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NovoTTF
TM
for Unresectable
Malignant Pleural
Mesothelioma
-100L System
Caution: Federal law restricts this device to sale by or on the order of a physician
Humanitarian Device. Authorized by Federal Law for use in adult patients with unresectable, locally
advanced or metastatic, malignant pleural mesothelioma (MPM) concurrently with pemetrexed and
platinum-based chemotherapy.
The effectiveness of this device for this use has not been demonstrated.
Revision: 01.1, Release date: May 2019
Manufactured by Novocure Ltd., Topaz Bldg., Matam Center, Haifa 3190500, Israel
PATIENT INFORMATION
AND OPERATION
MANUAL
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Table of Contents
Related Manuals for novocure NovoTTF-100L
Summary of Contents for novocure NovoTTF-100L
- Page 1 (MPM) concurrently with pemetrexed and platinum-based chemotherapy. The effectiveness of this device for this use has not been demonstrated. Revision: 01.1, Release date: May 2019 Manufactured by Novocure Ltd., Topaz Bldg., Matam Center, Haifa 3190500, Israel...
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Page 2: Table Of Contents
Table of Contents 2 Glossary ........................................3 3 What Is the NovoTTF-100L System and How Does It Work? ......................4 4 Contraindications, Warnings and Precautions ...........................4 5 What Are the Risks of Using the NovoTTF-100L System? ....................... 7 6 What Are the Benefits of Using the NovoTTF-100L System? ......................8 7 What Studies Have Been Conducted with the NovoTTF-100L System? ..................8... -
Page 3: Glossary
Glossary Cancer – abnormal cell division that spreads without control Carboplatin – a type of cancer drug used to treat MPM Chemotherapy – medication used to destroy cancer cells Cisplatin – a type of cancer drug used to treat MPM Clinical trial –... -
Page 4: What Is The Novottf-100L System And How Does It Work
Do not use the NovoTTF-100L System if you are known to be sensitive to gels like the gel used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes. In this case, skin contact with the gel used with the NovoTTF-100L System may commonly cause increased redness and itching, and rarely may even lead to severe allergies such as a fall in blood pressure and breathing difficulty. - Page 5 Precautions Caution – Do not use any parts that do not come with the NovoTTF-100L System, or that were not sent to you by the device manufacturer or given to you by your doctor. Use of other parts, manufactured by other companies or for use with other devices, can damage the device.
- Page 6 Notice - You should carry the Troubleshooting Guide (Section 26 of the patient information and operation manual) at all times. This guide is necessary to ensure the NovoTTF-100L system works properly. If you do not work the system correctly you may have a break in your treatment.
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Page 7: What Are The Risks Of Using The Novottf-100L System
What Are the Risks of Using the NovoTTF-100L System? Skin irritation is often seen under the transducer arrays when using the NovoTTF-100L System. This will look like a red rash, small sores or blisters on your chest. In general, this will not cause skin damage that cannot be fixed. -
Page 8: What Are The Benefits Of Using The Novottf-100L System
What Are the Benefits of Using the NovoTTF-100L System? All patients in the clinical study used the NovoTTF-100L together with cancer drugs. Half of the patients using NovoTTF- 100L together with cancer drugs lived for more than 18.2 months after their treatment started. Also, 4 out of each 10 patients using NovoTTF-100L together with cancer drugs were alive after two years (42%). -
Page 9: About Novottf-100L System
After this short training, with the help of a family member or care provider if needed, you will be able to properly use the NovoTTF-100L System. You will also be able to change the batteries, charge the batteries and replace the transducer arrays as needed. -
Page 10: Overview Of The Novottf-100L System
Overview of the NovoTTF-100L 1. Power supply 2. Charger for portable batteries 3. Insulated ILE Transducer Arrays 4. Device & battery carrying bag 5. NovoTTF-100L electric field generator (the Device) 6. Portable battery 7. Connection cable & box Overview of the NovoTTF-100L... -
Page 11: The Device
The Device ∞ The NovoTTF-100L System is an automatic system. ∞ You will need to learn how to place it in a carrying bag, connect a portable battery and operate the system. ∞ The following controls will allow you to do this: 1. -
Page 12: The Ile Transducer Arrays
∞ An ILE Transducer Array is an adhesive patch which delivers Tumor Treating Fields to the chest. ∞ The ILE transducer arrays are supplied sterile and are to be used with the NovoTTF-100L System only. ∞ ILE transducer arrays come in two sizes – small and large. You should use either large or small transducer arrays on the chest and upper abdomen, back and both sides of your thorax, depending on your torso size. -
Page 13: Preparing Your Skin For Transducer Array Placement
Preparing Your Skin for Transducer Array Placement ∞ Wash your skin on the chest abdomen back and flanks using a gentle soap. ∞ Remove any remnant adhesive from your skin from prior transducer arrays by wiping with baby oil. ∞ If you have any hair on your torso, shave your entire torso using an electric shaver. Make sure no stubble is left. ∞... -
Page 14: Connecting The Transducer Arrays To The Device
Connecting the Transducer Arrays to the Device ∞ Connect the four black and white Transducer Array connectors to the corresponding black and white coded sockets on the NovoTTF-100L System connection cable. ∞ Press firmly to verify the connectors are inserted all the way. -
Page 15: Starting & Stopping The Device
Starting & Stopping the Device ∞ To start treatment, connect a charged battery to the blue battery socket (see section 13) and connect the connection cable to the grey connection cable socket on the device. Both of these connectors are keyed such that they can only be inserted if the arrows on the connectors face up towards the labels on the ports. - Page 16 Starting & Stopping the Device ∞ Stopping treatment may be performed in each of the following situations: ∞ When the device is running properly: Press the TTFields button – The three blue indicators surrounding the TTFields ON/OFF button will turn off. ...
- Page 17 Starting & Stopping the Device ∞ When an Error condition occurs: The device automatically shuts off the TTFields output to the patient, a loud intermittent beep is sounded and the red Error indicator lights up. Press the TTFields button on the front panel in order to stop the alarm sound. The red Error indicator ...
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Page 18: Connecting & Disconnecting The Portable Battery
Connecting & Disconnecting the Portable Battery ∞ When the yellow Low Battery indicator lights up, the battery should be replaced according to the following procedure: ∞ Press the TTFields button once to turn off the alarm sound. ∞ Turn OFF power switch. ∞... - Page 19 Connecting & Disconnecting the Portable Battery Connecting & Disconnecting the Portable Battery...
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Page 20: Charging The Portable Battery
∞ All 3 portable batteries which are not in use should be placed in the charger and their cables connected to the charging sockets at all times. ∞ Always select a fully charged battery when replacing a battery in the NovoTTF-100L device (the Charge indicator of the battery must be green). -
Page 21: Using The Power Supply
∞ The plug-in power supply input is designed to operate on either 120V AC (US) or 230V AC (EU). ∞ When in use the power supply will become warm. ∞ When in use, support the filter box so the weight of the box is not hanging on the line from the NovoTTF-100L device. 1. Plug-In Power Supply 2. -
Page 22: Disconnecting From The Device
To accomplish this: Stop TTFields. Turn OFF the NovoTTF-100L device Disconnect the connection cable by grasping the connector on the grey sleeve and pulling out. To restart treatment, insert the connection cable connector in the grey connection cable socket. -
Page 23: Carrying The Device
∞ Do not place the device in a bag not intended for use with the NovoTTF-100L device. ∞ In order to wear the bag, place the strap over your shoulder or use the backpack option ∞... -
Page 24: Glossary Of Graphic Symbols
Li-ion The novoTTF-100L device and additional 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 Applied part –... - Page 25 Expiration date – do not use beyond this date YYYY-MM Power ON / OFF switch for the NovoTTF-100L device: When the switch is in the I position the device is ON When the switch is in the O position the device is OFF...
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Page 26: 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 conditions specified below: ∞ Mainly for home use. ∞ For indoor use only (chargers, power supply, battery rack) ∞ Not for use in shower, bath tub or sink, or in heavy rain ∞... -
Page 27: Troubleshooting
7. Restart treatment 8. If alarm persists, turn OFF and call a Novocure representative Low Battery indicator 1. Charger malfunction 1. Replace battery or power supply with a fully charged remains on after battery. - Page 28 2. Device malfunction If problem persists: device 1. Press TTFields button to stop therapy. 2. Turn OFF power switch 3. Call Novocure representative Device dropped Incorrect use 1. Press TTFields button to stop therapy. or wet 2. Turn OFF power switch 3.
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Page 29: Assistance & Information
The system’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 nCompass™ Support if you have questions related to travel restrictions. Note: The NovoTTF-100L System and transducer arrays will activate metal detectors. Assistance & Information... -
Page 30: Malignant Pleural Mesothelioma (Mpm)
These side effects include pain, hair loss, skin irritation, nausea, vomiting, loss of appetite, effects related to breathing, and tiredness. NovoTTF-100L System leads to skin related problems under the transducer arrays in many people. - Page 31 ©2019 Novocure. All rights reserved. NovoTTF-100L System and Novocure are trademarks of Novocure. Document Number: QSD-QR-371. Revision 01.1. Release Date: May 2019...
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