BIOTRONIK Reliaty Manual de usuario
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
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