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novocure Optune NovoTTF 200A, User Manual

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novocure Optune NovoTTF 200A User Manual Download Page 38

30

19

Glossary of Graphic Symbols

For INE transducer Arrays

The INE Transducer arrays are sterilized by Gamma 
irradiation

Do not resterilize

Do not 

use the INE Transducer arrays if their packaging is 

breached

The INE Transducer arrays are for single use 
and should not be re-used

Protect from heat and radioactive sources

Do not 

expose the INE Transducer arrays to water

Fragile, handle with care

Temperature range for storage is between 
5°C and 27°C

Consult instructions for use

Caution

Medical device

Batch code

Summary of Contents for Optune NovoTTF 200A

Page 1: ...USER MANUAL...

Page 2: ...Document number QSD EUUM 002 EN Version 02...

Page 3: ...cer Arrays On Your Head 18 12 Connecting the INE Transducer Arrays to the Device 20 13 Starting Stopping the Device 21 14 Connecting Disconnecting the Battery 18 15 Charging the Battery 22 16 Using th...

Page 4: ...4 This manual is intended for patients receiving TTFields treatment using the Optune Treatment Kit and INE Transducer arrays Sterile...

Page 5: ...tune does not need regular maintenance The Optune Treatment Kit also does not have any settings for you to change The only things you need to do are check that the device has a power source connected...

Page 6: ...hould be started more than 4 weeks after surgery and radiation therapy with adjuvant Temozolomide Treatment may be given together with maintenance Temozolomide according to the prescribing information...

Page 7: ...sed on electrocardiogram ECG stickers or transcutaneous electrical nerve stimulation TENS electrodes In this case skin contact with the gel used with Optune Treatment Kit may commonly cause increased...

Page 8: ...teroids 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 infec...

Page 9: ...f time Getting the INE Transducer arrays very wet is likely to cause the INE Transducer arrays to come loose from your head If this happens the device will operate the notification signal and you will...

Page 10: ...r supply you may have a break in your treatment Breaks in treatment may lower your chance to respond to treatment Notice Batteries may weaken over time and need to be replaced You will know this has h...

Page 11: ...In the clinical study half of the patients in both groups lived for more than 6 4 months 22 out of each 100 patients lived for one year or longer Patients using Optune after their tumor reappeared ha...

Page 12: ...to be alive longer than patients who used temozolomide alone Benefit of Optune Temozolomide Half of Patients in Study All Patients in Study Correct use Almost 5 months longer Almost 7 months longer A...

Page 13: ...PS9100 2 Charger for batteries Model ICH9100 3 Insulated Transducer array INE Model INE9020 and INE9020W 4 Device battery carrying bag Model BAG9100 5 Optune electric field generator the Device Model...

Page 14: ...ssible You will need to learn how to place it in a carrying bag connect a battery and operate the system The following controls will allow you to operate the Optune device 1 Optune power button 2 Powe...

Page 15: ...your next visit to your physician Before using an INE Transducer array make sure its package is sealed Do not use an INE Transducer array which has been opened previously Although the transducer arra...

Page 16: ...rom Its Package Wash your hands before opening the envelope with the INE Transducer Arrays Open the see through envelope of four 4 INE Transducer arrays by gently pulling apart the opposing edges of t...

Page 17: ...hesive from previous INE Transducer arrays Baby oil is used to remove remaining adhesive It will not stop the device from working Shave your entire scalp using an electric shaver Do not leave any stub...

Page 18: ...ransducer array goes where on your head The INE Transducer array locations and colors are front back black right left white Prepare your skin for the INE Transducer arrays as described in Section 4 Pe...

Page 19: ...19...

Page 20: ...ay with the black connector into the black socket labeled N1 see diagram Connect the other three INE Transducer array connectors in the same way Press firmly to be sure the connectors are pushed in al...

Page 21: ...front of the device will light up green If a charged battery is installed and there is no power supply plugged in the Battery indicator will also light up green If a power supply connected to the main...

Page 22: ...d ON a notification signal will sound indicating that the device is ON but the therapy is OFF This is a reminder to start the therapy The therapy button should be pressed once to silence the notificat...

Page 23: ...fixing problems Restart the device and restart treatment if no problem is found If the notification signal does not stop contact technical support Section 16 c When the Low Battery indicator lights up...

Page 24: ...the TTFields button on the front of the device to stop the notification signal The red Error and the yellow Battery lights will turn off 2 Turn off the device using the on off switch 3 Replace the bat...

Page 25: ......

Page 26: ...ttery slot Optune 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...

Page 27: ...battery with a charged battery Option One to be used if near the direct wall power supply allows you to change the battery without interrupting therapy This can be used before the battery is complete...

Page 28: ...or the system to run a self check this takes about 10 seconds then press the TTFields button see Section 6 Place the used battery in the charger for recharging as described in Section 9 Checking the B...

Page 29: ...21 Full Charge Empty 25 Charge 50 Charge 75 Charge...

Page 30: ...ng green indicates that the battery is charging The light will flash faster when the battery reaches approximately 80 of a full charge 5 When the battery is fully charged about 4 to 5 hours the charge...

Page 31: ...only when the power cable is physically disconnected either from the mains or from the charger itself Notice The charger is considered class II equipment without signal input output and applied part...

Page 32: ...wer Supply 1 Plug in the power supply to a standard wall outlet using the power cord that comes with the system 2 You do not need to remove the battery from the device to use the plug in power supply...

Page 33: ...before removing the plug in power supply The device will automatically switch to battery power once the power supply is removed 2 Remove the connector of the plug in power supply from the socket on th...

Page 34: ...cable plugs into the device in the socket on the left of the front panel The connection cable socket has a picture of a person next to it and a white ring around it The connection cable plugs into the...

Page 35: ...e device using the power button Unplug the connection cable from the socket by holding the sleeve and pulling Do not pull on the cord You may now move around without the device but you will still be c...

Page 36: ...ng the TTFields button 2 Turn off the Optune device using the power button 3 Unplug the transducer array connectors from the connection box by pulling as shown in the picture below You may have to wig...

Page 37: ...he 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 Optune has a fan that needs airflow The bag that comes with the devic...

Page 38: ...INE Transducer arrays if their packaging is breached The INE Transducer arrays are for single use and should not be re used Protect from heat and radioactive sources Do not expose the INE Transducer a...

Page 39: ...that are used up or no longer in use For Device Caution Consult the instructions for use for important cautionary information such as warnings and precautions Date of Manufacturing Fragile handle with...

Page 40: ...nt 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 Power ON OFF switch for Opt...

Page 41: ...33 Serial Number Class II equipment per IEC 60601 1 Medical device...

Page 42: ...re not intended for use in a shower a bath tub or a sink or in heavy rain Also they are not for use in presence of flammable mixtures If any system parts are dropped on floor there shall be no safety...

Page 43: ...water Transportation of the INE Transducer arrays shall be possible using air ground transportation in weather protected conditions as specified below Temperature range 0 C 40 C No direct exposure to...

Page 44: ...ks If the redness gets worse 1 See your treating doctor Blisters beneath the INE Transducer arrays Rare side effect See your treating doctor Itching beneath the INE Transducer arrays Rare side effect...

Page 45: ...d If Low Battery indicator is on 1 Replace battery as described above 2 Turn on treatment If the Error indicator lights up but the Low Battery indicator is not lit 1 Press the TTfields button to stop...

Page 46: ...should appear to be damaged or broken in any way 4 If device cannot be powered on by both the battery or the power supply or if anything appears to be damaged please reach out to your device support s...

Page 47: ...apy power the device down and reach out to your device support specialist Notification signal sounds several minutes after the device was powered on Therapy Timeout The device will operate the notific...

Page 48: ...p the notification signal 2 Wait a few seconds and try to re start therapy If the notification signal recurs within Stop the notification signal and power the device down completely Disconnect all plu...

Page 49: ...cream when switching transducer arrays 2 Shift transducer arrays 3 4 of an inch from the last location so the adhesive gel is between the red marks If the redness gets worse See your doctor Blisters u...

Page 50: ...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 51: ...cle processes EN ISO 15223 1 Medical devices Symbols to be used with medical device labels labeling and information to be supplied Sterile transducer arrays comply with the latest editions of the foll...

Page 52: ...ilization process for medical devices EN ISO 11137 2 Sterilization of health care products Radiation Part 2 Establishing the sterilization dose ISO 11137 3 Sterilization of health care products Radiat...

Page 53: ...45 BS EN 62368 1 Audio video information and communication technology equipment Safety requirements...

Page 54: ...to the power supply The applied part is classified as BF The system is not intended for use in the presence of flammable mixtures Disinfection is not required The INE Transducer arrays are provided s...

Page 55: ...ITY of the Optune Treatment Kit Table 1 Guidance and MANUFACTURER S declaration ELECTROMAGNETIC EMISSIONS for all ME EQUIPMENT and ME SYSTEMS Guidance and manufacturer s declaration electromagnetic em...

Page 56: ...uildings used for domestic purposes Harmonic emissions IEC 61000 3 2 Class A Voltage fluctuations flicker emissions IEC 61000 3 3 Complies Warning The Optune Treatment Kit the ICH9100 charger and the...

Page 57: ...E UT is the a c mains voltage prior to application of the test level Guidance and manufacturer s declaration electromagnetic immunity The ICH9100 charger and the SPS9100 power supply are intended for...

Page 58: ...power quality should be that of a typical commercial or hospital environment Power frequency 50 60 Hz magnetic field 3 A m 3 A m Power frequency magnetic fields should be at levels characteristic of a...

Page 59: ...that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Conducted RF IEC 3 Vrms 3 Vrms Portable and mobile RF communications eq...

Page 60: ...on from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadc...

Page 61: ...the maximum output power of the communications equipment Separation distance according to frequency of transmitter m Rated maximum output power of transmitter W 150 kHz to 80 MHz 80 MHz to 800 MHz 80...

Page 62: ...e glioblastoma grade IV glioma or grade IV astrocytoma INE Transducer Array array of insulated transducers applied to the scalp to deliver the TTFields Local in one part of the body MRI scan a procedu...

Page 63: ...ue using the equipment if it passed its expected service life and do not stop the treatment Optune device and additional parts expected service life is as below Optune device 12 months Connection cabl...

Page 64: ...56 Manufactured by Novocure GmbH Business Village D4 Park 6 Platz 10 Root 6039 Switzerland MDSS GmbH Schiffgraben 41 30175 Hannover Germany...

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