MELAG Vacuklav 23 B+ Manual de usuario

Technical Manual

Vacuklav® 23 B+

Vacuklav® 31 B+

Steam sterilizer

from software version 5.20

Read this manual carefully 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.

Contents

1 General guidelines ...............................................................................................................................................................4

Symbols used.......................................................................................................................................................................4

Formatting rules ...................................................................................................................................................................4

2 Installation requirements.....................................................................................................................................................5

Installation location...............................................................................................................................................................5

Electromagnetic environments.............................................................................................................................................5

Space requirements .............................................................................................................................................................6

On-site requirements............................................................................................................................................................8

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 charts ..........................................................................................................................................................20

1 General guidelines

Should the manual no longer be legible, is damaged or has been lost, you can download a new copy from

MELAG download centre at www.melag.com.

Symbols used

Symbol 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 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 the display of the device are marked as display text.

2 Installation requirements

Installation location

WARNING

Failure to comply with the set-up conditions can result in injuries and/or damage to the

steam sterilizer.

nThe steam sterilizer should only be setup, installed and commissioned by persons

authorized by MELAG.

nThe steam sterilizer is not suitable for operation in explosive atmospheres.

nThe steam sterilizer is conceived for use outside the patient area. The device should be

located a minimum of 1.5m radius away from the treatment area.

Property Vacuklav 23 B+ Vacuklav 31 B+

Installation surface level and horizontal

Installation location interior of a building (dry and protected from dust)

Floor loading (normal operation) 2.7 kN/m² 3.2 kN/m²

Max. floor loading (hydraulic

pressure test)

3.4 kN/m² 3.9 kN/m²

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.

Electromagnetic environments

When assessing the Electromagnetic Compatibility (EMC) of this device, the emitted interference threshold

values for Class B devices and the stability for operation in an electromagnetic environment as described

in IEC 61326-1 were taken as the basis. The device is thus suitable for operation in all institutions and do-

mestic settings connected to a public mains power supply. The floor should be made of wood or concrete

or be tiled with ceramic tiling. If the floor is fitted with synthetic material, the relative humidity must amount

to a minimum of 30%.

2 Installation requirements

Space requirements

Fig.1: View from the front, the right and above

Dimensions Vacuklav 23 B+ Vacuklav 31 B+

Width A 42.5 cm

Height B 49 cm

Depth, total C 74 cm 62 cm

Clearance between the device feet C145 cm 37 cm

Clearance from rear device foot up to the rear panel C27 cm 8 cm

Min. clearance to the side D15 cm

Min. clearance to the side of the door hinge D210 cm

Min. clearance to the rear E 10 cm

Tank lid (width) F 23 cm

Tank lid (depth) F119.5 cm

Tank lid (clearance to the rear) F223 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 accessible in order to enable easy filling of the

storage tank and to ensure good ventilation.

2 Installation requirements

The steam sterilizer works with a cooler on the rear of the device. The function and life-span of the steam

sterilizer can be compromised if heat dissipation via the cooler is restricted in any way. The steam sterilizer

may only be installed if sufficient air circulation can be guaranteed.

Additional space requirement for the feed water supply

Additional space is required for a storage container or a water treatment unit. It is also necessary to

guarantee free access to the hoses 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 possible to pull out the device for operation (pos. a).

2. There must be an exhaust air shaft in the rear area of the installation space that discharges the warm

air upwards (pos. b).

3. There must be an exhaust air shaft in the rear area of the installation space that discharges the warm

air to the rear (pos. c).

4-5 cm

2 Installation requirements

On-site requirements

Mains supply

Implement the following safety measures when dealing with the cable and power plug:

uNever damage or alter the power plug or cable.

uNever bend or twist the power cable.

uNever remove the plug by pulling on the power cable. Always take a grip on the plug.

uNever place any heavy objects on the power cable.

uNever run the power cable over areas in which it could become trapped (e.g. doors or windows).

uNever lead the cable along a source of heat.

uNever use any nails, paper fasteners or similar objects to fix the cable.

uShould the power plug or cable suffer damage, switch off the device. The power cable or plug

should only be replaced by authorised technicians.

uThe mains socket must be freely accessible after installation so that the steam sterilizer can be

disconnected from the electricity supply at any time.

On-site requirements of the mains connection

Property

Electricity supply 220-240 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 the

practice

Manual filling via the internal storage

tank

Optional: to a water treatment unit,

e.g. MELAdem

Manual emptying via the internal

storage tank.

Optional: automatically via the one-

way outlet with the MELAG upgrade

kit for the tank outlet

Wall outflow, nominal width DN 40 or

to a siphon (flush outflow)

Installation height -- min. 30 cm under the steam sterilizer

Max. water temperature 35 °C 70 °C

Recommended flow

pressure

1.5 bar at 3 l/min --

Min. water pressure

(static)

corresponding to the water treatment

unit1)

Max. water pressure

(static)

10 bar --

Max. water

consumption2)

approx. 700 ml --

Water quality Distilled or demineralised water in

accordance with EN 13060, Appendix

1) Optional when using a water treatment unit

2) In the Prion program with porous full load.

2 Installation requirements

Connection of a water treatment unit

MELAdem 40 MELAdem 47

Permissible water

pressure

1.5-10 bar 2-6 bar

Water stop For insurance reasons, MELAG recommends the installation of a water stop

with a cut-off valve (e.g. from MELAG), as the MELAdem 40 / MELAdem 47

are under constant water pressure from the domestic water supply.

PLEASE NOTE

The outlet hose must be fitted at a constant decline without kinks or sagging. Deviations

to the installation arrangements require consultation with MELAG.

Failure to do so can result in malfunctions of the steam sterilizer.

System and network safety

The device is fitted with multiple external interfaces. Comply with the following information 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 port RS-232 PC MELAview

saving log data and querying device data

MELAtrace

saving log data

Modem Data transfer via points of presence

MELAnet Box Provides a LAN (Ethernet) interface for

the device, see below (Ethernet)

MELAview/MELAtrace

Saving log data

FTP server

saving log data

MELAprint42/44 Log printing

MELAflash CF card printer Writing log data on a MELAflash CF card

NOTICE

When performing a device software update, use only the update data authorized by

MELAG for the corresponding device type.

2 Installation requirements

Operating the device with memory media

To prevent data loss, only use memory media to save the log data with the following characteristics:

nFunctional capability (without malware etc.)

nWriteable

nFormatted with a correct file system

Perform regular data backup. Restrict access to the device and systems with access authorization to the

necessary circle of persons.

Only use MELAflash CF cards.

Operating the device in the local network (LAN)

NOTICE

Do not connect the device to a public network (e.g. the internet).

An Ethernet/IP-based network connection (LAN) is required to operate the device in a local network. In its

delivery state, the MELAnet Box IP address is 192.168.40.100.

NOTICE

Check the IP address carefully during the conversion for a manual configuration before

connecting the 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 Source port Destination

port

Direction Aims

TCP ≥1025 21 Outgoing FTP control

TCP any ≥1025 Listening / incoming FTP (active) data transfer

(MELAnetBox set to FTP logging)

TCP any 80 Listening / incoming Data transfer to the web browser

TCP any 65001 Listening / incoming Data transfer of log data

(MELAnetBox set to TCP logging)

Network bandwidth / Quality of Service (QoS)

The device does not place any requirements on the LAN bandwidth for data transfer, that exceed the

standard time-out times of the respective logs.

Process Volume max. Volume normal

Transfer status, program, standby log 2kB 1.9kB

Graphic log 110kB 110kB

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