BIOTRONIK SE and KG QFORCE Qubic Force User Manual 418425 D GA Qubic Force en

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Document Description	15_QFORCE UserMan
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Date Submitted	2016-09-28 00:00:00
Date Available	2017-03-27 00:00:00
Creation Date	2016-09-28 08:22:29
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Document Title	418425--D_GA_Qubic-Force_en.fm
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Document Author:	BIOTRONIK SE & Co. KG // Woermannkehre 1 // D-12359 Berlin // Germany

EP // External devices // Technical Manual
Qubic Force
Device for visualization of contact force
of the catheter tip on the cardiac wall
1
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
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
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
The following tests were performed according to IEC 60601-1-2: 2014:
Section of Test
IEC 606011-2:2014
Test level
7.1
EN 55011 (CISPR 11)
Conducted interference
emissions
Group 1
Class A
EN 55011 (CISPR 11)
Radiated emissions
8.9
8.9 / 8.10
IEC 61000-4-2
Electrostatic discharge
(ESD)
IEC 61000-4-3
Electromagnetic fields
8.9
IEC 61000-4-4
Transient conducted
surge voltages (EFT,
bursts)
IEC 61000-4-5
Surge voltage waves on
supply lines
IEC 61000-4-6
Conducted radiofrequency interference
IEC 61000-4-8
Power frequency magnetic
fields
±8 kV contact discharge
±15 kV air discharge
Modulation: 1 kHz
3 V/m, 80 MHz – 2.7 GHz
Limits for RF communication
equipment per Table 9 in
IEC 60601-1-2 (9-28 V/m)
± 2kV mains supply
± 1kV signal line
± 2 kV common mode
± 1 kV common mode
Modulation: 1 kHz
3V
6 V in ISM bands
30 A/m
50/60 Hz
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 peripheral 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
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
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, condensation 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 peripheral 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 60364-7710:2002 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.
Replace any cable that shows even slight damage.
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.
Ensure that the contacts of all connector ports and connectors are clean.
Soiled contacts can lead to signal distortions, and thus to false diagnoses.
Ensure that there is no condensation on the plugs or in the connector
ports. If condensation is present, dry it before use.
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
Turn the device off and unplug the power cord.
Use a suitable tool to pull the fuse holder out.
Replace the old fuses with new ones of the same type.
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.
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.
14 Device Handling
3 Device Handling
Device Handling3418423Technical ManualQubic Force
Device Overview
Front view
Explanation of items
Item
Description
Tare key
z Sets the displayed values for contact force and the angle at
which the ablation catheter is applied to the cardiac wall to zero
Marker key
z Marks the current values in the log file for the current
procedure and stores a current screenshot
z Transfers the log file for the current procedure and the stored
screenshots to a USB flash memory stick
On/off key
For switching the device on/off
Ventilation slots
To protect the device from overheating
USB port
To connect a mouse, keyboard or USB flash memory stick
without an independent power supply
Redel port for generator
For connecting a compatible RF generator using the corresponding patient cable
Device Handling
15
Item
Description
Redel port for ablation catheter
z For connecting the electrical plug of the ablation catheter using
patient cable PK-147
Optical port for ablation catheter
z For connecting the optical plug of the ablation catheter
On/off light indicator (LED)
z Lights up green when the device is switched on
Rear view of device
10
16
11
15
14
12
13
Explanation of items
Item
10
Description
Redel port for expansion
General, analog connection for expansions
(No use of this port is planned at present. Consult BIOTRONIK.)
11
12
Ventilation slots
z To protect the device from overheating
Binary interface 1 (RS-232 port)
General, serial connection for expansions
(No use of this port is planned at present. Consult BIOTRONIK.)
13
Binary interface 2 (RS-232 port)
General, serial connection for expansions
(No use of this port is planned at present. Consult BIOTRONIK.)
16 Device Handling
Item
Description
14
Power cord port and device fuse
z For connecting the power cord
15
Ethernet port (not suitable for network connection)
z General, digital connection for expansions
(No use of this port is planned at present. Consult BIOTRONIK.)
16
Monitor port
To connect a monitor
Symbols on the device
Explanation of symbols
Symbol
Description
On/off light indicator
Tare
Marker
Warning of invisible intense light from an SLED
Since this light corresponds to laser class 1, this optical
port poses no risk to the user or patient.
Ablation catheter
Type CF applied part, defibrillation protected
USB port
Radiofrequency unit of the RF generator
Follow the instructions for use
Device Handling
Symbol
17
Description
On/off key
Binary interface 1 or 2
Monitor port
Ethernet
Fuse
Setting up the Device
General
W CAUTION
Functional impairment due to external damage
Mechanical impact can permanently impair the function of an unpackaged
system even from a height of 5 cm (roughly 2") or greater.
z Do not use if the device or the packaging is visibly damaged.
z Contact BIOTRONIK for testing and, if necessary, repair of the device.
Qubic Force must be set up in such a way that it can be connected up to the
RF generator and to an external monitor. Connect an external monitor with
a display screen of at least 10 inches that can display to a resolution of 1024
x 768 pixels. Set up the monitor so that it can be viewed easily by the user and
is not positioned any further than 1.5 m from the user during any electrophysiological examination. Depending on the display screen size being used,
it may be possible to increase the distance of the user from the monitor with
a resolution of 1024 x 768 pixels.
Setting up the device
z 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 out the power plug on the device at any time. Make sure that the
ventilation slots remain unobstructed.
The physician must not touch any plug connections such as USB ports
and the patient at the same time.
18 Device Handling
Connections and Cables
Connecting the power cord
The power cord port on the device is designed to accept the power cord. The
power cord port is located on the rear side of the device.
Before connecting, ensure that the power supply conditions are met (see
Power supply, p. 10).
z Connect the power cord to the power cord port on the device.
Connecting ablation catheters
The AlCath Force ablation catheter is connected using the PK-147 cable. The
Redel port for the electrical plug of the ablation catheter is marked red and
is located on the front of the device. The optical port for the optical plug of
the ablation catheter is also located on the front of the device.
Connect the PK-147 cable to the red Redel port on the device.
Connect the PK-147 cable to the AlCath Force ablation catheter.
z Connect the optical plug on the ablation catheter to the optical port on the
device.
Refer to the technical manual of the ablation catheter.
Once connected, it may take up to 10 s before the ablation catheter can be
used.
Device Handling
19
The first connection of the AlCath force ablation catheter to Qubic Force is
stored and, from this time, the AlCath Force ablation catheter can be used
for 24 hours. During this time, you can remove the AlCath Force ablation
catheter from the device, for example.
The values used to obtain contact force and application angle are automatically tared by the device upon first connecting the AlCath Force ablation
catheter and each time the Qubic Force is started.
Connecting the RF generator
W CAUTION
There is a risk of exceeding the leakage current limits when connecting
external devices that have their own power supply as well as a risk of
making an electrically conductive connection to other devices.
Connect to the covered blue Redel port for the RF generator only devices
that comply with IEC 60601-2-2 standard and are CF-type applied parts.
Before initial commissioning, check and document all device combinations according to IEC standard 60601-1.
Perform this inspection at least once per year according to the legal
requirements.
The Redel port on the Qubic Force for the RF generator is marked blue and
is located on the front of the device:
Select the appropriate patient cable for the RF generator that you are
using.
Connect the appropriate patient cable to the Redel port marked in blue on
the Qubic Force.
Connect the appropriate patient cable to the Redel port for the ablation
catheter on the RF generator.
Follow the instructions in the technical manual for the RF generator and
for the patient cable that you are using.
20 Device Handling
The following RF generators are connected using the correct patient cable
as indicated below:
RF generator
Patient cables
Qubic RF
PK-147
EP-Shuttle
SmartAblate HF Generator
PK-150
IBI-1500 T11
PK-142
Atakr II
PK-112
HAT 300 Smart
PK-111
Note: While the AlCath Force ablation catheter and an RF generator are
connected to Qubic Force it is always possible to start a cardiac radio
frequency ablation, even if there is an error in how the contact force is
displayed or if the Qubic Force is switched off.
Device Handling
21
Connecting an external monitor
W CAUTION
Risk of exceeding the leakage currents when connecting external devices
with their own power supply or an electrically conductive connection to
other devices
Only connect devices that comply with IEC 60601-1 standard or
IEC 60950.
Before initial commissioning, check and document all device combinations according to IEC standard 60601-1.
Perform this inspection at least once per year according to the legal
requirements.
The monitor port is located on the rear side of the device.
Using the VK-124 cable, connect the external monitor to the monitor port.
The device has a monitor port for connecting it to an external monitor with
the VK-124 cable. Connect an external monitor with a display screen of at
least 10 inches that can display to a resolution of 1024 x 768 pixels. Set up
the monitor so that it can be viewed easily by the user and is not positioned
any further than 1.5 m from the user during any electrophysiological study.
Depending on the display screen size being used, it may be possible to
increase the distance of the user from the monitor with a resolution of
1024 x 768 pixels.
22 Device Handling
Connecting keyboard, mouse or USB stick
W WARNING
Risk of energy being conducted to the patient
If the device and the patient are touched at the same time, electrical energy
can be conducted from the device into the patient.
z Never touch the device and the patient at the same time.
The USB port on the device is designed solely for connection of a mouse, a
keyboard or a USB flash memory stick (USB flash drive) without an independent power supply. You can connect and disconnect these accessories while
the device is still active.
The USB port is located on the front of the device.
Connect the mouse, keyboard or USB stick to the USB port.
Device Handling
23
Switching On and Off
Switching the device on and off
The on/off key is located on the right side at the rear of the device.
W WARNING
Risk of energy being conducted to the patient
If the device and the patient are touched at the same time, electrical energy
can be conducted from the device into the patient.
z Never touch the device and the patient at the same time.
Note: While the AlCath Force ablation catheter and a RF generator are
connected to Qubic Force it is always possible to start a cardiac radio
frequency ablation, even if there is an error in how the contact force is
displayed or if the Qubic Force is switched off.
To switch the device on or off, press the on/off key.
After switching on the device, the on/off light indicator on the front left
lights up and Qubic Force performs a self-test. After the self-test, the
main view appears on the external monitor.
To disconnect Qubic Force from the mains supply, pull the power plug of
the device.
24 Device Handling
Keys on the Device
Tare key
Note: In order to prevent incorrect values for the contact force, make sure
that no force is acting on the cardiac wall when you press the Tare key.
During insertion and positioning of the AlCath Force ablation catheter in the
heart, the vectors indicating the values for determination of contact force
and the application angle are identified and transmitted to the device. This
means that values for contact force and the application angle are already
displayed before the actual cardiac radiofrequency ablation is performed. It
may be useful to set these values to zero prior to beginning the cardiac
radiofrequency ablation so as to better assess the applied contact force and
the application angle. The displayed values for the contact force and angle
are set to zero using the Tare key.
The device is automatically tared upon first connecting the AlCath Force
ablation catheter to it and each time the Qubic Force is started. When you
disconnect the ablation catheter and then connect it again while the device
is still active, the values used to obtain contact force and application angle
are not automatically tared again.
The Tare key is located towards the upper right on the front of the device.
Press the Tare key to set the displayed values for contact force and the
angle to zero.
Device Handling
25
Marker key
A log file for the current procedure is created when an AlCath Force ablation
catheter is connected. The log stores values including the contact force and
the application angle.
The following can be done using the Marker key:
z Mark the current values in the log file for the current procedure and store
a screenshot.
z Transfer the log file for the current procedure and all stored screenshots
to a connected USB stick.
The log file for the current procedure exists only until another AlCath Force
ablation catheter is connected. Connecting a new AlCath Force ablation
catheter overwrites the existing log file for the current procedure.
The Marker key is located on the upper right on the front of the device.
Do the following to mark the current values in the log file for the current
procedure and to store a screenshot:
z Press the Marker key for less than 5 seconds.
The screenshot is backed up to a USB flash memory stick, if connected.
Do the following to transfer the log file for the current procedure and all
stored screenshots to a connected USB stick:
z Hold the Marker key down for more than 5 seconds.
26 Using the Software
4 Using the Software
Using the Software4418423Technical ManualQubic Force
The Main View
General overview
After switching on the device, the on/off light indicator on the front left lights
up and Qubic Force performs a self-test. After the self-test, the main view
appears on the external monitor.
Using the Software
27
Areas of the screen
The Qubic Force screen contains four areas that present information differently:
Item
Explanation
Status bar
Numerical display
Graphic display
Trend display
28 Using the Software
The Status Bar
General overview
The status bar is located at the top right edge. It is visible in the main view
and the Settings view.
Symbol AlCath Force ablation catheter
No AlCath Force ablation catheter has been connected.
An AlCath Force ablation catheter has been connected,
checked successfully, and can be used.
The green marker changes to gray after 10 seconds.
An AlCath Force ablation catheter has been connected but an
error occurred and it cannot be used.
A connected AlCath Force ablation catheter has been
removed.
Data
Marker and Explanation
export screenshot
symbol symbol
Have not been used during the current electrophysiological study
Data has been successfully exported or the
screenshot has been stored and the current
values marked in the log file for the current
procedure.
The green marker changes to gray after
10 seconds.
An error has occurred and the data has not been
successfully exported or no screenshot has been
stored and the current values have not been
marked in the log file for the current procedure.
Using the Software
29
The Numerical Display
General overview
The numerical display is located in the left main area of the screen.
If an AlCath Force ablation catheter is connected, the following current
values are shown:
z F: The current contact force of the ablation catheter tip on the cardiac
wall, in grams (g)
z FTI: The current force-time integral in gram seconds (gs)
The force-time integral is calculated from the following formula:
t2
FTI: F (t) *dt
t1
t1: Start of radiofrequency ablation
z t2: End or duration since start of radiofrequency ablation
z F: Current contact force
If there is no ablation catheter AlCath Force connected, no information will
be displayed in this area.
30 Using the Software
The Graphic Display
General overview
The graphic display is located in the right main area of the screen.
If an AlCath Force ablation catheter is connected, the following information
is displayed graphically depending on the configuration of the device:
z The angle at which the ablation catheter is applied to the cardiac wall
z The delivery of ablation energy (only if a RF generator is connected to
Qubic Force.)
z Exceedance of the set contact force limit
z A possible foreseeable perforation of the cardiac wall because the
following values are not within the respective tolerance range:
– The contact force is above the set limit.
– And the angle at which the ablation catheter is applied to the cardiac
wall is below the set limit.
The contact force limit (Fmax = 40 g) is preset in the factory settings. To adjust
this value and also set the visual warning limit for the angle at which the
ablation catheter is applied to the cardiac wall, a mouse or keyboard must
be connected and you have to switch to the Settings view (The Settings View,
p. 33).
Using the Software
31
Display of the angle at which the ablation catheter is applied to the
cardiac wall
z The white line in the light gray area of the circle moves between
0° (1) and 90° (2). The orange line shows the angle limit.
The area within the circle symbolizes the cardiac wall and moves
according to the angle of the catheter on the cardiac wall.
Display of the delivery of ablation energy
z The catheter tip turns blue.
Display of exceedance of the set contact force limit
z The white area inside the catheter display turns orange.
In the numerical display on the left side, the value for contact force is also
shown in orange.
32 Using the Software
Indication of possible perforation of the cardiac wall
z The white area inside the catheter display turns orange.
The display of the cardiac wall turns orange and shows an indentation.
In the numerical display on the left side, the value for contact force is also
shown in orange.
The Trend Display
General overview
The trend display is located in the lower area of the screen.
If an AlCath Force ablation catheter is connected, the following information
is displayed depending on the configuration of the device:
z Contact force over time
F: Contact force in grams (g)
t: Time in seconds (s)
z The orange line marks the set contact force limit.
z The blue range highlights the delivery of ablation energy (only if a RF
generator is connected to Qubic Force).
Using the Software
33
The contact force limit (Fmax = 40 g) and the duration of the trend display
(t = 20 s) are preset in the factory settings. To adjust these values, a mouse
or keyboard must be connected and you have to switch to the Settings view
(The Settings View, p. 33).
The Settings View
Switching to the Settings view
z Connect a keyboard or mouse to the USB port.
z Press any key.
Overview
You can set the following values in the Settings view:
z Δt: Duration of the trend display
z Fmax: Contact force limit
z Limit for the angle at which the ablation catheter can be applied to the
cardiac wall
Setting a limit (0...90°) activates the visual warning for a possible foreseeable perforation of the cardiac wall in the graphic display of the main view.
Also, the checkbox lights up green.
34 Using the Software
Closing the Settings view
z If you have connected a keyboard, there are three ways of closing the
Settings view:
– Press the Esc key.
Your changed settings will not be applied.
– Navigate to the button with the checkmark using the tab key and
confirm by pressing the Enter key.
Your changed settings will be applied.
– Navigate to the button with the cross using the tab key and confirm by
pressing the Enter key.
Your changed settings will not be applied.
If you have connected a mouse, there are two ways of closing the Settings
view:
– Click with the mouse pointer on the button with the checkmark.
Your changed settings will be applied.
– Click with the mouse pointer on the button with the cross.
Your changed settings will not be applied.
The Settings view closes automatically once one of the following actions is
performed:
z An AlCath Force ablation catheter is connected.
z A key on the device is pressed.
Using the Software
35
Working with the keyboard
The button that is activated and whose value you can change is surrounded
by a frame.
z Switching between the buttons:
Press the Tab key on the keyboard.
z Activating/confirming a button:
Press the Enter key on the keyboard.
z Changing the values:
Press the arrow keys on the keyboard.
z Resetting to factory settings:
Navigate to the button with the wrench symbol in the arrow using the tab
key and confirm by pressing the Enter key.
– All settings are reset to the factory settings.
The button with the key is intended for internal use only.
–
Working with a mouse
The button that is activated and whose value you can change is surrounded
by a frame.
z Switching between the buttons:
Click the mouse pointer on the respective arrow key or button.
z Activating/confirming a button:
Click the mouse pointer on the respective button.
z Changing the values:
Click the mouse pointer on the respective arrow keys of the button.
z Resetting to factory settings:
Click the mouse pointer on the button with the wrench symbol in the
arrow.
– All settings are reset to the factory settings.
The button with the key is intended for internal use only.
–
36 Appendix
5 Appendix
Appendix5418423Technical ManualQubic Force
Technical Data
Physical properties
Property
Design
Dimensions (W x H x D)
230 x 150 x 240 mm
Weight with power cord
4.7 kg (± 300 g)
Housing material
Polyurethane (PUR)
General classification
Property
Design
Medical product classification
Class IIb in compliance with
Directive 93/42/EEC (MDD)
Mode of operation
Continuous operation
Longevity
Property
Design
Longevity
5 years
Ambient conditions
Property
Design
Temperature range for operation
+10°C ... +40°C
Temperature range for storage
0°C ... +50°C
Atmospheric pressure for operation 700 ... 1060 hPa
Atmospheric pressure for storage
700 ... 1060 hPa
Relative humidity
30% ... 75%, no condensation
Operation at altitudes
Up to 2000 m
Safety equipment
Property
Design
Applied part classification
CF, defibrillation protected with the
specified cables
Degree of protection
IP 30
Appendix
Power cord port
Property
Design
Supply voltage
100–240 V, ± 10%
50/60 Hz, ± 1 Hz
max. 0.2 A-0.47 A/AC
Protection class
Fuse type
T 1.6 AH, 250 V
Max. power input
Duration
25 W
Peak
40 W
Level of efficiency
> 85%
(at 230 V/50 Hz)
On/off light indicator
Green LED, lit continuously
Light source
Property
Design
Type
SLED (superluminescent diode)
Laser class
Type of radiation
Infrared light
Spectral interval
1510–1590 nm
Radiant flux
< 10 mW
RFID communication
Property
Design
Type
RFID conforming to ISO 15693
Frequency band
13.56 Mhz
Max. power of transmission
200 mW
37
38 Appendix
Measurement accuracy of the contact force system, consisting of
AlCath Force and Qubic Force
Measurement accuracy without delivery of ablation energy
Contact force (F)
Measurement accuracy
< 20 g
±3g
20 g ≤ F ≤150 g
± 15%
Possible offset during delivery of ablation energy
Contact force (F)
Offset
≤ 80 g
± 10 g
Parameter Values
Parameters of the main view
Parameter
Unit
Range of
values
Step
size
Contact force
Grams (g)
0 – 150 g
Force-time integral
Gram seconds (gs)
0 – 9999 gs
Degrees (°)
0 – 90°
Contact force
Grams (g)
0 – 150 g
–
Time
Seconds (s)
15 – 90 s
In the numerical display
In the graphic display
Angle of ablation catheter
to cardiac wall
In the trend display
Parameters in Settings view
Parameter
Factory
setting
Unit
Range of Step
values
size
Contact force limit
40 g
Grams (g)
10 – 70 g 1
Angle limit for ablation
catheter to cardiac wall
Off
Degrees (°)
0 ... 90°,
Off
Length of time axis in trend
display
20 s
Seconds (s)
15 – 90 s
Appendix
39
Accessories
Accessories
Not all accessory products are available in every country.
Item designation
Description
Order no.
Qubic Force
Device with installed application
software
405250
AlCath Force
BIOTRONIK Ablation
catheter
Variant red:
Range 48 mm and length of tip
electrode 65 mm
405562
Variant blue:
Range 57 mm and length of tip
electrode 75 mm
405561
Variant green:
Range 65 mm and length of tip
electrode 85 mm
405560
Variant black:
Range 73 mm and length of tip
electrode 95 mm
405583
Variant cyan:
Range 80 mm and length of tip
electrode 105 mm
405559
VK-124
Video cable for connecting an external 417863
monitor; 5.0 m long
Video cable for connecting an external 417864
monitor; 15 m long
PK-111
Cable for connecting the
HAT 300 Smart RF generator
330080
PK-112
Cable for connecting the Atakr II RF
generator
330081
PK-142
Cable for connecting the IBI-1500 T11
RF generator
362442
PK-147
Cable for connecting the AlCath Force 398853
ablation catheter, the Qubic RF RF
generator and the EP-Shuttle RF
generator by BIOTRONIK; cable length
2.5 m; sterile
PK-150
Cable for connecting the SmartAblate
RF generator
402668
NK-3
Power cord for EU
107526
40 Appendix
Item designation
Description
Order no.
NK-11 (3 m)
Power cord for USA and Japan
128865
NK-16-GB (2 m)
Power cord for the United Kingdom
330705
NK-19-CN (2.5 m)
Power cord for China
339034
NK-21-AU, UY (2.5 m)
Power cord for Australia and Uruguay 339035
NK-22-AR (2.5 m)
Power cord for Argentina
339039
NK-26-CL, IT (2.5 m)
Power cord for Chile and Italy
339043
NK-28-DK (2.5 m)
Power cord for Denmark
339059
NK-25-CH (2.5 m)
Power cord for Switzerland
339042
NK-27-IL (2.5 m)
Power cord for Israel
339044
NK-33-BR (2.5 m)
Power cord for Brazil
378933
Country-Related Information
Canada
z Industry Canada
The device is registered at Innovation, Science and Economic Development Canada under the following identification:
IC 4708A-QFORCE
USA
z Federal Communication Commission
The device is registered with the Federal Communications Commission
under the following number:
FCC ID: QRIQFORCE
z Note:
This equipment has been tested and found to comply with the limits for a
Class A digital device, pursuant to part 15 of the FCC Rules. These directives are designed to provide reasonable protection against harmful interference in a commercial installation. This equipment generates, uses and
can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio
communications. Operation of this equipment in a residential area is
likely to cause harmful interference in which case the user will be
required to correct the interference at his own expense.
Appendix
41
Legend for the Label
The label icons symbolize the following:
Manufacturing date
BIOTRONIK order number
Serial number
Temperature limit for storage
Air pressure limit for storage
Humidity limit for storage
Follow the instructions for use
Contents
CE mark
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.
Return devices that are no longer used to BIOTRONIK.
Qubic Force
Patient with inserted diagnostic or ablation catheter
42 Directories
6 Directories
Directories6418423Technical ManualQubic Force
Index
Ablation catheter
Connecting, 18
Accessories, 39
Ambient conditions, 9
Characteristics, 36
Cleaning, 11
Compatible RF generators, 2
Connecting
Ablation catheter, 18
External monitor, 21
Keyboard, 22
Mouse, 22
RF generator, 19
USB stick, 22
Connection
Power cord, 18
Contraindications, 2
Damage, 9
Device
Factory settings, 38
General description, 2
Overview, 14
Disinfection, 11
Disposal, 13
Disposal of cables, 13
Electromagnetic interference, 4
Electrostatic potentials, 8
Emergency equipment, 7
Expert knowledge, 4
Expertise, 3, 4
External monitor
Connecting, 21
Factory settings, 38
Fuse replacement, 13
Directories
Graphic display, 30
Inspection, 12
Installation location, 17
Intended medical use, 2
Intended use, 2
Interference
Electromagnetic, 4
Introduction, 2
Keyboard
Connecting, 22
Keys on the Device, 24
Main functions, 2
Main view, 26
Maintenance, 11
Inspection, 12
Test before each use, 12
Monitor port, 21
Mouse
Connecting, 22
Numerical display, 29
Operating conditions, 9
Overview, 2
Parameter values, 38
Patient group, 2
Potential equalization, 8
Power cord
Connect, 18
Power supply, 10
Range of values, 38
Redel port
Ablation catheter, 18
RF generator, 19
RF generator
Connecting, 19
43
44 Directories
Safety warnings
General, 7
Screen, 26
Set markers, 25
Status bar, 28
Sterilization, 12
Storage conditions, 9
Switching off, 23
Switching on, 23
Symbols
On the device, 16
Packaging, 41
TareSet to zeroSet values to zero, 24
Target group
Patients, 2
Technical manual, 3
Technical Data
Measurement accuracy, 38
Technical data, 36
Ambient conditions, 36
General classification, 36
Longevity, 36
Power cord port, 37
Safety equipment, 36
Technical details
Light source, 37
RFID communication, 37
Technical manual, 3
Transport conditions, 9
Transport damage, 9
Trend display, 32
USB port, 22
USB stick
Connecting, 22
View
Settings, 33
© BIOTRONIK SE & Co. KG
All rights reserved.
Specifications subject to modification,
revision and improvement.
® All product names in use may be trademarks
or registered trademarks held by BIOTRONIK
or the respective owner.
J 0123
J 0681
2016
2016
16-D-36
Revision: D (2016-08-22)
BIOTRONIK SE & Co. KG
Woermannkehre 1
12359 Berlin · Germany
Tel +49 (0) 30 68905-0
Fax +49 (0) 30 6852804
sales@biotronik.com
www.biotronik.com

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