to the left)7 Opening for door opening in an

emergency*)8 Power switch (covered,

accessible from the side)9 Ethernet connection10 Overheat control reset button11 Allen key 5 mm to open the door

in an emergency12 Quick coupling for emptying the

storage tank13 Front device foot (adjustable)14 Manometer for pressure display

on the double-jacket steamgenerator*)

*) behind cover

22

23

24

20

16

19

15

18

27

21

26 25

17

Fig. 2: View from rear

15 Ethernet connection16 Ethernet connection, optional

(upgradeable)17 Optional connection of a Flex

display18 Spring safety valve chamber19 Sterile filter20 Spring safety valve double jacket21 Emergency overflow22 One-way discharge23 Feed water inflow (swivel screw

connection for Ø8x1 hose,alternative straight)

24 Connection pressure release25 Cooler26 Rear device foot (fixed)27 Power cable connection


15

35 34 3233

29

30

28

31

Fig. 3: View from front, door open

28 Mount for the water treatmentunit MELAdem

29 Spring clip for fixing the mount“Plus”

30 Door spindle31 Sterilization chamber32 Chamber sealing face33 Door seal34 Round blank35 Bushing

Energy-saving keyPressing the energy-saving key activates the energy-saving mode and switches off the display. Thedouble jacket will not be heated until the next program start. This corresponds to waiting time 2, see alsoSettings [} page 42], Energy-saving mode [} page 53].

Pressing the energy-saving key again will switch the display back on.

NOTICEThe energy-saving mode can not be activated during a program run.

Load mountsThe steam sterilizer is always delivered with a mount for holding trays or cassettes. Detailed informationregarding the various mounts, their combinability with various load holders and their application can befound in the operating manual of the mounts


16

A spring clip is located on the rear panel of the sterilization chamber to fix the mount. When using a “Plus”mount, slide the mount into the sterilization chamber to its fullest extent, until the mount snaps into thespring clip.

Colour-touch displayThe operating panel consists of a colour 5 inch touch display.

Status barMenu bar

Main area

Action bar

Symbols in the status bar MeaningProgram/tests Indicates whether a program/test is running

Immediate output Indicates whether immediate output is activated/deactivated

Additional drying Indicates whether additional drying is activated/deactivated

Graphic logs Indicates whether the graphic log recording is activated/deactivated

Energy-savingmode

Indicates whether the steam sterilizer is currently in energy-savingmode

Service area Indicates whether a service technician is logged-in to the service area

CF card status Indicates whether a CF card has been inserted and whether a readingor writing action is in process.


17

Symbol in the menu bar MeaningProgram/tests Lists all sterilization programs and tests e.g. Vacuum test, Bowie &

Dick- test etc.Log output Here you can display the entire log list or the list of logs from a

restricted time e.g. the day, month etc. You can also delete specific logtypes and logs.

Settings Here you can perform various settings such as date and time,brightness etc. It also enables one-time setting of the "standard"logging settings regarding log output.

Info/status window Displays information regarding the software version and device datae.g. total number of batches, maintenance counter, log settings, logmemory and further technical values.

Service area Only for technicians

Help menu Depending on the window selected and the operating situation, givesinformation regarding operation or the function of the window currentlyselected.

Symbols in the action bar MeaningDoor open Opens the door of the steam sterilizer

Back Returns to the previous window

Forwards Navigates to the next window

Cancel/returnwithout saving

Navigates to the superordinate menu, leaves the window withoutsaving

Zoom (+) Displays further details such as further values after a completedprogram

Start time pre-selection

Navigates to the "Start time pre-selection" menu

Delete Deletes logs from the internal log memory / deletes the log printer orlabel printer stored as standard

Search Searches for label printer(s)/log printer(s)

LED status barThe status bar on the lowest edge of the display indicates different situations with various colours

Colour of theLED

Meaning

Blue Standby, program running, drying has not yet begunGreen Drying running, program completed successfullyYellow Warning message, software update is runningRed Malfunction message, program not completed successfully

5 First steps

18

5 First steps

Setup and Installation

PLEASE NOTICEComply with the specifications of the technical manual during set-up and installation.This contains all building-side requirements.

Record of installation and set-upThe responsible stockist is to complete the record of installation and setup as proof of the correct setup,installation and commissioning. A copy is to be sent to MELAG Medizintechnik oHG and the stockist. Thisis a constituent part of any guarantee claim.

Feed water supplyThe steam sterilizer requires the use of distilled or demineralized water water, known as feed water.DIN EN 13060 requires that feed water be used in accordance with the guideline values in appendix C.

The steam sterilizer requires c. 3 L feed water for the first filling of the steam generator.

The feed water supply is effected either via the internal feed water tank or via a separate water treatmentunit (e.g. MELAdem 40/MELAdem 47). The used feed water, so called waste water is either collected inthe internal storage tank on the waste water side (left) and emptied manually or disposed of automaticallyvia a building-side waste water connection.

Using the internal water storage containerThe internal storage tank holds max. 5 litres. This volume of feed water is sufficient for up to 7 sterilizationruns.

1. To fill the storage tank with fresh feed water removethe lid and fill the right-hand chamber of the storagetank with fresh feed water up to the MAX mark.

2. Set the feed water supply in the displayto INTERNAL, see Settings [} page 42] ... Watersupply.

5 First steps

19

Switching on the steam sterilizer

ü The steam sterilizer is connected to the electricity supply.

ü The feed water supply is secure. The steam sterilizer requires c. 3 L feed water for the first filling of thesteam generator.

1. Switch on the steam sterilizer at the power switch.

2. When the welcome screen appears, pressCONTINUE. The display switches to the main menu.

The feed water level is checked and pre-heated immediately after activation.

Depending on the device type, it requires a heat-up time of c. 9 - 13 minutes after being switched on. Thistime is required for the pre-heating of the double-jacket steam generator.

Opening and closing the doorThe steam sterilizer is fitted with a motor-driven automatic door locking mechanism with a threadedspindle. Entry on the display is only possible when the door is closed.

Opening the door

The door is opened by pressing on the door symbol on the display.

When opening the door, comply with the following instructions, so as to ensure faultless operation of thedoor locking mechanism.

u Never use force to open the door.

u Do not pull vigorously at the door to open it. The door opens automatically.

PLEASE NOTICEThe door is to be left open only whilst loading and unloading the steam sterilizer.Keeping the door closed saves energy.

5 First steps

20

Closing the doorTo close the door, press it firmly inwards until the automatic door lock engages. After the door has beenclosed, the display returns to the program menu. The door is locked pressure-tight upon program start.

When closing the door, comply with the following instructions to guarantee faultless operation of the doorlocking mechanism:

u Do not exert too little pressure when pushing the door closed.

u Hold the door closed for min. 3 seconds until the door lock engages.

u Never slam the door.

6 Loading the steam sterilizer

21


Preparing the sterilization materialCleaning and disinfection must always have been performed before sterilization. Only in this way is itpossible to guarantee the subsequent sterilization of the sterilization material. The materials used, thecleaning fluid and treatment procedures used are of decisive significance.

Decontaminating the instruments

WARNINGThe incorrect decontamination of instruments could result in any dirt residue beingloosened by the steam pressure during sterilization.The use of unsuitable care agents e.g. water repellent agents or oils impermeable tosteam could result in unsterile instruments. This represents a danger to the health ofboth patients and yourself.

NOTICEThe presence of residual disinfection and cleaning fluids results in corrosion.This could result in increased maintenance requirements and a restriction of the steamsterilizer function.

Please ensure the following when treating used and brand-new instruments:

u Follow both the instrument manufacturer’s instructions regarding decontamination and sterilization andcomply with the relevant standards and directives e.g. from the BGV A1, RKI and DGSV.

u Clean the instruments exceptionally thoroughly e.g. using an ultrasonic device or washer-disinfector.

u Rinse the instruments after washing and disinfecting, where possible with de-mineralized or distilledwater and then dry the instruments thoroughly with a clean, non-fuzzing cloth.

u Use only those care agents suitable for steam sterilization. Consult the manufacturer of the careagents. Do not use any water repellent agents or oils impermeable to steam.

u When using ultrasound devices, care equipment for handpieces and washer-disinfectors, pleasecomply with the manufacturer’s treatment instructions.

Treating textiles

WARNINGThe incorrect decontamination of textiles, e.g. a textile package can prevent steampenetration and/or produce poor drying results. The textiles could not be sterilized.This could endanger the health of patient and practice team.

Please comply with the following points when treating textiles and putting the textiles in sterilizationcontainers:

u Comply with both the manufacturer's instructions of the textiles regarding treatment and sterilization aswell as the relevant standards and directives e.g. from the RKI and DGSV.

u Arrange the folds in the textiles parallel to each other.

u Stack textiles vertically wherever possible and not too closely together in the sterilization container.This enables the development of flow channels.

u Retain the vertical stacking system when packing textiles in the sterilization container.


22

u If textile packages do not remain together, wrap the textiles in sterilization paper.

u Only ever sterilize dry textiles.

u The textiles may not be permitted to come into direct contact with the sterilization chamber; otherwisethey will become saturated with condensate.

Loading the steam sterilizerEffective sterilization and good drying is only possible if the steam sterilizer has been loaded correctly.

Ensure the following during loading:

u Insert trays or cassettes in the chamber only with their appropriate mount.

u Use perforated trays such as those from MELAG. Only in this way can condensate drain off. The usea non-perforated base or half-shell to accommodate the sterilization material can result in poor dryingresults.

u The use of paper tray inserts can also result in poor drying results.

u Wherever possible, please ensure the separate sterilization of textiles and instruments in separatesterilization containers or sterilization packaging. This leads to better drying results.

PackagingOnly ever use packaging materials and systems (sterile barrier systems) which fulfil the standardDIN EN ISO 11607-1. The correct use of suitable packaging is important in achieving successfulsterilization results. You can use re-usable rigid packaging systems such as e.g. standard tray cassettes orsoft packaging such as transparent sterilization packaging, paper bags, sterilization paper, textiles orfleece.

Closed sterilization containers

CAUTIONThe use of unsuitable sterilization containers results in insufficient steam penetrationand even failure of the sterilization. This can also prevent condensate drain-off.This produces poor drying results. This can result in unsterile instruments and thusendanger the health of patient and practice team.

CAUTIONIncorrect stacking of the sterilization containers can result in the dripping condensatebeing unable to drain off to the chamber floor. This can saturate sterilization materialdirectly underneath it.This produces poor drying results. This can result in unsterile instruments and thusendanger the health of patient and practice team.n Do not cover the perforations when stacking the sterilization containers.

Please comply with the following when using closed sterilization containers for sterilization material:

u Use aluminium sterilization containers. Aluminium retains and conducts heat and thus acceleratesdrying.

u Closed sterilization containers must be either perforated or have a valve on at least one side -optimally the bottom. MELAG sterilization containers fulfil the requirements for successful sterilizationand drying.

u The perforations of one-sided perforated sterilization containers should be at the top of any containersas with MELAstore-Boxes.

u Wherever possible, please ensure that sterilization containers are only stacked on top of those ofidentical size, so that the condensate can run down their sides.

u Ensure that the perforations are not covered when stacking the containers.


23

Soft sterilization packagingSoft sterilization packaging can be used in both sterilization containers and on trays. Please comply withthe following when using soft sterilization packaging e.g. MELAfol:

u Arrange soft sterilization packaging in a perpendicular position and at narrow intervals.

u Do not place multiple soft sterilization packages flat on top of each other on a tray or in a container.

u If the seam seal tears during sterilization, this could be caused by the choice of undersized packaging.Should this not be the case, re-pack the instruments and sterilize them again.

u Should the seam seal rip during sterilization, extend the sealing pulse on the film sealing device ormake a double seam.

Multiple wrappingThe steam sterilizer works with a fractionated vacuum procedure. This permits the use of multiplewrapping.

Mixed loadsPlease observe the following when sterilizing mixed loads

u Always place textiles at the top

u Place the sterilization containers at the bottom

u Place unwrapped instruments at the bottom

u Place the heaviest loads at the bottom

u Place transparent sterilization packaging and paper bags at the top - except in combination withtextiles. In this case, place them at the bottom.

u Place transparent sterilization packages on their edge wherever possible and with the paper sidefacing downwards.

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7 Sterilization

Important information regarding routine operationPlease comply with the recommendations issued by the Robert-Koch-Institute (RKI) and the informationcontained in DIN 58946-7 (Germany).

Manufacturer's recommendation for the routine operation of Class B steam sterilizers 1

When is it necessary tomake checks?

How should the checks be made?

Once per working day ▪ Visual check of the door seal and the door seal for damage.

▪ Check the operating agents (electricity, feed water and waterconnection if necessary).

▪ Check the documentation media (printer paper / computer / network)

We recommend performing the steam penetration test withMELAcontrol/MELAcontrol PRO in the Universal-Program (testsystem in accordance with DIN EN 867-5).

Once a week ▪ Vacuum test

Tip: In the mornings before starting work - the steam sterilizer mustbe cold and dry.

Batch-related tests With “Critical B” instruments:

▪ MELAcontrol/MELAcontrol PRO must be used as batch control withevery sterilization cycle.

With “Critical A” instruments:

▪ The process indicator (type 5 in accordance with DIN EN ISO 11140)must be used as batch control with every sterilization cycle.

With “Critical A + B” instruments:

▪ MELAcontrol/MELAcontrol PRO must be used as batch control withevery sterilization cycle.

This simplifies the working procedure and increases security. You canomit the daily steam penetration test with MELAcontrol/MELAcontrol PRO(see above). The use of another test system in accordance with DIN EN867-5 is possible. The number of the available test systems means thatMELAG is not able to provide technical support when using a differentsystem.

The indicator test strips used need not be stored.

PLEASE NOTICEThe results of the tests must be documented.

1) in accordance with the current recommendations from the Robert-Koch-Institut

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Selecting the programNow select the sterilization program according to how and whether the sterilization material is packed. It isalso necessary to take into account the temperature resistance of the sterilization material. All sterilizationand additional programs are displayed in the Programs & Tests menu. The following table showswhich sterilization material fits which program and which additional programs are available.

Universal-Program

Quick-Program B

Quick-Program S

Gentle-Program

Prion-Program

Sterilizationtemperature

134 °C 134 °C 134 °C 121 °C 134 °C

Sterilization pressure 2.1 bar 2.1 bar 2.1 bar 1.1 bar 2.1 barSterilization time 5:30 min. 5:30 min. 03:30 min. 20:30 min. 20:30 min.Operating time 2 Vacuklav 41 B+

c. 23 min. c. 16 min. c. 12 min. c. 40 min. c. 38 Min.

Operating time2)

Vacuklav 43 B+c. 25 min. c. 16 min. c. 13 min. c. 42 min. c. 39 min.

Intelligent drying 4 - 30 min. 4 - 30 min. 4 - 30 min. 4 - 30 min. 4 - 30 min.Time-controlled drying 12 min. c. 6 min. c. 2 min. 12 Min. 12 Min.

Program name Packaging Especially suitable for Load41 B+/43 B+

Universal-Program Single and multiplewrapping

Mixed load; long narrow-bore hollow bodies

6 kg/7 kgor

9 kg with MELAstore

Quick-Program B Single wrapped andunwrappedinstruments (notextiles)

Long narrow-bore hollowbodies

single wrapped max.1.5 kg-----

unwrapped 6 kg/7 kgQuick-Program S Only unwrapped (no

textiles)Single massiveinstruments; transferinstruments; simple hollowbodies

6 kg/7 kg

Gentle-Program Single and multiplewrapped

textiles; thermo-unstableitems (e.g. plastic, rubberarticles)

Textiles 2 kg/2.5 kg-----

Thermo-unstableequipment6 kg/7 kg

or9 kg with MELAstore

Prion-Program Single and multiplewrapped

instruments undersuspicion of carrying thedanger of infection throughabnormally alteredproteins (e.g. Creutzfeld-Jacob, BSE)

6 kg/7 kgor

9 kg with MELAstore

2) without drying with a full load and dependent upon the loading and setup conditions (such as the temperature of thecooling water, if fixed water connection present and the mains voltage)

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Additional programs Use/functionVacuum test For measuring the leakage rate, test with a dry and cold device (test

without load)

Bowie & Dick test Steam penetration test with special test package (available fromspecialist stockists)

Conductivity meas. For manual measurement of the feed water quality

Draining For emptying and pressure release of the double-jacket steamgenerator, e.g. for service, maintenance or before transport

Additional program options

Additional dryingUsed with the types of load specified in this chapter, the program-specific drying times guarantee verygood drying of the sterilized equipment. For difficult drying tasks you can activate the additional dryingfunction retrospectively during a running program, see Settings [} page 42].

Start time pre-selection

NOTICEUnsupervised operation of electrical devices, including this steam sterilizer at theoperator’s risk. MELAG accepts no liability what so ever for any damage resulting fromunsupervised operation.

This function enables you to select any program and start it at a time of your choice. The start time pre-selection is only active for the unique time and program selection. That means that after completion of theprogram, the pre-selected start time expires. You can switch-off the steam sterilizer during the start timepre-selection. However, the steam sterilizer must be switched on before the timer runs out.

Please note, the security query means that this function is not possible for Quick-Program S. To set aprogram start to a particular number, proceed as follows:

1. After selecting the program, press the symbol inthe action bar. The display switches to the settingswindow.

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27

2. For example, to change the time, tap directly on theparameters Hour or Minutes. The selected field ishighlighted light blue.

3. Change e.g. the hour by pressing the pushbuttons

and .

4. Then press START. The display remains in thestart time pre-selection window.

Ê After the start of the start time pre-selection noother menu apart from the Info & Status menucan be selected.

Starting the programWith the start of the program, the door closes pressure-tight and the steam sterilizer checks the quantity offeed water and its conductivity.

} To start a program, press the START key.

PLEASE NOTICEWhen starting Quick-Program S, a warning and an acoustic signal indicates that thisprogram only permits the sterilization of unwrapped instruments. If the load containswrapped instruments only, confirm with YES to start the program.

Program runA program runs in three phases, the heating up and air removal phase, the sterilization phase and thedrying phase. After program start, you can follow the program run on the display. It shows the chambertemperature and pressure as well as the time until the end of sterilization / the drying.

Sterilization phaseThe display enables you to see whether the sterilization phase has already been completed successfully.The coloured ring and the LED status bar switches from blue to green as soon as the drying phase hasbeen introduced.

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The sterilization phase is unsuccessful if the operator or the system (responding to a fault) aborts theprogram run. A system abort returns the steam sterilizer to a pressureless state. This explains why asystem abort takes longer as an abort by the operator.

Drying phaseThe steam sterilizer provides excellent drying of the sterilization material. If difficult-to-dry items requirebetter drying, you can undertake the following steps to improve drying:

u Load the steam sterilizer properly. Stand the transparent and paper sterilization packaging upright.Comply with the specifications of section Loading the steam sterilizer [} page 22]. Use the optionalpackage holder if necessary.

u Activate the Additional drying function.

Following the program run on the computerYou can follow the current progress of a sterilization program on every computer in the practice network.

ü The steam sterilizer has been assigned an IP address and is integrated in the practice network.

1. Open a web browser (we recommend Mozilla Firefoxor Internet Explorer) and enter the IP address of thesteam sterilizer in the address bar of the web browser.

2. Confirm with [ENTER]. Now you can display theprogram run or information about your steam sterilizer(e.g. serial number, software version and selectedvalues).

Manual program abortYou can abort a current program in all phases. If you end the program before drying begins, thesterilization material remains unsterile.

WARNINGHot steam can be released from the device when opening the door after a program abort.This could result in burns.n Use a tray lifter to remove the tray.

n Never touch the sterilized equipment, the chamber or the door with bare hands. The com-ponents are hot.

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Program abort before the start of drying

WARNINGDanger of infection from early program abortAborting a program before the drying phase begins means that the load is unsterile. Thisendangers the health of your patients and practice team.n If necessary, repack the load and repeat the sterilization for the sterilization material af-

fected.

Should you still wish to do so, proceed as follows to abort the program during drying:

1. Press CANCEL on the action bar.

2. Confirm the security query with YES.

3. After a short time, you can open the door by pressing

the symbol. The display shows a warning; thelog records the sterilization as NOT successful.

Program abort after the start of dryingShould you abort a program after drying has started, the sterilization is having been completedsuccessfully. The steam sterilizer issues a malfunction message. You then need to expect insufficientdrying, especially in the case of wrapped sterilized equipment and a full load. Sterile storage requiressufficient drying. To ensure this, please allow programs with wrapped sterilized equipment to continue tothe end of the drying phase as far as is possible. Unwrapped instruments sterilized in a Quick-Program dryafter being removed from their own warmth.

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Proceed as follows to abort the program during drying:

1. Press STOP on the action bar.

2. Confirm the security query with YES.

3. After a short time, you can open the door by

pressing the door symbol.

Program endWhen the program has ended successfully, the corresponding message will be issued on the display.Working in the Settings menu → Logging if immediate output after program end is activated, (=Immediate output), the log of the completed program will be outputted to the activated output medium afteropening the door.

Before opening the door, you can view further values from the program which has just completed, e.g. the

plateau time conductivity by pressing the magnifying glass symbol .

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31

The approval processAccording to RKI "Hygiene requirements for the treatment of medical products", instrument treatment endswith the documented approval for storage and application of the sterilized equipment. The approvalprocess consists of batch indication and batch approval and must be performed by authorized and expertpersonnel.

Batch indication comprises the checking of the indicators used in the sterilization program e.g.MELAcontrol/MELAcontrol PRO. Approval of the indicator strip is possible only if it changes colour entirely.

Batch approval comprises the checking of the process parameters using the sterilization results on thesteam sterilizer and the sterilization log as well as checking of the individual packaging for damage andresidual moisture. The sterilization log records the approval of the batch and any indicators. Depending onthe setting in the user administration, approval for the sterilized equipment requires the user PIN of theperson who provides approval for the batch and the indicators.

Removing the sterilized equipment

CAUTIONDanger of burns from hot metal surfacesn Allow the device to cool sufficiently before opening.

n Do not touch any hot metal parts.

CAUTIONUnsterile instruments resulting from damaged or burst packaging. This endangers thehealth of your patients and practice team.n Should the packaging be damaged or have burst, re-pack the sterilization material and re-

sterilize it.

If you remove the sterilized equipment from the device directly after the end of the program, it is possiblethat the instruments can be partially damp. According to the Arbeitskreis für Instrumentenaufbereitung(AKI; red broschure 10. Edition; S.57): "In practice, residual moisture in the form of a few drops of watercapable of evaporating within 15 minutes is tolerated, but actual pools of water are not acceptable."

Comply with the following specifications when removing the sterilized equipment:

u Never use force to open the door. This could damage the device and / or result in the emission of hotsteam.

u Hold the mount level when removing it from the steam sterilizer. Otherwise, the load could slide off.

u When removing the load from the steam sterilizer separately, ensure that the mount does not slide outunintended.

u Use a tray lifter to remove the tray.

u Never touch the sterilized equipment, the device interior or the inside of the the door with unprotectedhands. The components are hot.

u Check the packaging on the sterilized equipment for damage when removing it from the device.Should the packaging be damaged, re-pack the sterilization material and re-sterilize it.

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Storing sterile instrumentsThe maximum storage time is dependent on the packaging and the storage conditions. For standard-conform packaged sterilized equipment – (if protected from dust) it can amount to up to six months.Comply with the provisions of DIN 58953, part 8 and the criteria specified below for the storage ofsterilized equipment:

u Comply with the maximum storage duration in accordance with the packaging type.

u Do not store the sterilized equipment in the decontamination room.

u Store the sterilized equipment in a dust-protected environment e.g. in a closed instrument cabinet.

u Store the sterilized equipment in a moisture-protected environment (e.g. alcohol, disinfectant)

u Store the sterilized equipment in an environment protected against excess temperature variations.

8 Logging

33

8 Logging

Batch documentationThe batch documentation acts as proof of the successful conclusion of the sterilization process andrepresents an obligatory part of quality control. The data, such as type of program as well as batch andprocess parameters of the completed programs, are stored in an internal log memory of the device.

To obtain the batch documentation, you can read out the internal log memory and transfer its data tovarious output media. This can be performed immediately at the end of every program or at a later point,such as at the end of the day.

Capacity of the internal log memoryThe steam sterilizer is equipped with an internal log memory. This saves all the data regarding thesterilization program automatically. The capacity of the internal log memory is sufficient for c. 100 logs. Ifthe internal log memory becomes almost full and at least one log has not been outputted via an activatedoutput medium, the following warning "Internal log memory is almost full" will appear on the display. If thiswarning appears, working in the Settings menu → Logging provide the pre-determined output mediaand output the logs affected (→ Log output menu).

Shortly afterwards, the following message is displayed: Internal log memory full. You now have the lastchance to archive logs which have not been outputted (confirm query with YES) before the data in thesteam sterilizer log memory (up to the last 40 logs) is automatically deleted.

Output mediaYou are able to output and archive the logs of the completed programs on the following output media:

▪ MELAflash CF card

▪ A computer (via the practice network)

▪ Label print-out with the MELAprint 60 label printer

▪ MELAprint 42 log printer with network adapter

Any combination of the output media is possible. Log output on multiply activated media is performedsuccessively. In its delivery state, the MELAflash CF card is activated as the output medium for text andgraphic logs from the steam sterilizer. Automatic logging (= Immediate output) is thus activated.

Detailed information regarding the activation and setting of log output is to be found in the chapter settings,logging [} page 42].

Using the CF card as an output medium

NOTICEPremature removal of the CF card from the card slot or its inappropriate handling canresult in data loss, damage to the CF card, the device and/or its software.n Never push the CF card in the slot with force.

n Never remove the CF card from the slot whilst it is being written or read. The square in theupper right-hand corner of the display lights up during reading and writing access.

The card slot for the CF card is located on the right-hand side of the display housing.

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34

Proceed as follows in order to insert the CF card in the slot.

ü The CF card is set as the output medium in the Settings → Logging menu.

1. Insert the CF card in the card slot fully with the raisedfinger edge pointing rightwards and to the rear. If the CF card is inserted correctly, a blue square willilluminate in the right upper corner of the display.

2. Check whether the CF card has been selected asthe output medium.

Using the computer as an output mediumYou can connect the steam sterilizer directly to a computer or integrate it in an existing (practice) networkvia FTP or TCP. The computer must be fitted with a RJ45 socket (LAN).

Further information pertaining to the requirements and setting of the computer as an output medium isavailable in the chapter Settings, logging [} page 42].

Reading out a text log on the computerAll text logs can be opened and printed out using a text editor, a word processing program or aspreadsheet program. Graphic logs cab only be displayed with the MELAtrace/MELAview documentationsoftware.

Each text log (e.g. PRO, .STR, .STB etc.) must be linked with the text editor to enable the computer toopen them automatically with a text editor. The meanings of the endings are outlined in the sectionSubsequent log output [} page 36]. The following examples show how you can link the Windows 7 editorwith a specific text log.

1. Working in Windows Explorer, double click on thelog file.

2. If the file ending is unfamiliar, Windows 7 will displaythe following message:

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35

3. Select "Select a program from a list of installedprograms" and confirm with "OK".

4. You can then open files with this ending via adouble-click in Windows Editor.

Using the label printer as an output mediumThe use of a label printer facilitates batch traceability. Using the sterilization date, the storage duration,batch number, user ID of the person approving the application for use, the steam sterilizer used and thefile name it is possible to assign the sterilized instruments to the patient and sterilization batch. Faultlesspackages containing sterilized equipment are marked with labels after sterilization. As such, thepreconditions for correct "Approval" by the person conferred with the task of decontamination are given. Allinformation regarding the correct sterilization procedure can be attributed to the instruments used inpatient records.

Type, serial numberSterilization date/total batchesDaily batches/No. total batches

User ID

File name

Storage period

NOTICETo facilitate easy assignation of a package marked with a label to a specific batch, thesterilization log file name must not be changed.

Outputting text logs automatically after program end(immediate output)If you want to output the associated text and graphic logs on an output medium immediately after the endof a program, use the "Immediate output" option. In its delivery state, the immediate output of the text andgraphic logs via the CF card after program end is activated.

If the output medium selected for this purpose has not been connected, the logs are saved in the internalmemory and a warning is issued. The steam sterilizer provides the option of outputting this log at the nextpossible opportunity. Graphic logs cannot be saved in the internal log memory; they are lost. Furtherinformation pertaining to the output of graphic logs is available in the section Outputting graphic logs(optional) [} page 42].

The following points must be fulfilled for immediate output:

u The date and time have been set correctly.

u The output medium must have been selected and connected.

u Immediate output must be activated in the Settings menu → Logging.

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36

Information regarding the setting of immediate output and the desired output medium is provided in thechapter Settings, logging [} page 42].

Subsequent log outputThe Log output menu provides the option of outputting text logs subsequently and independently of thepoint of the program end. You can set the output media yourself. The output medium is selected asstandard, which are also selected under Settings → Logging, as far as automatic immediate output isactivated.

The Log output menu offers various opportunities for log output. All program logs present in the memoryare displayed in the Logging list. You can sort the list according to date, time, program and outcome bypressing on the column headings. Here is an overview of all possible output media.

Designation File ending ExplanationLast log .PRO The log of the last successful completed program is

outputted.Logs of the day .PRO The log of the last successful program of the current day is

outputted.Logs of the week .PRO Logs of all successfully completed programs of the week -

Monday to Sunday - are outputted.Logs of the month .PRO Logs of all successfully completed program performed in the

current month are outputted.All logs .PRO The logs of all the successfully completed programs are

outputted.Last fault log STR The last malfunction log are outputted.Fault logs of the day .STR The malfunction logs of the current day are outputted.etc. ...Legend log file .LEG Contains an explanation of all abbreviations contained in the

log.Status log .STA A summary of all important settings and system states

(counter, measured values etc.)Fault in standby .STR This log type is generated following the malfunctions

registered during a time at which no program was active.System log .LOG A sort of log book listing all malfunctions and changes to the

system in order of their incidence.Delete all logs Deletes all logs stored in the internal log memory. Caution: All

logs will be deleted which were not previously outputted toanother output medium.

Outputting a log from the log listProceed as follows to output a specific log from the internal memory:

1. Navigate to the Log output menu andselect Logging list.

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37

2. A list with all text logs is displayed which have beensaved in the internal memory. To ease the search,you can filter the log sort sequence by date, programor event by selecting the top line.

3. Select a log and press CONTINUE.

4. Select an output medium and press OUTPUT.

Outputting the daily/weekly logs etc.Proceed as follows e.g. to output all the logs of a week:

1. Navigate to Log output and select Logs of theweek.

2. Press CONTINUE.

3. Select an output medium and press OUTPUT.

Proceed in a similar fashion to output all logs, all the logs of that month etc.

8 Logging

38

Finding a log

PLEASE NOTICEIf possible, do not rename the directories, otherwise logs will be stored in both therenamed directory as well as the new device directory generated automatically by thesteam sterilizer.

Storage location for logsWhen transferring the logs to a CF card, they will be stored in a separate folder in the main directory.Direct transfer of the log to a computer via the network and using the MELAG FTP server allows you towork directly in the FTP server to determine directly where on your computer the device directory with logfiles is to be saved. With output via TCP and e.g. MELAtrace, you can work directly in the program todetermine the folder in which they are to be saved.

Log directoryAll memory media (CF card or computer) contain a folder with the encoded serial number of the steamsterilizer concerned. The folder name consists of five characters identical with the first five characters ofevery log, e.g. E00T7. This folder contains sub-folders with the month of log generation e.g. 01_2016 forJanuary 2016. This contains all logs generated by the steam sterilizer this month. The device directory isentered in the main directory on the CF card.

The steam sterilizer checks the memory medium after every type of log output (immediate output after acompleted cycle or the transfer of multiple logs simultaneously). Should a directory not exist, itautomatically creates a directory for the device and the month. If the logs are subject to multiple outputtingon the identical memory medium, the device directory will create a "Duplicate" directory.

Further information pertaining to the meaning of the file endings on the logs is available in sectionSubsequent log output [} page 36].

8 Logging

39

----------------------------------------!0 01100ED0E001!1 E00T717U.PRO----------------------------------------10 MELAG Vacuklav 41 B+----------------------------------------15 Program: Universal-Program20 Program type: 134 °C wrapped25 Date: 09.03.201730 Daily batches: 14 Total: 0157835 User: Deactivated36 Indicators changed: deactivated37 Batch approved: deactivated======40 Universal-Program successfullycompleted42 = = ======45 Temperature: 135.3 +0.25/-0.18 °C50 Pressure: 2.17 +0.02/-0.01 bar55 Plateau time: 05 min 30 s60 Conductivity: 8 µS/cm (359:11.1)65 Start time: 20:22:0170 End time: 20:43:19 (21:18 min)======80 SN:201441-B1051======81 MR V3.218 09.03.201782 Para V3.226 17.02.201783 BO V3.323 09.03.2017----------------------------------------Step Time t[m:s] P[mbar] T[°C]SP-S 0:00 0:00 1002 96.3SK11 0:13 0:13 1680 95.7SK12 0:37 0:24 1285 104.8SK11 0:46 0:09 1665 106.8..SK22 2:38 0:20 1284 116.6SF12 3:12 0:34 499 112.7SF13 3:42 0:30 1667 113.3.SF43 8:25 0:24 1749 113.6SH01 9:10 0:45 2780 130.5SH02 9:31 0:21 2847 131.7SS01 9:53 0:22 3065 134.0SS02 15:23 5:30 3169 135.3SA00 15:53 0:30 1292 112.1SI02 17:33 1:40 79 57.9.SB10 21:14 0:12 804 91.3SB20 21:18 0:04 919 92.3SP-E 21:18 0:00 925 92.3>> Never change the code in the followingline <<010041D8BE14B1319E55772A0DF975054F7EBF32EE1372767ED3B3801EB10F3FB01A3212D41D71441C3B8B6474777962766F018680B68C56C219074FD6E7814D506F0A2F3077782541CC2CD05C425DA19A5EF5192C68174C868556542F7B8B05E97C6E4616CDCFFA811E126FD67363FB74128A5F83AE6F37F45A9E240C88615F1618D340060C1027205C83C2>>Authentication of batch log<<----------------------------------------0.00 0.0 0.0 0.0 ---.- 0.0-edk----etm---etd---etp---etv--ett-END-

!0 Ident number!1 File name----------10 Steam sterilizer type----------15 Program name20 Program sterilization parameters25 Date30 Daily and total batch number35 User ID 36 Batch indication37 Batch approval=====40 Control notification42 Warning or malfunction message with program abort=====45 Sterilization temperature with max. deviations50 Sterilization pressure with max. deviations55 Sterilization time60 Conductivity of the feed water65 Time at program start70 Time at program end==========80 Device serial number==========81 Current version of the device firmware82 Current version of the device parameters83 Current version of the user interface----------Step – Program step

Time – Time (min:sec) which has elapsed since the programstart

t [m:s] – Duration (minutes:seconds) which a program steprequires

P [mbar] – Chamber pressure

T [˚C] – Chamber temperature

Key for the program steps:SK – ConditioningSF – FractionationSH – HoldingSS – SterilizationSA – Pressure releaseST – DryingSI – Intelligent dryingSB – VentilationSP-E – End

Proof of authenticity (electronic signature)Should neverbe altered; decoding the code (by MELAG) indicateswhether the data was generated on a MELAG steamsterilizer and has been changed.

----------Sensor measurement values are displayed here in thecase of a malfunction. The values are helpful for atechnician.

Fig. 4: Example log of a successfully completed program

9 Functional checks

40

9 Functional checks

PLEASE NOTICEPlease comply with the recommendations issued by the Robert-Koch-Institute (RKI) andDIN 58946-7.

Manual functional checksYou can follow the program run on the display via the values displayed there. You can also use the logsrecorded for every program to determine the success of a program. The test programs enable you toperform an additional function check at any time.

Vacuum testThe steam sterilizer can be checked for leakages in the steam system using the Vacuum test. Thisdetermines the leakage rate at the same time.

Perform a vacuum test in the following circumstances:

▪ Once a week in routine operation

▪ During commissioning

▪ Following longer operating pauses

▪ Following a malfunction (e.g. in the vacuum system)

Perform the Vacuum test with the steam sterilizer in a cold and dry state as follows:


2. Working in the Programs & Tests menu, selectvacuum test and press START.

9 Functional checks

41

Bowie & Dick testThe Bowie & Dick test serves as the proof of steam penetration of porous materials such as e.g. textiles.You can perform a routine function check for proof of steam penetration. Use the Bowie & Dick testprogram to this end. Specialist stockists provide various test systems for the Bowie & Dick test. Performthe test according to the test system manufacturer information.


2. Working in the Programs & Tests menu, selectBowie & Dick test and press START.

Evaluation of the indicator documents following the colour changeDepending on the manufacturer batch, treatment indicator strips often exhibit differing intensities in thecolour change resulting from different lengths of storage or other influences. Of crucial importance forevaluating the Bowie & Dick test is not the strength of contrast in the colour change on the test sheet, butits even nature. If the treatment strips / treatment indicator sheet indicates an equal distribution of colourchange, the air removal of the sterilization chamber is without fault. If the treatment indicator strips or thetreatment indicator sheets are uncoloured or exhibit less colour in the centre of the star in comparison tothe end, air removal was insufficient. In such a case, please consult the stockist customer services of thecustomer services / authorized stockist.

10 Settings

42

10 Settings

LoggingAll settings pertaining to the output of text and graphic logs i.e. output medium, log format, immediateoutput etc. are performed in the Settings menu → Logging.

To this end, you are led through a settings wizard.

Immediate log outputIn its delivery state, the immediate output of the text and graphic logs via the CF card is activatedimmediately after the program end.

Deactivate immediate outputIf log output is not to be performed immediately following the end of a program, but saved in the internalmemory, (e.g. to be collected and outputted together within a single week), you can deactivate theimmediate output option. Proceed in the following fashion:

ü Navigate to Settings → Logging.

1. Remove the checkmark in front of the Immediateoutput option.

2. Press repeatedly on CONTINUE until you come tothe summary window.

3. Press SAVE to save the setting.

Outputting graphic logs (optional)

PLEASE NOTICEGraphic logs cannot be saved in the internal log memory. A subsequent output ofgraphic logs is thus not possible.

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43

If you wish to output a graphic log (optional) in addition to a text log, proceed as follows:

ü Navigate to Settings → Logging.

ü Immediate output is activated.

1. Set a checkmark next to the Graphic logs option andcheck whether the checkmark is also set next to theImmediate output option.

2. Press CONTINUE and select the CF card and/orcomputer as an output medium.

3. If necessary, change the intervals and pressCONTINUE.

4. Working in this window, check whether at least oneof the two output media have been selected for textlogs.

5. Check whether the activated output medium isconnected (computer) or has been inserted(MELAflash CF card).

6. Press repeatedly on CONTINUE until you come tothe summary window.

7. Press SAVE to save the setting.

Explanation of the possible settings for graphic recording:

Interval ExplanationCF card (CFC) recording interval in sec. – indicates the time intervals in which the program curve

is recorded on the CF card. The smaller the time interval, themore exact the curve. In the example, the time interval is set at 1second.

PC recording interval in sec. – indicates the time intervals in which the program curveis recorded, if the computer is selected as output medium. Thesmaller the time interval, the more exact the curve. In theexample, the time interval is set at 1 second.

PC backup interval in sec. – indicates the time interval in which the graphic data fromthe steam sterilizer is saved on the computer. In example 1, thebackup interval is set to 1 seconds.

10 Settings

44

Using the computer as an output mediumLog transmission can be performed via an FTP server / service or TCP. The following section shows howto set the desired connection:

ü Navigate to the Settings → Logging menu.

ü The steam sterilizer is connected to a computer via a network cable (RJ45).

ü Depending on the output type, an FTP server / service or a suitable program e.g. MELAtrace /MELAview is installed.

1. Press on CONTINUE until you reach the window forselecting the output medium.

2. Select the computer as an output medium andpress CONTINUE.

Ê The selection window opens and asks whetherthe connection to the computer should be ef-fected via FTP or TCP.

IP addresses

PLEASE NOTICEThose setting up the (practice) network will require in-depth understanding of thenetwork technology.Errors in the handling of IP addresses can result in malfunctions and data loss in youruser network.n Setting of IP addresses should only be performed by the system administrator of the (prac-

tice) network.

The device is equipped as standard with IP addresses which all belong to a common network with thesubnet mask stated in the following depiction.

Device IP address RemarksSteam sterilizer 192.168.40.40 Preset works sideComputer 192.168.40.140 Preset works sideLog printer MELAprint 42 192.168.40.240 Preset works sideLabel printer MELAprint 60 192.168.40.160 Preset works sideGateway 192.168.40.244 Not relevant within a networkSubnet mask 255.255.255.0 Possibly to be adopted by

customer network

10 Settings

45

If a device is to be integrated in a pre-existing (practice) network, observe and comply with the following:

ü The IP addresses listed in the table have not yet been assigned in the (practice) network.

ü The device cannot be automatically administered in a dynamic (practice) network (i.e. a DHCPnetwork).

1. Select the Settings menu → Logging. Thesetting wizard opens.

2. Working in the logging wizard, navigate to the windowin which the IP addresses of the individual devices arelisted.

3. Select e.g. the steam sterilizer. The settings windowopens.

4. Select the number block which you wish to changedirectly.

5. Use the C button to delete the numbers. Enter anew number block and confirm with SAVE.

6. Proceed in a similar fashion with the other deviceswhich are to be integrated in the network.

Log formatDifferent data is issued depending on the nature of the logging format.

} The logging format is determined under Settings→ Logging.

You can choose between the following formats.

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46

Format DescriptionFormat 0 Short form - only the log header is outputted.Format 1 The log header and the program steps are outputted.Format 2 Standard format - in addition to the log header and the program steps, a key is displayed

explaining the individual program steps. In logs outputted via the log printer MELAprint 42, thecorresponding legend row is always located under the row to which it refers.

In logs outputted via the log printer MELAprint 42, the corresponding legend row is always located underthe row to which it refers.

User administrationAn individual ID and user PIN can be issued to every user to facilitate reliable traceability via the approvalprocess after the end of a sterilization program. The user is able to authenticate himself before providingthe batch with approval. You can determine the necessity of user authentication via a PIN in the Useradministration menu by setting a checkmark against Batch approval with PIN . Activation of this optiondocuments the user ID and the outcome of the approval procedure in the log header.

Adding a user

1. Select Settings → User administration.

2. Entry of the Admin PIN is necessary to reach the Useradministration menu and undertake settings. Enter theAdmin PIN (standard 1000) and confirm with LOGIN.The display switches to the User administrationwindow.

3. Press "Continue to user list" to display the user list.

10 Settings

47

4. Select a free ID and select EDIT in order to create anew user. The first ID is reserved for the Admin PIN.

5. Enter a 4-digit PIN in the right-hand key pad for theselected User ID.

6. Accept all the settings with SAVE and then leavethe menu.

7. Pressing the symbol enables you to leave themenu.

Deleting a user

1. Select the User administration option asdescribed above and open the user list.

2. Select the User ID which you wish to delete.

3. Press the symbol to delete this menu.

Ê A warming is issued.

4. Confirming the warning with YES will set the PINnumber of this ID to “0”.

Ê A new PIN can be issued for this user ID at anytime.

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48

Changing the Admin PIN

PLEASE NOTICEIf you forget the Admin PIN, consult your stockist/MELAG customer services provider.

The Admin PIN (standard: 1000) can be edited like every other User PIN and should be changed afterdelivery.

Formatting the CF card

NOTICEAll data saved on the CF card is deleted during formatting.n Check whether important data is stored on the CF card.

n Save any logs or other data on the computer or another memory medium.

1. Insert the CF card in the steam sterilizer card slotcorrectly (tangible raised bar on the edge pointingback right). Do not use force.

2. Select the Settings → Format CF card. Thedisplay switches to the corresponding window.

3. To start formatting, press the OK button. Confirmthe security query with YES. You can remove theCF card as soon as formatting has been completed.

Additional dryingSelecting additional drying extends the drying time of conventional drying by 50 %. Activating intelligentdrying restricts the criteria for ending the drying phase.

1. Select Settings → Additional drying. Thedisplay switches to the settings window.

2. Press YES or NO, to chose whether additionaldrying should be performed during the nextprogram run.

10 Settings

49

3. Confirm with SAVE.

Intelligent dryingIn contrast to a conventional time-controlled drying procedure, with which the duration of the drying phaseis determined by the program, the duration of the intelligent drying is automatically calculated using theresidual moisture in the sterilization chamber. A number of factors play a role in this process including e.g.the nature of the load, wrapped or unwrapped, the load quantity, the distribution of the load in thesterilization chamber etc. Comply with the specifications in section Loading the steam sterilizer [} page22].

Intelligent drying is activated in the delivery state. Should you wish to deactivate intelligent drying, proceedas follows:

1. Select the Settings → Device settings→ Intelligent drying . The display switchesto the corresponding window.

2. If you wish to deactivate intelligent drying, select NO.


Water supplySelect the corresponding setting in the display, depending on whether the feed watersupply is effectedusing the internal storage tank or a water treatment unit:

1. Select the Settings menu.

2. Navigate to Water supply → Devicesettings.

Ê The display switches to Water supply window.

3. Select EXTERNAL, if the supply is to be performedvia the internal storage tank or INTERNAL, if you haveconnected a water treatment unit.


10 Settings

50

Date & timeCorrect batch documentation requires the correct date and time setting on the steam sterilizer. Ensure thatyou take into account the clock change in autumn and summer, as this is not adjusted automatically. Oncethe time has been set on the steam sterilizer, it is very accurate. Set the date and time as follows:

1. Select Settings → Date & time. The displayswitches to the settings window.

2. Select the parameters which you wish to change(day, month, year / hour, minute second). Themarked parameter is depicted light blue, here e.g.the hour.

3. Change the respective value via the

and pushbuttons. Repeat this step forall the parameters which you wish to change.

4. Confirm the changes with SAVE.

Ê The display will be restarted after saving andthen changes automatically to the Programs &Tests menu.

Brightness

1. Select Settings → Brightness. The displayswitches to the settings window.

2. Press the pushbuttons or to adjust thebrightness and contrast on the display.


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51

Volume

1. Select Settings → Volume. The display switchesto the settings window.

2. Press the or pushbutton to adjust thevolume.


Key tone

1. Select Settings → Key tone. The displayswitches to the settings window.

2. Press YES or NO to determine whether a toneshould be emitted every time a pushbutton ispressed. This can be deactivated at any time.


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52

ScreensaverA screensaver can be activated to protect the display in standby operation. This displays a continuousslide show of any pictures.

Select images for the slide show

1. Select Settings → Screensaver . The displayswitches to the settings window.

2. Tap on a picture to select it. The white framearound the picture indicates which picture iscurrently selected.

3. Repeated tapping on the picture selects/deselects itfor the slide show.

Ê The checkmark on the lower right-hand corner indicates whether the picture has been se-

lected for the slide show.

4. Press CONTINUE to make further settings.

Set the display duration of the images and the waiting time of the slide show.Proceed as follows to alter one of the named options:

1. Select the parameter directly that you wish to change.The marked parameters are displayed light blue.

2. Change the respective parameter value via the

and pushbuttons.

3. Confirm the settings with SAVE. The displayswitches automatically to the Settings menu.

Table 1: Explanation of the slide show options

Display duration perimage

Indicates the time in seconds between the display of two separate pictures.

Waiting time Indicates how long the display remains in normal mode before the slide showstarts.

Activated Setting/unsetting the checkmark activates/deactivates the screensaver.

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53

Log printer MELAprint 42If you wish to output the sterilization log via the log printer MELAprint 42, you need to set this on the steamsterilizer once. The operating manual of the log printer indicates how to set it up.

Label printer MELAprint 60If you wish to output the sterilization logs via the label printer MELAprint 60, you need to set this on thesteam sterilizer once. The operating manual of the label printer indicates how to set it up.

Sensitivity

1. Select Settings → Touchscreensensitivity. The display switches to the settingswindow.

2. You can determine the pressure required to

activate a pushbutton. using the and pushbuttons.


Energy-saving modeIf the steam sterilizer is not be switched off during longer operating pauses, it can be operated in energy-saving mode. This reduces the time which the steam sterilizer requires in order to pre-heat the double-jacket steam generator to the necessary start temperature after deactivation. Two waiting times can be setin energy-saving mode:

Waiting time 1 (W1): After a re-set waiting time of 15 minutes, the temperature of the double-jacket steamgenerator will sink to 103°C. The program run time becomes c. 2 minutes longer upon the next start.

Waiting time (W2): After a pre-set waiting time of 60 minutes, the double-jacket steam generator is nolonger heated. Accordingly, the length of the program run time increases by about 5 minutes upon the nextstart, depending on the length of the operating pause, as the double jacket steam generator must first bepre-heated to the necessary start temperature.

Setup of the energy-saving mode is described here:

1. Select Settings → Energy saving mode. Thedisplay switches to the settings window.

10 Settings

54

2. Select Waiting time 1 directly by touching the time.The area is displayed light blue.

3. Change the minutes using the and

pushbuttons.

4. Repeat the step for waiting time 2.

5. Press CONTINUE.

Switching off the displayOptionally, you can choose whether the display is to be switched off when the steam sterilizer is in energy-saving mode: The double jacket will not be heated until the next program start. This corresponds to waitingtime 2.

1. Set the checkmark next to "Activated" and set thenumber of seconds after which the display is to bedeactivated.

2. Confirm the settings with SAVE. The displayswitches automatically to the Settings menu.

3. You can switch the display back on by touching thescreen.

11 Maintenance

55

11 Maintenance

Servicing intervalsInterval Measure Device componentsWeekly Check for soiling, deposits or

damageChamber inc. door seal and chambersealing face, mount for the load

With every filling of thestorage tank

Check the storage tank forsoiling and clean it if necessarybefore filling

Internal storage tank

Every 2 weeks Clean the left-hand chamber ofthe storage tank (waste water)

Internal storage tank

After 2 months Oil the door spindle Door mechanismAfter 2 years or2000 cycles

Maintenance By the authorized customer servicesworking in accordance with themaintenance instructions.

As required Cleaning the surfaces Housing parts

Cleaning

NOTICEInappropriately performed cleaning can lead to the scratching of and damage to surfacesand the development of leaks in sealing surfaces.This also favours the development of soiling deposits and corrosion in the sterilizationchamber.n Comply with all information regarding cleaning of the part affected.

Door seal, chamber, chamber sealing face, mount, traysCheck the chamber, door seal, chamber sealing face and the load mount once a week for soiling,deposits or damage.

If you find any impurities, remove the trays or cassettes from the chamber from the front. Clean the soiledcomponents.

When cleaning the chamber, load mount and chamber seal face, please comply with the following:

u Switch off the steam sterilizer before cleaning and remove the power plug from the socket.

u Ensure that the chamber is not hot.

u Use a soft, non-fuzzing cloth.

u First soak the cloth with cleaning alcohol or spirit and attempt to remove the impurities with thismethod.

u Use a chlorine- and vinegar-free cleaning fluid.

u Only if the chamber, mount or chamber seal face has persistent soiling should you use a mild, non-scouring, stainless steel cleaning agent, with a pH value between 5 and 8.

u Use a neutral liquid cleaning agent to clean the door seal.

u You should not allow cleaning fluid to enter the piping coming from the chamber of the steam sterilizer.

u Do not use any hard objects such as a metal saucepan cleaner or a steel brush.

Housing partsWhere necessary, clean the housing parts with a neutral fluid cleaner or spirit.

11 Maintenance

56

Internal storage tankShould you use the internal storage tank for the feed water supply, perform regular checks and cleaning asfollows:

IntervalUpon every refill Check the storage tank for soiling. If necessary, clean the storage tank with

fresh feed water before filling.Every 2 weeks Clean the left-hand chamber of the storage tank (waste water).

Empty the chamber of the internal storage tank

1. Open the service hatch in the lower area of the steamsterilizer.

2. Place a min. 5 L bucket in front of the steamsterilizer.

3. Connect the drain hose onto one of the drain fittingson the waste water side (pos. a) or the feed water side(pos. b) until it snaps into place. The knob must bevertical.

ba

4. Open the water drain tap by turning the knob 1/4 in aclockwise direction.

5. To remove the drain hose, turn the hose connectioninto the vertical position.

11 Maintenance

57

Cleaning the feed and waste water sideYou can remove the cover of the storage tank completely to clean the chambers of the internal storagetank.

1. Remove the fore tank lid.

2. Grasp the cover on the filling opening and then lift thecover upwards a little.

3. Remove the cover from the rubber seal completely.

Avoiding stainingOnly after cleaning instruments properly prior to sterilization is it possible to avoid residue from the load orthe instrument decontamination from being released during sterilization. Loosened dirt residue can clogthe filter, nozzles and valves of the steam sterilizer and deposit themselves on the instruments andchamber as deposits and stains.

All steam-conducting parts of the steam sterilizer consist of non-rusting material. This rules out thepossibility of stain or rust development being caused by the steam sterilizer. The development of rust isalways extraneous rust.

Incorrect instrument decontamination can result in the accretion of rust even on stainless steel instrumentsof leading manufacturers. Often, an instrument which drops rust can suffice to cause the development ofrust on another instrument or in the steam sterilizer. Remove foreign rust from the instruments using achlorine-free stainless steel cleaning agent (see section Cleaning [} page 55]) or send the damagedinstruments to the manufacturer.

The extent of stain accretion on the instruments is also dependant on the feed water used for steamgeneration.

Oiling the door spindleOil the door spindle every two months as follows:

1. Clean the spindle with a non-fuzzing cloth.

2. Place two drops of oil in the bushing on the door of the steam sterilizer from the oil can included in thescope of delivery (art. no. 27515).

Instructions for oiling the door spindle are printed on the inside of the door of the steam sterilizer.

11 Maintenance

58

Maintenance

NOTICEContinuing operation beyond the maintenance interval can result in malfunctions in thedevice.n Maintenance should only be performed by trained and authorized customer services techni-

cians, or stockist technicians.

n Maintain the specified servicing intervals.

Regular maintenance is vital to ensure reliable operation and value retention of the steam sterilizer. Allfunction and safety-relevant components and electrical units must be checked during maintenance andreplaced where necessary. Maintenance is performed in accordance with the maintenance instructionspertinent to this steam sterilizer.

Arrange for regular maintenance in 2 year intervals or after 2000 program cycles. The steam sterilizer willissue a maintenance message at the relevant time.

12 Pause times

59

12 Pause times

Frequency of sterilizationPause times between the individual programs are not necessary, as the sterilization chamber ismaintained permanently at the same temperature. After the end/abort of the drying time and removal of thesterilized equipment, you can load the steam sterilizer again and start a new program.

DecommissioningWhen decommissioning the steam sterilizer for a long pause (e.g. due to holiday), proceed as follows:

1. Switch off the steam sterilizer at the power switch.

2. After deactivating, wait until the pressure display manometer of the deactivation pressure shows zerobar.

3. Remove the power plug from the socket and if necessary, allow the steam sterilizer to cool.

4. Empty the internal storage tank.

5. Shut off if present, the water inflow of the water treatment unit.

Emptying the double jacketYou have the option of draining the water in the double jacket steam generator easily via the Drainingprogram. In order to do so, the steam sterilizer is heated once, building up pressure in the double-jacket sothat the water can be drained fully from the double jacket steam generator.


2. Working in the Programs & Tests menu, selectthe Draining program and press START.

3. Switch off the steam sterilizer in the program endwindow "Draining successful" so that the steamsterilizer does not feed water back into the doublejacket.

12 Pause times

60

Transport

CAUTIONDanger of injury from incorrect carrying.Lifting and carrying too heavy a load can result in spinal injury. Failure to comply withthese provisions can result in crushing.n The device should always be carried by two people.

n Use the suitable carrying straps to carry the device.

n Please note that the distance between the base plate and the setup surface is low.

n Please ensure that you comply with the transport instructions.

Please comply with the following during transport, within a room or the practice:

u Decommission the steam sterilizer, see: Decommissioning [} page 59].

u Remove the connection hoses connected on the rear of the device.

u Should you wish to leave the mount and trays or cassettes in the chamber during transport, protect thesurface of the round blank. To do so, place some foam or bubble wrap between the round blank andmount.

u Close the steam sterilizer door before moving it.

Emptying the double jacketYou have the option of draining the water in the double jacket steam generator easily via the Drainingprogram. In order to do so, the steam sterilizer is heated once, building up pressure in the double-jacket sothat the water can be drained fully from the double jacket steam generator.


2. Working in the Programs & Tests menu, selectthe Draining program and press START.

3. Switch off the steam sterilizer in the program endwindow "Draining successful" so that the steamsterilizer does not feed water back into the doublejacket.

Transport within the practicePlease comply with the following during transport, within a room or the practice:

u Decommission the steam sterilizer, see section Decommissioning [} page 59].

u Remove the connection hoses connected on the rear of the device.

u Should you wish to leave the mounts and tray or cassettes in the chamber during transport, protect thesurface of the round blank. To do so, place some foam or bubble wrap between the round blank andmount.

u Close the steam sterilizer door before moving it.

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61

Transport over long-distance / dispatchFor transport over longer distances, during the danger of frost and / for despatch or during maintenance,an authorized person must prepare the steam sterilizer according to instructions and empty the double-jacket steam generator entirely.

Recommissioning after relocationWhen recommissioning after a move, proceed as with the first commissioning; see technical manual.

13 Malfunctions

62

13 Malfunctions

Not all notifications on the display are malfunction messages. Warnings and malfunction messages areissued on the display with an event number. This number serves identification purposes.

Type of the displaynotification

Explanation

Messages A number of notifications are messages providing information.Messages are not malfunction messages or warnings. They supportthe operation of the steam sterilizer.

Warnings Warning messages are displayed when necessary. These containinstructions which apply to you, the operator. Warning messagesare not malfunction messages. They help to ensure malfunction-free operation and to recognize undesirable situations. Comply withthese warnings early in order to avoid malfunctions.

Malfunction messages Malfunction messages are issued when it is not possible to ensuresafe operation or safety of sterilization. These can appear on thedisplay shortly after switching on the device or during a programrun. If a fault occurs during a program run, the program will beaborted. Aborting a program before the drying phase means thatthe load is unsterile. If necessary, repack the load and repeat thesterilization for the sterilization material affected.

WARNINGDanger of infection from early program abortAborting a program before the drying phase begins means that the load is unsterile. Thisendangers the health of your patients and practice team.n If necessary, repack the load and repeat the sterilization for the sterilization material af-

fected.

Before contacting customer servicesEnsure that you have complied with all instructions relating to a warning or malfunction message issued onthe display of the steam sterilizer. The following table contains a summary of the most important events.Should you be unable to find the relevant event in the table below, or your efforts do not redress theproblem, you can contact your nearest stockist or an authorized MELAG customer service provider. Toenable us to give the best possible service, please have your steam sterilizer serial number and a detaileddescription of the fault to hand.

MessagesIncident Possible causes What you can doM248 The vacuum test was performed, despite

residual moisture in the chamber or witha load.

Repeat vacuum test, when steam sterilizer is coldand empty

13 Malfunctions

63

WarningsIncident Possible causes What you can doW63W65

With an internal storage tank for feedwater: water of insufficient quality waspoured into the storage container(>60 µS/cm) With a water quality:

Empty and clean the storage tank and fill with feedwater of sufficient quality

With a water treatment unit: mixed-bedresin in the water treatment unitexhausted

Replace the mixed-bed resin in the water treatmentunit

W67W68

Waste water side of the storage tank(left-hand chamber) is full

Empty the waste water side

With connection of the waste waterconnection to a siphon: Waste waterhose kinked

Check installation of waste water hose

W72W73W74W75

The feed water quality declines (>40 µS/cm), the mixed-bed resin will soon beexhausted

You can still perform all work with the steamsterilizer and should fill fresh feed water or replacethe mixed-bed resin cartridge as soon as possible.

W76 See W67

W79W80

The waste water side of the internalstorage tank was not emptied or emptiedincompletely.

Empty the waste water side of the storage tank (left-hand chamber) completely

W128 Waste water hose kinked or installedsagging

Check the waste water hose: The hose must beinstalled at a constant decline without sagging.

W129 Steam sterilizer overloaded Check the loadPoor electricity supply (under-sizeddomestic installation to the socket,damaged socket, multiple devices on asingle socket/fuse)

Check the network supply

W192 The internal storage tank (right-handchamber) must contain sufficient waterfor the subsequent rinsing process.

Fill the storage tank with feed water or ensure thewater supply of the water treatment unit

W192 The waste water side of the internalstorage tank (left-hand chamber) mustbe empty for the subsequent rinsingprocess.

Empty the waste water side of the storage tank (left-hand chamber) completely

W351 2 years have passed / 2000 sterilizationprograms have been conducted sincefirst commissioning or the lastmaintenance

Contact an authorized customer services provideror your stockist to arrange servicing. The devicecan still be started.

W377 The log printer is not connected correctly Connect the log printer in accordance with theseparate operating manual

W386 The internal log memory of the steamsterilizer is almost completely full

Output all logs on any output medium, e.g. a CFcard via the Log output menu.

Malfunction messagesIncident Possible causes What you can doF61 With an internal storage tank for feed

water: no water in the storage tankFill the internal storage tank (right-hand chamber)

With a water treatment unit: does notproduce any water because the waterinflow tap is not open

Open the water inflow for the water treatment unit

F64 See W63F78 See W79

13 Malfunctions

64

Incident Possible causes What you can doF102 See W128

F113 Steam sterilizer switched off during arunning program

Do not switch off the steam sterilizer at the powerswitch whilst a program is running

The power plug has been disconnected,power outage in the building supply

Check the power plug and building power plug;operate the steam sterilizer on a separate electricalcircuit

F124F125F126

See W134

F136 Ambient temperature too high,ventilation slots covered,minimum clearance to the sides notmaintained

Comply with the setup conditions

Door remains open permanently Close the doorF175F176

ACOUT1 main heating / ACOUT2 controlheating, electrical supply interrupted,FOY1+ FOY2 can occur in alternation.

1. Switch off the device and press the overheatcontrol reset button back in.

2. Acknowledge the malfunction message.

3. Switch the steam sterilizer off and then back onagain.

4. Proceed with sterilization / perform an emptysterilization run.

F183 See F124

F414 With a direct water water connection:Waste water hose kinked

Check the w for kinks or pinching

Ambient temperature too high, installedsteam sterilizer receives too little or nocooling air

Ensure sufficient air inflow on the rear of the steamsterilizer; maintain the set-up conditions.

Steam sterilizer is overloaded Maintain maximum load quantityThe steam sterilizer was operatedwithout a mount with the result that e.g.the textile package has come into directcontact with the chamber and absorbeda large amount of condensate

Use a mount, comply with the instructions for thecorrect loading of the steam sterilizer

Cooling air ingress holes on the baseplate are covered e.g. by paper.

Remove any objects (e.g. paper) from below thesteam sterilizer.

Packaging residue chokes the pressurerelease nozzle in the sterilizationchamber

Check for packaging residue in sterilizationchamber

F428F439

With a direct water water connection:Waste water hose kinked

Check the waste water hose for kinks or pinching

Poor installation (multiple devicesattached to a single siphon, saggingwaste water hose)

Comply with the setup conditions

Packaging residue chokes the pressurerelease nozzle in the sterilizationchamber

Check for packaging residue in sterilizationchamber

14 Technical data

65

14 Technical data

Device type Vacuklav 41 B+ Evolution Vacuklav 43 B+ EvolutionDevice dimensions (HxWxD) 56.5 x 47 x 57.5 cm 56.5 x 47 x 69 cmChamber diameter/depth Ø 25 cm | 35 cm Ø 25 cm | 45 cmChamber volume 18.4 litres 23.8 litresEmpty weight 60 kg 69 kgOperating weight 81 kg 91 kgElectricity supply 220-240 V, 50/60 Hz, 3400 WBuilding fuses 16 A, FI protection 30 mAWaste heat (with maximumload)

1.7 kWh

Noise emission 64 dB(A)Ambient temperature 5-40 °C (ideal range 16-26 °C)Relative humidity max. 80% at 31 °C, decreases in a linear fashion up to max. 50%

relative humidity at 40 °CMax. height 2000 mLength of the power cable 2 mDegree of protection (followingIEC 60529)

IP20

CE marking CE 0197, CE 0035Feed water connectionWater quality DIN EN 13060, Appendix CMin. flow pressure 1.5 bars at 3 l/minMin. static water pressure 2 barMax. static water pressure 10 barMax. water consumption 0.74 L 0.83 LWaste water connectionMax. through-flow volume 1.5 L 1.5 LMax. water temperature 98 °C 98 °C

15 Accessories and spare parts

66

15 Accessories and spare parts

You can obtain the specified articles and an overview of further accessories from your stockist.

Category Article Order no.Mounts Mount C "Plus"

for 6 trays or 3 MELAstore-Boxes 10081375 81385

Mount D "Plus"for 2 MELAstore boxes 200 or 2 MELAstoreboxes 100 and 2 narrow trays

82645 82655

Mount E "Plus"for 6 trays (standard) and 2 narrow trays.

82400 82700

Mount F "Plus"for 3 MELAstore-Boxes 100 and 2 narrow trays

82665 82675

Trays Tray 00280 00230Tray, narrow 01320 01310

Sterilization container witha single-use paper filter inaccordance with DIN EN868-8

15K (18 x 12 x 4.5 cm) 0115115M (35 x 12 x 4.5 cm) 0115215G (35 x 12 x 8 cm) 0115317K (20 x 14 x 5 cm) 0117117M, for 45 cm chamber depth (41 x 14 x 5 cm) --- 0117217G, for 45 cm chamber depth (41 x 14 x 9 cm) --- 0117323M, for 45 cm chamber depth (42 x 16 x 6 cm) --- 0123123G, for 45 cm chamber depth (42 x 16 x 12 cm) --- 0123228M (32 x 16 x 6 cm) 0128428G (32 x 16 x 12 cm) 01285

MELAstore System MELAstore-Tray 50 (18 x 11.8 x 3 cm) 01180MELAstore-Tray 100 (27.5 x 17.6 x 3 cm) 01181MELAstore-Tray 200 (27.5 x 17.6 x 4.3 cm) 01182MELAstore-Box 100 (31.2 x 19 x 4.6 cm) 01191MELAstore-Box 200 (31.2 x 19 x 6.5 cm) 01192

Test body system MELAcontrol consisting of a Helix test body and250 indicator strips

01080

MELAcontrol consisting of a Helix test body and 40indicator strips

01075

Water treatment MELAdem 40 ion exchanger 01049MELAdem 47 reverse osmosis unit 01047

For documentation: MELAflash CF card 01043MELAflash card reader 01048Label-Printer MELAprint 60 01160Network cable (cross-over), 2 m 15813Network cable (cross-over), 5 m 15814Network cable (cross-over), 10 m 15815

Other Water stop (leakage water detector) 01056Surface-mounted siphon 37410

Category Article Order no.Spare Parts 1x Oil for door lock socket 27515

Glossary

67

GlossaryAir leakage

An air leakage is a location through which air canpass in and out without this being desired. Verifica-tion of the leakage serves to prove that the volumeof air ingress in the chamber during the vacuumphase does not exceed a value which would pre-vent steam penetration of the sterilizer load andthat the air leakage does not cause the possiblecontamination of the sterilizer load during the dry-ing phase.

AKIAbbr.: working group instrument preparation( "Arbeitskreis Instrumentenaufbereitung")

Authorized personnelAn authorized personnel can be medical stockists,depot technicians or MELAG-authorized customerservices trained by MELAG.

BatchCollection of sterilization material which has beenprocessed together in the same sterilization pro-gram.

BGV A1BGV is the abbreviation for Berufsgenossenschaft-liche Vorschriften (regulations from a professionalassociation). A1 stands for principles of prevention

Bowie & Dick testSteam penetration test with a standard test pack-age; described in DIN EN 285; the test is recog-nized in the large-scale sterilization industry.

CF cardAbbr.: "Compact Flash Card"; a memory card fordigital data with a compact size. CF is a standard.

CondensateFluid (e.g. water) produced by the cooling of andresultant separation from the vaporous state.

ConductivityConductivity is the opposite of electrical resistance;measured in micro-Siemens/centimetre (µS/cm);the greater the amount of dissolute matter in thewater, the better it can conduct electrical currentand thus the higher its conductivity.

CorrosionThe chemical alteration or destruction of metal ma-terials by water and chemicals

Delay in boilingThis refers to the phenomenon that it is possibleunder certain circumstances to heat a fluid beyondits boiling point without them boiling. This repres-ents an unstable state; even low-level agitation can

produce a large bubble within the shortest period,which expands explosively.

Demineralized waterWater without the minerals usually found in normalspring or tap water; is produced through ion ex-change of normal tap water. It is used here as feedwater.

DGSVAbbr.: Deutsche Gesellschaft für Sterilgutversor-gung (German Society German Society for SterileSupply). The DSGV training centres are specifiedin DIN 58946, part 6 as "Requirements of person-nel".

DIN 58946-7Standard – sterilization - steam steam sterilizers -part 7: Building requirements and requirementsplaced on the operating agents and the operationof steam sterilizers in the health-care branch

DIN 58953Standard – sterilization, sterile equipment supply

DIN EN 13060Standard – small steam sterilizers

DIN EN 867-5Standard – non-biological systems for use in steril-izers – part 5: The determination of indicator sys-tems and test bodies for the performance inspec-tion of type B and type S small sterilizers.

DIN EN ISO 11140-1Standard – the sterilization of products for use inmedical treatment – chemical indicators – part 1:General requirements

DIN EN ISO 11607-1Standard - packaging for medical devices to besterilized in the final packaging - Part 1: Require-ments placed on materials, sterile barrier systemsand packaging systems

Distilled waterFrom the Latin aqua destillata; also referred to asaqua dest; water which to a great extent is freefrom salts, organic material and micro-organisms,is produced from normal tap water or pre-cleanedwater through the process of distillation (evapora-tion and subsequent condensation). It is used hereas feed water.

Double-jacket steam generatorServes the quick generation of steam outside thesterilization chamber, surrounds the sterilizationchamber

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Dynamic pressure test of the sterilization chamberServes to prove that the rate of pressure variationsduring a sterilization cycle does not exceed a par-ticular value which could result in the damage ofthe packaging material. [see also DIN EN 13060]

Empty chamber testTest run without a load, performed to assess theperformance of a sterilizer without the influence ofa load; facilitating verification of the temperaturesmaintained in comparison to the temperatures set.[see also DIN EN 13060]

EvacuationCreation of a vacuum in a vessel

Feed waterFeed water is required to produce steam for steril-ization. Guide values for water quality in accord-ance with DIN EN 285 / DIN EN 13060 – AppendixC

Fractionated vacuum procedureA technical procedure in steam sterilization; the re-peated evacuation of the sterilization chamber inalternation with steam injection.

FTPAbbr.: (File Transfer Protocol) is a data transmis-sion procedure serving to transport data from theinternet. This data can include programs, files oreven information. Special FTP programs (FTP cli-ents) serve to load the data onto a server.

Heat-up phaseThe time required after the steam sterilizer hasbeen switched on / after the start of a sterilizationprogram, to heat the double-jacket steam gener-ator before the sterilization procedure starts. Theduration is dependent on temperature at whichsterilization takes place.

Hollow body ASee product with narrow lumen

Hollow body article BSee simple hollow body

MELAG network adapterEthernet printer module for the MELAprint 42 logprinter; a printer connection on one side and a net-work connection on the other

Mixed loadswrapped and unwrapped sterilization materialwithin a single load

Multiple wrappinge.g. wrapped instruments sealed in a double layerof film or wrapped in film and placed in an addi-tional container or a container wrapped in textiles.

Network cable (crossover)A crossover cable connects two computers(through network cards) directly without the use ofa hub/switch. This type of connection correspondswith the network connection of the steam sterilizerin the practice network. The crossover cable doesnot run in parallel between the connectors, rathercertain skinners are crossed.

PorousPermeable for fluids and air e.g. textiles

Porous full loadServes to prove that the values set on the controlsatisfy the necessary sterilization conditions in por-ous loads with a maximum mass for which the ster-ilizer is designed in accordance with DIN EN13060 [see also DIN EN 13060]

Porous partial loadServes to prove that the values set on the controlallow steam to enter the pre-determined test pack-age quickly and equally [see also DIN EN 13060]

Process evaluation systemAlso known as the self-monitoring system – thisobserves itself and compares the various sensorsduring a current program.

Product with narrow lumenAn article open on one side to which the followingapplies: 1 ≤ L/D ≤ 750 and L ≤ 1500 mm or an art-icle with an opening on both sides which is: 2 ≤ L/D≤ 1500 and L ≤ 3000 mm and which does not cor-respond to a hollow body article B; L…length ofhollow body article; D…Diameter of hollow bodyarticle [see also DIN EN 13060]

RKIAbbr.: "Robert-Koch-Institute". It is one of the mostimportant bodies for the safeguarding of publichealth in Germany.

Simple hollow bodiesAn article open on one side to which the followingapplies: 1 ≤ L/D ≤ 5 and D ≥ 5 mm or an articlewith an opening on both sides which is: 2 ≤ L/D ≤10 and D ≥ 5; L…hollow body article length; D…hollow body article diameter [see also DIN EN13060]

Single wrappingWrapped once e.g. instruments sealed in foil – inopposition to: Multiple wrapping

Soft sterilization packaginge.g. a paper bag or transparent sterilization pack-aging.

SolidWithout hollows or gaps, solid, compact, closed

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Solid loadServes to prove that the necessary sterilizationconditions have been reached within the entireload with the values set in the control. The loadmust represent the largest weight of massive in-struments designed for sterilization in a sterilizer inaccordance with DIN EN 13060. [see also DIN EN13060]

Sterile barrier systemA closed minimum packaging which prevents theentrance of micro-organisms e.g. through sealingbags, sealed and re-usable containers and foldedsterilization towels etc.

Sterilization chamberThe interior of a sterilizer accommodates the steril-ization material

Sterilization materialUnsterile, sterilizable material which is still to besterilized.

Sterilized equipmentAlso referred to as a batch: a load which hasalready been sterilized, i.e. is sterile

TCPAbbr.: Transmission control protocol: refers to astandard protocol for connecting computers andnetworks.

VacuumIn common parlance, an area devoid of all mater-ialIn the technical sense: volumes with a reducedgas pressure (at least air pressure)

VDEAbbr. (German): "Verband der Elektrotechnik,Elektronik und Informationstechnik e.V." (Allianceof the Electronics, Electrotechnical and IT In-dustry).

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MELAG Medizintechnik oHGGeneststraße 6-1010829 BerlinGermany

E-Mail: [email protected]: www.melag.com

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BA Evo 41B+ 43B+ enUser Manual Vacuklav 41 B+ Evolution Vacuklav 43 B+ Evolution Steam sterilizer as of software version v3.218 EN Dear doctor, We thank you for your confidence demonstrated