Melag Euroclav 23-29 Technical description

Technical Description
Autoclave
Euroklav®23 VS+
®
Euroklav
as of software version 4.06
29 VS+
Dear doctor,
We thank you for your confidence demonstrated by the purchase of this autoclave.
More than 55 years ago, MELAG began as a medium-sized family-run enterprise to specialise in the manufacture of sterilization equipment for medical practices. In the meantime our company has grown into one of the world's leading producers of sterilization equipment. Verification of it success has been the sale of more than 400,000 MELAG units worldwide, attesting to the high quality of our sterilizers, which are exclusively made in Germany.
This autoclave has also been manufactured and tested according to the most stringent quality criteria. Nevertheless, please read the Technical description carefully before the initial start-up of the device. The long-term serviceability and the retention of value of your autoclave depend primarily on the careful preparation of the instruments and the regular maintenance of the device.
MELAG - General Management and employees
For physicians, physician's assistants, and service personnel
Please read this Technical description before you start operation of the autoclave. The instructions contain important safety precautions. Make sure to keep the Technical description near to the autoclave. The instructions are a part of the product.
Technical description of Euroklav®23 VS+, Euroklav®29 VS+
MELAG Medical Technology Berlin
Valid for Euroklav
as of software version 4.06
1st Edition October 2007
Responsible for the contents: Engineering Department
MELAG Medical Technology
Document: BA_2_GB_23VS+_29VS+.doc/ Revision: 1 – 07/1063
Subject to technical changes
®
23 VS+, Euroklav®29 VS+
Geneststraße 9-10
10829 Berlin
Germany
E-mail: info@melag.de
www.melag.de
© 2007 MELAG Berlin
Foreword
Thank you for deciding to buy this MELAG autoclave.
Device name
Technical description
Avoid dangers
This Technical description describes both the autoclaves Euroklav and Euroklav®29 VS+. They are identical except for their chamber depth and device depth.
The device name "autoclave" is used in this Technical description to
designate the steam sterilizers Euroklav
The Technical description contains important safety instructions and
information which you need to operate the autoclave. Read these instructions carefully and thoroughly in proper sequence.
Please read all the safety instructions attentively before using the
autoclave.
About this manual
®
23 VS+
®
23 VS+ and Euroklav®29 VS+.
Example of emphasis
Conductivity
Universal program
Chapter 6 – Logging
Symbol
Danger!
Warning!
measurement
Meaning Explanation
Risk to health Indicates a dangerous situation which if not avoided
Observe
Important
Glossary entry Words or phrases marked with an arrow are
Software
Cross-
without fail
information
Meaning Explanation
citation
reference
could entail slight to life-threatening injuries.
Indicates a dangerous situation which if not avoided could entail damage to the instruments, the practice equipment or the autoclave.
Indicates important information.
explained in the glossary. The glossary is listed alphabetically. It can be found at the end of this manual.
Words or phrases appearing on the display of the autoclave are marked as software citations.
Reference to another text section within this Technical description.
Figure 1/(5)
Cross-
reference
Reference to a detail in a figure – in the example, to Part No. 5 in Figure 1.
Safety instructions
Instruction
Mains cable and power
Setting up, installation,
commissioning
Preparation and
sterilization of textiles and
instruments
Program termination
Removal of the items to be
sterilized
Maintenance
Carrying the autoclave
Do not sterilize any liquids with this autoclave.
Never damage or change the mains cable or power plug.
plug
Only have the autoclave set up, installed, and commissioned by
Follow the instructions of the textile and instrument manufacturers for
Take heed that when opening the door after terminating a running
Never open the door by force.
Have the maintenance done only by authorized persons.
Two people are necessary to carry the autoclave.
If repeated error messages occur while operating the autoclave, turn
Errors
To operate the autoclave, pay attention to the following safety instructions given below and in the individual chapters of this Technical description.
Never operate the autoclave if the mains cable or power plug are damaged.
Never pull on the mains cable to take it out of the socket. Always take hold of the power plug itself.
people authorised by MELAG.
Only operate the autoclave in areas which are not subject to explosion hazards.
The electric connections and connections for feed water and used water may only be completed by a specialist technician.
preparing and sterilizing textiles and instruments.
Observe the relevant standards and directives for the preparation and sterilization of textiles and instruments, e.g. RKI [Robert Koch Institute] and DGSV [German Society for Sterile Supply].
Only use wrapping materials and systems which are suitable for steam sterilization according to the manufacturer's information.
program, hot water steam can escape out of the chamber, depending on when the program was terminated.
Depending on the time of the program termination, the load might not be sterile. Observe the clear instructions shown on the display of the autoclave. If necessary, sterilize the affected objects after rewrapping.
Use a tray lifter to remove the tray. Never touch the sterilized items, the chamber or the door with unprotected hands. The parts are hot.
Check the wrapping of the sterilized objects for damage when removing them from the autoclave. If a wrapping is damaged, wrap the object again and re-sterilize it.
Use a suitable carrying strap to transport the autoclave.
the device off and notify your specialist dealer.
Only have the autoclave repaired by authorized persons.
Contents
Chapter 1 – Performance Specification.............. 6
Proper use.............................................................. 6
User benefit ............................................................ 6
Overview of sterilization programs.......................... 8
Chapter 2 – Device Description........................... 9
Scope of delivery .................................................... 9
Device views......................................................... 10
Effective capacity.................................................. 11
Mountings for the load .......................................... 11
Control panel ........................................................ 12
Supply with feed water ......................................... 12
Chapter 3 – Initial start-up ................................. 14
Conditions for setting up, installing and starting up
............................................................................. 14
Set-up location requirements................................ 14
Connections required ........................................... 15
Prerequisites for initial start-up ............................. 17
Record of installation and setting up..................... 17
Switch on autoclave.............................................. 17
Chapter 4 – Sterilization..................................... 18
Create prerequisites ............................................. 18
Select feed water supply ...................................... 18
Prepare items to be sterilized ............................... 19
Load the autoclave ............................................... 20
Close the door ...................................................... 22
Select program ..................................................... 22
Select automatic pre-heating ................................ 23
Select additional drying ........................................ 24
Start program........................................................ 24
Program is running ............................................... 24
Manually terminate program................................. 25
Sterilization phase is finished ............................... 26
Drying phase ........................................................ 26
Program is finished............................................... 27
Display batch number........................................... 27
Remove sterilized items ....................................... 27
Storage of sterilized items .................................... 28
MELAnet Box as output medium .......................... 32
Computer as output medium ................................ 32
Automatic immediate log output ........................... 33
Output the logs subsequently ............................... 33
Display protocol memory ...................................... 35
Read log files correctly ......................................... 35
Chapter 6 – Maintenance ................................... 37
Cleaning ............................................................... 37
Avoid formation of spots ....................................... 38
Use qualitatively high-grade feed water................ 39
Exchange the door seal........................................ 39
Maintenance ......................................................... 39
Chapter 7 – Operating pauses........................... 41
Sterilization frequency .......................................... 41
Pause times.......................................................... 41
Shut-down ............................................................ 42
Transport .............................................................. 42
Re-startup after change of locality ........................ 42
Chapter 8 – Function test................................... 43
Automatic function test ......................................... 43
Manual function test ............................................. 43
Testing in daily operation...................................... 44
Vacuum test.......................................................... 44
Bowie & Dick test.................................................. 44
Display water quality............................................. 45
Validation.............................................................. 45
Chapter 9 – Errors .............................................. 46
A warning is not an error ...................................... 46
Warning messages............................................... 46
Error message ...................................................... 46
Before you call...................................................... 47
No display on the screen ...................................... 53
Too large feed water consumption ....................... 53
Bad drying results................................................. 53
Glossary.............................................................. 54
Chapter 5 – Logging........................................... 29
Batch documentation............................................ 29
Set date and time ................................................. 30
Use printer as output medium............................... 30
Employing MELAflash as output medium ............. 32
Appendix A – Accessories................................. 57
Appendix B – Symbols on the autoclave ......... 58
Chapter 1 – Performance Specification
In this chapter you learn
Under which conditions and for which purpose you should use this autoclave What benefit you can achieve by using this autoclave Which sterilization programs you can use
Proper use
Application area
Sterilization tasks
Danger of burning!
Warning!
The autoclave is intended for use in every kind of general medical area
where no Class B autoclave is required due to the instruments used and type of packaging.
According to →DIN EN 13060 this autoclave is considered a Class S
sterilizer. As a universal autoclave, it is suited for sterilizing wrapped simple hollow body instruments (Hollow Body B) and smaller quantities of textiles.
Use the autoclave only for the intended purposes outlined in the
Observe the following instructions for using the autoclave:
Do not sterilize any liquids with this autoclave. It is not approved for the sterilization of liquids.
In case of non-observance, the consequences could be →delayed boiling, damage to the autoclave and burns.
related technical documents and only in connection with the devices and components approved by MELAG.
The sterilization of instruments and textiles with this autoclave, like the foregoing instrument sterilization, is only to be done by competent personnel.
Only use instruments, wrappings and textiles which are suitable for steam sterilization according to the manufacturer's information.
In case of non-observance the consequences can entail damage to the autoclave and/or to the items to be sterilized.
User benefit
Universal use
Low time expenditure,
overheating protection
Automatic pre-heating
6
The autoclave sterilizes on the basis of the pre-vacuum method
combined with the fractionated flow method. These methods ensure the complete and effective wetting or penetration of the items to be sterilized with saturated steam. The procedure can also be used to safely and quickly sterilize wrapped instruments or textiles.
To generate the sterilization steam, the autoclave uses an →integrated
steam generator. The sterilizer chamber is protected from overheating and you can sterilize instruments and small quantities of textiles in a short time.
The cold chamber is preheated on activation of preheating or can be
maintained at a specific temperature between two sterilizations. This shortens the program time periods and reduces the formation of condensate to give improved drying results.
Chapter 1 – Performance Specification
Internal feed water supply
in one-way and circulatory
flow system
Automatic feed water
supply
Optimal drying for
wrapped items to be
sterilized
Optimized total operating
High safety with
extensive
safety devices
Additional
function check
Effective batch documentation
The autoclave works both according to the feed water one-way system as
well as the feed water circulatory flow system. In the one-way system, it uses fresh purified feed water for every sterilization run. The quality of the feed water is constantly monitored via integrated conductivity measurement. This prevents stains on instruments and soiling of the autoclave, provided the instruments have been carefully prepared. In the feed water circulatory flow system, the autoclave works in a more water-conserving manner, since the feed water is used for several sterilization runs. The quality of the feed water is constantly monitored via integrated conductivity measurement here as well.
The →feed water for generating the steam is automatically supplied via
an internal water storage tank or a water treatment unit (e.g. MELAdem 40, MELAdem
®
47).
The sterilized items are dried with the pulsating overpressure and
vacuum drying method. This way you achieve optimal drying results for wrapped objects as well.
The autoclave works with an electronic parameter control. This way the
time
autoclave optimizes the total operating time of a program depending on the load.
The autoclave verifies pressure and temperature in the sterilization
chamber at all times and its door locking system does not permit opening the door when there is overpressure in the chamber. A process evaluation system is integrated in the electronics of the autoclave. It monitors the process parameters such as temperature, time and pressure during a program. It monitors the parameters with respect to their limit values at activation and control and guarantees a safe and successful sterilization. If one or more parameters are above or fall below the determined limit values, the autoclave outputs a warning or fault messages and, if necessary, aborts the program. In the event of an automatic program abort, observe the information on the display.
With the help of the test programs, you can conduct an additional
function check at any time. With the Bowie & Dick-test, you can verify the autoclave for sufficient steam penetration of porous sterilizing materials (e.g. textiles). With Conductivity measurement, you can verify the water quality of the feed water.
The autoclave has an internal log memory which can save up to 40
program cycles. All data of the completed programs are automatically stored here. You can read out the internal log memory immediately after the end of the program, or at a later time.
®
7
Chapter 1 – Performance Specification
Overview of sterilization programs
Type tests Universal-
Program
Program type as per
DIN EN 13060
Dynamic pressure test of the sterilization
chamber
Air leak X X X X
Empty chamber test X X X X
Solid load X X X X
Porous partial load X X X
Porous full load
Hollow body B X X X X
Hollow body A
Simple wrapping X X X X
Multiple wrapping X X X X
Drying solid load X X X X
Drying porous load X X X
Type S Type S Type S Type S
X X X X
Quick­Program S
Gentle­Program
Prion­Program
Sterilization temperature 134°C 134°C 121°C 134°C
Sterilization pressure 2 bar 2 bar 1 bar 2 bar
Sterilization time 5.5 min. 3.5 min. 20.5 min. 20.5 min.
X = Conformity with all applicable sections of the standard DIN EN 13060
8
Chapter 2 – Device Description
In this chapter you learn
Which components are included in the standard scope of delivery Which components the autoclave contains What safety devices the autoclave has How the operating elements are designed and how you should use them How the menus of the user interface are structured What kind of water supply the autoclave needs
Scope of delivery
®
Standard scope of delivery
As option
Euroklav
Technical description
Technical Manual
Warranty certificate
Manufacturer's inspection report
Pressure device directive certificate
Record of installation and setting up
1 Mounting for trays or cassettes
1 hose for draining the internal storage tank
1 TORX wrench for removing the carrying strap
1 lever for emergency unlocking of the door
1 tank filter key
2 replacement device safeguards on the inside door of the autoclaves
Trays
Tray lifter
Standard tray cassette and lifter
Additional tray mounts
Log printer MELAprint MELAflash CF card writer with CF card and card reader MELAnet Box
23 VS+ or Euroklav®29 VS+
®
42
9
Chapter 2 – Device Description
Front side
Front side below with opened door
(6) Serial data and printer connection (RS232)*
(9) Connection for emptying the storage tank feed water (10) Connection for emptying the storage tank waste water
*hidden behind the white cover
Back side
(11) Tank cap
Fig. 1: Device views
Device views
Operating and display field
(1)
Door (pivots opens to the left)
(2)
sliding closure grip
(3)
Mains switch
(4)
Front foot of the unit (adjustable)
(5)
(7)
Device safeguards – 2x 16A/ gRl
(8)
Reset button for overheating protection
(12)
Safety valve
(13)
Sterile filter
(14)
One-way drain
(15)
Purified feed water inlet via internal storage tank
(16)
Hose bridge for internal feed water supply
(17)
Power cable
10
Chapter 2 – Device Description
Interior view
Fig. 2: Interior view
(1)
Chamber
(2)
Mounting to hold trays/ cassettes
(3)
Door locking pin
(4)
Chamber sealing surface
(5)
Blue door seal
(6)
Door plate
Effective capacity
Device type
Euroklav®23 VS+
Euroklav®29 VS+
Diameter Depth Volume
25 cm
25 cm
Mountings for the load
The autoclave is always delivered with a mounting to hold trays or
cassettes.
The mounting (A) is standard and can hold either five trays or three standard tray cassettes rotated by 90°.
Fig. 3: Mounting A
Fig. 4: Mounting B
The mounting (B) can hold four standard tray cassettes or four trays.
The mounting (D) can hold two high cassettes (e.g. for implant
cassettes) or four trays rotated by 90°.
45 cm 22 litres
35 cm 18 litres
Fig. 5: Mounting D
11
Chapter 2 – Device Description
Control panel
The control panel consists of a two-line alphanumerical LED display and four
membrane keys.
chamber pressure (bar) and
(steam)- temperature (°C)
Time (h:min:s)
2-line LED display
for program status display and parameter display
Function key (-) and (+)
to select, set and display special functions: print, date/time, preheating, total batches, conductivity, acknowledge error, for unlocking the door
KEY (+)
Program selection button (P)
to select the sterilization programs/ test
programs and select or set options
(submenus) of the special functions
Start – Stop button (S)
to start programs, terminate programs / drying as well as control of the special functions
Initial state
The display switches to the initial state after every switch-on, where the
current time and the chamber pressure in bar and the (steam) temperature in °C is displayed.
Feed water with internal
storage tank
Internal storage tank
Distilling unit MELAdest
Feed water via water
treatment system
Supply with feed water
The autoclave requires →demineralized or →distilled →feed water for
®
65
steam production according to VDE 0510. The feed water supply is provided either by an external water storage tank or with a water treatment
unit (e.g. MELAdem
®
40/ MELAdem
®
47). The autoclave automatically
sucks in the feed water.
If you employ the internal storage tank for the feed water supply, you must
fill it manually from time to time. At the given point in time, the autoclave outputs an appropriate message. Only use water according to →VDE 0510 as feed water.
The internal storage tank holds maximum 5 litres. This quantity of →feed
water suffices for up to 7 sterilizations.
®
With the MELAdest
65 distilling unit, you can produce feed water in the
practice cost-effectively.
A water treatment unit is connected to the domestic water supply. It
produces the feed water required for generating the steam for the autoclave. The purified feed water connection for the autoclave is directly connected to the water treatment unit. If you use a water treatment unit, then there is always sufficient feed water available. You no longer have to manually fill the water storage tank. The waste water can either be collected in an internal storage tank and manually emptied or automatically drained via the one-way drain.
12
Chapter 2 – Device Description
Water treatment units
MELAdem
MELAdem®47
®
40 and
The water treatment units MELAdem®40 and MELAdem
optimal purified feed water quality for the autoclave. The selection of the respective unit depends on the number of sterilizations per day and the respective loads. Both MELAG autoclaves can be supplemented with a water treatment unit.
NOTICE:
Please first consult with MELAG if you would like to employ water treatment units of other manufacturers.
®
47 produce the
13
Chapter 3 – Initial start-up
In this chapter you learn
Who may set up, install and start up the autoclave Which prerequisites you must create for setting up, installing and starting up the
autoclave
Conditions for setting up, installing and starting up
Only have the autoclave set up, installed, and started up by people →authorized by MELAG.
According to the currently valid VDE standards, this device is not
Danger!
suitable for use in areas subject to explosion hazards.
The autoclave is intended for use outside the patient environment. The minimum distance to the treatment area must have a radius of at least 1.5 metres.
Damages to the autoclave and/or injuries can occur in case this precaution is not observed.
Set-up location requirements
Location
Warning!
Distance to the surrounding
surfaces
Set up the autoclave in a dry and dustproof location. The air humidity
should be 30% to 60% and the ambient temperature 16° to 26 °C.
Without fail, keep the specified distance free to the surrounding
The distance to the surrounding surfaces must be at least 10 centimetres
surfaces at the sides and above the autoclave.
Non-observance can lead to heat accumulation. This could adversely affect the function of the autoclave and entail the shortening of the vacuum pump's service life and result in extended program times.
on both sides and 10 centimetres at the back side. The autoclave should be freely accessible from above, so that the built-in storage tank can be filled and a good ventilation is guaranteed.
14
Chapter 3 – Initial start-up
r
Space requirements Euroklav®23 VS+ Euroklav®29 VS+
Width
Height
B
Depth
A= 42.5 cm
B= 48.5 cm
C= 69 cm
D= 43.5 cm
E= 9 cm
F
A
DE
C
G
F= 10 cm
G= 10 cm
maximum acoustic power for Euroklav®23 VS+ and Euroklav®29 VS+: < 52 dB (A)
Additional space for
feed water supply
Other than for the autoclave, the water treatment unit for the feed water
supply require space.
NOTICE:
In no case may you subject the water storage tank to sunlight. This way you avoid algae formation. The maximum suction height from the external storage tank is 1.5 metres.
MELAdem
®
40
can be directly hung on to the autoclave on the side
Space requirement for
water treatment unit
The attachment can be next to the autoclave or above or below the
autoclave
MELAdem
®
47
Attachment next to the autoclave or above or below the autoclave (e.g.
lower cabinet)
delivered with water storage tank
A= 42.5 cm
B= 48.5 cm
C= 61 cm
D= 32 cm
E= 12 cm
F= 10 cm
G= 10 cm
Water treatment unit Width Height Depth Diameter
MELAdem MELAdem MELAdem
®
40 32 cm 35 cm 15 cm
®
47 module housing 39 cm 47 cm 15 cm
®
47 water storage tank 51 cm
24 cm
Connections required
The electric connections and connections for feed water and used
Danger of injury!
water may only be completed by a specialist technician.
Non-observance could lead to a short-circuit and/or fire and/or wate damage and/or electrical shock. Serious injuries could be the consequence.
15
Chapter 3 – Initial start-up
Electrical connection
Connected load
Waste-water drain
Danger of injury!
Insert power plug into the
socket
Provide the following electrical connections for the autoclave:
Electric circuit with 220V-240V and 50/60 Hz
16 A separate fuse protection – at least Automat Type B
Protection from leakage current 30 mA
®
as of software version 4.07
2600 W for Euroklav 2100 W for Euroklav
software version 4.06 3000 W for Euroklav®29 VS+ ;
2400 W for Euroklav
NOTICE:
23 VS+
®
29 VS+
®
23 VS+
In order to prevent water damage, MELAG recommends the use of a leak monitor, e.g. water stop valve from MELAG (Art. No. 01056).
The autoclave is connected to the drain via the one-way drain (see page
10, Fig. 1/ (14)).
The connection must be located below the autoclave.
The one-way drain hose can be connected as follows:
To an existing sink drain
To a separate drain pipe when using the surface-mounted siphon
from MELAG (Art. No. 37410 – not in the standard scope of delivery)
You can reorder a 2-m long hose (Art. No. 36585) for the one-way drain hose.
NOTICE:
The waste-water hose must be laid dip-free with continuous descent. For waste-water paths which are longer than two metres we recommend a fixed laying of HT (high temperature) piping by a specialised installation firm.
Observe the following precautionary measures when handling the mains cable and power plug:
Never splice or modify the mains cable.
Never bend or twist the mains cable.
Never pull on the mains cable to take it out of the socket. Always
take hold of the power plug itself.
Never place any heavy objects on the mains cable.
Never run the mains cable over places where it could be squeezed
(e.g. doors or windows).
Do not run the mains cable along a heat source.
Do not use any nails, staples or similar objects to fixate a cable.
If the mains cable or the power plug is damaged, turn off the autoclave. Mains cables or power plugs may only be replaced by →authorised persons.
If these points are not observed, the cable or plug can be damaged and/or a fire or electrical shock might occur. Serious injuries could be the consequence.
Plug the power plug into the socket.
16
Chapter 3 – Initial start-up
Prerequisites for initial start-up
The following prerequisites must be satisfied for initial start-up:
The feed water supply must be secured.
The power supply of the autoclave must be assured.
Record of installation and setting up
NOTICE:
As documentation of proper setting up, installation and setting up as well as for your warranty claim, the record of installation must be filled out by the person responsible and a copy sent to MELAG.
Switch on autoclave
Switch on mains
After switching on
Turn the mains switch on to power the autoclave (page 10, Fig. 1/(4)).
After switching on the autoclave with the mains switch, the display
shows in alternation to the initial state the message Unlocking door with button (+), if the door is closed.
Directly after having switched on the autoclave and before initial start-up,
remove the trays and accessories from the chamber.
Press the KEY (+) to unlock the door. After pressing the key you can
open the door
17
Chapter 4 – Sterilization
In this chapter you learn
Which prerequisites should be created for a smoothly-running sterilization How to switch between internal and external feed water supply How to switch between the one-way and circulatory feed water system What you should observe when preparing the items to be sterilized How to correctly load the autoclave Which programs you should use for what How you start a program Which stages a program runs through How to cancel a program How to recognise when the sterilization is successfully finished What you can do to improve the drying results What you must consider when removing the items to be sterilized
Provide feed water
Switching on
Switch between internal and
external feed water supply
Create prerequisites
Create the prerequisites for a smooth and successful sterilization process as follows:
If you use an internal storage tank for the feed water supply, fill this
with feed water of the respective quality (see page 39, Use
qualitatively high-grade feed water ). You can use the removable
funnel insert to conveniently fill fresh feed water into the right chamber of the storage tank up to the MAX mark. Simply remove the filter for
cleaning.
If you employ a water treatment system, e.g. MELAdem
MELAdem water storage tank of the MELAdem
If the autoclave is still not switched on, switch it at the mains switch
tap on at least one hour before the sterilization..
(page 10, Fig. 1/(4)). (See as of page 17, Switch on autoclave).
®
47, and the water feed is closed, then open it up. If the
®
47 is empty, turn the water feed
®
40,
Select feed water supply
Depending on whether the feed water should be supplied from the internal
storage tank or whether you employ a water treatment unit for the feed water supply, select the appropriate setting on the display.
Select the setup menu by simultaneous brief pressing of the K
and (-). The display shows Function: Last batch number..
Navigate with the K
Function: Feed water–supply.
Press the K
e.g. Feed water-supply – intern.
To set the value to Feed water-supply – extern, press the K
(P) again.
EY (P). The currently set option appears on the display,
EY (+) or (-), up to the display
EYS (+)
EY
18
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