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Acutus Medical Qubic Force, Technical Manual, Page: 5 / 52

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Acutus Medical Qubic Force Technical Manual Download Page 5

3

Introduction

Other Technical Manuals

The following additional technical manuals must be followed to ensure the 

safe and correct use of the device:

•  Technical manuals for other system components in the cardiac cath-

eter laboratory, not supplied with the Qubic Force (e.g., AcQBlate® 
FORCE ablation catheter, RF generator, lab monitoring system, and 
external monitor)

•  Technical manuals for the intended catheters, indifferent electrodes, 

patient cables, and adapters

•  Technical manuals for other designated accessories

Summary of Contents for Qubic Force

Page 1: ...Qubic Force Device for visualization of contact force of the catheter tip on the cardiac wall EP External devices Technical Manual...

Page 2: ...ing 15 Device Overview 15 Setting up the Device 19 Connections and Cables 20 Switching On and Off 25 Keys on the Device 26 4 UsingtheSoftware 28 The Main View 28 The Status Bar 29 The Numerical Displa...

Page 3: ...y 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...

Page 4: ...manual Device startup Device handling Using the software Target group This technical manual is intended for cardiologists electrophysiologists and cardiac surgeons possessing knowledge in the followi...

Page 5: ...nical manuals for other system components in the cardiac cath eter laboratory not supplied with the Qubic Force e g AcQBlate FORCE ablation catheter RF generator lab monitoring system and external mon...

Page 6: ...ll 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...

Page 7: ...4 3 Electromagnetic fields 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 8 9 IEC 61000 4 4 Transient conducted surge voltages EFT b...

Page 8: ...s other inexplicable behavior Correct operation of the device can be restored with the following miscellaneous measures Switch off electronic device generating the disturbance Remove the source of int...

Page 9: ...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 manufa...

Page 10: ...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 Acutus Medical for testing and if necessary...

Page 11: ...ce 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 di...

Page 12: ...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 Only...

Page 13: ...05VV 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 Cable and plug connections WARNING Allergic reaction The cable materi...

Page 14: ...surface of the device Cleaning and disinfecting Use lint free soft cloths Clean the housing with a damp cloth and mild soap solution or 70 isopropanol Disinfect with alcohol based agents such as Aero...

Page 15: ...ts of the regular safety inspection according to medical device standards This ensures the safety of the device Inspections should be performed If malfunctions are suspected Once a year The inspection...

Page 16: ...onmentally friendly manner it will result in environmental pollution as this device contains materials which must be disposed of in accordance with environmental protection requirements e g WEEE RoHS...

Page 17: ...contact force and the angle at which the ablation catheter is applied to the cardiac wall to zero 2 Marker key Marks the current values in the log file for the current proce dure and stores a current...

Page 18: ...rt for generator For connecting a compatible RF generator using the corre sponding patient cable 7 Redel port for ablation catheter For connecting the electrical plug of the ablation catheter using pa...

Page 19: ...232 port General serial connection for expansions No use of this port is planned at present Consult Acutus Medical 13 Binary interface 2 RS 232 port General serial connection for expansions No use of...

Page 20: ...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...

Page 21: ...d 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 scree...

Page 22: ...same time ConnectionsandCables 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 con...

Page 23: ...om the device for example The values used to obtain contact force and application angle are automatically stored by the device upon first connecting the AcQBlate FORCE ablation catheter and each time...

Page 24: ...the instructions in the technical manual for the RF generator and for the patient cable that you are using The following RF generators are connected using the correct patient cable as indicated below...

Page 25: ...nts 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 mo...

Page 26: ...nto the patient 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 w...

Page 27: ...While the AcQBlate 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 contac...

Page 28: ...d 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 fo...

Page 29: ...current procedure exists only until another AcQBlate FORCE ablation catheter is connected Connecting a new AcQBlate FORCE ablation catheter overwrites the existing log file for the current procedure...

Page 30: ...theSoftware TheMainView 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 app...

Page 31: ...contains four areas that present information differently Item Explanation 1 Status bar 2 Numerical display 3 Graphic display 4 Trend display TheStatusBar General overview The status bar is located at...

Page 32: ...nnected AcQBlate FORCE ablation catheter has been removed Data export symbol Marker and screenshot symbol Explanation Have not been used during the current electro physiological study Data has been su...

Page 33: ...contact force of the ablation catheter tip on the cardiac wall in grams g FTI The current force time integral in gram seconds gs The force time integral is calculated from the following formula t2 FTI...

Page 34: ...rce Exceedance of the set contact force limit A possible foreseeable perforation of the cardiac wall because the following values are not within the respective tolerance range The contact force is abo...

Page 35: ...angle limit The area within the circle symbolizes the cardiac wall and moves ac cording to the angle of the catheter on the cardiac wall Display of the delivery of ablation energy The catheter tip tur...

Page 36: ...ide 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 orang...

Page 37: ...limit The blue range highlights the delivery of ablation energy only if a RF generator is connected to Qubic Force The contact force limit Fmax 40 g and the duration of the trend display t 20 s are p...

Page 38: ...sing 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...

Page 39: ...ended for internal use only Working with a mouse The button that is activated and whose value you can change is surrounded by a frame Switching between the buttons Click the mouse pointer on the respe...

Page 40: ...de 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 Atm...

Page 41: ...ak 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 1 Type of radiation Infrared l...

Page 42: ...rameter Unit Range of values Step size In the numerical display Contact force Grams g 0 150 g 1 Force time integral Gram seconds gs 0 9999 gs 1 In the graphic display Angle of ablation catheter to car...

Page 43: ...ip electrode 95 mm 900205 Variant cyan Range 80 mm and length of tip electrode 105 mm 900206 VK 124 Video cable for connecting an external monitor 5 0 m long 417863 Video cable for connecting an exter...

Page 44: ...Develop ment Canada under the following identification IC 4708A QFORCE USA Federal Communication Commission The device is registered with the Federal Communications Commission under the following num...

Page 45: ...limit for storage Follow the Instructions for Use Quantity of devices Keep dry CE mark Device contains materials that must be correctly disposed of in accordance with environmental protection regulat...

Page 46: ...with inserted diagnostic or ablation catheter Manufacturer Deadly Risks of Using Non Approved Chargers and Cables European Importer Medical Device Authorized representative in the European community...

Page 47: ...8 Cleaning 12 Compatible RF generators 2 Connecting Ablation catheter 20 External monitor 23 Keyboard 24 Mouse 24 RF generator 21 USB stick 24 Connection Power cord 20 Contraindications 1 D Damage 9 D...

Page 48: ...settings 40 Fuse replacement 13 G Graphic display 32 I Inspection 13 Installation location 20 Intended medical use 1 Intended use 1 Interference Electromagnetic 4 Introduction 1 K Keyboard Connecting...

Page 49: ...8 Power cord Connect 20 Power supply 11 R Range of values 40 Redel port Ablation catheter 20 RF generator 21 RF generator Connecting 21 S Safety warnings General 7 Screen 28 Set markers 27 Status bar...

Page 50: ...nt accuracy 40 Technical data 38 Ambient conditions 38 General classification 38 Longevity 38 Power cord port 39 Safety equipment 38 Technical details Light source 39 RFID communication 39 Technical m...

Page 51: ......

Page 52: ...TUS MEDICAL NV Ikaroslaan 25 1930 Zaventem Belgium Phone 32 2 669 75 00 Fax 32 2 669 75 01 MDSS GmbH Schiffgraben 41 30175 Hannover Germany Acutus Medical the Acutus Medical logo and AcQBlate are regi...

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