MELAG Cliniclave 45 Technical Manual
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MELAG Cliniclave 45 Technical Manual

Large steam sterilizer
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Technical Manual
Cliniclave
Cliniclave
Large steam sterilizer
from software version 3.218
EN
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.
®
45
®
45 M
0197

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Summary of Contents for MELAG Cliniclave 45

  • Page 1 Technical Manual ® Cliniclave ® Cliniclave 45 M Large steam sterilizer from software version 3.218 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.

  • Page 3: Table Of Contents

    3 Setup and installation ................................ 15 Dispatch / delivery ................................ 15 Removal from the packaging ............................. 15 Installing Cliniclave 45 ............................... 19 Installing Cliniclave 45 M .............................. 26 4 Operational readiness................................ 34 Determining the delivery capacity and the conductivity of the reverse osmosis unit ............ 34 Operational readiness................................ 35 Checking the pressure of the reverse osmosis unit...................... 36...

  • Page 4: General Guidelines

    They represent a component of the product. 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...

  • Page 5: Installation Requirements

    2 Installation requirements 2 Installation requirements Installation material The installation set (art. no. ME09027) for the water connection includes: Qty. Article Art. no. Siphon for Cliniclave series (incl. extension pipe) ME72420 Rubber seal 3/4'' for external water supply ME56950 Hose clamp Hanger bolt M8x60 Included in the scope of delivery of the steam sterilizer (and required for installation): Qty.

  • Page 6: Installation Location

    The steam sterilizer should only be setup, installed and commissioned by persons authorised by MELAG. The steam sterilizer is not suitable for operation in explosive atmospheres. The 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.

  • Page 7: On-Side Connections For Installation

    Improper installation may lead to a short-circuit, fire, water damage or electrical shock. This could result in serious injury. Only have the device set up, installed and commissioned by people authorised by MELAG. Implement the following safety measures when dealing with the cable and power plug: Never damage or alter the power plug or cable.
  • Page 8 2 Installation requirements Building-side requirements of the mains connection Property On-site requirements Cliniclave 45 Cliniclave 45 M Local requirements The electrical equipment must accord with DIN VDE 0100. A main switch (all- pole) should be fitted outside the installation room. This must be marked as a separator for the device and be easily accessible for the operator.
  • Page 9 EN 1717, fluid category class 5 Leakage water detector MELAG recommends the installation of a leakage water detector with a cut-off valve (e.g. MELAG water stop). PLEASE NOTE Fit the outlet hose at a constant decline without kinks or sagging. In case of deviations to the installation arrangements, consult with MELAG.

  • Page 10: Space Requirements

    2 Installation requirements Space requirements Space requirement for Cliniclave 45: left: fore view, door hinge left right: view from above, door hinge left (D ) and door hinge right Device dimensions Cliniclave 45 Width 64 cm Height device with floor unit...
  • Page 11 2 Installation requirements Space requirement Cliniclave 45 M left: fore view, door hinge left right: view from above, door hinge left (D ) and door hinge right Device dimensions Cliniclave 45 M Width 64 cm Height device with floor unit 158 cm Height to door of steam sterilizer...

  • Page 12: Safeguarding In Accordance With En 1717

    2 Installation requirements Safeguarding in accordance with EN 1717 The connection of the device to the water line is comparable with the connection of a washing machine in a domestic context. In general, the connection of consumers to the drinking water supply should be per- formed in accordance with EN 1717, so that the drinking water supply is protected against contamination through the possible flow back of the water.

  • Page 13: System And Network Safety

    NOTICE When performing a device software update, use only the update data authorized by MELAG for the corresponding device type. Operating the device with memory media To prevent data loss, only use memory media to save the log data with the following characteristics: Functional capability (without malware etc.)
  • Page 14 2 Installation requirements 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 device is configured to obtain the IP address automatically from a DHCP server operat- ed in a LAN.

  • Page 15: Setup And Installation

    WARNING Improper installation may lead to a short-circuit, fire, water damage or electrical shock. This could result in serious injury. Only have the device set up, installed and commissioned by people authorised by MELAG. Dispatch / delivery CAUTION Danger of back injury and crushing from lifting excess loads.
  • Page 16 3 Setup and installation Ensure that the four pins on the underside of the steam sterilizer (marking) are guided into slots on the floor unit. The power cable and the inlet hose must be led into the floor unit and may not become jammed. Align the steam sterilizer with the floor unit so that the housing parts are flush along the side (use the transport bars).
  • Page 17 3 Setup and installation Working with a minimum of six people, lift the steam sterilizer from the shipping pallet onto the floor unit so that the device door and the floor unit door face to the same side. Ensure that the six pins on the underside of the steam sterilizer (marking) are guided into slots on the floor unit.
  • Page 18 3 Setup and installation Connecting the display Remove the display from the service hatch and remove the packaging. Connect the Ethernet cable of the device to the display. Slide the display into the fore long groove at the device. Guide both lateral display locking elements into the same guide groove on the steam sterilizer.

  • Page 19: Installing Cliniclave 45

    Installing Cliniclave 45 Installing the steam sterilizer PLEASE NOTE To prevent water damage, MELAG recommends the use of a leakage water detector e.g. the MELAG water stop. Installing the leakage water detector (optional). Lead the cold water inflow hose with Aqua-Stop (pos. a) through the lower opening in the rear panel of...
  • Page 20 3 Setup and installation Installing the MELAdem 56 (optional) Proceed as follows to connect the reverse osmosis unit and prepare flushing: Loosen the screws (TX20) (pos. a ) on the cover of the osmosis module and pull the cover upwards. Proceed with caution.
  • Page 21 3 Setup and installation Do not yet remove the sealing cap on the feed water connection of the pressure tank (upper-most T-piece). Open the valve (pos. h) on the pressure tank and measure the primary pressure using the manometer included in the scope of delivery. The target pressure is 0.6 bar.
  • Page 22 3 Setup and installation Aligning the device To align the device, it must be located in its final installation location. Align the device using a spirit level so that it is plumb on all sides. To this end, place the spirit level on the top of the unit cover (1x fore - 1x rear - 1x right and 1x left).
  • Page 23 In order to reduce the installation time and ensure quicker commissioning of the device, a separate con- tainer with feed water of sufficient quality (Cliniclave 45: min. 13 l; Cliniclave 45 M: min. 20 l) in accordance with EN 285, Appendix B, Table B.1 is required, see Feed water quality [} page 45].
  • Page 24 3 Setup and installation B) Checking the direction of rotation of the vacuum pump Open the cold water inflow. Connect the power plug and activate the device. The vacuum pump will run for a short while after activation. Directly during activation, check whether the silicone cap (marking) on the de-calcification connection contracts, i.e.
  • Page 25 3 Setup and installation Connect the free end of the permeate line to the lower T-piece of the pressure tank (pos. a). Open the pressure tank shut-off valve (pos. b). The feed water connection (pos. c) on the upper T-piece of the pressure tank remains closed. Place the pressure tank in the floor unit.

  • Page 26: Installing Cliniclave 45 M

    Installing Cliniclave 45 M Installing the steam sterilizer PLEASE NOTE To prevent water damage, MELAG recommends the use of a leakage water detector e.g. the MELAG water stop. Install the leakage water detector (optional). Lead the cold water inflow hose with Aqua-Stop (pos. a) through the lower opening in the rear panel of...
  • Page 27 3 Setup and installation Connect the network cable to the network socket/ the label printer (optional). Installing the MELAdem 56 M (optional) Proceed as follows to connect the reverse osmosis unit and prepare flushing: Remove the closure caps from the hose connections on the floor trough of the steam sterilizer.
  • Page 28 3 Setup and installation Lead the outlet hose (pos. e) and the inlet hose (pos. f) through the conduit on the right-hand side of the osmosis unit. Remove the sealing caps on the hose connections of the reverse osmosis unit and connect the outlet hose (pos. g) and the inlet hose (pos. h) with the corresponding connections of the reverse osmosis unit.
  • Page 29 3 Setup and installation Connect the power plug of the reverse osmosis unit to the cable socket (pos. k) on the underside of the steam sterilizer. Slide the reverse osmosis unit into the floor unit. The reverse osmosis unit is flushed during the Test runs [} page 30].
  • Page 30 In order to reduce the installation time and ensure quicker commissioning of the device, a separate con- tainer with feed water of sufficient quality (Cliniclave 45: min. 13 l; Cliniclave 45 M: min. 20 l) in accordance with EN 285, Appendix B, Table B.1 is required, see Feed water quality [} page 45].
  • Page 31 3 Setup and installation Lead the free end of the feed water hose (pos. b) into the container. PLEASE NOTE The feed water hose must reach to the floor of the container so that the water is pumped in even when the water level falls. Unscrew the filter container of the ion exchanger (pos. c) using the container key (included in the scope of delivery of the reverse osmosis unit).
  • Page 32 3 Setup and installation Directly during activation, check whether the silicone cap (marking) on the de-calcification connection contracts, i. e. suction. This indicates a correct direction of rotation. Ê If the silicone cap does not contract, switch off the device immediately and check the rotating field of the practice socket or the wiring of the phases, see Checking the rotating field direction...
  • Page 33 3 Setup and installation Connect the free end of the permeate line (pos. D) to the ion exchanger filter container. Open the pressure tank shut-off valve. The feed water connection (pos. E) at the rear of the manometer on the pressure tank remains closed. Leave menu Diagnosis &...

  • Page 34: Operational Readiness

    4 Operational readiness 4 Operational readiness Determining the delivery capacity and the conductivity of the reverse osmosis unit Proceed as follows to determine the delivery capacity of the reverse osmosis unit: Select menu Diagnosis & Service. Ê The reverse osmosis unit does not function in this state.

  • Page 35: Operational Readiness

    MELAG Conductivity meter). The conductivity should not exceed 5 µS/cm. Operational readiness When using the MELAG water treatment unit From a pressure of 1.5 bar in the pressure tank, you can convert the feed water supply to the reverse os- mosis unit by proceeding as follows: Select menu Diagnosis &...

  • Page 36: Checking The Pressure Of The Reverse Osmosis Unit

    ▪ Advise users to check the pressure on the manometer before switching off the device. In daily operation, the operating pressure should amount to a minimum of 2 bar. If the pressure is < 2 bar, MELAG recommends leaving the device switched on until 2.5 bar is reached. This avoids unnecessary waiting times, warnings and any program aborts.

  • Page 37: Settings And Adjustment

    5 Settings and adjustment 5 Settings and adjustment Setting the door hinge The opening angle of the door in its delivery state is approx. 95°. This can be set to any angle up to 170°. Working with a separate set of instructions “Setting the door hinge” (doc. JA_005-13) set the opening an- gle of both doors to fit the space provision of the practice and the wishes of the operators.

  • Page 38: Inserting The Shelf

    5 Settings and adjustment Inserting the shelf You can insert the shelf (pos. a) at the desired height. You can install the tool bracket (pos.  b) in the mounting intended for this purpose. It can be used to store the carrying handles, the special key (hex for the casters) and the Allen key for opening the door in an emergency.

  • Page 39: Settings On The Device

    5 Settings and adjustment Guide both lateral display locking elements into the same guide groove on the steam sterilizer. Press the display downwards until you feel it engaging. Settings on the device Date and time Check the date and time and set if necessary. Consult the user manual. Display settings If required, working in the Settings menu, adjust the brightness, key tone and the touch-sensitivity.
  • Page 40 Further alterations to the program run are possible in each individual case and will still ensure the effectiveness of the sterilization, but may only be performed by authorized technicians. Please consult your stockist or MELAG. System and status log Output a system and status log and document this on the record of installation and setup.

  • Page 41: Frequently Asked Questions (Faq)

    FAT16 or FAT32. CF cards from which a software update is to be per- formed may only be formatted in a FAT16 file system. The device can only file or read data on CF cards formatted in this way. CF cards supplied by MELAG fulfil these requirements and have already been formatted.

  • Page 42: How To Integrate The Device In A (Practice) Network

    Working in the (practice) network, determine which computer should run on the FTP server. If an FTP server has not yet been installed, install the MELAG FTP server for preference and set the steam sterilizer as user with a user name and password.
  • Page 43 6 Frequently Asked Questions (FAQ) 2. Connecting the network cable Connect the network cable to any network data connection of the device and connect it to the (practice) network, see Connecting the network cable (optional) [} page 19]. 3. Adjusting IP addresses in the steam sterilizer NOTICE The setting up in the (practice) network will require in-depth understanding of the network technology.

  • Page 44: How Do I Determine The Ip Address Or Network Setting Of A Computer (Windows 7/10)

    6 Frequently Asked Questions (FAQ) Check whether the IP address of the computer set in the steam sterilizer is correct. Ê If the IP address of the practice computer deviates from the IP address set in the steam sterilizer, adapt the IP address of the computer in the steam sterilizer.

  • Page 45: Technical Tables

    7 Technical tables 7 Technical tables Feed water quality EN 285 Appendix B, Table B.1 – Impurities in the feed water for an assigned steam generator Substance/property Feed water Evaporation residue ≤ 10 mg/l Silicates ≤ 1 mg/l Iron ≤ 0.2 mg/l Cadmium ≤ 0.005 mg/l Lead ≤ 0.05 mg/l Residues of heavy metals apart from ≤ 0.1 mg/l iron, cadmium, lead...

  • Page 46: Precision And Drift Behaviour

    7 Technical tables Precision and drift behaviour Sensors Temperature sensors Sensor type PT 1000 Class A according to DIN EN 60751 Precision (at 135 °C) ± 0.42 K Drift per year ± 0.05 K Drift in 5 years ± 0.25 K Pressure sensor Sensor type Piezoresistant absolute pressure sensor 0 to 4000 mbar Precision ± 0.3 % corresponds to ± 12 mbar corresponds to approx.

  • Page 47: Nominal Value Tolerances

    7 Technical tables Entire measuring chain of the pressure measurement Precision at pure addition of ± 0.70 % corresponds to ± 28.0 mbar corresponds to approx. individual errors ± 0.30 K steam temperature Precision per Gauss' law of ± 0.41 % corresponds to ± 16.5 mbar corresponds to approx. propagation ± 0.18 K steam temperature Nominal value tolerances Universal-Program...

  • Page 48: Pressure-Time Charts

    7 Technical tables Pressure-time charts Fig. 1: Pressure-time chart for the Universal-Program, 134 °C and 2.1 bar Fig. 2: Pressure-time chart for the Quick-Program B, 134 °C and 2.1 bar...
  • Page 49 7 Technical tables Fig. 3: Pressure-time chart for the Quick-Program S, 134 °C 2.1 bar Fig. 4: Pressure-time chart for the Gentle-Program, 121 °C 1.1 bar Fig. 5: Pressure-time chart for the Prion-Program, 134 °C 2.1 bar...
  • Page 50 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: Cliniclave 45 / Cliniclave 45 M ®...
  • Page 52 MELAG Medizintechnik GmbH & Co. KG Geneststraße 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 Your stockist...

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Cliniclave 45 m

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