novocure Optune Patient Information And Operation Manual
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novocure Optune Patient Information And Operation Manual

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PATIENT INFORMATION
AND OPERATION MANUAL

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  • Page 1 PATIENT INFORMATION AND OPERATION MANUAL...

  • Page 2: Table Of Contents

    4 Contraindications, Warnings and Precautions ...........................5 5 What Are the Risks of Treatment with Optune? ..........................8 6 What Are the Benefits of Treatment with Optune? ........................11 7 What Studies Have Been Conducted with Optune? ........................12 8 About Optune ......................................14 9 Overview of Optune Treatment Kit ..............................15...

  • Page 3: Glossary Of Medical Terms

    Electric Field Generator (the device) – a portable device for delivering TTFields to the brain of patients with recurrent and newly diagnosed GBM Optune Treatment Kit – the Electric Field Generator and other parts including batteries, charger, connection cable, ®...

  • Page 4: What Is Optune ® And How Does It Work

    Your doctor has prescribed Optune because you are a good candidate for the device. Optune is a treatment for adult patients (22 years of age or older). Optune is used after surgery and radiation with chemotherapy have been used if possible. A discussion of brain cancer and treatment options is found at the end of this Patient Manual in Section 29.

  • Page 5: Contraindications, Warnings And Precautions

    Warning – Optune is not intended to be used as a substitute for chemotherapy but rather as an adjunct to treatment with TMZ for newly diagnosed GBM. Warning – Do not use Optune if you are 21 years old or younger. It is unknown what side effects the device may cause in these cases or if it will be effective.
  • Page 6 Breaks in treatment may lower your chance to respond to treatment. 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.
  • Page 7 Breaks in treatment may lower your chance to respond to treatment. Notice! You should carry the Troubleshooting Guide (Section 26) at all times. This guide is necessary to ensure Optune ®...

  • Page 8: What Are The Risks Of Treatment With Optune

    ® Skin irritation is often seen under the transducer arrays when using Optune. This will look like a red rash, small sores or blisters on your scalp. In general, this will not cause skin damage that cannot be fixed. The irritation can be treated with steroid cream or by moving the transducer arrays.
  • Page 9 What Are the Risks of Treatment with Optune ® The table below shows the occurrence of certain events when Optune was used correctly and incorrectly in the clinical study in patients whose tumor reappeared after cancer drugs. Occurrence of Certain Problems with Correct and Incorrect Use of Optune...
  • Page 10 ® In a clinical study of Optune together with temozolomide (before the tumor reappeared), the device led to skin irritation in about half of the patients (53%). Most of these cases were not severe and were treated with topical creams. Only a handful of patients (2%) had severe skin irritation.

  • Page 11: What Are The Benefits Of Treatment With Optune

    700 patients had joined the study. The table below shows the amount of time that patients who used Optune with temozolomide were observed to be alive longer than patients who used temozolomide alone.

  • Page 12: What Studies Have Been Conducted With Optune

    100 subjects were alive at one year when using Optune or cancer drugs. Finally, when subjects used Optune, the tumor shrank to at least half of its original size in 14 out of 100 (14%) Optune subjects compared to 7 out of 73 (10%) cancer drugs subjects.
  • Page 13 695 patients had joined the study. The table below shows the amount of time that patients who used Optune with temozolomide were observed to be alive longer than patients who used temozolomide alone.

  • Page 14: About Optune

    TTFields are intended to kill cancer cells. Your doctor has prescribed Optune for use at home. You may be able to use Optune on your own, or you may need help from a doctor, family member, or other caregiver. Use Optune as many hours per day as possible. Only take short breaks for personal needs.

  • Page 15: Overview Of Optune Treatment Kit

    3. Charger for Portable Batteries 4. Plug In Power Supply 5. Connection Cable and Box (CAD) 6. Transducer Arrays 7. Power Cords 8. Shoulder Bag and Strap 9. Portable Battery Case Overview of Optune Treatment Kit \\DC - 099263/000001 - 12620961 v1...

  • Page 16: Overview Of Transducer Arrays

    Shave the scalp again before you apply a new set of transducer arrays. Please contact Novocure to arrange for proper disposal of used transducer arrays. Do not dispose of your used transducer arrays in household trash.

  • Page 17: Before You Put On The Transducer Arrays

    Remember: Black goes on the back, white goes on the right. Change the four (4) transducer arrays at least two times per week (every 4 days at most) to continue treatment with Optune . You may change the transducer ®...

  • Page 18: Removing The Transducer Arrays From The Package

    Removing the Transducer Arrays from the Package Open the envelope of four transducer arrays by gently pulling apart the edges of the envelope (see the picture below). Removing the Transducer Arrays from the Package \\DC - 099263/000001 - 12620961 v1...

  • Page 19: Prepare Your Head For Transducer Array Placement

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

  • Page 20: Place The Transducer Arrays On Your Head

    Place the Transducer Arrays on Your Head After you prepare your scalp (Section 13), put the transducer arrays on your head with the help of a doctor or caregiver if needed. Every 4 days (at most), remove the transducer arrays, prepare the scalp (as outlined in Section 13) and put on a new set of transducer arrays.

  • Page 21: Connect The Transducer Arrays To The Device

    Disposal Please contact Novocure to arrange for proper disposal of used transducer arrays. Do not throw them in the trash. Connect the Transducer Arrays to the Device, Disposal \\DC - 099263/000001 - 12620961 v1...

  • Page 22: Connecting & Disconnecting The Portable Battery

    “click”, indicating the battery is in place. Take care not to drop the battery in place or force it into the battery slot. Optune uses one battery at a time. The other three batteries should stay in the battery charger.
  • Page 23 Connecting & Disconnecting the Portable Battery Option Two: If you are not near the wall power supply, or if the battery has totally depleted please replace the battery using these steps: 1. Press the TTFields button to stop the treatment. 2.

  • Page 24: Charging The Portable Battery

    Charging the Portable Battery Checking the Battery Gauge While you are using Optune ® , you may want to check how much energy is left in your battery. Checking the battery will not interfere with or stop your treatment. To check the battery life, press the button once on the top of the battery cartridge. The battery life will be indicated by the lighted gauge to the right of the button.
  • Page 25 Charging the Portable Battery The battery charger recharges used batteries. The battery charger uses power from a standard wall outlet. Each battery sits in a slot that connects it directly to the charger. 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.
  • Page 26 Charging the Portable Battery 1. Battery Charging Slot 2. Battery Charge Indicator 3. Charger Power Indicator Front view of the battery charger showing how the batteries are inserted into the charger Notice: The charger is not intended for use in the presence of flammable mixtures. Charging the Portable Battery...

  • Page 27: Using The Plug-In Power Supply

    Using the Plug-In 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.

  • Page 28: The Connection Cable & Connection Box

    The Connection Cable & Connection Box The connection cable is the coiled, stretchy cord that runs from the device to the connection box. The four black (2) and white (2) transducer array connectors plug into the connection box. The black and white coding matches with the transducer array position on the head.
  • Page 29 The four transducer arrays are plugged into the connection cable box as described in Section 15. The connection cable is plugged into the device at the P1 (patient) socket. 1. Stop treatment by pressing the TTFields button. 2. Turn off the Optune device using the power button. ®...

  • Page 30: The Electric Field Generator

    The picture below shows the device controls to work the system. You do not need to adjust any settings. You only need to turn the device and the therapy off and on. 1. Optune ® Power Switch 2.

  • Page 31: To Start & Stop The Device

    To Start & Stop the Device To Start Treatment, 1. Put the transducer arrays on the scalp (with the help of a caregiver if needed). Plug the transducer arrays into the connection cable box (Sections 14 and 15). 2. Plug the connection cable into the device with the arrows on the connector up (as described in Section 20). 3.
  • Page 32 To Start & Stop the Device If a wall power supply is plugged into the device the device will run using the wall power supply and the "Battery" indicator will not illuminate. 6. Press the TTFields therapy button once – this will start treatment. The ”TTFIELDS”...
  • Page 33 To Start & Stop the Device B. 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). In this case, once the red Error light illuminates, the treatment has stopped. To turn off the device: 1.

  • Page 34: Carrying The Device

    Both the electric field generator and the battery fit in a carrying bag. The bag can be carried in one of two ways: by the handle on top or over the shoulder/ cross-body with a carrying strap attached. Note: Do not place the device in a different bag. Optune has a fan on the inside that needs air flow. The bag that ®...

  • Page 35: Glossary Of Graphic Symbols

    Do not expose the device to direct rain Batteries are lithium ion. Contact technical support to arrange for proper disposal of batteries that are used up or no longer in use Optune ® should be kept away from extreme heat and sources of radiation BF type applied part –...

  • Page 36: Storage And Transportation By The Distributer

    Storage and Transportation by the Distributer Storage Conditions Temperature range: 23°F to 104°F for the device and additional parts Temperature range: 41°F to 81°F for the transducer arrays Relative humidity range: 15-75% for the device and additional parts Relative humidity range: 35-50% for the transducer arrays Transport Conditions Transportation of the device and additional parts is possible using air/ground transportation in weather protected conditions as specified below:...

  • Page 37: 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 Device power 1. Device not connected to 1. If on battery – check battery gauge to verify it is not indicator light does power source depleted.
  • Page 38 Troubleshooting Problem Possible Causes Actions to be Taken Notification alarm 1. Therapy Timeout The notification alarm on the device will sound if it is sounds 10 minutes powered on for 10 minutes, but therapy is not initiated. after the device was This is a reminder to start therapy and does not indicate a powered on malfunction.

  • Page 39: Assistance & Information

    ® Optune's portable 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 contact Novocure Support if you have questions related to travel restrictions.

  • Page 40: Brain Cancer

    Radiation therapy and cancer drugs can allow patients to live longer than if they had no treatment. Adding Optune to temozolomide can allow patients to live even longer than with temozolomide alone. Radiation and cancer drugs have side effects.

  • Page 41: Emitted Radiation & Electromagnetic Compatibility

    Guidance and Manufacturer’s Declaration – Electromagnetic Emissions Optune Treatment Kit is intended for use in the electromagnetic environment specified below. The customer or the user of Optune Treatment Kit should ensure that it is used in such an environment. Emissions test Compliance Electromagnetic environment –...
  • Page 42 ME EQUIPMENT and ME SYSTEMS Guidance and Manufacturer’s Declaration – Electromagnetic Immunity Optune Treatment Kit is intended for use in the electromagnetic environment specified below. The customer or the user of Optune Treatment Kit should ensure that it is used in such an environment.
  • Page 43 The ICH9100 charger is working properly when all the LEDs are lit. The SPS9100 power supply is working properly when the blue LEDs surrounding the TTFields button on Optune Treatment Kit are lit and no notification signal sounds.
  • Page 44 To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which Optune Treatment Kit is used exceeds the applicable RF compliance level above, Optune Treatment Kit should be observed to verify normal operation.
  • Page 45 ® Treatment Kit Optune Treatment Kit is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of Optune Treatment Kit can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and Optune Treatment Kit as recommended below, according to the maximum output power of the communications equipment.
  • Page 46 ©2019 Novocure. All rights reserved. Optune and Novocure are trademarks of Novocure. Document Number: QSD-QR-704. REV 05 Release Date: January 2019...

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