Setting up and using the programmer 7-2
Using the programmer display screen 7-12
Starting a patient session 7-22
Programming parameter values 7-25
Live Rhythm Monitor 7-27
Recording live waveforms 7-42
Printing reports 7-46
Preferences 7-51
Changes This Session 7-54
Ending a patient session 7-55
8. Conducting system tests
System tests overview 8-2
Underlying Rhythm test 8-3
Pacing Threshold test 8-4
Lead Impedance test 8-6
EGM Width test 8-9
Manual EGM Amplitude test 8-13
Test Charge/Dump 8-15
Data collection overview 10-2
Quick Look 10-4
Setting up data collection 10-6
Counter data 10-10
Episode Data 10-14
Patient Information 10-27
Battery and Lead Measurements 10-31
Device Status Indicators 10-33
Saving and retrieving ICD data 10-35
Table of contents
11. Patient Alert monitoring system
Patient Alert setup 11-2
Instructions for the patient 11-7
Instructions for clinic personnel 11-9
Patient Alert event log 11-10
12. Implant and follow-up
Pre-Implant information 12-2
Operative set-up 12-3
Surgical approach 12-5
Sensing and pacing measurements 12-7
Defibrillation testing 12-8
Placing the ICD 12-14
Replacing the ICD 12-15
Pre-discharge evaluation 12-16
Follow-up recommendations 12-17
A. Appendix A - Warnings and precautions
General warnings A-2
Sterilization, storage, and handling A-2
Implantation and ICD programming A-3
Onyx VR System Reference Guidevii
Table of contents
Lead evaluation and lead connection A-4
Follow-up testing A-5
ICD explant and disposal A-6
Environmental and medical therapy hazards A-7
Home and occupational environments A-9
Before implanting the ICD, it is strongly recommended that you follow
these instructions:
■
Refer to the product Implant Manual (included in the ICD package) for
information about ICD indications.
■
Thoroughly read this manual and the technical manuals for the leads
used with the device.
■
Discuss the procedure and the ICD system with the patient and any
other interested parties, and provide them with any information
packaged with the ICD.
Customer education
Medtronic invites physicians to attend an education seminar on the
complete ICD system. The course includes indications for use, an
overview of ICD system functions, implant procedures, and patient
management.
Technical support
Medtronic employs highly trained representatives and engineers located
throughout the world to serve you and, upon request, to provide training
to qualified hospital personnel in the use of Medtronic products.
In addition, Medtronic maintains a professional staff of consultants to
provide technical consultation to product users. For medical consultation,
Medtronic can often refer product users to outside medical consultants
with appropriate expertise.
For more information, contact your local Medtronic representative, or call
or write Medtronic at the appropriate address or telephone number listed
on the back cover.
Onyx VR System Reference Guideix
1
Introduction
References
Automatic defibrillation was invented and patented in 1953 by Dr. F.
Zacouto, who designed an external device that delivered a defibrillation
impulse to the heart upon detection of very rapid ECG activity in
combination with the absence of arterial pulsations.
The primary reference for background information is Zacouto FI, Guize
LJ. Fundamentals of Orthorhythmic Pacing. In: Luderitz B, ed. Cardiac Pacing Diagnostic and Therapeutic Tools. New York: Springer-Verlag;
1976: 212-218.
See these additional references for more background information:
This software is provided as an informational tool for the end user. The
user is responsible for accurate input of patient information into the
software. Medtronic makes no representation as to the accuracy or
completeness of the data input into the software. Medtronic SHALL NOT
BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL OR
CONSEQUENTIAL DAMAGES TO ANY THIRD PARTY WHICH
RESULTS FROM THE USE OF THE INFORMATION PROVIDED IN THE
SOFTWARE.
Abbreviations and Acronyms
ATPAntitachycardia Pacing
BOLBeginning of Life
bpmbeats per minute
CNIDCombined (VT and VF) Number of Intervals to Detect
Quick Look programming summary, with QuickLink to stored episodes and observations
■
Chart ready full-size report printing (Refer to the reference manual provided with your programmer)
■
Non-invasive EP Study functions: ventricular inductions/manual therapies.
■
Auto-Resume feature automatically resumes detection after an induction (see “Auto-Resume” on
page 9-3)
■
Smart Auto Cap Formation extends the formation timer after therapeutic charging
1-4Onyx VR System Reference Guide
1
Physical characteristics
Tabl e 1-2. Onyx VR physical characteristics
Volume39 cc
Mass77 g
H x W x D
Surface area of device can69.0 cm
Radiopaque IDb
Materials in contact with human
tissue
BatteryLithium silver vanadium oxide
Connector configurationOne IS-1 connector for pacing and sensing,
a
c
Quick reference
Physical characteristics
69.3 mm x 50.8 mm x 13.5 mm
2
PRP
Titanium/polyurethane/silicone rubber
Two DF-1 connectors for high voltage
therapy, Active Can electrode
SVC
(HVX)
IS-1 V
RV
(HVB)
DF-1
Can (HVA)
a
This measurement refers to the thickness (depth) of the can; grommets may protrude slightly
beyond the surface.
b
Engineering series number follows the radiopaque code.
c
These materials have been successfully tested for the ability to avoid biological
incompatibility. The device does not produce an injurious temperature in the
surrounding tissue.
Onyx VR System Reference Guide1-5
1
Quick reference
Electrical characteristics
Electrical characteristics
Longevity
Table 1-3 below provides longevity estimates based on accelerated battery discharge data and device
modeling with the following programmed values:
■
60 ppm (min-1) pacing rate
■
2 V pacing pulse amplitude
■
0.6 ms pacing pulse width
■
30 J delivered therapy energy
■
six-month automatic capacitor formation intervals
Note: The EGM pre-storage feature is set to Off.
1
Tab le 1- 3. Onyx VR Projected longevity in years with 2 V pacing pulse
Percent
pacing
0%Semi-annual7.07.0
15%Semi-annual6.97.0
50%Semi-annual6.66.7
100%Semi-annual6.16.5
1.
With two-month extensions per 30 J charge (maximum of 12 months between formations). Therapeutic charging is in addition to
capacitor formations.
amplitude and 0.6 ms pacing pulse width
Therapeutic shock
frequency
Quarterly6.46.4
Quarterly6.36.3
Quarterly6.06.2
Quarterly5.76.0
500 Ω pacing
impedance
900 Ω pacing
impedance
1-6Onyx VR System Reference Guide
1
Quick reference
Electrical characteristics
Table 1-4 below provides longevity estimates based on accelerated battery discharge data and device
modeling with the following programmed values:
■
60 ppm (min-1) pacing rate
■
3 V pacing pulse amplitude
■
0.4 ms pacing pulse width
■
30 J delivered therapy energy
■
six-month automatic capacitor formation intervals
1
Note: The EGM pre-storage feature is set to Off.
.
Tabl e 1-4. Onyx VR projected longevity in years with 3V pacing pulse
amplitude and 0.4 ms pacing pulse width
Percent
pacing
0%Semi-annual7.07.0
15%Semi-annual6.76.9
50%Semi-annual6.06.5
100%Semi-annual5.46.0
Therapeutic shock
frequency
500 Ω pacing
impedance
900 Ω pacing
impedance
Quarterly6.46.4
Quarterly6.26.3
Quarterly5.66.0
Quarterly5.05.5
1.
With two-month extensions per 30 J charge (maximum of 12 months between formations). Therapeutic charging is in addition to
capacitor formations.
Onyx VR System Reference Guide1-7
1
Quick reference
Electrical characteristics
The following factors result in decreased longevity:
■
an increase in pacing rate, pacing amplitude or pulse width, the ratio of bradycardia paced to sensed
events, or the charging frequency
■
a decrease in pacing impedance
■
using the pre-onset EGM storage feature or Holter telemetry.
To maximize ICD longevity:
■
Optimize pacing rate and output parameters for the patient.
■
Set the delivered energy value for the first programmed high voltage therapy to a value lower than
maximum energy.
■
Set the automatic capacitor formation interval to a longer value (unless a shorter interval is required
to maintain clinically acceptable charge times).
■
Use the pre-onset EGM storage feature and Holter telemetry only for short periods of time.
Battery voltage
Battery voltage appears on the programmer display and on printed reports. For more information, see
“Replacement indicators” on page 12-18 and “Preparing the ICD for implant” on page 12-4.
Tab le 1- 5. Battery voltage Indicators
Elective Replacement (ERI)
a
≤ 2.55 V
Pacing mode and rate (magnet and non-magnet)as programmed
End of Life (EOL)
b
≤ 2.40 V
Pacing mode and rate (magnet and non-magnet)as programmed
a
The minimum time between ERI and End of Life is three months, assuming 100% VVI pacing
at 60 ppm (min
b
When the battery reaches EOL, immediate replacement is recommended. See also “Charge
Circuit Inactive” on page 5-4.
-1
), 3 V, 0.4 ms; 510 Ω pacing load; and six 30 J charges.
1-8Onyx VR System Reference Guide
1
Quick reference
Electrical characteristics
Charge time
The high voltage capacitors charge more rapidly just following a capacitor formation, when they are fully
formed. Between formations, the capacitors gradually deform, resulting in longer charge times toward the
end of the formation interval. See “Using Automatic Capacitor Formation to manage charge time” on
page 8-17 for information on managing charge time. Also, see “Test Charge/Dump” on page 8-15 for
instructions on using the Test Charge feature to measure charge time. Table 1-6 provides typical full
energy charge times at BOL and ERI based on the time interval since the last capacitor formation. A full
energy charge is any charge to full energy (either via a capacitor formation or therapy delivery).
Tab le 1- 6. Typical Full Energy (30 J Delivered) charge times
Capacitors
fully formed
At Beginning of Life
(BOL)
Near Elective
Replacement Indicator
(ERI)
a
Typical values for stated conditions, actual charge time performance may vary.
6 seconds≈ 1 second
14 seconds≈ 1 seconds
1 month after
capacitor
formation
longer than
fully formed
longer than
fully formed
a
6 months
after
capacitor
formation
≈ 2 seconds
longer than
fully formed
≈ 5 seconds
longer than
fully formed
Onyx VR System Reference Guide1-9
1
Quick reference
Electrical characteristics
High voltage therapy energy
Table 1-7 compares delivered energy levels to energy levels stored by the device.
Note: The stored energy of the device is derived from the peak capacitor voltage and is always greater
than the energy delivered by the device.
Tab le 1- 7. Comparing programmed (actual delivereda) and storedb energy levels
Programmed (Actual
Delivered) Energy (J)
0.40.5.099111.94
0.60.8.1310122.16
0.81.0.1711132.38
1.01.2.2212142.59
1.21.5.2613152.81
1.41.7.3014163.02
1.62.0.3515183.24
1.82.2.3916193.46
22.4.4318213.89
33.6.6520244.32
44.7.8622264.75
55.91.0824285.18
67.11.3026315.62
78.31.5128336.05
89.41.7330356.48
a
Energy and voltage delivered at connector block into a 75 Ω load.
b
Energy stored at end of charge on capacitor.
c
Typical charge time at BOL, with fully formed capacitors.
Stored
Energy (J)
Charge
Time
c
(sec)
Programmed (Actual
Delivered) Energy (J)
Stored
Energy (J)
Charge
Time
c
(sec)
1-10Onyx VR System Reference Guide
1
Quick reference
Magnet application
Magnet application
Applying a magnet closes a reed switch within the ICD. When the magnet is removed, the ICD returns to
its programmed operations.
Tab le 1- 8. Effects of magnet application
Pacing ModeAs programmed
Pacing Rate and IntervalAs programmed
VF, VT, and FVT Detection and
Therapy
Patient Alert
Audible Tones
a
The programming head contains a magnet which can suspend detection. However, if the
Resume option in the programmer has been enabled, detection will remain enabled.
b
The alert sounds only if the Patient Alert is programmed On for any alert except POR. A POR
alert causes an alarm every 20 hours, even if Patient Alert is programmed to Off.
b
Suspended
(30 seconds or less)
Continuous tone (alarm OK)
On/Off intermittent tone (seek follow-up)
High/Low dual tone (urgent follow-up)
a
Onyx VR System Reference Guide1-11
1
Quick reference
Emergency settings
Emergency settings
The table below lists the values that can be selected for the ICD emergency therapy parameters. Default
values are highlighted in bold, italicized text. The Notes column lists letters that correspond to notes on
page 1-25.
The tables that follow (Table 1-10 to Table 1-17) list the values that can be selected for all ICD
programmable parameters. As applicable, these tables also indicate the Medtronic nominal value, the
POR value, and the shipped value for each parameter.
Medtronic nominal values – These values are suggested settings for parameters under nominal
conditions. Medtronic nominal values, if applicable, are indicated in the Programmable Values column in
bold, italicized text.
POR values – These are the values to which the ICD resets parameters after a power-on reset (POR). If
a POR occurs, the ICD sounds a high-urgency Patient Alert tone every 20 hours. See the “Power-On
Reset recovery procedure” on page 10-34.
Shipped values – These are the programmed parameter values when the ICD is shipped from Medtronic.
The Notes column in each table lists letters that correspond to notes on page 1-25. These include
exceptions or clarifications that relate to the values listed in the programmable parameter tables.