10 Prescription Device ........... 12 11 Product Support ..........13 Part II Product Overview 1 Falcon HST main unit device ......17 2 Falcon HST Cradle ..........19 3 Suggested Falcon HST Consumables ....20 4 Profusion PSG application ........ 21 Part III Using the Falcon HST 1 Before use ............
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6 Information screen ..........54 7 Configuration screens ........57 8 Waveform display ..........65 9 Attaching the Falcon HST ......... 66 10 Go to sleep ............73 11 Manually / Automatic Power off the unit ... 74 12 Wake ..............79 13 Study Setup and Converting ......
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Contents Falcon HST User Manual New Study setup ........155 Upload a Study ........... 163 Upload a manually started Study ....166 EXG Channel Labeling (Cloud ............................169 Control Centre) ............................175 Settings Docked Mode "Cloud" ..........176 EXG Channel Labeling (Cloud Mode) ....... 178 Pairing the Falcon .............
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Contents Falcon HST User Manual 1 Regulatory compliance ........234 2 Transport and Storage conditions ....234 3 Operating Conditions ........235 4 Power Supply ..........235 5 Wireless Interface ........... 236 6 Functional Oxygen Saturation ......236 7 Heart Rate ............236 8 Sleeping position ..........
Falcon HST User Manual Before You Begin Before You Begin The Falcon HST User Guide contains the necessary information for the proper use of the Falcon HST device and its application. WARNING Read this manual. Please familiarise yourself with the contents of the manual before using the device.
Falcon HST User Manual Before You Begin Limited Warranty Compumedics Limited warrants each new device to be free from defects in workmanship and materials under normal use and service for twelve (12) months from the date of shipment. Compumedics’ sole...
Falcon HST User Manual Before You Begin Intended Use The Falcon HST is intended for use in the recording, displaying, analysis, printing, and storage of human biological parameters such as brain, heart and muscle activity, eye movement, breathing and body movements.
Falcon HST User Manual Before You Begin Labelling Definitions Where you see this symbol, it means “WARNING” or “CAUTION”. Failure to follow operating instructions could put the patient or operator at risk. Where you see this symbol on any device label it means “RF electromagnetic energy emitted for diagnosis or treatment”.
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Falcon HST User Manual Before You Begin This symbol indicates the Humidity limits within which the package can be kept and handled This symbol indicates the Pressure limits within which the package can be kept and handled This symbol indicates the manufacturer of this medical device.
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Falcon HST User Manual Before You Begin This symbol indicates the authorize representative in the European Community. This symbol indicates the degree of protection provided by an enclosure. In this case the first ‘2’ means that the IP22 protection against solid objects of dimension more than 12.5mm and the...
Failure to comply may result in skin burns. Do not use the Falcon HST with HF surgical equipment. Do not use the Falcon HST with a defibrillator. Discontinue the use if any skin irritation, pain, burning...
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Use only a Power Adapter and Charging Cable that meets the specifications outlined in the specifications section in this document with the Falcon HST to recharge the unit, and not to open the assembly. Use of the Falcon HST adjacent to or...
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WARNING Do not immerse in fluid or run fluid over the Falcon HST. Do not use Falcon HST if the label is off. Do not use Falcon HST if the plastic enclosure is broken. Do not replace or remove the battery from Falcon HST.
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Falcon HST User Manual Before You Begin Do not use the Falcon HST if it appears or is suspected to be damaged. Do not repair, open or modify the Falcon HST. Do not use the Falcon HST if the internal parts have been exposed to liquids.
The Falcon HST is not provided sterile. The Falcon HST is designed for performing sleep studies. The typical operating time of such studies is less than 10 hours, and the Falcon HST device is designed to provide recording duration in excess of this time.
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Falcon HST User Manual Before You Begin The version of software, hardware and operating system being used. A description of what happened and what you were doing when the problem occurred. The exact wording of any messages that appeared on your screen.
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Fax: 09599 Freiberg, +49 3731 2596 553 Germany Compumedics E-Mail Address Compumedics can also be contacted by sending e mail via the Internet. This will be most beneficial to international users. The Compumedics e-mail address is: support@compumedics.com.au Compumedics Home page...
The Falcon HST consists of four components that the user can interact with. Falcon HST main unit device This is the actual Falcon HST device that does the recording of the data which represents your sleep signals. Figure 1 - Falcon HST main unit device...
Falcon HST Cradle The Falcon HST cradle. The Falcon HST cradle is used to charge the Falcon HST device as well as provide access to a PC via a USB connection for downloading the data recorded. The cradle has a...
Falcon HST User Manual Product Overview Suggested Falcon HST Consumables The Falcon HST device can use various sensors to record the signals from the patient. These are readily available from the industry and can either be disposable single-use or reusable sensors.
Cloud Control Centre 1.0.0 onwards and Cloud Services), is used to convert the acquired data from the Falcon HST as well as set up the device for recording. The Profusion Sleep Control Centre, Nexus 360 Control Centre and Cloud Control Centre communicates with the Falcon HST via a USB interface.
Falcon HST User Manual Using the Falcon HST Using the Falcon HST The Falcon HST is designed to be used under the direction of a sleep physician. If a study is ordered the Falcon HST will either be setup in the sleep laboratory...
Falcon HST User Manual Using the Falcon HST Before use Before using the Falcon HST, you need to make sure the device is charged. You can check that the unit has been charged by observing the battery status ICON on the main screen. If the ICON is Solid GREEN, then the battery is charged.
Falcon HST User Manual Using the Falcon HST 3.1.1 Home Screen Layout The Falcon HST Home Screen gives a user access to: - · Start a manual recording. · View the various signal waveforms. · Access to the unit's setup information menu.
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Falcon HST User Manual Using the Falcon HST Figure 3b - Falcon HST main screen See Figure 3b for the Falcon HST main screen Undocked displaying: - · Battery remaining level icon - Shows a graphical indication of the Falcon's internal battery level: - Ø...
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Falcon HST User Manual Using the Falcon HST Figure 3c - Falcon HST main screen See Figure 3c for the Falcon HST main screen Undocked displaying: - · Scheduled Study information - Shows the scheduled study start Date, Start time and the study duration.
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Using the Falcon HST Figure 3e - Falcon HST main screen Figure 3f - Falcon HST main screen See Figure 3f for the Falcon HST main screen Undocked displaying: - · Oximter finger probe Status: - Ø Green - Attached.
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Falcon HST User Manual Using the Falcon HST Figure 3g - Falcon HST main screen See Figure 3g for the Falcon HST main screen Undocked displaying: - · Electrode Status: - Ø Green - Attached. Ø Orange - Unattached. ·...
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Falcon HST User Manual Using the Falcon HST Docked unit layout (USB mode) Figure 3h - Falcon HST main screen See Figure 3h for the Falcon HST main screen Docked displaying: - · Battery remaining level icon - Shows a graphical indication of the Falcon's internal battery level: - Ø...
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Falcon HST User Manual Using the Falcon HST Docked unit layout (Cloud mode) Figure 3i - Falcon HST main screen See Figure 3i for the Falcon HST main screen Docked displaying: - · Patient's Name: - Ø When a scheduled study is initially download - Patient name is display while docked.
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Falcon HST User Manual Using the Falcon HST Figure 3j - Falcon HST main screen See Figure ji for the Falcon HST main screen Docked displaying: - · Downloaded scheduled study confirmation screen "X" - Press the "X" icon if the currently displayed patient name and scheduled study is not correct.
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Falcon HST User Manual Using the Falcon HST Figure 3k - Falcon HST main screen See Figure 3k for the Falcon HST main screen Docked displaying: - · Wi-Fi network connection status - When the Wi-Fi icon is GREEN the unit is connected to a valid network.
Your Falcon HST device will come with a Bluetooth oximeter. This is the wristOx2 from Nonin (Model 3150). When a Falcon HST is unpaired with a BT Oximeter, the icon on the main window shows a ringed button with a question mark (see Figure 4a below).
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Falcon HST User Manual Using the Falcon HST Once paired the BT icon will change from a "Question mark" to a Bluetooth symbol (see Figure 4b below). Figure 4b - Bluetooth symbol showing paired. If the Falcon had previously been paired, you can pair a new device by going through the status menu (via clicking the “i”...
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Falcon HST User Manual Using the Falcon HST Figure 5 - information screen – Note config circles. Figure 6 - drag from the left circle to the right circle, or while pressing the left circle, touch the right circle to unlock the config.
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Falcon HST User Manual Using the Falcon HST Figure 7 - The circles will turn green when unlocked. Figure 8 - Once in the config screen, select Bluetooth. Once you are in the config screen, you select Bluetooth and the right “arrow” to get the Bluetooth configuration screen.
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Falcon HST User Manual Using the Falcon HST Figure 9 - Bluetooth configuration screen Once in the Bluetooth configuration screen, select the scan button to scan for nearby oximeters. The Scan button will change to scanning while the scan is in progress.
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Falcon HST User Manual Using the Falcon HST Once the scanning is complete, it will display any detected oximeters it found along with any devices it already knew about. Figure 11 - list of detected oximeter devices In the Bluetooth config screen, you can highlight the device you want to pair with, note the name and serial number to check it’s the correct device, and then...
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Falcon HST User Manual Using the Falcon HST The connect button text will change to connecting. Figure 12 - Connecting to a device Once the connection is successful, the screen will show the current values from the oximeter. Figure 13 - connected oximeter The oximeter is now paired, and you can return to the main screen by pressing the exit button.
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Falcon HST User Manual Using the Falcon HST Once you have a paired oximeter, the main screen will show either the connected or disconnected state of the oximeter. A connected oximeter finger probe will be displayed as a GREEN finger icon on the graphical hand with the Bluetooth icon WITH "radiated"...
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Falcon HST User Manual Using the Falcon HST With a paired oximeter but unconnected finger probe, the main screen will show the graphical hand as a ORANGE finger icon and the Bluetooth icon WITHOUT the "radiated" waves. Figure 15 - Main screen showing disconnected oximeter.
Falcon HST User Manual Using the Falcon HST Manually Start/Stop a recording If the study was not already programmed, or you want to start it early or do a small study to check the signals, it is possible to start it manually. It would be best to connect all the desired signals and put on the oximeter.
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Falcon HST User Manual Using the Falcon HST The screen has a round button with a triangle in it. Press this button to enter Manual Record Mode. Figure 16 - Idle screen with the start record near the bottom left.
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Falcon HST User Manual Using the Falcon HST Once you confirm the recording, the Falcon will return to the main screen with an elapsed time animated icon and a stop recording button. The elapsed time also lists the timer at which the...
Falcon HST User Manual Using the Falcon HST Auto start mode If, during the unit's setup, a Scheduled Start time and Duration was programmed, the unit will display the start Date, Time and Duration. This allows you to check if an auto-start time is set and when it will commence.
Falcon HST User Manual Using the Falcon HST Recording indication While the falcon is recording, the elapsed time icon will be animated and appear to rotate. Next to the animated time icon, the elapsed time will be displayed. Below the Elapsed time is the study end time - "Stopping at ..".
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Falcon HST User Manual Using the Falcon HST Manually started recording will display a "STOP" icon at the bottom of the screen. To end the recording prior to internal storage capacity being reached, press the "STOP" icon. If the "STOP" icon is NOT pressed...
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Falcon HST User Manual Using the Falcon HST For Scheduled start/end recordings the unit will end the recording at the displayed time and power down. Figure 19b - Recording time icon and remainder display If the Bluetooth icon is NOT radiating this indicates that the Bluetooth is not receiving data from the oximeter.
Falcon HST User Manual Using the Falcon HST Information screen The Falcon HST can display various information. Press the “I” icon on the Home screen to access the information menu. The Information menu can be accessed either with the unit docked or undocked.
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Falcon HST User Manual Using the Falcon HST Figure 22c - Information screen To navigate to the information screen, use the arrows on the right side of the screen. To access the configuration options, use the two circles at the bottom of the screen.
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Falcon HST User Manual Using the Falcon HST · Wrist Oximeter's MAC address. · Oximter's status. · Scheduled study details - Single or Multi-Night. · Last Scheduled study start date and time. · Last Scheduled study duration. · Falcon's serial number.
Falcon HST User Manual Using the Falcon HST Configuration screens The configuration screen is used to setup the Falcon for: - Mode of Operation - USB or Cloud. Set Date and Time - Date and time setting are normally done via the various attached platforms, (Profusion Control Centre, Nexus 360 Control Centre, Cloud Control Centre and Cloud mode).
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Falcon HST User Manual Using the Falcon HST To enter the Configuration menu: - · Press the "i" icon on the home screen. Two circles will appear at the bottom of the screen. · Press and hold the LEFT circle and touch the RIGHT or press, hold and slide the LEFT circle to the RIGHT circle.
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Falcon HST User Manual Using the Falcon HST Figure 6 - drag from the left circle to the right circle, or while pressing the left circle, touch the right circle to unlock the config. Figure 7 - Rright circle & Left circles change to GREEN.
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Falcon HST User Manual Using the Falcon HST The configuration screen that can be accessed from the Information screen allows for setting various configurations such as the date and time in the unit, managing the Bluetooth connections and configuration of the Wi-Fi capability.
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Falcon HST User Manual Using the Falcon HST Docked Mode Docked Mode allows the Falcon's functional operation when Docked. Figure 25a - Docked Mode. Docked Mode USB - allows the Falcon when docked to be connected to a workstation via a USB...
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Falcon HST User Manual Using the Falcon HST To enter USB mode highlight the "Docked Mode" menu and press the right hand arrow to list "USB". Pressing the right hand arrow will toggle the "Docked Mode" selection between USB, CLOUD and USB+WIFI.
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Falcon HST User Manual Using the Falcon HST Docked Mode CLOUD - allows the Falcon when docked to be connected to a Wi-Fi access point for programming the device for scheduled studies, setting date and time, uploading acquired studies, (Cloud Services operation) and for setting the EXG channel labels.
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Falcon HST User Manual Using the Falcon HST Docked Mode USB+WIFI - allows the Falcon when docked to be connected to a a workstation via a USB cable for programming the device for scheduled studies, setting date and time, uploading acquired...
Falcon HST User Manual Using the Falcon HST Waveform display To see the waveforms and test their quality, you can select the waveform icon from the main screen. Figure 26 – Select the icon for the waveform screen. This will then display a series of waveform screens, which you can step through by selecting Next or Exit if desired.
Attaching the Falcon HST First, attach the electrode and sensor cables to the unit. NOTE: Please follow the Falcon HST setup video for the order and placement of the various electrodes and sensors used. Two cables are attached to the top and bottom snap connectors on the rear of the Falcon unit.
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Falcon HST User Manual Using the Falcon HST One cable, either disposable or reusable, attaches to the top two studs on the rear of the Falcon device. This is for the ECG electrodes. Figure 29 – suggested disposable ECG Electrode cable.
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Falcon HST User Manual Using the Falcon HST Once the cables are attached, the unit should look like Figure 32 and Figure 33 below. (Suggested ECG and lower effort belt disposable cables shown). Figure 31 - Rear of Falcon with cables attached.
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Falcon HST User Manual Using the Falcon HST Now that the suggested cables are attached, you can attach either a disposable or reusable industry supplied effort belts. The effort belts are mounted on the Falcon unit, with the upper belt mounting on the studs on the remaining rear of the unit and the lower belt mounting on the lower belt cable.
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Falcon HST User Manual Using the Falcon HST Once the unit is mounted on the belts, the belt length can be adjusted using the industry supplied belt adjustment clip and or adjustment methods as detailed on the supplied sensor. Figure 34 -Industry suggested disposable Belt adjustment clip or similar.
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Falcon HST User Manual Using the Falcon HST If electrodes are being used, then they should be placed in the desired locations on the. We recommend the ECG leads be attached to ECG sticky dot electrodes placed on the left and right clavicles, although other ECG lead placements are suitable alternatives.
3.10 Go to sleep Now you can just go to sleep as normal. Note that even if you are aware of the Falcon HST, you will soon forget and sleep normally. In "Scheduled Start Recording Mode" the unit is programmed to automatically commence recording along with automatically stopping recording in the morning.
Falcon HST User Manual Using the Falcon HST 3.11 Manually / Automatic Power off the unit If the unit has been manually powered on, it can be either manually or automatically powered off. If the unit is left idle, it will automatically power off after a preset time, approximately 2 minutes.
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Falcon HST User Manual Using the Falcon HST If the Power Button is pressed, the unit will display, after 3 seconds, “Please Release Button to Power Off or Continue to hold to rest”. Releasing the power button while this screen is displayed will power down the unit.
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Falcon HST User Manual Using the Falcon HST The unit can also be manually powered off through the configuration screen. To access the configuration screen, use the two circles at the bottom. To unlock and enter the configuration screen, follow these steps.
Falcon HST User Manual Using the Falcon HST 3.12 Wake When you wake up you should remove the sensors and dispose of the appropriately. See the instructions in the Falcon Quick Start Guide - AJ886, section "When you Wake". The unit is programmed to automatically stop...
Falcon HST User Manual Using the Falcon HST 3.13 Study Setup and Converting The Falcon HST unit records the data to its internal storage drive. When the Falcon Unit has "Dock Mode" set to "USB", the unit uses eitherProfusion Control Centre...
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When the unit is docked, the icon to start a study is disabled, ("Docked Mode - USB) or display "Enter Study Key", ("Docked Mode - Cloud). While it is docked, the Falcon HST will automatically charge from the docking station. It will also show a message warning, ("Docked Mode...
Falcon HST User Manual Using the Falcon HST 3.13.1 Docked Mode "USB" Docked Mode allows the Falcon's functional operation when Docked. To enter "Docked Mode" see the section on "Configuration screens ". Figure 25a - Docked Mode. Docked Mode USB - allows the Falcon when...
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Falcon HST User Manual Using the Falcon HST To enter USB mode highlight the "Docked Mode" menu and press the right hand arrow to list "USB". Pressing the right hand arrow will toggle the "Docked Mode" selection between USB, CLOUD and USB+WIFI.
Falcon HST User Manual Using the Falcon HST 3.13.1.1 Profusion Control Centre The computer should be running the Profusion PSG software suite or have at least Profusion Control Centre installed. For correct Falcon support you should have profusion sleep version 5.1 build 691 or later.
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Falcon HST User Manual Using the Falcon HST Figure 52 - Data card setup entries. Select the “Data Card Drive” corresponding to the attached Falcon’s USB Drive from the drop-down list. Enter the Patient’s reference, Last name and first name.
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Falcon HST User Manual Using the Falcon HST Figure 53 - Data card setup Manual/Auto record and AUX Channel selection. The AUX Channel is defaulted to EMG – Chin EMG as the preferred input. “Un-Check” Manual recording to enable scheduled start recording time and duration.
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Falcon HST User Manual Using the Falcon HST Figure 54 - Data card setup completed Once all information is entered, press “Setup” at the bottom of the window. A message indicating the information was successfully transferred to the Falcon unit and a confirmation to “Unmount media and Close”...
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Falcon HST User Manual Using the Falcon HST Data Card Convert Once a study has been recorded and the unit returned, you can select Data Card Convert to convert the recorded study for review. This will display the data conversion dialogue.
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Falcon HST User Manual Using the Falcon HST When the Falcon HST is placed on the dock cradle, it automatically enables the USB and will appear at the drive location. When the Falcon HST device is detected, the card converter utility will read the data and fill in the relevant information in the dialogue.
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Falcon HST User Manual Using the Falcon HST or the study sessions dialogue to see a list of studies and select the correct one for conversion. Figure 58 - Study sessions on the card The study session dialogue lists all sessions on the Falcon’s media storage.
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Falcon HST User Manual Using the Falcon HST Figure 59 - Convert Once the selected session has been chosen and all relevant information entered, press the “Convert” button at the bottom of the dialogue window. A convert progress bar will be shown when the “Convert”...
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Falcon HST User Manual Using the Falcon HST 3.13.1.1.1 System Setup Prior to using the application to setup. convert and run the conversion analysis, elements of Profusion Control Centre need to be setup. These are required to system set the Falcon's date and time, the Falcon's internal storage management and to enable conversion analysis to be performed.
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Falcon HST User Manual Using the Falcon HST In the General Options dialogue, you should go to the bottom and select Falcon Options. Falcon Options allows management of the Falcon’s media storage, selection to perform analysis during the conversion process and the settings to enable the Falcon’s date and time settings to be synchronised...
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Falcon HST User Manual Using the Falcon HST Figure 48 – Falcon HST Management “Session Clean-up Options” will delete those studies that have been converted on a “First in, first out” basis when the threshold entered has been reached. “After Data Card Conversion”, when enabled, will perform automatic analysis on the converted study.
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Falcon HST User Manual Using the Falcon HST Figure 49 – Windows Device Manager To find the “COM” port the attached Falcon is using, open Windows Device Manager, expand the “Ports (COM & LPT)” entry on the list, see what is displayed and note the “USB Serial Device (COMX)”...
NOTE - It's important that the input labels used in the Input Assignments and analysis sections match the acquired data labeling. Conversion Files section The Falcon HST device gets its EXG (High-Speed) channel names assigned during setup. The setup can be performed in the: •...
Falcon studies within the Nexus 360 environment. Nexus 360 Control Centre is similar to setting up and converting Falcon HST studies in the Profusion Control Centre. It has its own simplified Control centre – Cloud Control Centre.
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Falcon HST User Manual Using the Falcon HST • The “Docked” home screen should be displayed. • Listing Last study Patient ref number. • Number of converted studies. • Date, time and duration of the last scheduled study. • Should also display: •...
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Falcon HST User Manual Using the Falcon HST When selecting "New" a "Study Details" screen is displayed and the relevant patient information needs to be entered. Once completed, select "Ok", at the bottom of the screen top exit this windows.
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Falcon HST User Manual Using the Falcon HST If a "Manual" recording is to be conducted, "Check" the "Manual recording" option. If a "Scheduled" recording is to be conducted, "UNCheck" the "Manual recording" option, select the study start time, the study start date and the "Check"...
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Falcon HST User Manual Using the Falcon HST A list of Falcon study sessions will be listed. The last study session will be at the bottom of the list The Study sessions list will show the study data, time, duration and if it has been converted or not.
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Falcon HST User Manual Using the Falcon HST The Convert Data Card screen will be populated with the study/patient information. If the patient information needs to be changed, it can be done in the "Lower" section of the screen. A new patient can be entered by selecting "New" in the lower section.
NOTE - It's important that the input labels used in the Input Assignments and analysis sections match the acquired data labeling. Conversion Files section The Falcon HST device gets its EXG (High-Speed) channel names assigned during setup. The setup can be performed in the: •...
Cloud Control Centre is a web based application for setting and converting/uploading Falcon studies. Cloud Services (USB) is similar to setting up and converting Falcon HST studies in the Profusion Control Centre. It has its own simplified Control centre – Cloud Control Centre.
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Falcon HST User Manual Using the Falcon HST • The “Docked” home screen should be displayed. • Listing Last study Patient ref number. • Number of converted studies. • Date, time and duration of the last scheduled study. • Should also display: •...
Falcon HST User Manual Using the Falcon HST 3.13.1.3.1 Provider's USB Portal This section looks at what the "Home Care Provider's" aspect of scheduling appointments for "Cloud Services" within Nexus 360. Prov ider’s Portal • Cloud Control Center short-cut can be added to the Nexus 360 Home Page.
Falcon HST User Manual Using the Falcon HST 3.13.1.3.1.1 Services Attributes - USB Before a "Study Key" can be generated during the "Appointments" section, provisions within the selected "Services" need to be made to accommodate this facility. 1. Select “Manage – Organisation Settings –...
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Falcon HST User Manual Using the Falcon HST This will open the selected Services Attribute. In the Service Attribute is the facility to enable the "Study Time Zone". Select “Edit" against the required attribute to be changed or add a new attribute as detailed below, see STUDY_TIMEZONE.
Falcon HST User Manual Using the Falcon HST 3.13.1.3.1.2 Scheduling a USB Study Studies can be scheduled to be an automatic start/stop, manually start with a fixed duration or manually start with a manually stop. Scheduled studies are done within Nexus 360's Appointment section.
Falcon HST User Manual Using the Falcon HST 3.13.1.3.2 Customer's USB Portal This section looks at what the Pharmacy's aspect of using "Cloud Control Centre". Customer’s Portal • In the Browser, enter the Cloud Control Centre’s URL to enter the Cloud Control Centre’s web page.
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Falcon HST User Manual Using the Falcon HST Time at Study Time Zone. • If the Falcon device date and time are not synced to the Cloud Control Centre, it must be updated. • Use Windows “Device Manager” to check the COM port used when the Falcon is connected to the computer.
Falcon HST User Manual Using the Falcon HST 3.13.1.3.2.2 Scheduled USB Studies Scheduled studies are done by the Provider and will appear in the Cloud Control Centre "Study Setup" screen.. Scheduled Studies • A list of scheduled studies is displayed.
Falcon HST User Manual Using the Falcon HST 3.13.1.3.2.3 New Study setup If a new study is required to be done and is not in the "Study Setup" list it can be created by the following procedure: -. New Study •...
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Falcon HST User Manual Using the Falcon HST If a new Patient is required to be entered, follow the procedure below: - • New Patients can be entered by selection Enter the patient's information into the "Add New Patient" window.
Falcon HST User Manual Using the Falcon HST 3.13.1.3.2.4 Upload a Study Acquired studies will be automatically uploaded when the Falcon is docked powered on and connected to the workstation running the Cloud Control Centre application.. Upload. • Select “Please select the device path”.
Falcon HST User Manual Using the Falcon HST 3.13.1.3.2.5 Upload a manually started Study In the event of a study needing to be performed prior to setting up or using a scheduled entry, a manual start study can be done using the manual start/stop process on the Falcon.
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Falcon HST User Manual Using the Falcon HST The following will lead you through the process when dealing with an Anonymous study to enable it to be uploaded and registered on Nexus 360. • Select the “Anonymous Patient”. • Fill in the:- •...
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Falcon HST User Manual Using the Falcon HST Docked Mode CLOUD - allows the Falcon when docked to be connected to a Wi-Fi access point for programming the device for scheduled studies, setting date and time, uploading acquired studies, (Cloud Services operation) and for setting the EXG channel labels.
Falcon HST User Manual Using the Falcon HST 3.13.2.2 Pairing the Falcon The Falcon requires "Pairing" with it's respective Nexus 360 server in order to communicate to setup/schedule studies and to upload =acquired studies. In order to do this a "Pairing Service" has been established to enable a device to be allocated a "Pairing Pin"...
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Falcon HST User Manual Using the Falcon HST Pairing Pin (Adding dev ice into Nexus 360) • Dock Falcon HST – Powered. • Once wi-fi is connected, the wi-fi icon turns GREEN. • The “Pairing Pin” screen will be displayed.
Falcon HST User Manual Using the Falcon HST 3.13.2.3 Setting up Wi-Fi To use the Falcon in "Cloud" mode, it needs have access to a local Wi-Fi access network point which has internet capability. • Dock the unit and power it on.
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Falcon HST User Manual Using the Falcon HST • Enter the SSID password. • Toggle the keyboard by pressing the Green key adjacent to “Caps” for numbers and special characters. • Pressing an entry key will cycle through the corresponding characters every 1 second.
Falcon HST User Manual Using the Falcon HST 3.13.2.4 Provider's Wi-Fi Portal This section looks at what the "Home Care Provider's" aspect of scheduling appointments for "Cloud Services" within Nexus 360. It is believed that when used via a "Home Care Provider"...
Falcon HST User Manual Using the Falcon HST 3.13.2.4.1 Services Attributes - Wi-Fi Before a "Study Key" can be generated during the "Appointments" section, provisions within the selected "Services" need to be made to accommodate this facility. 1. Select “Manage – Organisation Settings –...
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Falcon HST User Manual Using the Falcon HST This will open the selected Services Attribute. Select “Edit" against the required attribute to be changed or add a new attribute as detailed below, see REGISTRATION_MODE. Change the “Value” entry to PinCode and press “Save”.
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Falcon HST User Manual Using the Falcon HST Also in the Service Attribute is the facility to enable the "Study Time Zone". Select “Edit" against the required attribute to be changed or add a new attribute as detailed below, see STUDY_TIMEZONE.
Falcon HST User Manual Using the Falcon HST 3.13.2.4.2 Scheduling a Wi-Fi Study Studies can be scheduled to be an automatic start/stop, manually start with a fixed duration or manually start with a manually stop. Prov ider’s Portal Study Key •...
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Falcon HST User Manual Using the Falcon HST • In Nexus 360 – Appointments screen. • Select the “Study Key” icon against the scheduled study. • This displays the “Study Setup Key” to be entered into the "Study Key" screen on the Falcon.
Falcon HST User Manual Using the Falcon HST 3.13.2.5 Customter's Wi-Fi Portal This section looks at what the Pharmacy's aspect of using "Cloud - Wi-Fi". Customer’s Portal The Falcon unit will automatically update its real time clock when it has established Wi-Fi communications locally.
Falcon HST User Manual Using the Falcon HST 3.13.2.5.1 Scheduled Studies - Wi-Fi Study Key Scheduling of a study is done by the provider, see Provider's Wi-Fi Portal A study Key is provided to the customer, (pharmacy), which is supplied via means of a printed sheet or email.
Falcon HST User Manual Using the Falcon HST The procedure of entering the Study Key is as follows: - Customer’s Portal Study Key • The unit will enter the “Enter Study Key” screen. • While docked, the unit will stay in this screen unit once it is removed from the dock or a Study Key is entered.
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Falcon HST User Manual Using the Falcon HST • Press the " " icon on the screen to confirm that the correct patient name has been entered or press the "X" icon to go back to enter a different Study Key.
Falcon HST User Manual Using the Falcon HST 3.13.2.5.2 Uploading a Wi-Fi study Acquired studies that have not been uploaded/converted on the Falcon will be automatically uploaded when the unit is docked and powered on within the location of its listed Wi-Fi, (SSID), access point.
Service and Maintenance Cleaning instruction WARNING This is an electrical device. Confirm that the Falcon HST is not charging or turned on. Symbols or specific instruction etched on the instruments should be strictly followed. Preparation for cleaning: Remove the charging cable that is attached to the device.
Depending on the duty cycle of usage the Falcon HST battery may need replacing on a periodic basis. This should not be less than annual. Technical information such as diagrams and parts list...
Falcon HST User Manual Service and Maintenance Disposal As the Falcon HST device does not store any patient data or information, there are no cybersecurity concerns with regards to its disposal. Since it constitutes electronic waste; however, it should be disposed of in a socially responsible manner that is also conforming to local laws and regulations.
Falcon HST User Manual Service and Maintenance Firmware Update Firmware updates can be performed "In-Field". Firmware updates provide bug fixes as well as new feature implementation for the device. Two files will be used to upgrade the device's firmware - (Checksum.bin & Root.wic).
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During the firmware upgrade process the Falcon will give feedback that a new firmware has been detected and is in the process of programming. • Off the dock – Power the Falcon HST. • The splash screen will show New Firmware and update automatically.
Falcon HST User Manual Service and Maintenance Conversion Files Conversion files are used by the various converters to set the converted output into a customers expected presentation for scoring and reviewing as well as assign the users input channel labeling and the input assignments required for analysis processing.
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Falcon HST User Manual Service and Maintenance • Unsure Events can be enabled/disabled for display and reporting by selecting “YES/NO”. • Ensure the "Input Assignments" and the "Automatic Analysis" settings are as required. Change if necessary. • NOTE - It's important that the input labels used in the Input Assignments and analysis sections match the acquired data labeling.
Falcon HST before use on a patient. Any of the sensors must not be used outside of their expiration date. These sensors do not contact each other during use based on their different intended anatomical locations.
Falcon HST User Manual Specifications Specifications Regulatory compliance Type: Class II equipment Applied parts: Type BF Degree of protection: IP22 Degree of safety: Equipment not suitable for use in the presence of a FLAMMABLE ANAESTHETIC MIXTURE WITH AIR or with...
Falcon HST User Manual Specifications Operating Conditions Temperature range: 0°C (+32°F) to 45°C (+104°F) Humidity: 10 to 95% RH (non- condensing) Atmospheric 54 kPa to 106 kPa pressure: Altitude: Less than 3,000 m Power Supply Internal Power 3.7 VDC Lithium Battery...
Falcon HST User Manual Specifications Wireless Interface Type: Bluetooth Low Energy (BLE) Transmit Power: < -6.0 dBm Frequency band: 2402.0 to 2483.5 MHz FCC ID: 2AT9S8040-0001 Functional Oxygen Saturation For specifications on the oximeter please refer to the manufacturer’s documentation...
Falcon HST User Manual Specifications 6.12 EXG Channels Number: 4 differentials Type: Applied parts. 4 Channels with two electrode connectors. Connection: Industry standard touch proof connectors with a combination of single touch proof, two pin touch proof and snap electrodes.
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Falcon HST User Manual Specifications ECG Usage When used to measure ECG the Falcon HST does not provide heart rate calculations or pause determination. There is no ST segment test function. ECG usage is for visual signal acquisition only as an...
Falcon HST User Manual Specifications 6.13 Environmental Protection WEEE 2002/96/EC is a European Directive that requires the proper disposal of electrical and electronic equipment. These devices should be disposed of separately, not as unsorted municipal waste. To dispose of your device, you should use appropriate collection, reuse, and recycling systems available in your region.
Falcon HST User Manual Specifications 6.14 Cybersecurity controls for Intended Use Environment Falcon device doesn’t contain patient information. The data in the form of stored physiological data is not patient identifying. Which this data is stored in secure manner, physical access of device should be maintained.
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 Falcon HST, including cables specified manufacturer.
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Falcon HST User Manual Specifications Use of associated consumables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and results in improper operation. CAUTION...
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Falcon HST User Manual Specifications 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.
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Falcon HST User Manual Specifications Guidance and manufacture’s declaration – electromagnetic emission The device is intended for use in the electromagnetic environment specified below . The customer of the user of the device should assure that it is used in such an environment.
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Guidance and manufacture’s declaration – electromagnetic immunity The device is intended for use in the electromagnetic environment specified below . The customer or the user of COMPUMEDICS should assure that it is used in such an environment. Electrom agnetic IEC 60601...
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Falcon HST User Manual Specifications Voltage dips, >95% dip in >95% dip in Mains pow er quality short should be that of a interruptions and typical commercial or voltage variations for 1 cycle for 1 cycle hospital environment. If on pow er supply...
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Falcon HST User Manual Specifications Guidance and m anufacture’s declaration – electrom agnetic im m unity The device is intended for use in the electromagnetic environment specified below . The customer or the user of the device should assure that it is used in such an environment.
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Falcon HST User Manual Specifications Where P is the maximum output pow er rating of the transmitter in w atts according transmitter manufacturer and d is the recommended separation distance in Radiated 3 V/m metres (m). 80 MHz Field strengths...
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Falcon HST User Manual Specifications NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
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Specifications Recom m ended separation distances betw een portable and m obile RF com m unications equipm ent and the Falcon HST. The device is intended for use in an electromagnetic environment in w hich radiated RF disturbances are controlled. The customer or the...
Falcon HST User Manual Troubleshooting Troubleshooting If you experience a problem with your device, you should first following troubleshooting suggestions. If the problem cannot be solved, please contact your supplier or Compumedics. Problem Possible Cause Solution Falcon HST is Faulty USB...
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Falcon HST User Manual Troubleshooting Invalid time is Falcon HST Check the time clock is not displayed on the shown on the correctly set Falcon HST and report adjust as necessary If a new Nonin Placing the Remove the Nonin Wrist wrist strap.
Falcon HST User Manual Troubleshooting Troubleshooting Nonin Wrist Oximeter If the Nonin Wrist Oximeter screen shows a "Blank" screen it means that the oximeter probe is not connected or the oximeter batteries need replacing. Check that the oximeter probe is on the finger correctly or replace the oximeter batteries.
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Falcon HST User Manual Troubleshooting If the Nonin Wrist Oximeter screen shows a "circle with a diagonal line" above the "heart" symbol it means that the oximeter probe is misaligned and should be adjusted. If the Nonin Wrist Oximeter screen shows a "radiating Bluetooth"...
Falcon HST User Manual Troubleshooting Troubleshooting USB Cables Before you start Prove that the dock works with a known USB-C to C cable on a known PC with a known Falcon device. Once the USB-C to C works, confirm that any USBA to C cable you intend to use also works.
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Falcon HST User Manual Troubleshooting If this does not happen: - try the other ports - check the USB drivers for the controllers in the PC are up to date - check that the ports have not been disabled by whatever...
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Falcon HST User Manual Troubleshooting Once the set-up is complete, ensure all the connection points shown on the display screen is turned into green colour from orange. Check SpO2 connectivity and ensure the battery is full on the SpO2 device.
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Falcon HST User Manual Troubleshooting Ensure correct set-up time and date is entered in when setting up the device via Profusion Control Centre, Nexus360 control centre or Cloud Control Center. Once configured, safely eject device drive before undocking. Once undocked, ensure the patients name, auto-start date and time is displayed on the device.
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Falcon HST User Manual Troubleshooting For more information please contact: Com pum edics Com pum edics Com pum edics Lim ited, Australia: USA, Inc.: Europe Gm bH: Headquarters Petriplatz 5, 30-40 Flockhart Street D-09599 Freiberg, 5015 West WT Harris Abbotsford VIC 3067,...
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