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MELAG Vacuklav 23 B+, Техническое руководство, Страница: 23 / 24

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Certificate of Suitability 

According to the recommendations of the Commission for Hospital Hygiene and 
Infection Prevention at the Robert Koch Institute 
 

 

Manufacturer: 

MELAG Medizintechnik GmbH & Co. KG 

Address: 

 

Geneststraße 6-10 
10829 Berlin 

Country: 

Germany 

Product: 

Vacuklav

®

 23 B+/ Vacuklav

®

 31 B+ 

Type of device: 

Steam sterilizer 

Classification: 

Class IIb 

Device type acc. to EN 13060: 

Type B 

We declare that the product specified above is suitable for the steam sterilization of  

▪ 

Solid instruments (wrapped and unwrapped) 

▪ 

Porous goods (wrapped and unwrapped) 

▪ 

Instruments with narrow lumen (wrapped and unwrapped) 

▪ 

Simple hollow bodies (wrapped and unwrapped) 

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

Be sure to observe the manufacturer’s instructions for medical devices intended for 
sterilization according to EN ISO 17664. 

We declare that the following test system is suited for testing the product specified 
above: 

▪ 

Helix test body according to EN 867-5: 
MELA

control

®

 Helix and MELA

control

® 

Pro 

 

Berlin, 01.10.2021 

 

Dr. Steffen Gebauer 

(Management)

 

 

Содержание Vacuklav 23 B+

Страница 1: ...efully and in the correct order before setting up and commissioning the device The instructions in clude important safety information You also receive a user manual with the device Please store this manual and the user manual carefully and in close proximity to the device They represent a component of the product ...

Страница 2: ......

Страница 3: ... System and network safety 9 3 Setup and installation 11 Removing from the packaging 11 Aligning the door seal sealing lips 11 Installation examples 13 Aligning the steam sterilizer 17 Test runs 17 Instructing the users 17 4 Settings and adjustment 18 Settings on the steam sterilizer 18 5 Technical tables 19 Feed water quality 19 Nominal value tolerances 19 Empty chamber test 20 Pressure time char...

Страница 4: ...h 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 the instruments the practice fittings or the device Draws your attention to important information Formatting rules Example Explanation see Chapter 2 Reference to another text section within this document Universal Program Words or phrases appearing on...

Страница 5: ... m 3 9 kN m Max altitude 2000 m Waste heat with max load 0 9 kWh Ambient temperature 5 40 C recommended max 25 C Relative humidity max 80 at 31 C decreases in a linear fashion up to max 50 relative humidity at 40 C Steam egress can occur during operation Do not set up the device in the immediate proximity of a smoke detector Maintain clearance from materials which could suffer damage from steam El...

Страница 6: ...el C2 7 cm 8 cm Min clearance to the side D1 5 cm Min clearance to the side of the door hinge D2 10 cm Min clearance to the rear E 10 cm Tank lid width F 23 cm Tank lid depth F1 19 5 cm Tank lid clearance to the rear F2 23 cm Free area with a fully opened door G 66 cm 54 cm Min clearance to the top can be pulled out with exhaust shaft 5 20 cm The area above the steam sterilizer should be freely ac...

Страница 7: ...oses and cables leading from the steam sterilizer to the water treatment unit Space requirements MELAdem 40 MELAdem 47 Water treatment unit Pressure tank Width 32 cm 40 cm Height 35 cm 46 cm 40 cm Depth 16 cm 18 cm Diameter approx 28 cm Requirements for the installation of a device If the installation of the device is mandatory one of the following measures must be implemented 1 It must be possibl...

Страница 8: ...0 240 V 50 60 Hz Max voltage range 207 253 V Building fuses separate power circuit with 16 A fuse 30 mA RCD protection to guarantee continued practice operation during steam sterilizer malfunction Length of power cable 1 35 m Other additional socket for the MELAprint 42 44 log printer etc Comply with the specifications in the connection diagram Water connection Feed water Wastewater Connection in ...

Страница 9: ...tion pertaining to the use of these interfaces to ensure safe operation of the device especially to ensure incorporation in the lo cal network LAN Interfaces and connections NOTICE Only connect the hardware to the device which is listed in the following table Only use the software which has been intended for the purpose and approved by the manufacturer Interface Type Hardware Purpose software COM ...

Страница 10: ...e device to the LAN An incorrectly entered IP address can cause IP conflicts in the network and thus disturb another device in your network In the LAN with a firewall only permit connections to and from the device which correspond to the intend ed use of the device All ports not used are blocked on the device side The device is able to make the following connections as standard via MELAnet Box Log...

Страница 11: ...two people n Use the correct carrying straps to carry the device n Comply with the safety regulations issued by your professional association 1 Remove the steam sterilizer from the box using the carrying straps 2 Unscrew the four screws from each side of the unit cover to remove the straps 3 Then re screw these screws without the flat washers 4 Store the carrying straps and washers in a safe place...

Страница 12: ... your thumb PLEASE NOTE Note the differences in the widths of the sealing surfaces when inserting the door seal The door can only be shut correctly and the sterilization chamber sealed if the door seal sits correctly in the groove 3 Insert the door seal into the groove Ê The wide sealing surface points towards the chamber ...

Страница 13: ...orage tank without an additional water connection No further installation is required apart from the electrical connection The wastewater is collected in the left hand side chamber of the storage tank and is to be emptied manually A float switch installed in the storage and wastewater tank notifies insufficient feed water or a full wastewa ter chamber 4 3 2 1 5 Pos Description Art no 1 Silicon hos...

Страница 14: ...rew connection MELAjet ME53465 ME27300 2 Water stop Leak water detector with cut off valve and sensor optional ME01056 3 Water tap with safety combination 4 MELAdem 40 ion exchanger ME01049 4 1 Filter for MELAdem ME48240 ME01049 4 2 PUR hose black 6 4 mm inlet hose feed water ME28820 ME01049 4 3 PUR hose black 6 4 mm inlet hose MELAdem 40 ME28820 ME01049 5 Mounting set EN 1717 for MELAdem optional...

Страница 15: ...w the back panel of the steam sterilizer 2 Mount the safety combination art no ME82375 3 Connect the water inflow hose to the upper connection of the safety combination 4 Connect the MELAdem 40 cold water adapter art no ME09037 to the lower connection of the safety combination 5 Connect the water inlet hose for the MELAdem 40 to the MELAdem 40 cold water adapter 6 Guide the hoses through the openi...

Страница 16: ...1056 3 Water tap with safety combination 4 Mounting set EN 1717 for MELAdem ME25410 4 1 Tap water supply hose EN 1717 2 5 m ME24930 ME25410 4 2 Safety combination EN 1717 incl holder ME82375 ME25410 5 MELAdem 47 reverse osmosis unit ME01047 5 1 Filter for MELAdem ME48240 ME01047 5 2 PUR hose black 6 4 mm inlet hose feed water ME28820 ME01047 5 3 Pressure tank MELAdem 47 with shut off valve and hos...

Страница 17: ... To ensure fault free operation the steam sterilizer must be set up horizontally with the aid of a spirit level placed on the chamber seal face Then extend the fore device feet by five Vacuklav 23 B or three Vacuklav 31 B revolutions to effect a slight rearwards slope of the device Test runs Vacuum test with a cold sterilization chamber Perform a vacuum test with an empty cold sterilization chambe...

Страница 18: ... information is provided in the device user manual Additional program options The Autom preheating function heats the steam sterilizer chamber to a preheating temperature of the respective program before program start or holds this temperature between two program runs This will shorten the cycle times It also reduces condensate formation on the chamber wall The Additional drying function increases...

Страница 19: ...ppearance colourless clear without sediments Hardness 0 02 mmol l Nominal value tolerances Step Universal Program Quick Program B Prion Program Gentle Program Quick Program S All values in mbar P T P T P T P T P T 1 Frac tionation 80 50 20 150 Evacuation 1400 50 30 Steam intake 2 Frac tionation 180 50 20 250 Evacuation 1400 50 30 Steam intake 3 Frac tionation 180 50 20 Evacuation 1400 50 30 Steam ...

Страница 20: ...ra ture sensor see circular marking in the following figure The temperature in the rest of the sterilization chamber is almost the same all over Schematic side and fore view of the sterilization chamber Pressure time charts Universal Program 134 C 2 1 bar Pressure mbar 3170 0 Fig 2 Pressure time chart for the Universal Program 134 C and 2 1 bar ...

Страница 21: ...rogram S 134 C 2 1 bar Pressure mbar 0 3170 Fig 3 Pressure time chart for the Quick Program S 134 C and 2 1 bar Quick Program B 134 C 2 1 bar Pressure mbar 0 3170 Fig 4 Pressure time chart for the Quick Program B 134 C and 2 1 bar ...

Страница 22: ...le Program 121 C 1 1 bar Pressure mbar 0 2170 Fig 5 Pressure time chart for the Gentle Program 121 C and 1 1 bar Prion Program 134 C 2 1 bar Pressure mbar 0 3170 Fig 6 Pressure time chart for the Prion Program 134 C and 2 1 bar ...

Страница 23: ...he steam sterilization of Solid instruments wrapped and unwrapped Porous goods wrapped and unwrapped Instruments with narrow lumen wrapped and unwrapped Simple hollow bodies wrapped and unwrapped References to loading quantities and loading variations are outlined in the user manual and must be observed Be sure to observe the manufacturer s instructions for medical devices intended for sterilizati...

Страница 24: ...aße 6 10 10829 Berlin Germany Email info melag com Web www melag com Original instructions Responsible for content MELAG Medizintechnik GmbH Co KG We reserve the right to technical alterations TH_23B _31B _EN pdf Rev 13 21 4797 Modification date 2022 03 18 ...

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