spencer Health Solutions SPN01 Smart in-home Medication Dispenser User Manual Administration of MERPS GSOP UP PF s
HAP Innovations, LLC Smart in-home Medication Dispenser Administration of MERPS GSOP UP PF s
User manual
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| Mirror Download [FCC.gov] | |
| Document ID | 3124202 |
| Application ID | plUih/h1R8fd+QLWZfaZCg== |
| Document Description | User manual |
| Short Term Confidential | No |
| Permanent Confidential | No |
| Supercede | No |
| Document Type | User Manual |
| Display Format | Adobe Acrobat PDF - pdf |
| Filesize | 81.46kB (1018223 bits) |
| Date Submitted | 2016-09-06 00:00:00 |
| Date Available | 2016-09-06 00:00:00 |
| Creation Date | 2016-09-02 15:14:33 |
| Producing Software | Adobe PDF Library 15.0 |
| Document Lastmod | 2016-09-02 15:14:39 |
| Document Title | Administration of MERPS GSOP UP PF Documents |
| Document Creator | Acrobat PDFMaker 15 for Word |
| Document Author: | Kim Porter |
spencer User Manual for spencer (insert copyright materials) spencer This device is pending compliance with Part 15 of the FCC Rules and with Industry Canada licence-exempt RSS standard(s). Operation is subject to the following three conditions: (1) this device may not cause harmful interference, (2) this device must accept any interference received, including interference that may cause undesired operation, and (3) Changes or modifications made to this equipment not expressly approved by HAP Innovations, LLC may void the FCC authorization to operate this equipment. Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts de licence. L'exploitation est autorisée aux trois conditions suivantes: (1) l'appareil ne doit pas produire de brouillage, et (2) l'utilisateur de l'appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage est susceptible d'en compromettre le fonctionnement. (3) Les changements ou modifications apportées à cet équipement non expressément approuvée par HAP Innovations, LLC peuvent annuler l'autorisation FCC d'utiliser cet équipement. This device has a single port, a USB port, in the back, adjacent to where the power cord is attached. The spencer device does not come with any accessories that can be connected. However, it will have Bluetooth functionality. The device has a rechargeable battery that is not removable. If the battery is in use due to no electrical power, the system continues to dispense medication until the battery charge is exhausted. Since the battery is not removable, there are no user instructions for maintenance, other than to check the battery periodically to ensure it is working. In case of an extended emergency that causes the battery charge to run out, the lid to the device opens automatically, enabling the end user to remove necessary medications. spencer Table of Contents Getting Started .............................................................................................................................. 4 Overview of spencer ........................................................................................................................................... 4 Important safety information ............................................................................................................................... 4 Support ............................................................................................................................................................... 5 Features .............................................................................................................................................................. 5 Prerequisites ....................................................................................................................................................... 6 spencer terms/components ................................................................................................................................ 6 Screens and Navigation ..................................................................................................................................... 8 Touch Screen ..................................................................................................................................................... 8 Navigation ........................................................................................................................................................... 8 Setting Up .................................................................................................................................... 11 Loading the Refill ........................................................................................................................ 12 Dispensing Your Medications (Meds) ........................................................................................ 14 Normal Dispense .............................................................................................................................................. 14 Late Dispense ................................................................................................................................................... 17 Missed Dispense .............................................................................................................................................. 17 Meds and Readings..................................................................................................................... 19 Meds on the Go ................................................................................................................................................ 19 Your Schedule .................................................................................................................................................. 21 See Your Pills ................................................................................................................................................... 22 Readings ........................................................................................................................................................... 23 Blood Sugar ...................................................................................................................................................... 23 Settings & Help............................................................................................................................ 24 Contact Pharmacist .......................................................................................................................................... 24 Video Tutorials .................................................................................................................................................. 24 Help .................................................................................................................................................................. 25 Replace Refill .................................................................................................................................................... 25 Shutdown .......................................................................................................................................................... 27 Version .............................................................................................................................................................. 27 Alert Volume ..................................................................................................................................................... 28 Child Lock ......................................................................................................................................................... 28 Set Child Lock ................................................................................................................................................... 28 Set Security PIN ............................................................................................................................................... 29 Error messages ........................................................................................................................... 31 Add error here .............................................................................................................................................................31 Add error here .............................................................................................................................................................31 spencer Getting Started Overview of spencer An in-home medication dispenser, spencer is a new way to connect you with your pharmacist and care teams to help you stay on track with your medication and health goals. It makes taking multiple medications simple. A working health hub, spencer records your adherence to your medication regimen and provides this information to your caregiver and pharmacist. Spencer also enables you and your pharmacist to communicate about your health. The pharmacist can leave reminders, and you can let the pharmacist know your progress or concerns. Important safety information • Place spencer in an indoor living area, on a hard, dry, flat surface. • Do not place spencer on a radiator or other heated surface. • Do not plug spencer into an electrical outlet that is controlled by a wall switch, as someone could accidentally switch off the power. • To reduce the risk of electrical shock or fire, do not place spencer in or near water or other liquids. • Do not spray cleaners directly onto spencer because moisture could get inside and cause damage. Wipe with a dry or slightly damp cloth; do not use harsh cleaners. • spencer has a rechargeable battery that is not removable. If the battery is in use due to no electrical power, the system continues to dispense medication until the battery charge is exhausted. spencer A green light in the top right corner of the front face flashes to indicate that battery power is on. Support When spencer directs you to call your pharmacist for medication-related questions or issues, the pharmacy number is provided on spencer’s screen. Touch Settings & Help > Contact Pharmacist. For help with the device itself, call the HAP Innovations support number: xxx-xxxxxxx. Features Need pictures here. Check what is available in this release. Feature Description Refills containing medication pouches Spooled specifically for you by your pharmacist Usability Large, easy-to-read font; clear, to-the-point instructions; colors that indicate certain statuses Design Sleek design that fits on countertop Dispense reminders • Alert tone with adjustable volume; sound intensifies for missed dose • Flashing light that increases in frequency Easy to load into spencer spencer Feature Description for missed dose • Change in screen color from blue (normal) to amber (late) to red (missed). Secure data storage for each user1 Records of your spencer transactions and communications with care team and pharmacy; these are encrypted so that they are secure and only visible to designated individuals. Training Videos Short videos explaining how to use spencer. Touching Settings & Help > Video Tutorials displays a list of the different videos. (See “Video Tutorials” section.) Meds to Go Option that lets you dispense medications for specific dates and times that you are going to be away from spencer. Child Lock Option to lock the system for anyone who does not know the personal identification number (PIN) or password. You set the password. Note: Your personal information is put into code form (“encrypted”) to limit who can see it. The information is protected and adheres to the Federal Health Insurance Portability and Accountability Act (HIPAA). Prerequisites Signing up on the HAP Web site (onboarding). Obtaining spencer and refill(s). Training spencer terms/components Component Description Barcodes Small box-shaped patterns of varying black lines that can be read by a computer. Individual pill pouches and refill covers have barcodes to identify end user and medication specifics. Brake Small metal wire in the lower right of refill that holds the strip in place when needed. Cloud When the end user is onboarded, the relevant identifying and medical information is encrypted and sent to the Cloud, where it will be stored securely and accessed only according to HIPAA specifications. The Cloud in turn sends the necessary information for pouches and refill barcodes to be generated for the end user. spencer Component Description Dispense Index The sequential position of each pouch within a single dispense window. For example, 1 of 3, 2 of 3, 3 of 3, 1 of 1, etc.. End User For the purpose of this document, the person registered to receive medications from the spencer dispensing device. HIPAA Health Insurance Portability and Accountability Act; Federal law requiring security and privacy for an individual’s health information. Lid Door-like panel at the top of the spencer device that opens and closes for inserting, securing, and removing the refill. Menu List of options on the touch screen. Examples are Meds to Go and Settings & Help. Mouth The slot (located beneath the touch screens for both spencer and the spooler) where the pouches are delivered to the end user. Pouch Plastic package containing pills and identifying information as produced by the packaging system. Parata Adherence Strip System (PASS)/ Strip Packager A type of pill-packaging device that fills pouches with the end user’s individual doses of medications; also sends clinical data for the end user and medications to the HAP Cloud. Portal Web pages containing essential information about spencer’s end users, each user’s transactions within spencer, pharmacies in the spencer network, etc; the information is subject to HIPAA privacy specifications. Pouch/Packet Plastic package containing medications and identifying information as produced by a strip packaging system. Refill The device on which the medication pouches are spooled. This device fits inside a cover, which in turn fits inside spencer. Refill Cover HAP Innovations design for the spooler’s housing. The cover is made of cardboard, so it is lightweight and easy to assemble, carry, and insert into spencer. A barcode on the exterior of the cover contains the essential identifying information for the end user and end user’s medications. Spooler Tool (separate from spencer) that winds the strip, validates strip information, and prints labels. Strip Series of pill pouches attached from end to end and spencer Component Description used for spooling in the spencer Refill. Touch Screen Front display panel that enables you to interact with spencer by touching with your finger. (Touch screens are also used on cell phones and computer tablets.) Screens and Navigation Touch Screen The spencer Touch Screen guides you through the dispensing process and enables you to take action by touching certain buttons on the screen. For example, touching Dispense with your finger tells spencer you are ready to receive your current medications. Touching Help displays a Help menu with instructions on how to use spencer and answers to frequently asked questions (FAQs). If spencer goes to sleep (menu items are not available), just touch the screen to wake spencer and display the home screen. Spencer rotates through various screen savers when it is in idle state. (Give example.) Navigation Number nn Description Home screen Function Displays the date, time, and Main menus (Meds & Readings and Settings & Help). Additionally, • With no refill inserted, says “Ready for Refill” • With refill inserted, shows time of next dose, Box or label at top of screen Shows the screen you are currently on Green button Indicates that the named screen is currently active House icon Takes you to the Home screen Back arrow Takes you to the previous screen 15 Grey button Is not active (function cannot be performed until another one is complete) 10 Blue button Is active (enables you to perform the named function when you touch it) spencer Number Description Function Blue normal-dispense screen Reminds you to take meds during normal dispense time Amber warning screen Warns you that your dispense time is almost past Red missed-meds screen Warns that you have missed your medications Sample error screen Tells you of system error and provides some means of help Help button Opens screen that explains how to get your medications or otherwise correct an error Need new screens and new numbering. Colors, Buttons, and Icons spencer Colors, Buttons, and Icons spencer Colors, Buttons, and Icons Note: Error Messages are explained in the Error messages section of this manual. To see “wrong user” Errors – wrong user (pouch and barcode don’t match – or just say no when asked How does a user shut spencer down if something is going wrong? Setting Up 1. Take spencer out of the carrying case. 2. Set it on a flat, dry surface. 3. Plug it in. It automatically powers on. (Do not turn on using the power button.) An internal cellular module automatically connects spencer to a cellular network. The Welcome screen is displayed, giving you the option to watch a tutorial video or go to the Home screen. spencer 4. To watch the instructional video, touch Play. See the “Video Tutorials” section. 5. To go to the home screen, touch the Home icon. See or go to ?xxxxx. Does this take you home of to the Hi, I’m Spencer. I’m here to help …. Loading the Refill 1. Align the front of the refill with the front of spencer. (The barcode and mouth are on the front at the bottom. Also, check for the blue arrows.) 2. Insert the refill into spencer, ensuring it is seated securely. 3. Gently close the lid until it “catches” and finishes closing itself. A spencer greeting is displayed. • This section totally is guess work and needs attention. If this is the first time you have used spencer: Message?? User confirmation? spencer Should be lower case Spencer xxxxxxx xxxx xxxxx xxxxx xxxx • If this is for a new refill but you have used spencer before: Message?? • If this is to re-start a refill that was interrupted for some reason: Message?? spencer xxxxxxx xxxx xxxxx Dispensing Your Medications (Meds) Normal Dispense When the dispense time arrives, a blue screen is displayed to tell you it’s time for your medications, the dispense button blinks, and an alert is played. spencer 4. Touch Dispense. A screen similar to the following is displayed. The blue status bar tells you the status of the dispense. Note: you should not touch the pouch until it is ready. When ready, spencer displays a screen similar to the following. The mouth flashes blue to let you know the meds are ready. spencer The screen below shows that 1 pouch out of 4 is ready. The number of pouches will vary per end user and per dispense schedule. 5. Remove the pouch or pouches of medications from the mouth. Any reminders, questions, or other messages from your pharmacist may be displayed at the end of a dispense time. An example is shown below: 6. If the message requires a response, touch the appropriate button on the screen. In this example, touch OK. spencer Late Dispense If the normal reminder goes unnoticed for a period of time, an amber screen is displayed to tell you that limited time is left to take your medications; the dispense button blinks, and a louder alert is played. 1. To dispense your meds, follow the steps above under “Normal Dispense,” starting with step 4. Missed Dispense If the late dispense reminder expires, a red screen is displayed to tell you that you have missed 1 or more doses. The light flashes red. A screen similar to the following is displayed when you have missed a dose (or doses). A screen similar to the following is displayed to tell you when you have missed a dose (or doses) AND that your next dose is now due. spencer 1. Touch Dispense or Dispense Missed Doses to dispense all missed doses. A screen similar to the following is displayed. Replace screen below with newer red one. 2. Touch OK and contact your healthcare professional as needed. spencer Meds and Readings 1. On the home screen, touch Meds & Readings. The Meds & Readings screen is displayed, showing the following menu options. These are explained in detail in the subsections below. Menu Option Description Meds on the Go Enables you to dispense meds to take with you for a time period that you define. Your Schedule Shows past and upcoming dispense times. See Your Pills Displays pictures of your pills with their names and dosage. Readings Lets you view graphs tracking your blood sugar, weight, adherence to your meds schedule, and other health information entered in spencer. Meds on the Go 1. On the Meds & Readings screen, touch Meds on the Go. spencer The Meds on the Go screen is displayed. The default number of doses to dispense is 1. The maximum is based on the number of doses you have left in your refill. 2. Touch More or Less to change to the number of doses you want. A message is displayed below the number asking you to confirm the date and time for the last to-go dose. (The first to-go dose is the next one on your schedule.) 3. Touch No if the date and time are not correct and Yes if they are. 4. (a) If you touch No, you are returned to the Meds & Readings screen. (b) If you touch Yes, the Confirm Dates screen is displayed. The Dispense button flashes. spencer 5. Review the dates and times to be sure they are accurate. 6. (a) If accurate, touch Dispense. The doses are dispensed and recorded with spencer as being “manual.” (b) If not accurate, touch the back arrow and adjust the dates and times on the Meds to Go screen. (For instructions on adjusting dates and times, start with step 2 in this section, “Meds on the Go.”) Optionally, touch the Home icon to return to the Home screen. Your Schedule 1. On the Meds & Readings screen, touch Your Schedule. The Your Schedule screen is displayed, showing the history of previous dispenses and the schedule for pending dispenses. spencer 2. Touch the Newer and Older arrows to see the schedule for today in ascending or descending order, respectively. You can also scroll by moving your finger up and down on the screen (“swiping”). Note: Today means xxxxx. See Your Pills 1. On the Meds & Readings screen, touch See your Pills. The See your Pills screen is displayed, providing the names and strengths of your meds. Pictures and/or descriptions are also provided. spencer 2. Use the Up arrows to scroll the screen up and the Down arrows to scroll down. You can also scroll by moving your finger up and down on the screen (“swiping”). Note In this example, the Up arrow button is grey, indicating that the button is not active (i.e., Synthroid is the top of the list). You can scroll down but not up. Readings 1. On the Meds & Readings screen, touch Readings. The Readings screen is displayed, showing the following menu option. These are explained in detail in the subsections below. Menu Option Blood Sugar Blood Sugar Description Which will be on this release? spencer Settings & Help 1. On the home screen, touch Settings & Help. The Settings & Help screen is displayed, showing the following menu options. These are explained in detail in the subsections below. Menu Option Description Contact Pharmacist Displays contact information for your pharmacy. Video Tutorials Enables you to view videos explaining how to use spencer. What is status of these? Help Provides help/instructions for replacing the refill and shutting spencer down. Also gives information about the hardware and software versions for your particular spencer. Alert Volume Enables you to set the volume for spencer – for alerts and other audio features. Child Lock Provides guidance in setting up a Personal Identification Number (PIN) or password so that you can restrict spencer access. This feature is optional. Contact Pharmacist 1. On the Settings & Help screen, touch Contact Pharmacist. The Contact Pharmacist screen is displayed, showing pharmacy name, contact information, and hours of operation. Video Tutorials 1. On the Settings & Help screen, touch Video Tutorials. Need screen for this. (Not greeting screen with tutorials, but the one you access via settings & Help) 1. Touch the volume control button on the right to increase the volume. 2. Touch the volume control button on the left to decrease the volume. spencer 3. Touch Play to display the menu for video selection. The refresh button is grey (inactive) until you start playing a video. It then becomes blue (active) so you can rewind the video to view again. Help 1. On the Settings & Help screen, touch Help. The Help screen is displayed, showing the following menu options. These are explained in detail in the subsections below. Menu Option Description Replace Refill Provides instructions for replacing the refill. Shutdown Provides instructions to shut spencer down. Version Shows the software and hardware versions and spencer’s serial number. Replace Refill Add steps for removing child lock where applicable. 1. On the Help screen, touch Replace Refill. The Replace Refill screen is displayed. spencer 2. Touch Unlock Lid. A confirmation screen is displayed. Are you sure you want to replace the refill? 3. (a) If yes, touch Yes and go to the next step. (b) If no, touch Cancel to go back to the confirmation screen or touch the Home icon to go the Home screen. Skip steps 4 and 5. If Child Lock is on, a screen is displayed asking for your security PIN. 4. Enter your 4-digit PIN and touch Unlock. (If Child Lock is off, skip this step.) spencer If you chose Yes, the Ready for Refill screen is displayed, and the spencer lid is opened slightly. Go to step 4. If you chose Cancel, the xxx page is displayed. (returns you to the confirmation screen and not to home page) 5. To replace the refill (meaning you touched Yes in the previous step), open the lid, remove the current refill, and insert the new refill. Shutdown See if child lock interferes with this. 1. On the Help screen, touch Shutdown. A confirmation screen is displayed. 2. Touch Shutdown to power down the spencer device or Cancel if you do not want to power down. If you chose Shutdown, spencer is turned off. If you chose Cancel, the xxx screen is displayed. Version 1. On the Help screen, touch Version. The Version screen is displayed, showing the • Versions for software, hardware, and firmware • Serial number for your spencer and its Internet Protocol (IP) address • WiFi Network to which your spencer is attached. spencer 2. Touch Refresh to update the screen, in case any changes have been made recently. Alert Volume 1. On the Settings & Help screen, touch Alert Volume. Child Lock Walk through this again. 1. On the Settings & Help screen, touch Child Lock. The Child Lock screen is displayed, showing the following menu options. These are explained in detail in the subsections below. Menu Option Description Turn On Child Lock/ Turn Off Child Lock Provides instructions for turning Child Lock off or on, depending on the current setting. Set Security PIN Provides instructions to enter a new PIN or change an existing PIN. Set Child Lock If you need to set or change a PIN, see the “Set Security PIN” section. 1. On the Child Lock screen, touch Turn On Child Lock or Turn Off Child Lock. spencer The appropriate screen is displayed (depending on your choice). 2. Enter your 4-digit PIN number and touch Unlock or Lock (depending on your choice). Note: When Child Lock is ON, you must enter your PIN to dispense medicines, replace refill, or turn Child Lock off. Set Security PIN 1. If you want to change the existing Security Personal Identification Number (PIN) or add a PIN for the first time, touch Set Security PIN. The Set Security PIN screen is displayed, asking you to enter your existing PIN and/or enter a new one. 2. If you are changing your existing password, enter the existing 4-digit password and touch Enter. If you are entering a brand new password, skip this step. 3. In the Set Security PIN screen, touch the 4 numbers on the screen for your new PIN and touch Set PIN. 4. Touch Set PIN. Another screen is displayed, asking you to confirm the new PIN. spencer 5. Touch the PIN numbers again and touch Enter. A screen is displayed showing the new, confirmed PIN and reminding you to write it somewhere. 6. Write the number on a notepad, spreadsheet, etc., and store it somewhere secure. 7. Touch Return. You are returned to the Settings & Help screen. The Home screen displays a note that dispensing is locked. spencer Error messages Add error here Add error here The blah, blah A pouch barcode has scanned that is not in the list from the Cloud. The pouch may have been spooled already but not cancelled.
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