MELAG Careclave 618 User manual

Technical Manual
Careclave® 618
Combination steam sterilizer
from software version 20.0.4
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 material ..............................................................................................................................................................5
Installation location...............................................................................................................................................................6
Space requirements .............................................................................................................................................................7
Mains supply ........................................................................................................................................................................8
Water connection .................................................................................................................................................................9
Compressed air connection ...............................................................................................................................................10
System and network safety ................................................................................................................................................10
3 Setup and installation ........................................................................................................................................................13
Removing from the packaging ...........................................................................................................................................13
Cover caps or Carebox holders .........................................................................................................................................13
Connecting the power cable and removing accessories....................................................................................................15
Connecting the feed water supply (installation examples) .................................................................................................16
Connection to wastewater system .....................................................................................................................................18
Aligning the device .............................................................................................................................................................19
Setting up the Carebox ......................................................................................................................................................19
Test runs ............................................................................................................................................................................19
Instructing the users...........................................................................................................................................................19
4 Settings and adjustment....................................................................................................................................................20
Service connection.............................................................................................................................................................20
Settings on the device........................................................................................................................................................20
5 Technical tables .................................................................................................................................................................21
Feed water quality..............................................................................................................................................................21
Precision and drift behaviour..............................................................................................................................................21
Nominal value tolerances...................................................................................................................................................22
Empty chamber test ...........................................................................................................................................................24
Pressure-time chart............................................................................................................................................................24
Type plate steam generator ...............................................................................................................................................27

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.
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.
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 material
Qty. Article
3 Hollow screw G 1/4“
3 QSS-E swivel
6 Cu seal 13.5x18.5
2 Cu seal 13.5x20
1 5 m PUR hose, black
1 5 m PTFE plastic pipe
2 Double hose nozzle for siphon
1 Raw water adapter MELAdem 40
1 Coupling connector - compressed air
2 Fitting
2 QSS-E straight
1 Double chamber siphon
The following additional material can be ordered as required:
Qty. Article Art. no.
1 2-way compressed air distributor 80220
1 Water distributor MELAdem 53 for connecting several
devices
69005
1 Surface-mounted siphon 37410
1 Removal valve MELAdem 91900
1 Water stop valve 01056
1 PTFE plastic pipe, 8/6x1 mm, running metres 39180
1 PUR hose 6/4, running metres 28820
1 Water tap 3/4“ with safety combination 37310
1 Additional water tap with unit combination (for connection
to a pre-existing angle valve)
58130
1 Carrying straps ME21121
The following material can be ordered to supply the device with feed water:
Qty. Article Art. no.
1 Water treatment unit MELAdem 47 01047
1 Water treatment unit MELAdem 53 01038
1 Water treatment unit MELAdem 53 C 01036
1 Pressure increase pump for MELAdem 47 ME22500
1 Filling pump ME65010
1 Safety device according to EN 1717 for MELAdem
Backflow preventer CA
Backflow preventer CA
Securing combination HD
ME82382
ME82383
ME82384
1 Connection hose for backflow preventer/securing
combination
ME21794

2 Installation requirements
6
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
Installation location 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
Floor loading (normal
operation)
2.6 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
7
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 (from 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
8
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 incorporation of a device
If the incorporation of the device is absolutely necessary, one of the following measures must be implemented:
1. The device must be able to be pulled out for operation (pos.a).
2. In the installation space, there must be an exhaust air duct in the rear area which diverts the warm air upwards
(pos.b).
3. In the installation space, there must be an exhaust air duct in the rear area which diverts the warm air actively 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 authorized technicians.

2 Installation requirements
9
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 16 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
Max. water temperature 35 °C (ideal 15-20 °C) 90 °C for 30 seconds, maximum 98
°C for 1 second
Water quality distilled or demineralized water in
accordance with EN 13060,
Appendix C
--
Measures for protecting the drinking
water
The device 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 recommended, even if it is not 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
10
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
11
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
12
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
13
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
14
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.
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
15
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 user interface 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.
4. Press the OPEN DOOR button to open the door.
5. Remove all accessories from the sterilization chamber.

3 Setup and installation
16
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.
Example 1: Using the MELAdem 47 reverse osmosis unit
Remove the plastic cover on the back of the device.
Connect the permeate line (feed water) (16) of the water treatment unit to the feed water connection MELAdem (7) of the
device using a swivel screw connection. Connect the concentrate line (17) of the water treatment unit (18) to the waste
water connection of the double-chamber wastewater trap (13) using the fitting.
Connect the compressed air supply (19) to the compressed air connection (6) of the device.
Connect the overflow funnel (3) and the waste water connection (5) with two separate hoses (9 and 14) to the double-
chamber wastewater trap (13) via the double hose nozzle (11).
When connecting the water treatment unit directly to the domestic water network, MELAG recommends the additional in-
stallation of the leak detector (22) with cut-off valve and sensor, as well as the use of a safety device according to EN
1717 (4). The non-return cover cap may only be installed in the water outlet hose of the overflow funnel (9). A non-return
cover cap must not be installed in the water outlet hose (14).
Hook the safety device according to EN 1717 (4) into the fastening next to the overflow funnel (3) and fix it with the sup-
plied screw. Connect the water supply hoses (1) to the water treatment unit (18) and water tap (20). Observe the flow di-
rection of the fresh water indicated on the safety device.
Put the plastic cover on the back of the device.
PLEASE NOTE
If the line pressure is below 3 bar or when operating several devices in parallel, the pressure increase
pump for MELAdem 47 must be used.
2
5
6
20
8
15
18
1416
41
22
21
19
7
10
11
12
13
17
3
9

3 Setup and installation
17
1 Water inflow hose 12 Wall outlet, provided on site (DN40)
2 Rear view of the Careclave 13 Double chamber siphon*
3 Overflow funnel 14 Water outlet hose
4 Safety device according to EN 1717 15 Pressure vessel of the water treatment unit
5 Waste water connection 16 Permeate line (feed water)
6 Compressed air connection 17 Concentrate line
7 Feed water connection MELAdem 18 Water treatment unit MELAdem 47
8 Removal valve MELAdem 19 Compressed air supply, provided on site
9 Water outlet hose overflow funnel 20 Water tap, provided on site
10 Waste water connection MELAdem 21 Mains socket
11 2x double hose nozzle for siphon 22 Water stop (leakage water detector) with
cut-off valve and sensor**
* alternatively, a surface-mounted siphon (available separately) can be used
** not included in the scope of delivery of the Careclave
Example 2: Use of the water treatment unit MELAdem 53/53 C
Connect the water treatment unit MELAdem 53 / 53 C to the feed water connection MELAdem (7) of the device either by
means of a water distributor (11) or via a water branch (not shown).
Remove the plastic cover on the back of the device.
Connect the compressed air supply (17) to the compressed air connection (6) of the device.
Connect the overflow funnel (4) and the waste water connection (5) with two separate hoses (9 and 15) to the double-
chamber wastewater trap (14) via the double hose nozzle (12).
When connecting the water treatment unit directly to the domestic water network, it is necessary to install the leak detec-
tor (20) with cut-off valve and sensor, and it is recommended to use a safety device according to EN 1717 (3). The non-
return cover cap may only be installed in the water outlet hose of the overflow funnel (15). A non-return cover cap must
not be installed in the water outlet hose (9).
Hook the safety device according to EN 1717 (3) into the fastening above the overflow funnel (4) and fix it with the sup-
plied screw. Connect the water supply hoses (1) to the water treatment unit (16) and water tap (18). Observe the flow di-
rection of the fresh water indicated on the safety device.
Put the plastic cover on the back of the device.
PLEASE NOTE
The MELAdem waste water connection must be closed with a sealing screw and copper seal.

3 Setup and installation
18
3
5
6
7
18
10
16 15
2 41a
20
19
17
8
9
11
12
13
14
1b
1 a Water inflow hose 11 Water distributor
1 b Water inflow hose or connection hose for
backflow preventer/securing combination
12 2x double hose nozzle for siphon
2 Rear view of the Careclave 13 Wall outlet, provided on site (DN40)
3 Safety device according to EN 1717 14 Double chamber siphon*
4 Overflow funnel 15 Water outlet hose overflow funnel
5 Waste water connection MELAdem 16 Water treatment unit MELAdem 53/53 C
6 Compressed air connection 17 Compressed air supply, provided on site
7 Feed water connection MELAdem 18 Water tap, provided on site
8 Permeate line (feed water) 19 Mains socket
9 Water outlet hose 20 Water stop (leakage water detector) with
cut-off valve and sensor**
10 Removal valve MELAdem
* alternatively, a surface-mounted siphon (available separately) can be used
** not included in the scope of delivery of the Careclave
Connection to wastewater system
NOTICE
The Careclave connection set must be used for connection to the sewage system, as other waste
water fittings may be made of materials that are not resistant to dental oil.
Since the backflow valve is not resistant to dental oil, the water outlet hose may only be connected to the
lowest connection as shown in the following illustration. The backflow valve may only be installed at the points
described.
PLEASE NOTE
For safe operation of the device, two drain hoses must be installed between the device and the
siphon.
nThe siphon must not be more than 2.5 m away from the device.
nThe hoses must be installed with a continuous slope.

3 Setup and installation
19
1. Cut two suitable drain hoses from the supplied PTFE plastic pipe.
2. Connect the overflow funnel (1) and the waste water connection (3) of the device with separate hoses via the double
hose nozzle to a double-chamber wastewater trap.
3. Perform a drain test by pouring approx. 500 ml into the overflow funnel.
ÊThe outlet hopper must be empty within 30 s.
12
3
1 Outlet hose overflow funnel with
backflow valve
2 optional waste water connection for
another device or a water treatment unit
3 Outlet hose without backflow valve
Aligning the device
To enable malfunction-free operation, the device must be set up in a horizontal position using a spirit level placed on the
chamber flange. Then extend the front device feet by three revolutions to effect a slight rearwards slope of the device.
Setting up the Carebox
1. Remove the Carebox from its packaging.
2. Replace the pre-installed blind adapters with the required instrument adapters according to the user manual.
3. If necessary, replace the supplied Carebox identification plate with an individually labelled version.
Test runs
Carry out the test runs according to the record of installation and setup. Successful test runs are a prerequisite for com-
missioning the device.
Instructing the users
Hand over the manufacturer’s inspection report. The declaration of conformity regarding the pressure equipment direc-
tive and the Medical Devices Directive are included in the manufacturer's inspection report.
Conduct a training program for the users and record the details in the training log.

4 Settings and adjustment
20
4 Settings and adjustment
Service connection
PLEASE NOTE
While using the service connection with MELAview, no other activities may be carried out on the
device.
The service connection enables the diagnosis of the device and the control of valves via the MELAview 4 Service soft-
ware.
Settings on the device
Date and time
Check the date and time and set if necessary. Consult the user manual.
Display settings
If necessary, adjust the brightness of the display in theSettings >Brightness menu.
Volume
If necessary, adjust the volume in theSettings >Volume menu.
Contact data of the service partner
Enter the name and address of the responsible service partner in theSettings >Service menu.
Resetting the maintenance counter
Reset the maintenance counter according to separate instructions (“Reset maintenance counter”, doc: AS_001-21).
User administration and logging
Instruct the user in the user administration and possible logging: see user manual. The Admin PIN can be found in the
user manual.
IP addresses
The IP address is automatically obtained by the device via DHCP. If necessary, a static IP can be assigned to the device.
Drying and other program modifications
The programs of the autoclave correspond in their sequences of fractionating, heating, sterilizing, pressure release, dry-
ing and aeration and its parameters pressure, temperature and time to the usual, practice-relevant requirements. For
some programs, some options are available by default in the respective program options to influence the program se-
quence.
Changes to the program sequence can be made to the parameters of the , Care and the Carebox detection functions.
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 persons. 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.
Counter status and measured values
You have the option of calling up counter status and other current technical data of the autoclave via theDevice sta-
tus >Counters and measurements button.