novocure Optune User manual

PATIENT INFORMATION
AND OPERATION MANUAL

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Table of Contents
2 Glossary of Medical Terms......................................................................................................................................................................3
3What Is Optune®and How Does It Work? ..........................................................................................................................................4
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
10 Overview of Transducer Arrays ............................................................................................................................................................16
11 Before You Put on the Transducer Arrays......................................................................................................................................... 17
12 Removing the Transducer Arrays from the Package......................................................................................................................18
13 Prepare Your Head for Transducer Array Placement.....................................................................................................................19
14 Place the Transducer Arrays on Your Head..................................................................................................................................... 20
15 Connect the Transducer Arrays to the Device.................................................................................................................................21
16 Disposal ......................................................................................................................................................................................................21
17 Connecting & Disconnecting the Portable Battery ....................................................................................................................... 22
18 Charging the Portable Battery ............................................................................................................................................................. 24
19 Using the Plug-In Power Supply ..........................................................................................................................................................27
20 The Connection Cable & Connection Box...................................................................................................................................... 28
21 The Electric Field Generator ................................................................................................................................................................ 30
22 To Start & Stop the Device ....................................................................................................................................................................31
23 Carrying the Device................................................................................................................................................................................ 34
24 Glossary of Graphic Symbols................................................................................................................................................................35
25 Storage and Transportation by the Distributer................................................................................................................................ 36
26 Troubleshooting.......................................................................................................................................................................................37
27 Assistance & Information ...................................................................................................................................................................... 39
28 Traveling with Optune ........................................................................................................................................................................... 39
29 Brain Cancer............................................................................................................................................................................................. 40
30 Emitted Radiation & Electromagnetic Compatibility ......................................................................................................................41
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2 Glossary of Medical Terms
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) – a type of brain cancer; other medical names for GBM are “glioblastoma”, “grade IV
glioma” or “grade IV astrocytoma”
Local – in one part of the body
MRI scan – a procedure that uses a magnet to create pictures of areas inside the body
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,
transducer arrays, power supply and carrying case
Radiation – a treatment involving x-rays used to kill tumor cells
Recurrence/Recurrent – when cancer comes back after removal
Steroids – when taken by mouth or IV (through the vein), a medication used to lower swelling around a brain tumor and
help with symptoms related to the brain. When used on the skin, a medication that can reduce inflammation
Systemic – throughout the body
Temozolomide (TMZ) – a type of cancer drug used to treat newly diagnosed GBM
Topical – on the surface of the skin
Transducer Array – adhesive bandages that hold insulated ceramic discs that deliver TTFields to the scalp
TTFields – Tumor Treating Fields: Alternating electric fields, delivered using transducer arrays to the part of the body with
a solid tumor. The fields have been shown to destroy tumor cells
Tumor – an abnormal growth of tissue
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3 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.
A doctor may use Optune to treat a patient with newly diagnosed brain cancer (called glioblastoma multiforme,
or “GBM”) in the higher parts of the brain, together with temozolomide (a type of cancer drug).
A doctor may also use Optune to treat a patient with GBM that reappears after they have had chemotherapy
(cancer drugs). When Optune is used after it reappears it is used alone, instead of standard medical therapy for GBM.
Optune is a portable device. It produces electric fields, called tumor treatment fields (“TTFields”). Transducer arrays
connected to the device deliver TTFields to your head. The TTFields are intended to destroy brain cancer cells.
The device and battery are carried in a shoulder bag. You should use them all the time.
In this manual, the term “Optune Treatment Kit” refers to the Electric Field Generator (also called “the device”),
connection cable, transducer arrays, power supply, battery and battery charger.
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4 Contraindications, Warnings and Precautions
Contraindications
Do not use Optune®if you have an active implanted medical device, a skull defect (such as, missing bone with no
replacement) or bullet fragments. Examples of active electronic devices include deep brain stimulators, spinal cord
stimulators, vagus nerve stimulators, pacemakers, defibrillators and programmable shunts. Use of Optune together
with implanted electronic devices has not been tested and may lead to malfunctioning of the implanted device.
Use of Optune together with skull defects or bullet fragments has not been tested and may possibly lead to tissue
damage or render Optune ineective.
Do not use Optune if you are known to be sensitive to conductive hydrogels 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 Optune may commonly cause increased redness and itching, and rarely may even lead to severe allergic
reactions such as shock and respiratory failure.
Warnings
Warning – Use Optune only after receiving training from qualified personnel, such as your doctor, a nurse, or other
medical personnel who have completed a training course given by the device manufacturer (Novocure). Ask to see a
certificate signed by Novocure that says they completed a training course. Your training will include a detailed review
of this manual and practice in the use of the system. In addition, you will be trained in what to do if there are problems
with treatment. Use of Optune without receiving this training can result in breaks in treatment and may rarely cause
increased scalp rash, open sores on your head, allergic reactions or even an electric shock.
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 eects the device may cause
in these cases or if it will be eective.
Warning – Do not use Optune 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 was not tested
in pregnant women. It is unknown what side eects the device may cause if you are pregnant or if it will be eective.
Warning – In case of skin irritation, which appears as redness under the transducer arrays (a mild rash), use high potency
topical steroids (your doctor can prescribe this for you) when replacing transducer arrays. This will help relieve your
skin irritation. If you do not use this cream, the skin irritation can become more serious and may even lead to skin
break down, infections, pain and blisters. If this happens, stop using the topical steroid cream and contact your doctor.
Your doctor will supply you with an antibiotic cream to use when replacing transducer arrays. If you do not use this
cream, your symptoms may continue and your doctor may ask you to take a break from treatment until your skin heals.
Taking a break from treatment may lower your chance to respond to treatment.
Warning – All servicing procedures must be performed by qualified and trained personnel. If you attempt to open and
service the system alone you may cause damage to the system. You could also get an electric shock by touching the
inner parts of the device.
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