MELAG Vacuklav 43-B Technical Manual
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MELAG Vacuklav 43-B Technical Manual

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Technical Manual
Autoclave
Vacuklav
Vacuklav
Please read the accompanying User Manual before you start operation of the auto-
clave. The instructions contain important safety precautions. Make sure to keep the
Technical Manual together with the User Manual near the autoclave. The instructions
are part of the product.
®
41-B
®
43-B
For Users and Service personnel

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Summary of Contents for MELAG Vacuklav 43-B

  • Page 1 Technical Manual Autoclave ® Vacuklav 41-B ® Vacuklav 43-B For Users and Service personnel Please read the accompanying User Manual before you start operation of the auto- clave. The instructions contain important safety precautions. Make sure to keep the Technical Manual together with the User Manual near the autoclave. The instructions are part of the product.
  • Page 2 The Technical Manual is meant for inter- ested persons and service personnel. Technical Manual Vacuklav ® 41-B, Vacuklav ® 43-B MELAG Medical Technology Berlin ® ® Valid for Vacuklav 41-B, Vacuklav 43-B as of software version 2.4x...

  • Page 3: Table Of Contents

    One-way drain..............................11 Supply with → feed water..........................12 Installation material............................12 Installation examples............................13 Record of installation and setting up......................... 16 Please send to MELAG............................ 16 Device and installation data..........................16 Executed work..............................17 Contrast setting..............................19 Counter readings.............................. 19 Program modifications............................
  • Page 4 Konformitätserklärung im Sinne der EG Richtlinie über Medizinprodukte 93/42/EWG Declaration of conformity Vacuklav ® 41-B ® Vacuklav 43-B In accordance with the EC- guidelines for medical devices 93/42/EWG Manufacturer: MELAG oHG Address: Geneststraße 9 – 10 10829 Berlin Country: Germany Product: Steam sterilizer (autoclave) Type of device: Vacuklav ®...
  • Page 5 Declaration of conformity Vacuklav ® 41-B ® Vacuklav 43-B Declaration of conformity according to EN 13060 for small steam sterilizers Manufacturer: MELAG oHG Address: Geneststraße 9 - 10 10829 Berlin Country: Germany Product: Steam sterilizer (autoclave) Type of device: Vacuklav ®...
  • Page 6 41-B ® Vacuklav 43-B According to the recommendations of the Commission for Hospital Hygiene and In- fection Prevention at the Robert-Koch Institute (of April 2006) Manufacturer: MELAG oHG Address: Geneststraße 9 - 10 10829 Berlin Country: Germany Product: Steam sterilizer (autoclave)
  • Page 7 Technical Manual Vacuklav ® 41-B and Vacuklav ® 43-B Evidence Based Sterilization www.melag.de...
  • Page 8 41-B ® Vacuklav 43-B According to the recommendations of the Commission for Hospital Hygiene and In- fection Prevention at the Robert-Koch Institute (of April 2006) Manufacturer: MELAG oHG Address: Geneststraße 9 - 10 10829 Berlin Country: Germany Product: Steam sterilizer (autoclave)

  • Page 9: Device Views

    Technical Manual Vacuklav ® 41-B and Vacuklav ® 43-B Device views Front side Protective cap for slot of the →CF card Control panel Door (pivot opens to the left) Protective cap for manometer to display the pressure of the →double jacket steam-generator Cap for emergency opening of the door Mains switch (concealed, accessible from the side) Ethernet-1-Data connection*...

  • Page 10: Device Views Flex-Display

    Technical Manual Vacuklav ® 41-B und Vacuklav ® 43-B Device views Flex-Display Front side Protective cap for slot of the →CF card Control panel Door (pivot opens to the left) Protective cap for manometer to display the pressure of the →double jacket steam-generator Cap for emergency opening of the door Mains switch (concealed, accessible from the side) Ethernet-1-Data connection*...

  • Page 11: Installation And Setting Up

    Technical Manual Vacuklav ® 41-B and Vacuklav ® 43-B Installation and setting up Please read the User Manual of the autoclave and the water treatment Warning unit before setting up the autoclave. If the autoclave has already been put into operation, please observe the following before setting up again in case of any eventual transport: Warning ■...

  • Page 12: Space Requirements

    Waste water hose A 1 m wastewater hose (MELAG Art. No. 39180) can be ordered from MELAG to directly connect the autoclave to the waste water, i.e. the pres- sure discharge goes directly into the siphon of the domestic water supply.

  • Page 13: Supply With → Feed Water

    2.5 L to fill the double jacket. For this reason we recommend you to refill Notice! the right chamber of the internal storage tank afterwards immediately. Installation material Additional material, that can be ordered MELAG Art. Water connection-Set MELAdem ® 09033 Water connection-Set MELAdem ®...

  • Page 14: Installation Examples

    Installation and setting up Installation examples Example 1 – Standard scope of delivery Direct of →feed water from the internal storage tank Wastewater is collected in the wastewa- ter chamber of the storage tank No water connection necessary The autoclave is supplied with feed water directly over a hose from the internal stor- age tank.
  • Page 15 53430) with feed water inlet fixture for hose ∅6x1 (MELAG Art. No. 21140) because of the other hose diameter. Likewise exchange the two Cu seals (MELAG Art. No. 42360) – in the water connection set). The used feed water (wastewater) is conducted under pressure directly over the one-way drain hose (MELAG Art. No. 39180) into the...
  • Page 16 Feed water filter MELAdem ® Double-chamber waste water trap (MELAG Art. No. 26635) Wall drain (NW40 – available on-site) Double hose nozzle with anti-flooding flap (MELAG Art. No. 37400 – contained in the surface-mounted si- phon with Art. No. 37410 ® (10)

  • Page 17: Record Of Installation And Setting Up

    The returned form is prerequisite for the MELAG factory warranty. Device and installation data We, hereinafter referred to as specialist MELAG dealer, have today installed, instructed the personnel and performed the initial start-up of the autoclave Vacuklav ® 41-B/43-B as described below:...

  • Page 18: Executed Work

    Wastewater is collected in the internal storage tank (no wastewater connection) One-way drain connected to the existing siphon of the domestic water supply or the double-chamber wastewater trap from MELAG Align the autoclave For fault-free operation, the autoclave must be set up horizontally with the help of a water level located close to the sterilization-chamber flange.

  • Page 20: Contrast Setting

    Further changes to the program cycles are possible in individual cases and within the scope of the guaranteed sterilization efficiency, but can only be ex- ecuted by authorised persons. Please consult your specialist dealer or con- tact MELAG.

  • Page 21: Electromagnetic Compatibility

    Technical Manual Vacuklav ® 41-B and Vacuklav ® 43-B Electromagnetic compatibility Electromagnetic environment The autoclave is designed for operation in an environment as described Warning below. The customer or user must ensure that the autoclave is operated in such an environment as here described The abbreviation HF is used for high frequency in the following tables.

  • Page 22: Recommended Protective Distances

    Technical Manual Vacuklav ® 41-B and Vacuklav ® 44-B Interference im- IEC 60601 Compliance level Electromagnetic environment guideline munity tests test level Portable and mobile radio equipment should not be placed closer to the autoclave (including hoses and pipes) than the recommended protective distance calcu- lated according to the formula for the transmitting fre- quency.

  • Page 23: Technical Tables

    Technical Manual Vacuklav ® 41-B and Vacuklav ® 43-B Technical tables Precision and drift behaviour – Sensors PT 1000 Class A according to DIN EN 60751 Sensor type ±0.42 K Precision at 135 °C Drift per year ±0.05 K Drift in 5 years ±0.25 K Table 6: Precision and drift behaviour of the temperature sensors n piezoresistant absolute pressure sensor 0 to 4000 mbar...

  • Page 24: Nominal Value Tolerances

    Technical Manual Vacuklav ® 41-B and Vacuklav ® 43-B Nominal value tolerances Tolrenaces for nominal values to be achieved by Premium autoclaves Universal program Quick B Prion pr. Gentle pr. Quick S ◄ same meaning as in Universal pr. Step Press. P Tolerance Tol.

  • Page 25: Pressure-Time-Charts

    Technical tables Pressure-Time-Charts Fig. 6: Pressure-Time chart for Universal-Program, 134 °C and 2.1 bar Fig. 7: Pressure-Time chart for Quick-Program B, 134 °C and 2.1 bar...
  • Page 26 Technical Manual Vacuklav ® 41-B and Vacuklav ® 43-B Fig. 8: Pressure-Time chart for Quick-Program S, 134 °C and 2. bar Fig. 9: Pressure-Time chart for Gentle-Program, 121 °C and 1.1 bar...

  • Page 27: Quality Of The → Feed Water

    Technical tables Fig. 10: Pressure-Time chart for Prion-Program, 134 °C and 2.1 bar Quality of the → feed water Residue on evaporation ≤ mg/L Silcon, SiO2 ≤ mg/L Iron ≤ mg/L Cadmium ≤ 0.005 mg/L Lead ≤ 0.05 mg/L Heavy metals except for those named ≤...

  • Page 28: Frequently Asked Questions (Faq) About The Software

    Logs can now be read out by a suitable program (e.g. MELAview V2.0) via a TCP Port ▪ The FTP server password consists of the word MELAG+ a five digit sequence, which can be changed in the SETUP Menu under LAN TCP/IP FTP  FTP-Server-Password-Attachment ▪...
  • Page 29 Frequently asked questions (FAQ) about the software against manipulation). ▪ Formatting CF Cards at the autoclave is possible V2.0: DOCU menu ▪ Aside from the automatic log, any number of media can be selected for a "manual" log output ▪ Still more criteria for the selection of log output ▪...
  • Page 30 CF be formatted with the file system FAT16. Only on cards formatted in such a card at the autoclave (see manner can the autoclave store or read data. Cards delivered by MELAG question 5). are already correctly formatted.
  • Page 31 Direct transfer of the log on a computer via the network and using the FTP server MELAG FTP server allows you to determine directly in the FTP server where on your computer the device directory with log files is to be saved.
  • Page 32 CF card to your PC. To do this, create a folder on the hard drive of your PC named for instance MELAG Autoclave Logs, where you can save and archive the log files. You can copy the log files from the CF card to the PC using the Windows Explorer.
  • Page 33 Frequently asked questions (FAQ) about the software Example: file.END represents a log file whose extension "END" is not yet recog- nized by the operating system. 1. Double-click on the log file in the Win- dows Explorer If the extension is not known, Win- dows XP issues the following message.
  • Page 34 Technical Manual Vacuklav ® 41-B and Vacuklav ® 43-B Device IP address Comment Autoclave itself 192.168.40.40 Default setting ex factory Computer 192.168.40.140 Default setting ex factory MELAprint 192.168.40.240 Default setting ex factory [Client3] [192.168.40.144] [..] not employed or not modifiable Gateway 192.168.40.244 Not relevant within a network.
  • Page 35 12 How is the MELAprint log printer directly connec- ted to the autoclave? Procedure when connecting The actual network function is carried out by a MELAG network ad- the log printer apter (Type.-No. 40295). Prerequisite is therefore the network adapter connected with the MELAprint ®...
  • Page 36 14). A FTP server program must be available which allows the cre- ation of users with edit rights independent of the operating system. MELAG provides its own FTP program free of charge. Using the MELAG FTP server, it is possible to register multiple autoclaves as users simultaneously and receive data from the autoclaves in paral- lel.
  • Page 37 MELAview V2.0 and follow the installation instructions. In order to be able to install the MELAG FTP server, the free media library “→Microsoft .NET Framework 2.0“ or a higher version must be Notice installed on your computer.
  • Page 38 (see Question 10, page ! Server started on Port 21 Over a longer time period, the following lines are repeated: ▪ the password MELAG(12345) was not < 14:12:22 192.168.40.100 USER: 200440-B1000 entered correctly < 14:12:22 192.168.40.100 USER: 200440-B1000 << Incorrect login or password >>...
  • Page 39 Frequently asked questions (FAQ) about the software Table 20: Check the autoclave software (e.g. after an update) If while the status is being displayed you simultaneously press the keys 2 and 3 again within 30 seconds, then you can exit the status display only Notice by switching off the autoclave.
  • Page 40 You can employ every CF card formatted with FAT16 (file system) as an with FAT16 update CF card. The CF cards delivered from MELAG are already format- ted accordingly. As it is possible to record graphic logs on the CF card above version 2.4, we recommend using only CF cards with 1GB or more memory capacity, preferably MELAG-approved MELAflash CF cards.
  • Page 41 Frequently asked questions (FAQ) about the software sub-folders are permitted. They are ignored. Logs or other files in the main directory do not disturb the update. Update from Version 1 to For the update from Version 1 to Version 2, the autoclave software only Version 2 updates the modules 1 to 5.
  • Page 42 Technical Manual Vacuklav ® 41-B and Vacuklav ® 43-B 18 What are concealed key combinations and which are available? The functions of the keys in the respective operating situation are shown by the labelling in the display. (Softkeys). Furthermore there are functions which are concealed, i.e. not displayed. The key combinations available for the user are presented here.

  • Page 43: Checklist For Software Update

    You can tell by the labelling (e.g. 40-B) which type of device the CF card is for. MELAG also delivers cards which contain the update data for all autoclave types of the premium class. They are recognized by the labelling "premium ALL…"...
  • Page 44 Technical Manual Vacuklav ® 41-B and Vacuklav ® 43-B yes: No update neces- continue to 4 sary end Have you archived all the ex- For the update of Version 1 to Version 2 of the autoclave software, there is isting logs on a CF card that yet no warning that subsequent to a firmware update all logs are lost which are still in the internal auto- are found in the internal autoclave storage and were not yet backed up on...
  • Page 45 Carry out update process once again, look for ap- End propriate error in FAQ or contact MELAG.

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