MELAG Careclave 618 Combination Steam Sterilizer Instruction Manual

MELAG Careclave 618 Combination Steam Sterilizer

Product Information

The Combination steam sterilizer is a technical device designed for sterilizing instruments and practice fittings. It is equipped with software version 21.0.3 and is intended for use outside the patient area. The product comes with a user manual that contains important safety information. The manual should be stored carefully and kept in close proximity to the device.

Symbols Used

• Indicates a dangerous situation, which if not avoided, could entail slight to life-threatening injuries.
• Burns Indicates a dangerous situation, which if not avoided, could lead to burns.
• Damage Draws your attention to a situation, which if not avoided, could result in damage to the instruments, the practice fittings, or the device.
• Important Information Draws your attention to important information.

Product Usage Instructions

Installation Requirements

Installation Location:

• The steam sterilizer should only be set up, installed, and commissioned by persons authorized by MELAG.
• The steam sterilizer is not suitable for operation in explosive atmospheres.
• The device should be located a minimum of 1.5 m radius away from the treatment area.

Property Installation Surface:
The steam sterilizer should be installed on a level and horizontal interior surface of a building that is dry and protected from dust.

• Max. Altitude: The device is suitable for operation at altitudes up to 2000 m.
• Overvoltage Category: The device can handle transient overvoltage up to the values of overvoltage category II 2.
• Degree of Contamination (in accordance with EN 61010): The device is suitable for use in environments with a degree of contamination in accordance with EN 61010.
• Operating Weight: The steam sterilizer has an operating weight of 1.7 kWh.

Floor Loading:

• Floor loading during normal operation should be considered.
• Floor load during hydraulic pressure test should be considered.

Ambient Temperature:
The device should be operated within the specified ambient temperature range.

Relative Humidity:
The device should be operated within the specified relative humidity range.

Space Requirements

Dimensions:

• Width: Specify the width of the device.
• Height: Specify the height of the device.
• Height without color touch display: Specify the height of the device without the color touch display.
• Depth: Specify the depth of the device.

Clearance:

• Clearance between the device feet: Specify the clearance between the feet of the device.
• Clearance from rear device foot up to the cover: Specify the clearance from the rear foot of the device up to the cover.
• Min. clearance to the side: Specify the minimum clearance required to the side of the device.
• Min. clearance to the side of the door hinge: Specify the minimum clearance required to the side of the door hinge.
• Min. clearance to the rear: Specify the minimum clearance required to the rear of the device.
• Clearance when door fully open: Specify the clearance required when the door is fully open.
• Max. clearance with open door: Specify the maximum clearance required with the door open.
• Min. clearance to the top: Specify the minimum clearance required to the top of the device.

Follow these installation requirements carefully to ensure safe and proper setup of the Combination steam sterilizer.

Read this manual carefully and in the correct order before setting up and commissioning the device. The instructions include 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.

General guidelines

Read this manual carefully and in the correct order before setting up and commissioning the device. The instructions include 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 the MELAG download center at www.melag.com.

Symbols used

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

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.

Installation requirements

Installation location

WARNING
Failure to comply with the setup conditions can result in injuries and/or damage to the steam sterilizer.

• 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.

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
Heat emission per hour (with maximum load)| 1.7 kWh
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 %.

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.

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 is required above the MELAdem 53 / MELAdem 53 C for free access to the hose connections.

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).

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

• Never damage or alter the power plug or cable.
• Never bend or twist the power cable.
• Never remove the plug by pulling on the power cable. Always take a grip on the plug.
• Never place any heavy objects on the power cable.
• Never run the power cable over areas in which it could become trapped (e.g. doors or windows).
• Never lead the cable along a source of heat.
• Never use any nails, paper fasteners or similar objects to fix the cable.
• Should the power plug or cable suffer damage, switch off the device. The power cable or plug should only be replaced by authorised technicians.
• The power cable may not be replaced by a cable determined to be insufficient.
• The 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.

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 at least 13 A, 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 printer MELAprint 60/80
Length of the power cable| 2 m
Disconnecting device| Power connector

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.

For hygienic reasons, the device is separated from the wastewater with a free fall section; this requires an open con-struction. The wastewater must always be able to flow freely and unhindered to the wall drain. The wall drain should be located directly under the device. The maximum length of the water drain hose must not exceed 2.5 m. The wastewater hose must be installed with a continuous slope. When put into operation for the first time, the device is filled with 4 l of demineralised water according to EN 13060, An-nex C. Please ensure that a sufficient quantity of demineralised water is available.

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.

• E.g. only 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:

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.

(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 60/80| Label print
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 60/80

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.)
• Writeable
• Formatted 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 printer
UDP| 3000| 62000| Listening / incoming| Search answers printer
TCP| ≥ 1025| 9100| Outgoing| Data transfer to the printer

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.

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.

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.

• The device should always be carried by two people.
• Use 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 cut-outs on both side panels of the device for attaching the Carebox holders. Alternatively, these can be closed with the cover caps included in the scope of delivery.

Attaching the cover caps

• Press 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.

• For a room wall installation, the spacers are not used.

1. Insert the fastening hook into the recess at an angle and pointing upwards.
2. Pull the fastening hook vertically downwards until it clicks into place.
3. Secure the bracket with the short screw provided.
4. Glue the three spacers to the back of the bracket.
5. Place the bracket over the corresponding recess on the device (moisten the spacers for easier mounting).
6. Pull the bracket 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.

   • After a short waiting time, the Favourites menu is displayed.
     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.

   • Use 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.

6. Close the door.

7. Press the power switch to shut down the machine.

8. Remove the mains 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:

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).

side
4| Compressed air connection| —| —
4.1| 2x Cu seal 13.5×18.5| 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 13.5×18.5| 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 13.5×20| 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| Water tap 3/4” with safety combination| ME37310| —
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 for wall mouting| ME70685| ME01038/ ME01036
16.4| Tap water supply 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 for MELAdem 53 for connecting several devices| ME69005| —
20| External tap for demineralised water| ME91900| —
| Hose PUR (black) 6/4 mm (10 m)| ME28820| —
| Hose PTFE (8/6 mm, 5 m, wastewater hose)| ME39180| —

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).

side
4| Compressed air connection| —| —
4.1| 2x Cu seal 13.5×18.5| 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 13.5×18.5| 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 13.5×20| 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| 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 for wall mouting| 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 for MELAdem 53 for connecting several devices| ME69005| —
21| External tap for demineralised water| ME91900| —
| Hose PUR (black) 6/4 mm (10 m)| ME28820| —
| Hose PTFE (8/6 mm, 5 m, wastewater hose)| ME39180| —

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.

side
4| Compressed air connection| —| —
4.1| 2x Cu seal 13.5×18.5| 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 13.5×18.5| ME36060| Installation set
5.2| Banjo bolt G 1/4″| —| Installation set
5.3| QSS-E Swivel| —| Installation set
6| Hose PUR (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
9| Double-chamber siphon| ME26635| Installation set
10| 2x double hose nozzle for siphon| ME37400| Installation set
10.1| 2x Cu seal 13.5×20| ME32050| Installation set
---|---|---|---
10.2| 2x QSS-E straight| ME38710| Installation set
10.3| 2x wastewater adapter G1/4″ internal thread| ME56930| Installation set
11| Wall outlet NW40| —| present on the building side
12| Compressed air supply| —| present on the building side
12.1| Coupling plug for compressed air on 6 mm hose| ME80230| Installation set
13| Water tap 3/4” with safety combination| ME37310| —
14| Mains connection| —| present on the building side
15| MELAdem 47 reverse osmosis unit| ME01047| —
15.1| Water inflow hose| ME37220| ME01047
15.2| Hose PUR (black) 6/4 mm (10 m)| ME28820| ME01047
15.3| Filter for MELAdem| ME48240| ME01047
15.4| Pressure tank MELAdem 47 (with shut-off valve and hose)| ME57065| ME01047
16| Safety combination HD| ME82384| —
17| Type AA safety device for separation from wastewater disposal in accordance with EN 1717| —| present on the building side
18| Water stop (leak water detector with cut-off valve and sensor)| ME01056| —
| The following additional material can be ordered:| |
19| External tap for demineralised water| ME91900| —
| Hose PTFE (8/6 mm, 5 m, wastewater hose)| ME39180| —

Example 4: Using the reverse osmosis unit MELAdem 47 (EA)

• 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 (17).

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.

side
4| Compressed air connection| —| —
4.1| 2x Cu seal 13.5×18.5| 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 13.5×18.5| 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
9| Double-chamber siphon| ME26635| Installation set
10| 2x double hose nozzle for siphon| ME37400| Installation set
10.1| 2x Cu seal 13.5×20| ME32050| Installation set
10.2| 2x QSS-E straight| ME38710| Installation set
---|---|---|---
10.3| 2x wastewater adapter G1/4″ internal thread| ME56930| Installation set
11| Wall outlet NW40| —| present on the building side
12| Compressed air supply| —| present on the building side
12.1| Coupling plug for compressed air on 6 mm hose| ME80230| Installation set
13| Water tap| —| present on the building side
14| Mains connection| —| present on the building side
15| MELAdem 47 reverse osmosis unit| ME01047| —
15.1| Water inflow hose| ME37220| ME01047
15.2| PUR hose (black) 6/4 mm| ME28820| ME01047
15.3| Filter for MELAdem| ME48240| ME01047
15.4| Pressure tank MELAdem 47 (with shut-off valve and hose)| ME57065| ME01047
16| Safety combination HD| ME82384| —
17| Type AA safety device for separation from wastewater disposal in accordance with EN 1717| —| present on the building side
18| Water stop (leak water detector with cut-off valve and sensor)| ME01056| —
| The following additional material can be ordered:| |
19| External tap for demineralised water| ME91900| —
| Hose PUR (black) 6/4 mm (10 m)| ME28820| —
| Hose PTFE (8/6 mm, 5 m, wastewater hose)| ME39180| —

Connection to wastewater system

NOTICE
The Careclave connection set must be used for connection to the wastewater system, as other waste water fittings may be made of materials that are not resistant to dental oil.

Since the backflow flap is not resistant to dental oil, the water drainage hose may only be connected to the lowest connection as shown in the following illustration. The backflow flap 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.

• The siphon must not be more than 2.5 m away from the device.
• For a continuous gradient, the hoses should be kept as short as possible.

1. Cut two suitable drain hoses from the supplied PTFE hose.

2. Remove the backflow flap from the double hose nozzle (pos. 3) for connecting the wastewater connection.

3. Connect the overflow funnel (pos. 1) and the wastewater connection (pos. 3) of the device with separate hoses via the double hose nozzle to a double chamber siphon.

4. Perform a drain test by pouring approx. 500 ml into the overflow funnel.

   • The drain funnel must be empty within 30 s.

5. Drain hose overflow funnel with backflow flap

6. Optional wastewater connection for another device or a water treatment unit

7. Drain hose without backflow flap

Connection to the compressed air supply

1. Assemble the compressed air connection, consisting of the banjo bolt (G 1/4″), SVS-E swivel and two copper seals (13.5×18.5).
2. Mount the assembled compressed air connection on the steam sterilizer.
3. Shorten the PUR 6/4 hose to the required length.
4. Connect the PUR hose to the steam sterilizer.
5. Connect the PUR hose with the coupling plug to the compressed air supply on the building side.

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.

PLEASE NOTE
To execute the service program Oil dosing venting it is necessary to log on as an administrator or service technician.

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 is included in the manufacturer’s inspection report. Conduct a training program for the users and record the details in the training log.

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

PLEASE NOTE
To define and change settings it is sometimes necessary to log in as an administrator.

Further information can be found in the user manual.

• 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.

• 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 steam sterilizer correspond in their sequences of fractionating, heating, sterilizing, pressure release, drying 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 Drying, Care and the Carebox detection func-tions.
  • 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 steam sterilizer via the Device status > Counters and measurements button.

Technical tables

Feed water quality

Minimum requirements to the feed water following EN 13060, Appendix C

Precision and drift behaviour

Sensors

Temperature sensors

Pressure sensor

steam
Drift per year| ± 0.2 % corresponds to ± 8 mbar corresponds to approx. ± 0.09 K steam
Drift in 5 years| ± 1.0 % corresponds to ± 40 mbar corresponds to approx. ± 0.44 K steam

Drift behaviour of the circulation pressure sensor and the circulation temperature sensor

Measuring chains
Measuring chain for the temperature measurement on the electronics (without sensor)

Measuring chain for the pressure measurement on the electronics (without sensor)

Precision| ± 0.2 % corresponds to ± 8.0 mbar corresponds to approx. ± 0.09 K steam
---|---
Drift per year| ± 0.004 % corresponds to ± 0.16 mbar corresponds to approx. ± 0.017 K steam
---|---
Drift in 5 years| ± 0.02 % corresponds to ± 0.8 mbar corresponds to approx. ± 0.09 K steam

After 1 year
Entire measuring chain of the temperature measurement

Entire measuring chain of the pressure measurement

Precision| at pure addition of indiv. errors| ± 0.70 % corresponds to ± 28.0 mbar corresponds to approx.

± 0.30 K steam temperature

---|---|---
Precision| per Gauss’ law of propagation| ± 0.41 % corresponds to ± 16.5 mbar corresponds to approx.

± 0.18 K steam temperature

After 5 year
Entire measuring chain of the temperature measurement

Entire measuring chain of the pressure measurement

Precision| at pure addition of individual errors| ± 0.70 % corresponds to ± 28.0 mbar corresponds to approx.

± 0.30 K steam temperature

---|---|---
Precision| per Gauss’ law of propagation| ± 0.41 % corresponds to ± 16.5 mbar corresponds to approx.

± 0.18 K steam temperature

Nominal value tolerances

Step| P [mbar a]| T [°C]| Care-S and.

Care- B

| Care- Therm| Univer- sal-B| Gentle-B| Quick-S| Program phase
---|---|---|---|---|---|---|---|---
Tolerance P / T
SP-S| —| —| —| —| —| —| —| Program start
CP1| —| —| —| —| —| —| —| Carebox detection
KU1| w 3000| —| +2000/

-200

| ◄| x| x| x| Exterior cleaning
ZU1| w 3000| —| +2000/

-200

| ◄| x| x| x| Exterior cleaning
WU1| w 3000| w 55| P: +2000/

-200

and T≥ 55 °C

| ◄| x| x| x| Exterior cleaning – warm
DH1| —| A0 3000| x| min. A0 3000| x| x| x| Disinfection heating| *)
P1| —| —| —| —| x| x| x| Nursing process
P2| —| —| —| —| x| x| x| Nursing process
SV1| c 500| —| +30/-30| x| x| x| x| Pre-evacuation
SK11| c 525| —| +100/-20| x| x| x| x| Steam entry drive channels
SK12| c 550| —| +100/-20| x| x| x| x| Steam inlet spray channels
Step| P [mbar a]| T [°C]| Care-S and.

Care- B

| Care- Therm| Univer- sal-B| Gentle-B| Quick-S| Program phase
---|---|---|---|---|---|---|---|---
Tolerance P / T
SK13| c 1500| —| +100/-20| x| x| x| x| Steam intake sterilization chamber
SH1| c 1500| —| +100/

-100

| x| x| x| x| Holding conditioning
SF2| c 500| —| +30/-30| x| x| x| x| Fractionation evacuation
SK21| c 525| —| +100/-20| x| x| x| x| Steam entry drive channels
SK22| c 550| —| +100/-20| x| x| x| x| Steam inlet spray channels
SK11| c 1900| —| x| x| +100/-20| c 1800 ●| c 1800 ●| Conditioning steam intake| ****

**)

SK12| c 1900| —| x| x| +100/

-500

| c 1800 ●| ●| Holding conditioning
SK13| c 1300| —| x| x| +20/-50| ●| ●| Conditioning pressure release
SF12| c 300| —| x| x| +30/-30| ●| c 225 ●| Fractionation evacuation
SF13| c 2100| —| x| x| +100/-20| c 1800 ●| ●| Fractionation steam intake
SF21| c 1300| —| x| x| +20/-50| ●| ●| Fractionation pressure release
SF22| c 200| —| x| x| +30/-30| ●| c 150 ●| Fractionation evacuation
SF23| c 2100| —| x| x| +100/-20| c 1800 ●| x| Fractionation steam intake
SF31| c 1300| —| x| x| +20/-50| ●| x| Fractionation pressure release
SF32| c 500| —| x| x| +30/-30| ●| x| Fractionation evacuation
SF33| c 2000| —| x| x| +100/-20| c 1500 ◄| ◄| Fractionation steam intake
SH1| c 2950| —| +60/-60| x| ◄| c 1850 ◄| ◄| Holding steam intake
SH2| c 2950| —| +60/-60| x| ◄| c 1950 ◄| ◄| Holding control
SS1| c 3031| c 134| +60/-60| x| ◄| c 2080 ◄| ◄| Sterilization entry
SS2| c 3170| c 135.3| +60/-60| x| ◄| c 2150 ◄| ◄| Sterilization
SA1| c 3000| —| +20/-50| x| x| x| x| Pressure release Carebox
SA2| c 1943| —| +20/-50| x| 1300| ◄| ◄| Pressure release
TVA| c 190| —| —| ◄| ◄| x| x| Drying evacuation
TDL| c 741| —| —                ◄| ◄| x| x| Compressed air drying
ST12| c 80| —| x| x| —| —| —| Holding drying| ****

**)

ST13| c 180| —| x| x| —| —| —| Drying ventilation
ST21| c 80| —| x| x| —| —| —| Drying evacuation
ST22| c 80| —| x| x| —| —| —| Holding drying
ST23| c 180| —| x| x| —| —| —| Drying ventilation
ST31| c 80| —| x| x| —| —| —| Drying evacuation
ST32| c 80| —| x| x| —| —| —| Holding drying
SB12| c ***)| —| —| —| —| —| —| Ventilation
SP-E| —| —| Value| ◄| ◄| ◄| ◄| Program end

Key:

• only Care-Therm
• only Universal-B
• as in the Universal-B — not specified
• Ambient pressure
• as in Care-S x not applicable

Empty chamber test
The coldest point in the sterilization chamber during the empty chamber test lies directly on the temperature sensor (see circular marking in the following figure). The temperature in the rest of the sterilization chamber is almost the same all over (0.6 K range).

Schematic side and fore view of the sterilization chamber

Pressure-time chart
Pressure-time diagram for Care-Therm, A0 > 3000

Pressure-time diagram for Care-B

Pressure-time diagram for Care-S, 134°C and 2.1 bar

Pressure-time diagram for Universal-B, 134°C and 2.1 bar

Pressure-time diagram for Quick-S

Pressure-time diagram for Prion-B

Pressure-time diagram for Gentle-B

Type plate steam generator

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: Careclave® 618
• Type of device: Combination steam sterilizers (steam sterilizer with washer-disinfector functionality)
• Classification: Class IIb
• Device type acc. to EN 13060: Type B

We herewith declare that the above designated product is suited for sterilization of

• Solid instruments (wrapped and unwrapped)
• Porous goods (wrapped and unwrapped)
• Products with narrow lumen (wrapped and unwrapped)
• Simple hollow items (wrapped and unwrapped)

Instructions on load quantities and loading variants are specified in the user manual and must be observed. Be sure to observe the manufacturer’s instructions for medical devices intended for sterilization according to EN ISO 17664.

We herewith declare that the following test system is suited for testing the above cited steam sterilizer.

• Helix-Test body according to EN 867-5: MELAcontrol® Helix and MELAcontrol® Pro

In addition, the Careclave is intended for the reprocessing of dental transfer instruments and hollow bodies classified as semi-critical, which are connected in the Carebox:

• Handpieces
• Contra-angles
• Turbines
• Ultrasonic and air scaler tips

The internal and external cleaning as well as the subsequent thermal disinfection comply with the specifications of EN ISO 15883-1 and -2. Optionally, automatic lubrication with care oil can also be carried out.

Berlin, 01.10.2021

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.

References

• Welcome to the MELAG Hygiene World | Melag
• Welcome to the MELAG Hygiene World | Melag
• Careclave® 4-in1 Solution | Order Here

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