Qubic Connect Device for data transmission from the cardiac catheter laboratory Technical Manual 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. 22-D-xx Revision: A (2022-11-22) BIOTRONIK, Inc. 6024 Jean Road Lake Oswego, OR 97035-5369
(800) 5470394 (24-hour) Tel Fax (503) 6359936 marketing@biotronikusa.com BIOTRONIK SE & Co. KG Woermannkehre 1 12359 Berlin / Germany Tel +49 (0) 30 68905-0 Fax +49 (0) 30 6852804 sales@biotronik.com www.biotronik.com 476463--A Table of Contents 1 Table of Contents 1 About this Technical Manual .................................................... 2 Objective ........................................................................................ 2 Conventions .................................................................................. 2 2 Device Description ................................................................... 4 Intended Purpose ......................................................................... 4 Intended Conditions of Use .......................................................... 4 3 Safety ....................................................................................... 5 Conditions for Operation .............................................................. 5 Maintenance, Care, and Disposal ................................................ 6 4 Device Handling ....................................................................... 8 Device Overview ............................................................................ 8 Setting up the Device .................................................................. 15 Connections and Cables ............................................................. 17 Connecting the Device ................................................................ 19 Activating Qubic Connect Service .............................................. 19 Configuring Connection to the Internet with WIFI and LAN ..... 21 Connecting the AcQMap System ................................................ 23 Troubleshooting ..................................................................... 24 Appendix ................................................................................. 27 Technical Data ............................................................................ 27 Accessories ................................................................................. 31 Country-Related Information ..................................................... 32 Legend for the Label .................................................................. 34 Index ....................................................................................... 36 5 6 476463--A 2 About this Technical Manual 1 About this Technical Manual Objective This technical manual provides information on how to use Qubic Connect. Among others, the following topics are explained:
Device startup Device handling Disposal Transportation Technical manuals are either included in hard copy form in the storage package or available in digital form on the internet:
https://manuals.biotronik.com. 1. Consult the technical manual. 2. Keep the technical manual for future reference. Conventions Identification of Safety Warnings The following symbol draws attention to potential safety risks:
Follow all safety warnings indicated by this symbol to avoid possible serious or fatal injury or damage to the system. Safety warnings are also indicated by a signal word. Signal word Meaning Attention Non-compliance leads to a potentially dangerous situation that can cause minor injuries and/or material damage. About this Technical Manual 3 Typographical Conventions The following typographical conventions are used in this technical manual:
Instructions The individual steps of an instruction are numbered. Prerequisites, intermediate results, and results may be specified. Prerequisite This is a prerequisite. 1. Step 2. Step Intermediate result 3. Step Result This is the result. Elements Description and appearance Cross refer-
ences Cross references are indicated using "see" or "see also". Highlights Text that needs to be highlighted is shown in bold. Useful information is indicated using the word Note. Notes Figures Figures that show the product or the user interface are used for illustration. The details shown in the figure may differ from that of the delivered product or your software version. Gender If personal designations are used only in the male or female form for reasons of better readability, this expressly includes all other gender identities. 4 Device Description 2 Device Description Intended Purpose The Qubic Connect is designed for downloading data from medical products or devices used in an EP lab and uploading the data to the BIOTRONIK Cloud Services. The Qubic Connect device is designed for stationary and mobile usage. Intended Conditions of Use Application environment The Qubic Connect may be used anywhere within the specified temperature, pressure, and humidity ranges (see Operating Conditions). The Qubic Connect is typically placed in the control room of an EP lab on the office desk, for example. Safety 5 3 Safety Conditions for Operation Transport and Storage If the package is damaged, please contact BIOTRONIK immediately. Do not put the device into operation. The ambient conditions for shipping and storage are:
Temperature
+0C (32F)... +50C (122F) Relative humidity 30%... 75%, no condensation Atmospheric pressure 700... 1060hPa Operating Conditions Attention After transporting the equipment from a cold location to a warm location, condensation may form, particularly on metal parts of the device, and damage the electronics. After transport, wait approximately 2h until the device has reached room temperature and the condensation has dried up before using the system. The ambient conditions for operation are:
Temperature
+0C (32F)... +40C (104F) Relative humidity 30%... 75%, no condensation Atmospheric pressure 700... 1060hPa Power Supply Qubic Connect is operated via an external power supply brick
(12VDC/5A) in a medical room outside the patient environment Qubic Connect is not connected to the AC voltage supply. The external power supply brick must meet the requirements of IEC62368-1. 6 Safety Cable and Plug Connections Replace any cable that shows even slight damage. Ensure that the contacts of all connector ports and connectors are clean. Dirty contacts can lead to signal distortions. Ensure that there is no condensation on the plugs or in the connector ports. If condensation is present, dry it before use. Do not force the plugs into the connector ports. Do not pull on the cable when disconnecting the plugs. Rather, release the lock on the plug. Maintenance, Care, and Disposal General information Note the following points before cleaning and disinfecting:
Unplug Qubic Connect from the power supply brick before cleaning and disinfecting. Let cleaning and disinfection agents evaporate before operating the device. Do not use any strong and abrasive cleaning agents or organic solvents such as ether or benzine, as they corrode the surface of the device. Cleaning and Disinfecting Clean the device with a damp cloth and a mild soap solution. For disinfecting, use an alcohol-based, hydrogen peroxide-based, or quaternary compound-based disinfectant. The disinfection of the device was tested using the following agents:
Alcohol-based disinfectant Aerodesin 2000 Isopropyl (70%) Ethanol (85%) Hydrogen peroxide-based disinfectant 2 percent ready-to-use solution with Terralin PAA Quaternary compound-based disinfectant 2 percent ready-to-use solution with Terralin protect Safety 7 Test before Each Use A short test of the device and the approved accessories should be performed prior to each use. It includes a visual inspection and a simple function test. Inspect the housing for mechanical damage, dents, loose parts, cracks, etc. Inspect cables and connection areas to ensure proper insulation, no breaks, etc. Qubic Connect runs automatic self-tests on a regular basis. If the self-
test fails, the device displays a notification for the user (see Troubleshooting). If you find any damage or failures, please contact BIOTRONIK. If no error message appears, the device is ready to be used. Maintenance Qubic Connect is intended for continuous operation. When correctly in-
use, ongoing maintenance is typically not required. Disposal The symbol on the type plate, a crossed out garbage can, indicates that the device must be disposed of in accordance with Directive 2012/19/EU on waste electrical and electronic equipment (WEEE2). Disposal of this device in an environmentally unsound manner will result in environmental pollution, as this device contains materials that must be disposed of in accordance with environmental protection regulations
(e.g., WEEE, RoHS, REACH). Return devices that are no longer in use to BIOTRONIK. 8 Device Handling 4 Device Handling Device Overview Front View 1112467835 Device Handling 9 Item Description 1 2 3 4 5 6 7 8 QR code For connecting with BIOTRONIK support. Indicator LED BIOCLOUD Shows the data transfer to the BIOTRONIK Cloud. Storage of the data received from the Qubic Connect device and provision of the data. Indicator LED MOBILE Shows whether the device has an LTE connection. Indicator LED WIFI Shows whether the device has a WIFI connection. Indicator LED LAN Shows whether the device has a LAN connection. Indicator LED A, B, C, D Shows the connection to an EP device. Currently, only the AcQMap system is intended to be used. Stand Enables to stand the device in an upright position. Two antennas To improve the signal quality of the cellular phone network. 10 Device Handling Rear View of Device Item Description 1 2 3 Power supply port For connecting the external power supply brick WAN port Enables internet access via an Ethernet connection Four LAN Ethernet ports For connection to an EP device. Currently, only the AcQMap system is intended to be connected using the VK-118 cable. To connect to the Qubic Connect GUI using a laptop or PC. 1123 Device Handling 11 Symbols on the Device Explanation of symbols Symbol Meaning Power supply connection symbol Symbol for the WAN Ethernet connection Symbols for the Ethernet connec-
tions of the EP devices Manufacturing date Manufacturer Serial number ABCD 12 Device Handling Symbol Meaning CE mark Global Trade Item Number Device contains materials that must be correctly disposed of in accordance with environmental protection regulations. The Euro-
pean Directive 2012/19/EU on waste electrical and electronic equipment (WEEE2) applies. Return devices that are no longer used to BIOTRONIK. GTIN Device Handling 13 LED Symbols and Display Status The Qubic Connect LED symbols are displayed in green and yellow. Symbol on the device Explana-
tion LED display Bio Cloud LED display Mobile LED display WIFI LED display solid yellow Data upload not possible LED display flashing yellow Device is estab-
lishing the connec-
tion to the BIOTRON IK Cloud Service n/a n/a n/a n/a LED display flashing green Device is estab-
lishing the connec-
tion to the BIOTRON IK Cloud Service Setting up the LTE connec-
tion to the BIOTRON IK Cloud Service Setting up the WLAN connec-
tion to the BIOTRON IK Cloud Service LED display solid green Data transfer to BIOTRON IK cloud running Connec-
tion to BIOTRON IK Cloud Service via cellular phone network Connec-
tion to the BIOTRON IK Cloud Service via WLAN of the hospital IT infra-
structure 14 Device Handling Symbol on the device Explana-
tion LED display WAN LED display devices LED display devices LED display devices LED display devices LED display solid green Connec-
tion to the BIOTRON IK Cloud Service via Ethernet of the hospital IT infra-
structure Connec-
tion with the AcQMap system LED display solid yellow LED display flashing yellow n/a n/a LED display flashing green Setting up the Ethernet
(WAN) for the BIOTRON IK Cloud Service Data transfer to/from the AcQMap system Data transfer to/from the AcQMap system not possible Connec-
tion to the AcQMap system in progress n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a n/a ABCD Device Handling 15 Setting up the Device General Qubic Connect can be wall mounted, stood upright using a stand, and placed on a table. Standing the Device Upright The device can be placed upright using a stand. 1. Place the Qubic Connect on a flat, dry surface using the stand. 2. Make sure to place the device upright in the holder. 16 Device Handling Mounting the Device on the Wall Item Description 1 Mounting holes There are two mounting holes for screws on the underside of the housing to attach the Qubic Connect to the wall. 1. Please use suitable screws such as the universal chipboard screw 3.5 with countersunk head (diameter 7 mm). 1 Device Handling 17 Placing the Device on the Table 1. Place the device on a stable table to prevent it from falling. 2. Do not place any objects on the device so that the LED display remains visible. Connections and Cables Basic notes for cables and connections Do not force the plugs into the connector ports. Do not pull on the cable when disconnecting the plugs. If necessary, release the lock on the plug. 18 Device Handling Connecting the Power Supply Brick Qubic Connect is powered via the provided power supply brick and power cord. Only use the power supply brick supplied with the product. The port for the power supply brick is located on the rear side. Prerequisite Before connecting, ensure that the power supply conditions are met
(see Power Supply). 1. Connect the external power supply brick to the AC power supply via the power cord. 2. Connect the DC output of the external power supply brick to the power supply port of the Qubic Connect. 3. To disconnect Qubic Connect from the electrical power supply, pull out the external power supply brick from the power supply port. Device Handling 19 Connecting the Device Note Qubic Connect does not have an on/off switch. The device is put into operation when it is connected to the electrical power supply. 1. Connect the device to the electrical power supply (see Connecting the Power Supply Brick). Result The LED display BIOcloud first flashes yellow. The LED is solid yellow or green. The device is ready for use. Activating Qubic Connect Service In the Qubic Connect web front end, you can configure the system, activate the Home Monitoring Service, and troubleshoot. Prerequisite Qubic Connect is connected to the electrical power supply. 1. Connect the Ethernet cable VK-118 to the Ethernet port on the Qubic Connect and connect it to a computer or laptop. 2. To enable access to the Qubic Connect GUI, open a browser. Qubic Connect was tested with the Edge browser and with Mozilla Firefox. 3. Enter the URL in the browser. 4. Create a new account and enter an e-mail address and a password into the text fields. 5. Select the Register button to register. This takes you to the main menu dialog. 20 Device Handling 6. To use the Home Monitoring Service, select the HMSC INFO dialog. 7. Activate the Activate Home Monitoring Service Center button. 8. In the text fields, enter the user group data provided by BIOTRONIK and the registration ID and select the associated country. Note Internet access via cellular phone network is enabled by default, and Qubic Connect automatically tests the internet connection. If the signal strength is poor or there is no internet connection, you have the option to configure the internet connection (see Configuring Internet with WIFI and LAN). Device Handling 21 Configuring Connection to the Internet with WIFI and LAN To configure the internet connection, proceed as follows:
Prerequisite The system has booted up. Qubic Connect is connected to a laptop or PC via an Ethernet cable and the Qubic Connect GUI is accessible. 1. Activate the Internet dialog at the top of the main menu. 2. From the Basic Configuration menu, select the Configure internet access button. 3. Enable LAN. 4. If you select WIFI, you must first connect to a network. 22 Device Handling 5. Select the configuration symbol to access the text entry fields for internet settings. 1. Enter the settings assigned by the hospital IT department. To save the entry, select the Save button. If the internet connection cannot be established, contact the hospital IT department. Device Handling 23 Connecting the AcQMap System The AcQMap system is connected to the Qubic Connect device using the VK-118 Ethernet cable. The Ethernet ports are located on the back of the device. Prerequisite The AcQMap system is booted up and the required apps for the Qubic Connect Service are available on the AcQMap. 1. Connect the AcQMap System to one of the rear panel ports using the VK-118 Ethernet cable. 2. The LED of the selected connection should be green (either flashing or solid). 24 Troubleshooting 5 Troubleshooting There is a QR code on the device that gives you access to BIOTRONIK support. Malfunctions of the Qubic Connect can be recognized by the following behavior of the LED symbol display:
Error possibili-
ties LED symbol LED status Description Fix 1 2 3 Contact BIOTRONIK support Contact BIOTRONIK support Contact BIOTRONIK support Flashing yellow Device failure Solid yellow illumination Flashing yellow Flashing yellow Flashing green The device started, but a critical error occurred BIO Cloud connection is estab-
lished via LTE. If the signal lasts longer than two minutes, no connection to the BIO Cloud can be estab-
lished. LED symbol Error possibili-
ties 4 5 Troubleshooting 25 LED status Description Fix Flashing yellow Flashing green Flashing yellow Flashing green Contact BIOTRONIK support Call the hospital IT department to verify that the internet settings are ok. If ok call BIOTRONIK support. BIO Cloud connection is estab-
lished via WLAN. If the signal lasts longer than two minutes, no connection to the BIO Cloud can be estab-
lished. BIO Cloud connection is estab-
lished via LAN. If the signal lasts longer than two minutes, no connection to the BIO Cloud can be estab-
lished. 26 Troubleshooting Error possibili-
ties LED symbol LED status Description Fix 6 7 8 Solid yellow illumination Flashing yellow Solid yellow illumination BIO Cloud connection error during data upload Data transfer to Qubic Connect not possible Solid yellow illumination Connection with Qubic Connect not possible Contact BIOTRONIK support Plug in the laptop and access the Qubic Connect GUI. Check if the data could not be retrieved. Contact BIOTRONIK support AA Appendix 27 6 Appendix Technical Data Physical Characteristics of Communication Unit Category Design Dimensions (WxDxH) 300mmx225mmx46mm /
Weight 1.6kg Degree of protection IP30 Operating mode Continuous operation Disclosure pursuant to Section33REACH, Regulation (EC) No.1907/2006 See:
https://www.biotronik.com/material-
compliance Physical Characteristics of Stand Category Design Dimensions (WxDxH) 175mmx106mmx50mm /
Weight 0.3kg Longevity Category Longevity Properties 5 years 28 Appendix Ambient Conditions Category Operation Transport and storage Temperature
+10C+40C/
+50F+104F 0C+50C/
+32F+122F Relative humidity 20%75%, non-condensing Atmospheric pres-
sure 700hPa1060hPa Radio Interface Category Model Frequency LTE Properties Telit LM940 700/800/850/900/1700/1800/1900/2100/2 300/2500/2600 Power of transmission Max. 0.2 W (Class 3) Mobile Specifications Category Design Max. power of transmission
+max. 0.2 W (Class 3) Model Telit LM940 Appendix 29 Radio Interface to WiFi Network Category Properties Frequency band 2.4 GHz ISM Band 802.11b/g/n Operating frequency
[MHz]
2400-2483. 5 Transmitter power FCC region Max. 30dBm
(1000mW) Transmitter power ETSI region Max. 20dBm
(100mW)
*for indoor use only WAN-Ethernet Interface 5 GHz Unlicensed National Information Infrastructure (U-NII) Band 802.11a/n/ac U-NII-1/2A U-NII-2C U-NII-3 5150-5350*
5470-5725 5725-5850 Max. 24dBm
(250mW) Max. 20dBm
(100mW) Max. 24dBm
(250mW) Max. 20dBm
(200mW) Max. 30dBm
(1000mW) Max. 14dBm
(25mW) Category Properties Number of connections 1 Type Bandwidth Ethernet 100 Mbit/s LAN-Ethernet Interface Category Properties Number of connections 4 Type Bandwidth Ethernet 100 Mbit/s 30 Appendix Power Supply Category Input voltage Properties 12 V DC/5 A Type Coaxial 5.5x 2.5 socket Appendix 31 Accessories Item designation Description Order no. NK-41 NK-40 Ethernet cable VK-118 Power cord US Power cord EU Length 5 m Stand QC Stand Power supply, 12V DC 65W Power supply brick 449306 449305 397252 471175 473717 32 Appendix Country-Related Information Telemetry information for the USA:
This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:
1. 2. This device may not cause harmful interference, and This device must accept any interference received, including interference that may cause undesired operation Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. Note:
This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. This device will be registered with the Federal Communications Commission under the following number:
FCC ID: QRI-QCONNECT Appendix 33 Telemetry information for Canada:
This device contains licence-exempt transmitter(s)/receiver(s) that comply with Innovation, Science and Economic Development Canadas licence-exempt RSS(s). Operation is subject to the following two conditions:
1. 2. This device may not cause interference. This device must accept any interference, including interference that may cause undesired operation of the device. This device will be registered with Innovation, Science and Economic Development Canada under the following number:
IC: 4708AQRI-QCONNECT 34 Appendix Legend for the Label Symbol Meaning Manufacturer Consult the instructions for use!
Distributor Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Medical device Unique device identification Contents Qubic Connect Ethernet cable Power cord Power supply brick Stand QC Air pressure limit MDUDI Appendix 35 Symbol Meaning Humidity limit Temperature limit CE mark Manufacturing date BIOTRONIK order number Serial number Device contains materials that must be correctly disposed of in accordance with environmental protection regulations. The European Directive 2012/19/EU on waste electrical and electronic equipment (WEEE2) applies. Return devices that are no longer used to BIOTRONIK. REF 36 Index Index A Accessories Activating Qubic Connect Service 31 19 T Technical data Transport damage Troubleshooting 27 5 24 C Cleaning and disinfecting Configuring the internet Connecting the AcQMap system 6 21 Connecting the device Connecting the power supply brick 23 19 18 D Device overview Disposal I Intended conditions of use Intended purpose 9, 10 7 4 4 M Mounting the device on the wall O Operating conditions 16 5 P Placing the device on the table 17 5 Power supply S Setting up the device Shipping conditions Standing the device upright Storage conditions 15 5 15 5