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IEC 60601-1 and IEC 60601-1-2 for medical devices. NOTE: Any serious incident that has occurred in relation to the Trackit Solo should be reported to the manufacturer and, where applicable, the competent authority of the EU Member State in which the user and/ or patient is established.
The information in this section is subject to change without notice. Except as stated below, Lifelines Ltd makes no warranty of any kind with regard to this material, including, but not limited to, the implied warranties of merchantability and fitness for a particular purpose. Lifelines shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing, performance or use of this material.
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The manufacturer and distributor consider themselves responsible for the equipment’s safety, reliability and performance only if: y any peripheral equipment to be used with the Trackit Solo is supplied by third-party providers recommended by the manufacturer; y assembly operations, extensions, readjustments, modifications, or repairs are carried out by person authorised by the manufacturer;...
When in close proximity to the Trackit Solo and the EEG amplifier do not use mobile phones, transmitters, power transformers, motors, or other equipment that generates magnetic fields. Do not allow any liquid to enter the case of the Trackit Solo. Do not use acetone on any of the instruments.
The HD camera is fitted to a retractable extension pole. The Trackit Solo feature a Lithium-ion battery power source and can run on battery for up to 3 hours (EEG software dependant).
The Trackit Solo is lightweight and durable. It possesses a shoulder strap and a handle that allows it to be carried. This allows the Trackit Solo to be moved with the patient. The Trackit Solo is designed such that it can be wirelessly connected to an ambulatory amplifier by clinical personnel, and then used by the patient for the duration of an EEG study in their home or clinical environment.
USER MANUAL Installation and Maintenance Installation and Maintenance The following section must be read and understood before the equipment is switched Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the Appendix. The function or safety of the equipment could be impaired if it has been subjected to unfavourable conditions in storage or in transit.
Interference 2�5 The Trackit Solo will continue to operate in the presence of radio frequency magnetic fields (RF) and the effects of electrostatic discharges (ESD) and other interference, in accordance with the requirements of IEC 60601-1-2. However, EEG systems record signals of very low amplitude, and these signals themselves are not immune to the effects of RF, ESD and low-frequency magnetic field interference.
No servicing or maintenance of the equipment should take place while in use with a patient. Cleaning and disinfection Prior to each re-use of the system, all the outer surfaces of the Trackit Solo and its accessories may be cleaned, as required, with a cloth moistened with a mild detergent solution.
Overview Buttons Display Brightness Indicators Figure 2 Front of Trackit Solo Indicators Battery LED – • Flashing blue LED while charging, • Solid blue LED when not charging (while plugged in) or discharging (while unplugged) • Flashing orange LED when battery is low (< 25%, less than 1-hour operating time remaining).
3�2�1 To activate the Trackit Solo, push and quickly release the Power Button. The display will come on in a few seconds. To put the Trackit Solo in Standby mode, push and quickly release the Power Button. To exit Standby push and quickly release the Power Button again.
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Device Connectivity The Trackit Solo offers three USB ports for device connectivity; 1 x USB3.0 port and 2 x USB2.0 ports. The USB3.0 port can be used to connect an HDMI monitor to the device, using a USB3.0-HDMI adapter (not included).
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Charging stopped due to battery over-temperature. If the charging stops due to over temperature, then check that the Trackit Solo is not near a heat source or in direct sunlight and check that the air vents are not blocked. Move the Trackit Solo to a cooler location.
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USER MANUAL Operation Port Lock Installation USB Port Locks Insert the USB Port Lock by hand by pressing inwards with your fingers. RJ45 Port Lock Insertion The RJ45 port lock can only be installed while in the unlocked position. Insert by holding the sides so that it does not go into the locked position during installation.
LTE / 4G Mobile connectivity 4�1 SIM card The Trackit Solo uses an LTE/4G modem to provide mobile data connectivity. The modem uses a nano-SIM card. Access to the SIM card is provided on the rear of the Solo, under the blue cover. Insert...
USER MANUAL LTE/4G Mobile Connectivity Web User Interface (UI) 4�3 The LTE Modem uses a web User Interface (UI) to manage and monitor the mobile data network activity. When the LTE Modem is enabled, the web UI can be accessed from the Chrome browser on the Solo, via the URL http:/ / my.usb or http:/ /192.168.1.1.
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USER MANUAL Appendix 1: Trackit Solo Specifications Appendix 1: Trackit Solo Specifications Overview Intel® Core™ i7-1165G7, 4-Core, up to 4.7 GHz 16 GB Storage 512GB Flash Operating System Windows 10 Enterprise 10.1” LED-backlight, high-brightness (800 nits) capacitive touch screen Display...
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USER MANUAL Appendix 1: Trackit Solo Specifications Networking & Wireless 1000Mbps Ethernet Wi-Fi 802.11ax; 2.4GHz/ 5GHz dual band WLAN LTE / 4G Model Inseego MC800 QUALCOMM® SDX20 Chipset LTE CAT 18, 480 Mbps LTE Max Throughput Technology Bands B1/B2/B3/B4/B5/B7/B12/B13/B14/B17/B18/B20/B28/B29/B30/B66 HSPA+/UMTS: B1/B2/B4/B5/B8 4FF (Nano SIM) FCC (US), ISED (CAN), CE (EU), RCM (AUS), RSM (NZ), PTCRB;...
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USER MANUAL Appendix 1: Trackit Solo Specifications Classification No patient-applied parts, no accessible Degree of protection against electrical shock: metalwork Type of protection against electrical shock: Class II device Degree of protection against harmful ingress of water: Ordinary (no protection).
Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Trackit Solo, including cables specified by Lifelines Ltd. Otherwise, degradation of the performance of this equipment could result.
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USER MANUAL Appendix 2: EMC Compliance For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
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