FORMIO™ Pacing System
Contents
1. Boston Scientific Advancing science for life FORMIO Pacing System ImageReady MR Conditional Pacing System Mx The FORMIO pacing system from Boston Scientific provides an ImageReady MR conditional pacing system FORMIO offers RightRate the newest generation of MV sensor technology and the only MV sensor clinically proven to restore chronotropic competence and RYTHMIO designed to minimize unnecessary RV pacing without clinically significant pauses therefore reducing the risk of HF J development FORMIO also offers enhanced features and diagnostics including Sv AP Scan HRV platform and Respiratory Rate Trend designed to provide you with is 1 Y SORE greater insight into your patient s disease progression FORMIO has been designed to FORMIO MRI maximize efficiency and ease of use with PaceSafe in both the atrium and ventricle fe providing dynamic adjustment of pacing outputs to ensure capture FORMIO is gosine LATITUDE NXT Remote Patient Management enabled the only system to meet ESC Class 1 Recommendations offering the opportunity for convenient remote a patient monitoring and follow up a Chronotropic competence is defined by the Model of the Cardiac Chronotropic Response to Exercise Wilkoff B Corey J Blackburn G A mathematical model of the cardiac chronotropic response to exercise Journal of Electrophysiology 1989 3 176 180 b To date Dec 2012 Mechanical2. min 100 110 300 170 Tolerance 5 ms ATR Duration cycles 0 8 16 32 64 128 256 512 1024 2048 8 Tolerance 1 cardiac cycle Entry Count cycles 1 cant 8 Exit Count cycles eZ ke 8 ATR Fallback Mode VDI DDI VDIR DDIR DDI ATR Fallback Time min sec 00 00 00 15 00 30 00 45 01 00 01 15 01 30 00 30 ATR Fallback LRL min ATR Ventricular Rate Regulation VRR ATR Maximum Pacing Rate MPR min Atrial Flutter Response Atrial Flutter Response Trigger Rate min PMT Termination Ventricular Rate Regulation VRR BiV VRR Maximum Pacing Rate MPR min APP ProACt APP ProACt Max Pacing Rate min 01 45 02 00 S10 3B ony 18S Off On W 515 coc ISD Off On 100 110 300 Off On Off On 50 55 185 Off On 50 55 185 70 Tolerance 5 ms On 130 Tolerance 5 ms On 170 Tolerance 5 ms On Off 130 Tolerance 5 ms Off 80 Tolerance 5 ms This parameter gets disabled during Temporary Brady angop then Temporary Brady ATR Fallback Mode is VDI Sensitivity The programmed Normal Brady values will be used as the nominal values for Temporary Brady pacing ATR Trigger Rate and Atrial Flutter Response Trigger Rate are linked If either of these rates is reprogrammed the other will automatically change to the same value If Normal Brady ATR Fallback Mode is DDIR or DDI then Temporary Brady ATR Fallback Mode is D
3. 3 5 4 0 5 0 PAY Balls cap OLA e OO Off 12 24 48 1 0 non programmable DOO for DDD R DDI R or DOO normal Brady modes VOO for VDD R VVI R or VOO normal Brady modes AOO for AAI R or AOO normal Brady mode Off for normal Brady mode Off 20 min above the normal mode LRL 5 0 Tolerance 15 or 100 mV whichever is greater 5 0 Tolerance 15 or 100 mV whichever is greater 24 1 0 Tolerance 0 03 ms Sensor Trending Parameter Programmable Values Nominal Setting Recording Method Beat To Beat Off 30 Second Average 30 second average Data Storage Continuous Fixed Continuous Ventricular Tachy EGM Storage Parameter Programmable Values Nominal Setting Ventricular Tachy EGM Storage VT Detection Rate min SU 88 22 Zl 220 160 Tolerance 5 ms a The VT Detection Rate must be 5 min higher than the Maximum Tracking Rate Maximum Sensor Rate and the Maximum Pacing Rate and must be 15 min higher than the Lower Rate Limit ImageReady is only available in INGENIO MRI ADVANTIO MRI VITALIO MRI and FORMIO MRI pacemakers Only these pacemakers are MR Conditional FORMIO Pacing System ImageReady MR Conditional Pacing System Atrial Tachy Parameters Parameter Programmable Values Nominal Setting poneer eee eee reer P E a aa wood sa SRE ESES aa a aLNE TS Ta ESE TESTA LORE SO SE See te cee ce ATR Trigger Rate
4. MRI pacemakers Only these pacemakers are MR Conditional FORMIO Pacing System ImageReady MR Conditional Pacing System Backup EP Test Parameter Programmable Values Backup Pacing Mode Off On Backup Pacing Lower Rate Limit min SLO BS sen leks 60 Tolerance 5 ms Backup Pacing V Refractory ms 150 160 500 250 Tolerance 5ms EP Test Pacing Outputs Atrial Amplitude OM Ol OZ cod EO coco D 5 0 Tolerance 15 or 100 mV whichever when test is in the atrium V is greater EP Test Pacing Outputs V Amplitude V Off 0 1 0 2 3 5 4 0 7 5 7 5 Tolerance 15 or 100 mV whichever is greater EP Test Pacing Outputs Atrial Pulse Width ONO ae 1 0 Tolerance 0 03 ms at when test is in the atrium ms lt 1 8 ms 0 08 ms at 1 8 ms EP Test Pacing Outputs V Pulse Width ms 0 1 0 2 2 0 1 0 Tolerance 0 03 ms at lt 1 8 ms 0 08 ms at 1 8 ms a This parameter only applies when the test is in the atrium b The programmed Normal Brady value will be used as the nominal value PES Programmed Electrical Stimulation Parameter Programmable Values Nominal Setting EEN m E TN as SSID AA Ss Disc cb cates stat NEA TNE AEA s a GS EEA EAAS E ETE S2 Decrement ms 0 10 eon O 0 S1 Interval ms 120 130 750 600 Tolerance 5 ms S2 Interval ms Off 120 130 750 600 Tolerance 5 ms S3 Interval ms Off 120 130 750 Off Tolera
5. his parameter is disabled during Temporary Brady his parameter is automatically enabled if Auto is selected for the Pulse Amplitude When the Pulse Amplitude is set to Auto or Pulse Amplitude Daily Trend is enabled the pulse width is fixed at 0 4 ms his value is located on the Lead Setup screen ImageReady is only available in INGENIO MRI ADVANTIO MRI VITALIO MRI and FORMIO MRI pacemakers Only these pacemakers are MR Conditional FORMIO Pacing System ImageReady MR Conditional Pacing System Brady Mode Values Based on NASPE BPEG Codes IV Programmability rate modulation V Antitachyarrhythmia Functions Position l Category Chambers Paced 0 None A Atrium Letters V Ventricle D Dual A amp V ll ll Chambers Response to Sensed Sensing 0 None 0 None A Atrium T Triggered V Ventricle Inhibited D Dual A amp V D Dual T amp P Simple Programmable M Multiprogrammable C Communicating R Rate Modulation P Pacing Antitachyarrhythmia S Shock D Dual P amp S Mfrs Designation S Single A or V Only S Single A or V MRI Protection Parameters Parameter Programmable Values Nominal Setting MRI Brady Mode MRI Lower Rate Limit LRL min MRI Atrial Amplitude V MRI Ventricular Amplitude V MRI Protection Time out hours MRI Pulse Width atrial and ventricular ms Off VOO A00 DOO 30 35 100 2 0 2 1
6. DI and If Normal Brady ATR Fallback Mode is VDIR or VDI Parameter Programmable Values Nominal Setting Sensing Method Atrial Sensitivity AGC Right Ventricular Sensitivity AGC Atrial Sensitivity Fixed Right Ventricular Sensitivity Fixed AGC Fixed AGC 0 15 AGC 0 2 AGC 0 25 AGC 0 3 AGC 0 4 AGC 1 0 AGC 1 5 AGC 0 15 AGC 0 2 AGC 0 25 AGC 0 3 AGC 0 4 AGC 1 0 AGC 1 5 Fixed 0 15 Fixed 0 25 Fixed 0 5 Fixed 0 75 Fixed 1 0 Fixed 1 5 Fixed 8 0 Fixed 9 0 Fixed 10 0 Fixed 0 25 Fixed 0 5 Fixed 0 75 Fixed 1 0 Fixed 1 5 Fixed 8 0 Fixed 9 0 Fixed 10 0 AGC 0 25 AGC 0 6 Fixed 0 75 Fixed 2 5 Separately programmable for Temporary Brady In single chamber models the chamber chosen determines the nominal value a b The programmed Normal Brady values will be used as the nominal values for Temporary Brady pacing c d The programmed value for Sensing Method determines the applicable values AGC or Fixed in each chamber Daily Lead Measurements Parameter Programmable Values Nominal Setting Atrial Intrinsic Amplitude Ventricular Intrinsic Amplitude Atrial Pace Impedance Ventricular Pace Impedance Atrial Pace Impedance Alert Range Minimum Q Ventricular Pace Impedance Alert Range Minimum Q 200 250 500 200 250 500 ImageReady is only available in INGENIO MRI ADVANTIO MRI VITALIO MRI and FORMIO
7. Setting Exit Storage Enable Electrocautery Protection Storage Enable MRI Protection ImageReady is only available in INGENIO MRI ADVANTIO MAI VITALIO MRI and FORMIO MRI pacemakers Only these pacemakers are MR Conditional Longevity projections as described in device user manual Settings 60 min 1 A 2 0 V V 1 0 V 500 ohms 100 paced MV blended sensor On Onset EGM On Right Ventricular Automatic Capture On and Right Atrial Automatic Threshold On Please refer to the Pacing System MRI Technical Guide as the system is designated as MR Conditional in accordance with specified conditions FORMIO Pacing System ImageReady MR Conditional Pacing System Pacing Therapy Parameters Specified into 750Q load Parameter Programmable Values Nominal Setting Mode 4 Lower Rate Limit LRL min Maximum Tracking Rate MTR min Maximum Sensor Rate MSR min Pulse Amplitude atrium V Pulse Amplitude right ventricle V Pulse Amplitude Daily Trend independently programmable in each chamber Pulse Width atrium right ventricle ms Accelerometer Accelerometer Activity Threshold Accelerometer Reaction Time sec Accelerometer Response Factor Accelerometer Recovery Time min Minute Ventilation Minute Ventilation Response Factor Minute Ventilation Fitness Level Patient s Age Patient s Gender Ventilatory Threshold min Ventilatory Th
8. Specifications Size mm Projected Model Type HxWxD Mass g Volume cc Longevity yrs Connector J279 DR 47x 44 5x7 5 24 5 12 8 2 IS 1 FORMIO MRI Pulse Generator Circuitry Designed with minimized use of ferromagnetic materials which can interact with the fields generated during a typical MRI scan Designed to tolerate voltages that may be induced during MAI scans Power Supply Lithium carbon monoflouride silver Vanadium Oxide Cell MRI Lead Compatibility Pulse Generator compatible with all FINELINE II Sterox and FINELINE II Sterox EZ Pacing Leads models MRI Conditions Full body scan at 1 5T SAR 2W Kg for all FINELINE II models Pulse Generator X ray ID tag 4880011 MRI Protection Mode Modifies the behavior of the pulse generator and has been designed to accommodate the MRI scanner electromagnetic environment MRI Protection Time out Automatic timeout function that returns Pulse Generator to original pacing settings Options off 12 24 48 Nominal 24 hours Programmable Parameters AP Scan Sleep Start Time Sleep Duration ZIP Telemetry Settings Parameter Programmable Values Nominal Setting Communication Mode Enable use of ZIP telemetry May require limited use of wand Enable use of ZIP Telemetry may require limited use of wand Use wand for all telemetry Device Mode Parameter Device Mode Programmable Values Nominal
9. e Magnet Response 30 40 400 32 64 128 256 512 1024 AA R with VVI Backup Off 150 160 500 150 160 500 150 160 500 150 160 500 Off 150 200 500 Smart 45 65 85 105 125 150 175 200 Smart 45 65 85 45 65 85 A00 VOO DOO Inhibit Pacing Off Store EGM Pace Async 300 Tolerance 5 ms 32 Tolerance 1 cycle Off 280 Tolerance 5 ms 240 Tolerance 5 ms 250 Tolerance 5 ms 230 Tolerance 5 ms 400 Tolerance 5 ms 125 Tolerance 5 ms 45 Tolerance 5 ms 65 Tolerance 5 ms DOO for DDD R and DDI R modes VOO for VDD R and VVI R modes AOO for AAI R mode Pace Async a b pro moo R S he programmed Normal Brady values will be used as the nominal values for Temporary Brady pacing efer to the NASPE BPEG codes below for an explanation of the programmable values The identification code of the North American Society of Pacing and Electrophysiology NASPE and the British Pacing and Electrophysiology Group BPEG is based on the categories listed in the table he basic pulse period is equal to the pacing rate and the pulse interval no hysteresis Runaway protection circuitry inhibits bradycardia pacing above 205 min Magnet application may affect pacing rate test pulse interval eparately programmable for Temporary Brady Values are not affected by temperature variation within the range 20 C 43 C
10. lar Unipolar Off Bipolar Off Unipolar Bipolar Bipolar Unipolar Unipolar Bipolar Off On 30 40 400 30 40 400 30 40 400 ImageReady is only available in INGENIO MRI ADVANTIO MRI VITALIO MRI and FORMIO MRI pacemakers Only these pacemakers are MR Conditional 60 Tolerance 5 ms 130 Tolerance 5 ms 130 Tolerance 5 ms 3 5 Tolerance 15 or 100 mV whichever is greater 3 5 Tolerance 15 or 100 mV whichever is greater Disabled 0 4 Tolerance 0 03 ms at lt 1 8 ms 0 08 ms at 1 8 ms Passive Medium 30 8 2 Passive 3 Active 56 60 Male 120 Tolerance 5 ms 70 On Off Tolerance 5 ms Off Tolerance 1 cycle Off Tolerance 1 130 Tolerance 5 ms Off 3 20 2 On Unipolar Unipolar On 180 Tolerance 5 ms 80 Tolerance 5 ms 150 Tolerance 5 ms FORMIO Pacing System ImageReady MR Conditional Pacing System Pacing Therapy Parameters Specified into 750Q load continued Parameter Programmable Values Nominal Setting AV Search AV Search Search AV Delay ms AV Search Search Interval cycles RYTHMIQ Maximum A Refractory PVARP ms Minimum A Refractory PVARP ms Maximum V Refractory VRP ms Minimum V Refractory VRP ms PVARP After PVC ms A Blank after V Pace ms A Blank after RV Sense ms RV Blank after A Pace ms Noise Respons
11. nce 5 ms S4 Interval ms Off 120 130 750 Off Tolerance 5 ms S5 Interval ms Off 120 130 750 Off Tolerance 5 ms a Applied to the atrium or ventricle as commanded by the programmer Manual Burst Pacing Parameter Programmable Values Nominal Setting pee E ae err a a EON RENNER ean E LE E p oe He NEA RRE Minimum Interval ms 100 110 750 200 Tolerance 5 ms Decrement ms 0 10 50 50 Tolerance 5 ms a Applied to the atrium or ventricle depending on the chamber selected Boston Scientific F ifa ImageReady is only available in INGENIO MRI ADVANTIO MRI VITALIO MRI and FORMIO MRI pacemakers Advancing science for life Only these pacemakers are MR Conditional ene www bostonscientific international com All cited trademarks are the property of their respective owners CAUTION The law restricts these devices to sale by or on the order of a physician Indications contraindications warnings and instructions for use can be found in the product labelling supplied with each device Information for the use only in countries with 2013 Boston Scientific Corporation applicable health authority product registrations or its affiliates All rights reserved CRM 125713 AA Dec12 Printed in Germany by medicalvision DINCRM0784EA
12. reshold Response Respiration related Trend Rate Hysteresis Hysteresis Offset min Rate Hysteresis Search Hysteresis cycles Rate Smoothing up down Rate Smoothing Maximum Pacing Rate min Sudden Brady Response SBR SBR Atrial Paces Before Therapy SBR Atrial Pacing Rate Increase min SBR Therapy Duration min SBR Inhibit During Rest Atrial Pace Sense Configuration Right Ventricle Pace Sense Configuration Safety Switch independently programmable in each chamber Maximum Paced AV Delay ms Minimum Paced AV Delay ms Maximum Sensed AV Delay ms DDD R DDI R DOO VDD R VVI R VOO AAI R AOO Off Temporary DDD DDI DOO VDD VVI VOO AAI AOO Off SO HE oon UES 50 55 185 50200 coon tele Auto 0 1 0 2 3 5 4 0 5 0 Temporary 0 1 0 2 3 5 4 0 5 0 Nui O11 OZ coo A C0 5 HEF Temporary 0 1 0 2 3 5 4 0 7 5 Disabled Enabled OO cue ZO On Passive Very Low Low Medium Low Medium Medium High High Very High 10 20 50 I coer IB 2 3 2 16 On Passive Off P 16 Sedentary Active Athletic Endurance Sports lt 5 6 10 11 15 91 95 96 Male Female 30 35 185 Off 85 70 55 Off On O TA sc 0 Oi ff 256 512 1024 2048 4096 Oni eE Sh 1215 Ne Zi 2s 50 55 185 Ose l TZ a4 15 Off On Unipolar Bipolar Bipolar Unipolar Unipolar Bipo
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