MELAG Careclave 618 User manual

Technical Manual
Careclave® 618
Combination steam sterilizer
from software version 21.0.3
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.

Contents
Contents
1 General guidelines ...............................................................................................................................................................4
Symbols used.......................................................................................................................................................................4
Formatting rules ...................................................................................................................................................................4
2 Installation requirements.....................................................................................................................................................5
Installation location...............................................................................................................................................................5
Space requirements .............................................................................................................................................................6
Mains supply ........................................................................................................................................................................7
Water connection .................................................................................................................................................................8
Compressed air connection .................................................................................................................................................9
System and network safety ..................................................................................................................................................9
3 Setup and installation ........................................................................................................................................................12
Removing from the packaging ...........................................................................................................................................12
Cover caps or Carebox holders .........................................................................................................................................12
Connecting the power cable and removing accessories....................................................................................................14
Connecting the feed water supply (installation examples) .................................................................................................15
Connection to wastewater system .....................................................................................................................................23
Connection to the compressed air supply ..........................................................................................................................24
Aligning the device .............................................................................................................................................................24
Setting up the Carebox ......................................................................................................................................................24
Test runs ............................................................................................................................................................................24
Instructing the users...........................................................................................................................................................24
4 Settings and adjustment....................................................................................................................................................25
Service connection.............................................................................................................................................................25
Settings on the device........................................................................................................................................................25
5 Technical tables .................................................................................................................................................................26
Feed water quality..............................................................................................................................................................26
Precision and drift behaviour..............................................................................................................................................26
Nominal value tolerances...................................................................................................................................................27
Empty chamber test ...........................................................................................................................................................29
Pressure-time chart............................................................................................................................................................29
Type plate steam generator ...............................................................................................................................................32

1 General guidelines
4
1 General guidelines
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.
Should the manual no longer be legible, is damaged or has been lost, you can download a new copy from MELAG down-
load centre at www.melag.com.
Symbols used
Symbol Explanation
Indicates a dangerous situation, which if not avoided, could entail slight to life-threatening
injuries.
Indicates a dangerous situation, which if not avoided, could lead to burns.
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
Universal-
Program
Words or phrases appearing on the display of the device are marked as display text.
Prerequisites for the following handling instruction.
Refer to the glossary or another text section.
Information for safe handling.

2 Installation requirements
5
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
Installation surface level and horizontal
Place of installation interior of a building
Max. altitude 2000 m
Overvoltage category transient overvoltage up to the values of overvoltage
category II
Degree of contamination
(in accordance with EN
61010)
2
Operating weight 82.5 kg
Floor loading (normal
operation)
2.6 kN/m²
Floor load (hydraulic
pressure test)
2.91 kN/m²
Waste heat (with maximum
load)
1.7 KW
Ambient temperature 5-40 °C (ideal range 16-26 °C)
Relative humidity max. 80 % at temperatures of up to 30 °C, max. 50% at
40 °C (decreasing in linear fashion in-between)
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 tak-
en as the basis. The device is thus suitable for operation in all institutions and domestic 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
6
Space requirements
Dimensions
Width A 48 cm
Height B1 56.2 cm
Height without colour touch display B2 49.7 cm
Depth C 65.3 cm
Clearance between the device feet C1 27.05 cm
Clearance from rear device foot up to the cover C2 23.1 cm
Min. clearance to the side D1 7 cm
Min. clearance to the side of the door hinge D2 3 cm
Min. clearance to the side D3 19 cm
Min. clearance to the rear E 1 cm
Clearance when door fully open F 58 cm
Max. clearance with open door G 38.5 cm
Min. clearance to the top B1 + 4cm
Above, the device should be freely accessible to ensure access to the storage tank and the accessories compartment
and to ensure good ventilation. The device operates with a cooler at the back of the device. The function and life-span
can be compromised if heat dissipation via the cooler is restricted in any way. Installation of the device is therefore
strongly discouraged and only possible if sufficient air circulation is ensured, e.g. with an exhaust shaft in the upper rear
area of the cupboard unit. To ensure good access, it must be possible to pull the device out of the cupboard unit.

2 Installation requirements
7
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 ac-
cess to the hoses and cables leading from from the device to the water treatment unit.
Space require-
ments
MELAdem 47 Storage container
Osmosis module Storage tank
Width 42 cm Ø 24 cm 21 cm
Height 47 cm 51 cm 38 cm
Depth 15 cm -- 23 cm
Space is required above the MELAdem53 / MELAdem 53 C for clear access to the hose connections.
Dimensions MELAdem 53 MELAdem 53 C
Diameter 24cm 24cm
Height of the unit incl.
connecting parts
57cm 45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
a
b
c
Mains supply
Implement the following safety measures when dealing with the cable and power plug:
nNever damage or alter the power plug or cable.
nNever bend or twist the power cable.
nNever remove the plug by pulling on the power cable. Always take a grip on the plug.
nNever place any heavy objects on the power cable.
nNever run the power cable over areas in which it could become trapped (e.g. doors or windows).
nNever lead the cable along a source of heat.
nNever use any nails, paper fasteners or similar objects to fix the cable.
nShould the power plug or cable suffer damage, switch off the device. The power cable or plug should only be
replaced by authorised technicians.

2 Installation requirements
8
nThe mains socket must be freely accessible after installation so that the steam sterilizer can be disconnected from
the electricity supply at any time.
nThe power cable may not be replaced by a cable determined to be insufficient.
nThe mains socket must be freely accessible after installation so that the device can be disconnected from the
electrical mains at any time if necessary by pulling the power plug.
Property Building-side requirements
Power supply 220-240 V 50 Hz
Fluctuations of the mains supply voltage up to +/- 10% of the nominal
voltage
Max. power consumption in
operation
3000 W
Building fuse protection Separate circuit with min. 13A, residual current device (RCD) with rated
residual current = 30 mA (to ensure continued operation of the device in
practice in case of malfunctions)
Other additional socket 220-240 V, 50 Hz for label printer MELAprint 60
Length of the power cable 2 m
Separator Power plug
Water connection
Feed water Wastewater
Connection in the practice to a water treatment unit, e.g.
MELAdem
Wall outlet, nominal width DN 40 or
to a siphon (flush outflow)
Installation height -- min. 30 cm below the device
Max. water consumption 5 l/h --
Average water consumption 2.5 l/h --
Min. flow pressure 0.5 bar at 1.0 l/min --
Max. throughflow volume -- 2 l/min
Min. water pressure (static) 1 bar --
Max. water pressure (static) 10 bar --
Min. water temperature 1 °C --
Max. water temperature 35 °C (ideal 15-20 °C) 90 °C for 30 s, max. 98 °C for 1 s
Water quality distilled or demineralized water in
accordance with EN 13060,
Appendix C
--
Measures for protecting the drinking
water
The steam sterilizer is equipped with all required components in
accordance with EN1717 to protect the drinking water.
To secure the water treatment units MELAdem47, MELAdem53 and
MELAdem53C it is recommended to install a safety device in accordance
with EN1717.
Further country specific measures may be required for protecting the
drinking water.
Leakage water detector The installation of a leakage water detector with cut-off valve (e.g. the water stop
from MELAG) is required.
When the device is put into operation for the first time, the double jacket is filled with 4 l of demineralised water according
to EN 13060, Appendix C. Please ensure that a sufficient quantity of demineralised water is available.

2 Installation requirements
9
Compressed air connection
PLEASE NOTE
The device must not be connected to the supply network for medical gases, e.g. for ventilation and
anaesthesia equipment, in accordance with EN ISO 7396-1.
nOnly use compressed air for treatment units (according to EN ISO 7494-2).
According to EN 13060, the device must not be operated without the sterile filter integrated in the compressed air hose.
The externally provided compressed air must meet the following conditions:
Property Requirements
Quality dried, condensate-free, bacteria-free, oil-free and filtered with a filter
fineness ≤2 µm
Pressure range 4 to 8 bar (58 to 116 psi)
Min. compressed air supply 55 l/min
Average compressed air
consumption
50 l per cycle
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 local 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 Software/purpose
USB Type-B USB type-A socket
(via USB type-B to type-A cable)
MELAview Service
Saving log data, querying device data
using diagnostics mode
USB Type-A MELAG USB flash drive
with FAT32 file system
Saving log data
MELAG USB flash drive
with FAT32 file system and
software-update container
Device software update
MELAprint 60 Label printing
Ethernet Ethernet
IEEE 802.3
Switch port
(Practical network)
MELAview
saving log data, querying device data
MELAtrace
saving log data
FTP server
saving log data
Label printing via MELAprint60
NOTICE
When performing a device software update, use only the update data authorized by MELAG for the
corresponding device type.

2 Installation requirements
10
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 MELAG USB flash drives.
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 operated in a LAN.
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 intended 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:
Log Source port Destination
port
Direction Aims
TCP 63000 - 64000 21 Outgoing FTP control
TCP any 63000 - 64000 Listening /
incoming
FTP (passive) data transfer (device set to
FTP logging)
UDP 68 67 Outgoing Communication to DHCP server - requests
to the DHCP server
UDP 67 68 Listening /
incoming
Answers from DHCP server(s)
TCP any 3333 Listening /
incoming
Data transfer log data (device set to TCP
logging)
UDP 62000 3000 Outgoing Broadcast search label printer
UDP 3000 62000 Listening /
incoming
Search results label printer
TCP ≥ 1025 9100 Outgoing Data transfer to the label printer

2 Installation requirements
11
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
Program log 1MB 200kB
Malfunction log 64kB 10kB
Status log 64kB 20kB
System log 40MB -

3 Setup and installation
12
3 Setup and installation
WARNING
Improper installation may lead to a short-circuit, fire, water damage or electrical shock.
This could result in serious injury.
nOnly have the device set up, installed and commissioned by people authorized by MELAG.
Removing from the packaging
CAUTION
Danger of injury from incorrect carrying.
Lifting and carrying too heavy a load can result in spinal injury. Failure to comply with these provisions can
result in crushing.
nThe device should always be carried by two people.
nUse the correct carrying straps to carry the device.
1. Remove the device from the box using the carrying straps.
2. To remove the straps, loosen the four knurled screws.
3. Pull the fastening system out of the device openings.
4. Store the carrying straps carefully.
Cover caps or Carebox holders
There are rectangular recesses on both side panels of the device for attaching the Carebox holders. Alternatively, these
can be closed with the cover caps included in the delivery.

3 Setup and installation
13
Attaching the cover caps
uPress the cover caps into the free recess as shown.
Attaching the holder for the Carebox
PLEASE NOTE
The spacers are intended for installation on the side wall of the device.
nFor a room wall installation, the spacers are not used.
1. Insert the fastening hook into the recess at an angle and pointing
upwards.
1
1
11
10
9
8
7
6
5
4
3
2
1
6
2. Secure the holder with the short screw provided.
3. Glue the three spacers to the back side of the holder.

3 Setup and installation
14
4. Place the holder over the corresponding recess on the device
(moisten the spacers for easier mounting).
5. Pull the holder and the fastening hook vertically downwards until
they click into place.
Connecting the power cable and removing accessories
NOTICE
Before switching on for the first time, the device must have acclimatised to the required ambient
temperature (5 – 40 °C).
1. Connect the power cable to the rear of the device and fold down the
safety latch.
2. Connect the device power plug to the mains socket.
3. Switch on the device at the power switch. The start screen
appears on the display.
ÊThe favourites menu is displayed after a short waiting time.
PLEASE NOTE
After starting, the device tries to deliver feed water into the tank and into the double jacket.
If no feed water is available yet, a malfunction message is displayed.
nUse the door mode to avoid the malfunction message.
4. Press the OPEN DOOR button to open the door.
5. Remove all accessories from the sterilization chamber.

3 Setup and installation
15
6. Close the door.
7. Press the power switch to shut down the device.
8. Remove the power plug to disconnect the device from the power
supply.
Connecting the feed water supply (installation examples)
The following pages provide examples for the recommended installation types for the feed water supply. The connection
of a different water treatment unit with the same water quality is possible after consultation with MELAG.
PLEASE NOTE
For detailed information on the cold water connection of the water treatment unit, see the user manual
of the unit.
Installation material
The following additional material can be ordered as required:
Qty. Article Art. no.
1 2-way compressed air distributor ME80220
1 Surface-mounted siphon ME37410
1 3/4” water inflow tap with safety combination ME37310
1 Additional water tap with unit combination (for connection
to a pre-existing angle valve)
ME58130
1 Pressure increase pump for MELAdem 47 ME22500
1 Filling pump P10 ME65010
1 MELAjet spray pistol ME27300
Example 1: Use of the water treatment unit MELAdem 53/53 C (HD)
Cut the PUR 6/4 mm (5 m) hose for the compressed air supply (4) and the feed water connection (5) into two suitable
pieces.
Connect the water treatment unit MELAdem 53/53 C to the feed water connection (5) of the device either via a water
branch (17) or by means of a water distributor (19). Insert the filter for MELAdem (18) in between.
Fix the safety combination HD (16.3) to the house wall, observing the flow direction indicated on the safety combination.
Keep the minimum distance of the drop section under the safety combination.
Cut the PTFE 8/6 mm (5 m) hose for the overflow funnel (2) and the wastewater connection (3) into two suitable pieces.
The direct connection of the water treatment unit to the domestic water system requires the installation of the water stop
(1).

3 Setup and installation
16
min. 25 cm
2
14
20
16 8
16.1
1
15
13
17/19
11
12
10
16.3
16.2
18
7
3
4
5
6
9
16.4
Position Description Art. no. contained in
1 Water stop (leak water detector with cut-off valve and sensor) ME01056 --
2 Overflow funnel -- present on the
device side
3 Wastewater connection -- --
3.1 Threaded connection 1/8” on hose 8/6 mm ME89120 present on the
device side
4 Compressed air connection -- --
4.1 2x Cu seal 13.5x18.5 ME36060 Installation set
4.2 Banjo bolt G 1/4" -- Installation set
4.3 QSS-E Swivel -- Installation set
5 Feed water connection, water treatment unit -- --
5.1 2x Cu seal 13.5x18.5 ME36060 Installation set
5.2 Banjo bolt G 1/4" -- Installation set
5.3 QSS-E Swivel -- Installation set
6 PUR hose (black) 6/4 mm see above Installation set
7 PUR hose (black) 6/4 mm see above Installation set
8 PTFE hose (8/6 mm) see above Installation set
9 PTFE hose (8/6 mm) see above Installation set
10 Double-chamber siphon ME26635 Installation set
11 2x double hose nozzle for siphon ME37400 Installation set
11.1 2x Cu seal 13.5x20 ME32050 Installation set
11.2 2x QSS-E straight ME38710 Installation set
11.3 2x wastewater adapter G1/4" internal thread ME56930 Installation set
12 Wall outlet NW40 -- present on the
building side
13 Compressed air supply -- present on the
building side
13.1 Coupling plug for compressed air on 6 mm hose ME80230 Installation set
14 3/4” water inflow tap with safety combination ME37310 --
15 Mains connection -- present on the
building side

3 Setup and installation
17
Position Description Art. no. contained in
16 MELAdem53/53C ME01038/
ME01036
--
16.1 Tap water supply hose EN 1717, 2.5 m ME24930 ME01038/
ME01036
16.2 Pipe elbow with drain valve ME70405 ME01038/
ME01036
16.3 Safety combination HD according to EN 1717 with wall bracket ME70685 ME01038/
ME01036
16.4 Feed hose EN 1717, 0.8m ME24932 ME01038/
ME01036
17 Cold water adapter 3/4" to 1/4" (direct connection water hose) ME09037 Installation set
18 Filter for MELAdem ME48240 --
The following additional material can be ordered:
19 Water distributor MELAdem 53 for connecting several devices ME69005 --
20 External tap for demineralised water ME91900 --
PUR hose (black) 6/4mm (10m) ME28820 --
Hose PTFE (8/6 mm, 5 m, wastewater hose) ME39180 --

3 Setup and installation
18
Example 2: Use of the water treatment unit MELAdem 53/53 C (EA)
Cut the PUR 6/4 mm (5 m) hose for the compressed air supply (4) and the feed water connection (5) into two suitable
pieces.
Connect the water treatment unit MELAdem 53/53 C to the MELAdem feed water connection (5) of the device either via
a water branch (17) or by means of a water distributor (20). Insert the filter for MELAdem (18) in between.
Cut the PTFE 8/6 mm (5 m) hose for the overflow funnel (2) and the wastewater connection (3) into two suitable pieces.
The direct connection of the water treatment unit to the domestic water system requires the installation of the water stop
(19).
2
3
4
5
1
21
16 8
16.1
19
15
13
6
17/20
11
12
10
16.2
18
9
7
Position Description Art. no. contained in
1 Return flow inhibitor type EA ME75300 --
2 Overflow funnel -- present on the
device side
3 Wastewater connection -- --
3.1 Threaded connection 1/8” on hose 8/6 mm ME89120 present on the
device side
4 Compressed air connection -- --
4.1 2x Cu seal 13.5x18.5 ME36060 Installation set
4.2 Banjo bolt G 1/4" -- Installation set
4.3 QSS-E Swivel -- Installation set
5 Feed water connection, water treatment unit -- --
5.1 2x Cu seal 13.5x18.5 ME36060 Installation set
5.2 Banjo bolt G 1/4" -- Installation set
5.3 QSS-E Swivel -- Installation set
6 PUR hose (black) 6/4 mm see above Installation set
7 PUR hose (black) 6/4 mm see above Installation set
8 PTFE hose (8/6 mm) see above Installation set
9 PTFE hose (8/6 mm) see above Installation set
10 Double-chamber siphon ME26635 Installation set
11 2x double hose nozzle for siphon ME37400 Installation set
11.1 2x Cu seal 13.5x20 ME32050 Installation set
11.2 2x QSS-E straight ME38710 Installation set
11.3 2x wastewater adapter G1/4" internal thread ME56930 Installation set

3 Setup and installation
19
Position Description Art. no. contained in
12 Wall outlet NW40 -- present on the
building side
13 Compressed air supply -- present on the
building side
13.1 Coupling plug for compressed air on 6 mm hose ME80230 Installation set
14 Water tap -- present on the
building side
15 Mains connection -- present on the
building side
16 MELAdem53/53C ME01038/
ME01036
--
16.1 Tap water supply hose EN 1717, 2.5 m ME24930 ME01038/
ME01036
16.2 Pipe elbow with drain valve ME70405 ME01038/
ME01036
16.3 Safety combination HD according to EN 1717 with wall bracket ME70685 ME01038/
ME01036
17 Cold water adapter 3/4" to 1/4" (direct connection water hose) ME09037 Installation set
18 Filter for MELAdem ME48240 --
19 Water stop (leak water detector with cut-off valve and sensor) ME01056 --
The following additional material can be ordered:
20 Water distributor MELAdem 53 for connecting several devices ME69005 --
21 External tap for demineralised water ME91900 --
PUR hose (black) 6/4mm (10m) ME28820 --
Hose PTFE (8/6 mm, 5 m, wastewater hose) ME39180 --

3 Setup and installation
20
Example 3: Using the reverse osmosis unit MELAdem47 (HD)
Hook the safety combination HD (16) into the fastening next to the overflow funnel (2) and fix it with the screw supplied.
Observe the flow direction indicated on the safety combination.
Shorten the PUR 6/4 mm (5 m) hose for the compressed air supply (4) to the required length.
Cut the PTFE 8/6 mm (5 m) hose for the overflow funnel (2) and the wastewater connection (3) into two suitable pieces.
The direct connection of the water treatment unit to the domestic water system requires the installation of the water stop
(18).
PLEASE NOTE
If the line pressure is less than 3 bar or if several devices are operated simultaneously, the pressure
increase pump for MELAdem 47 must be used.
2
3
4
5
13
20
15.4 715.3
1
18
14
12
15.2
10
11
9
16
8
17
6
15.1 15
Position Description Art. no. contained in
1 Tap water supply hose EN 1717, 2.5 m ME24930 --
2 Overflow funnel -- present on the
device side
3 Wastewater connection -- --
3.1 Threaded connection 1/8” on hose 8/6 mm ME89120 present on the
device side
4 Compressed air connection -- --
4.1 2x Cu seal 13.5x18.5 ME36060 Installation set
4.2 Banjo bolt G 1/4" -- Installation set
4.3 QSS-E Swivel -- Installation set
5 Feed water connection, water treatment unit -- --
5.1 2x Cu seal 13.5x18.5 ME36060 Installation set
5.2 Banjo bolt G 1/4" -- Installation set
5.3 QSS-E Swivel -- Installation set
6 PUR hose (black) 6/4 mm see above Installation set
7 PTFE hose (8/6 mm) see above Installation set
8 PTFE hose (8/6 mm) see above Installation set