novocure Optune NovoTTF 200A User Manual
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novocure Optune NovoTTF 200A User Manual

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  • Page 1 USER MANUAL...
  • Page 2 Document number QSD-EUUM-001-EN Revision 04 Release date: July 12, 2016...

  • 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 Overview of Optune Treatment Kit ............12 The Device ..................
  • Page 4 ® This manual is intended for both physicians prescribing the use of Optune Treatment Kit and INE Transducer arrays (Sterile), and for patients receiving TTField treatment using this device.

  • Page 5: About Optune ® Treatment Kit

    About Optune ® Treatment Kit Optune Treatment Kit (NovoTTF-200A) is intended for the treatment of patients with recurrent GBM and for the treatment of patients with newly diagnosed GBM (together with maintenance Temozolomide). Optune Treatment Kit a portable medical device. It delivers electric fields called “TTFields” to the tumor in the brain using INE Transducer arrays.

  • 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.
  • 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 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. Using Optune Treatment Kit for less than 18 hours a day lowers the chances that you will respond 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: 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 INE9000) Device & battery carrying bag (Model BAG9100) Optune electric field generator (the Device) (Model TFH9100) Battery (Model IBH9100) Connection cable &...

  • Page 13: 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 14: 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 15 The blue indicators surrounding the TTFields therapy ON/OFF button will light up and remain on for as long as treatment continues. 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 16 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. The red Error light will light up (as shown below).
  • Page 17 When your battery runs out (after about 2–3 hours), the notification signal will beep, and the TTFields therapy will stop. When this happens the "Battery" indicator will turn yellow and red Error light will light up. This notification signal sound is the same sound the device makes for an error.

  • Page 18: 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 19 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 20 Option Two: If you are not near the power supply, or if the battery has totally depleted please replace the battery using these steps: 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 21 Full Charge 75%Charge 50%Charge 25%Charge Empty...

  • Page 22: 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 23 Back view of the battery charger and rack showing where to turn the charger on and off and where to connect the charger power cord 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.

  • Page 24: 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 25 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 26: 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 27 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 28 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 29: 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 30: Glossary Of Graphic Symbols

    Glossary of Graphic Symbols Caution - Consult the instructions for use for important cautionary information such as warnings and precautions Date of Manufacturing Fragile – handle with care Follow instructions for use Do not expose to temperatures below -5°C or above 40°C Do not expose to humidity below 15% or above 93% Manufacturer information Do not enter rooms with high humidity or danger of direct...
  • Page 31 Optune Treatment Kit parts should be kept away from extreme heat and sources of radiation BF type applied part – symbolizes the part which comes in contact with the patient Expiration date – do not use beyond this date YYYY-MM Power ON / OFF switch for Optune : When the switch is in the I position the device is ON.

  • Page 32: Environmental Conditions For Normal Operation, Storage And Transportation

    Environmental Conditions for Normal Operation, Storage and Transportation Conditions for operation All system components shall be normally used under the conditions specified below: The system is intended mainly for home use. The battery charger and the power supply are for indoor use only. The device additional parts and transducer array are not intended for use in a shower, a bath tub or a sink, or in heavy rain.
  • Page 33 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 34: Troubleshooting

    Troubleshooting Note, when calling your device support specialist or the Technical Support line, please have the serial number of the equipment accessible. 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...
  • Page 35 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 array/ connection 2. Evaluate the connectors, if 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 36 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 37 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 38: 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 39: Appendix A - Information For Physicians

    Appendix A – Information for Physicians Before starting treatment for the patient: Send a recent post-surgical MRI to Novocure by Mail (Novocure GmbH, Park 6, CH-6039 Root D4, Switzerland). For detailed instructions on how to place INE Transducer arrays refer to the INE Transducer array (sterile) user manual.

  • Page 40: Appendix B - Applicable Standards

    Appendix B – Applicable Standards The Optune Treatment Kit as whole complies with the EN 60601-1 series latest editions.

  • Page 41: Appendix C - Input Output Specifications

    Appendix C – 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 42: Appendix D - Emitted Radiation & Electromagnetic Compatibility

    Appendix D – 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 43 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 44 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 45 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 46 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 47 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 48 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 communications equipment and Optune Treatment Kit is intended for use in an electromagnetic environment in which Optune Treatment Kit...

  • Page 49: Appendix E - Glossary

    Appendix E – 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 50: Appendix F - Expected Service Life

    Appendix F – Expected Service Life Optune device and additional parts expected service life is as below: Optune device – 3.5 months Connection cable – 3.5 months Power supply – 20 months Battery – 20 months (or until the expiration date) Charger –...

  • Page 51: Appendix G - Safety And Effectiveness Results - Newly Diagnosed Gbm

    Appendix G – Safety and Effectiveness Results – newly diagnosed GBM Pilot Clinical Study in Newly Diagnosed GBM Optune together with temozolomide (TMZ) has been tested in ten newly diagnosed GBM subjects in a single center, pilot study in Europe. Median progression free survival (PFS) of the patients in this study exceeded historical controls dramatically (14.4 months versus 7.1 months, respectively).
  • Page 52 Primary Efficacy Endpoint - Progression Free Survival (ITT) Interim Analysis Final Analysis Optune/TMZ TMZ Alone Optune/TMZ TMZ Alone Median (95% CI) 7.2 (5.9, 8.2) 4.0 (3.0, 4.3) 7.1 (6.0, 8.1) 4.2 (3.9, 5.5) Log-rank test p=0.0013 p=0.0010 Hazard Ratio (95% CI) 0.621 (0.468, 0823) 0.694 (0.558, 0863) PFS was a pre-specified endpoint in the ITT population.
  • Page 53 Overall Survival (PP) Interim Analysis Final Analysis Optune/TMZ TMZ Alone Optune/TMZ TMZ Alone Median (95% CI) 20.5 (16.6, 24.9) 15.6 (12.9, 18.5) 19.6 (16.6, 24.1) 15.2 (13.5, 18.2) Log-rank test p=0.0042 p=0.0030 Hazard Ratio (95% CI) 0.666 (0.495, 0898) 0.683 (0.529, 0.882) The study was designed to test overall survival (OS) only if PFS met its threshold for superiority (hierarchical testing at a p-value of 0.0059).
  • Page 54 Quality of Life: Quality of Life assessments were based on the interim analysis cohort of 315 subjects. Quality of life, cognitive function and functional status were all maintained throughout treatment with the device, leading to the clear conclusion that use of Optune does not harm patients’ quality of life, cognitive function or ability to perform activities of daily living.
  • Page 55 Patients treated with Optune/TMZ experienced a small increase in TMZ-related AEs and SAEs due to the longer TMZ exposure afforded to these patient by their longer PFS. The only AEs which may have been caused by Optune therapy are the known skin irritation seen in 45% of patients in this study (1% severe), falls which were seen at a slightly higher incidence in patients carrying the device, headaches related to wearing the arrays 24 hours a day and mild psychiatric symptoms (anxiety, insomnia, confusion) which could be caused by the need to incorporate the device and arrays into daily life.

  • Page 56: Appendix H - Safety And Effectiveness Results - Recurrent Gbm

    Appendix H – Safety and Effectiveness Results – recurrent Pilot Clinical Study in Recurrent GBM Optune has been tested in 10 recurrent GBM subjects in a single center, pilot study in Europe. In this study, Optune monotherapy led to a significant increase in time to progression (from 13 to 26 weeks; p=0.013), progression free survival at 6 months (PFS6) (from 15 to 50%) and overall survival (OS) (from 6.0 to 14.7 months;...
  • Page 57 Correlation between Treatment Compliance and Overall Survival: Optune has an internal log file which allows the calculation of patient compliance with treatment. Significantly higher overall survival (p=0.0447) was observed in patients who were treated 75% or more of the time on average (OS=7.7 months) compared to patients treated less than 75% of the time on average (OS=4.5 months).
  • Page 58 Occurrence of moderate (grade 2) and severe (grade 3-4) medical problems in recurrent GBM patients using Optune Treatment Kit as a monotherapy compared to patients on cancer drugs Optune (n=116) Active Control (n=91) System Adverse event % (% gr. 3+4) % (% gr.
  • Page 59 Other Clinical Experience in Recurrent GBM- Patient Registry Dataset Patient population: The Patient Registry Dataset (PRiDe) is a post-marketing registry of all recurrent GBM patients who received Optune in a real-world, clinical practice setting in the US between 2011 and 2013.
  • Page 60 Variable Median OS Hazard Ratio P Value (mo) No. of recurrences — — 0.6(95%CI,0.4–0.9) .0271a 3rd-5th 0.3(95%CI,0.2–0.5) <.0001b Compliance ≥75% 13.5 0.4(95%CI,0.3–0.6) <.0001 <75% Karnofsky performance status (KPS) 90 – 100 14.8 — — 70 – 90 0.6(95%CI,0.4–0.9) .0070c 10 – 60 0.4(95%CI,0.2–0.6) <.0001d Bevacizumab use...
  • Page 61 Manufactured by Novocure Ltd., Topaz Bldg., Matam Center, Haifa 3190500, Israel MDSS GmbH., Schiffgraben 41, 30175 Hannover, Germany...

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