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BIOTRONIK EVIA Скачать руководство пользователя страница 16

15

General Safety Instructions

Possible Electromagnetic Complications

Electromagnetic

interference (EMI)

Any implant can be sensitive to interference, for example, when external signals
are sensed as intrinsic rhythm or if measurements prevent rate adaptation.

• BIOTRONIK implants have been designed so that their susceptibility to EMI is

minimal.

• Due to the intensity and variety of EMI, there is no guarantee for safety. It is gen-

erally assumed that EMI produces only minor symptoms in patients - if any.

• Depending on the pacing mode and the type of interference, sources of interfer-

ence may lead to pulse inhibition or triggering, an increase in the sensor-
dependent pacing rate or fixed-rate pacing.

• Under unfavorable conditions, for exam

ple during diagnostic or therapeutic

procedures, the interference sources may induce such a high level of energy
into the pacing system that the implant or cardiac tissue around the lead tip is
damaged.

Implant behavior

in case of EMI

Upon exceeding the interference rate, th

e implant switches to another pacing

mode. Depending on whether the interference occurs in one chamber or both
chambers, the implant switches to the A00(R), V00(R) or D00(R) mode for the dura-

tion of the interference.

Static magnetic fields

The Reed contact in the pacemaker closes be

ginning at a field strength of 1.5 tesla.

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Содержание EVIA

Страница 1: ...improvement 2009 D xx BIOTRONIK Home Monitoring and Entovis are registered trademarks of BIOTRONIK GmbH Co KG This product conforms with the directives 90 385 EEC relating to active implantable medica...

Страница 2: ...sbiotronik Evia DR T DR SR T SR Pacemaker Bradycardia therapy Technical manual for the implant Doc Id 365353 A Index 365353 ATechnical manual for the implantEvia DR T DR SR T SR...

Страница 3: ...2...

Страница 4: ...ications 13 Possible Technical Complications 14 Possible Electromagnetic Complications 15 Possible Risks 16 Prior to Implantation 17 Indications and Contraindications 17 Ambient Conditions 18 Sterilit...

Страница 5: ...ensing DR T 38 Pacing and Sensing SR T 40 Rate Adaptation 41 Preset Programs DR T 42 Preset Programs SR T 44 Tolerances of Parameter Values 45 Technical Data 47 Mechanical Characteristics 47 Electrica...

Страница 6: ...icular or AV sequential pacing Diagnosis and therapy forms The cardiac rhythm is automatically monitored and bradycardia arrhythmias are treated All major therapeutic approaches from the field of card...

Страница 7: ...d are equipped for active or passive fixation They are implanted using a lead introducer set Some leads are coated with polyurethane to increase the sliding properties of the lead The coating of stero...

Страница 8: ...ew of the analysis results is displayed for the attending physicians on the protected Internet platform HMSC Home Monitoring Service Center Data transmission from the implant is performed on a daily b...

Страница 9: ...riant with Home Monitoring Variant without Home Monitoring Dual chamber Evia DR T Evia DR Single chamber Evia SR T Evia SR Note The setting of the pacing mode depends on the individual diagnosis the m...

Страница 10: ...varying amplitudes The sensitivity for the atrium and ventricle is adapted automatically on an ongoing basis The measurement data are averaged and the trend can be displayed Thresholds atrial as well...

Страница 11: ...impedances Current statistics on bradycardia therapy Individually adjustable remote interrogation messages which enhance the standard message with additional information relevant for follow up IEGM o...

Страница 12: ...s the following Implant Screwdriver Order numbers Evia The implants can be obtained as follows Accessories All BIOTRONIK products correspond to the requirements of the EC Directive 90 385 EEC BIOTRONI...

Страница 13: ...12 Product Description...

Страница 14: ...during tests or subsequent electrophysiolog ical examinations In rare cases the set parameters may become ineffective In particular it cannot be excluded that tachyarrhythmias be induced Skeletal myo...

Страница 15: ...echnical Complications Technical malfunctions Technical implant malfunctions cannot entirely be excluded Possible causes can include the following Lead dislocation Lead fracture Insulation defects Imp...

Страница 16: ...es of interfer ence may lead to pulse inhibition or triggering an increase in the sensor dependent pacing rate or fixed rate pacing Under unfavorable conditions for example during diagnostic or therap...

Страница 17: ...cedures are contraindicated Therapeutic ultrasound and diathermy damage to the patient via excess warm ing of body tissue near the implant system Transcutaneous electrical nerve stimulation TENS Litho...

Страница 18: ...f r Kardiologie Herz und Kreislaufforschung and the ESC European Society of Cardiology Likewise those published by the Heart Rhythm Society HRS the American College of Cardiology ACC the American Hea...

Страница 19: ...in the implant The following temperatures are permitted for transport storage and use 10 C to 45 C 50 F to 113 F Storage location Implants are not to be stored close to magnets or sources of electroma...

Страница 20: ...aged Sterile container The implant and accessories are packaged respectively in two separately sealed plastic containers The inner plastic container is also sterile on the outside so that it can be tr...

Страница 21: ...cked implant is dropped on a hard surface during handling electronic parts could be damaged Use a replacement implant Send the damaged implant to BIOTRONIK 1 Peel off the sealing paper of the outer pl...

Страница 22: ...he implant pocket and prepare the vein 2 Implant the leads and perform measurements 3 Connect implant and leads The implant starts auto initialization on its own 4 Insert the implant 5 Guide the fixat...

Страница 23: ...ntricle to V 3 Push the lead connector into the header without bending the conduc tor until the connector tip becomes visible behind the set screw block 4 If the lead connector cannot be inserted comp...

Страница 24: ...rity or measurement of lead impedances is not necessary Behavior during auto initialization During reprogramming auto initialization is canceled and the transferred program is immediately active Durin...

Страница 25: ...diac events To prevent undersensing due to electromagnetic interference in special cases a trig gered pacing mode can be displayed Avoiding asynchronous pacing High pacing rates with long refractory p...

Страница 26: ...avior Set all parameters so as to prevent constant changing between atrial and ven tricular controlled modes If an ICD is implanted at the same time do not permit unipolar pacing If an ICD is implante...

Страница 27: ...26 Implantation...

Страница 28: ...the implant Follow up with the programmer Proceed as follows 1 Record and evaluate the external ECG 2 Check the pacing function 3 Interrogate the implant 4 Evaluate the status and automatically measu...

Страница 29: ...ular phones to the ear opposite the side on which the device is implanted Cellular phones should also be kept at least 15 cm away from the implant If the power of transmission is greater than 3 watts...

Страница 30: ...sic rate as well as the magnet rate After interrogation of the pacemaker Change of the pacing mode with ERI From dual chamber modes the pacemaker switches to single chamber pacing This replacement mod...

Страница 31: ...100 pacing and the data of the battery manufacturer For a lead impedance of 300 Ohm instead of 500 Ohm these times decrease by max 30 Parameter with high pulse energy 110 ppm 4 6 V 1 5 ms 500 Ohm Para...

Страница 32: ...nts should not be cremated Explant the implant before the cremation of a deceased patient Disposal BIOTRONIK takes back used products for the purpose of environmentally safe dis posal Clean the explan...

Страница 33: ...32 After Implantation...

Страница 34: ...available Implant type Pacing mode Standard DR T DDD CLS VVI CLS DDDR DDIR DVIR DOOR VDDR VDIR VVIR VVTR VOOR AAIR AATR AOOR DDD DDT DDI DVI DOO VDD VDI VVI VVT VOO AAI AAT AOO OFF DDDR SR T VVI CLS V...

Страница 35: ...ndard Rate hysteresis OFF 5 5 90 ppm OFF Repetitive hysteresis OFF 1 1 15 OFF Scan hysteresis OFF 1 1 15 OFF Parameter Range of values Standard AV delay Low medium high fixed individual Low AV delay 1...

Страница 36: ...FF ON ON Intervention rate 100 10 250 ppm 160 ppm Switch to mode DDI DDI R when permanent DDD R VDI VDI R when permanent VDD R DDIR VDIR Onset criterion 3 1 8 5 Resolution criterion 3 1 8 5 Change of...

Страница 37: ...ues Standard Far field protection after Vs 100 10 220 ms 100 ms Far field protection after Vp 100 10 220 ms 150 ms Ventricular blanking after Ap 30 5 100 ms 30 ms Parameter Range of values Standard PM...

Страница 38: ...22 3 140 5 200 ppm OFF Night begins 00 00 10 min 23 59 hh mm 22 00 hh mm Night ends 00 00 10 min 23 59 hh mm 06 00 hh mm Parameter Range of values Standard Rate hysteresis OFF 5 5 90 ppm OFF Repetitiv...

Страница 39: ...7 5 mV AUTO Parameter Range of values Standard Atrial capture control ATM monitoring only OFF OFF Min amplitude 0 5 1 4 8 V 1 0 V Threshold test start 2 4 3 0 3 6 4 2 4 8 V 3 0 V Safety margin 0 5 1...

Страница 40: ...ar Unipolar Parameter Range of values IEGM recordings 20 quantity each max 10 s Types of IEGM recordings High atrial rate HAR Mode switching MSW High ventricular rate HVR Patient triggered Pt IEGM rec...

Страница 41: ...mplitude 0 7 V 0 7 V Threshold test start 2 4 3 0 3 6 4 2 4 8 V 3 0 V Safety margin 0 3 1 1 2 V 0 5 V Search time Interval time of day Interval Interval 0 1 0 3 1 3 6 12 24 h 24 h Time of day 00 00 15...

Страница 42: ...low low medium high very high Medium Resting rate control OFF 10 10 50 ppm 20 ppm CLS required Yes no No Parameter Range of values Standard Sensor gain 1 23 4 Max activity rate 80 5 160 ppm 120 ppm A...

Страница 43: ...ety delay 100 ms Far field protection after Vs 100 ms Far field protection after Vp 150 ms Ventricular blanking period after Ap 32 ms PMT protection ON VA criterion 380 ms Magnet response AUTO AUTO Pu...

Страница 44: ...lly determined and set Pacing polarity Unipolar Unipolar Sensing polarity Unipolar Unipolar Automatic lead check A V ON ON Active capture control ATM OFF IEGM recording HAR ON OFF Home Monitoring OFF...

Страница 45: ...I In the AAI mode the safe program is also AAI Basic rate 60 ppm 70 ppm Night program OFF OFF Rate hysteresis OFF OFF Magnet response AUTO AUTO Pulse amplitude 3 0 V 4 8 V Pulse width 0 4 ms 1 0 ms Se...

Страница 46: ...se duration 0 1 0 4 ms 0 04 ms 0 5 1 0 ms 0 10 ms 1 25 1 5 ms 0 15 ms Sensitivity A 45502 2 1 Delta pulse 0 1 0 5 mV 0 10 mV 0 6 7 5 mV 20 Sensitivity V 45502 2 1 Delta pulse 0 5 7 5 mV 20 Refractory...

Страница 47: ...pm Magnet interval 664 ms 20 ms Pulse amplitude 0 2 V 0 10 V 0 3 7 5 V 20 25 Pulse width 0 1 0 4 ms 0 04 ms 0 5 1 0 ms 0 10 ms 1 25 1 5 ms 0 15 ms Sensitivity 45502 2 1 Delta pulse 0 5 7 5 mV 20 Refra...

Страница 48: ...FCC Rules and must not cause harmful interference to stations operating in the 400 150 406 000 MHz band in the Meteorological Aids i e transmitters and receivers used to communicate weather data the M...

Страница 49: ...ng pacing duration tb the pulse amplitude is reduced dependent on the pacing impedance Resistance to interference All variants of BIOTRONIK implants comply with the requirements of prEN 45502 2 2 2006...

Страница 50: ...150 LiS 3150M System LiJ Ag SVO CFx QMR LiJ LiMn02 Implant DR SR DR T SR T DR SR DR T SR T Battery voltage at BOS 2 8 V 3 0 V 2 8 V 3 1 V Open circuit volt age 2 8 V 3 0 V 2 8 V 3 1 V Nominal capacity...

Страница 51: ...months SR T by 8 months After 1 5 years DR T by 9 months SR T by 12 months Amplitude Impedance Ohms Pacing 10 50 100 SR T SR SR T SR SR T SR 1 5 V 500 23 3 21 3 21 7 19 8 19 9 18 3 1000 23 6 21 5 22...

Страница 52: ...ant will be registered with Industry Canada under the following number IC 4708A PRIMUS The code IC in front of the certification registration number only indicates that the technical requirements for...

Страница 53: ...Use by Storage temperature BIOTRONIK order number Serial number Product identification number Sterilization with ethylene oxide Resterilization prohibited Not for reuse Non sterile Usage information...

Страница 54: ...compatible leads example Silicone coated implant with NBG encoding and des ignation of the compatible leads example Screwdriver Position of connector ports in the header example Unipolar IS 1 connecto...

Страница 55: ...54 Technical Data...

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