novocure OPTUNE GIO User Manual
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novocure OPTUNE GIO User Manual

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User Manual
QSD-QR-814 EU(EN) Rev01.0 Optune Gio Flex User Manual
Issue Date : December 2023
Page 1/61

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  • Page 1 User Manual QSD-QR-814 EU(EN) Rev01.0 Optune Gio Flex User Manual Issue Date : December 2023 Page 1/61...

  • Page 2: Table Of Contents

    CONTRAINDICATIONS, WARNINGS, PRECAUTIONS AND NOTICES ......6 CLINICAL BENEFIT & CLINICAL EVIDENCE ............10 WHAT ARE THE RISKS OF USING THE OPTUNE GIO TREATMENT KIT AND FLEX TRANSDUCER ARRAYS? ..................12 OVERVIEW OF THE OPTUNE GIO TREATMENT KIT ..........13 THE DEVICE ....................
  • Page 3 This manual is intended for patients receiving TTFields treatment using the Optune Gio treatment kit with flex transducer arrays (Sterile). QSD-QR-814 EU(EN) Rev01.0 Optune Gio Flex User Manual Issue Date : December 2023 Page 3/61...

  • Page 4: About The Optune Gio Treatment Kit

    Your doctor has prescribed Optune Gio Treatment Kit for use at home. You may be able to use Optune Gio Treatment Kit on your own, or you may need help from a doctor, family member, or other caregiver. Use Optune Gio Treatment Kit as many hours per day as possible, at least 18 hours per day.

  • Page 5: Intended Purpose

    4 glioma. Newly diagnosed WHO grade 4 glioma Optune Gio is intended for the treatment of adult patients (18 years of age or older) with newly diagnosed WHO grade 4 glioma, following maximal debulking surgery or biopsy, radiation therapy and/or chemotherapy, concomitant with maintenance Temozolomide with or without Lomustine, and after systemic therapy is stopped.

  • Page 6: Contraindications, Warnings, Precautions And Notices

    AND NOTICES CONTRAINDICATIONS Do not use the Optune Gio 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. The Optune Gio treatment kit was not tested in pregnant women.
  • Page 7 Warning - Do not use the Optune Gio treatment kit if you are younger than 18 years of age. It is unknown what side effects the device may cause in these cases or if it will be effective.
  • Page 8 PRECAUTIONS Caution - Keep the Optune Gio treatment kit out of the reach of children and pets. Caution - Do not use any parts that do not come with the Optune Gio treatment kit or that were not sent to you by the device manufacturer or given to you by your doctor.
  • Page 9 Notice! The Optune Gio treatment kit and the flex transducer arrays will activate metal detectors. Notice! You should use the Optune Gio treatment kit for at least 18 hours a day to get the best response to treatment. Using the Optune Gio treatment kit for less than 18 hours a day lowers the chances that you will respond to treatment.

  • Page 10: Clinical Benefit & Clinical Evidence

    Patients using the Optune Gio treatment kit after their tumor reappeared had a better quality of life. Below is a table showing the effects on the benefit of the Optune Gio treatment kit, when it is used correctly or incorrectly after the tumor reappeared.
  • Page 11 3 months longer Almost 5 months longer In addition, more patients who used the Optune Gio treatment kit with temozolomide were alive after 2 years than patients using temozolomide alone. Patients Alive 2 Years after the Start of Treatment (Optune Gio + Temozolomide vs.

  • Page 12: What Are The Risks Of Using The Optune Gio Treatment Kit And Flex Transducer Arrays

    Gio treatment kit. This will look like a red rash, small sores or blisters on your scalp. In general, the Optune Gio treatment kit will not cause skin damage that cannot be fixed. The irritation can be treated with topical steroid cream or by moving the flex transducer arrays.

  • Page 13: Overview Of The Optune Gio Treatment Kit

    OVERVIEW OF THE OPTUNE GIO TREATMENT KIT 1. Electric field generator (Optune Gio; the Device) (Model TFH9100) 2. Connection cable & box (Model CAD9100) 3. Charger for batteries (Model ICH9100) 4. Battery (Model IBH9100) 5. Plug in power supply (Model SPS9100) 6.

  • Page 14: The Device

    THE DEVICE The Optune Gio treatment kit treatment parameters are preset and cannot be changed by the patient. TTFields 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

    You will need to use four (4) flex transducer arrays at one time. Change the 4 flex transducer arrays twice a week to continue treatment with the Optune Gio treatment kit. You may change the flex transducer arrays with the help of a doctor, a nurse or caregiver if needed.

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

    Open the see through package of each of the four (4) flex transducer arrays • by gently pulling apart the opposing edges of the package as shown in the illustration. QSD-QR-814 EU(EN) Rev01.0 Optune Gio Flex User Manual Issue Date : December 2023 Page 16/61...

  • Page 17: Preparing Your Head For The Flex Transducer Array Placement

    15 minutes to ensure skin penetration. Any residues may be removed by cleaning the skin and wipe your scalp again with 70% Alcohol. Apply the flex transducer arrays after your scalp is dry. QSD-QR-814 EU(EN) Rev01.0 Optune Gio Flex User Manual Issue Date : December 2023 Page 17/61...

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

    Peel off the three (3) white liners covering the gel from the first flex transducer array. NOTICE: make sure there is no transparent cover is over the gel. In case there is, carefully remove before proceeding. QSD-QR-814 EU(EN) Rev01.0 Optune Gio Flex User Manual Issue Date : December 2023 Page 18/61...
  • Page 19 Put the flex transducer arrays on your head as shown in the flex transducer array layout map that you received. Placement is based on the location of your tumor. QSD-QR-814 EU(EN) Rev01.0 Optune Gio Flex User Manual Issue Date : December 2023...
  • Page 20 Place the other three flex transducer arrays in the same way. Press the flex transducer array firmly to your scalp. Press the entire edge of the flex transducer array tape to your scalp. QSD-QR-814 EU(EN) Rev01.0 Optune Gio Flex User Manual Issue Date : December 2023 Page 20/61...

  • Page 21: Connecting The Flex Transducer Arrays To The Device

    Wrap them with a small piece of tape, if you wish. You may clip the connection cable to your belt. • QSD-QR-814 EU(EN) Rev01.0 Optune Gio Flex User Manual Issue Date : December 2023 Page 21/61...

  • Page 22: Starting And Stopping The Device

    • Wait approximately 10 seconds for the self-check to be completed. The "Power" • indicator on the front of the device will light up green. QSD-QR-814 EU(EN) Rev01.0 Optune Gio Flex User Manual Issue Date : December 2023 Page 22/61...
  • Page 23 Press the TTFields ON/OFF button once – this will start treatment. • The blue indicators surrounding the TTFields ON/OFF button will light up and remain on for as long as treatment continues. QSD-QR-814 EU(EN) Rev01.0 Optune Gio Flex User Manual Issue Date : December 2023 Page 23/61...
  • Page 24 OFF. This is a reminder to start the treatment. The TTFields button should be pressed once to silence the notification signal and again to start the treatment. QSD-QR-814 EU(EN) Rev01.0 Optune Gio Flex User Manual Issue Date : December 2023 Page 24/61...
  • Page 25 Then, turn off the device by turning the power button on the bottom of the • device to the off position. QSD-QR-814 EU(EN) Rev01.0 Optune Gio Flex User Manual Issue Date : December 2023 Page 25/61...
  • Page 26 Error light will light up. However, in this case both the yellow "Battery" and red "Error" indicators will light up instead of just the red light. QSD-QR-814 EU(EN) Rev01.0 Optune Gio Flex User Manual Issue Date : December 2023...
  • Page 27 The red Error and the yellow Battery lights will turn off. Turn off the device using the on/off power switch. • Replace the battery using the steps in Section 14. • QSD-QR-814 EU(EN) Rev01.0 Optune Gio Flex User Manual Issue Date : December 2023 Page 27/61...

  • Page 28: Connecting & Disconnecting The Battery

    Take care not to drop the battery in place or to force it into the battery slot. The Optune Gio device uses one (1) battery at a time. The other three (3) batteries should stay in the battery charger. Each battery lasts 2 to 3 hours. Replace the battery each time it runs out (when the yellow Low Battery indicator light is on, as described in Section 15).
  • Page 29 Over nine to twelve months, the length of time the batteries can run the device (before the low battery notification signal beeps) will get shorter. When this happens, contact technical support (see Section 26) to get replacement batteries. QSD-QR-814 EU(EN) Rev01.0 Optune Gio Flex User Manual Issue Date : December 2023 Page 29/61...
  • Page 30 Please follow these steps: Plug the power supply cord into the back of the Optune Gio device. (See Section 16) • The lights on the display panel will indicate you are no longer running on battery •...
  • Page 31 Checking the Battery Gauge While you are using Optune Gio, you may want to check how much power is left in the battery. Checking the battery will not interfere with or stop your treatment. To check the battery power press the button on the top of the battery cartridge once.

  • Page 32: Charging The Battery

    Charger Mains Cable Back view of the battery charger showing where to turn the charger on and off and where to connect the charger power cord QSD-QR-814 EU(EN) Rev01.0 Optune Gio Flex User Manual Issue Date : December 2023 Page 32/61...
  • Page 33 (part which come into physical contact with the patient). Mode of operation - continuous operation. The charger is not intended for use in the presence of flammable mixtures. Sterilization or disinfection are not required. QSD-QR-814 EU(EN) Rev01.0 Optune Gio Flex User Manual Issue Date : December 2023 Page 33/61...

  • Page 34: Using The Power Supply

    If it is running, it will automatically switch from battery power to plug-in power supply. AC Port located next to the power switch QSD-QR-814 EU(EN) Rev01.0 Optune Gio Flex User Manual Issue Date : December 2023 Page 34/61...
  • Page 35 3. If the device is not turned on, turn on the power switch and wait for the self-check to be completed (about 10 seconds). Push the TTFields button to start the treatment. 4. Store the plug-in power supply for future use. QSD-QR-814 EU(EN) Rev01.0 Optune Gio Flex User Manual Issue Date : December 2023 Page 35/61...

  • Page 36: The Connection Cable & Box

    Do not force the connection cable into the socket. It should push in easily if properly aligned. QSD-QR-814 EU(EN) Rev01.0 Optune Gio Flex User Manual Issue Date : December 2023 Page 36/61...
  • Page 37 2. Turn on the device using the power button. Wait for self-check to be completed (about 10 seconds). 3. Turn on the TTFields using the TTFields ON/OFF button. QSD-QR-814 EU(EN) Rev01.0 Optune Gio Flex User Manual Issue Date : December 2023 Page 37/61...
  • Page 38 1. Stop treatment by pressing the TTFields ON/OFF button. 2. Turn off the Optune Gio device using the power button. 3. Unplug the flex transducer array connectors from the connection box by pulling as shown in the picture below.

  • Page 39: Carrying The Device

    Note: Do not place the device in a different bag. Optune Gio has a fan that needs airflow. The bag that comes with the device is designed to allow for proper airflow. If you put the device in a bag without proper airflow, it could overheat and trigger the notification signal.

  • Page 40: Glossary Of Symbols

    GLOSSARY OF SYMBOLS Follow instructions for use Medical device Manufacturer information: Novocure GmbH, Business Village D4, Park 6/Platz 10, 6039 Root, Switzerland Model number Reference Number Serial Number Lot Number Unique Device Identifier Indicates a device carries Unique Device Identifying information.
  • Page 41 12.5 mm in diameter or greater and against ingress of vertical falling water drops. IP22: Optune Gio device protects persons against access to hazardous parts with fingers. Protects the equipment inside the enclosure against ingress of solid foreign objects of 12.5 mm in diameter or greater and against ingress of vertical falling water drops when enclosure is tilted up to 15°.
  • Page 42 Importer details: Novocure Netherlands B.V., Prins Hendriklaan 26, 1075 BD, Amsterdam, The Netherlands Power ON / OFF switch for the Optune Gio device and the battery charger: When the switch is in the I position the device is ON and will light up green.

  • Page 43: Environmental Conditions For Operation, Storage And Transportation

    Transportation of the flex transducer arrays shall be possible using air/ground transportation in weather-protected conditions as specified below: • Temperature range: 0°C to 40°C • No direct exposure to water QSD-QR-814 EU(EN) Rev01.0 Optune Gio Flex User Manual Issue Date : December 2023 Page 43/61...

  • Page 44: Travelling With Optune Gio

    Optune Gio treatment kit. EXPECTED PRODUCT LIFE The expected product life for the Optune Gio device and all components of the treatment kit is 5 years. The expected product life of the flex transducer arrays is 6 months. The flex transducer arrays have an expiration date.

  • Page 45: Troubleshooting

    If problem persists: indicator Charger malfunction does not Turn OFF power switch light up after Device malfunction Call your Device Support Specialist turning ON the device QSD-QR-814 EU(EN) Rev01.0 Optune Gio Flex User Manual Issue Date : December 2023 Page 45/61...
  • Page 46 If something is damaged, replace the damaged item. Reconnect all connections in proper order and turn on the device. Verify that the self- test is completed and press the QSD-QR-814 EU(EN) Rev01.0 Optune Gio Flex User Manual Issue Date : December 2023 Page 46/61...
  • Page 47 OR if one of the showing the batteries will not charge or causes battery is full the charger LED to turn red – call your Device Support Specialist. QSD-QR-814 EU(EN) Rev01.0 Optune Gio Flex User Manual Issue Date : December 2023 Page 47/61...
  • Page 48 5. Power source anything appears to be damaged, please malfunction reach out to your device support specialist. QSD-QR-814 EU(EN) Rev01.0 Optune Gio Flex User Manual Issue Date : December 2023 Page 48/61...

  • Page 49: Expected Service Life

    Please continue using the equipment if it passed its expected service life and do not stop the treatment. Optune Gio device and additional parts expected service life is as below: Optune Gio device – 12 months •...

  • Page 50: Assistance & Information

    If you feel any change in your health or any side effects from the treatment call your doctor. REPORTING If you experience a serious incident that occurs while using the Optune Gio treatment kit or the flex transducer arrays you should report it to the manufacturer (Novocure) DeviceSafety@Novocure.com and the competent authority of the Member State in which you reside.

  • Page 51: Glossary

    TTFields to the brain of patients with recurrent or newly diagnosed WHO grade 4 glioma. EN 60601-1 – Harmonized standards series for safety of medical electrical equipment QSD-QR-814 EU(EN) Rev01.0 Optune Gio Flex User Manual Issue Date : December 2023 Page 51/61...

  • Page 52: Applicable Standards

    APPLICABLE STANDARDS The Optune Gio treatment kit electronic components and the sterile transducer arrays comply with the latest editions of the following safety standards: • EN 60601-1 Medical electrical equipment — Part 1: General requirements for basic safety and essential performance EN 60601-1-2 Medical electrical equipment —...

  • Page 53: Input Output Specifications

    INPUT OUTPUT SPECIFICATIONS The Optune Gio 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.

  • Page 54: Emitted Radiation & Electromagnetic Compatibility

    EMC information provided below. Portable and mobile RF communications equipment can affect the Optune Gio treatment kit and the accompanying battery charger. The Optune Gio device should be used with the following cables and additional parts only: 1. CAD9100 connection cable 2.
  • Page 55 Complies flicker emissions IEC 61000-3-3 Warning: The Optune Gio device, the ICH9100 charger and the SPS9100 power supply should not be used adjacent to or stacked with other equipment QSD-QR-814 EU(EN) Rev01.0 Optune Gio Flex User Manual Issue Date : December 2023...
  • Page 56 Guidance and manufacturer’s declaration – electromagnetic immunity The Optune Gio treatment kit is intended for use in the electromagnetic environment specified below. The customer or the user of the Optune Gio treatment kit should ensure that it is used in such an environment.
  • Page 57 IEC 61000-4-8 commercial or hospital environment. NOTE UT is the a.c. mains voltage prior to application of the test level = 120V and 230V QSD-QR-814 EU(EN) Rev01.0 Optune Gio Flex User Manual Issue Date : December 2023 Page 57/61...
  • Page 58 Guidance and manufacturer’s declaration – electromagnetic immunity The Optune Gio treatment kit is intended for use in the electromagnetic environment specified below. The customer or the user of the Optune Gio treatment kit should ensure that it is used in such an environment.
  • Page 59 If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the ICH9100 charger and the SPS9100 power supply. Normal operation: The Optune Gio treatment kit is working properly when the blue LED surrounding the TTFields button are lit and no notification signal sounds. The ICH9100 charger is working properly when all the LEDs are lit.
  • Page 60 5800MH transmitter W The Optune Gio treatment kit is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Optune Gio treatment kit can help prevent electromagnetic interference by maintaining a...
  • Page 61 MDSS GmbH, Schiffgraben 41, 30175 Hannover, Germany Importer details: Novocure Netherlands B.V., Prins Hendriklaan 26, 1075 BD, Amsterdam, The Netherlands QSD-QR-814 EU(EN) Rev 01.0 manuals.novocure.eu QSD-QR-814 EU(EN) Rev01.0 Optune Gio Flex User Manual Issue Date : December 2023 Page 61/61...

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