Melag Vacuklav 31-B User manual

Operating Manual

for the

Autoclave

Vacuklav 31 B

Dear Doctor:

Thank you very much for the trust which you have shown by purchasing this autoclave.

For 50 years now, MELAG — a medium-sized family-owned and -operated business — has specialised in the production of sterilization equipment for medical practice. During this period, MELAG has succeeded in becoming a leading manufacturer of sterilization equipment. More than 335,000 MELAG units sold throughout the world testify to the exceptional quality of our products — which are manufactured exclusively in Germany.

As all other MELAG products, this autoclave was manufactured and tested according to strict quality criteria. Before placing this unit into operation, please carefully read this Operating Manual. The long-term functional effectiveness and the preservation of the value of your autoclave will primarily depend on careful preparation of instruments before sterilization, and on proper care of the unit.

The staff and management of MELAG

The functional effectiveness and the preservation of value of this unit depend on:

1. Proper preparation of the instruments to be sterilized

2. Proper care of the autoclave

3. The use of sufficiently pure demineralized / distilled water

DESCRIPTION OF THE UNIT ...........................................................................................................................				6
1.1	Views of the unit...................................................................................................................................			6
1.2	Technical data......................................................................................................................................			6
1.2.1		Primary technical data ..................................................................................................................		6
1.2.2		Capacity / weights.........................................................................................................................		6
1.2.3		Operating media ...........................................................................................................................		6
1.2.4		Operational parameter ..................................................................................................................		6
	1.2.4.1		Programs / operating times....................................................................................................	6
	1.2.4.2		Consumption of energy / water..............................................................................................	6
1.3	Installation examples............................................................................................................................			7
1.4	Control panel........................................................................................................................................			8
1.5	Performance features of this autoclave ...............................................................................................			8
1.5.1		Preliminary air removal by sub-atmospheric pulsing ....................................................................		8
1.5.2		Sterilization and disinfection functions..........................................................................................		8
1.5.3		Separate steam generation...........................................................................................................		8
1.5.4		One-way system / conductivity measurement / automatic re-supply of water..............................		8
1.5.5		Electronic parameter control.........................................................................................................		8
1.5.6		Vacuum drying ..............................................................................................................................		8
1.5.7		Pre-heating ...................................................................................................................................		9
1.5.8		Documentation of results ..............................................................................................................		9

2 INSTALLATION ..........................................................................................................................................		9
2.1	Requirements for installation................................................................................................................	9
2.2	Transport straps ...................................................................................................................................	9
2.3	Levelling ...............................................................................................................................................	9
2.4	Mains power supply .............................................................................................................................	9
2.5	Outlet connection for one-way water .................................................................................................	10
2.6	Internal water supply with demineralized / distilled water ..................................................................	10
2.7	Connection of a water treatment system ...........................................................................................	10
2.8	Emptying the water storage tank........................................................................................................	10

3 PLACING THE AUTOCLAVE INTO OPERATION ..................................................................................		10
3.1	Printer connection and initialisation (optional) ...................................................................................	10
3.1.1 Connection of the MELAprint®42 ................................................................................................		10
3.1.2 Initialisation of the printer / setting for immediate printout ..........................................................		10
3.2	Vacuum test .......................................................................................................................................	11
3.3	Trial run ..............................................................................................................................................	12
3.4	Installation log – sent to MELAG........................................................................................................	12
3.5	Safety instructions..............................................................................................................................	13

4 FOR EACH STERILIZATION CYCLE ......................................................................................................			14
4.1	Water and power................................................................................................................................		14
4.1.1		Demineralized / distilled water ....................................................................................................	14
4.1.2		Power supply ..............................................................................................................................	14
4.2	Preparation of instruments .................................................................................................................		14
4.3	Loading the autoclave ........................................................................................................................		15
4.4	Closing the door .................................................................................................................................		16
4.5	Selection of the program ....................................................................................................................		16
4.6	Start of program .................................................................................................................................		17
4.7	Program sequence.............................................................................................................................		17
Printout of cycle log.......................................................................................................................................			19
4.8	Removing the sterilized items ............................................................................................................		19
4.9	Sterile storage ....................................................................................................................................		19
4.10	Sterilization frequency / interval periods ............................................................................................		20
4.11	Manual abort of the program..............................................................................................................		20

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Operating Manual for the Vacuklav®31-B

	4.11.1 Aborting during the sterilization / disinfection phases.................................................................			20
	4.11.2		Interruption of a drying phase .....................................................................................................	21
4.13		Response in case of warnings and error messages..........................................................................		22
4.14		Operational shutdowns ......................................................................................................................		22
5	PLACING THE AUTOCLAVE OUT OF OPERATION / TRANSPORT /
			PUTTING THE AUTOCLAVE BACK INTO SERVICE ....................................................	22
6	SPECIAL FUNCTIONS.............................................................................................................................			23
6.1		Display of water quality (conductivity) / pre-heat temperature of the sterilization chamber..............		23
6.2		Selection for additional drying............................................................................................................		23
6.3		Logging / documentation of sterilization + disinfection cycles ...........................................................		23
	6.3.1		Output of logs ..............................................................................................................................	23
		6.3.1.1	External printer ....................................................................................................................	23
		6.3.1.1.1 Connection of the external printer Melaprint®42................................................................		23
		6.3.1.1.2 Initialization of the printer...................................................................................................		24
		6.3.1.2	Connection to an external PC..............................................................................................	25
		6.3.1.2.1	Installation..........................................................................................................................	25
		6.3.1.2.2 Initializing the output on your PC.......................................................................................		25
		6.3.1.3	No printer .............................................................................................................................	25
	6.3.2		Immediate printout option: YES or NO .......................................................................................	25
	6.3.3		Printing out stored cycles at a later time .....................................................................................	26
	6.3.4		Printing out all stored cycles .......................................................................................................	27
	6.3.5		Displaying the contents of the printer memory ...........................................................................	28
	6.3.6		Deleting stored cycles from the memory ....................................................................................	29
	6.3.7		Test printout ................................................................................................................................	30
6.4		Setting the date and time of day ........................................................................................................		31
6.5		Automatic pre-heating ........................................................................................................................		32
6.6		Total-cycle counter.............................................................................................................................		33
6.7		Changing the setting for supply of demineralized / distilled water .....................................................		34
6.8		Program modifications .......................................................................................................................		34
7	FAULTY OPERATION / MALFUNCTIONS..............................................................................................			35
7.1		What to do in case of malfunctions ....................................................................................................		35
7.2		Malfunctions without an error message .............................................................................................		35
	7.2.1		An empty display window ............................................................................................................	35
	7.2.2		The autoclave uses too much demineralized / distilled water ....................................................	35
	7.2.3		Poor drying ..................................................................................................................................	35
7.3		Warning messages ............................................................................................................................		36
7.4		Error messages..................................................................................................................................		38
8	PRESERVING THE VALUE OF THIS DEVICE........................................................................................			41
8.1		Preparation of instruments .................................................................................................................		41
8.2		Drag-in rust (rust brought into the autoclave) ....................................................................................		41
8.3		Regular care of the Vacuklav®31-B....................................................................................................		42
	8.3.1		Cleaning ......................................................................................................................................	42
	8.3.2		Use of demineralized / distilled water .........................................................................................	42
8.4		Monitoring the functions of the autoclave ..........................................................................................		43
	8.4.1		Continuous monitoring of sterilization progress ..........................................................................	43
	8.4.2		Periodical bacteriological monitoring (every 6 months) ..............................................................	43
	8.4.3		Periodic maintenance recommendation .....................................................................................	43
9	ANNEX			44
9.1		Instructions .........................................................................................................................on drying		44
	9.1.1 .............................................................................		The drying process in sterilization containers	44
	9.1.2 ........................................................................................................................................		Textiles	45
	9.1.3 .................................................................................................................................		Instruments	46
	9.1.4 .................................................................................................................		Loading the autoclave	46
	9.1.5 ................................................................		Loading of containers with soft sterilization packages	46
	9.1.6 .............................................................................................		Stacking of sterilization containers	47
	9.1.7 ...........................................................................................................		Removing sterilized items	47
	9.1.8 ................................................................................		Further improvement of the drying process	47
10	INDEX........................................................................................................................................................			48

Seite 3

Page 4

1 Description of the unit

1.1Views of the unit __________________________________________________________

	19
	18	1
	17
		2	Rückansicht
	16	3
		4
		5
		6
		7
		8
Frontansicht		9
	15	10
	14
	13	11
	12

20 21

Seitenansicht

Fig. 1 Views of the Vacuklav®31-B
1	Water storage tank	11	Power cable
2	Emergency overflow (OUT)	12	Front adjustable feet of the unit
3	One-way drain (OUT)	13	Serial data and printer interface (RS 232)
4	Spring-operated safety valve	14	Fuses for the unit: 2 × 16 A / FF
5	Connection for demineralized / distilled	15	Power switch
	water (OUT)
6	Sterile filter	16	Sliding-lock handle
7	Connection for pressure release for	17	Hinged door (opens to the left)
	water storage tank (IN)
8	Cooler	18	Operator’s control and monitoring panel
9	Connection for demineralized / distilled	19	Cover to water tank
	water (IN) (quick-fitted threaded	20	Drain hose for water tank, drain side (OUT)
	connection for 6 × 1 hose)	21	Drain hose for water tank, demineralized-water side (OUT)
10	Connection for pressure release (OUT)

1.2Technical data _______________________________________________________

1.2.1Primary technical data _____________________________________________________________

Sterilization chamber ( × depth)		25 cm × 36 cm
Power ratings		2400 W / 230V AC / 10.4 A / 50 ... 60 Hz
Sterilization pressure / temp.		2 bar / 134°C; 1 bar / 121°C
Disinfection pressure / temp.		0.3 bar / 105°C
Maximum load		5 kg of instruments or 1.8 kg of textiles
Outside dimensions		48.5 cm high × 42.5 cm wide × 59.5 cm deep
1.2.2	Capacity / weights_________________________________________________________________
Weight of unit (without load)		43 kg
Volume of chamber		17.6 litre
Maximum loading		5 kg of instruments or 1.8 kg of textiles
Water storage tank (demineralized /		Fresh-water side: 5 litres (approx. 7 cycles); drain side: 3 litres
distilled water)
Loading variations		Mount “B” for max. 4 norm tray cassettes or 4 MELAG trays
		Mount “C” for max. 3 norm tray cassettes or 6 MELAG trays
		MELAG sterilization containers: 28M,G, 23R, 15K,M,G, 17K,R;
		MELAG Package Holders
1.2.3	Operating media __________________________________________________________________
Power ratings:
Electricity ratings		230 V AC / 10.4 A / 50 ... 60 Hz
Power ratings		2400 W; fuse = 16 A; RCCB (residual current circuit breaker); 30 mA
aqua dem / aqua dest		Demineralized / steam-distilled water in accordance with VDE 0510
1.2.4	Operational parameter _____________________________________________________________

1.2.4.1 Programs / operating times_________________________________________________________

Program	Operating time (not including drying period)		Drying
	Hot start; load = 0.5 kg	Hot start; load = 5 kg
"Quick program" (134°C, 2 bar)	12 min	20 min	10 min
"Universal program" (134°C, 2 bar)	23 min	38 min	15 min
"Gentle program" (121°C, 1 bar)	41 min	50 min (1,8 kg textiles)	20 min
" Prion Program" (134°C, 2bar )	40 min	55 min	15 min
"Bowie & Dick" (134°C, 2 bar)	33 min	40 min	5 min
"Vacuum Test"	—	18 min (empty)	--

1.2.4.2 Consumption of energy / water _____________________________________________________

Power consumption
"Pre-heating"
One-time heating up to pre-heating	approx. 0.12 kWh ( = 0.03 DEM1 )
temperature (134°C)
"Stand by" operation per hour	approx. 0.2 kWh ( = 0.05 DEM)
"Program cycle" (including drying)	0.3 kWh (= 0.075 DEM) for “Quick program” / hot start / light load, up
	to ...
	1.1 kWh ( = 0.275 DEM) for “Gentle program” / cold start / full load
Consumption of demineralized /	300 ml ( = 0.06	DEM2.) for “Quick program”
distilled water	500 ml ( = 0.10	DEM) for “Universal program”
	600 ml ( = 0.12	DEM) for “Gentle program”

1Based on following price for one kWh: = 0.25 DEM

2Based on following price for one litre of distilled water from the MELAdest®65: 0.20 DEM

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Operating Manual for the Vacuklav®31-B

1.3Installation examples_____________________________________________________

Example 1

A A

Example 2

B

A	A
Example 3	Example 4

B B

Fig. 2. Installation examples for Vacuklav (A) with double-chamber trap (B)*1

*1 Alternative: a separate drain with stench trap, instead of the double-chamber trap.

Example 1	Example 2
Vacuklav 31-B rear view	Vacuklav 31-B rear view
Standard version = version as supplied	MELAdem 37 (optional), external water supply,
(with internal supply of water)	with manual draining of the waste-water tank
	Leak detector with shutoffvalve and sensor
	(optional)

Example 3

Vacuklav 31-B rear view

MELAdem 37 (optional), external water supply, with manual draining of the waste-water tank MELAjet (optional)

Leak detector with shutoff valve and sensor (optional)

Example 4

Vacuklav 31-B rear view

MELAdem 47 (optional), with drain of waste water automatically into a double-chamber trap

Leak detector with shutoff valve and sensor (optional)

Page 7

1.4Control panel ___________________________________________________________

2 x 20-character alphanumeric LED display For display of program status and parameters, and for operator for basic and special functions

Function buttons

For selections, settings, and display of special functions: printing, date and time of day, pre-heating, total sterilised loads, water conductivity, error-report acknowledgement

Program

Start / Stop

Program selection button	Start / stop button
For selection of the sterilisation programs and	For starting and stopping of
test programs, and for selection/settings of	programs, drying, and for
options (sub-menus) for the special functions	control fo special functions

Fig. 3: Vacuklav 31-B control panel

1.5Performance features of this autoclave______________________________________

1.5.1Preliminary air removal by sub-atmospheric pulsing ________________________________________

Preliminary air removal by sub-atmospheric pulsing repeatedly evacuates the air from the autoclave and alternately introduces steam between evacuations: providing the required penetration of the sterilized objects with saturated steam. This ensures fast and effective execution of difficult sterilization tasks: e.g., instruments with narrow bores and large amounts of textiles. This autoclave also features a special program for the Bowie & Dick Test (a recognised procedure used in large-scale sterilization to confirm steam penetration.

1.5.2Sterilization categories _________________________________________________________________

The Vacuklav®31-B features three sterilization programs for temperatures at 134°C: the “Universal Program” (for wrapped objects), the “Prion Program” (a special Universal Program), the “Fast Program” for unwrapped items, and the “Gentle Program” (a sterilization program for textiles and rubber articles at 121°C). The user can at any time perform additional functional checks of the autoclave by running the Bowie & Dick Test for steam penetration, and the Vacuum Test for leak testing. The additional program "MELAsteam®" is available as an option, and functions at a temperature of 136°C.

1.5.3Separate steam generation______________________________________________________________

The powerful steam generator outside the actual sterilization chamber makes it possible to sterilize large loads of instruments or textiles in a short time. No waiting periods are necessary between the sterilization cycles, and excess temperatures within the sterilization chamber cannot occur.

1.5.4One-way system / conductivity measurement / automatic re-supply of water ____________________

The Vacuklav®31-B operates with the tried-and-proven one-way system: this means that all evaporated water and all impurities contained in this water are removed from the autoclave upon pressure release. For the following program cycle, new demineralized / distilled water is therefore used. An integrated conductivity measurement system monitors the quality of the demineralized / distilled water used in steam generation. For heavy use of the autoclave, we recommend supply of the demineralized / distilled water by connection of a water-treatment system such as the MELAdem® 47 or MELAdem® 37. If the instruments are carefully prepared, this arrangement prevents spots on the items sterilized, and avoids fouling of the autoclave.

1.5.5Electronic parameter control ____________________________________________________________

The microprocessor installed in the Vacuklav®31-B implements electronic parameter control, which continuously monitors pressure, temperature, and time in the programs. The process evaluation and monitoring system contained in the program control system compares momentary process parameters with standard process data and monitors the process with respect to limit temperatures, limit times, and limit pressures. This function detects malfunctions in the program cycle and guarantees the security of the sterilization / disinfection results.

1.5.6 Vacuum drying________________________________________________________________________

The vacuum drying feature ensures good drying results, even for wrapped items.

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Operating Manual for the Vacuklav®31-B

1.5.7Pre-heating___________________________________________________________________________

Activating the pre-heating function warms up the cold autoclave chamber before sterilization, or maintains the temperature between sterilization cycles. This shortens the duration of cycles and considerably reduces the formation of condensation, thus optimising drying results.

1.5.8Documentation of results _______________________________________________________________

The memory of the electronic control system stores records of the previous 40 programs. For effective hard-copy documentation and for checking purposes a MELAprint®42 printer can be connected to print out a record immediately after completion of a program, or to print out records from the memory. By connection of a PC, the program MELAwin® can also transfer the records to the PC, for permanent archiving of all results, and for printing out these results as needed.

2 Installation

For the steps required to prepare for and carry out the setting up and installation of this autoclave, see the separate instructions contained in “Setting up the Vacuklav®31-B”.

2.1Requirements for installation ______________________________________________

The autoclave should be set up in a dry place which is protected against dust. The base should be stable and capable of supporting the weight of the appliance (unloaded weight = 43 kg). The space required by the autoclave can be seen from the external dimensions (see Section 1.2.1 here). A minimum additional space of 10 cm should be allowed on both sides and above the autoclave in order to ensure that heat can escape.

The electrical power supply should be a separate 230V AC circuit with a 16 A fuse.

This autoclave operates with a blower for the cooling system, on the rear side of the unit. If there is a restriction of the escape of heat above the unit, this can impair the functioning and shorten the service life of the autoclave.

IMPORTANT: We therefore urgently advise our users not to install the autoclave in an area where there is not sufficient circulation of air.

If the user decides to install an automatic one-way water system, it is necessary to have a connection to the wastewater plumbing near the autoclave, preferably a wall outlet (NW 40) or a sink drain (standard length of outflow pipe = 2 m, with 16 mm diameter). The work surface on which the autoclave stands must be higher than the outlet, and the outlet pipe must be without bends and twists which could prevent water flowing out freely. At the same time, the work surface must provide convenient access to the autoclave, and the display must be clearly visible.

The autoclave can be supplied with demineralized / distilled water from the integrated dual-chamber storage tank, with freshwater and wastewater chambers. Alternatively, the Vacuklav®31-B can also be connected to an external water purifier – the MELAdem®47 or MELAdem®37 (or an equivalent water purification system). However, please note that this will require additional space.

2.2Transport ribbons _______________________________________________________

Lift the autoclave out of the packaging by using the transport straps. The straps themselves are each removed by unscrewing the two retaining screws, which must then be screwed firmly back in place without washers.

2.3Levelling ______________________________________________________________

In order to operate properly, and to allow unimpeded return flow of condensate into the steam generator, the autoclave must be installed so that it definitely slopes toward the rear. First install the autoclave in a horizontal (level) position, and check that this position is in fact horizontal with a spirit level at the chamber flange. Then extend the front feet to lift up the front side of the autoclave, by screwing the feet out by at least three (3) turns.

2.4Mains power supply _____________________________________________________

The electric cable of the appliance must be plugged into a mains socket rated at 230 V / 50 Hz. The power rating of the autoclave is 2400 W. In order to avoid overloading the building electricity supply, we recommend using a separate electrical circuit fitted with a 16 A fuse and optionally protected with a type RCCB (residual current circuit breaker) with a tripping current of 30 mA.

Page 9

2.5Outlet connection for one-way water _______________________________________

The connection for the one-way water outlet at the back of the unit (3) must be hooked up to the drainage system of the building by means of the outlet pipe supplied (transparent pipe). It is important that the pipe should have a steady downward gradient, without twists and kinks. The outlet must be connected to an existing sink drain, or to a separate NW40 drain pipe with use of the wall-mounted drain (MELAG article no. 37410).

2.6Internal water supply with demineralized / distilled water ______________________

If the user decides for internal supply of the autoclave with demineralized / distilled water, this water is taken from the right chamber of the built-in water storage tank. To install the internal system for supply of demineralized / distilled water, connect the hose at the demineralized / distilled water connection of the supply tank to the swivell threaded connection at the supply point for demineralized / distilled water on the rear side of the autoclave. For this variation of water supply, the autoclave is delivered ready for installation. To fill the feed water tank, remove the cover of the tank and fill the right chamber with demineralized / distilled water up to the maximum mark.

2.7Connection of a water treatment system ____________________________________

The autoclave can be directly connected to a water treatment system for direct supply with demineralized / distilled water. Instead of being connected to the water storage tank (as in Section 2.6), the demineralized / distilled water connection is hooked up directly to the water treatment system. The reverse-osmosis system MELAdem®47 and the ion-exchanger MELAdem®37 are designed to optimally satisfy the requirements of the Vacuklav®31-B. Please consult the operating manuals of these reverse-osmosis systems for detailed instructions on installation and placing into operation. If you decide to use water treatment systems made by other manufacturers, be sure that they deliver water with sufficient quality and quantity. Please get in touch with the company MELAG before connecting such systems made by other manufacturers. In addition, a water stop valve (MELAG article no. 01056) should be installed upstream of such water treatment systems, in order to satisfy insurance requirements.

2.8Emptying the water storage tank __________________________________________

It is easy to completely empty the water storage tank of this autoclave. This is required, for example, to clean or repair the autoclave, or to place it out of operation. To drain the tank, pull the drain hoses out of the front panel at the plug (see Fig. 1: drain side [21], and tank side, with demineralized water [22]). Pull out the plugs, and allow the water to drain into a separate container.

3 Placing the autoclave into operation

3.1Printer connection and initialisation (optional) _______________________________

3.1.1Connection of the MELAprint®42 _________________________________________________________

The accessory printer MELAprint®42 is designed for connection to the autoclave Vacuklav®31-B. This is an optional item which is not supplied with the normal scope of delivery for the autoclave. Follow the instructions in Section 6.3.1.1.1 of this manual to connect the printer to the autoclave.

3.1.2Initialisation of the printer / setting for immediate printout____________________________________

Follow the instructions in Section 6.3.1.1.2 of this manual to initialise the external printer after it has been connected. This initialisation will log the printer on to the computer control system in the autoclave. Follow the instructions in Section 6.3.2 of this manual to set the immediate-printout option to "Yes". This means that the system will automatically print out a report when the system program has come to an end.

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Operating Manual for the Vacuklav®31-B

3.2Vacuum test ____________________________________________________________

A vacuum test (leak test) should be conducted under the following conditions to assure proper functioning of the autoclave:

−Once when a new autoclave is set up for the first time

−When the autoclave is being put back into service after a long period of inactivity

−When the autoclave is moved to a new location

−Periodically as part of routine operations.

The vacuum test should be performed on the cold autoclave as follows:

Operator action:		Shown on the display:
1. Switch on the autoclave		P l e a s e w a i t	Program	Start-Stop
	at the power switch: After
	the following message ...
		D o o r u n l o c k i n g
	... the display will show the	1 4 : 2 7 : 1 2	Program	Start-Stop
	initial state:
		0 . 0 2 b a r 2 5 ° C
2.	Press the “Program” button	V a c u u m t e s t	Program	Start-Stop
	several times until the pro-
	gram “Vacuum test” ap-
	pears.
3.	Close the door	D o o r	Program	Start-Stop
		c l o s e d
4.	Press the “Start – Stop”	V a c u u m t e s t : S t a r t	Program	Start-Stop
	button
		P r e s s . = 9 8 0 m b a r
5.	The vacuum pressure has	V a c u u m t e s t 0 0 : 0 0	Program	Start-Stop
	been reached. The equilibra-
	tion time begins to run (wait-
	ing time until beginning of	P r e s s . = 8 0 m b a r
	measurement).
6.	After the waiting time has	V a c u u m t e s t 0 7 : 5 2	Program	Start-Stop
	run out (5 min), the measur-
	ing time will begin (here:
	7 min 52 s).	P r e s s u r e = 8 2 m b a r

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	Operator action:		Shown on the display:
	7.	After the measuring time has		Program	Start-Stop
		run out (10 min), the cham-	V e n t i l a t e
		ber is vented, and ...
			– 0 . 5 6 b a r 2 5 ° C
		... then the leak rate is given
		(with connected printer and		Program	Start-Stop
		setting for immediate print-
		out = “Yes”, a record will	L e a k r a t e = 0 . 2 m b a r
		now be printed out. After the
		message “Please wait –
		door unlocking”, the follow-
		ing request will appear:		Program	Start-Stop
			O p e n d o o r
			p l e a s e
	8. Open the door.			Program	Start-Stop
			Vacuum test

If the leak rate determined is greater than the maximum permissible value, the following will appear in the display and on the printed log: “Test not successful”. In such a case, follow the instructions given in this manual under Section 7.3.

3.3Trial run _______________________________________________________________

To continue the functional check of the autoclave, carry out the trial run by loading the autoclave with a typical load for your daily work, and then run the program “Universal program, 134°C, wrapped”. Load the autoclave and use the “Program” button to select this program. Then press the button “Start – Stop”. If the program runs correctly (also see Section 4.7 here), the following message will appear at the end of the program:

Program Start-Stop

Universal program run successfully

This display will also show the maximum values achieved for pressure and temperature. If a printer is connected, and with setting for immediate printout = “Yes”, a record will now be printed out.

3.4Installation log – sent to MELAG ___________________________________________

As documentation that the autoclave has been set up properly, an installation record should be produced by an authorised person and a copy sent to MELAG. This is important in the event that you wish to make claims under warranty provisions.

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Operating Manual for the Vacuklav®31-B

3.5Safety instructions ______________________________________________________

*Danger: Be careful when opening the door of the autoclave, especially if you are interrupting a drying cycle. Small amounts of residual steam can escape through the door and can burn operating personnel.

*Warning: After opening the autoclave door, do not touch exposed hot metal parts. Warning: These parts can burn operating personnel. Be sure to use a MELAG or standard tray handle to remove still-hot trays from the autoclave. Be sure to use suitable hand protection (for example, potholders or gloves) when removing other sterilizing containers.

*We recommend the installation of a leak monitor in the water supply line (see Section 2, Installation, for instructions).

*If you wish to connect to this autoclave water-treatment systems which are made by other equipment manufacturers, get in touch with the MELAG company before you install this equipment.

*This device is not suitable for the sterilization of liquids.

*According to presently valid regulations published by the Society of German Electrical Engineers (VDE), this device is not suitable for operation in hazardous areas which are endangered by the possibility of explosion (for example, in hazardous atmospheres).

*Important: Empty the water supply tank before moving the autoclave. If the autoclave has water inside, do not tip it.

*This device may be repaired only by the company MELAG or by persons authorised by

MELAG (specialist personnel or customer-care staff). These persons must use original spare parts and must observe the instructions for service published by MELAG.

*Danger: Do not open the enclosure to this device before disconnecting the electrical power plug from its outlet.

*This autoclave will properly sterilize only if the operating personnel observe the instructions in this Operating Manual – especially the instructions for loading the autoclave in accordance with the program required.

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4 For each sterilization cycle

4.1Water and power _______________________________________________________

4.1.1Demineralized / distilled water__________________________________________________________

This autoclave automatically checks to make sure that there is enough demineralized / distilled water, and it checks that the quality of the demineralized / distilled water is sufficient for starting a program. In order to start a program without delay, to avoid error messages, and to prevent a program from stopping before it is finished (see Sections 7.3 and 7.4), please make sure to carry out the following:

1.Before starting the first sterilization cycle of a day, check to make sure that there is enough water in the right side of the dual-chamber water supply tank (this applies if you are using the system’s own internal supply: i.e., if you are not using a connected water-treatment system). If there is not enough water in the tank, fill with water of sufficient quality (see Section 8.3.2 of this manual).

2.If you use a direct water supply from the MELAdem®47 water-treatment system, make sure that the water feed to the autoclave is open in time. If the pressure tank is empty, this feed must be opened at least one hour before starting a program. This step is not necessary if the water supply remains open continuously .

4.1.2Power supply________________________________________________________________________

Switch on the power switch at the bottom right of the front of the autoclave. The message “Please wait – Door unlocking” will appear in the display. After approx. 15 s, the device will then be in its initial state.

Time of day (h:min:s)

Chamber pressure (bar) Temperature (steam) (°C)

1 4 : 2 7 : 1 2

0 . 0 2 b a r 2 5 ° C

Program Start-Stop

4.2Preparation of instruments ________________________________________________

MELAG — use of non-rusting materials for parts which come into contact with steam

All parts of the Vacuklav®31-B which come into contact with steam are made of non-rusting materials. The sterilization chamber and the chamber door are of stainless steel, steam lines are Teflon®, and threaded connections and solenoid valves are brass.

Drag-in rust

The non-rusting parts used in the Vacuklav®31-B ensure that the autoclave itself cannot cause rust to form. In any cases in which rust has developed on the autoclave or on the sterilized items inside, investigations have consistently shown that this rust has been dragged into the autoclave from the outside by rusty instruments. We must point out that rust can form on stainless-steel instruments made by even the best manufacturers.

One main cause of instrument rusting is improper treatment with chemical cleaning and disinfecting agents during preparation for sterilization.

Preparation of instruments for sterilization

The problem of drag-in rust shows how important it is to properly prepare items for sterilization. It is urgently necessary to observe the following procedures:

1.Clean and prepare (for example, by oiling) handpieces and contra angles as described in the instructions provided by the manufacturers of these items.

2.Immediately after their medical use, all other instruments must be placed in a disinfection and/or cleaning solution in accordance with UVV/VBG 103 and properly cleaned and disinfected there.

3.Always be sure to use the correct dosage of disinfection and/or cleaning agents in these solutions.

4.Important: Be sure to carefully follow the instructions for the length of time that the instruments must soak in the solutions.

5.We also recommend the use of ultrasonic equipment, recommended cleaning and care equipment for handpieces and contra angles, as well as thermal disinfecting techniques.

6.The proper cleaning of instruments is also essentially important in preventing particles of soiled matter from separating from the instruments during sterilization and from clogging the filters, nozzles, and valves of the autoclave. It is extremely important to use a brush to very carefully clean the locks, joints, and hinges of the instruments before sterilization.

7.Important: Use a brush under running water to completely rinse all cleaning and disinfecting agents from instruments before placing them in the autoclave. Residue of chemical cleaning and disinfecting agents must by no means be allowed to enter the autoclave, since they will cause corrosion there.

8.As a final step before placing the instruments into the autoclave, rinse them with demineralized water, and dry them well.

9.Be sure to use oil (as indicated in the manufacturers’ instructions) to prepare turbines and handpieces for sterilization, in order to ensure their long service life.

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Operating Manual for the Vacuklav®31-B

Instruments new from the factory:

Be sure also to follow the above-described pre-cleaning procedure even for instruments new from the factory. Often there are small amounts of oil, grease, and impurities still on new instruments, from their production.

Important: It is absolutely necessary to carefully follow the instructions for preparation and re-sterilization procedures which are provided by manufacturers of instruments.

4.3Loading the autoclave ____________________________________________________

The correct loading of the autoclave is essentially important in guaranteeing the sterilization effectiveness and the proper drying of the items being sterilized. Be sure to observe the following basic instructions in loading the autoclave:

Tray mounts:

There are 2 different tray mounts for the Vacuklav®31-B:

1.Tray mount “B” (MELAG art.-no. 40234) for loading of either a maximum of 4 trays, or 4 standard tray cassettes

2.Tray mount “C” (MELAG art.-no. 40232) for loading of either a maximum of 6 trays, or 3 standard tray cassettes.

Both of these tray mounts are also designed to support the following MELAG sterilization containers: Types 15K,M,G; Type 17K,R; Type 23R, Type 28M,G.

In normal cases the autoclave should always be operated with a tray mount, since this ensures optimal steam penetration and drying. In exceptional cases, it may be possible to remove the tray mount and place the suitable containers directly into the sterilization chamber (for example, with use of sterilization containers of other manufacturers). But please check with your specialist dealer or with MELAG before attempting this solution.

For sterilization of instruments sealed in see-through sterilization packaging, we recommend the use of the MELAG Package Stand (MELAG article no. 22410). The Package Support considerably improves the results of the drying process for instruments wrapped in this way.

Trays:

Trays used for the loading of sterilized items must be perforated, in order to allow the condensate to run out. MELAG trays fulfil this requirement. We cannot advise the use of non-perforated trays or bowls (e.g., unperforated standard-tray supports), since they do not allow proper trying.

Closed sterilization containers:

Closed sterilization containers must be perforated on at least one side (preferably the bottom), or they must have valves, in order to allow the steam to properly penetrate and the condensate to flow out. All MELAG sterilization containers satisfy this requirement, with perforations on two sides and with a sterile filter cloth insert. We cannot recommend sterilization with sterilization containers with holes only on the top, since they do not allow proper drying.

See-through sterilization packaging:

If you use see-through sterilization packaging (for example, MELAfol®), these should be placed vertically on the tray for sterilization. We recommend the use of MELAG Foil Holders (MELAG article no. 22410).

Important: Do not stack the see-through sterilization packages horizontally on top of each other. If the sealing seam of the package breaks during sterilization, please use a longer sealing pulse on the MELAG MELASEAL Package Sealing Device, or seal with a double seam.

If standard tray cassettes are sealed in MELAfol® (250 mm wide), clamps or tape must be used to reinforce the side seam and to prevent it from breaking open. In addition, be sure to press excess air out of the package before sealing it.

Multiple packaging:

Air removal by sub-atmospheric pulsing allows multiple-wrapping.

Loading limits:

Be careful not to exceed the prescribed maximum loading amounts: 5kg of instruments or 1.8kg of textiles.

Mixed loads of textiles and instruments:

If you are sterilizing textiles and instruments at the same time, place the textiles above the instruments and do not allow the textiles to come into direct contact with the instruments. Do not sterilize textiles and instruments in the same sterilization container. Important: Do not by any means allow the textiles to come into direct contact with the wall of the sterilization chamber. Please observe the following instructions for different types of packaging in one sterilization cycle:

Place the see-through sterilization packaging and paper packing on the top (but if you are using a combination with textiles: then arrange these packages on the bottom)

Sterilization of liquids:

Danger: The Vacuklav®31-B is not suitable for the sterilization of liquids.

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