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Appendix E – Expected Service Life

Expected service life reflects the average time during which the equipment specified

below is expected to work without malfunctioning. Please continue 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 cable – 11 months

Power supply – 5 years

Battery – 11 months (or until the expiration date)

Charger – 7 years

INE arrays have an expiration date. Please do not use the arrays after the expiration date.

Содержание Optune NovoTTF 200A

Страница 1: ...USER MANUAL...

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

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 19: ...19...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 25: ......

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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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