BIOTRONIK SE and KG QFORCE Users Manual
EP // External devces // Techncal Manual
Qubc Force
Devce for vsualzaton of contact force
of the catheter tp on the cardac wall
Table of Contents
Table of Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
About the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
About this Technical Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
Safety during Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Required Expertise . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Electromagnetic Interference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
General Safety Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Operating Conditions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
Maintenance, Care and Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
Device Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
Device Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
Setting up the Device. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17
Connections and Cables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18
Switching On and Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Keys on the Device. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Using the Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26
The Main View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26
The Status Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
The Numerical Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
The Graphic Display. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30
The Trend Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
The Settings View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .36
Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .36
Parameter Values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39
Country-Related Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40
Legend for the Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Directories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .42
1
418425--D
2 Introduction
1 Introduction
Introduction1418423Technical ManualQubic Force
About the Device
General description
Qubic Force is used with the AlCath Force ablation catheter, a compatible
radiofrequency (RF) generator, and an external monitor. Qubic Force is a
device for visualization of the contact force of the ablation catheter tip on the
cardiac wall during an electrophysiological study in cardiac catheter laboratories with or without cardiac radiofrequency (RF) ablation. An external
monitor is placed in a position easily visible to the user and connected to the
Qubic Force. The contact force is displayed which allows the user to monitor
the contact force of the ablation catheter tip on the cardiac wall, establish
proper contact on the cardiac wall, and influence lesion formation.
Intended medical use
The relevant cardiology association guidelines do not contain a medical
indication for the visualization of the contact force of the catheter tip on the
cardiac wall and therefore contain no indication for the use of Qubic Force.
Qubic Force is not required to perform an electrophysiological study in
cardiac catheter laboratories with or without cardiac radiofrequency
ablation, but this device does provide important information to the user, for
example for the assessment of lesion formation and optimization of ablation
parameters.
Contraindications
There are no specific contraindications for the use of Qubic Force. For information on contraindications for the ablation catheter and the RF generator,
please consult their technical manuals.
Patient group
Use of Qubic Force is indicated for all patients subjected to a therapeutic
electrophysiological study. For studies using Qubic Force, there are no
restrictions in terms of the age, sex, weight, state of health, nationality, or
condition of the patient.
Compatible RF generators
The following RF generators are compatible with Qubic Force:
z BIOTRONIK: Qubic RF
z Stockert: EP-Shuttle
z Biosense Webster: SmartAblate™ HF Generator (manufacturer: Stockert)
z St. Jude Medical: IBI-1500 T11
z Medtronic: Atakr II
z Osykpa: HAT 300 Smart
Introduction 3
About this Technical Manual
Objective
This technical manual provides all the safety information required to use the
device.
The following topics are covered in this manual:
z Device startup
z Device handling
z Using the software
Target group
This technical manual is intended for cardiologists, electrophysiologists and
cardiac surgeons possessing knowledge in the following areas:
z Catheterization procedures
z Procedures for ablating the intracardiac stimulation and conduction
systems
This technical manual is also intended for clinical and technical assistants
possessing expertise in handling devices in cardiac catheter laboratories.
Additional required expertise is:
z Basic medical knowledge of the examination method employed
z Ability to work with a PC
z Ability to use software-controlled medical devices
Other Technical Manuals
The following additional technical manuals must be followed to ensure the
safe and correct use of the device:
z Technical manuals for other system components in the cardiac catheter
laboratory, not supplied with the Qubic Force (e.g., AlCath Force ablation
catheter, RF generator, lab monitoring system, and external monitor)
z Technical manuals for the intended catheters, indifferent electrodes,
patient cables, and adapters
z Technical manuals for other designated accessories
4 Safety during Use
2 Safety during Use
Safety during Use2418423Technical ManualQubic Force
Required Expertise
Required expertise
Qubic Force is intended for use by cardiologists, electrophysiologists,
cardiac surgeons, and clinical and technical assistants specialized in
handling devices in cardiac catheter laboratories and trained in handling the
Qubic Force. In addition to having basic medical knowledge, the user must
be thoroughly familiar with the electrophysiology of the heart, catheterization procedures, and the method of ablating the intracardiac stimulation and
conduction system.
Only trained and qualified medical personnel with this knowledge can
properly operate the device.
Note: Please note that in principle there is a risk of cardiac wall perforation
during a cardiac radio frequency ablation and that this cannot entirely be
excluded despite the use of Qubic Force. Therefore, take any measures to
minimize this risk as much as possible.
Electromagnetic Interference
Possible electromagnetic interference
This device is protected against electromagnetic interference and electrostatic discharges in the specialized environment of a cardiac catheter laboratory containing high-frequency surgical instruments and X-Ray devices.
At the same time, the emitted interference is reduced to a minimum.
The device thus fulfills the requirements of EN 60601-1-2 as they apply to
CISPR 11 class A in relation to both interference emitted and resistance to
interference. The following norms do not apply here:
z IEC 61000-3-2
Harmonic distortion (harmonic currents in the mains supply)
z IEC 61000-3-3
Voltage fluctuations and flicker in the mains supply
Safety during Use 5
The following tests were performed according to IEC 60601-1-2: 2014:
Section of
Test Test level
IEC 606011-2:2014
7.1 EN 55011 (CISPR 11)
Conducted interference
emissions
EN 55011 (CISPR 11)
Radiated emissions
8.9 IEC 61000-4-2
Electrostatic discharge
(ESD)
8.9 / 8.10 IEC 61000-4-3
Electromagnetic fields
8.9 IEC 61000-4-4
Transient conducted
surge voltages (EFT,
bursts)
z Group 1
z Class A
z ±8 kV contact discharge
z ±15 kV air discharge
z Modulation: 1 kHz
z 3 V/m, 80 MHz – 2.7 GHz
z Limits for RF communication
equipment per Table 9 in
IEC 60601-1-2 (9-28 V/m)
z ± 2kV mains supply
z ± 1kV signal line
IEC 61000-4-5
Surge voltage waves on
z ± 2 kV common mode
z ± 1 kV common mode
supply lines
IEC 61000-4-6
Conducted radio-
frequency interference
IEC 61000-4-8
Power frequency magnetic
z Modulation: 1 kHz
z 3 V
z 6 V in ISM bands
z 30 A/m
z 50/60 Hz
fields
IEC 61000-4-11
Voltage fluctuations and
interruptions in supply
voltage
Even when, as pointed out above, the device complies with the requirements
of EN 60601-1-2, strong electromagnetic disturbances may occur in the
immediate vicinity of electrical motors, high-voltage power lines, PCs,
monitors and other – perhaps defective – electrical devices which may cause
the Tare key to be triggered unintentionally and may sometimes impair the
functioning of the device.
6 Safety during Use
This kind of device malfunction should be considered as a possible cause if
the following is observed:
z The values displayed for contact force and application angle are set to
zero with the AlCath Force ablation catheter connected, as long as the
Tare key has not been pressed.
z The device displays other inexplicable behavior.
Correct operation of the device can be restored with the following miscellaneous measures:
z Switch off electronic device generating the disturbance.
z Remove the source of interference from the device.
z Switch the device on and off or break the electrical connection between
the device and the source of the interference if this can be done safely.
If the interference continues, contact BIOTRONIK immediately.
W WARNING
Risk of electromagnetic interference through the use of unauthorized
accessories
The use of accessories, transducers or cables not listed by BIOTRONIK or
of accessories other than those specified by BIOTRONIK, can produce
elevated electromagnetic emissions or cause degradation in the device's
resistance to electromagnetic interference. Such effects can lead to the
faulty operation of the device.
z Use only accessories authorized by BIOTRONIK.
W WARNING
Risk of electromagnetic interference through the use of portable RF
communication devices
If portable RF communication devices (including peripheral devices such as
antenna cables and external antennae) are operated closer than 30 cm (12
inches) from this device, this can result in a reduction in its performance.
This applies even if using the cables specified by BIOTRONIK.
z When operating portable RF communication devices (including periph-
eral devices such as antenna cables and external antennae), keep such
devices at a distance of at least 30 cm (12 inches) from this device.
Safety during Use 7
General Safety Warnings
Risks of improper handling
Disregarding the safety warnings can endanger the patient, the staff and the
equipment.
Note: Failure to observe the safety warnings voids all damage claims and
manufacturer liability.
The following dangers can, for example, arise in the event of improper use:
z Failure of important device functions
z Personal endangerment due to electrical impact
Changes not permitted
Only the manufacturer or a party expressly authorized by BIOTRONIK may
perform corrective maintenance, enhancements or modifications to the
device.
Replacement parts and accessories
Use only accessories authorized by BIOTRONIK. Using any other parts voids
liability for any consequences, as well as the product guarantee and
warranty.
RF accessories
Use only RF accessories certified according to Standard IEC 60601-2-2.
Defective devices
Do not use defective or damaged devices.
Physician supervision
The device may only be used under the constant supervision of a physician.
The patient must be monitored at all times using an external surface ECG
with rate control.
Patient observation
Ensure that patients are individually observed over a suitable period of time
in order to monitor the compatibility and effectiveness of the electrophysiological therapy.
Emergency equipment
During an examination, keep resuscitation equipment (e.g., cardiac defibrillator, external pacemaker) available and ready for use at all times in order
to perform life-supporting measures immediately in the event of an emergency.
8 Safety during Use
Liquids
Never use a damp or wet device. Protect the device from accidental ingression of fluids (e.g. infusion fluids).
If the device becomes wet, immediately unplug and stop using the device.
Contact BIOTRONIK for testing and, if necessary, repair of the device.
Electrostatic potentials
Ensure that electrostatic potentials between medical staff and patients are
balanced. Before handling the device, the electrostatic potential between the
physician or medical staff and the patient must be balanced by touching the
patient at a point as far away from the catheters or leads as possible.
Leakage currents
Avoid leakage currents between all connected devices. Such leakage
currents can cause lethal arrhythmias.
Potential equalization cables must be attached to all connected components, if present.
Before initial commissioning, check and document all device combinations.
National and international directives concerning the use of electromedical
devices also apply to patient cables.
Touching contacts on cables and catheters
Do not touch the contacts on the patient cable or the catheters. The device
has electrical contact with the patient's heart and blood via the implanted
catheters. Touching the contacts on the patient cable or catheters could
expose the patient's heart to dangerous electrical currents.
Defibrillation
When connected with the approved patient cable, the device is defibrillation
protected. However, damage cannot be ruled out in all circumstances.
Following a defibrillation, the recovery time can take up to 10 seconds until
the device is ready for use again. Check all functions of the device, following
a defibrillation. During defibrillation, do not touch the patient, the device the
patient is connected to, or the attached accessories. Otherwise, there is a
danger that you may suffer an electrical shock.
Risk of infection
Contaminated devices can lead to infection. Clean and disinfect the device on
a regular basis. Refer to the cleaning instructions for all other system
components.
Safety during Use 9
Operating Conditions
Storage and transportation
If the packaging is damaged, please contact BIOTRONIK immediately. Do not
put the device into operation.
The ambient conditions for shipping and storage are:
Temperature 0°C ... +50°C
Relative humidity 30% ... 75%, no condensation
Atmospheric pressure 700 ... 1060 hPa
Operating conditions
Note: After transporting the equipment from a cold to a warm area, conden-
sation may form, particularly on metal parts of the device, and damage the
electronics.
z After transport, wait approximately 2 hours until the device has reached
room temperature and the condensation has dried up before using the
system.
W WARNING
Risk of electromagnetic interference
The use of this device close to or in direct contact with other devices should
be avoided, as this may lead to the device operating incorrectly.
z Where usage in such a manner is unavoidable, you should monitor this
device and the device or devices being used together with it in order to
check that they are all working correctly.
W WARNING
Risk of electromagnetic interference through the use of portable RF
communication devices
If portable RF communication devices (including peripheral devices such as
antenna cables and external antennae) are operated closer than 30 cm (12
inches) from this device, this can result in a reduction in its performance.
This observation also applies even to the specified cable.
z When operating portable RF communication devices (including periph-
eral devices such as antenna cables and external antennae), keep such
devices at a distance of at least 30 cm (12 inches) from this device.
10 Safety during Use
Only operate the device in rooms that fulfill the following conditions:
z No danger of explosion
z Suitable for medical purposes
z Class I power outlet with protective conductor connection
Place the device in a position protected from spray water. Place the device
on a flat, dry surface. Place the device in a position where it cannot slip, even
with cables connected, nor be touched by the patient, and so that you can pull
the power plug out of the device at any time. Make sure that the ventilation
slots remain unobstructed. The device cannot be sterilized and therefore
must not be operated in sterile areas.
The ambient conditions for operation are:
Temperature +10°C ... +40°C
Relative humidity 30% ... 75%, no condensation
Atmospheric pressure 700 ... 1060 hPa
Operation at altitudes Up to 2000 m AMSL
Power supply
The device is operated via the AC voltage (100 to 240 V at 50 / 60 Hz) of a room
used for medical purposes.
W CAUTION
Possibility of electric shock
To avoid the risk of electric shock, connect the device only to a power supply
fitted with a PE conductor.
The electrical port must fulfill the following conditions:
z The power outlet fulfills at least the requirements of IEC 60364-7-
710:2002 group 2.
z The device cable feeds directly into a permanently installed socket. No
portable multiple socket outlets may be used.
z When used in combination with other devices, no portable multiple socket
outlets should be used.
z Only power cords which are suitable for medical devices can be used,
such as power cords from BIOTRONIK or equivalent power cords labeled
H05VV 3 x 0.75 mm, H05VV 3 x 1 mm, or SJT AWG18.
To disconnect Qubic Force from the mains supply, pull the power plug out of
the device.
Safety during Use 11
Cable and plug connections
W WARNING
Allergic reaction
The cable material may trigger allergic reactions in extremely rare cases.
z Prevent the cable from contacting the skin or wounds.
z Replace any cable that shows even slight damage.
z Lay all cables between the patient and the device, as well as within the
measuring apparatus, in such a way that they pose no danger of tripping
and that any tensile forces that may occur can be safely buffered.
z Ensure that the contacts of all connector ports and connectors are clean.
Soiled contacts can lead to signal distortions, and thus to false diagnoses.
z Ensure that there is no condensation on the plugs or in the connector
ports. If condensation is present, dry it before use.
z Do not force the plugs into the connector ports. Do not pull on the cable
when disconnecting the plugs. Rather, release the lock on the plug.
Maintenance, Care and Disposal
General information
Note: Note the following points before cleaning and disinfecting:
z Disconnect the power plug before cleaning and disinfecting the device
surfaces.
z Let cleaning and disinfection agents evaporate before operating the
device.
z Do not use any strong and abrasive cleaning agents or organic solvents
such as ether or benzine, as they corrode the surface of the device.
Cleaning and disinfecting
z Use lint-free, soft cloths.
z Clean the housing with a damp cloth and mild soap solution or 70%
isopropanol.
z Disinfect with alcohol-based agents such as Aerodesin 2000.
12 Safety during Use
Sterilization
z The device is not sterile and cannot be sterilized.
W CAUTION
Infection of the patient from operation of the non-sterile device
Qubic Force is not sterile and cannot be sterilized. If, during the ablation
therapy of the patient, the physician operates the device at the same time,
infection of the patient can result.
z During ablation therapy, do not operate the device at the same time.
Test before each use
z A test of the device and the approved accessories should be performed
prior to each use. This test consists of the following visual inspections and
a simple functional test:
– Inspect the housing for mechanical damage, dents, loose parts,
cracks, etc.
– Inspect cables and connection areas to ensure proper insulation, the
absence of breaks, etc.
– Inspect the labeling for legibility.
– Perform a simple electrical function test by switching on the device.
An internal function test is performed automatically.
If no error message appears, then no errors were found and the device
can be used.
– Inspect the displays (e.g., display of characters and language).
Inspection
The inspection consists of the regular safety inspection according to medical
device standards. This ensures the safety of the device.
z Inspections should be performed:
– If malfunctions are suspected
– Once a year
z The inspection can be performed by BIOTRONIK.
z The inspection must conform to the manufacturer's specifications. These
are available upon request. The specifications list all necessary test steps
and the necessary equipment.
z The instructions for performing the inspection are directed at people
whose education, knowledge, and experience obtained through practical
work provide the basis for proper execution.
Safety during Use 13
Fuse replacement
The fuses are located above the power cord port in a fuse holder.
Step Action
1 Turn the device off and unplug the power cord.
2 Use a suitable tool to pull the fuse holder out.
3 Replace the old fuses with new ones of the same type.
4 Re-insert the fuse holder. Ensure that it locks securely in
place.
Note: Defective fuses can indicate a technical defect in the device. Conduct
an inspection after changing fuses and before resuming operation of the
device.
Disposal
z This device contains materials that must be correctly disposed of in
accordance with environmental protection regulations. The European
Directive 2012/19/EC regarding waste electrical and electronic
equipment (WEEE) applies.
z The symbol on the label – a crossed out garbage can – indicates that the
device must be disposed of in accordance with the WEEE directive. The
black bar indicates that the device was delivered after the national implementation of the WEEE directive had been enforced locally.
z Return devices that are no longer in use to BIOTRONIK.
Disposal of cables
Note: Cables that are to be disposed of must be treated as medical waste,
in accordance with environmental regulations, if they have been in contact
with blood.
Uncontaminated cables must be disposed of in accordance with Directive
2012/19/EU on waste electrical and electronic equipment (WEEE) or in
accordance with the regulations applicable locally.
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