OncoTherm EHY-2000plus User Manual
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OncoTherm EHY-2000plus User Manual

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USER'S MANUAL
EHY-2000plus
OncoTherm Kft.
Both the hardware and software are
specially developed for the OncoTherm
systems.
Copyrights belong to OncoTherm Kft.
All rights reserved.
This book is sold subject to the condition that it
shall not by any way of trade or otherwise, be
lent, re-sold, hired out or otherwise circulated
without the OncoTherm prior consent in any
form of binding or cover other than that in
which it is purchased and without a similar
condition including this condition being
imposed on the subsequent purchase.

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Summary of Contents for OncoTherm EHY-2000plus

  • Page 1 OncoTherm prior consent in any form of binding or cover other than that in which it is purchased and without a similar condition including this condition being imposed on the subsequent purchase.
  • Page 2 User’s Manual EHY-2000plus Oncotherm Kft. Date: 2018.07.27. Version: 24 UM - EHY2000plus-R24...

  • Page 3: Table Of Contents

    ............................14 ONTRA INDICATION ..............................15 IMPORTANT MEDICAL NOTICES ..........................16 DEVICE CONTROL ..............................21 Display-EHY-2000plus ............................21 Control panel of waterbed .......................... 27 Tuning ................................. 28 Starting the device ............................30 Doing a treatment ............................32 Switch off the device ............................. 34 Time-meters ...............................
  • Page 4 plus Alternative configuration ..........................53 TECHNICAL DESCRIPTION ............................54 HE MAIN UNIT ............................... 54 ECHNICAL DATA ............................... 54 ECHNICAL DATA OF THE WATERBED ........................... 55 LEANING ................................. 56 ERVICING AINTENANCE ............................57 ISPOSAL ................................... 57 CCESSORIES ................................58 APPENDIX 1 – GUARANTEE ............................60 APPENDIX 2 –...

  • Page 5: Introduction

    The design and production of EHY-2000plus is controlled by the rigorous EU standards, certified for ISO 13485 certified also by the German TÜV SÜD Product Service GmbH (Munich). The product is completely manufactured in the European Union.

  • Page 6: Contacts

    Contacts Please do not hesitate to contact us if you have any questions: Questions in connection with production and management: Oncotherm Group Dr. Olivér Szász CEO Hungary/Germany Belgische Allee 9, D-53842 Troisdorf, Germany Phone: +49-2241-319-920 Fax: +49-2241-319-9211 Email: info@oncotherm.de Gyár utca 2., H-2040 Budaörs, Hungary...

  • Page 7: Safety Warning

    To reduce the risk of fire or electric shock, do not expose this appliance to rain or moisture. Due to dangerous high voltage, do not open the cabinet. For technical support please contact the qualified personnel of Oncotherm. UM - EHY2000plus-R24...

  • Page 8: Symbols And Their Definitions

    This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste but has to be collected separately. Please contact the authorized representative of Oncotherm Group for information concerning the decommissioning of your equipment.

  • Page 9: Installation

    Installation General The device must be installed by a qualified technician/engineer on behalf of the Oncotherm Group compliance with instructions provided. manufacturer declines all responsibility for improper installation which may harm people and damage property. When the packing is removed, check that the appliance is not damaged. If you have any doubts, do not use the appliance, but call for a qualified technician.
  • Page 10 10. To move the device into another room and/or into any other place from the place where it was installed originally please ask for the assistance of the Oncotherm service. The unauthorized relocation is strictly prohibited in order to avoid the mains and grounding discrepancies and the possible electric shock.

  • Page 11: Installation Notices

    The approval must be in written form from the Oncotherm Group. The relocation and/or using mains-socket other than the originally installed, must be done only by the Oncotherm or its authorized service-representative. Only the qualified and authorised Oncotherm personnel should service the unit when it does not operate normally or shows marked change in its performance.

  • Page 12: Safety

    2. Do not use any extension- and radio-frequency-cables, only those which are provided by the authorized service and/or by the Oncotherm. 3. Before starting any cleaning work on the device it must be disconnected from the electric supply by removing the plug from the socket.

  • Page 13: Resident Risks

    16. The patient’s surface must not be damp. After cleaning the surface the user has to wait until it is dry. 17. Using EHY-2000plus without a heated waterbed may decrease the temperature of the body of the patient. In case of everyday use, keep the bed switched on permanently.

  • Page 14: General Description

    General description Intended use The EHY-2000plus device is intended for the adjuvant treatment of deep- seated primer and metastasized solid malignant tumors in combination regimen with chemotherapy and/or radiation therapy. The performance of the EHY- 2000plus device is supported with clinical evidences in the following indications: ▪...

  • Page 15: Side Effects

    Side effects Short-term and long-term unwanted side-effects may be associated with the use of the EHY-2000plus device: Short-term side-effects: Moderate pain during the procedure, Skin effects, typically the local skin hyperemia in the area of exposure, Fatigue, short-term asthenia,...

  • Page 16: Contra Indication

    plus Contra indication • Cannot be used when the patient is under deep-sedation or anesthesia (missing thermal sensitivity). Application of analgesics in the treated area is prohibited. • Cannot be used when the patient is unconscious. • Cannot be used when the patient is not able to communicate with the physician.

  • Page 17: Important Medical Notices

    plus Important medical notices Please remember: 1. The user of this device has to be a physician and/or a trained clinical staff under the physician’s control. 2. The treatment has to be permanently monitored by the staff. 3. The treatment needs extra care, when the patient has reduced thermal sensitivity on the treated area.
  • Page 18 19. Do not treat near the eyes of the patient. The direct RF-radiation can cause temporary or permanent blindness. The treatment of the head requires special training at one of the OncoTherm reference clinics. For brain treatment, please follow the protocol detailed in Appendix 8 of the User’s manual.
  • Page 19 2000plus in the vicinity of large electro-magnetic sources and/or high- power machines (power transformer, X-ray units, NMR, CT, etc. It should be noted that microwaves could influence the Oncotherm device in the treatment room and vice-versa. Make sure that these machines are well shielded.
  • Page 20 plus 27. Before the treatment any sharp objects (knives, scissors, needles, pens pencils, glasses etc.) have to be left far away from the waterbed. 28. Using waterbed mattress without checking its sufficient amount of water can be dangerous, the patient could be burnt. 29.
  • Page 21 plus Written consent for the treatment According to medical regulation in some countries, a written consent has to be signed by the patient before the start of the first treatment. This consent has to contain the following points: a. Clear capacity (or ability) to make the decision. b.

  • Page 22: Device Control

    Device control The Oncotherm EHY-2000plus is devoted to the high level requirements of modern medical practice. The equipment is isolated from the common power-network for safety purposes and supported by a specially developed software. Display-EHY-2000plus UM - EHY2000plus-R24...
  • Page 23 plus The “temperature coefficient” s equivalent with the static temperature, which does the same distortion which is the actual distortion rate in the tissue. In this meaning the temperature coefficient is the parameterization of the actual distortion rate in the tumor. UM - EHY2000plus-R24...
  • Page 24 plus UM - EHY2000plus-R24...
  • Page 25 plus The actual denotations are: German: English German English German Forwarded Manual Leistungsabgabe Manual mode Power Control Reflected Opt. Leistungsreflexion Opt. Modem Power Modem Treatment Leistungaufnahme Network Netz Power Temp. Temp. Koeffizient Amplifier Verstärker Coefficient Energy Controller Controller Energiemenge dose Time Zeit Error...
  • Page 26 plus Hungarian: English Hungarian English Hungarian Forwarded Manual Kiadott teljesítmény Kézi vezérlés Power Control Reflected Visszavert Opt. Modem Optikai Modem Power teljesítmény Treatment Kezelési Belső hálózat Network Power teljesítmény ECM hőmérséklet Erősítő Temp. Amplifier Coefficient Vezérlő Controller Energy dose Energia mennyiség Idő...
  • Page 27 plus parameters for the treatment. Pressing this button during the treatment will start the retuning algorithm, to find a new tuner position. Pressing the Start-button for a longer time changes the Modulation-mode. (If it was off, then it will turn on, and if it was on, it will turn off.) Modulation does not have any effect on temperature.

  • Page 28: Control Panel Of Waterbed

    plus Display-WEY-2000plus waterbed Cooler status display Temp fault lamp Danger! No sensor lamp Overheat lamp Temperature Water loss lamp displays temp Heating power Up/Down On/Off Cooling Cooling power temp/Sound lamp reset Control panel of waterbed “Temp. fault” lamp: 1 yellow lamp shows if the temperature is not correct. It alerts the user if the surface temperature differs with more than +/-1 ºC from the setting in stabilized state.

  • Page 29: Tuning

    Tuning The EHY-2000plus has a special radio frequency generator, which must be carefully tuned to the patient. If it is not done, the energy released from the device (in the form of radio frequency) will not heat the patient, but will be lost in the air, cables, and in the internal electronic parts.
  • Page 30 plus Preparation before treatment The treatment starts with the preparation of the patient for the actual treatment through medicine and psychological attention. After the treatment immunology support is suggested. The most optimal electrode has to be chosen for the treatment. For the suggested electrodes see Appendix 3.

  • Page 31: Starting The Device

    During the self-test procedure the emergency buzzers will give sound signals (all the three main units must give the signal) for testing purposes. If you cannot hear these testing sound signals, please report it to the OncoTherm service team. UM - EHY2000plus-R24...
  • Page 32 plus After the self-test procedure you will get the “GOOD”- message in the info window. Now the device is ready for use. (Remark: The waterbed for proper treatment must be on heated state.) UM - EHY2000plus-R24...

  • Page 33: Doing A Treatment

    plus Doing a treatment The patient lies down in the bed in a comfortable position. Note that the • patient has to keep this position during the whole treatment process, so please take care of the proper arrangement. Place the applicator on them on the area intended to be treated.
  • Page 34 plus To start the RF power output (treatment), just press the START button. • After the start the device tunes to the patient at a low power level. The tuning motor movements are indicated on the display in the Information point.

  • Page 35: Switch Off The Device

    plus If the tuning is not successful within 90 seconds, the device will indicate it with a sound signal and the “Error” LED will be blinking until the tuning is not successful. In this case the electrode should be re-positioned to reach a better electrical contact with the patient.

  • Page 36: Time-Meters

    plus Time-meters On the front of the device a counter shows the overall running time. This information is for service purposes. On the front of the device another counter shows the summarized treatment time. This is for controlling of the active time of the device. Treatment cannot be provided (device is blocked automatically) in case of any manipulation or damage of the time-meters.
  • Page 37 The error codes indicating the error exactly can be seen on the waterbed display at the “Cooler state” point. Please forward these error codes to Oncotherm to ease the maintenance of the device. UM - EHY2000plus-R24...
  • Page 38 These errors are critical and the device cannot be used in these cases. If the error remains after a restart, call the Oncotherm service and report the error code to ease the repair of the device.

  • Page 39: The Usage Of The Web-Box

    This way the physician and the hospital’s administration staff have the possibility to control, check and download information from the EHY-2000plus. System structure The installation structure of the Web-box for the EHY-2000plus can be represented as shown below: The Web-box should be placed outside of the patient environment.

  • Page 40: Usage

    Explorer icon, Mozilla Firefox, Google Chrome, …) to enter the web viewing. 2. Type in the IP address of the EHY-2000plus device (by default it is 10.0.0.235) or select the shortcut function to the device if it has already been inserted by our service technician.
  • Page 41 plus 5. By default your user name is “User” and the password is “EHY”. After logging in you will enter the “Main menu”. In the menu you can choose from the different tasks which are possible to manage or to see. This menu includes e.g. test results, treatment control, patient management and important medical notes.
  • Page 42 On the following diagram you can see the structure of the program. Start Webmap Login Oncotherm.org Select patient for Main menu Treatment Retune treatment Treatment view Set time Patient Add patient Set power management View patient log Change patient...

  • Page 43: Treatment Menu

    plus Treatment menu The main function of the Treatment menu is the control of the device. Entering the treatment menu you will get onto the „Select patient” page. Here the patient’s name can be set from the predefined list on this screen or add a new patient (this option leads you to the Patient management menu).
  • Page 44 plus You can set the parameters of the treatment: • treatment time by the „Set time” option • treatment power by the „Set power” option • turn on or off the modulation of the power by the „Modulation on/Modulation off” button (the text of the button depends on the current setting) These parameters are changeable during the treatment too.
  • Page 45 plus If the „Treatment power” is much less than the „Forwarded power” (the Reflected power is more than 25% of the „Forwarded power”), use the „Re- tune” button to tune the device to the patient. If the re-tuning is not successful, please pause the treatment by the „Pause”...
  • Page 46 plus treatment power” page you should type the requested power value into the edit box and confirm the change by clicking on the “Set power” button. If you do not type in a new value, after 30 seconds the software will step back automatically to the “Treatment management view”...

  • Page 47: Treatment View

    plus Treatment view The second option, which you can choose in the main menu, is the treatment view. The „Treatment view” screen is very similar to the „Treatment management view”, because you can monitor the same parameters, but the difference is that you cannot modify the treatment parameters. This function is useful if there is a central station –...
  • Page 48 plus The first option in the menu is “Add patient”. On this page you can add new patients to the patient list by typing in the patient’s name and their date of birth. The next option in the “Patient management” menu is the “View patient log” page.
  • Page 49 plus The table shows the major parameters of one treatment of the patient chosen on the previous page. The major parameters are: • Patient’s name • Treatment date • Used energy • Power graph • Temperature graph • Event list You can check the patient’s next, previous, first or last treatment by clicking on the appropriate link.
  • Page 50 plus Here you can inactivate the not treated patients (like on the page mentioned before). You can reactivate the hidden patients as well. Administration menu In the “Administration” menu you can find various support functions like treatment log saving and recovering, user list editing and time and date setting.
  • Page 51 plus The first option in the menu is the “Edit user list” option. The new and old users can be managed. This is required for logging in into the system. In case you edit your own login name and password, note that you can still log out.
  • Page 52 plus To recover the patient logs from the saved data, please copy the saved coded text into the dialog box and then press the “Show” button. By choosing the “Report options” link in the “Administration” menu you can select what kind of data will be printed in the Patient report. The first column shows the options, the second: if it is on/off, the third one: checkout box.

  • Page 53: Important Notices

    • The patient should be monitored continuously not only through the web server but in the room as well. • All warnings mentioned in the EHY-2000plus user’s manual have to be considered • The logged computers must be certified and linked on to the web server by a service technician.

  • Page 54: Requested Technical Background

    plus Requested technical background Client browser Any kind of computer and browser are suitable and support the HTTP protocol. Our web box does not require any java or flash support but it requires a cookie support. Your computer also has to be identified by the web server to have a connection allowance with the critical sites.

  • Page 55: Technical Description

    plus Technical description The main RF-unit The unit's output power is stable, highly precise and well integrated, containing the following parameters: The equipment is a high-tech, high-quality unit, having the latest available techniques inside. The device is shown in the figure. Technical data Line voltage: AC 230/110 V 50-60Hz...

  • Page 56: Technical Data Of The Waterbed

    plus Technical data of the waterbed (WEY: 6DDFFEE) Line voltage goes through the high frequency control unit Surface temperature: 25 … 38ºC, adjustable (step 0.1ºC) Display: Surface temperature, res. 0.1ºC Set temperature, res. 0.1ºC 4 lamps and 2 buzzers for errors Warming-up time (24 >...

  • Page 57: Cleaning

    Transportation and storage: The Oncotherm service is responsible for transportation and storage. The following storage conditions are valid for transportation- and storage time for 15 weeks: Temperature: +5°C……+55°C filled with water -5°C……+55°C without water!!! Relative humidity: 10%………75% Air pressure: 500hPa…..1060hPa...

  • Page 58: Servicing/Maintenance

    Servicing/Maintenance The user is required to have the unit serviced once every half year under normal operating conditions. Only authorized Oncotherm service technicians can do this work. The user must obtain certification concerning to the nature and extent of the work with information on any alteration made to the nominal data or operating range.

  • Page 59: Accessories

    plus Accessories Order Photo Accessories number 1. User’s manual 2. Water-cooled bolus asymmetric electrode standard (20 cm) / 1028 6/01/200CO/DD-EE Water-cooled bolus asymmetric electrode large (30 cm) (option) / 6/01/300CO/DD-EE 1026 Water-cooled bolus asymmetric electrode small (10 cm) (option)/ 6/01/AABH/DD-EE 1027 3.
  • Page 60 Memory foam pillow with metal coated material and 11563 cover (optional) WARNING! To use any accessory ACCESSORIES other than those specified, may result in increased EMISSION or decreased IMMUNITY of the EHY-2000plus device, therefore it is strictly forbidden. UM - EHY2000plus-R24...

  • Page 61: Appendix 1 - Guarantee

    Any suggestions and/or requests for further development of the system are highly appreciated and very welcomed. Quality references: EHY-2000plus are marked, TÜV Product Service (Munich) has given the EC Certificate. The device is constructed and produced to satisfy the IEC 60601-1 standard and the 93/42/EEC MDD (Medical Device Directive).

  • Page 62: Appendix 2 - Declaration Of Conformity Sample

    plus Appendix 2 – Declaration of Conformity sample UM - EHY2000plus-R24...

  • Page 63: Appendix 3 - Table Of Proposed Electrodes

    plus Appendix 3 – Table of proposed electrodes Operator’s table: Electrode-skin Treated part of the Proposed Treatment Proposed distance body electrode**** time [min] power* [W] [cm] Lungs large 140-150 Kidney standard 100-120 Liver large 120-140 Stomach standard Pancreas large 100-120 Lymphatic nodes standard 80-100...

  • Page 64: Appendix 4 - Refilling Of The Bolus Electrode

    plus Appendix 4 – Refilling of the bolus electrode 1. Please, unplug the cooling water quick connectors and the electric cable connector. The fixing safety button of the power plug has to be pressed down before pulling it out and be kept pressed throughout the procedure. Loosen the electrode fixing bolt, screw and pull it out of the electrode- holder arm.
  • Page 65 3. Lift up the electrode to such a height that the bolus does not touch the mounting surface. First of all, fill up the electrode with a special liquid provided by Oncotherm to avoid algae formation. Use the small bottle with the label: “Algae control” After this you can fill up the electrode with distilled water in this position.
  • Page 66 plus 5. Tilt the electrode in a small angle so that the open filling up hole must be higher than the closed one. Please press the bolus up until water appears on the open filling up hole. With this process you de-aerated the bolus. 6.
  • Page 67 plus Take care that during this process, air must not get into the bolus. Take care that you can continuously see the water in the filling hole. Now, in this position screw in the packing nut. 7. Turn up the electrode and check the appropriate volume of the water in the bolus and that it is de-aerated once more.
  • Page 68 plus Attention! In the next pictures we are showing some examples of non-proper filling up of the electrodes and we are also showing how to avoid the mistakes. Air must not remain in the electrode because this blocks or misleads the tuning and the auto matching procedure and so suppresses the efficacy of the treatment.
  • Page 69 plus By pushing the bolus with the entire palm you can reach the metallic electrode plate: not enough water in the electrode. In this case, during the treatment the RF radiator electrode will be too close to the patient and could cause burn. Please fill more water into the electrode. To correct this mistake, go back to point 3.

  • Page 70: Appendix 5 - Electromagnetic Compatibility Information

    EQUIPMENT and SYSTEMS (see 6.8.3.201 a) 3)) Guidance and manufacturer’s declaration-electromagnetic emissions (T.201) The EHY-2000plus device is intended for use in the electromagnetic environment specified below. The customer or the user of the EHY-2000plus should assure that it is used in such environment. Emission test Compliance...
  • Page 71 Guidance and manufacturer’s declaration-electromagnetic immunity (T.202) The EHY-2000plus is intended for use in the electromagnetic environment specified below. The customer or the user of the EHY-2000plus should assure that it is used in such environment. Immunity test IEC 60601 test...
  • Page 72 6.8.3.201 b)) Guidance and manufacturer’s declaration-electromagnetic immunity (T.204) The EHY-2000plus device is intended for use in the electromagnetic environment specified below. The customer or the user of the EHY-2000plus should assure that it is used in such environment. Immunity Compliance...
  • Page 73 The EHY-2000plus device is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the EHY-2000plus can help to prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the EHY-2000plus device as recommended below, according to the maximum output power of the communications equipment.
  • Page 74 plus WEY-2000plus Table 201 – Guidance and manufacturer´s declaration – electromagnetic emission– for all EQUIPMENT AND SYSTEMS (see 6.8.3.201 a) 3)) Guidance and manufacturer’s declaration-electromagnetic emissions (T.201) The WEY-2000plus device is intended for use in the electromagnetic environment specified below. The customer or the user of the WEY-2000plus should assure that it is used in such environment.
  • Page 75 plus Table 202- Guidance and manufacturer’s declaration-electromagnetic immunity-for all EQUIPMENT and SYSTEMS (see 6.8.3.201 a) 6)) Guidance and manufacturer’s declaration-electromagnetic immunity (T.202) The WEY-2000plus device is intended for use in the electromagnetic environment specified below. The customer or the user of the WEY-2000plus should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level...
  • Page 76 plus Table 204 – Guidance and manufacturer´s declaration – electromagnetic immunity– for EQUIPMENT and SYSTEM that are not LIFE-SUPPORTING(see 6.8.3.201 Guidance and manufacturer’s declaration-electromagnetic immunity (T.204) The WEY-2000plus device is intended for use in the electromagnetic environment specified below. The customer or the user of the WEY-2000plus should assure that it is used in such environment. IEC 60601 test Compliance Immunity test...
  • Page 77 EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING (see 6.8.3.201 b)) Recommended separation distances between portable and mobile RF communications equipment and the EHY-2000plus (T.206) The WEY-2000plus device is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the WEY-2000plus can help to prevent...

  • Page 78: Appendix 6 - Treatment In 9 Steps

    plus Appendix 6 - Treatment in 9 steps The following points contain the steps of a typical treatment. It is suggested to keep a copy of this page near the device. 1. Choose the proper electrode and disinfect it. 2. Fix the electrode on the holding arm and connect the water tubes. 3.

  • Page 79: Appendix 7 - Patient Consent

    SUPPLY OF PATIENT CONSENT FORMS: A supply of "Patient's Consent" forms as printed above, is available, free of charge from Oncotherm GmbH, Belgische Allee 9, D-53842, Troisdorf , Germany (info@oncotherm.de) Phone: +49-2241-319-920 UM - EHY2000plus-R24...

  • Page 80: Appendix 8 - Brain Treatment

    Appendix 8 - Brain Treatment The brain treatment needs extra care (at least half year experience of use and a special training at Oncotherm training clinics are also required). The main points are: 1. Please use the small or the medium size electrode. At the beginning (if you have enough place to position it) please use the medium size, because its energy density is smaller.
  • Page 81 plus to be sure where the RF- current flows. 9. The patient must be in a relaxed position. Please fix their position with pillows or blankets at the waist or chest, and somehow fix the body so that the patient does not have to keep their body by force. 10.

  • Page 82: Appendix 9 - Rollicel Datasheet

    plus Appendix 9 - ROLLICEL datasheet UM - EHY2000plus-R24...

  • Page 83: Appendix 10 - Memory Foam Pillow

    This accessory to treat the head with way the treated area (the patient’s the EHY-2000, the EHY-2000plus, the head) will be exactly between the EHY-2010 EHY-3010ML two electrodes and it increases the devices. This instruction is only valid efficacy of the treatment.
  • Page 84 plus 2. Place the outlet of the memory pillow right on the heating panel. Fold back waterbed mattress and the cover, and in the meantime place the pillow right position. 4. Lay the patient in the desired position. Place the electrode on the treated area.
  • Page 85 plus Cleaning of the memory foam pillow cover The cover of the pillow can be cleaned. However, when it is removed, or pulled up again, use gloves because of the special metal fabric of the pillow. The metal fabric cannot be washed. UM - EHY2000plus-R24...
  • Page 86 Oncotherm Group OncoTherm GmbH OncoTherm Kft. Gyár u. 2 Belgische Allee 9 HU-2040 Budaörs D-53842 Troisdorf Tel.: 0049 2241 31992 0 Tel.: 0036 23 5555 10 www.oncotherm.com UM-EHY-2000plus-R23 UM-EHY-2000plus-E-R24...

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