Acutus Medical Qubic Force Technical Manual
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Acutus Medical Qubic Force Technical Manual

Device for visualization of contact force of the catheter tip on the cardiac wall
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EP // External devices // Technical
Manual
Qubic
Force
Device for visualization of contact force
of the catheter tip on the cardiac wall

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Summary of Contents for Acutus Medical Qubic Force

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

  • Page 2: Table Of Contents

    Table of Contents Introduction About the Device About this Technical Manual Safety during Use Required Expertise General Safety Warnings Operating Conditions Maintenance, Care and Disposal Device Handling Device Overview Setting up the Device Connections and Cables Switching On and Off Keys on the Device Using the Software The Main View...

  • Page 3: Introduction

    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...

  • Page 4: About This Technical Manual

    Introduction Compatible RF generators The following RF generators are compatible with Qubic Force: • BIOTRONIK: Qubic RF • Stockert: EP-Shuttle • Biosense Webster: SMARTABLATE™ HF Generator (manufacturer: Stockert) • St. Jude Medical: IBI-1500 T11 • Medtronic: Atakr II • Osykpa: HAT 300 Smart...
  • Page 5 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,...

  • Page 6: Safety During Use

    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.
  • Page 7 Safety during Use The following tests were performed according to IEC 60601-1-2: 2014: Section of Test Test level IEC 60601- 1-2:2014 EN 55011 (CISPR 11) • Group 1 Conducted • Class A interference emissions EN 55011 (CISPR 11) Radiated emissions IEC 61000-4-2 • ±8 kV contact discharge Electrostatic...
  • Page 8 Risk of electromagnetic interference through the use of unau- thorized accessories The use of accessories, transducers or cables not listed by Acutus Medical or of accessories other than those specified by Acutus Medical, can produce elevated electromagnetic emissions or cause degradation in the device’s resistance to electromagnetic interference.

  • Page 9: General Safety Warnings

    • Failure of important device functions • Personal endangerment due to electrical impact Changes not permitted Only the manufacturer or a party expressly authorized by Acutus Medical may perform corrective maintenance, enhancements or modifications to the device. Replacement parts and accessories Use only accessories authorized by Acutus Medical.
  • Page 10 (e.g. infusion fluids). If the device becomes wet, immediately unplug and stop using the device. Contact Acutus Medical for testing and, if necessary, repair of the device. Electrostatic potentials Ensure that electrostatic potentials between medical staff and patients are balanced.

  • Page 11: Operating Conditions

    Refer to the cleaning instructions for all other system components. Operating Conditions Storage and transportation If the packaging is damaged, please contact Acutus Medical immediately. Do not put the device into operation. The ambient conditions for shipping and storage are: Temperature 0°C ...
  • Page 12 Safety during Use 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. • 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.
  • Page 13 Acutus Medical 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.

  • Page 14: Maintenance, Care And Disposal

    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.
  • Page 15 • Inspections should be performed: – If malfunctions are suspected – Once a year • The inspection can be performed by Acutus Medical. • 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.
  • Page 16 (e.g., WEEE, RoHS, REACH). Return devices that are no longer in use to Acutus Medical. Disposal of cables Note: Cables that are to be disposed of must be treated as medical...

  • Page 17: Device Handling

    Device Handling Device Handling Device Overview Front view Explanation of items Item Description Tare key • 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 • Marks the current values in the log file for the current proce- dure and stores a current screenshot • Transfers the log file for the current procedure and the...
  • Page 18 Device Handling 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 corre- sponding patient cable Redel port for ablation catheter • For connecting the electrical plug of the ablation catheter...
  • Page 19 Device Handling Rear view of device Explanation of items Item Description Redel port for expansion • General, analog connection for expansions (No use of this port is planned at present. Consult Acutus Medical.) Ventilation slots • 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.
  • Page 20 Device Handling 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.

  • Page 21: Setting Up The Device

    • Contact Acutus Medical 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.

  • Page 22: Connections And Cables

    Device Handling Setting up the device • 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 can- not 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.
  • Page 23 FORCE ablation catheter from 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 the Qubic Force is started. Connecting the RF generator CAUTION...
  • Page 24 Device Handling 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.
  • Page 25 Device Handling Connecting an external monitor 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.
  • Page 26 Device Handling Connecting keyboard, mouse or USB stick 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. • Never touch the device and the patient at the same time.

  • Page 27: Switching On And Off

    • Never touch the device and the patient at the same time. Note: 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 contact force is displayed or if the Qubic Force is switched off.

  • Page 28: Keys On The Device

    Tare key. The device is automatically tared upon first connecting the AcQBlate® 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.
  • Page 29 Device Handling Marker key A log file for the current procedure is created when an AcQBlate® 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: • Mark the current values in the log file for the current procedure and store a screenshot.

  • Page 30: Using The Software

    Using the Software 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.

  • Page 31: The Status Bar

    Using the Software 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 The Status Bar General overview The status bar is located at the top right edge. It is visible in the main view...
  • Page 32 Using the Software Symbol AcQBlate® FORCE ablation catheter • No AcQBlate® FORCE ablation catheter has been connect- • An AcQBlate® FORCE ablation catheter has been connect- ed, checked successfully, and can be used. • The green marker changes to gray after 10 seconds. • An AcQBlate®...

  • Page 33: The Numerical Display

    Using the Software The Numerical Display General overview The numerical display is located in the left main area of the screen. If an AcQBlate® FORCE ablation catheter is connected, the following current values are shown: • F: The current 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:...

  • Page 34: The Graphic Display

    • The angle at which the ablation catheter is applied to the cardiac wall • The delivery of ablation energy (only if a RF generator is connected to Qubic Force.) • 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: –...
  • Page 35 Using the Software Display of the angle at which the ablation catheter is applied to the cardiac wall • 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 ac- cording to the angle of the catheter on the cardiac wall.

  • Page 36: The Trend Display

    Using the Software Indication of possible perforation of the cardiac wall • 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.

  • Page 37: The Settings View

    • The orange line marks the set contact force limit. • The blue range highlights the delivery of ablation energy (only if a RF generator is connected to Qubic Force). The contact force limit (F = 40 g) and the duration of the trend display (t = 20 s) are preset in the factory settings.
  • Page 38 Using the Software You can set the following values in the Settings view: • Δt: Duration of the trend display • F : Contact force limit • 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...
  • Page 39 Using the Software Press the Tab key on the keyboard. • Activating/confirming a button: Press the Enter key on the keyboard. • Changing the values: Press the arrow keys on the keyboard. • 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.

  • Page 40: Appendix

    Appendix Appendix 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...
  • Page 41 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 >...

  • Page 42: Parameter Values

    Appendix Measurement accuracy of the contact force system, consisting of AcQBlate® FORCE Catheter and Qubic Force Measurement accuracy without delivery of ablation energy Contact force (F) Measurement accuracy < 20 g ± 3 g 20 g ≤ F ≤ 150 g ±...

  • Page 43: Accessories

    Appendix Accessories Accessories Not all accessory products are available in every country. Item Description Order designation Qubic Force Device with installed application software 900012 AcQBlate® Variant red: 900202 FORCE Range 48 mm and length of tip electrode 65 mm Ablation...

  • Page 44: Country-Related Information

    Appendix Item designation Description Order 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...

  • Page 45: Legend For The Label

    Appendix Legend for the Label The label icons symbolize the following: Date of Manufacture Acutus Medical order number Serial number Temperature limit for storage Air pressure limit for storage Follow the Instructions for Use Quantity of devices Keep dry CE mark...
  • Page 46 Appendix Patient 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 Humidity Limitation...

  • Page 47: Directories

    Directories Directories Index Ablation catheter Connecting, Accessories, 41 Ambient conditions, 10 Characteristics, 38 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 Damage, 9 Device...
  • Page 48 Directories Electromagnetic interference, 4 Electrostatic potentials, 8 Emergency equipment, 8 Expert knowledge, 4 Expertise, 3, 4 External monitor Connecting, 23 Factory settings, 40 Fuse replacement, 13 Graphic display, 32 Inspection, 13 Installation location, 20 Intended medical use, 1 Intended use, 1 Interference Electromagnetic, 4 Introduction, 1...
  • Page 49 Directories Operating conditions, 9 Overview, 1 Parameter values, 40 Patient group, 1 Potential equalization, 8 Power cord Connect, 20 Power supply, 11 Range of values, 40 Redel port Ablation catheter, 20 RF generator, 21 RF generator Connecting, 21 Safety warnings General, 7 Screen, 28 Set markers, 27...
  • Page 50 Directories Tare Set to zero, Set values to zero, 26 Target group Patients, 1 Technical manual, 2 Technical Data Measurement 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...
  • Page 52 Phone: +32 2 669 75 00 Fax: +1 442-232-6081 Fax: +32 2 669 75 01 acutusmedical.com Acutus Medical®, the Acutus Medical logo and AcQBlate® are registered trademarks of Acutus Medical, Inc. Copyright © 2020 Acutus Medical, Inc. All rights reserved. acutus.com/patents OM-20 Rev B 2020-11...

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