Download Reliaty Pacing System Analyzer

Cardiac Rhythm Management
External Devices
User's Guide
Reliaty
Pacing System Analyzer
1
Table of Contents
Indications/Contraindications/Warnings/Precautions/
General Safety Instructions.................................................................... 3
Overview............................................................................................... 18
System Overview.................................................................................. 19
Starting Reliaty.................................................................................... 20
Connecting to Reliaty........................................................................... 22
External Monitor...................................................................................... 22
Patient Cables......................................................................................... 23
User Interface...................................................................................... 24
Buttons.................................................................................................... 24
Graphical Interface.................................................................................. 26
Channel Selection................................................................................... 29
Testing.................................................................................................. 30
Sensing.................................................................................................... 30
Threshold and Impedance...................................................................... 31
Conduction and Wenckebach.................................................................. 32
Burst Pacing............................................................................................ 34
Maximum Pacing..................................................................................... 35
Safe Program....................................................................................... 36
Print and Export................................................................................... 37
Report Screen.......................................................................................... 37
Report List............................................................................................... 38
Device Settings..................................................................................... 40
Preferred Settings................................................................................... 40
System Settings....................................................................................... 41
Visual and Audio Signals...................................................................... 43
Patient Cables...................................................................................... 44
Power Supply........................................................................................ 45
Battery Exchange.................................................................................... 46
Power Supply Management.................................................................... 47
Technical Specifications....................................................................... 49
Cleaning................................................................................................... 49
Device Specifications.............................................................................. 49
Specifications/System Messages/Symbols.......................................... 53
2
3
Indications and Contraindications for Use
Note: Federal (USA) law restricts this device to sale by, or on
the order of, a physician (or properly licensed practitioner).
Indications / Contraindications /
Warnings / Precautions / General
Safety Instructions
Indications for Use:
The Reliaty pacing system analyzer is indicated for use
in pacing lead system analysis during the implantation of
pacemakers and defibrillators.
Note: During implantation of cardiac pacemaker and ICD
systems, the device does not measure shock impedance and
defibrillation threshold (DFT).
Intended Use
The Reliaty is intended to be used during the implantation of
pacemakers and defibrillators to evaluate the placement and
integrity of pacing leads and to determine the appropriate
pacing parameters for the implanted device.
Only trained medical personnel may use the device. While
the device is in use, the medical staff must continuously
monitor the patient with the aid of a surface ECG monitor,
and always have cardiac emergency equipment (e.g., external
pacemaker, defibrillator) in an operational status available
for immediate life support. Consider additional pre-emptive
measures in patients where loss of pacing could cause lifethreatening danger.
In support of this intended use, the device provides the
following measurement/diagnostic capabilities:
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Indications and Contraindications for Use
• For the sensing of intrinsic events of the heart:
-------
P/R wave amplitudes and slew rate
Rates (PP, RR interval)
Intrinsic AV delay (PR interval)
Conduction times
Wenckebach point
VV delay
• For the pacing of the heart:
-- Pacing threshold in up to 3 chambers
-- Lead impedances
-- Burst pacing
Note: The device may not be used as a life-support system.
During the implantation, the device is suitable for temporary
external pacing in up to three chambers while the medical
staff must continuously monitor the patient with the aid of a
surface ECG monitor.
Contraindications:
The following applications are contraindicated:
• With AV conduction disorders:
-- Atrial single-chamber pacing
• With competing intrinsic rhythms:
-- Asynchronous modes
• With chronic atrial tachycardia as well as chronic atrial
fibrillation or flutter:
-- Modes with atrial control (DDD, VDD)
• With poor tolerance of high ventricular rates (e.g., with
angina pectoris):
-- Tracking modes (i.e., atrial control modes) and
propensity for atrial tachycardia
• Use as an external pacemaker outside of the
implantation procedure.
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Indications and Contraindications for Use
Possible Complications
Depending on the patient's condition and depending on the
scope and type of pacing program, the following possible
complications associated with the use of pacing system
analyzers are reported in medical references: life-threatening
atrial and ventricular arrhythmia, bradycardia, tachycardia,
and asystole.
Warnings:
Danger from loss of power
Operating the device with depleted batteries, unapproved
battery types or no batteries can endanger the patient if linepower is temporarily interrupted.
• Do not use the device with depleted batteries, unapproved
battery types, or when the battery magazines are not fully
populated with batteries.
When the battery level indicator is red, the device has less
than 30 minutes of remaining battery service time.
• For additional patient safety connect the external power
supply at this point.
• When operating on battery power, do not attempt to
replace the batteries in either battery magazine when the
battery level indicator is red.
• Do not plug in a USB device or attach an external VGA
monitor when the battery level indicator is red.
Fatal injury if exposed to fluids
Before cleaning and disinfecting device surfaces, disconnect
the external power supply.
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Indications and Contraindications for Use
Danger of explosion if exposed to cleaning and
disinfecting agents
Before operating the device, let cleaning and disinfection
agents evaporate.
Danger from contamination
The device cannot be sterilized.
• Do not allow the device to enter a sterile area.
Danger from loss of pacing support
After the device is switched on, the pacing functions are
switched off for approximately 15 seconds while a self-test is
conducted, so that no pacing is possible in this time.
• Keep a separate pacing device ready for emergencies.
Single chamber atrial modes are contraindicated for patients
with impaired AV conduction.
• If the patient has impaired AV conduction, a Wenckebach
test must not be performed.
Connecting the patient cable to the wrong lead may result
in ineffective sensing and pacing behavior and loss of
pacing support.
• Verify that the RV patient cable is connected to the RV
lead before selecting cross-chamber LV pacing.
Danger from electrical leakage currents
Electrical currents can be dangerous to the patient.
• Never touch the patient and the device's electrical
contacts at the same time.
Danger from electrostatic charges
The lead system is in electrical contact with the patients’
heart and blood. Touching the metal clips on the patient cable
or the pacing lead may induce dangerous electrical currents
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Indications and Contraindications for Use
in the patient’s heart.
• Do not touch the metal clips on the patient cable or the
pacing lead.
Electrical currents can be dangerous to the patient.
• Discharge any electrical static charge on your person before
touching the patient, the patient cables or the device.
Danger from loss of function
Moisture from wet cable can impair cable function and
endanger the patient.
• Do not use wet cables.
Incorrect positioning of the protective sleeves over the cable
clip(s) can cause unintended electrical connections that can
impair cable function and endanger the patient.
• Before connecting cables ensure correct position of
protective sleeves.
Danger from allergic reaction
The contact of the cable and open wounds may result in
allergic reaction of the patient.
• Do not allow the cable to come into contact with an open
wound.
Danger from electrical currents
Unused cable connections can induce electrical currents into
the patient's heart.
• Attach unused cable connections close to the patient.
Danger from defibrillation
While the device is designed and tested to be defibrillator
safe, the patient can be endangered and the device can be
damaged.
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Indications and Contraindications for Use
• Whenever possible disconnect the device from the patient
when defibrillating.
• If the device is connected to the patient during
defibrillation, check its operations afterwards.
Danger from HF surgery
The device is equipped with protective circuitry to prevent
damage when used with HF surgery. Although this circuitry
has been tested to and exceeds standard requirements, its
efficiency is limited and depends on the strength, waveform,
and conduction path of the induced current.
In addition, use of HF surgery may induce dangerous
currents into the patient cables which may be conducted
into patient’s heart.
Therefore:
• Disconnect the patient cables from the device when
performing HF surgery procedures.
• Check the operations of the device if HF surgery has
been used.
Danger from abruptly terminating pacing
Abruptly terminating pacing may result in extended periods
of asystole in some patients.
• Gradually decrease the pacing rate until the patient's
intrinsic rate is detected for a controlled transition from
pacing to intrinsic action.
Danger from loss of capture
Pacing threshold testing implies loss of capture. At loss of
capture, asystole and pacing during vulnerable periods
can occur.
• Consider the health of the patient prior to performing a
pacing threshold test.
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Indications and Contraindications for Use
Danger from induction
Always have cardiac emergency equipment (e.g., external
pacemaker, defibrillator) in an operational status available
for immediate life support. Consider additional pre-emptive
measures in patients where loss of pacing could cause lifethreatening danger. Only activate the burst pacing when all
necessary provisions have been made.
Precautions:
Functional impairment due to external damage.
Mechanical impact, for example dropping the unit –
unpackaged, from a height of over 5 cm (2 inches) – can
permanently impair the function of the system.
• Do not use the device if there is apparent damage.
• If damage has occurred, contact BIOTRONIK to test, and
if necessary, repair the device.
Danger from unauthorized modification of the equipment
Modification of the device or its accessories may place the
health and safety of the operator and/or patient at risk.
• Do not modify the device or its accessories.
Damage by cleaning agents
Do not use strong, abrasive cleaning agents or other organic
solvents such as ether or benzine. These agents corrode the
surface of the device.
General Safety Instructions:
Technical Manual
The device may be used only in accordance with this
technical manual.
Risks of improper handling
Disregarding the safety warnings can endanger the patient,
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Indications and Contraindications for Use
the user, or others, as well as the equipment.
Note: Failure to observe the safety precautions voids all
damage claims and manufacturer liability.
The following dangers may arise in the event of improper use:
• Failure of important device functions.
• Personal endangerment due to electrical effects.
No modification of equipment
Do not modify the device or its accessories. Modifications
may put the health and safety of the operator and/or patient
at risk.
Physician supervision
The device may only be operated under the constant
supervision of a physician. During a procedure, the patient
must be continuously monitored by medical personnel with
the aid of a surface ECG monitor.
Emergency equipment
During the procedure, always have emergency resuscitation
equipment (e.g., external pacemaker, defibrillator) in an
operational status available for immediate life support.
Consider additional pre-emptive measures in patients where
loss of pacing could cause life-threatening danger.
External pacing
The device may not be used as a life-support system. During
the duration of the implantation, the device is suitable
for temporary external pacing while the patient is being
continuously monitored by medical personnel.
Touching clips of cables and leads
Do not touch the metal clips on the patient cable or the
pacing lead. The device is in electrical contact with the
patient's heart and blood via the implanted leads. Touching
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Indications and Contraindications for Use
the metal clips on the patient cable or the pacing lead may
expose the patient's heart to dangerous electrical currents.
Connecting cables to leads
Verify that RV patient cable is connected to the RV lead before
selecting cross-chamber LV pacing polarities. Connecting
the patient cable to the wrong lead may result in ineffective
sensing and pacing behavior and loss of pacing support.
Patient cables
Patient cables should not be connected to the device before
it has reached the ready-for-operation status. After the
device is "ready-for-operation", securely attach all patient
cable connections.
Wet cables
Do not use wet cables.
Cables and wounds
Do not allow the cable to come into contact with an
open wound.
Unused cable connections
Attach unused cable connections close to the patient.
Protective sleeves of cables
Before connecting cables ensure correct position of
protective sleeves.
Liquids
Avoid spilling liquids on the device or its accessories. While
the device is designed for limited protection against the
ingress of particulate matter, it is not protected against the
ingress of fluids.
Electrostatic potentials
Avoid delivering dangerous electrostatic shocks to the patient
or equipment. Before handling the device, the patient cable or
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Indications and Contraindications for Use
the corresponding leads, the electrostatic potential between
physician or medical technicians and the patient must be
equalized, for instance by touching the patient at a point as
far as possible from the leads.
Leakage currents
Avoid leakage currents between all connected devices, the
patient cable, and the patient if line-powered devices are
used in the vicinity of the patient. Such leakage currents may
trigger lethal arrhythmias.
Potential equalization cables, if present, must be attached to
all connected components.
National and international regulations concerning the use of
electromedical devices also apply to patient cables.
Self-test
Be aware that the when the device is turned on, it performs
an internal self-test for approximately 15 seconds. During
this time the device's pacing outputs are inactive and the
device is unavailable for use.
Pacing threshold test
Consider the health of the patient prior to performing a
pacing threshold test. A loss of capture, asystole and pacing
during vulnerable periods can occur.
Termination of pacing
Do not abruptly terminate pacing. The sudden termination
of pacing can lead to extended periods of asystole in some
patients. Gradually decrease the pacing rate until the
patient's intrinsic rate is detected.
External ECG device
During the implantation, the medical staff must continuously
monitor the patient with the aid of a surface ECG monitor.
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Indications and Contraindications for Use
Pacing mode selection
Select a pacing mode that is consistent with the patient
cable connections to the leads. Loss of pacing may be a
consequence of inconsistent selection and may cause lifethreatening danger to the patient.
Wenckebach test
Because atrial single chamber pacing is contraindicated for
use in patients with no AV conduction, the Wenckebach test
may not be performed on such patients.
Burst pacing
Burst pacing can induce or accelerate dangerous arrhythmias.
Always have cardiac emergency equipment (e.g., external
pacemaker, defibrillator) in an operational status available
for immediate life support when using this feature. Consider
additional pre-emptive measures in patients where loss of
pacing could cause life-threatening danger.
High-frequency surgery
The device is equipped with protective circuitry to prevent
damage when used with HF surgery. Although this circuitry
has been tested to and exceeds standard requirements, its
efficiency is limited and depends on the strength, waveform
and conduction path of the induced current.
In addition, use of HF surgery may induce dangerous
currents into the patient cables which may be conducted
into patient’s heart.
Therefore:
• Disconnect the patient cables from the device when
performing HF surgery procedures.
• Check the operations of the device if HF surgery has
been used.
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Indications and Contraindications for Use
Defibrillation
While the device is designed and tested to be defibrillator
safe, whenever possible, disconnect the device from the
patient when defibrillating. If the device is attached during
defibrillation, check its operations afterwards.
Basic advice
Only the manufacturer may perform corrective maintenance,
enhancements or modifications to the device.
Connecting accessories
Do not connect a USB flash memory stick, a Bluetooth
adapter or an external VGA monitor while the device is
operating on low battery power (i.e., when the battery gauge
is displayed red). Connecting one of these devices may cause
a sudden increase in power consumption and cause the
device to prematurely shut off.
Sensitivity
Electromagnetic interference may cause noise on the IEGM
traces and spurious sense events and as a consequence may
influence the timing of the pacing delivered to the patient.
Lower sensitivity settings increase the susceptibility of
the device to interfere with electromagnetic fields of other
devices or equipment. A sensitivity setting at or above 1 mV is
strongly recommended, if clinically suitable.
Replacement parts and accessories
Ensure safety compliance by using only original replacement
parts and accessories authorized by BIOTRONIK. Using any
other parts voids the liability for subsequent events, the
guarantee, and the warranty.
Defects
Do not put defective or damaged devices into operation.
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Indications and Contraindications for Use
Installation site
The device may only be operated in an environment that
meets the following conditions:
• The ambient temperature, relative humidity and
atmospheric pressure are within the specified operating
conditions.
• Sterile operating conditions can be maintained.
• There are no explosive gases in the vicinity of the device.
• There is always a cardiac emergency equipment (e.g.,
external pacemaker, defibrillator) in an operational status
available for immediate life support. Consider additional
pre-emptive measures in patients where loss of pacing
could cause life-threatening danger.
• The patient is monitored with a surface ECG monitor.
The device should stand on a level, dry surface. It should
be placed so that it cannot slide, especially when cables
are connected.
Cable and lead connections
• Inspect cables prior to use. Replace cables if they are
worn or damaged.
• Arrange cables to avoid entanglement with equipment or
medical staff.
• Cable connections and plugs must be cleaned as defined
in Cleaning on page 49 and Patient Cables on page 44.
Soiled contacts can lead to signal distortions and
false diagnoses.
• All electrical contacts must be dry.
• Make sure that cables are securely connected. When
disconnecting cables from the device, clasp the locking
connector and pull. Do not pull on the cable.
• All lead connections are swap-safe and encoded at the
lead connectors. Do not force cables to connect together
or force lead connectors into the connector ports.
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Indications and Contraindications for Use
Note: Before connecting the patient cable to the leads,
ensure that the leads are securely implanted in the
patient’s heart.
• Patient cables may only be used by healthcare
professionals that are qualified for intracardial
examinations and therapy.
• Precautionary measures must be maintained while
conducting an intracardial examination. Use in suitable
rooms featuring X-ray facility and cardiac emergency
equipment (e.g., external pacemaker, defibrillator) in an
operational status available for immediate life support.
Consider additional pre-emptive measures in patients
where loss of pacing could cause life-threatening danger.
• No patient cables should be connected to the device
before it has reached the ready-for-operation status.
Current parameter settings should be verified, prior to
connecting the patient cables to the device.
Note: It is possible to connect or disconnect the patient
cables while the device is on.
Possible electromagnetic interferences
When used with its approved accessories and configure and
operated in accordance with the instruction in this document,
this device meets the electromagnetic compatibility
requirements of IEC 60601-1-2.
However, strong electromagnetic interference can occur in
close proximity to other electrical equipment. Therefore the
device should not be placed adjacent to or stacked on other
electrical equipment.
Electromagnetic interference may cause interference with
the device, including:
17
Indications and Contraindications for Use
• Resetting of the device.
• Noise on the IEGM traces, spurious sense events.
If electromagnetic interference occurs, try the following, as
appropriate:
• Switching off the source of interference.
• Moving the source of interference away from the device.
• Disconnecting any electrical connections between the
device and the source of interference.
• Switching the device off and back on, again.
• If the interference continues, contact your local
BIOTRONIK representative immediately.
Note:
• Portable and mobile RF communication equipment can
affect the operation of the device.
• Use of accessories that are not approved by BIOTRONIK
can increase the device’s electromagnetic emissions and/
or electromagnetic susceptibility.
Note: Electromagnetic interference may cause noise
on the IEGM traces and spurious sense events and as a
consequence may influence the timing of the pacing delivered
to the patient. Lower sensitivity settings increase the
susceptibility of the device to interfere with electromagnetic
fields of other devices or equipment. A sensitivity setting at or
above 1 mV is strongly recommended, if clinically suitable.
Note: Prolonged exposure to electromagnetic interference
may cause the device to pace asynchronously.
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Overview
Overview
Reliaty is a portable medical diagnostic device intended
to be used during the implantation of pacemakers and
defibrillators to evaluate the placement and integrity of
pacing leads and to determine the appropriate pacing
parameters for the implanted device.
The user controls the operations of Reliaty through the LCD
touch-screen, parameter wheel, and control buttons. Figures
1 and 2 provide an overview of external features. The device
provides three-chamber pacing and sensing and can display
up to three channels of real-time IEGMs and markers. The
device provides standard PSA functionality, including lead
impedance measurements, intrinsic amplitude, timing
measurements, and pacing thresholds. It has a report feature
that provides a summary of device measurements, along with
optional IEGM traces.
19
System Overview
System Overview
Connectors for patient cables
Secondary power
Tilt stand
VGA interface
USB port
AC power
Figure 1: Reliaty PSA
Safe program
LED indicators
Measurement
keys
Maximum stimulation
Preferred settings
Figure 2: Reliaty PSA front panel
Parameter wheel
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Starting Reliaty
Starting Reliaty
Check battery cartridges and power supply before turning the
device on. The ON/OFF button is located on the right side of
the device. Press the ON/OFF button to turn on Reliaty. The
start screen appears shortly after the device is turned on. A
self-test then runs for approximately 15 seconds. After the
self-test, the device is ready for use. To turn the device off,
press the ON/OFF button again.
Checkup prior to use
• Perform a checkup on the device and the approved
accessories before each use:
-- Inspect the housing for mechanical damage,
dents, loose parts, cracks or tampering.
-- Inspect the legibility of the labeling.
-- Inspect cables for damage to the insulation,
connectors or electrical contacts.
-- Replace damaged or worn cables.
-- Turn the device on.
-- Verify that all indicator lights flash briefly.
-- Wait 15 seconds to allow an internal self-test to
complete.
-- Verify that no error messages are displayed.
• If the device has mechanical damage or does not pass its
internal self-test, do not use the device and contact your
local BIOTRONIK representative immediately.
21
Starting Reliaty
Periodic Inspection
• A complete inspection of the device needs to be
performed:
-- in suspicion of malfunction;
-- every two years.
• Excessive electrical power, e.g. combined use of HF
surgery equipment or a defibrillator on a patient
during use of the pacing system analyzer, may damage
the device. Check the operation of the device after
such usage and initiate this inspection if any signs of
malfunction exist, especially if failure messages during
start-up self-test occur on the display.
• This inspection needs to be performed according to
manufacturer’s instructions. These instructions can be
provided on demand and state all required test steps and
devices related to the check.
• If you have any questions, please contact your local
BIOTRONIK representative.
22
Connecting to Reliaty
Connecting to Reliaty
External
Monitor
Figure 3: Reliaty VGA port
It is possible to connect or disconnect an external monitor
while the device is on. Connect the VGA plug of the monitor
to the VGA port, as shown in Figure 3. If the VGA port is set
to Auto and Reliaty detects a connection to a VGA monitor,
Reliaty will enable its external VGA port. The device may
not detect some VGA monitors, so it may be necessary
to manually enable the external port. For instructions
on enabling or disabling this feature, refer to the Device
Settings section on page 40.
23
Connecting to Reliaty
Patient
Cables
Figure 4: Patient cables port
For a list of compatible cables, see the Patient Cables
section on page 44.
Connect to right side of the heart
• To connect to the right side of the heart (RA/RV), insert
the patient cable’s locking connector into port
,
shown in Figure 4.
• Ensure that the plug has locked into the port.
• Connect the patient connections of the patient cable or
adapter to the RA/RV leads of the patient.
Connect to the left side of the heart
• To connect to the left side of the heart (LV), insert the
patient cable’s locking connector into port
, shown
in Figure 4.
• Ensure that the plug has locked into the port.
• Connect the patient connections of the patient cable or
adapter to the LV leads of the patient.
Remove the cables
• Disconnect the patient cable or adapter from the pacing
lead by opening the clips and removing the pacing lead.
• Disconnect the patient cable from Reliaty by pulling on
the cable’s locking connector.
24
User Interface
User Interface
Buttons
Figure 5: User interface and buttons
LEDs: The LEDs, shown in Figure 5, along the top of the
front panel indicate pacing or sensing in each of the three
chambers. See Visual and Audio Signals section on page 43
for more information.
VVI: Selecting the red button to the left of
will start
pacing in the safe program immediately, which is VVI at 60
bpm. For more information on safe program, see the Safe
Program section on page 36.
25
User Interface
Parameter wheel: To adjust a selected parameter, turn
the wheel to the right or left. The new values are effective
immediately. To increment the value, turn the wheel
clockwise. To decrement the value, turn the wheel
counter-clockwise.
Max Stim: This button delivers pacing at 10 V at 2.0 ms. For
more information, see the Maximum Pacing section on page 35.
Pref. Set.: This button activates the user-defined preferred
settings. See the Preferred Settings section on page 40 for
more information.
Measurement keys: Pressing the Sensing, Threshold, or
Impedance key will save the current measured value in the
selected channel to the report. See the Testing section on
page 30 for more information.
Timing/Freeze: Pressing the Timing/Freeze key will open the
Freeze window, which displays the most recent IEGM. See
the Testing section on page 30 for more information.
26
User Interface
Graphical
Interface
Figure 6: User interface
Information bar: Along the top of the screen, the current
mode, rate in each channel, and power supply indicator are
displayed to provide basic information.
Modes: Pressing the Mode button opens a drop down menu
with common single- and dual-chamber modes. The Mode
button is indicated by the black rectangle in Figure 6.
Sensing button: Pressing the Sense button, available in
each chamber, toggles to ON or OFF to adjust the mode to
enable or disable sensing in a particular chamber. When
sensing is ON in a particular channel, the circle on the
button is filled in. When sensing is OFF in a particular
channel, the circle is not filled. The Sense button is marked
by the blue rectangle in Figure 6.
27
User Interface
Pacing button: Pressing the Pace button, available in each
chamber, toggles to ON or OFF to adjust the mode to enable
or disable pacing in a particular chamber. Like the Sense
button, the Pace button indicates whether pacing is ON or
OFF in a particular channel using a filled in or empty circle.
The Pace button is marked by the red rectangle in Figure 6.
Channel button: Pressing a channel button activates or
deactivates each channel. When deactivated, the channel
will be grayed out. The Channel button is indicated by the
green rectangle in Figure 6.
Tracking button: Pressing the Tracking button will switch the
mode between a tracking mode and a non-tracking mode
(e.g., DDD to DDI). The Tracking button is indicated by the
yellow rectangle in Figure 6.
Tests: Selecting the Tests button will send the user to the
Tests screen to perform basic lead tests. See page 30 for
more information on testing.
Report: Selecting the Report button will send the user to
the Report screen to view, export, or print a measurement
report. See page 37 for more information on reports.
Burst: Selecting the Burst button will send the user to the
Burst pacing screen to perform high rate pacing. See page 34
for more information on burst pacing.
Pref. set.: Selecting the Pref. set. button will send the user
to the Preferred Settings screen to view or change system
settings and user-defined settings. See page 40 for more
information on preferred settings.
28
User Interface
Basic rate: Selecting the Rate button will allow the user
to increase or decrease the basic rate by adjusting the
parameter wheel. The Rate button is indicated by the orange
rectangle in Figure 6.
Amplitude and pulse width: Selecting the Amplitude or Pulse
Width buttons, available in each chamber, allows the user
to adjust the output by adjusting the parameter wheel. The
Amplitude and Pulse Width buttons are indicated by the
purple rectangle in Figure 6. If a chamber is not pacing due to
the current mode, the output buttons for that chamber will be
grayed out, as shown by the LV channel in Figure 6. The user
can still make changes to the amplitude and pulse width, but
the chamber will remain grayed out and inactive.
More: Selecting the More button opens the following
additional adjustable parameters: AV delay, VV offset,
sensitivity in each channel, and LV polarity.
29
User Interface
Channel
Selection
Figure 7: Selecting a Channel
Reliaty is capable of testing in three channels: atrium, right
ventricle, and left ventricle. Each channel can be inactive,
active, or selected.
Inactive: The channel is not being tested and is not used in
the current mode. Its inactivity is indicated by a grayed out
appearance. The output on this channel can still be adjusted,
and the new output will be in effect when the channel is
activated again. In Figure 7, the LV channel is inactive.
Active: The channel will have an associated IEGM and will no
longer be grayed out. To activate an inactive channel, select
the associated channel button. In Figure 7, the RV and A
channels are active.
Selected: Only one active channel can be selected at a time.
To conduct and save measurements for a channel, the
associated channel must be selected. When pressing one
of the measurement buttons on the front panel, only the
measurements of the selected channel are saved. In Figure 7,
the A channel is active and selected.
30
Testing
Testing
All tests can be performed from the Tests screen, accessible
by pressing the Tests button, located along the bottom of
the Reliaty screen.
Sensing
Figure 8: P/R wave amplitude measurements in Reliaty
P/R wave amplitude measurements are used to assess the
ability of the implanted device to sense the intrinsic activity
of the heart at the current lead position within the heart. If
the intrinsic heart rate of the patient is above the set pacing
rate or pacing is disabled, the heart’s intrinsic activity can
be measured. See below for instructions on performing a
sensing test.
• Select the desired channel.
• Press the Sense button to adjust the mode to allow for
sensing in that channel.
• Adjust the mode, rate, and AV delay to promote intrinsic
activity. Sensed values are displayed on that channel’s
IEGM, as shown in Figure 8.
31
Testing
• Press the Sensing button on the front panel to save
the displayed sensing measurements on the selected
channel and a 5-second IEGM to the report.
• Repeat the procedure for other channels as necessary.
Threshold
and
Impedance
Figure 9: Threshold and impedance measurements in Reliaty
Pacing threshold measurements are used to assess the
ability of the implanted device to effectively and efficiently
pace the heart at the current lead position. Lead impedance
measurements are used in assessing the integrity of the
lead and the connection of the lead’s electrodes with the
myocardium. A lead impedance measurement is made on
each paced event. The last lead impedance measurement,
in each channel, is displayed on the left-side of the IEGM
window next to the IEGM trace for that channel, as shown
with the red boxes in Figure 9. Also, the pacing amplitudes
are displayed with their respective event on each channel’s
IEGM, also shown in Figure 9. Perform the threshold and
impedance measurements as follows:
32
Testing
• Press the Channel button to activate and select the
desired channel.
• Press the Pace button to adjust the mode to allow pacing
in that channel.
• Adjust the rate and/or AV delay to force pacing in
that channel.
• Use the parameter wheel to decrease the pacing
amplitude until loss of capture occurs.
• Increase the pacing amplitude until capture is
re-established.
• Press the Threshold measurement key on the front
panel to save the current pacing settings of the selected
channel and save a 5-second IEGM to the report.
• Use the parameter wheel to increase the pacing
amplitude to a safe value (5 V to 10 V).
• Press the Impedance measurement key on the front panel
to save the displayed impedance measurement, the current
pacing settings, and a 5-second IEGM to the report.
Conduction
and
Wenckebach
Figure 10: Freeze screen to allow timing measurements
33
Testing
Conduction
Conduction measurements are used to determine
appropriate pacing parameters for the implanted device.
Antegrade conduction time is measured by sensing in the
ventricle and measuring from atrial event to ventricular
sensed event. The retrograde conduction time is measured
by pacing in the ventricles and measuring the time interval
between the ventricular pace and any subsequently induced
P-wave. Perform a conduction test as follows:
• Adjust the mode and rate to allow for antegrade or
retrograde conduction.
• Press the Timing/Freeze key on the front panel, which will
bring up the Timing/Freeze window, shown in Figure 10.
• Adjust the slide bar to move the viewing window.
• Use the calipers to make time-based measurements.
• Use the grid to make amplitude-based measurements.
• Press the Save button to save the strip to the report.
Wenckebach
The patient’s intrinsic Wenckebach point measurements
are useful in determining the appropriate pacing settings
for the implanted device. For instructions on measuring the
Wenckebach point, see below.
• Adjust the mode to allow for pacing in the atrium and
sensing in the ventricle.
• Increase the pacing rate until Wenckebach behavior is
displayed on the IEGM.
• Press the Timing/Freeze key.
• Adjust the slide bar to move the viewing window.
• Use the calipers to make time-based measurements.
• Use the grid to make amplitude-based measurements.
• Press the Save button to save the strip to the report.
34
Testing
Burst
Pacing
Figure 11: Burst pacing pop-up window
Figure 12: Burst pacing screen
Burst pacing can be used to terminate certain types of
arrhythmias. During burst pacing, the currently selected
channel is stimulated with a fixed pulse amplitude (7.5 V),
fixed pulse width (1.0 ms), and an adjustable pacing rate.
35
Testing
Burst pacing is possible on all three channels, but with only
one channel at a time. For instructions on performing burst
pacing, see below.
• Go to the Burst screen by pressing the Burst button from
any other screen.
• A window will pop up, as shown in Figure 11. Click OK.
• Select the respective burst rate button to select the
chamber where the burst pacing shall be applied, as
shown in Figure 12.
• Use the parameter wheel to adjust the burst rate.
• Press the burst deliver button to apply burst pacing with
the selected burst rate.
The burst is delivered as long as the button is pressed.
Maximum burst duration is 30 seconds. If the burst deliver
button is held longer than 30 seconds, Reliaty will stop
delivering burst pacing.
While burst pacing in the atrium, the device will provide
ventricular backup pacing if the pacing mode is a ventricular
pacing mode when starting the burst. If the pacing mode is
not a ventricular pacing mode, ventricular pacing support will
not be provided.
Maximum
Pacing
The Maximum pacing amplitude is used to assess whether
the extracardiac muscle or phrenic nerve can be inadvertently
stimulated by paces with the lead in its current position
within the heart. During maximum pacing, the currently
selected channel is paced with an output of 10 V at 2.0 ms.
For instructions on delivering maximum pacing, see below.
• Activate and select the desired channel.
• Adjust the mode to allow pacing in this channel.
• Deliver maximum pacing by pressing the Max Stim key on
the front panel and holding it.
• Terminate maximum pacing by releasing the Max Stim key.
36
Safe Program
Safe Program
The Safe program function sets critical pacing parameters
to preset, safe values. The Safe program, when initiated,
immediately interrupts all other Reliaty functions.
The Safe program settings (non-programmable) are
listed below:
Mode: Rate: Output: Sensitivity:
Refractory Period:
VVI RV
60 bpm
7.5 V at 1.0 ms
2.5 mV
250 ms
To deliver the Safe program, press the Safe program key
on the front panel. The Safe program is immediately active
without any other confirmation. To change the Safe program
parameters back to their original values, select each
parameter and use the parameter wheel on the front panel to
make the adjustments or press the Pref. set. key on the front
panel to activate preferred settings.
37
Print and Export
Print and Export
Report
Screen
Figure 13: Report screen
To print or export a report, navigate to the Report screen by
selecting the Report button along the bottom of the Reliaty
screen, as shown in Figure 13. To view a detailed report with
both measured values and 5 second snapshots of the IEGM
window, press the Details button.
To export a PDF, connect a USB flash drive to the USB port.
The Report screen will display measurements from the
current report. From the Report screen, select the Print/
Export button. A pop-up window will show export options.
Select the USB to export the report to the USB drive.
To print a report to an external Bluetooth® printer, connect
a Bluetooth® module to the USB port. The Report screen
displays a summary of the measurements saved in the
current report. Press the Print/Export button. A pop-up
window will show export options. Select the printer to
print the report.
38
Print and Export
Press the Details button to see the associated IEGM strips.
Press the Print/Export button to print or export the report
with all details.
Report
List
Figure 14: Report list
To manage the reports, go the Reports screen. Press the
Report List button to see the list of all stored reports, as
shown in Figure 14.
View a report: Select an entry from the list and press the View
Report button to display a report.
Name a report: Select an entry from the list and press the
Rename Report button to rename a report. Use the screen
keyboard to change the name of the report.
Create a report: Press the New Report button to add a new
report. All following measurements will be saved to this
report until a new report is created or Reliaty is turned off.
39
Print and Export
Edit a report: To store new measurements on an existing
report, select the report from the list. The report is then
marked blue and all further testing and additional testing
measurements will be stored in this report. This is useful for
documenting different configurations during implant or to
store more than one Freeze screen per implantation. Reliaty
allows the user to store one Freeze screen per report to
document timing. A new Freeze screen recorded overwrites
the previously saved Freeze screen.
Up to 15 reports can be stored in the Report list. Each report
is displayed in the Report list with date and time or a name.
Once 15 reports have been stored and a new report is added,
the oldest report is automatically deleted. The Report list
remains stored when the device is switched off.
40
Device Settings
Device Settings
Figure 15: Preferring settings
Preferred
Settings
Access the Preferred Settings screen by pressing the Pref.
set. button on the screen. In this screen, the user can
configure the pacing parameters (preferred settings) and the
system settings such as date, time, language, or illumination
as shown in Figure 15.
Reliaty begins with the preferred parameters when it is
initially turned on. To adjust these parameters, select the
parameter and use the parameter wheel to change the value
or select the new setting from a list. Use the slide bar to view
the complete list of settings. As these settings are changed,
the new system settings are effective immediately and no
confirmation is required. Changes to preferred settings can
be made without affecting current device operations. Any
changes made to preferred settings will be saved.
The preferred settings can be activated in the Tests screen by
pressing the Pref. set. key on the front panel.
41
System
Settings
Device Settings
System settings are the general settings of the device. A change
in the system settings can be made without affecting the current
operation of the device. All changes to system settings are saved
permanently in Reliaty, even after it is turned off.
To change a system setting, select the Pref. set. button to
move to the Preferred Settings page. Select the value and
change it using the control knob on the front panel. The new
value is immediately effective. From this screen, adjustments
can be made to the following parameters: date, time, date
format, language, and illumination.
Illumination brightness: The illumination brightness of the
display is preset to a basic value (Normal) to provide an
optimal compromise between light intensity of the display
and service time for battery operation. To change the
illumination brightness on the Pref. set. screen, press the
Illumination button repeatedly to activate one of the following
settings: Normal, Bright, Long life. Note: The Bright setting
will decrease battery life.
Factory settings: All system settings can be reset to the
factory default values. To reset all settings to factory values,
press the Reset pref. settings button. The system settings
are changed to the factory settings. The current operational
settings are not affected by this change.
VGA settings: To change the VGA settings, press the VGA
button, seen in Figure 15, to switch among OFF, ON, and
Auto detect (recommended). The auto detect setting will
automatically turn on the VGA port when a VGA monitor
connection is detected. If the device is not detecting the
monitor, switch the VGA settings to ON. To conserve battery
when not using a VGA monitor, switch to the VGA settings to OFF.
42
Device Settings
Maintenance code: The Maintenance code is used for service
purposes only.
Export system logfile: This option is used during unexpected
device behavior. A logfile is exported via a USB stick, and the
exported information is then used for analysis.
43
Visual and Audio Signals
Visual and Audio Signals
Reliaty includes audio and visual signals to alert the user. These
signals include a tone for confirmation of user input, a beep to
warn for low battery, and LEDs to indicate pacing and sensing.
Confirmation of user input: Reliaty emits audible signals to
confirm user input. A high tone indicates a successful action
that changes the behavior of Reliaty. A deep tone confirms
the user input, but there is no direct effect if the action was
not successful. For example, if changes are made to the
output of an inactive channel, a deep tone will confirm that
these changes were successful even though the changes do
not directly affect current device function.
Battery: Reliaty emits a beep every 20 seconds when the
battery gauge is red (< 30 minutes of battery life remaining) to
warn the user to switch to a different power source.
LED: The LEDs along the top of the front panel indicate
pacing and sensing in each channel. Each channel has two
LEDs: a green LED to indicate sensing and a yellow LED to
indicate pacing.
44
Patient Cables
Patient Cables
See Table 1 for a list of cables that are compatible
with Reliaty.
Cable
Description
Length
Sterilization
Cycles
50 cycles of
re-sterilization
PK-141
Alligator clips
2.8 m
(110.2 in)
Re-sterilizable
with steam at
134°C
PK-67-L
and
PK-67-S
with
adapters
Alligator clips
with PA-4 adapter;
Connector for 2 mm
pins with adapter
PA-1-B; IS-1
connector with PA-2
adapter
2.6 m (L)
(102.4 in)
and
0.8 m (S)
(31.5 in)
Re-sterilizable
with steam at
121°C
20 cycles of
re-sterilization
Alligator clips
2m
(78.7 in)
(PK-155)
PK-155 is
disposable
and cannot be
re-sterilized
N/A
PK-67-L
and
PK-67-S
with
PK-155
Table 1: Cables compatible with Reliaty
45
Power Supply
Power Supply
Secondary power
AC power
Figure 16: Power supply
Reliaty has a redundant power supply, which includes two
separate battery cartridges (only one is shown in Figure 16)
and an external power supply, as shown in Figure 16. The
primary power source is the external power source, which can
be attached while Reliaty is operating on secondary supply, i.e.,
the batteries. When the external power supply is unavailable,
the device automatically switches from the primary to the
secondary power source without loss of function.
Reliaty includes two battery cartridges, that serve as the
secondary power source for the device. Each cartridge
requires four disposable AA batteries. With Duracell MN 1500
or Energizer E91 LR6 batteries, operating time with these
batteries is at least 12 hours* when the batteries are new.
Also, the batteries should be removed if Reliaty will not be
used for a prolonged period of time to avoid draining battery
life. Rechargeable batteries are contraindicated for Reliaty
because they do not allow for a precise calculation of the
remaining operation time. Rechargeable batteries cannot be
recharged via Reliaty.
*
With two chamber stimulation at 70 bpm, 5 V, 0.5 ms, 500 ohm and
no external devices connected
46
Power Supply
Battery
Exchange
Figure 17: Replacing Reliaty batteries
Batteries can be replaced while the device is still in use
and operates using the second battery cartridge or external
power source. Battery replacement while the device is in use
will not interrupt Reliaty operation when a second battery
cartridge or external power source is also used. The battery
compartments are located on the right and left side of the
device. See below for instructions regarding replacing the
batteries and refer to Figure 17.
• Open the battery compartment by pushing up on the
locking mechanism.
• Pull the battery cartridge out.
• Remove all old batteries. For optimal device performance,
replace all four batteries at the same time with new
batteries.
• Insert the four new batteries as indicated by the terminal
notations on the battery cartridge.
• Push the battery cartridge into the battery compartment
until the locking mechanism latch is heard.
47
Power Supply
To ensure operation of Reliaty during battery replacement,
replace the batteries in the depleted cartridge first. Reliaty
comes with a third battery cartridge for quick
battery exchange.
Power
Supply
Management
Replace left
cartridge
Replace right
cartridge
Immediately connect the external power supply!
Do not replace any battery cartridge.
Figure 18: Reliaty Test screen with Power Supply Indicators
The Power Supply Indicator displays the type of power supply
and also indicates overall battery status. See Table 2 for a
description of the different indicators and their meaning. The
images on the lower left and right corners indicate which
cartridge needs to be replaced, as shown in Figure 18. The
images on the lower left and right corners are not used when
the device is using an external power supply.
48
Power Supply
Image
Definition
External power supply connected,
batteries not used
Remaining operation time is currently
being calculated
Using battery only, remaining operation
time is longer than 4 hours
Using battery only, remaining operation
time is between 2 and 4 hours
Using battery only, operation time is
below 30 minutes
Table 2: Reliaty power supply indicators
49
Technical Specifications
Technical Specifications
Cleaning
Device
Specifications
• Use soft, lint-free cloth.
• Housing: Clean with a damp cloth and mild soap solution
or a mixture of 70% isopropanol and 30% water. Disinfect
with alcohol or aldehyde-based agents.
• Connectors: Visually inspect the connectors to make sure
that the ports are free of debris.
• Patient cables and adapters: Clean with a mixture of 70%
isopropanol and 30% water. Disinfect by exposing to water
with a 2% concentration of Lysoformin for 15 minutes.
• Sterilization: Reliaty cannot be sterilized. The PK-155
cable is for single use only and cannot be sterilized. Other
approved cables can be re-sterilized and re-used.
Dimensions
Parameter
Specification
Length x Width x Height
220 x 180 x 60 mm (8.7 x 7.1 x 2.4 in)
Weight (including batteries)
1.2 kg (2.6 lbs)
Housing material
ABS flame resistant
Display/Touch screen
Parameter
Specification
Size (diagonal)
177.8 mm (7.0 in)
Resolution
800 x 480 pixel
Backlight
LED
Screen brightness
350 cd/m2
Touch screen
Resistive
Pace/sense indicators
6 LEDs (3 green, 3 yellow)
50
Technical Specifications
Input/Output
Parameter
Specification
USB port
USB 2.0 standard (12 MBit/S)
Bluetooth® interface
Support external HP PCL5
compatible printer
VGA interface
DE-15 DDC2 only for
medical monitor
External power supply
Socket for barrel connector
5.5 mm / 2.5 mm (0.19 in / 0.098 in)
Patient connectors
2 Redel connectors PKN06
Environmental conditions
Parameter
Specification
Temperature (Storage)
0…50°C (32...122°F)
Humidity (Storage)
30…75%
Atmospheric Pressure
(Storage)
50…106 kPa
Temperature (Operation)
10…40°C (50...104°F)
Humidity (Operation)
30…75%
Atmospheric Pressure
(Operation)
70…106 kPa
51
Technical Specifications
Parameters
Parameter
Specification
Factory
Settings
Mode
DDD, DDI, VDD, VDI,
VVI, VOO, AAI, AOO,
OAO, OVO, ODO
VVI
Active channels
A: ON, OFF; RV: ON,
OFF; LV: ON, OFF
A: ON, RV: ON,
LV: ON
Pace
A: ON, OFF; RV: ON,
OFF; LV: ON, OFF
A: OFF, RV: OFF,
LV: OFF
Sense
A: ON, OFF; RV: ON,
OFF; LV: ON, OFF
A: ON, RV: ON,
LV: ON
Tracking
ON, OFF
OFF
AV delay
0…(5)…300 ms
120 ms
VV delay (RV→LV)
-100…(5)…100 ms
+5 ms
Basic rate (A, RV, LV)
30…180 bpm, with
30…(1)…100 bpm
and 100…(2)…180
bpm
90 bpm
Pulse amplitude
(A, RV, LV)
0.1…(0.1)…10 V
5V
Pulse width (A, RV, LV)
0.1…(0.1)…2.0 ms
0.5 ms
Sensitivity, atrium
0.2…(0.1)…20 mV
1.0 mV
Sensitivity, ventricle
0.5…(0.1)…20 mV
2.5 mV
LV: Pacing polarity
BIPL, CRBP, IVBP,
RRBP
BIPL
IEGM Filter
ON/OFF
OFF a)
Burst frequency
80…(10)…1000 bpm
100 bpm
52
Technical Specifications
Parameter
Specification
Burst time maximum
30 s
High rate protection
200 bpm
Blanking after
pace-cross-chamber
25 ms
Blanking after
pace-same chamber
125 ms
Autoshort after pace
(A, RV, LV)
15 ms
Measurement time
sense (A, RV, LV)
60 ms
Noise interval
70 ms
Atrial Refractory
Period
425 ms
Ventricular Refractory
Period
250 ms
Factory
Settings
In certain environments, switching the IEGM Filters on may result in a reduction
of EMI interferences or noise on the IEGM traces. However, activated IEGM Filters
may attenuate peak IEGM potentials from cardiac activity, thus influencing the
morphology of the IEGM signal. The default setting for the IEGM Filters is off upon
start of the device.
a)
53
System Messages/Symbols
Specifications / System Messages / Symbols
Scope of Delivery and Accessories
Name
Quantity
Order no.
Reliaty
1
365 530
Bag
1
370 109
External power supply
1
367 905
Power cord
1
380 080
Battery cartridge
3 (2 inside device)
365 382
Batteries
8
370 736
Technical Manual
1
Quick Reference Guide
1
Available Accessories
Name
Order no.
Details
Patient cable PK-67-L
123 672
Applicable with PK-155
Patient cable PK-67-S
123 438
Applicable with PA-2, PA-4
Patient cable PK-141
353 181
-
54
System Messages/Symbols
System Messages
System Messages: Meaning and Measures
Message text
Meaning
Measures
Error while creating
PDF file is corrupt.
the *.pdf - file!
Storage medium
out of space!
Insufficient
remaining memory
on storage device.
•Delete unused data on
storage device.
•Use storage device with
greater capacity.
Storage device not
ready!
Files cannot be
exported to storage
device.
Ensure the following:
•Storage device is compatible.
•Storage device is properly
connected.
Storage device
write-protected!
Files cannot be
exported to storage
device.
Ensure that the storage device
does not have write protection
enabled.
Bluetooth device
not ready!
Data cannot be
transferred to
Bluetooth adapter.
Ensure the following:
•Bluetooth adapter is
compatible.
•Bluetooth adapter is properly
connected.
Printer
communication
error!
Data cannot be
transferred to
Bluetooth printer.
Ensure the following:
•Printer is Bluetooth enabled,
powered on, and within close
proximity.
Printer not ready!
Data cannot be
transferred to
Bluetooth printer.
Ensure the following:
•Printer is Bluetooth enabled,
powered on, and within close
proximity.
No storage/
Bluetooth device
connected!
Data cannot be
transferred to
storage device or
Bluetooth adapter.
Ensure the following:
•Storage device or Bluetooth
adapter is compatible.
•Storage device or Bluetooth
adapter is properly connected.
55
System Messages/Symbols
Critical Error Messages
Triggered by a built-in self-test routine, the device can also
show a critical error message. The message consists of a
condition code number and a proposed measure. In case
the device repeatedly shows such error message, note
the condition number and contact your local BIOTRONIK
representative.
Country-Related Information
UL certification
Reliaty has been certified by Underwriters Laboratories Inc.
with respect to electrical shock, fire and mechanical hazards
only in accordance with:
•
•
•
•
UL 60601-1
CAN/CSAC22.2 No. 601.1
IEC 60601-1: 1988 + A1 + A2
IEC 60601-2-31: 1994 + A1
UL-certified devices are identified as follows:
56
System Messages/Symbols
Legend for the Label
The label icons symbolize the following:
Pacing system analyzer
BIOTRONIK order number
Serial number of device
Date of manufacture
Storage and transport temperature limitation
Storage and transport atmospheric
pressure limitation
Storage and transport humidity limitation
CE conformity marking
Caution: Federal (U.S.A.) law restricts this
device to sale by, or on the order of, a physician.
Contents
Consult instructions for use
57
System Messages/Symbols
BIOTRONIK, Inc.
6024 Jean Road
Lake Oswego, OR 97035-5369
(800) 547-0394 (24-hour)
(800) 291-0470 (fax)
www.biotronik.com
M4144-A 06/12
© 2012 BIOTRONIK, Inc.
All rights reserved. MN015r1 6/14/12