BIOTRONIK Evia HF Technical Manual

Manual is about: Implantable Pulse Generators

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Cardiac Rhythm Management

Heart Failure Therapy

Evia HF / HF-T

Technical Manual

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Summary of Evia HF

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Cardiac rhythm management heart failure therapy evia hf / hf-t evia hf / hf-t technical manual.
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Evia hf / hf-t implantable pulse generators evia hf / hf-t x-ray identification radiopaque identification a radiopaque identification code is visible on standard x-ray, and identifies the pulse generator: evia hf / hf-t sf caution because of the numerous available 3.2-mm configurations (e.G., the is...
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Page i table of contents evia hf / hf-t technical manual contents 1. Device description ...............................................................................................................1 2. Indications .......................................................................................
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Chapter table of contents evia hf / hf-t technical manual page ii 5.5.4.1 dynamic av delay ..................................................................................................31 5.5.4.2 av hysteresis .........................................................................................
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Chapter table of contents evia hf / hf-t technical manual page iii 5.18 home monitoring (evia hf-t) ......................................................................................60 5.18.1 transmission of information ...............................................................................
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Chapter table of contents evia hf / hf-t technical manual page iv 6.7.3 heart rate variability ..................................................................................................84 6.7.4 patient activity ....................................................................................
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Chapter table of contents evia hf / hf-t technical manual page v 10.6.1 description .............................................................................................................105 10.6.2 burst stimulation .................................................................................
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Chapter table of contents evia hf / hf-t technical manual page vi.
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Chapter 1 device description evia hf / hf-t technical manual page 1 1. Device description evia hf / hf-t is a multi-programmable, three chamber pulse generator with rate-adaptive pacing. The evia hf / hf-t pulse generator is biotronik’s state of the art pacing system with two methods of rate-adaptat...
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Chapter 1 device description evia hf / hf-t technical manual page 2 evia hf / hf-t is designed to meet all indications for bradycardia and resynchronization therapy as exhibited in a wide variety of patients. The evia hf / hf-t family is comprised of two crt-ps that are designed to handle a multitud...
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Chapter 2 indications evia hf / hf-t technical manual page 3 2. Indications the evia hf and evia hf-t cardiac resynchronization therapy pacemakers (crt-ps) are indicated for patients who have moderate to severe heart failure (nyha class iii/iv), including left ventricular dysfunction (ef ≤ 35%) and ...
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Chapter 2 indications evia hf / hf-t technical manual page 4.
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Chapter 3 contraindications evia hf / hf-t technical manual page 5 3. Contraindications use of evia hf / hf-t pulse generator is contraindicated for the following patients: • unipolar pacing is contraindicated for patients with an implanted cardioverter-defibrillator (icd) because it may cause unwan...
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Chapter 3 contraindications evia hf / hf-t technical manual page 6.
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Chapter 4 warnings and precautions evia hf / hf-t technical manual page 7 4. Warnings and precautions certain therapeutic and diagnostic procedures may cause undetected damage to a pulse generator, resulting in malfunction or failure at a later time. Please note the following warnings and precaution...
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Chapter 4 warnings and precautions evia hf / hf-t technical manual page 8 electrocautery electrocautery should never be performed within 15 cm (6 inches) of an implanted pulse generator or lead because of the danger of introducing fibrillatory currents into the heart and/ or damaging the pulse gener...
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Chapter 4 warnings and precautions evia hf / hf-t technical manual page 9 cross threading setscrew(s) to prevent cross threading the setscrew(s), do not back the setscrew(s) completely out of the threaded hole. Leave the torque wrench in the slot of the setscrew(s) while the lead is inserted. Tighte...
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Chapter 4 warnings and precautions evia hf / hf-t technical manual page 10 off mode use of the off mode should be avoided in pacemaker dependent patients. The off mode can be transmitted as a temporary program only to permit evaluation of the patient’s spontaneous rhythm. Myopotential sensing the fi...
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Chapter 4 warnings and precautions evia hf / hf-t technical manual page 11 use in cellular phone restricted areas the mobile patient device (transmitter/receiver) should not be utilized in areas where cellular phones are restricted or prohibited (i.E., commercial aircraft). 4.6 electromagnetic inter...
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Chapter 4 warnings and precautions evia hf / hf-t technical manual page 12 electronic article surveillance (eas) equipment such as retail theft prevention systems may interact with the pulse generators. Patients should be advised to walk directly through and not to remain near an eas system longer t...
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Chapter 5 programmable parameters evia hf / hf-t technical manual page 13 5. Programmable parameters for a complete list of programmable parameters and the available settings, see section 13. 5.1 pacing modes a complete list of pacing modes available in evia hf / hf-t is shown below. Figure 1: pacin...
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Chapter 5 programmable parameters evia hf / hf-t technical manual page 14 caution rate-adaptive pacing use rate-adaptive pacing with care in patients unable to tolerate increased pacing rates. Cls rate adaptation under certain circumstances (e.G., emi, lead dislodgment), the evia crt-p device may no...
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Chapter 5 programmable parameters evia hf / hf-t technical manual page 15 table 1: mode switching parameter summary intervention rate the intervention rate is the minimum atrial rate at which mode switching will occur and is programmable by the user. Switch to pacing switch to pacing is the mode the...
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Chapter 5 programmable parameters evia hf / hf-t technical manual page 16 the higher the resolution criterion, the harder it is to end a mode switching event. Conversely, the lower the value, the easier it is for mode switching to end. Basic rate during mode switching this refers to the basic pacing...
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Chapter 5 programmable parameters evia hf / hf-t technical manual page 17 the triggered pacing mode fixes the av delay to 180 ms and does not provide a safety av delay. Pacing modes with triggered response may be indicated in the presence of interference signals to prevent inappropriate pulse inhibi...
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Chapter 5 programmable parameters evia hf / hf-t technical manual page 18 caution programming modification extreme programming changes should only be made after careful clinical assessment. Clinical judgment should be used when programming permanent pacing rates below 40 ppm or above 100 ppm. 5.2.2 ...
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Chapter 5 programmable parameters evia hf / hf-t technical manual page 19 if hysteresis is used in the ddi mode, the av delay must be programmed shorter than the spontaneous av conduction time. Otherwise, stimulation in the absence of spontaneous activity occurs at the hysteresis rate instead of the...
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Chapter 5 programmable parameters evia hf / hf-t technical manual page 20 hysteresis rate b asic rate paced event 17 8 17 9 18 0 scan hysteresis programmed to 5 cycles 1 2 3 4 hysteresis rate b asic rate paced event 17 8 17 9 18 0 scan hysteresis programmed to 5 cycles sensed event hysteresis rate b...
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Chapter 5 programmable parameters evia hf / hf-t technical manual page 21 figure 6: night rate screen when night rate is active, the basic rate is reduced to the night rate using the sensor rate decrease value programmed in the device, even when the sensor is off. When night rate ends, evia crt-p us...
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Chapter 5 programmable parameters evia hf / hf-t technical manual page 22 the programmer automatically updates the pulse generator time-of-day clock each time the pulse generator is programmed. The actual time when the respective increase or decrease in rate occurs may begin up to 4 minutes after th...
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Chapter 5 programmable parameters evia hf / hf-t technical manual page 23 pacing outputs can be programmed in each chamber from 0.2 v to 7.5 v if capture control is inactive. Caution should be used when programming high outputs for an extended period of time, as this can result in reduced longevity....
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Chapter 5 programmable parameters evia hf / hf-t technical manual page 24 figure 8: pulse width note: when vcc is programmed to on or atm, the pulse width cannot be programmed to a value higher than 0.4 ms. 5.4 automatic sensitivity control (asc) chamber range default atrium auto, 0.1...(0.L)...1.5....
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Chapter 5 programmable parameters evia hf / hf-t technical manual page 25 figure 9: ensitivity screens for the atrium and ventricles automatic sensitivity control the automatic sensitivity control (asc) feature automatically measures the peak amplitude and adapts the sensing threshold automatically....
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Chapter 5 programmable parameters evia hf / hf-t technical manual page 26 post paced event summary following paced events, the detection hold-off period is extended slightly in all chambers to prevent oversensing of the paced complex. The step duration is twice that of sensed events to prevent t-wav...
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Chapter 5 programmable parameters evia hf / hf-t technical manual page 27 +/- minimum threshold 0.5 mv detection hold-off period (dhp) 2x step duratio n +/- sensitivity threshold from the previous event event detection pace event atrium dhp 120 ms step duration 82 ms post pace event – atrium - unipo...
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Chapter 5 programmable parameters evia hf / hf-t technical manual page 28 5.4.1 ventricular pacing parameter options ventricular pacing biv, rv ventricular pacing allows the user to program biv or rv only pacing, depending on the patient condition. The choice of biv pacing in this screen applies onl...
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Chapter 5 programmable parameters evia hf / hf-t technical manual page 29 5.5 timing features features related to pulse generator timing cycles. 5.5.1 refractory periods immediately upon sensing or pacing, the pulse generator starts a refractory period in the same channel. During the refractory peri...
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Chapter 5 programmable parameters evia hf / hf-t technical manual page 30 figure 15: pvarp timing table 6 shows the pvarp parameter values and ranges. Parameter name range standard value units pvarp auto, 175..(5)..600 250 ms ms pvarp after pvc pvarp + 150 ms to a maximum of 600 ms 400 ms ms table 6...
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Chapter 5 programmable parameters evia hf / hf-t technical manual page 31 5.5.4 av delay maximum av delay programmable value 350 ms maximum av delay programmable value with av hysteresis 450 ms i-opt av delay maximum 3 400 ms lower rate av delay upper rate av delay low 150 ms 120 ms medium 150 ms 75...
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Chapter 5 programmable parameters evia hf / hf-t technical manual page 32 rate ranges low below 70 bpm 70—90 bpm 91—110 bpm 111—130 bpm above 130 bpm 150 ms 140 ms 130 ms 120 ms 120 ms table 7: dynamic av delay settings in addition the dynamic av delays may be programmed individually for each rate r...
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Chapter 5 programmable parameters evia hf / hf-t technical manual page 33 av setting low medium high 15 ms 85 ms 125 ms 165 ms 50 ms 120 ms 160 ms 200 ms 75 ms 145 ms 185 ms 225 ms 100 ms 170 ms 210 ms 250 ms 120 ms 190 ms 230 ms 270 ms 130 ms 200 ms 240 ms 280 ms 140 ms 210 ms 250 ms 290 ms 150 ms ...
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Chapter 5 programmable parameters evia hf / hf-t technical manual page 34 5.5.4.4 av scan hysteresis with av scan hysteresis enabled, after 180 consecutive pacing cycles, the av delay is extended for the programmed number of pacing cycles. (1 … 10). If an intrinsic rhythm is detected within the exte...
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Chapter 5 programmable parameters evia hf / hf-t technical manual page 35 5.5.4.6 i-opt i-opt is a one-button feature designed to promote intrinsic activity in the ventricle. When programmed on, av hysteresis is extended to 400 ms, regardless of the programmed av delay. As the heart rate increases, ...
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Chapter 5 programmable parameters evia hf / hf-t technical manual page 36 the ax-vs interval distributions over the dynamic av delay screen as a way of guiding av delay and av hysteresis delay programming. Easyav neither modifies the programmed av delay settings nor does it make suggestions to the u...
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Chapter 5 programmable parameters evia hf / hf-t technical manual page 37 the blanking time shall be as short as possible in order to provide ventricular sensing when a ventricular depolarization could occur. Crosstalk may be encountered if a shorter blanking time, unipolar ventricular sensing, a hi...
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Chapter 5 programmable parameters evia hf / hf-t technical manual page 38 5.5.8 upper rate and utr response the upper rate is programmable (up to 200 ppm) for the dual chamber sensing modes [ddd-cls, ddd(r), vdd(r)], and for all triggered modes (single and dual chamber). The ventricular pacing rate ...
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Chapter 5 programmable parameters evia hf / hf-t technical manual page 39 lead polarity can be programmed separately for sensing and pacing in the atrium and ventricles. Figure 23: lv pacing options the programmed lead polarity determines whether the pulse generator senses or paces in a unipolar or ...
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Chapter 5 programmable parameters evia hf / hf-t technical manual page 40 the stimulation rate. Sensing and inhibition remains in effect during sensor controlled operation. In the case of high pacing rates, however, the refractory periods may cover a majority of the lower rate interval, resulting in...
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Chapter 5 programmable parameters evia hf / hf-t technical manual page 41 exertion is reached during maximum exercise levels. The rate increase, rate decrease and maximum sensor rate settings must be checked for their suitability with respect to the individual patient before adjusting the sensor gai...
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Chapter 5 programmable parameters evia hf / hf-t technical manual page 42 figure 27: automatic sensor gain 5.7.3 sensor threshold the effects of rate adaptation are limited to sensor signals exceeding the programmable sensor threshold. Sensor signals below this threshold do not affect rate response ...
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Chapter 5 programmable parameters evia hf / hf-t technical manual page 43 increase in rate (ppm/s) time to increase rate (seconds) 1 90 2 45 4 23 10 9 table 11: rate increase in ddir and dvir, the rate increase is slightly slower than indicated here (depending on the programmed av interval). The pro...
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Chapter 5 programmable parameters evia hf / hf-t technical manual page 44 5.7.7 rate decrease the rate decrease parameter determines the maximum rate of change in the pacing rate, if the sensor signal indicates decreasing exertion. In dddr, vddr, door, vvir, voor, aair, and aoor, the rate decrease s...
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Chapter 5 programmable parameters evia hf / hf-t technical manual page 45 termination the pulse generator will immediately mode switch to a non-atrial tracking mode (e.G., dddr to ddir) when the confirmation criteria have been met, and then the 2:1 lock-in management feature is suspended until the p...
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Chapter 5 programmable parameters evia hf / hf-t technical manual page 46 if an intrinsic event is detected during the 20 cycles of pacing, the device will again increase the pacing rate by 8 bpm and start a new 20-cycle interval up to a maximum rate of 120 bpm or msr. Programming of atrial overdriv...
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Chapter 5 programmable parameters evia hf / hf-t technical manual page 47 to prevent occurrence of a pmt, evia crt-ps start an atrial pmt protection interval after each ventricular paced event. If an atrial event is sensed within this pmt protection interval, this will neither start an av delay nor ...
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Chapter 5 programmable parameters evia hf / hf-t technical manual page 48 termination evia crt-p extends pvarp (post ventricular atrial refractory period) to the va interval + 50 ms. 5.12 adjustment of the pmt protection window the pmt protection window can be automatically adjusted. This automatic ...
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Chapter 5 programmable parameters evia hf / hf-t technical manual page 49 5.13.2 right/left ventricular capture control parameters figure 32: capture control screen capture control off, on, atm when ventricular capture control is off, the user can manually program the output based on current thresho...
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Chapter 5 programmable parameters evia hf / hf-t technical manual page 50 5.13.3 search type interval time of day this feature determines when the device performs a ventricular capture control test to check the current threshold. • interval — interval starts the next active threshold monitoring test...
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Chapter 5 programmable parameters evia hf / hf-t technical manual page 51 figure 33: vcc flow chart the feature includes three primary components: signal analysis, capture threshold search, and capture verification. The following paragraphs describe the operation of these three components (sa, atm, ...
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Chapter 5 programmable parameters evia hf / hf-t technical manual page 52 • if the first sa after activating vcc is completed successfully, but subsequent sa’s are not completed successfully, then vcc is suspended, and the pacing amplitude is programmed to the last measured threshold plus the safety...
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Chapter 5 programmable parameters evia hf / hf-t technical manual page 53 • the algorithm is designed to respond appropriately to fusion beats. In order to discriminate non- capture from fusion, a capture confirmation algorithm varies the av delay after detection of non- capture in the dual chamber ...
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Chapter 5 programmable parameters evia hf / hf-t technical manual page 54 • the ventricular rate is higher than 110 bpm: cv is suspended while the ventricular rate is higher than 110 bpm. When the ventricular rate drops below 110 bpm, cv is resumed. • mode switch: cv is suspended and the device is s...
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Chapter 5 programmable parameters evia hf / hf-t technical manual page 55 atrial event will be detected either due to the emerging intrinsic rhythm or due to retrograde conducted events caused by ventricular paces. The detection of sensed atrial activity is used to discriminate between atrial captur...
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Chapter 5 programmable parameters evia hf / hf-t technical manual page 56 off, on, atm when atrial capture control is off, the user can manually program the output based on current threshold and physician preference. When atrial capture control is on, the feature will determine the capture threshold...
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Chapter 5 programmable parameters evia hf / hf-t technical manual page 57 • time of day — the time of day allows the user to program a specific time of day when the active threshold monitoring test is performed. By default, the time is set to 2:00 a.M. This may be changed if the patient is sensitive...
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Chapter 5 programmable parameters evia hf / hf-t technical manual page 58 intelligent search this feature is designed to prevent frequent searches in patients without stable intrinsic ventricular activity. Each time the search is unsuccessful, the time interval is doubled from the previous interval,...
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Chapter 5 programmable parameters evia hf / hf-t technical manual page 59 programconsult is not an algorithm but uses preset settings based on the recommendations of the acc/aha/hrs guidelines for device based therapy. 5 programconsult only shows recommendations for specific parameter settings to th...
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Chapter 5 programmable parameters evia hf / hf-t technical manual page 60 hf with normal sinus function hf with permanent af hf with low cls response hf with medium cls response hf with high cls response mode ddd vvi-cls ddd-cls ddd-cls ddd-cls av delay 1 150 -- 150 150 150 av delay 2 140 -- 140 140...
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Chapter 5 programmable parameters evia hf / hf-t technical manual page 61 the implant’s home monitoring function can be used for the entire operational life of the implant (prior to eri) or for shorter periods, such as several weeks or months. Home monitoring can be utilized as a functional replacem...
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Chapter 5 programmable parameters evia hf / hf-t technical manual page 62 system requirements system recommendations (for optimal usage) screen resolution 1024 x 768 ≥ 1280 x 1024 internet bandwidth 56 kb/sec ≥ 128 kb/sec (dsl, cable modem) pc 800 mhz pentium processor, 128 mb ram n/a internet brows...
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Chapter 5 programmable parameters evia hf / hf-t technical manual page 63 • mode switch episode persisting beyond a programmable time limit note: the attending physician must notify the biotronik service center about which of these events he/ she wishes to be informed. 5.18.5 description of transmit...
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Chapter 5 programmable parameters evia hf / hf-t technical manual page 64 • mode switching • number of mode switches • duration of mode switches ventricular arrhythmia • high ventricular rate counters transmitted device settings the primary programmed parameters for the following are sent in the dat...
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Chapter 6 statistics evia hf / hf-t technical manual page 65 6. Statistics 6.1 statistics overview evia crt-ps can store a variety of statistical information. The various statistics consist of such features as rate histograms, event counters, sensor trends, ves statistics, and activity reports, whic...
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Chapter 6 statistics evia hf / hf-t technical manual page 66 6.1.1 general statistical information the evia crt-p statistics modes are always in operation and cannot be selected off. The counters within the statistic features do not operate when a magnet is applied to the pulse generator. The counte...
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Chapter 6 statistics evia hf / hf-t technical manual page 67 figure 35: event counters in the timing bradycardia statistics key points: lvs is only enabled when the feature lv t-wave protection is turned on. If this feature is not enabled, the lv pace will show 100% since the device will not have th...
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Chapter 6 statistics evia hf / hf-t technical manual page 68 figure 36: event sequences show the percentage of each of the pacing states key points: event episodes show the distribution of each state of pacing and, in hf-t devices, the distribution of resynchronized ventricular events. The first gra...
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Chapter 6 statistics evia hf / hf-t technical manual page 69 figure 37: rate trend 24 hours the rate trend 24 hour statistic, shown in figure 37 , counts the number of paced and sensed events and displays the information as a single data point in two different groups (heart rate and paced percentage...
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Chapter 6 statistics evia hf / hf-t technical manual page 70 6.2.4 rate trend 240 days figure 38: rate trend 240 days the rate trend 240 day statistic, shown in figure 38 , displays data in two different groups (heart rate and paced percentage). Data are collected every 24 hours and displayed on thi...
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Chapter 6 statistics evia hf / hf-t technical manual page 71 6.2.5 atrial and ventricular rate histogram figure 39: rate histogram in the heart rate histogram shown in figure 39 , the heart rate range is divided into 36 segments of 10 bpm bins ranging from less than 40 bpm to greater than 380 bpm. T...
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Chapter 6 statistics evia hf / hf-t technical manual page 72 6.3 arrhythmia statistics 6.3.1 atrial burden figure 40: atrial burden atrial burden is the percentage of time the patient is in an atrial tachycardia during a given day. The atrial-burden statistic, figure 40 , displays the number of atri...
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Chapter 6 statistics evia hf / hf-t technical manual page 73 percent of atrial burden is calculated based on the percentage of time out of the total follow-up duration that the patient was in at/af episodes. 6.3.2 time of occurrence the time of occurrence, shown in figure 41 , summarizes the times o...
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Chapter 6 statistics evia hf / hf-t technical manual page 74 the mode switching graph presents data as the number of mode switch events, as well as their total duration. The intervention rate for mode switch is listed on this page, as well. Note: if two mode switch events occur within 25 seconds of ...
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Chapter 6 statistics evia hf / hf-t technical manual page 75 note: pvc events that have an intrinsic atrial event occurring within 350 ms before the vs event will be classified as an asvs event and not a pvc. This is due to the as discrimination feature of evia crt-p, which is a hidden feature of th...
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Chapter 6 statistics evia hf / hf-t technical manual page 76 graph to closely match the rate histogram graph. The graph is divided into sixteen 10-beat bins. The duration of recording is displayed on the lower right corner. The user may use the arrow keys, or simply touch on any particular rate with...
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Chapter 6 statistics evia hf / hf-t technical manual page 77 6.4.2.2 activity this value reports any time that the sensor has detected patient activity. Presumably, most of this activity presents normal activities of daily living. Values that may appear too high or too low for that particular patien...
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Chapter 6 statistics evia hf / hf-t technical manual page 78 the lead impedance trend, shown in figure 46 , displays the impedance data collected since the last time the statistics were restarted. Impedance data is collected throughout the day, and the average value is displayed for the 24-hour peri...
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Chapter 6 statistics evia hf / hf-t technical manual page 79 figure 48: pulse amplitude histogram the pulse amplitude histogram, shown in figure 48 , displays the pulse amplitude of each paced event during the recording period. This data is displayed in the respective bins by count and overall perce...
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Chapter 6 statistics evia hf / hf-t technical manual page 80 • search pending • search delayed by mode switching • search block by noise • unstable rates present • search skipped due to unstable rates • signal quality insufficient • no stable threshold 6.6 sensing statistics 6.6.1 p- and r-wave tren...
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Chapter 6 statistics evia hf / hf-t technical manual page 81 figure 51: far-field histogram the far-field histogram in figure 51 provides information related to sensed events in the atrium occurring after ventricular paced or sensed events. Data is measured in 10 ms intervals. The maximum value meas...
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Chapter 6 statistics evia hf / hf-t technical manual page 82 the ap-vs interval distribution graph in figure 52 shows the ap-vs interval data at different rates. The as-vs interval is displayed for various rate ranges, labeled by the average heart rate. The programmed av delay and av hysteresis are ...
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Chapter 6 statistics evia hf / hf-t technical manual page 83 6.6.5 vp suppression this section provides information related to the number and amount of vp suppression that has occurred. Data in this section includes the number of vp suppression switches and the number of vs searches for vp suppressi...
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Chapter 6 statistics evia hf / hf-t technical manual page 84 6.7.3 heart rate variability heart rate variability, which is the standard deviation of the 5-minute mean normal to normal interval over the recorded time is available in the statistics of the evia hf / hf-t. This is based on the atrial ra...
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Chapter 6 statistics evia hf / hf-t technical manual page 85 • mean heart rate reports the average of the ventricular rate over a 24-hour period (based on vs, vp, vrs, and pvcs). • the resting heart rate reports minimum ventricular heart rate during the programmed resting period (default beginning a...
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Chapter 6 statistics evia hf / hf-t technical manual page 86 • maximum ventricular rate during episode • atrial iegm markers (i.E., atrial paced events, atrial sensed events, atrial unused or refractory sensed events) • ventricular iegm markers (i.E., ventricular paced events, ventricular sensed eve...
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Chapter 7 other functions/features evia hf / hf-t technical manual page 87 7. Other functions/features evia hf / hf-t pulse generators offer many additional functions and features to assist the physician in the care of the pacemaker patient. 7.1 safe program settings activating the preset values for...
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Chapter 7 other functions/features evia hf / hf-t technical manual page 88 7.3 temporary programming caution off mode – use of the off mode should be avoided in pacemaker dependent patients. The off mode can be transmitted as a temporary program only to permit evaluation of the patient’s spontaneous...
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Chapter 7 other functions/features evia hf / hf-t technical manual page 89 symptom, etiology and ecg indication are specified using the european passport code system. The passport code is an identification system of two character codes that represent specific conditions. A listing of the codes avail...
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Chapter 7 product storage and handling evia hf / hf-t technical manual page 90
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Chapter 8 product storage and handling evia hf / hf-t technical manual page 91 8. Product storage and handling 8.1 sterilization and storage the pulse generator is shipped in a cardboard box, equipped with a quality control seal and product information label. The label contains the model specificati...
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Chapter 8 product storage and handling evia hf / hf-t technical manual page 92 8.2 opening the sterile container the pulse generator is packaged in two plastic containers, one within the other. Each is individually sealed and then sterilized with ethylene oxide. Due to the double packing, the outsid...
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Chapter 9 lead connection evia hf / hf-t technical manual page 93 9. Lead connection evia crt-ps have been designed and are recommended for use with bipolar or unipolar leads having an is-1 connector. The is-1 configured leads may be placed in one or both chambers of the heart, depending upon model ...
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Chapter 9 lead connection evia hf / hf-t technical manual page 94 caution setscrew adjustment – back-off the setscrew(s) prior to insertion of lead connector(s) as failure to do so may result in damage to the lead(s), and/or difficulty connecting lead(s). Cross threading setscrew(s) – to prevent cro...
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Chapter 9 lead connection evia hf / hf-t technical manual page 95 2. Detection and configuration of the lead polarity the evia crt-p switches the lead polarity to bipolar immediately after a bipolar lead is detected. When the lead impedance is between 100 and 2500 ohms, the lead connected is classif...
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Chapter 9 lead connection evia hf / hf-t technical manual page 96.
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Chapter 10 follow-up procedures evia hf / hf-t technical manual page 97 10. Follow-up procedures 10.1 general considerations the pacemaker follow-up serves to verify appropriate function of the pacing system, and to optimize the parameter settings. In most instances, pacing system malfunction attrib...
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Chapter 10 follow-up procedures evia hf / hf-t technical manual page 98 10.3 threshold test figure 56: main threshold test screen the atrial and ventricular pacing thresholds are determined using a high-precision threshold test found under the threshold tab, as illustrated in figure 56 . The right o...
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Chapter 10 follow-up procedures evia hf / hf-t technical manual page 99 the evia crt-p allows real-time changes during the threshold tests. The user can now change any of the values while the test is ongoing. If a value is changed, the device will automatically stop the ongoing test and then restart...
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Chapter 10 follow-up procedures evia hf / hf-t technical manual page 100 as the threshold test begins, the selected pacing parameters are transmitted temporarily to the device. These parameters are default parameters (i.E.: the parameters programmed between test parameters) and should be adjusted to...
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Chapter 10 follow-up procedures evia hf / hf-t technical manual page 101 figure 61: sensing test options 10.4.1 start (test) the sensing test is performed in a ddi mode with programmable back-up support pacing when the start button is selected. Atrial values may be given even if the device is progra...
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Chapter 10 follow-up procedures evia hf / hf-t technical manual page 102 10.4.3 mode ddi, vvi, aai and vdd are the available modes for the sensing test the ddi mode provides programmable pacing support during the test and allows the user to measure atrial and ventricular values simultaneously. The v...
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Chapter 10 follow-up procedures evia hf / hf-t technical manual page 103 10.4.4.7 sensitivity atrium: auto, 0.1 - 7.5 mv. Default of auto ventricle: auto, 0.5 - 7.5 mv default of auto independently programmable for each chamber. 10.4.4.8 pacing polarity unipolar, bipolar. Independently programmable ...
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Chapter 10 follow-up procedures evia hf / hf-t technical manual page 104 figure 65: retrograde conduction test with a positive result retrograde conduction from the ventricle to the atrium can be confirmed when a 1:1 relationship with a constant v-a interval is present. The va interval is the time b...
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Chapter 10 follow-up procedures evia hf / hf-t technical manual page 105 10.5.3 follow-up history the evia crt-p can store up to 10 follow-ups. See figure 66 . The first follow-up performed is stored and will not be overwritten to serve as a baseline for future follow-up comparisons. Evia crt-p stor...
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Chapter 10 follow-up procedures evia hf / hf-t technical manual page 106 10.6.2 burst stimulation parameter range default coupling interval interval from last sensed event to the first paced event none, 80...(10)...2000 none burst rate 125...(25)...800 ppm 250 ppm burst minimum 125...(25)...800 ppm ...
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Chapter 10 follow-up procedures evia hf / hf-t technical manual page 107 programmed stimulation screen 10.6.4 back up pacing the back up pacing program remains active once nips has been selected and remains active during burst or programmed burst stimulation and within this menu. This program remain...
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Chapter 10 follow-up procedures evia hf / hf-t technical manual page 108 10.7 optimizing rate adaptation it is recommended to check the parameters controlling rate adaptation during each follow-up for their individual therapeutic suitability. Any intermediate change in the patient’s general well bei...
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Chapter 10 follow-up procedures evia hf / hf-t technical manual page 109 of work load or if the selected maximum sensor rate is achieved at too low of an exercise level, the sensor gain should be reduced by selecting a lower gain setting. If, on the other hand, rate adaptation is insufficient for a ...
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Chapter 10 elective replacement indication (eri) evia hf / hf-t technical manual page 110
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Chapter 11 elective replacement indication (eri) evia hf / hf-t technical manual page 111 11. Elective replacement indication (eri) the service time of evia crt-ps vary based on several factors, including battery properties, storage time, lead system impedance, programmed parameters, amount of pacin...
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Chapter 11 elective replacement indication (eri) evia hf / hf-t technical manual page 112 caution high output settings combined with very low lead impedance may reduce the life expectancy of the pulse generator to less than 1 year. Programming of pulse amplitudes, higher than 4.8 v, in combination w...
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Chapter 12 explantation evia hf / hf-t technical manual page 113 12. Explantation explanted pulse generators or explanted accessories may not be reused. Explanted pulse generators can be sent either to the local biotronik representative or the biotronik home office for expert disposal. If possible, ...
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Chapter 12 explantation evia hf / hf-t technical manual page 114 source cause possible effect cardiac perforation the above plus cardiac tamponade; muscle or nerve stimulation. Myocardial irritability at time of insertion, e.G., from an acute myocardial infarction fibrillation patient threshold elev...
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Chapter 13 technical data evia hf / hf-t technical manual page 115 13. Technical data 13.1 modes ddd-cls, vvi-cls, dddr-adir, dddr, ddir, dvir, vddr, vvir, aair, vdir, vvtr, aatr, door, voor, aoor note: programmability dependent on programmer software utilized. Bold parameters indicate factory setti...
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Chapter 13 technical data evia hf / hf-t technical manual page 116 lv tip > case lv ring > case upper rate 90…(10)…200 ppm vp suppression off; on atrial overdrive pacing on; off utr response wrl; 2:1 (automatic selection) rate limitation 8,9,10 190…220 ppm dynamic av delay off; low; medium; high, (i...
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Chapter 13 technical data evia hf / hf-t technical manual page 117 automatic; asynchronous; synchronous asynchronous magnet effect: paces at 90 ppm. Automatic magnet effect; 10 cycles at 90 ppm asynchronous; thereafter synchronous with the programmed basic rate synchronous magnet effect; synchronous...
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Chapter 13 technical data evia hf / hf-t technical manual page 118 sense: a unipolar; bipolar rv unipolar; bipolar lv unipolar; bipolar 13.2.1 rate adaptation sensor gain 1.0, 1.1, 1.3, 1.4, 1.6, 1.8, 2.0, 2.3, 2.6, 3.0, 3.3, 3.7, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 8.5, 10, 11, 13, 14, 16, 18, 20, 23 sen...
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Chapter 13 technical data evia hf / hf-t technical manual page 119 13.2.3 right/left ventricular capture control (rvcc/lvcc) ventricular capture control off, on, atm maximum vcc amplitude 2.4, 3.0, 3.6, 4.2 4.8 v safety margin rv - off, 0.3…(0.1)… 0.5…(0.1)… 1.2 v lv - 1.0 or 1.2 v search scheduling...
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Chapter 13 technical data evia hf / hf-t technical manual page 120 13.2.5 additional functions note: availability of the following functions is dependent upon pulse generator configuration. • temporary program activation • high precision threshold test in the range up to 7.5 v with 0.1 v resolution ...
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Chapter 13 technical data evia hf / hf-t technical manual page 121 burst mode burst chamber atrium back-up pacing modes voo,vvi rate / ppm 30…200 amplitude / v 0.2…7.5 pulse width / ms 0.1, 0.2, 0.3, 0.4, 0.5, 0.75, 1.0, 1.25, 1.5 pace polarity bipolar, unipolar 13.3 programmer ics 3000 or renamic 1...
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Chapter 13 order information evia hf / hf-t technical manual page 122.
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Chapter 14 order information evia hf / hf-t technical manual page 123 14. Order information pulse generator type order number evia hf 377 206 evia hf-t 377 208 fcc statement: (fcc id: qriprimus): this transmitter is authorized by rule under the medical device radiocommunication service (in part 95 o...
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Chapter 14 order information evia hf / hf-t technical manual page 124.
Page 133: Appendix A
Page 125 appendix a evia hf / hf-t technical manual appendix a mode-specific indications and contraindications rate-adaptive pacing evia hf/hf-t: dddr, dddr-adir, ddir, dvir, vddr, vvir, ddd-cls, vvi-cls, aair, vvtr, door, voor, aoor, aatr, vdir note: for indications specific to the vddr mode, see i...
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Page 126 appendix a evia hf / hf-t technical manual dvi the dvi mode is clearly indicated if • av sequential contraction is necessary due to symptomatic bradycardia and slow atrial rate, and/or • a pacemaker syndrome has already been documented. The dvi mode is conditionally indicated for • frequent...
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Page 127 appendix a evia hf / hf-t technical manual the vvi mode is contraindicated if • a pacemaker syndrome is known to exist or if the patient develops particular symptoms during temporary pacing or pulse generator implantation, and/or • there is a need to maximize the atrial contribution due to ...
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Page 128 appendix a evia hf / hf-t technical manual.
Page 137: Appendix B
Page 129 appendix b evia hf / hf-t technical manual appendix b known software anomalies anomaly possible effect on patient or implant procedure general programmer issues missing programmer parameter display rule for pvarp parameter (limit of programmed va limit + 50ms). Pvarp interval may be display...
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Evia hf / hf-t technical manual biotronik, inc. 6024 jean road lake oswego, or 97035-5369 (800) 547-0394 (24-hour) (800) 291-0470 (fax) www.Biotronik.Com m4142-b 09/16 © 2016 biotronik, inc. All rights reserved. Mn019ter1 9/1/16.