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BIOTRONIK SE & Co. KG
Woermannkehre 1
12359 Berlin · Germany
Tel +49 (0) 30 68905-0
Fax +49 (0) 30 6852804
[email protected]
www.biotronik.com

12-D-xx
Revision: B (2012-xx-xx)

to modification, revision and improvement.

® BIOTRONIK Home Monitoring, IEGM-Online HD

and SMART Detecton are registered trademarks

of BIOTRONIK SE & Co. KG

0123

0681 2012

393468--B_GA_Ilesto-II_mul-01xx_Cover.indd 2

27.09.2012 15:44:48

Содержание ICD Series

Страница 1: ...xxx xxx Technical Manual Technická příručka Brugermanual Gebrauchsanweisung Manual técnico Käyttöohje Manuel technique Manuale tecnico di istruzione Gebruikshandleiding Instrukcja obsługi Manual técnico Bruksanvisning en cs da de es fi fr it nl pl pt sv 393468 B_GA_Ilesto II_mul 01xx_Cover indd 1 27 09 2012 15 44 48 ...

Страница 2: ...nik com 12 D xx Revision B 2012 xx xx BIOTRONIK SE Co KG All rights reserved Specifications subject to modification revision and improvement BIOTRONIK Home Monitoring IEGM Online HD and SMART Detecton are registered trademarks of BIOTRONIK SE Co KG 0123 0681 2012 393468 B_GA_Ilesto II_mul 01xx_Cover indd 2 27 09 2012 15 44 48 ...

Страница 3: ... T ICD Family Tachyarrhythmia Therapy Cardiac Resynchronization Therapy Technical Manual for the Device Doc Id GA HW_en mul_393468 B Index GA HW_en mul_393468 BTechnical nbsp Manual for the nbsp DeviceIlesto 5 7 VR T VR T DX DR T HF T ...

Страница 4: ...2 ...

Страница 5: ...14 Possible Risks 15 Implantation 17 Implantation Procedure 17 Precautionary Measures while Programming 21 Magnet Response 24 Follow up 25 Patient Information 26 Replacement Indications 27 Explantation and Device Replacement 28 Parameters 29 Bradycardia CRT 29 Tachycardia 33 Sensing 35 Diagnostics 36 Home Monitoring 37 Technical Data 39 Mechanical Characteristics 39 Electrical Characteristics 40 B...

Страница 6: ...4 Table of Contents ...

Страница 7: ...dynamically not toler ated VT with shock delivery Cardiac resynchronization through multisite ventricular pacing triple chamber devices Compensation of bradycardia through ventricular single chamber devices or AV sequential pacing DX dual and triple chamber devices Diagnosis and therapy forms The device monitors the heart rhythm and automatically detects and terminates cardiac arrest resulting fro...

Страница 8: ...and dual chamber Single chamber and dual chamber ICDs are indicated for patients with the fol lowing risk Sudden cardiac death caused by ventricular arrhythmias Triple chamber Triple chamber ICDs are indicated for patients with the following risks Sudden cardiac death caused by ventricular arrhythmias Congestive heart failure with ventricular asynchrony Also indicated for primary prophylaxis in co...

Страница 9: ...potential antipole during shock delivery or in the case of unipolar lead configuration DF 1 IS 1 or DF4 IS 1 BIOTRONIK provides ICDs with headers for different standardized lead connec tions DF 1 IS 1 and DF4 IS 1 DF 1 IS 1 lead connection The device labeling provides information pertaining to possible lead connections depending on the device type and pertaining to connection assignment Note The d...

Страница 10: ... Programmer Implantation and follow up are performed with BIOTRONIK s portable pro grammer There is one with integrated RF telemetry and one with a separate SafeSync Module The programmer is used during implantation to transfer the current device program to the device The pacing thresholds can be determined and all tests can be performed during in office follow up In addition to this the programme...

Страница 11: ...f the single chamber device V Shock in the ventricle V Antitachycardia pacing ATP in the ventricle E Detection via IEGM analysis D Pacing in the atrium and ventricle D Sensing in the atrium and ventricle D Pulse inhibition and pulse triggering R Rate adaptation D Pacing in the atrium and ventricle D Sensing in the atrium and ventricle D Pulse inhibition and pulse triggering R Rate adaptation V Mul...

Страница 12: ...ded immediately A test message can be initiated at any time using the programmer to immedi ately check the Home Monitoring function Technical manuals The following technical manuals provide information about usage of the device sys tems Technical manual for the implant Technical manual for the HMSC Technical manuals for the programmer and the SafeSync Module Technical manual for device programs as...

Страница 13: ...The ICD can treat ventricular tachyarrhythmia with cardioversion and or defi brillation Shock polarity and energy can be programmed individually Shock energies between 2 0 and 40 J are possible Before delivery of the shock the ICD can be set to only deliver a shock when ongoing tachyarrhythmia is con firmed during this time period the device can identify spontaneous conversion of the tachyarrhythm...

Страница 14: ...e Service Center In addition to this test messages can be initiated using the programmer Appointments for Home Monitoring supported follow ups can be scheduled via the HMSC This applies to Ilesto 5 7 Important medical information in the device messages include the following Atrial and ventricular arrhythmias Parameters relevant to leads in the atrium and ventricle pacing thresh olds sensing amplit...

Страница 15: ... programmer after loading the device program it is deactivated during implantation on initial measurement of the pacing impedance Temperature Extremely low and high temperatures affect the service time of the battery in the device Temperatures of 5 C to 45 C are permitted for transport storage and use Sterile delivery The device and the screwdriver have been gas sterilized Sterility is guaranteed ...

Страница 16: ...g if the interference rate is exceeded Possible technical failures Technical failure of a device system cannot be entirely ruled out Possible causes can include the following Lead dislodgement lead fracture Insulation defects Device component failures Battery depletion Interrupted telemetry Electromagnetic interfer ence EMI Any device can be sensitive to interference if external signals are sensed...

Страница 17: ...e patient during and after every intervention External defibrillation The device is protected against the energy that is normally induced by external defi brillation Nevertheless any implanted device may be damaged by external defi brillation Specifically the current induced in the implanted leads may result in necrotic tissue formation close to the electrode tissue interface As a result sensing p...

Страница 18: ... the associated magnetic flux density damage or destruction of the device system by strong magnetic interaction and damage to the patient by exces sive warming of the body tissue in the area surrounding the device system Under certain conditions one can perform special measures with magnetic res onance imaging to protect the patient and device ...

Страница 19: ...telemetry or with sepa rate SafeSync Module and approved cable External multi channel ECG device Keep spare parts for all sterile components Keeping an external defi brillator ready In order to be able to respond to unforeseeable emergencies or possible technical failures of the device Keep an external defibrillator and paddles or patch electrodes ready Unpacking the device Peel the sealing paper ...

Страница 20: ...ened or tightened Loosen set screws with the supplied screwdriver Use only BIOTRONIK screw drivers with torque control Do not forcibly pull out the blind plug If lead repositioning is necessary re order sterile screwdrivers from BIO TRONIK Preventing short circuits in the header Ensure that connections are clean In case of contamination during implantation Clean lead connectors with a sterile clot...

Страница 21: ...e set screw block This indicator can vary depending on the manufacturer of the lead used 5 If you cannot easily plug the lead connector into the connection Use only sterile water as lubricant 6 If the lead connector cannot be inserted completely the set screw may be protruding into the drill hole of the set screw block Use the screwdriver to perpendicularly pierce through the slitted point in the ...

Страница 22: ...ove the programming head Activating ICD therapy Load the device program that is suitable for the device type in the programmer Activate ICD therapy Shipment mode is permanently deactivated once the leads have been con nected and initial measurement of the pacing impedance has been performed The device data are saved Take precautionary measures while programming If the device induces tachycardia wh...

Страница 23: ...itch off and reposition the programmer Turn off possible sources of interference Avoiding critical parameter settings No modes and parameter combinations that pose a risk to the patient should be set Prior to setting rate adaptation determine the patient s capacity for strain Check compatibility and effectiveness of parameter combinations after making settings Check for leads suitable for shock pa...

Страница 24: ...ot be terminated In rare cases chronic phrenic nerve stimulation cannot be terminated by repro gramming of the available left ventricular pacing configurations or by other mea sures As the case may be set a right ventricular mode both in the permanent program as well as the ATP in the post shock program and for mode switching Avoiding risks in the case of exclusive LV pacing Lead dislodgement in t...

Страница 25: ...ing implantation corresponds to approximately 10 days of service time and consumption during a 20 minute follow up corresponds to approximately 3 days Do not establish unnecessary RF telemetry After 5 minutes without input SafeSync switches to the economy mode Check the battery capacity of the device at regular intervals ...

Страница 26: ...nual activation or deactivation of the therapy before the device switches back to the previously set permanent therapy mode The same applies to programming head application to establish RF telemetry contact Application of a permanent magnet Applying a permanent magnet interrupts detection and therapy of tachycardia events After 8 hours of this type of deactivation the device automatically reacti v...

Страница 27: ...cian decides whether the data transmitted via Home Monitoring with regard to the patient s clinical condition as well as the technical state of the device system are sufficient If not an in office follow up has to be carried out Possible early detection due to information gained via Home Monitoring may necessitate an additional in office follow up For example the data may indicate at an early stag...

Страница 28: ... ference Electromagnetic interference should be avoided in daily activities Sources of interference should not be brought into close proximity with the device Draw the patient s attention to special household appliances security check points anti theft alarm systems strong electromagnetic fields cell phones and transmitters among other things Request patients to do the following Use cell phones on...

Страница 29: ...ion End of Service can be detected by Home Monitoring VT and VF detection and all therapies are deactivated The antibradycardia function remains active in the VVI mode Ventricular pacing RV basic rate 50 bpm without special pacemaker func tions such as hysteresis etc Pulse amplitude of 6 V pulse width of 1 5 ms Time of transmission for Home Monitoring 90 days CAUTION Temporally limited therapy If ...

Страница 30: ...t left in the patient then an additional uncontrolled current path to the heart can result Deactivate VT and VF therapies prior to device replacement Insulate connections that are not used Basic principles The device must not be resterilized and reused Cremation Devices should not be cremated Explant the device before the cremation of a deceased patient Disposal BIOTRONIK takes back used products ...

Страница 31: ... DR HF ICD therapy OFF ON ON x x x x Programs Display standard program Display safe program Display first interro gated program Individual 1 2 3 x x x x Parameter Range of values Standard VR DX DR HF Basic rate 30 5 100 10 160 bpm 40 bpm x x 60 bpm x x Night rate OFF 30 5 100 bpm OFF x x x x Begin of night 00 00 00 01 23 59 hh mm 06 00 hh mm x x x x End of night 22 00 hh mm Rate hysteresis OFF 5 5...

Страница 32: ...resis mode OFF Positive Negative IRSplus OFF x x OFF Positive Negative OFF x AV hysteresis positive 70 110 150 200 ms 70 ms x x x AV hysteresis negative 10 10 150 ms 50 ms x x x AV scan and repetitive positive OFF ON ON x x x Parameter Range of values Standard VR DX DR HF Post shock duration OFF 10 s 30 s 1 min 2 min 5 min 10 min 10 s x x x x Post shock basic rate 30 5 100 10 160 bpm 60 bpm x x x ...

Страница 33: ... Permanent RV BiV LV BiV x Triggering OFF RVs RVs PVC RVs x LV T wave protection OFF ON ON x Maximum trigger rate DDD R and VDD R UTR 20 90 10 160 bpm UTR 20 x DDI R VDI R and VVI R 90 10 160 bpm 130 bpm Initially paced chamber RV LV LV x VV delay after Vp 0 5 100 ms 5 ms x Parameter Range of values Standard VR DX DR HF PVARP AUTO 175 20 600 ms 225 ms x x x Blanking after atrial pacing 50 10 100 m...

Страница 34: ...e of values Standard VR DX DR HF Pulse amplitude A 0 5 0 25 4 0 0 5 6 0 7 5 V 2 5 V x x Pulse amplitude V RV x x x x Pulse amplitude LV x Pulse width A 0 4 0 5 0 25 1 5 ms 0 4 ms x x Pulse width V RV x x x x Pulse width LV 0 5 ms x Parameter Range of values Standard VR DX DR HF Capture control OFF ATM ON ATM x x x x Threshold test start 2 5 0 5 5 0 V ATM 2 5 V ON 3 5 V x x x x Minimum amplitude 1 ...

Страница 35: ...SMART detection ON Onset VT1 VT2 4 4 32 20 x x x Stability VT1 VT2 8 4 48 12 SMART detection OFF Onset VT1 VT2 OFF 4 4 32 20 x x x x Stability VT1 VT2 OFF 8 4 48 ms 24 ms Sustained VT OFF 1 2 3 5 10 20 30 min OFF x x x x Forced termination OFF 1 1 10 min 1 min x x x Parameter Range of values Standard VR DX DR HF ATP type for VT1 VT2 Burst Ramp OFF x x x x ATP type for VF OFF Burst Ramp Burst x x x...

Страница 36: ...FF 4 2 20 5 40 J 40 J x x x x 3rd nth shock for VT1 VT2 4 40 J 6 40 J 6 40 J x x x x 1 Shock for VF OFF 2 2 20 5 40 J 40 J x x x x 2 Shock for VF OFF 4 2 20 5 40 J 40 J x x x x 3rd nth Shock for VF 4 40 J 6 40 J 6 40 J x x x x For shock in VT1 VT2 and VF Confirmation OFF ON ON x x x x Polarity Normal Reverse Alternating Normal Waveform Biphasic Biphasic 2 Biphasig Shock path RV ICD SVC RV ICD RV S...

Страница 37: ... 50 75 50 x x x x Upper threshold LV 50 75 50 x Upper threshold duration after detection 110 150 50 500 ms VFS 110 ms 350 ms x x x x Upper threshold duration after pacing 400 ms Lower threshold RV 25 50 25 x x x x T wave suppression after pacing OFF ON OFF x x x x Minimum threshold A 0 2 0 1 2 0 mv 0 4 mv x x x Minimum threshold RV 0 5 0 1 2 5 mv 0 8 mv x x x x Minimum threshold LV 0 5 0 1 2 5 0 5...

Страница 38: ... ON x x x ON Periodic recording When Home Monitoring OFF OFF 30 30 180 days x x x x 90 days IEGM configuration RA RV LV RA RV FF FF RV LV x RA RV LV Parameter Range of values VR DX DR HF Standard Start resting period 0 00 1 00 23 00 hh mm x x x x 2 00 hh mm Duration of resting period 0 5 0 5 12 h x x x x 4 h AV delay modification in sensing test OFF 300 ms x x x 300 ms Thoracic impedance TI OFF ON...

Страница 39: ...ange of values Standard VR DX DR HF Home Monitoring OFF ON OFF x x x x Time of transmission STD 00 00 01 00 23 00 hh mm STD x x x x IEGM for Therapy episodes OFF ON ON x x x x Monitoring episodes Ongoing atrial episode OFF 6 12 18 h 12 h x x x ...

Страница 40: ...38 Parameters ...

Страница 41: ... IS 1 header Materials in contact with body tissue Housing Titanium Header Epoxy resin Blind plug and silicone plug Silopren or Silastik DF4 seal Silastik X ray identification NT Type Connection W x H x D in mm Volume in ccm Mass in g VR DX DR DF 1 65 x 55 x 11 31 80 HF DF 1 65 x 58 5 x 11 33 80 Type Connection W x H x D in mm Volume in ccm Mass g VR DF4 65 x 52 x 11 29 9 80 DR DF4 65 x 56 x 11 31...

Страница 42: ...ng in the 400 150 to 406 000 MHZ band and it must accept any interference received including interference that may cause undesired operation This device will be registered with Industry Canada under the following number IC 4708A TACHNXT The code IC in front of the certification registration number only indicates that the technical requirements for Industry Canada are met This device will be regist...

Страница 43: ...e programmed atrial sensitivity is intensified by a factor of 4 Shock energy peak voltage With shock path RV to housing SVC Rate Common mode rejection ratio Atrium DX Atrium DR HF V right VR DR HF V left HF 16 6 Hz 58 dB 53 dB 64 dB 66 dB 50 Hz 55 dB 55 dB 64 dB 66 dB 60 Hz 56 dB 56 dB 64 dB 68 dB only devices with a DF 1 IS 1 connection ATP amplitude Measured minimum Measured maximum Mean value R...

Страница 44: ...ings permanently set Capacitor reforming is performed 4 times per year and therefore at least 4 maximum charges for shocks have to be assumed per year even if less than 4 are delivered Calculation of the number of shocks Calculation of the number of shocks Longevity in years x number of shocks per year Ilesto 5 VR T Service times with GB 2992 or LiS 3410 RA battery Manufacturer GREATBATCH INC Clar...

Страница 45: ...in years at number of shocks per year 4 8 12 16 20 0 9 48 7 76 6 57 5 70 5 03 15 9 02 7 45 6 35 5 53 4 89 50 8 10 6 81 5 88 5 17 4 61 100 7 08 6 07 5 32 4 73 4 26 Stimulation Longevity in years at number of shocks per year 4 8 12 16 20 0 8 78 7 29 6 23 5 44 4 82 15 8 21 6 89 5 94 5 21 4 65 50 7 14 6 12 5 35 4 76 4 28 100 6 01 5 27 4 69 4 23 3 85 Stimulation Longevity in years at number of shocks p...

Страница 46: ...ars at number of shocks per year 4 8 12 16 20 0 10 73 8 82 7 48 6 50 5 74 15 10 22 8 47 7 23 6 31 5 59 50 9 20 7 76 6 70 5 90 5 27 100 8 05 6 92 6 07 5 40 4 87 Stimulation Longevity in years at number of shocks per year 4 8 12 16 20 0 9 96 8 29 7 10 6 20 5 51 15 9 33 7 85 6 77 5 95 5 31 50 8 12 6 97 6 11 5 43 4 89 100 6 85 6 01 5 36 4 83 4 40 ...

Страница 47: ...ges CE mark Contents Follow the instructions for use Sterilized with ethylene oxide Do not resterilize Do not reuse Do not use if packaging is damaged Non sterile Transmitter with non ionizing radiation at designated frequency Example Device NBG code and compatible leads Example Factory settings for therapy OFF Screwdriver Example of DF 1 IS 1 header Examples of DF 1 IS 1 or DF4 IS 1 header STERIL...

Страница 48: ...46 Technical Data Bipolar IS 1 connector Unipolar IS 1 connector Unipolar DF 1 connector DF4 connector ...

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