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novocure OPTUNE NovoTTF 200A User Manual

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Summary of Contents for novocure OPTUNE NovoTTF 200A

  • Page 1 USER MANUAL...
  • Page 2 Document number QSD-EUUM-002-EN Version 02...

  • Page 3: Table Of Contents

    TABLE OF CONTENTS ® About Optune Treatment Kit............. 5 Indications for Use ................6 Contraindications, Warnings & Precautions ........... 7 What are the Risks of Treatment with Optune Treatment Kit? ....11 What are the Benefits of Treatment with Optune Treatment Kit? .... 11 Overview of Optune Treatment Kit ............
  • Page 4 ® This manual is intended for patients receiving TTFields treatment using the Optune Treatment Kit and INE Transducer arrays (Sterile).

  • Page 5: About Optune ® Treatment Kit

    ® About Optune Treatment Kit Optune Treatment Kit a portable medical device. It delivers electric fields called “TTFields” to the tumor in the brain using INE Transducer arrays. TTFields are intended to kill cancer cells. The TTFields are transmitted at a frequency of 200 KHz and up to 707mA RMS output current.

  • Page 6: Indications For Use

    Indications for Use Optune Treatment Kit is intended for the treatment of patients with newly diagnosed GBM and for the treatment of patients with recurrent GBM. Newly diagnosed GBM NovoTTF-200A (Optune ) Treatment Kit is intended for the treatment of patients with newly diagnosed GBM, after surgery and radiotherapy with adjuvant Temozolomide, concomitant to maintenance Temozolomide.

  • Page 7: Contraindications, Warnings & Precautions

    Contraindications, Warnings & Precautions CONTRAINDICATIONS Do not use Optune Treatment Kit if you are pregnant, think you might be pregnant, or are trying to get pregnant. If you are a woman who is able to get pregnant, you must use birth control when using the device. Optune Treatment Kit was not tested in pregnant women.
  • Page 8 WARNINGS Warning - Use Optune Treatment Kit only after receiving training from qualified personnel, such as your doctor, a nurse, other medical personnel, or Novocure Device Support Specialist who have completed a training course given by the device manufacturer (Novocure). Your training will include a detailed review of this manual and practice in the use of the system.
  • Page 9 PRECAUTIONS Caution - Keep the Optune Treatment Kit out of the reach of children and pets. Caution - Do not use any parts that do not come with the Optune Treatment Kit or that were not sent to you by the device manufacturer or given to you by your doctor. Caution - Do not use the Optune Treatment Kit if any parts look damaged (torn wires, loose connectors, loose sockets, cracks or breaks in the plastic case).
  • Page 10 NOTICES Notice! Optune Treatment Kit is to be used with INE transducer arrays only. Notice! Optune Treatment Kit and INE Transducer arrays will activate metal detectors. Notice! You should use the Optune Treatment Kit for at least 18 hours a day to get the best response to treatment.

  • Page 11: What Are The Risks Of Treatment With Optune Treatment Kit

    What are the Risks of Treatment with Optune Treatment Kit? Skin irritation is often seen under the INE Transducer arrays when using the Optune Treatment Kit. This will look like a red rash, small sores or blisters on your scalp. In general, Optune will not cause skin damage that cannot be fixed.
  • Page 12 In the clinical study using Optune with temozolomide before patients’ tumors reappeared, the time from the start of treatment to death was measured when half of the patients had joined the study as well as at the time when all of the total 700 patients had joined the study.

  • Page 13: Overview Of Optune Treatment Kit

    Overview of Optune Treatment Kit Plug in power supply (Model SPS9100) Charger for batteries (Model ICH9100) Insulated Transducer array (INE) – (Model INE9020 and INE9020W) Device & battery carrying bag (Model BAG9100) Optune electric field generator (the Device) (Model TFH9100) Battery (Model IBH9100) Connection cable &...

  • Page 14: The Device

    The Device The Optune Treatment Kit treatment parameters are preset and cannot be changed by the patient. TTField treatment should be kept on as continuously as possible (24 hours a day, 7 days a week). Although 100% treatment time is impossible, breaks from treatment should be kept as short as possible.

  • Page 15: Before You Begin

    Before You Begin You will need to use four (4) INE Transducer arrays at one time. Change these 4 INE Transducer arrays twice a week to continue treatment with Optune® Treatment Kit. You may change the INE Transducer arrays with the help of a doctor, a nurse or caregiver if needed.

  • Page 16: Removing The Ine Transducer Array From Its Package

    Removing the INE Transducer Array from Its Package Wash your hands before opening the envelope with the INE Transducer Arrays. Open the see through envelope of four (4) INE Transducer arrays by gently pulling apart the opposing edges of the envelope as shown in the illustration.

  • Page 17: Preparing Your Head For Ine Transducer Array Placement

    Preparing Your Head for INE Transducer Array Placement Wash your head with a gentle shampoo. If this is the first time you have used the INE Transducer arrays, ignore this step and skip ahead to the next step (shaving). If you are replacing INE Transducer arrays, you, or your doctor or caregiver if needed, should wipe the skin with baby oil to remove any remaining adhesive from previous INE Transducer arrays.

  • Page 18: Placing The Ine Transducer Arrays On Your Head

    Placing The INE Transducer Arrays On Your Head After you prepare your scalp (Section 9), put the INE Transducer arrays on your head with the help of a doctor or caregiver if needed. Twice a week, remove the INE Transducer arrays, prepare the scalp (as outlined in Section 13) and put on a new set of INE Transducer arrays.

  • Page 20: Connecting The Ine Transducer Arrays To The Device

    Connecting the INE Transducer Arrays to the Device Connect each of the four INE Transducer array connectors with the black or white connector to the matching color socket on the connection cable. For example, plug the INE Transducer array with the black connector into the black socket (labeled “N1”; see diagram).

  • Page 21: Starting & Stopping The Device

    Starting & Stopping the Device To start treatment, connect a power source - either a charged battery or a power supply (see Section 8 or 10) to the device. 1. Turn the power button on the bottom of the device to the on position 2.
  • Page 22 Note: The green, blue and yellow indicators will dim in a dark room and will brighten in a light environment. The red error indicator light will not be dimmed in any case. If the therapy button is not pressed within several minutes after the device is turned ON, a notification signal will sound, indicating that the device is ON but the therapy is OFF.
  • Page 23 Then, turn off the device by turning the power button on the bottom of the device to the off position. If an Error Occurs: If an error occurs, the device will turn off the TTFields and make a loud beeping noise.
  • Page 24 To turn off the device: 1. Press the TTFields button on the front of the device to stop the notification signal. The red Error and the yellow Battery lights will turn off. 2. Turn off the device using the on/off switch. 3.

  • Page 26: Connecting & Disconnecting The Battery

    Connecting & Disconnecting the Battery The Optune Treatment Kit comes with 4 rechargeable batteries. Batteries slide into the device, while the blue buttons on both sides of the battery are being held. The battery should be inserted until there is a “click”, indicating the battery is in place. Take care not to drop the battery in place or to force it into the battery slot.
  • Page 27 Recharge the batteries in the charger (see Section 9) for four to five hours. The batteries will stay charged if they are off the charger for a short time (hours, but not days). For this reason, keep the extra batteries in the charger at all times, if possible. You can charge and use the batteries many times.
  • Page 28 Turn off the notification signal by pressing the TTFields button once. Turn off the device using the power button (on the bottom of the device). Remove the battery from the battery slot by pressing on the blue buttons on the side of the battery.
  • Page 29 Full Charge 75%Charge 50%Charge 25%Charge Empty...

  • Page 30: Charging The Battery

    Charging the Battery The battery charger recharges used batteries. The battery charger uses power from a standard wall outlet. Before charging the batteries, plug the charger power cord into a standard wall outlet and turn on the power button at the back of the charger. The small light in the center of the front panel will light up green indicating power is applied.
  • Page 31 Battery Charger opening Charger Indicator Charger Front view of the battery charger showing how the batteries are installed in the charger Notice: The charger is considered to be disconnected from the mains only when the power cable is physically disconnected either from the mains or from the charger itself. Notice: The charger is considered class II equipment, without signal input/ output and applied part (part which come into physical contact with the patient).

  • Page 32: Using The Power Supply

    Using the Power Supply When you plan to stay in one place for a while, like when you are sleeping, you may use the plug-in power supply instead of the batteries. Unlike the batteries, there is no limit to how long the device can work when you use the plug-in power supply. The plug-in power supply will work with either U.S.
  • Page 33 To Disconnect the Plug-In Power Supply and Go Back to Battery Power 1. Ensure that a charged battery is properly installed in the device before removing the power supply. If the TTFields are running, you do not need to turn them off before removing the plug-in power supply.

  • Page 34: The Connection Cable & Box

    The Connection Cable & Box The connection cable is the coiled, stretchy cord that runs from the device to the connection box. The four transducer array connectors (2 black and 2 white) plug into the connection box. The black and white coding matches with the transducer array position on the head, Black to the back and front, white to the either side.
  • Page 35 There are two ways to unplug from the device to take a break from treatment (after turning off the device): 1. Unplug the connection cable from the device. 2. Unplug the transducer arrays from the connection cable. To unplug the connection cable from the device: Stop treatment by pressing the TTFields button.
  • Page 36 To unplug the transducer arrays from the connection cable: To take a break from treatment and completely disconnect from the device but leave the transducer arrays on your head, unplug the transducer array cables from the connection cable box. The four transducer arrays are plugged into the connection cable box as described in Section 11.

  • Page 37: Carrying The Device

    Carrying the Device The electric field generator with the installed battery will fit in a carrying bag. The bag can be carried in a two ways: by the handle on top or over the shoulder or cross-body with a carrying strap attached. Note: Do not place the device in a different bag.

  • Page 38: Glossary Of Graphic Symbols

    Glossary of Graphic Symbols For INE transducer Arrays The INE Transducer arrays are sterilized by Gamma irradiation Do not resterilize Do not use the INE Transducer arrays if their packaging is breached The INE Transducer arrays are for single use and should not be re-used Protect from heat and radioactive sources Do not expose the INE Transducer arrays to water...
  • Page 39 INE9020/INE9020W Catalogue number Expiration Date YYYY-MM Date of Manufacturing Manufacturer information Contact technical support to arrange for proper disposal of arrays that are used up or no longer in use. For Device Caution - Consult the instructions for use for important cautionary information such as warnings and precautions Date of Manufacturing Fragile –...
  • Page 40 Do not enter rooms with high humidity or danger of direct exposure to water while wearing the device. Do not use the device if not within its carrying bag. For indoor use only Batteries are Lithium Ion. Contact technical support to arrange for proper disposal of batteries that are used up or no longer in use.
  • Page 41 Serial Number Class II equipment per IEC 60601-1 Medical device...

  • Page 42: Disposal

    Disposal Please contact Novocure to arrange for proper disposal of used INE Transducer arrays. Do not throw them in the trash. Novocure contacts local authorities for determination of proper disposal method for potentially biohazardous parts. Environmental Conditions Normal Operation, Storage and Transportation...
  • Page 43 Note: The batteries contain lithium ion material and are restricted from being checked as luggage for passenger aircraft travel. They can be carried in the passenger cabin. Please check with Novocure if you have any questions related to travel restrictions.

  • Page 44: Troubleshooting

    Troubleshooting Note, when calling your device support specialist or the Technical Support line, please have the serial number of the equipment accessible. INE Arrays Troubleshooting: Problem Possible Causes Actions to be Taken Redness of Common side effect Use hydrocortisone cream prescribed by the skin your doctor when replacing INE Transducer beneath the...
  • Page 45 Problem Possible Causes Actions to be Taken Any cable Excess physical Press TTFields button to stop therapy. detached force to cables Turn OFF power switch from INE Device Call your Device Support Specialist Transducer malfunction array/ connection cable/device Device Incorrect use Press TTFields button to stop therapy.
  • Page 46 Device Troubleshooting Problem Possible Causes Actions to be Taken When powering the 1. Device not connected to 1. If on battery – check battery Power source fuel gauge to verify it is not device on none of the depleted. If it is – replace with a lights come on 2.
  • Page 47 Any cable detached 1. Too much physical force to 1. Silence the notification signal cables by pressing the TTFields button. from transducer 2. Damaged Connector 2. Evaluate the connectors, if array/ connection intact – reconnect and re-start cable/device therapy. If anything appears damaged or cannot be properly connected do not try to use the device.
  • Page 48 Error indicator is on 1. Low battery If the Battery indicator is yellow: and there is an 2. A connection is loose or 1. Silence the notification signal notification signal disconnected by pressing the TTFields button – Power the device down after treatment was 3.
  • Page 49 Battery indicator is 1. Battery malfunction 1. Replace battery with an additional charged battery. Yellow though the 2. Device malfunction battery gauge is 2. Connect the original battery to the charger. showing the battery is full If problem continues across multiple batteries OR if one of batteries would not charge or causes the charger LED to turn...

  • Page 50: Assistance & Information

    If you are unable to get a hold of your Device Support Specialist, you can contact the EMEA Novocure technical support at 00800-88 34 35 37 (00800-TTFields); email: SupportEMEA@novocure.com. Please state the following information when you contact:...

  • Page 51: Appendix A - Applicable Standards

    Appendix A – Applicable Standards The Optune Treatment Kit electronic components comply with the latest editions of the following standards:  EN 60601-1Medical electrical equipment - Part 1: General requirements for safety  EN 60601-1-2 Medical electrical equipment-Part 1-2: General requirements for safety-Collateral standard: Electromagnetic compatibility-Requirements and tests ...
  • Page 52  EN ISO 10993-1 - Biological evaluation of medical devices - Part 1: Evaluation and testing  EN ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in- vitro cytotoxicity  EN ISO 10993-10 - Biological evaluation of medical devices - Part 10: Tests for irritation and delayed type hypersensitivity ...
  • Page 53  BS EN 62368-1 - Audio/video, information and communication technology equipment. Safety requirements...

  • Page 54: Appendix B - Input Output Specifications

    Appendix B – Input Output Specifications The Optune Treatment Kit including the battery charger are considered class II equipment according to EN 60601-1. Mode of operation – continuous. The device is portable when battery operated and stationary equipment when connected to the power supply. The applied part is classified as BF.
  • Page 55 Appendix – Emitted Radiation & Electromagnetic Compatibility The Optune Treatment Kit and the accompanying battery charger (ICH9100) and power supply (SPS9100) need special precautions regarding EMC and need to be installed and put into service according to the EMC information provided below. Portable and mobile RF communications equipment can affect the Optune Treatment Kit system and the accompanying battery charger.
  • Page 56 Guidance and manufacturer’s declaration – electromagnetic emissions The ICH9100 charger and the SPS9100 power supply are intended for use in the electromagnetic environment specified below. The customer or the user of the ICH9100 charger and the SPS9100 power supply should assure that it is used in such an environment.
  • Page 57 Surge ±1 kV line to line ±2 kV line to earth IEC 61000-4-5 Voltage dips, short <5 % UT interruptions and (>95 % dip in UT) voltage variations for 0,5 cycle on power supply 40 % UT input lines (60 % dip in UT) for 5 cycles 70 % UT IEC 61000-4-11...
  • Page 58 Electrical fast ±2 kV for ±2 kV Mains power quality transient/burst power supply should be that of a lines typical commercial or hospital environment. IEC 61000-4-4 ±1 kV for input/output lines Surge ±1 kV line to line ±1 kV line to line Mains power quality should be that of a typical commercial...
  • Page 59 Table 3 – Guidance and MANUFACTURER’S declaration – electromagnetic IMMUNITY – for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING Guidance and manufacturer’s declaration – electromagnetic immunity Optune Treatment Kit is intended for use in the electromagnetic environment specified below. The customer or Optune Treatment Kit the user of should assure that it is...
  • Page 60 where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as deter-mined by an electromagnetic site survey, a) should be less than the compliance level in each frequency...
  • Page 61 Table 4 – Recommended separation distances between portable and mobile RF communications equipment and the ME EQUIPMENT or ME SYSTEM – for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING Recommended separation distances between portable and mobile RF Optune Treatment Kit communications equipment and Optune Treatment Kit is intended for use in an electromagnetic environment in which...

  • Page 62: Appendix D - Glossary

    Appendix D – Glossary Cancer – abnormal cell division that spreads without control Chemotherapy – medication used to destroy cancer cells Clinical trial – a research study that involves people Contraindications – situations when a treatment should not be used Glioblastoma Multiforme (GBM) –...

  • Page 63: Appendix E - Expected Service Life

    Appendix E – Expected Service Life Expected service life reflects the average time during which the equipment specified below is expected to work without malfunctioning. Please continue using the equipment if it passed its expected service life and do not stop the treatment. Optune device and additional parts expected service life is as below: Optune device –...
  • Page 64 Manufactured by Novocure GmbH, Business Village D4, Park 6/Platz 10, Root 6039, Switzerland MDSS GmbH., Schiffgraben 41, 30175 Hannover, Germany...

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