BIOTRONIK Reliaty User manual

ardac Rhythm Management
External Devces
User's ude
Relaty
Pacng System Analyzer


1
Table of Contents
Indcatons/ontrandcatons/Warnngs/Precautons/
eneral Safety Instructons...................................................................3
Overvew.............................................................................................. 18
System Overvew ................................................................................. 19
Startng Relaty ................................................................................... 20
onnectng to Relaty...........................................................................22
External Montor.....................................................................................22
Patent ables ........................................................................................23
User Interface ..................................................................................... 24
Buttons ...................................................................................................24
raphcal Interface................................................................................. 26
hannel Selecton ..................................................................................29
Testng................................................................................................. 30
Sensng ...................................................................................................30
Threshold and Impedance .....................................................................31
onducton and Wenckebach.................................................................32
Burst Pacng...........................................................................................34
Maxmum Pacng....................................................................................35
Safe Program ...................................................................................... 36
Prnt and Export .................................................................................. 37
Report Screen.........................................................................................37
Report Lst..............................................................................................38
Devce Settngs.................................................................................... 40
Preferred Settngs..................................................................................40
System Settngs......................................................................................41
Vsual and Audo Sgnals ..................................................................... 43
Patent ables ..................................................................................... 44
Power Supply....................................................................................... 45
Battery Exchange ...................................................................................46
Power Supply Management ................................................................... 47
Techncal Speccatons ...................................................................... 49
leanng..................................................................................................49
Devce Speccatons..............................................................................49
Speccatons/System Messages/Symbols......................................... 53

2

3Indications 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 life-
threatening danger.
In support of this intended use, the device provides the
following measurement/diagnostic capabilities:

4Indications 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.

5
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 line-
power 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.
Indications and Contraindications for Use

6
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
Indications and Contraindications for Use

7
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.
Indications and Contraindications for Use

8
• 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.
Indications and Contraindications for Use

9
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 life-
threatening 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,
Indications and Contraindications for Use

10
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
Indications and Contraindications for Use

11
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
Indications and Contraindications for Use

12
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.
Indications and Contraindications for Use

13
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 life-
threatening 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.
Indications and Contraindications for Use

14
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.
Indications and Contraindications for Use

15 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.

16
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:
Indications and Contraindications for Use

17
• 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.
Indications and Contraindications for Use

18 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.
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