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

BIOTRONIK SE & Co. KG Qubic Force 418425 D GA Qubic Force en

15_QFORCE UserMan

Qubc ForceDevce for vsualzaton of contact force of the catheter tp on the cardac wallEP // External devces // Techncal Manual
1 Table of Contents Table of Contents Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2About the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2About this Technical Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3Safety during Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4Required Expertise . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4Electromagnetic Interference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4General Safety Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7Operating Conditions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9Maintenance, Care and Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11Device Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14Device Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14Setting up the Device. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17Connections and Cables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18Switching On and Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23Keys on the Device. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24Using the Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26The Main View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26The Status Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28The Numerical Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .29The Graphic Display. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .30The Trend Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .32The Settings View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .36Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .36Parameter Values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .38Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .39Country-Related Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40Legend for the Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .41Directories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .42Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .42418425--D
2Introduction1 Introduction Introduction1418423Technical ManualQubic ForceAbout the DeviceGeneral descriptionQubic 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 labora-tories 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 useThe 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.ContraindicationsThere are no specific contraindications for the use of Qubic Force. For infor-mation on contraindications for the ablation catheter and the RF generator, please consult their technical manuals.Patient groupUse 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 generatorsThe following RF generators are compatible with Qubic Force: zBIOTRONIK: Qubic RFzStockert: EP-ShuttlezBiosense Webster: SmartAblate™ HF Generator (manufacturer: Stockert)zSt. Jude Medical: IBI-1500 T11zMedtronic: Atakr IIzOsykpa: HAT 300 Smart
Introduction 3About this Technical ManualObjectiveThis technical manual provides all the safety information required to use the device.The following topics are covered in this manual: zDevice startupzDevice handlingzUsing the softwareTarget groupThis technical manual is intended for cardiologists, electrophysiologists and cardiac surgeons possessing knowledge in the following areas: zCatheterization procedureszProcedures for ablating the intracardiac stimulation and conduction systemsThis technical manual is also intended for clinical and technical assistants possessing expertise in handling devices in cardiac catheter laboratories.Additional required expertise is: zBasic medical knowledge of the examination method employedzAbility to work with a PCzAbility to use software-controlled medical devicesOther Technical ManualsThe following additional technical manuals must be followed to ensure the safe and correct use of the device: zTechnical 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)zTechnical manuals for the intended catheters, indifferent electrodes, patient cables, and adapterszTechnical manuals for other designated accessories
4Safety during Use2 Safety during Use Safety during Use2418423Technical ManualQubic ForceRequired ExpertiseRequired expertiseQubic 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, catheteriza-tion 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.Electromagnetic InterferencePossible electromagnetic interferenceThis device is protected against electromagnetic interference and electro-static discharges in the specialized environment of a cardiac catheter labo-ratory 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: zIEC 61000-3-2Harmonic distortion (harmonic currents in the mains supply)zIEC 61000-3-3Voltage fluctuations and flicker in the mains supplyNote: 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.
Safety during Use 5The following tests were performed according to IEC 60601-1-2: 2014: 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.Section of IEC 60601-1-2:2014Test Test level7.1 EN 55011 (CISPR 11)Conducted interference emissionszGroup 1zClass AEN 55011 (CISPR 11)Radiated emissions8.9 IEC 61000-4-2Electrostatic discharge (ESD)z±8 kV contact dischargez±15 kV air discharge8.9 / 8.10 IEC 61000-4-3Electromagnetic fieldszModulation: 1 kHzz3 V/m, 80 MHz – 2.7 GHzzLimits for RF communication equipment per Table 9 in IEC 60601-1-2 (9-28 V/m)8.9 IEC 61000-4-4Transient conducted surge voltages (EFT, bursts)z± 2kV mains supplyz± 1kV signal lineIEC 61000-4-5Surge voltage waves on supply lines z± 2 kV common modez± 1 kV common modeIEC 61000-4-6Conducted radio-frequency interferencezModulation: 1 kHzz3 Vz6 V in ISM bandsIEC 61000-4-8Power frequency magnetic fieldsz30 A/mz50/60 HzIEC 61000-4-11Voltage fluctuations and interruptions in supply voltage
6Safety during UseThis kind of device malfunction should be considered as a possible cause if the following is observed: zThe 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.zThe device displays other inexplicable behavior.Correct operation of the device can be restored with the following miscella-neous measures: zSwitch off electronic device generating the disturbance.zRemove the source of interference from the device.zSwitch 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.WWARNINGRisk of electromagnetic interference through the use of unauthorized accessoriesThe 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.zUse only accessories authorized by BIOTRONIK.WWARNINGRisk of electromagnetic interference through the use of portable RF communication devicesIf 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.zWhen 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 7General Safety WarningsRisks of improper handlingDisregarding the safety warnings can endanger the patient, the staff and the equipment.The following dangers can, for example, arise in the event of improper use: zFailure of important device functionszPersonal endangerment due to electrical impactChanges not permittedOnly the manufacturer or a party expressly authorized by BIOTRONIK may perform corrective maintenance, enhancements or modifications to the device.Replacement parts and accessoriesUse only accessories authorized by BIOTRONIK. Using any other parts voids liability for any consequences, as well as the product guarantee and warranty.RF accessoriesUse only RF accessories certified according to Standard IEC 60601-2-2.Defective devicesDo not use defective or damaged devices.Physician supervisionThe 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 observationEnsure that patients are individually observed over a suitable period of time in order to monitor the compatibility and effectiveness of the electrophysio-logical therapy.Emergency equipmentDuring an examination, keep resuscitation equipment (e.g., cardiac defibril-lator, external pacemaker) available and ready for use at all times in order to perform life-supporting measures immediately in the event of an emer-gency.Note: Failure to observe the safety warnings voids all damage claims and manufacturer liability.
8Safety during UseLiquidsNever use a damp or wet device. Protect the device from accidental ingres-sion 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 currentsAvoid leakage currents between all connected devices. Such leakage currents can cause lethal arrhythmias.Potential equalization cables must be attached to all connected compo-nents, 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 cathetersDo 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.DefibrillationWhen 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 infectionContaminated 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 9Operating ConditionsStorage and transportationIf the packaging is damaged, please contact BIOTRONIK immediately. Do not put the device into operation.The ambient conditions for shipping and storage are: Operating conditionsTemperature 0°C ... +50°CRelative humidity 30% ... 75%, no condensationAtmospheric pressure 700 ... 1060 hPaNote: 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.zAfter transport, wait approximately 2 hours until the device has reached room temperature and the condensation has dried up before using the system.WWARNINGRisk of electromagnetic interferenceThe 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.zWhere 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.WWARNINGRisk of electromagnetic interference through the use of portable RF communication devicesIf 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.zWhen 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 UseOnly operate the device in rooms that fulfill the following conditions: zNo danger of explosionzSuitable for medical purposeszClass I power outlet with protective conductor connectionPlace 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: Power supplyThe device is operated via the AC voltage (100 to 240 V at 50 / 60 Hz) of a room used for medical purposes.The electrical port must fulfill the following conditions: zThe power outlet fulfills at least the requirements of IEC 60364-7-710:2002 group 2.zThe device cable feeds directly into a permanently installed socket. No portable multiple socket outlets may be used.zWhen used in combination with other devices, no portable multiple socket outlets should be used.zOnly 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.Temperature +10°C ... +40°CRelative humidity 30% ... 75%, no condensationAtmospheric pressure 700 ... 1060 hPaOperation at altitudes Up to 2000 m AMSLWCAUTIONPossibility of electric shockTo avoid the risk of electric shock, connect the device only to a power supply fitted with a PE conductor.
Safety during Use 11Cable and plug connectionszReplace any cable that shows even slight damage.zLay 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.zEnsure that the contacts of all connector ports and connectors are clean. Soiled contacts can lead to signal distortions, and thus to false diagnoses.zEnsure that there is no condensation on the plugs or in the connector ports. If condensation is present, dry it before use.zDo 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 DisposalGeneral informationCleaning and disinfectingzUse lint-free, soft cloths.zClean the housing with a damp cloth and mild soap solution or 70% isopropanol.zDisinfect with alcohol-based agents such as Aerodesin 2000.WWARNINGAllergic reactionThe cable material may trigger allergic reactions in extremely rare cases.zPrevent the cable from contacting the skin or wounds.Note: Note the following points before cleaning and disinfecting: zDisconnect the power plug before cleaning and disinfecting the device surfaces.zLet cleaning and disinfection agents evaporate before operating the device.zDo not use any strong and abrasive cleaning agents or organic solvents such as ether or benzine, as they corrode the surface of the device.
12 Safety during UseSterilizationzThe device is not sterile and cannot be sterilized.Test before each usezA 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).InspectionThe inspection consists of the regular safety inspection according to medical device standards. This ensures the safety of the device. zInspections should be performed:– If malfunctions are suspected– Once a yearzThe inspection can be performed by BIOTRONIK.zThe inspection must conform to the manufacturer's specifications. These are available upon request. The specifications list all necessary test steps and the necessary equipment.zThe instructions for performing the inspection are directed at people whose education, knowledge, and experience obtained through practical work provide the basis for proper execution.WCAUTIONInfection of the patient from operation of the non-sterile deviceQubic 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.zDuring ablation therapy, do not operate the device at the same time.
Safety during Use 13Fuse replacementThe fuses are located above the power cord port in a fuse holder. DisposalzThis 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.zThe 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 imple-mentation of the WEEE directive had been enforced locally.zReturn devices that are no longer in use to BIOTRONIK.Disposal of cablesUncontaminated 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.Step Action1 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.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.
14 Device Handling3 Device Handling Device Handling3418423Technical ManualQubic ForceDevice OverviewFront viewExplanation of items Item Description1Tare key zSets the displayed values for contact force and the angle at which the ablation catheter is applied to the cardiac wall to zero2 Marker key zMarks the current values in the log file for the current procedure and stores a current screenshotzTransfers the log file for the current procedure and the stored screenshots to a USB flash memory stick3On/off key zFor switching the device on/off4 Ventilation slots zTo protect the device from overheating5 USB port zTo connect a mouse, keyboard or USB flash memory stick without an independent power supply6 Redel port for generator zFor connecting a compatible RF generator using the corre-sponding patient cable123495876
Device Handling 15Rear view of deviceExplanation of items 7 Redel port for ablation catheter zFor connecting the electrical plug of the ablation catheter using patient cable PK-1478 Optical port for ablation catheter zFor connecting the optical plug of the ablation catheter9 On/off light indicator (LED) zLights up green when the device is switched onItem Description10 Redel port for expansion zGeneral, analog connection for expansions(No use of this port is planned at present. Consult BIOTRONIK.)11 Ventilation slots zTo protect the device from overheating12 Binary interface 1 (RS-232 port) zGeneral, serial connection for expansions(No use of this port is planned at present. Consult BIOTRONIK.)13 Binary interface 2 (RS-232 port) zGeneral, serial connection for expansions(No use of this port is planned at present. Consult BIOTRONIK.)Item Description10111312151416
16 Device HandlingSymbols on the deviceExplanation of symbols 14 Power cord port and device fuse zFor connecting the power cord15 Ethernet port (not suitable for network connection) zGeneral, digital connection for expansions(No use of this port is planned at present. Consult BIOTRONIK.)16 Monitor port zTo connect a monitorSymbol DescriptionOn/off light indicatorTareMarkerWarning of invisible intense light from an SLEDSince this light corresponds to laser class 1, this optical port poses no risk to the user or patient.Ablation catheterType CF applied part, defibrillation protectedUSB portRadiofrequency unit of the RF generatorFollow the instructions for useItem Description
Device Handling 17Setting up the DeviceGeneralQubic 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 electro-physiological 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 devicezPlace 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.On/off keyBinary interface 1 or 2Monitor portEthernetFuseWCAUTIONFunctional impairment due to external damageMechanical impact can permanently impair the function of an unpackaged system even from a height of 5 cm (roughly 2") or greater.zDo not use if the device or the packaging is visibly damaged.zContact BIOTRONIK for testing and, if necessary, repair of the device.Symbol Description
18 Device HandlingConnections and CablesConnecting the power cordThe 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). zConnect the power cord to the power cord port on the device.Connecting ablation cathetersThe 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.zConnect the PK-147 cable to the red Redel port on the device.zConnect the PK-147 cable to the AlCath Force ablation catheter.zConnect 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 19The 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 automati-cally tared by the device upon first connecting the AlCath Force ablation catheter and each time the Qubic Force is started.Connecting the RF generatorThe Redel port on the Qubic Force for the RF generator is marked blue and is located on the front of the device:zSelect the appropriate patient cable for the RF generator that you are using.zConnect the appropriate patient cable to the Redel port marked in blue on the Qubic Force. zConnect 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.WCAUTIONThere 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.zConnect 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.zBefore initial commissioning, check and document all device combina-tions according to IEC standard 60601-1.zPerform this inspection at least once per year according to the legal requirements.
20 Device HandlingThe following RF generators are connected using the correct patient cable as indicated below: RF generator Patient cablesQubic RF PK-147EP-ShuttleSmartAblate HF Generator PK-150IBI-1500 T11 PK-142Atakr II PK-112HAT 300 Smart PK-111Note: 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 21Connecting an external monitorThe monitor port is located on the rear side of the device.zUsing 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.WCAUTIONRisk of exceeding the leakage currents when connecting external devices with their own power supply or an electrically conductive connection to other deviceszOnly connect devices that comply with IEC 60601-1 standard or IEC 60950.zBefore initial commissioning, check and document all device combina-tions according to IEC standard 60601-1.zPerform this inspection at least once per year according to the legal requirements.
22 Device HandlingConnecting keyboard, mouse or USB stickThe 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 indepen-dent 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.zConnect the mouse, keyboard or USB stick to the USB port.WWARNINGRisk of energy being conducted to the patientIf the device and the patient are touched at the same time, electrical energy can be conducted from the device into the patient.zNever touch the device and the patient at the same time.
Device Handling 23Switching On and OffSwitching the device on and offThe on/off key is located on the right side at the rear of the device. zTo 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.zTo disconnect Qubic Force from the mains supply, pull the power plug of the device.WWARNINGRisk of energy being conducted to the patientIf the device and the patient are touched at the same time, electrical energy can be conducted from the device into the patient.zNever 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.
24 Device HandlingKeys on the DeviceTare keyDuring 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.zPress the Tare key to set the displayed values for contact force and the angle to zero.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.
Device Handling 25Marker keyA 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: zMark the current values in the log file for the current procedure and store a screenshot.zTransfer 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: zPress 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: zHold the Marker key down for more than 5 seconds.
26 Using the Software4 Using the Software Using the Software4418423Technical ManualQubic ForceThe Main ViewGeneral overviewAfter 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 27Areas of the screenThe Qubic Force screen contains four areas that present information differ-ently:Item Explanation1 Status bar2 Numerical display3 Graphic display4 Trend display1324
28 Using the SoftwareThe Status BarGeneral overviewThe status bar is located at the top right edge. It is visible in the main view and the Settings view.Symbol AlCath Force ablation catheterzNo AlCath Force ablation catheter has been connected.zAn AlCath Force ablation catheter has been connected, checked successfully, and can be used.The green marker changes to gray after 10 seconds.zAn AlCath Force ablation catheter has been connected but an error occurred and it cannot be used.zA connected AlCath Force ablation catheter has been removed.Data export symbolMarker and screenshot symbolExplanationzHave not been used during the current electro-physiological studyzData 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.zAn 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 29The Numerical DisplayGeneral overviewThe 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:zF: The current contact force of the ablation catheter tip on the cardiac wall, in grams (g)zFTI: The current force-time integral in gram seconds (gs)The force-time integral is calculated from the following formula: zt1: Start of radiofrequency ablationzt2: End or duration since start of radiofrequency ablationzF: Current contact forceIf there is no ablation catheter AlCath Force connected, no information will be displayed in this area.FTI: F (t) *dtt1t2
30 Using the SoftwareThe Graphic DisplayGeneral overviewThe 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:zThe angle at which the ablation catheter is applied to the cardiac wallzThe delivery of ablation energy (only if a RF generator is connected to Qubic Force.)zExceedance of the set contact force limitzA 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 31Display of the angle at which the ablation catheter is applied to the cardiac wallzThe 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 energyzThe catheter tip turns blue.Display of exceedance of the set contact force limitzThe 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 SoftwareIndication of possible perforation of the cardiac wallzThe 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 DisplayGeneral overviewThe 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:zContact force over timeF: Contact force in grams (g)t: Time in seconds (s)zThe orange line marks the set contact force limit.zThe blue range highlights the delivery of ablation energy (only if a RF generator is connected to Qubic Force).
Using the Software 33The 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 ViewSwitching to the Settings viewzConnect a keyboard or mouse to the USB port.zPress any key.OverviewYou can set the following values in the Settings view: zΔt: Duration of the trend displayzFmax: Contact force limitzLimit for the angle at which the ablation catheter can be applied to the cardiac wallSetting a limit (0...90°) activates the visual warning for a possible foresee-able perforation of the cardiac wall in the graphic display of the main view. Also, the checkbox lights up green.
34 Using the SoftwareClosing the Settings viewzIf 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. zIf 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: zAn AlCath Force ablation catheter is connected.zA key on the device is pressed.
Using the Software 35Working with the keyboardThe button that is activated and whose value you can change is surrounded by a frame. zSwitching between the buttons:Press the Tab key on the keyboard.zActivating/confirming a button:Press the Enter key on the keyboard.zChanging the values:Press the arrow keys on the keyboard.zResetting 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.zThe button with the key is intended for internal use only. –Working with a mouseThe button that is activated and whose value you can change is surrounded by a frame. zSwitching between the buttons:Click the mouse pointer on the respective arrow key or button.zActivating/confirming a button:Click the mouse pointer on the respective button.zChanging the values:Click the mouse pointer on the respective arrow keys of the button.zResetting 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.zThe button with the key is intended for internal use only. –
36 Appendix5 Appendix Appendix5418423Technical ManualQubic ForceTechnical DataPhysical propertiesGeneral classification Longevity Ambient conditionsSafety equipment Property DesignDimensions (W x H x D) 230 x 150 x 240 mmWeight with power cord 4.7 kg (± 300 g)Housing material Polyurethane (PUR)Property DesignMedical product classification Class IIb in compliance with Directive 93/42/EEC (MDD)Mode of operation Continuous operationProperty DesignLongevity 5 yearsProperty DesignTemperature range for operation +10°C ... +40°CTemperature range for storage 0°C ... +50°CAtmospheric pressure for operation 700 ... 1060 hPaAtmospheric pressure for storage 700 ... 1060 hPaRelative humidity 30% ... 75%, no condensationOperation at altitudes Up to 2000 mProperty DesignApplied part classification CF, defibrillation protected with the specified cablesDegree of protection IP 30
Appendix 37Power cord port Light sourceRFID communicationProperty DesignSupply voltage 100–240 V, ± 10%50/60 Hz, ± 1 Hzmax. 0.2 A-0.47 A/AC Protection class IFuse type T 1.6 AH, 250 VMax. power input Duration 25 WPeak 40 WLevel of efficiency > 85%(at 230 V/50 Hz)On/off light indicator Green LED, lit continuouslyProperty DesignType SLED (superluminescent diode)Laser class 1Type of radiation Infrared lightSpectral interval 1510–1590 nmRadiant flux < 10 mWProperty DesignType RFID conforming to ISO 15693Frequency band 13.56 MhzMax. power of transmission 200 mW
38 AppendixMeasurement accuracy of the contact force system, consisting of AlCath Force and Qubic ForceMeasurement accuracy without delivery of ablation energy Possible offset during delivery of ablation energy Parameter ValuesParameters of the main viewParameters in Settings viewContact force (F) Measurement accuracy< 20 g ± 3 g20 g ≤ F ≤150 g ± 15%Contact force (F) Offset≤ 80 g ± 10 gParameter Unit Range of valuesStep sizeIn the numerical displayContact force Grams (g) 0 – 150 g 1Force-time integral Gram seconds (gs) 0 – 9999 gs 1In the graphic displayAngle of ablation catheter to cardiac wallDegrees (°) 0 – 90° 1In the trend displayContact force Grams (g) 0 – 150 g –Time Seconds (s) 15 – 90 s 1Parameter Factory settingUnit Range of valuesStep sizeContact force limit 40 g Grams (g) 10 – 70 g 1Angle limit for ablation catheter to cardiac wallOff Degrees (°) 0 ... 90°, Off1Length of time axis in trend display20 s Seconds (s) 15 – 90 s 1
Appendix 39AccessoriesAccessoriesNot all accessory products are available in every country. Item designation Description Order no.Qubic Force Device with installed application software405250AlCath ForceBIOTRONIK Ablation catheterVariant red:Range 48 mm and length of tip electrode 65 mm405562Variant blue:Range 57 mm and length of tip electrode 75 mm405561Variant green:Range 65 mm and length of tip electrode 85 mm405560Variant black:Range 73 mm and length of tip electrode 95 mm405583Variant cyan:Range 80 mm and length of tip electrode 105 mm405559VK-124 Video cable for connecting an external monitor; 5.0 m long417863Video cable for connecting an external monitor; 15 m long417864PK-111 Cable for connecting the HAT 300 Smart RF generator 330080PK-112 Cable for connecting the Atakr II RF generator330081PK-142 Cable for connecting the IBI-1500 T11 RF generator362442PK-147 Cable for connecting the AlCath Force ablation catheter, the Qubic RF RF generator and the EP-Shuttle RF generator by BIOTRONIK; cable length 2.5 m; sterile398853PK-150 Cable for connecting the SmartAblate RF generator402668NK-3 Power cord for EU 107526
40 AppendixCountry-Related InformationCanadazIndustry CanadaThe device is registered at Innovation, Science and Economic Develop-ment Canada under the following identification:IC 4708A-QFORCEUSAzFederal Communication CommissionThe device is registered with the Federal Communications Commission under the following number:FCC ID: QRIQFORCE zNote: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 direc-tives are designed to provide reasonable protection against harmful inter-ference in a commercial installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accor-dance 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. NK-11 (3 m) Power cord for USA and Japan 128865NK-16-GB (2 m) Power cord for the United Kingdom 330705NK-19-CN (2.5 m) Power cord for China 339034NK-21-AU, UY (2.5 m) Power cord for Australia and Uruguay 339035NK-22-AR (2.5 m) Power cord for Argentina 339039NK-26-CL, IT (2.5 m) Power cord for Chile and Italy 339043NK-28-DK (2.5 m) Power cord for Denmark 339059NK-25-CH (2.5 m) Power cord for Switzerland 339042NK-27-IL (2.5 m) Power cord for Israel 339044NK-33-BR (2.5 m) Power cord for Brazil 378933Item designation Description Order no.
Appendix 41Legend for the LabelThe label icons symbolize the following: Manufacturing dateBIOTRONIK order numberSerial numberTemperature limit for storageAir pressure limit for storageHumidity limit for storageFollow the instructions for useContentsCE markDevice contains materials that must be correctly disposed of in accordance with environmental protection regulations.The European Directive 2012/19/EC regarding waste elec-trical and electronic equipment (WEEE) applies.Return devices that are no longer used to BIOTRONIK.Qubic ForcePatient with inserted diagnostic or ablation catheter
42 Directories6 Directories Directories6418423Technical ManualQubic ForceIndexAAblation catheterConnecting, 18Accessories, 39Ambient conditions, 9CCharacteristics, 36Cleaning, 11Compatible RF generators, 2ConnectingAblation catheter, 18External monitor, 21Keyboard, 22Mouse, 22RF generator, 19USB stick, 22ConnectionPower cord, 18Contraindications, 2DDamage, 9DeviceFactory settings, 38General description, 2Overview, 14Disinfection, 11Disposal, 13Disposal of cables, 13EElectromagnetic interference, 4Electrostatic potentials, 8Emergency equipment, 7Expert knowledge, 4Expertise, 3, 4External monitorConnecting, 21FFactory settings, 38Fuse replacement, 13
Directories 43GGraphic display, 30IInspection, 12Installation location, 17Intended medical use, 2Intended use, 2InterferenceElectromagnetic, 4Introduction, 2KKeyboardConnecting, 22Keys on the Device, 24MMain functions, 2Main view, 26Maintenance, 11Inspection, 12Test before each use, 12Monitor port, 21MouseConnecting, 22NNumerical display, 29OOperating conditions, 9Overview, 2PParameter values, 38Patient group, 2Potential equalization, 8Power cordConnect, 18Power supply, 10RRange of values, 38Redel portAblation catheter, 18RF generator, 19RF generatorConnecting, 19
44 DirectoriesSSafety warningsGeneral, 7Screen, 26Set markers, 25Status bar, 28Sterilization, 12Storage conditions, 9Switching off, 23Switching on, 23SymbolsOn the device, 16Packaging, 41TTareSet to zeroSet values to zero, 24Target groupPatients, 2Technical manual, 3Technical DataMeasurement accuracy, 38Technical data, 36Ambient conditions, 36General classification, 36Longevity, 36Power cord port, 37Safety equipment, 36Technical detailsLight source, 37RFID communication, 37Technical manual, 3Transport conditions, 9Transport damage, 9Trend display, 32UUSB port, 22USB stickConnecting, 22VViewSettings, 33
BIOTRONIK SE & o K Woermannkehre 1 12359 Berln  ermany Tel +49 (0) 30 68905-0 Fax +49 (0) 30 6852804 salesbotronkcom wwwbotronkcom16-D-36 Revision: D (2016-08-22)© BIOTRONIK SE & Co. KGAll 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 2016J 0681 2016

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