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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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.
Introduction 3 About this Technical Manual Objective This technical manual provides all the safety information required to use the device.
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.
Safety during Use 5 The following tests were performed according to IEC 60601-1-2: 2014: Section of Test IEC 606011-2:2014 Test level 7.1 z EN 55011 (CISPR 11) Conducted interference emissions z Group 1 Class A EN 55011 (CISPR 11) Radiated emissions 8.9 8.9 / 8.10 IEC 61000-4-2 Electrostatic discharge (ESD) z IEC 61000-4-3 Electromagnetic fields z z z z 8.
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.
Safety during Use 7 General Safety Warnings Risks of improper handling Disregarding the safety warnings can endanger the patient, the staff and the equipment. Note: Failure to observe the safety warnings voids all damage claims and manufacturer liability.
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.
Safety during Use 9 Operating Conditions Storage and transportation If the packaging is damaged, please contact BIOTRONIK immediately. Do not put the device into operation. The ambient conditions for shipping and storage are: Temperature 0°C ... +50°C Relative humidity 30% ... 75%, no condensation Atmospheric pressure 700 ...
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.
Safety during Use 11 Cable and plug connections W WARNING Allergic reaction The cable material may trigger allergic reactions in extremely rare cases. z Prevent the cable from contacting the skin or wounds. z z z z z 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.
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.
Safety during Use 13 Fuse replacement The fuses are located above the power cord port in a fuse holder. Step Action 1 Turn the device off and unplug the power cord. 2 Use a suitable tool to pull the fuse holder out. 3 Replace the old fuses with new ones of the same type. 4 Re-insert the fuse holder. Ensure that it locks securely in place. Note: Defective fuses can indicate a technical defect in the device. Conduct an inspection after changing fuses and before resuming operation of the device.
14 Device Handling 3 Device Handling Device Handling3418423Technical ManualQubic Force Device Overview Front view 1 2 9 8 3 7 6 5 4 Explanation of items Item Description 1 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 2 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 screensho
Device Handling 15 Item Description 7 Redel port for ablation catheter z For connecting the electrical plug of the ablation catheter using patient cable PK-147 8 Optical port for ablation catheter z For connecting the optical plug of the ablation catheter 9 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 th
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.
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.
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.
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.
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
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 z z z 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.
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.
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.
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.
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.
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 1 3 2 4 The Qubic Force screen contains four areas that present information differently: Item Explanation 1 Status bar 2 Numerical display 3 Graphic display 4 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 z No AlCath Force ablation catheter has been connected. z An AlCath Force ablation catheter has been connected, checked successfully, and can be used. The green marker changes to gray after 10 seconds. z An AlCath Force ablation catheter has been connected but an error occurred and it cannot be used.
Using the Software 29 The Numerical Display General overview The numerical display is located in the left main area of the screen.
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.
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.
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.
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.
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.
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.
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.
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 I Fuse type T 1.6 AH, 250 V Max.
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 1 Force-time integral Gram seconds (gs) 0 – 9999
Appendix 39 Accessories Accessories Not all accessory products are available in every country. Item designation Description Order no.
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.
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.
42 Directories 6 Directories Directories6418423Technical ManualQubic Force Index A Ablation catheter Connecting, 18 Accessories, 39 Ambient conditions, 9 C 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 D Damage, 9 Device Factory settings, 38 General description, 2 Overview, 14 Disinfection, 11 Disposal, 13 Disposal of cables, 13 E Electro
Directories G Graphic display, 30 I Inspection, 12 Installation location, 17 Intended medical use, 2 Intended use, 2 Interference Electromagnetic, 4 Introduction, 2 K Keyboard Connecting, 22 Keys on the Device, 24 M Main functions, 2 Main view, 26 Maintenance, 11 Inspection, 12 Test before each use, 12 Monitor port, 21 Mouse Connecting, 22 N Numerical display, 29 O Operating conditions, 9 Overview, 2 P Parameter values, 38 Patient group, 2 Potential equalization, 8 Power cord Connect, 18 Power supply, 10 R
44 Directories S 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 T 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 Tech
© 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.
