MELAG SteriHero Speed+ User Manual
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MELAG SteriHero Speed+ User Manual

Steam sterilizer
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User manual
SteriHero
Steam sterilizer
from software version 2.11.1
EN
Dear customer,
We thank you for your confidence demonstrated by the purchase of this MELAG product. As an owner-run and operated
family concern founded in 1951, we have a long history of successful specialization in hygiene products for practice-
based use. Our focus on innovation, quality and the highest standards of operational reliability has established MELAG
as the world's leading manufacturer in the instrument reprocessing and hygiene field.
You, our customer are justified in your demand for the best products, quality and reliability. Providing
hygiene"
and
"Quality – made in
management system is subject to close monitoring: one instrument to this end is our annual multi-day audit conducted in
accordance with EN ISO 13485. This guarantees that all MELAG products are manufactured and tested in accordance
with strict quality criteria.
The MELAG management and team.
®
Speed+
Germany", we guarantee that these demands will be met. Our certified quality
"competence in
0197

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  • Page 1 2.11.1 Dear customer, We thank you for your confidence demonstrated by the purchase of this MELAG product. As an owner-run and operated family concern founded in 1951, we have a long history of successful specialization in hygiene products for practice- based use.

  • Page 3: Table Of Contents

    Contents Contents 1 General guidelines ................................ 6 Symbols used .................................. 6 Formatting rules................................... 6 Disposal .................................... 6 2 Safety..................................... 7 3 Performance specifications .............................. 8 Intended use .................................. 8 Sterilization procedure ................................. 8 Type of the feed water supply.............................. 8 Program runs .................................. 8 Safety equipment................................. 9 Performance characteristics of sterilization programs ....................... 10 4 Description of the device.............................. 11 Scope of delivery ................................ 11 Views of the device................................ 12...
  • Page 4 Contents 7 Important information for routine operation........................ 29 Feed water and wastewater containers .......................... 29 8 Sterilization .................................. 31 Preparing the load ................................ 31 Reprocessing instruments............................ 31 Reprocessing textiles .............................. 31 Loading the steam sterilizer............................... 32 Soft sterilization packaging ............................ 32 Multiple wrapping ................................. 32 Mixed loads .................................. 33 Loading volumes ................................ 33 Selecting the program................................ 33 Starting the program ................................ 35 Program options................................ 36...
  • Page 5 Contents Admin PIN .................................. 68 Checking the software version ............................. 69 Software update ................................ 69 Country parameters .............................. 70 12 Maintenance.................................. 71 Maintenance intervals................................ 71 Cleaning..................................... 71 Sterilization chamber, door seal, inner door surface, trays .................. 71 Housing parts ................................ 72 Feed water and wastewater containers ........................ 72 Avoiding staining................................ 72 Replacing the sterile filter .............................. 73 Replacing the door seal .............................. 73 Replacing the dust filter .............................. 74...

  • Page 6: General Guidelines

    Dispose of spare parts that are no longer used, e.g. seals, properly. MELAG draws the operator’s attention to the fact that they are responsible for deleting personal data on the device to be disposed of.

  • Page 7: Safety

    Please note that all serious accidents which occur in connection with the medical device (e.g. death or serious deterioration in the state of health of a patient) which were presumably caused by the device, must be reported to the manufacturer (MELAG) and the relevant authority of the member state, in which the user and/or patient resides.

  • Page 8: Performance Specifications

    3 Performance specifications 3 Performance specifications Intended use The steam sterilizer SteriHero Speed+ is mainly intended for use in the medical field. The steam sterilizer is a small steam sterilizer according to 13060. It uses the fractionated vacuum process to ensure effective steam penetration  ...

  • Page 9: Safety Equipment

    3 Performance specifications Program phases of a standard sterilization program Program phase Description 1. Air removal and heating Air removal up phase In the evacuation phase, the mixture of air and steam is repeatedly evacuated and steam is generated in the sterilization chamber. This efficiently removes air from the sterilization chamber and prepares the load for sterilization.

  • Page 10: Performance Characteristics Of Sterilization Programs

    3 Performance specifications Performance characteristics of sterilization programs The results in this table show which inspections were performed on the device. The marked fields demonstrate compliance with all the applicable sections of the standard 13060.   Type tests Universal B Quick-S Gentle B Prion B...

  • Page 11: Description Of The Device

    In addition, a separate feed water container with a capacity of at least 2 l is required (not included in the scope of delivery). To optimise work processes, MELAG recommends using a feed water container of the same size as the wastewater container.

  • Page 12: Views Of The Device

    4 Description of the device Views of the device Front Touch display Door (swings open to the left) Door handle Rear panel Spring loaded safety valve Cooler Type plate Wastewater connection Feed water connection Device foot Emergency door opening (behind clo- sure plug) Connection for power cable with locking clip...

  • Page 13: Symbols On The Device

    4 Description of the device Feed water hose Plug for feed water container Suction filter Outlet hose Wastewater container incl. screw cap Tray lifter Tool for emergency manual door open- Symbols on the device Type plate Manufacturer of the product Date of manufacture of the product Label as medical device Article number of the product...
  • Page 14 4 Description of the device Working overpressure in sterilization chamber Operating temperature in sterilization chamber Electrical connection of the product: Alternating current (AC) Warning symbols The marked area becomes hot during operation. Contact with it during or shortly after operation can pose the danger of burns.

  • Page 15: Touch Display

    4 Description of the device Touch display The user interface consists of a colour 4.3-inch touch display. USB connections for data export (e.g. log output) and data import (e.g. software update) are located on the rear of the device. The representation in the areas is dynamic and changes depending on the status of the device. Header area Main area State LED...
  • Page 16 4 Description of the device Button Name Description DEVICE STATUS Open device data (e.g. serial number, real-time conductivity meter) WARNING Warning message present Maximise warning view MALFUNCTION Malfunction message present Maximise malfunction message view Symbol Description User role administrator User role service technician User role practice employee Computer connected MELAtrace connected...

  • Page 17: Led Display And Acoustic Signals

    4 Description of the device Main area In the main area, the device is controlled via buttons for program selection and for activating/deactivating functions. The program status is displayed while a program is running. Messages and/or user instructions are displayed depending on the status of the device. Button Name Description...

  • Page 18: Installation Requirements

    5 Installation requirements 5 Installation requirements Installation location WARNING Failure to comply with the setup conditions can result in injuries and/or damage to the device. The device is not suitable for operation in explosive atmospheres. The device is intended for use outside the patient treatment area. The device should be located a minimum of 1.5 m radius away from the treatment area.

  • Page 19: Space Requirements

    5 Installation requirements Space requirements Dimensions SteriHero Speed+ Width 30 cm Height 30 cm Depth, total 59 cm Clearance between the device feet 25 cm Clearance from rear device foot up to the rear panel 18.5 cm Min. clearance to the side 5 cm Min. clearance to the side of the door hinge 10 cm Min.

  • Page 20: Mains Connection

    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. When performing a device software update, use only the update data authorised by MELAG for the corresponding device type.

  • Page 21: Operating The Device With Memory Media

    Perform regular data backup. Restrict access to the device and systems with access authorisation to the necessary circle of persons. Only use MELAG USB flash drives. Operating the device in the local network (LAN) Comply with the following for safe handling: To avoid security vulnerabilities, do not connect the device to a public network (e.g.

  • Page 22: Network Bandwidth / Quality Of Service (Qos)

    5 Installation requirements 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...

  • Page 23: Setup And Installation

    Removing from the packaging MELAG recommends wearing protective gloves when removing the device from the packaging: Carefully open the transport packaging from above. Remove the device from the transport packaging.

  • Page 24: Connecting The Mains Cable

    Comply with the following for safe handling: Only the power cable included in the scope of delivery may be connected to the device. The power cable may only be replaced by an original spare part from MELAG. Comply with all legal requirements and locally-specified connection conditions.

  • Page 25: Aligning The Device

    6 Setup and installation Plug the power plug of the device into the power socket of the practice. Aligning the device For fault-free operation, tilt the device slightly (2°) backwards so that the residual water/condensate can drain out of the sterilization chamber.

  • Page 26: Switching On The Device

    6 Setup and installation Switching on the device The following must be fulfilled or present: ü The device is connected to the power supply. ü The feed water container is connected and filled with fresh feed water of appropriate quality. ü...

  • Page 27: Opening The Door

    6 Setup and installation Opening the door After switching on the device The following must be fulfilled or present: ü The device is switched on and booted up. ü An audible click is heard. Pull the door handle carefully and not forcibly. PLEASE NOTE: The door is to be left open only whilst loading and unloading the device.

  • Page 28: Checking The Software Version

    The declaration of conformity of the Medical Device Regulation are included in the manufacturer's inspection report. Record of installation and setup The record of installation is to be completed and a copy sent to MELAG as proof of the correct setup, installation and initial commissioning. This is a constituent part of any guarantee claim.

  • Page 29: Important Information For Routine Operation

    EN 867-5 is possible. The number of   the available test systems means that MELAG is not able to provide technical support when using a different system. PLEASE NOTE Document the results of the tests.
  • Page 30 7 Important information for routine operation Empty the wastewater container immediately after filling or changing the feed water to prevent it from overflowing. PLEASE NOTE: When the screw cap of the wastewater container is screwed on or off, the outlet hose remains on the screw cap. The hose does not need to be held in place as it can be swivelled in the plug connection.

  • Page 31: Sterilization

    Use only those care agents suitable for steam sterilization. Consult the manufacturer of the care agents. Do not use any water repellent agents or oils impermeable to steam. MELAG recommends the use of MELAG Care Oil Spray. When using ultrasound devices, care equipment for handpieces and washer-disinfectors, comply with the manufacturer’s reprocessing instructions.

  • Page 32: Loading The Steam Sterilizer

    Loading the steam sterilizer Effective sterilization and good drying is only possible if the steam sterilizer has been loaded correctly. Ensure the following during loading: Always use trays from MELAG for sterilization of the load, see Components, accessories and spare parts [} Page 83].

  • Page 33: Mixed Loads

    Instruments Textiles Max. weight per component 1 kg 0.45 kg MELAG trays, see Components, accessories and spare parts [} Page 83]. Selecting the program All sterilization programs are displayed in the Programs menu. The following tables show you which program you use for which load and which service programs are also available to you.
  • Page 34 8 Sterilization Overview of sterilization programs Program Especially suitable for Maximum load Operating Drying** quantity time* • Transmission instruments Instruments: • Products with narrow • Single wrapped 1.5 kg 9-14 min lumen • Double wrapped 1.5 kg 9-14 min Universal-B •...

  • Page 35: Starting The Program

    8 Sterilization Starting the program The following must be fulfilled or present: ü The sterile filter and the dust filter are attached to the device. ü The load has been cleaned and disinfected, see Preparing the load [} Page 31]. ü The feed water container is filled with sufficient feed water, see Technical data [} Page 82].

  • Page 36: Program Options

    8 Sterilization Program options Before a program start, the drying time can be individually adjusted depending on the load quantity and type. This adjustment is saved for the current program run to be started, while the general drying settings are retained. For further information on setting the drying time, see Drying [} Page 64].

  • Page 37: Program In Progress

    8 Sterilization Program in progress After program start, you can follow the program run on the display. The following values are displayed during the program run: Program run display: a) Program parameter b) Program name c) Program phase d) Remaining run time (remaining program duration in minutes) e) Expected end of program Program is ended Program successful...
  • Page 38 8 Sterilization Program not successful WARNING Danger of contamination due to non-sterile load. If the safety LED (right LED) lights up red, the program was not completed successfully. The load was not sterilized. Check the display and the two LEDs at the end of each program. Read and follow the instructions on the display.

  • Page 39: Ending The Program Prematurely

    8 Sterilization Ending the program prematurely You can end the program prematurely. If you abort the program before the end of the drying phase, the load is not completely dried and should be used immediately. The following must be fulfilled or present: ü...

  • Page 40: Manual Program Abort

    8 Sterilization Manual program abort You can abort a current program in all phases. If you abort the program before the end of the sterilization phase, the load is not sterile. WARNING Danger of contamination as a result of premature program abort. Aborting a program before the drying phase begins means that the load is unsterile.

  • Page 41: Removing The Sterile Material

    8 Sterilization To confirm an unsuccessful program run, follow the instruction on the display and press the corresponding button. In the example view, the A button must be pressed to confirm! Ê If the entry is incorrect, it must be repeated. Wait for the pressure equalisation.

  • Page 42: Storing Sterile Material

    8 Sterilization Attaching the tray lifter correctly To remove the tray from the sterilization chamber, attach the tray lifter as shown. Storing sterile material The maximum storage time is dependent on the packaging and the storage conditions. Please observe the regulatory requirements for the storage period of sterile materials (in Germany e.g.

  • Page 43: Logging

    If the internal log memory is full with logs that have not been output, a corresponding message appears on the display. If this is the case, you should provide the specified output medium and output the relevant logs. If the program is continued, the oldest log is automatically overwritten. MELAG recommends immediately outputting logs automatically, see log output [} Page 57].

  • Page 44: Subsequent Log Output

    9 Logging Subsequent log output The following must be fulfilled or present: ü At least one output medium is connected and activated, see Log output [} Page 57]. In the main menu, press Logs. Select the log type to view and output single or multiple logs of a log type.

  • Page 45: Output Media

    9 Logging Follow the progress of the log output on the display. If the log output was not executed or not completed by pressing ABORT, an unsuccessful/incomplete output result is displayed. This contains the individual output result as a symbol for each output medium.

  • Page 46: Displaying Logs On The Computer

    9 Logging Displaying logs on the computer The log files are generated in HTML format and can be displayed and printed on the computer with a web browser or in MELAtrace. The program logs contain a legend entry for each line. The program logs contain graphic data and can be displayed as graphic logs in MELAtrace.

  • Page 47: Function Checks

    10 Function checks 10 Function checks Service programs Overview of service programs Program Use/function Vacuum test For measuring the leakage rate, test with a dry and cold device (without load) Vacuum test chamber: • Measurement of the leakage rate in the chamber Vacuum test cooler: •...

  • Page 48: Steam Penetration Test

    10 Function checks Wait until the vacuum test has finished. During the vacuum test, the evacuation pressure, the temperature and the expected end of the vacuum test are shown on the display. The sterilization chamber is ventilated after the end of the measuring time.
  • Page 49 10 Function checks Press START PROGRAM.

  • Page 50: Settings

    11 Settings 11 Settings Parameters such as language, date, drying etc. can be set in the submenus of the Settings menu. In the main menu, press Settings. Make settings in the corresponding submenus. Ê After saving, settings are immediately applied and the view changes from the respective submenu back to the Settings menu.

  • Page 51: General Settings

    11 Settings General settings General settings can be changed by any user. Language You can switch between the enabled languages in the Language submenu. Press Language in the Settings menu. Select the desired language using  or  Ê After a setting has been changed, the SAVE button is active. Confirm with SAVE.

  • Page 52: Time

    11 Settings Select the correct date in the calendar. Press (past) or (future) to select the month. TIP: Long press = 1-year increments Ê After a setting has been changed, the SAVE button is active. Press SAVE. Ê The view switches back to the Settings menu. Time The time of the device must be correctly set for proper batch documentation.

  • Page 53: Display

    11 Settings Press SAVE. Ê The view switches back to the Settings menu. Display Individualise the display brightness. Press Display in the Settings menu. Press Press one of the buttons to change the brightness of the display. The display brightness can be adjusted in several steps. Set the display darker Set the display brighter The colour bar below the value display gives you an impression of...

  • Page 54: Audio

    11 Settings Audio You can activate (ON) or deactivate (OFF) the signal tones in the Audio submenu. The signal tones are activated by default. Press Audio in the Settings menu. Select the desired setting by pressing OFF/ON. Ê After a setting has been changed, the SAVE button is active. Press SAVE.
  • Page 55 11 Settings Setting the activation period of energy saving mode Press Energy saving in the Settings menu. In Display/Preheater, press Press  or  to shorten or lengthen the time until energy saving mode is activated. TIP: short press = increments of 1 long press = increments of 5 Example view for the display activation period Press OK to confirm the setting.

  • Page 56: Dust Filter

    11 Settings Press in the header to open the information on energy saving. Press END ENERGY SAVING. Ê The previous view is displayed again. Dust filter You can view the status of the Dust filter counter as well as reset it in the dust filter submenu. Replace the dust filter after one year or 1000 cycles at the latest, see Maintenance intervals [} Page 71].

  • Page 57: Log Output

    11 Settings Press SAVE to accept the counter status. Ê The view switches back to the Settings menu. Log output In the Log output submenu, you can set how the log should be output by default for each output medium. Manual: The log is output subsequently from the device memory. Automatic: The log is output automatically at the end of the program.
  • Page 58 Log output on a FTP server Please use MELAG FTP Server to set up an FTP server. You can find the program in the download centre on our website at www.sterihero.com/en/service/downloadcenter. Automatic output to a FTP server is deactivated by default.
  • Page 59 11 Settings Select the desired output type by pressing  or  Ê The edited setting is displayed. Select this setting and confirm with OK. Set up the FTP server. Configure a FTP server Configure the FTP server by pressing in the bottom row. Enter the IP address and accept the changes by confirming with Ê...
  • Page 60 11 Settings After a setting has been changed, the TEST and SAVE buttons are active. Press TEST to check the connection with the FTP server settings. Confirm with OK. If the connection test fails, check your entries and test again. Press SAVE. Ê The selection has been set as default and the view changes back to the Log output submenu.
  • Page 61 11 Settings Change the output type by pressing PLEASE NOTE: Automatic output with MELAtrace is deactivated by default. Select the desired output type by pressing  or  Then confirm with OK to accept the selection. Ê The edited setting is displayed. Press SAVE.
  • Page 62 11 Settings Change the output type by pressing in the upper row. Ê The view for editing the setting opens. Select the desired output type by pressing   or  Then confirm with OK to accept the selection. Ê The edited configuration is displayed. Set up the printer, see Configuring the log printer [} Page 62].
  • Page 63 11 Settings Press SAVE. Example view of a selected configuration. Ê The selection has been set as default and the view changes back to the Log output submenu. Printer via network Press in the bottom row to configure the printer. Select Network by pressing   or ...

  • Page 64: Drying

    11 Settings Drying The program-specific drying time ensures excellent drying of the sterile material in most load configurations. If necessary, the drying time can be permanently adjusted to shorten the program run times or to achieve an extended drying time for loads that are difficult to dry. If you want to change the drying time permanently, proceed as follows: Press Drying in the Settings menu.

  • Page 65: Network

    11 Settings Network You can select an automatic configuration via DHCP or enter the required address details manually. DHCP is activated by default. Manual (static) entry Press Network in the Administration menu. Ê The current network configuration view is displayed. The entries are inserted automatically if the device is integrated in the practice network with a DHCP server.
  • Page 66 11 Settings Enter the address of the subnet mask of your network and confirm the selection with Ê The view for editing the default gateway is displayed. Enter the address of the default gateway of your network and confirm the selection with Ê...

  • Page 67: Administrative Settings

    11 Settings Administrative settings To make administrative settings, such as changes in user administration, you must log in as an administrator or service technician. Logging on user role In the main menu, press Administration. Select the desired role, e.g. Administrator. Enter the associated PIN. Ê...

  • Page 68: Admin Pin

    After logging out, the main menu is displayed in the user role “Practice employee”. Admin PIN When the device is delivered, the admin PIN is set to 1000 by default. MELAG recommends that you change the admin PIN upon commissioning.

  • Page 69: Checking The Software Version

    11 Settings Press SAVE. Ê The view switches back to the Administration menu. Checking the software version Open the status of the device with in the header of the display. Check the software version. Update the software if necessary, see Software update [} Page 69].

  • Page 70: Country Parameters

    11 Settings Country parameters You have the option of activating and deactivating special sterilization parameters for Japan and the Czech Republic/ Slovakia. The parameters are deactivated by default. The following must be fulfilled or present: ü You are logged in as an administrator or service technician, see Logging on user role [} Page 67].

  • Page 71: Maintenance

    Sterilization chamber, door seal, inner door surface, trays To maintain the value of your device and to avoid persistent contamination and deposits, MELAG recommends weekly cleaning of the surfaces. Use the Chamber Protect chamber cleaning set or, if not available, a neutral liquid cleaner or spirit.

  • Page 72: Housing Parts

    12 Maintenance The following must be fulfilled or present: ü Chamber Protect (if not available: neutral liquid cleaner or spirits) ü The door is open. ü The device has been switched off. ü The device has been completely cooled. ü Trays were removed from the sterilization chamber.

  • Page 73: Replacing The Sterile Filter

    12 Maintenance Replacing the sterile filter Comply with the following for safe handling: The following must be fulfilled or present: ü A new and dry sterile filter. Open the door. Unscrew the sterile filter (pos. a) counter-clockwise from the holding socket (pos.

  • Page 74: Replacing The Dust Filter

    At the same time, pull the hose downwards forcefully. PLEASE NOTE: MELAG recommends that the date of the last replacement be noted on the hose or on the device immediately (e.g. with a label), to ensure that the following replacement is carried out in good time.

  • Page 75: Pause Times

    13 Pause times 13 Pause times Frequency of sterilization Pause times between individual programs are not necessary. After the expiration or manual termination of drying and removal of the sterile material, you can immediately re-load the device and start a program.  ...

  • Page 76: Transport

    13 Pause times Transport Symbols on the packaging Indicates the temperature limits to which the device can be safely exposed. Denotes a device that may break or be damaged if handled carelessly. Indicates a device that must be protected against moisture. Indicates the upper limit of humidity to which the device can be safely exposed.

  • Page 77: Malfunctions

    Troubleshooting online All messages with current descriptions can be found in the Troubleshooting portal on the MELAG website (https://www.melag.com/en/service/troubleshooting). Displaying and reading messages If there are several messages, the number is shown in the corresponding button in the header.

  • Page 78: Malfunction Logs

    Should you be unable to find the relevant event, or your efforts do not redress the problem, you can contact your nearest stockist or authorised MELAG customer service provider. Have the following information ready: • The serial number of your device (see type plate or device status info) •...
  • Page 79 14 Malfunctions Event Possible cause What you can do 32025 There is not enough feed water in the feed water Please check whether there is enough feed water in container and/or the suction filter is not resting on the feed water container. If necessary, top up the 32060 the bottom of the container.
  • Page 80 14 Malfunctions Event Possible cause What you can do 36560 a) The network cable has been pulled out or is dam- a) Please check whether the network cable is cor- aged. rectly connected or damaged. b) The network cable is not compatible. b) Please check whether a 1:1 network cable is connected.

  • Page 81: Manual Door Emergency-Opening

    14 Malfunctions Manual door emergency-opening CAUTION Danger of scalding from hot steam. On opening the door, steam and hot water can escape from the sterilization chamber. e.g. if it is necessary to open the door immediately after the end of a program. This could result in scalding. Should steam be issued from the rear of the device after its deactivation, wait until the procedure has finished.

  • Page 82: Technical Data

    15 Technical data 15 Technical data Device type SteriHero Speed+ Device dimensions (H x W x D) 30 x 30 x 59 cm Empty weight 27.5 kg Operating weight 28 kg Sterilization chamber Dimensions (H x W x D) 8 x 20.3 x 31 cm Volume Electrical connection Power supply...

  • Page 83: Components, Accessories And Spare Parts

    7.5 cm x 25 cm) Test body systems MELAcontrol Helix ME01080 Other equipment Category Article Art. no. For the documentation MELAG USB flash drive ME19901 MELAprint 80 universal printer ME01108 Network cable, 2.5 m ME15817 Network cable, 5 m ME15814 Network cable, 10 m...

  • Page 84: Technical Tables

    17 Technical tables 17 Technical tables Feed water quality Minimum requirements to the feed water following 13060, Appendix C     Substance/property Feed water Evaporation residue ≤ 10 mg/l Silicon oxide, SiO ≤ 1 mg/l Iron ≤ 0.2 mg/l Cadmium ≤ 0.005 mg/l Lead ≤ 0.05 mg/l Traces of heavy metal apart from iron, cadmium, lead ≤ 0.1 mg/l Chloride ≤ 2 mg/l...

  • Page 85: Empty Chamber Test

    17 Technical tables Step Universal B Prion B Gentle B Quick-S Program phase P [mbar Tolerance P [mbar SS11 3030 60/-60 ◄ 2062 ◄ Preparation Sterilization SS12 3140 60/-60 ◄ 2140 ◄ Sterilization SA12 1055 60/-60 ◄ ◄ ◄ Pressure release SA13 1000 60/-60...

  • Page 86: Glossary

    MELAG who has sufficient specific health-care branch” device and technical knowledge. to perform maintenance and installation work on MELAG devices. Only they may DIN 58953 carry out this work. Standard for “Sterilization – Sterile supply”...
  • Page 87 Glossary placed on materials, sterile barrier systems, and packaging RKI is the abbreviation for “Robert Koch-Institut” [Robert systems” Koch Institute]. The Robert Koch Institute is the central institution for the detection, prevention, and control of Feed water diseases, especially infectious diseases. Feed water is required to generate the water vapour for sterilization;...
  • Page 88 Certificate of Suitability Manufacturer: MELAG Medizintechnik GmbH & Co. KG Address: Geneststraße 6-10 10829 Berlin Country: Germany Product: SteriHero ® Speed+ Type of device: Steam sterilizer Classification: Class IIa Device type acc. to EN 13060: Type B We declare that the product specified above is suitable for the steam sterilization of Solid instruments (wrapped and unwrapped) ▪...
  • Page 90 MELAG Medizintechnik GmbH & Co. KG Geneststraße 6-10 10829 Berlin Germany Email: info@sterihero.com Web: www.sterihero.com Original instructions Responsible for content: MELAG Medizintechnik GmbH & Co. KG We reserve the right to technical alterations Your stockist...

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