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S A F E T Y / R E G U L A T O R Y / L E G A L

Chapter 7: Safety, Regulatory and Legal

Approvals and Coverage

Overview

The CITE Solution is used by caregivers to better understand their patients needs. As with any technology,
those active participants are subject to exposure, regulations and legality. Phrazer/Kitsune is designed with
that in mind, providing safe operation, adhering to U.S. Food and Drug Administration (FDA) guidelines
and featuring characteristics that reduce the likelihood of litigation, the spread of disease, and improve
patient and staff experience. This chapter defines safety, regulatory and legal matters that have been taken
into consideration with the design of Phrazer/Kitsune. This includes information about alerts and warnings,
customer support, replacing parts or devices, patent notices, copyright and trademark notices, servicing,
third party devices and certifications (domestic and international).

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Содержание Phrazer Kitsune

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Страница 2: ... ITS DOCUMENTATION EVEN IF GEACOM INC OR GEACOM CANADA INC HAVE BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGE GEACOM INC AND GEACOM CANADA INC SPECIFICALLY DISCLAIM ANY WARRANTIES INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITYAND FITNESS FOR A PARTICULAR PURPOSE OUTSIDE OF THOSE IN THE LICENSE AGREEMENT THE HARDWARE SOFTWARE AND ACCOMPANYING DOCUMENTATION IF ANY PROVIDED H...

Страница 3: ... With an Existing Caregiver 16 3 4 Creating a New Caregiver Profile Username Password 17 3 5 Caregiver Home Screen 20 3 6 Settings Menu 21 3 6 1 Bluetooth Menu 22 3 6 2 WiFi Menu 23 3 6 3 Connecting to a WiFi Network 23 3 7 CITE Tools Resources 24 3 7 1 Staff Competencies 25 3 7 2 Screen Mirroring 25 3 8 Patients Menu 26 Chapter 4 Phrazer Kitsune Operation 27 4 1 Creating a Patient 28 4 2 Pulling ...

Страница 4: ...Audio 42 5 4 Discovering Patient Language via Interactive CITE Map 42 5 5 Timeout Function 45 5 6 Returning to the Caregiver User Interface 45 Chapter 6 Maintaining CITE Solutions 46 6 1 Cleaning 47 6 2 Charging Phrazer 47 6 3 Charging Kitsune 48 6 4 Swapping Batteries 48 6 5 Updating an Existing Product Software 49 Chapter 7 Safety Regulatory and Legal 51 7 1 Alerts and Warnings 52 7 2 Customer S...

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Страница 6: ...th Phrazer Kitsune now and into the future Our support services are available to you 24 7 and support specialists are ready to assist as needed For less urgent matters our website and Help Center provide you with the opportunity to comment review new features open support tickets and to post questions When used properly the CITE System provides you with legal and regulatory compliance improved acc...

Страница 7: ...s use one of the contact methods provided on the following page to get in touch with GeaCom s Support Specialists 1 2 Icon Keys The Icon Key identifies functional text found throughout this User Guide WARNING This text identifies information that if not followed explicitly could result in injury or death Warnings are mandatory instructions Caution This text identifies information that if not follo...

Страница 8: ... LED screen may be improved by reducing room lighting 1 4 General Contact Information For general inquires please visit our website www myphrazer com or contact us at GeaCom Inc 394 South Lake Avenue Suite 700 Duluth MN 55802 Phone 1 855 5GEACOM Email info geacom net 1 5 Support Contact Information For Customer Support please phone or email Phone US 218 213 9156 Canada 604 248 4461 Email support g...

Страница 9: ...G E T T I N G S T A R T E D W I T H P H R A Z E R K I T S U N E 4 This page intentionally left blank ...

Страница 10: ...aff with relevant actionable information through the patented Multi path Realtime Messaging MRM feature Phrazer Kitsune uses a unique combination of state of the art technology and validated Communication and Information Theory based designs and practices to accurately and timely engage the patient while providing comfort and reassurance If you are already familiar with the basics of operating Phr...

Страница 11: ... I T H P H R A Z E R K I T S U N E 2 1The CITE System One Phrazer Unit Two Handle Batteries One Crypto Key One Patient Kitsune One Caregiver Kitsune Accessories Power Supply Screen Cleaning Cloth 6 Patient Kitsune Caregiver Kitsune ...

Страница 12: ...des capturing the patient s spoken concerns and consent for treatment Camera Next to the microphone is a 13 megapixel camera and video recorder This camera is used to scan badges insurance cards credit cards capture images of the patient wounds area s of incident and to record consent to treat and more Swappable Handle Batteries Hot swappable batteries can be removed and replaced while Phrazer is ...

Страница 13: ...ger Port On the back side of Phrazer located at the bottom is an opening for the charge cord This opening is protected by a cover that can be pulled back to expose the slot for inserting the charger Serial Number Just above the charger port is a serial number There is a unique number assigned to each device This number is used for Customer Support device management and other manufacturing processe...

Страница 14: ...onnectors make contact with the pogo contacts on battery pack to provide power Pogo Contacts These are the connections on the battery that contact the pogo board Spring Plungers These provide pressure on the lock blade keeping the battery locked into place Index This is used as a guide to insert the battery properly into the handle WARNING Do not get this interior region wet as it could cause the ...

Страница 15: ...Patient Kitsune Kitsune is a wireless audio device that a patient can wear for private interactions Kitsune can also be converted to group mode by rotating the ear cups outward to provide a speaker experience For more detailed information on enhanced private ambient input for private authority interactions or other functionality please refer to the Kitsune User Guide Crypto Key The triangular key ...

Страница 16: ...view This chapter contains procedures regarding Phrazer Kitsune setup including the pairing process WiFi and data connection screen brightness volume adjustment Phrazer updating and Electronic Medical Record EMR connection Also in this chapter are procedures regarding the Phrazer caregiver interface e g creating or selecting a caregiver 11 ...

Страница 17: ...f Phrazer the On Off Switch is located on the right side roughly in line with the LED on top of Phrazer and the printed blue line 3 To turn on Phrazer a When looking at the back of Phrazer place the magnetic end of Crypto Key below the LED and drag the Crypto Key straight down to the bottom of Phrazer Note When the boot sequence is successfully triggered the green LEDs on Phrazer flicker and the s...

Страница 18: ... I Option 1 a From the caregiver home screen tap the caregiver image and select Logout b Phrazer will prompt whether you want to log out or shut down Select Shutdown and then Accept Note Phrazer will automatically turn off if left unplugged for a long enough period to fully drain the batteries 13 ...

Страница 19: ...e Crypto Key across the On Off switch or perform a press and hold by keeping the Crypto Key within the active range of the On Off switch for three or more seconds a Hold the Crypto Key over the On Off switch for 3 seconds to activate the display pop up to power down Phrazer b Select Power off Note Powering off with the Crypto Key alone can be performed from any screen 14 ...

Страница 20: ...across the LED on the right ear cup to turn ON you should see a solid blue light followed by a flashing blue light b From the flashing blue light slowly swipe the Crypto Key across the LED again LED should flash between red and blue Kitsune is now in pairing mode lasting for 10 seconds If Kitsune reverts back to the flashing only blue another swipe with the Crypto Key will get Kitsune back into pa...

Страница 21: ... login screen This is the custom login pattern your facility selected 2 After the facility login has been correctly entered the second tier of the login is displayed 3 From the caregiver login screen scan your QR code or barcode to pull up your profile or select desired profile and enter the username and password or enter the unique passcode that was created for the profile selected 16 OR ...

Страница 22: ...er an administrator must log into their profile first 1 From the caregiver home screen select CITE Tools Resources in the bottom left hand corner 2 Select Staff Profile Mgmt then Create Caregiver 3 Enter required text fields 4 Create a unique username and password or passcode and press Continue Note If using the passcode system the created passcode must consist of a minimum of four of the nine sel...

Страница 23: ...the sorting filter to display caregivers from A Z Z A or tap Most Recent to display caregivers in order of who most recently logged into Phrazer By default Phrazer will sort caregivers by who most recently logged into Phrazer 2 Search for specific names by selecting the search bar text box Search functionality is available by first letter of the name a first or last name only or a full name 3 When...

Страница 24: ...to connect with your system admin if you want to make a change to your profile to ensure it gets updated on all Phrazers 1 From the caregiver home screen tap the user ID badge 2 Select Edit and then select personal information should this be Personal Information 3 Select and edit the information 4 Press Save Exit 19 ...

Страница 25: ...n brightness battery life and network connections available on Phrazer CITE Tools Resources This pop out menu includes the Interactive CITE Map Phrazer Kitsune Training materials and value proposition clips screen mirroring language tools staff competency CITE Engagements and additional caregiver features Date Time This displays a visual representation of the current date and time Patients Menu Th...

Страница 26: ...ndicator of Phrazer s WiFi signal strength When this icon is selected the user can connect with new WiFi networks or modify existing networks Right Left and Internal Battery Charge Status These indicators display the level of remaining power in the two handle batteries and the internal battery Brightness Control This slider bar allows the user to drag right or left to increase or decrease the inte...

Страница 27: ...connected to either audio stream patient or caregiver Name Identifies the headset e g Kitsune or Caregiver Kitsune Test Audio Once selected you will hear audio playing though the Kitsune to verify it is connected to the correct audio source To stop the test audio prematurely back out of the Bluetooth settings Connection Status This area shows the current state of the Kitsunes that are in range of ...

Страница 28: ...Available Wireless Networks This area shows all the available networks within range of Phrazer Security Type Icon This icon shows if the wireless network has any security features or not 3 6 3 Connecting to a WiFi Network 1 Press the WiFi Connection icon in the Settings Menu 2 Ensure WiFi is ON If ON is not green press the ON icon located on top of the WiFi Menu 3 Select the desired network and en...

Страница 29: ... Kitsune best practices and uses You must have a connected Bluetooth Caregiver Kitsune to use Language Services This provides access to additional language services like Google Translate or access language vendors such as Language Line CyraCom and many more Staff Profile Management Allows your system admin to modify add or remove staff profiles Screen Mirroring This allows you to project Phrazer s...

Страница 30: ...e icons below e g 72 Hour Hold 3 7 2 Screen Mirroring Note Make sure that the device you want to cast to has the capabilities to receive and is connected to the correct network 1 From the home screen select the CITE Tools Resources tab Lower Left 2 Select Screen Mirroring 3 Phrazer will scan for devices that are on the same network and populate in the menu 4 Select the desired device to begin cast...

Страница 31: ...irst or last name or a full name Sort By This sorting filter can display patients from A Z Z A or tap Most Recent to display the patients who were most recently viewed on the device By default Phrazer will order patients who were most recently viewed first Patients These are individuals who have profiles currently loaded on Phrazer Caregivers can select from this list to view profiles and begin CI...

Страница 32: ...ement Overview This chapter contains procedures regarding the primary caregiver interface This includes creating a patient running CITE Engagements for new and existing patients and reviewing past CITE Engagements Phrazer Kitsune is a Journey Solution that empowers patients to actively progress their care through CITE Engagements 27 ...

Страница 33: ...N E 4 1 Creating a Patient 1 From the caregiver home screen select the Patients Menu icon on the lower right side of the screen 2 Select Create New Patient Is what they select Create Patient or Create New Patient This is also in the reference guide at the end 28 ...

Страница 34: ...tient s information or run additional CITE Engagements b If CITE Map is selected the patient will work through the Interactive CITE Map to identify their native language and culture When the caregiver logs back in a pop up notifies the caregiver of the selected language country and provides the opportunity to begin on boarding the patient in their native language using the on boarding CITE Engagem...

Страница 35: ...es and Transfers ADT Feed labeled ADT Feed 2 Find the patient that needs to be pulled to Phrazer and select the box left of the name and then press Pull Note It may be necessary to use the search function to locate a particular patient You can search using the first letters of the name first or last name only or full name Caution Do not push or pull profile information unless connected to a secure...

Страница 36: ...the caregiver home screen select the Patients Menu icon on the lower right side of the screen 2 Select desired patient from the list Note It may be necessary to use the search function to locate a particular patient You can search using the first letters of the name first or last name only or full name 31 ...

Страница 37: ...G E T T I N G S T A R T E D W I T H P H R A Z E R K I T S U N E 4 4 Patient Home 32 ...

Страница 38: ...tient information Patient Information Tap this icon to display patient s information e g name gender DOB Medications Tap this icon to display the current list of medications Previous Engagement Tap this icon to display all CITE Eengagements completed by the patient Notes Tap this icon to display notes on the selected patient Emergency Contact Tap this icon to display the current patient s emergenc...

Страница 39: ...ements Saved Playlist When a series of CITE Engagements are saved as a playlist it is displayed in this area Exit The user can press this to leave the active patient profile and return to the caregiver home screen Save Playlist Caregivers can save a series of CITE Engagements as a custom playlist Enter the desired CITE Engagements in the CITE Engagement Playlist Slots and press this icon to save a...

Страница 40: ...et of CITE Engagements consistently you can save that set as a custom CITE Engagement To save it as a list simply press hold and select a number for each CITE Engagement until the desired CITE Engagement playlist is achieved and tap the yellow Save star in the bottom right hand corner Name the list when prompted and select the yellow Save star again You will now find the saved playlist in the save...

Страница 41: ...o modify answers once the CITE Engagement is completed You do need signatures from the patient provider to confirm the modifications Print This allows you to print patient summaries Upload This allows you to transfer a patient s information in multiple ways Depending on how your deployment is set up it can be tied to the EMR Resume This allows you to resume the CITE Engagement where the patient le...

Страница 42: ...he CITE Engagement their summary will be automatically printed 1 From the patient home screen select the CITE Engagement you want to print 2 Review the summary to ensure it s the correct CITE Engagement then select the Print icon Phrazer will then either automatically print to the designated printer or you will be prompted with a print review pop up Note When successfully printed you will see a sm...

Страница 43: ...w the summary to ensure it s the correct CITE Engagement then select the Upload icon Note Phrazer will then begin transmission once the upload icon is selected You will see a confirmation icon next to the CITE Engagement summary that was pushed when complete 4 14 Getting Started with the Patient Entertainment Portal and Services PEPS 1 From the main login screen tap the icon on the top left corner...

Страница 44: ...n to create a PEPS user profile 3 Explore the PEPS home screen after the profile was created 4 Navigate by selecting the preferred icon and if you need to go back press the Back button located at the top left corner of the screen 5 If you have additional question about using PEPS please reference the PEPS information sheets 39 ...

Страница 45: ...ngwithaPatient Transitioning Phrazer Kitsune Overview This chapter serves as a guide to the caregiver including Phrazer Kitsune introduction to a patient LED feedback caregiver audio timeout function and the return of Phrazer Kitsune to the caregiver 40 ...

Страница 46: ...Journey Solution and accompanies the patient through each step of the care process The first and most critical step in this process is proper introduction of Phrazer Kitsune to a patient Phrazer Kitsune s physical shape is designed to elicit trust and connection with the caregiver by handing the device to the patient one side at a time Prior to transitioning Phrazer Kitsune to Patient 1 Ensure tha...

Страница 47: ...ted pain or concern on or near left anterior upper chest process adherence guidance shared in real time or when initiated to play when the listener is ready for information through MRM pathways 5 4 Discovering Patient Language via Interactive CITE Map If unable to assess the patient s native language or if assistance selecting their specific region for cultural cues is required use the Interactive...

Страница 48: ... subregion selection and in this example tapping NorthernAfrica will bring up the following map The countries that make up the region are indicated by the country s flag and an icon that represents a specific part of the country s culture or regional characteristics Note For this example the patient is Egyptian 43 ...

Страница 49: ... to its iconic representation within Egypt s ancient history The country s flag and geographic shape are represented next to the cultural icon providing three identifiable images related to the selected country 5 Select to display in English the top ten indigenous spoken languages in Egypt 6 Select to display in the native language the top ten indigenous spoken languages in Egypt This will assist ...

Страница 50: ...ing the patient where an on screen caregiver will speak in the patient s native language 5 5Timeout Function If at any time during a patient interaction there is no activity for five minutes an engagement informs the patient that if they do not interact with Phrazer Kitsune they will be locked out of this interaction and a caregiver will have to initiate the interaction again If the patient contin...

Страница 51: ...ution s durable construction will provide you with many years of service However to ensure peak performance precautions must be taken for maintenance and care This chapter contains instructions and information regarding maintenance This includes cleaning charging swapping batteries and additional management 46 ...

Страница 52: ...lowed to dry before the next use Caution General use of diluted bleach isopropyl ethanol and soap and water are approved cleaning solvents Stronger solvents such as acetone should not be used to clean Phrazer Kitsune If you have questions regarding approved cleaning products contact Customer Support Caution Do not submerge or pour liquids onto Phrazer or Kitsune Note Ensure Phrazer handles and tou...

Страница 53: ...t 2 Connect one end of micro USB power cord to the power outlet 3 Connect the micro USB connector to Kitsune Note When done properly the LED on Kitsune will slowly pulse red 6 4 Swapping Batteries Note It is easiest to replace handle batteries when Phrazer is placed display down and handles up in the air 48 ...

Страница 54: ... body of Phrazer If index is pointed away from the body of Phrazer the battery will not engage 4 Verify it has engaged by lightly pulling on blue end of the handle 6 5 Updating an Existing Product Software Note Updating Phrazer is an automatic process coordinated thought your system admin Note Phrazer checks for new updates at the facility s established update time If an update is available a remi...

Страница 55: ...S A F E T Y R E G U L A T O R Y L E G A L 50 This page intentionally left blank ...

Страница 56: ...ration adhering to U S Food and Drug Administration FDA guidelines and featuring characteristics that reduce the likelihood of litigation the spread of disease and improve patient and staff experience This chapter defines safety regulatory and legal matters that have been taken into consideration with the design of Phrazer Kitsune This includes information about alerts and warnings customer suppor...

Страница 57: ...select Phrazer 101 in the upper left hand corner on the caregiver home screen You can access a searchable and up to date version of this User Guide for both Phrazer and Kitsune under this section as well Phone GeaCom Inc provides Phrazer Kitsune Customer Support via Phone at US 218 213 9156 Canada 604 248 4461 Online Online Phrazer Kitsune Customer Support is available through the website at https...

Страница 58: ...ce is limited in time to the duration of this warranty This warranty is applicable only if Phrazer Kitsune is purchased directly or from an authorized distributor This warranty is invalid if the factory applied serial number has been altered or removed from the Device 7 4Third Party Devices Phrazer Kitsune is capable of connecting with and gathering data from a variety of third party devices that ...

Страница 59: ...mits for a Class A digital device pursuant to part 15 of FCC rules This device 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 Phrazer Spirit Model No SUP U4ARF1 FCC ID 2AB95 SUP U4ARF1 Responsible party contact Grant Sims System Administrator Project Engineer GeaCom Inc S...

Страница 60: ...ely exclusively on the information from Phrazer Kitsune as an alternative to medical examinations and expertise from a doctor or other professional healthcare provider If you think your patient may be suffering from any urgent medical condition you should forego use of Phrazer Kitsune and provide immediate medical attention 4 Limiting GeaCom Inc s and GeaCom Canada Inc s liability Nothing in this ...

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Страница 62: ...D down to bottom TURN ON PHRAZER TURN OFF PHRAZER Two Options Step 1 Tap the caregiver image select Logout and select Shutdown Step 2 Tap Accept and wait for Phrazer to shutdown 1 2 Step 1 Hold the Crypto Key over the spot indicated below until you see the Power Off pop up on Phrazer Step 2 Tap Power Off OPTION 1 OPTION 2 performed from any screen ...

Страница 63: ...LED two times LED should be flashing red blue Step 2 Tap Kitsune to Phrazer to Pair Step 3 Select Audio Stream Step 4 Wait for LED to Turn Blue Step 5 Select Settings Tab Step 6 Select Bluetooth Step 7 Verify Patient is Green Step 8 Test the Connection HOW TO PAIR CONNECT KITSUNE ...

Страница 64: ...Step 2 Caregiver Login Step 3 Select Patient Tab Step 4 Create New Patient Step 5 Select Step Process Step 6 Enter Information Step 7 Confirm Entered Information Step 8 On boarding Complete Tap and hold HOW TO ON BOARD A PATIENT ...

Страница 65: ...2 Caregiver Login Step 3 Select Patient Tab Step 4 Pull New Patient with ADT Step 5 Select Patient to Pull Step 6 Pull Patient Step 7 Verify Patient Populated Step 8 Select Patient to Begin Tap and hold SELECTING A SCHEDULED PATIENT ...

Страница 66: ...iver Login Step 5 Tap the Play Button Step 1 Facility Login Step 6 Tap and HOLD Engagement Step 7 Tap Play and Hand to Patient HOW TO RUN A CITE ENGAGEMENT Step 3 Select Patient Tab Tap and hold Step 4 Select a Patient ...

Страница 67: ...ait for Confirmation Step 5 View Summary Step 1 Facility Login Step 2 Caregiver Login Step 7 Review Select Print Icon HOW TO PRINT A SUMMARY Step 6 Print Summary Step 3 Select Patient Step 4 Select CITE Engagement ...

Страница 68: ... and Handoff Step 7 Select Engagement s Step 5 Select Patient Step 6 Tap the Play Button Step 1 Exit Patient Engagement HOW TO START NEW ENGAGEMENTS Step 2 Facility Login X2 Step 3 Caregiver Login Step 4 Select Exit Icon ...

Страница 69: ...pairing mode swipe Crypto Key 2X across LED tapping to Phrazer and connecting to patient audio stream Step 5 Test audio to confirm connection Step 6 If not resolved email call Customer Support Phrazer Unresponsive Step 1 Turn Phrazer off hold Crypto Key over On Off switch on the back of Phrazer for 3 seconds Step 2 Select Power Off Step 3 Wait 5 seconds Step 4 Turn Phrazer on Step 5 If not resolve...

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