Objective. Wearable. Fast and simple. Real-Time. Non-Invasive. Disposable Sensors. Multi-Species - PainTrace
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PainTrace® • PainTrace® is a pain biosignal that in conjunction with veterinary, or healthcare diagnosis, aids in the identification and measurement of pain. • The device can interpret the electrical signals produced by nerves, transmit this data via Bluetooth and quantify pain level in a real-time graph format of PainTrace® VS Time. • Ongoing data analysis and optimization will continually improve PainTrace®. Thank you for your support.
PainTrace® iPad Tips Screenshot: → Simultaneously press the power button and home button of the iPad. Screen Recording: → Touch and drag your finger diagonally from the upper right corner of the iPad screen. This will allow you to complete multiple actions quickly including screen recording. Closing / Exiting an App: → Double click the home button, swipe up on the tile associated with the app you want to close / exit. Adjusting Screen Lock Settings: → Settings > Display & Brightness > Auto-Lock 4 Reference: https://support.apple.com/en-ca/guide/ipad/ipad2c09c4d4/ipados
PainTrace® Outline 1. List Of Equipment TRAINING OUTLINE 2. Patient Prep Instructions 3. BioTraceIT App Instructions 4. Annotations 5. Acute Pain, Chronic Pain, And Anticipation / Anxiety 6. Questions
PainTrace® Instructions and Training • Clippers • Alcohol Prep Pads or Skin Prep Alcohol/Gauze • PainTrace® Sensors • PainTrace® Device, must be charged for 3 hours prior to use • Do not use the PainTrace® Device PainTrace® Device while & charging Cable / Leads • Device enabled with Bluetooth • Leads – Cable *Avoid bending or connecting device to kinking cables. sensors – clips or snaps
PainTrace® Instructions and Training • Wearable accessories • Device Pouch • Harness Wearables • Neck Wrap • iPad with BioTraceIT App to provide real-time visualization of PainTrace®. • Remote data viewing BioTraceIT App & iPad
PainTrace® Instructions and Training 1. Identify location for sensor placement and shave hair a. Sensors are placed symmetrically on both sides at the species specific location. b. A 25-50mm square area is shaved (if required). Companion Equine Bovine 2 – 3 finger widths caudal to Over the transverse processes Create an L-shape with your the axilla. With the dog of the second cervical hand aligning the fingertips standing square the sensor vertebrae adjacent to the with the base of the ear will be barely visible at the second cervical spine. and the thumb pointing caudal edge of the elbow. towards the body. Place the sensor in the center of space within the L-shape.
PainTrace® Instructions and Training 1. Identify location for sensor placement Sensor Placement on Humans: o Sensors are placed symmetrically on the left and right hands on the bottom of the hypothenar eminence. o This is located below the pinky finger just above the base of the palm. *For veterinary use and investigational use only.
PAINTRACE - CANINE
PAINTRACE - EQUINE The transverse processes of the second cervical vertebra are located approximately one hand’s width (4 or 5 inches) caudal to the vertical ramus of the mandible and are easily identified by deep palpation of a linear bony structure beneath the cutaneous and brachiocephalicus muscles. For best results, clip the hair from a 1-inch square over the left and right transverse processes of the second cervical vertebra. Figure was adapted from Popesko, P., Atlas of Topographical Anatomy of The Domestic Animals, Volume I, W.B. Saunders Co.
PainTrace® Instructions and Training 2. Prepare skin a. Clean skin with an alcohol prep pad or alcohol and gauze. b. Apply pressure during cleaning remove any oils, debris or dirt on the skin’s surface. *For veterinary use and investigational use only. c. Repeat cleaning with a new alcohol pad or gauze until it is visually clean upon final skin wipes. d. Allow skin time to dry prior to sensor application. NOTE: Skin prep is paramount for success. CANINE EQUINE
PainTrace® Instructions and Training 3. Apply the PainTrace® sensors / electrodes a. Apply the sensors / electrodes symmetrically on both sides. b. Ensure adhesive ring has good contact. c. Press firmly on the metal sensor to promote desired sensor to skin contact. *For veterinary use and investigational use only. CANINE EQUINE
PainTrace® Instructions and Training • It is important to ensure the PainTrace® Sensors, left and right sides, are securely attached to the skin. • We advise use of skin adhesive, such as SkinTac, may further secure the sensor to the skin. Carefully apply a thin layer to the shaved area of skin. NOTE: Before applying the sensors, allow time for the SkinTac to dry and the skin to become tacky. Ingredients: Isopropanol, Rosin *Should not be used on infected skin. 1 3 *MSDS: Liquid = MS407 Wipe = 407W 0 *Use alcohol to remove. B
PainTrace® Instructions and Training 4. Secure PainTrace® device a. Turn on by pressing the white button on the right for ≥ 5 secs. i. LED will glow pink/blue during press ii. LED will pulse green once upon release b. Place PainTrace® Device inside the wearable *For veterinary use and investigational use only. pouch ensuring port for cable is accessible. NOTE: The blue button on the left is for Bluetooth, if you are having connectivity issues press & release this button to re-initiate Bluetooth.
PainTrace® Instructions and Training 5. Connect cable / leads a. Connect the cable adapter to the PainTrace® device. i. Align the icon on the cable adapter to the opening on the device connector. ii. Press firmly to click into place. iii.There will be an audible click and the cable cannot be disconnected *For veterinary use and investigational use only. from the device when pulled assuring proper connection of the cable.
PainTrace® Instructions and Training 6. Connect leads a. Connect end of leads to the affixed sensors. b. The RED lead attaches to the RIGHT sensor. RED IS RIGHT. • Snap Connectors – simply press to snap onto the sensor. • Alligator Clip Connectors – ensure metal is touching metal. *For veterinary use and investigational use only. NOTE: The clip will not engage the sensor unless properly attached. Ensure there is metal on metal contact. CANINE EQUINE
PainTrace® Instructions and Training Optional Vet wrap or Elastikon can be placed over sensors and firmly wrapped twice around to further secure PainTrace® sensors to skin. Ensure the cable is not bunched or coiled under the wrap for the following reasons: o This may damage the cable. o This may irritate the patient’s skin.
BioTraceIT App Open App & Log In Stop View Patients PainTrace® iPad: • Connect to WiFi • Enable Bluetooth Examine & • Set local Date / Time Add or Search Annotate Patients *Please note ongoing development may result in different Start Connect tools available on the PainTrace® Device desktop and iPad apps.* For viewing saved traces, the browser version can be accessed on any device / laptop: dash.biotraceit.com
PainTrace® Instructions and Training Patients – Add a New Patient: On the iPad, Open the BioTraceIT App and Login A. Tap on the View Patients icon or the Patients icon on the side menu. B. Tap on Add New Patient icon. C. Complete patient consent. D. Fill in all mandatory fields and tap Save. (First name, gender, species, department.) NOTE: Add patients in advance to exams either on the iPad or dash.biotraceit.com NOTE: If you would prefer to type in date, format = YYYY-MM-DD.
PainTrace® Instructions and Training Patients – Searching Patients: A. Scroll through patients. B. Use the arrows to navigate through the patient list pages. C. Tap on the filter icon. D. You can filter by any combination of first name, species, gender and organization. E. Tap Reset to change your search. C A D B E
PainTrace® Instructions and Training Traces – Starting a New Trace: A. Open the Patient’s Record, scroll to the bottom and tap Start New Trace. B. In the Traces window, tap New Trace. C. The New Trace window will open with fields for Patient*, Visit Type, Body Region, Weight (kg), Medications and Device*. (* → Mandatory fields) D. Tap Start Trace. A B C
PainTrace® Instructions and Training NOTES: Using the PainTrace® data fields will aid your ability to track patient progress and identify pain related changes. Future software versions will connect to your practice management systems. For this reason please complete and update fields for: age, sex, species, weight, medications, etc. For your convenience the demographic fields are not mandatory, however it is to your advantage to complete patient information. For ongoing PainTrace® development thank you for adding as much information as possible to the Patient Record and New Trace window.
PainTrace® Instructions and Training NOTES: The device ID can be found on the label affixed to the back of the device. Bluetooth connection occurs once the device is selected from the drop down menu in the New Trace window not in the iPad settings. Return to your dashboard at any point by clicking on the logo at the top of the side menu. You can also access the Traces page by clicking on the Start Trace icon in the dashboard or by clicking on the Traces icon in the side menu. OR For ongoing PainTrace® development thank you for adding as much information as possible to the New Trace window.
PainTrace® Instructions and Training While Running a Trace please: o Do not logout of the BioTraceIT App. o Do not close the BioTraceIT App. o (by double-clicking the home button and swiping up on the app tile) o Do not power off iPad. o Do not turn the device off.
PainTrace® Instructions and Training Traces – Sensor Calibration: o Verify good sensor placement and sensor to skin contact. o Complete a Sensor Calibration at the start of the live trace. ❑ Press firmly on the left sensor for 2 seconds • A negative peak should appear. ❑ Wait 1 second. ❑ With equal pressure, press firmly on the right sensor for 2 seconds • A positive peak should appear (optimally same size) ❑ Tap to Text the following annotation Sensor Calibration ❑ Wait for PainTrace data to return to baseline before completing exam. ❑ A deflection greater than +/- 1 is acceptable based on the firmness of your sensor press.
PainTrace® Instructions and Training Traces – Annotations: o Real – Time Notes paired with points of time on the PainTrace® graph. o Important to record annotations so the graph can be properly interpreted. The more information = the more meaningful the PainTrace® data o In the BioTraceIT App there are two types of annotation methods: ▪ Tap to Text Annotation – Tap the graph at the desired point and type in the annotation ▪ Speech to Text – Based on a term list. o Written Annotation Notes: ❑ Record the time (HH:MM:SS) and the description / key term for the Activity / Anatomy / Medication / Observation / Protocol / Treatment. ❑ The live PainTrace x-axis gives the time in the format HH:MM:SS. ❑ It is important to record hours, minutes and seconds. This will allow for proper pairing of the annotations to the PainTrace during analysis.
PainTrace® Instructions and Training Traces – Annotations: Tap to Text o Tap the point on the graph you want to annotate, the following popup window will appear: o Type in the annotation and tap Add. o Can be completed during a live or saved trace. NOTE: Valuable in cases where the term is more difficult for Speech To Text to recognize or in the case of multiple annotations on a pain response containing a cluster of peaks.
PainTrace® Instructions and Training NOTE: In order for Speech to Text Annotation to work, tap OK on the following three prompts. During Login During Trace
PainTrace® Instructions and Training Traces – Annotations: Speech To Text: o Activate speech to text. o Can only be completed during a live trace. o Speak the terms and note the following: • The annotation will appear on the graph at the time speech begins. • Avoid other conversations while recording annotations. • Before completing your next annotation, allow time for the following: ➢ The addition of the current annotation to the graph. ➢ The patient’s possible pain response to the action or noxious stimulus. ➢ Recovery back to baseline.
PainTrace® Instructions and Training Traces – Annotations: Speech To Text: o Terms are categorized by 6 Types (for the complete list visit your knowledge base, only terms on the list will be recognized): ▪ Activity (walk, jog, trot) ▪ Anatomy (elbow, hind leg, cervical spine) ▪ Medication (acetaminophen, ketoprofen, gabapentin) ▪ Observation (allergy, groan, infection) ▪ Protocol (exam, measure, evaluation) ▪ Treatment (acupuncture, ekg, palpation) o The terms included in these categories tend to not appear in a regular conversation. o If you are speaking a term that is common in speech (Ex: Like, Care, Major), then you must pair this term with at least one term from the 6 types. o Currently, activity words are categorized as common. For success, pair an activity with the word begin. Ex: Begin Walk o All tenses of a word are recognized. Ex: Walk → Walks, Walking, Walked. o Example: Green = Annotation works ➢ Delta ➢ Pain Delta
PainTrace® Instructions and Training Traces – Annotations: Example of a live trace with annotations: ➢ Tap To Text → Yellow Star ➢ Speech To Text → Blue Circle
PainTrace® Instructions and Training Traces – Stopping a Trace Upon completion of exam: • Please do not disconnect the cable / leads or device from the patient until the trace has been stopped as it will generate a large peak. • Tap to text annotate Stop and tap add. • Tap the Stop icon.
PainTrace® Instructions and Training Upon completion of PainTrace® – Cable / Leads a. Twist the grey portion of the cable adapter to the left and gently pull to release. b. Unclip the leads from the sensors. c. Store carefully. *For veterinary use and investigational use only.
PainTrace® Instructions and Training Upon completion of PainTrace® – Device c. Turn off by pressing the white button on the right for ≥ 5 secs. i. LED will pulse red once upon release *For veterinary use and investigational use only.
PainTrace® Instructions and Training Analytics – Viewing Saved Traces: You can view saved traces on the iPad app or in the browser on any laptop / device A B (dash.biotraceit.com) Click on the Analytics icon in the side menu. A. Use the Select Patient drop down to choose the patient. B. Use the Select Traces drop down to choose a saved trace for viewing and analysis. NOTE: You can also access saved traces from the Trace List in the individual’s Patient Record. STAY TUNED FOR DATA ANALYTICS TRAINING IN THE NEAR FUTURE!
PainTrace® Instructions and Training Traces – Zooming Features: The following zooming features can be used on a live trace or a saved trace: Touch and Drag: touch the screen and drag the zoom window in the area you would like to enlarge. A B C D E A. Autoscale → returns graph to full view B. Zoom in C. Zoom out D. Pan mode → use this to navigate through the trace when you are zoomed in. E. Zoom mode → turns the Pan mode off and returns graph to zoom mode.
PainTrace® - Interpreting a Trace
PainTrace® Instructions and Training Positive Peak related to anxiety / anticipation / excitement
PainTrace® Instructions and Training ACUTE PAINTRACE® PEAK o Negative deflection from the baseline. o The larger and sharper the peak the more painful. o Negative peak = Pain peak CHRONIC PAINTRACE® BASELINE o Chronic Pain = Baseline Value and Baseline Delta Over Time. BASELINE o The more negative the baseline, the more painful o The more positive the baseline, the overall general good health o An increasing baseline denotes an increase in chronic pain o An increasing baseline may be related to improvement in health, anticipation or anxiety
PainTrace® Instructions and Training POSITIVE PAINTRACE® PEAK (under research; early data supports the following observations) o In awake patients, a positive peak will be observed before the negative deflection except for in anesthetised patients. When calculating pain the delta between the positive and the negative deflection from baseline will be used to calculate the pain experience. o Unrelated to pain the positive peak may be related to the following: • Anticipation: observed in chronic pain experience. • Anxiety: nervous or excitable patient; surprise. • Excitement: If the patient enjoys a certain activity and /or environment.
PainTrace® Instructions and Training PAIN & PAINTRACE® ACUTE PAIN: o Negative deflection from the baseline = Acute PainTrace® Peak. o Negative Peak = Pain Peak o Intense, sharp, shooting pain = high frequency / narrow negative peak. o Dull, sustained pain = low frequency / lower slope /broader negative change of the baseline. o If the pain increases during a pain experience, multiple peaks may appear or an increasingly more negative baseline [negative baseline delta]. o Pain peaks in a cluster are color coded based on largest peak. o Positive peak (anticipation / excitement / anxiety) preceding a negative peak is included in size of peak calculation.
PainTrace® Instructions and Training PAIN & PAINTRACE® o Color Coding System: • Species specific based on our research. • Pain peaks in a cluster are color coded based on largest peak. • Pain peak types: • After baseline – negative deflection from baseline. • After positive peak – negative deflection after a positive peak. Color Size of Peak Description (Amplitude) NA Positive Baseline 1–3 Mild Pain 4–6 Moderate Pain 7 – 10 Severe Pain ≥ 15 Extreme Pain Please Note: continued research will further adapt these scales.
PUT IT ALL TOGETHER Identify Correct Sensor Location and Shave Clean Skin Stop PainTrace® Thoroughly & Apply Sensors Open App on iPad Complete Exam and locate Patient’s Record Turn on Device & Start PainTrace® Bluetooth & Annotation Connect to iPad Connect Sensor Secure Device to Cable / Leads Patient RED is RIGHT
PainTrace® Benefits DETECT QUANTIFY TRACK Location Medications Intervention Outcome Acute Laser Healing Chronic Acupuncture Wellness ➢ Aids in pain diagnosis ➢ Engage clients through visualizing the pain ➢ Optimize interventions ➢ Support patient compliance ➢ Early detection ➢ Track a patient’s path to wellness
Questions? Contact Information: techsupport@biotraceit.com www.paintrace.com
For your convenience, if an update is required to our BioTraceIT™ App it will occur automatically on your iPad at 1 am your local time. We will inform you of any upcoming updates. If you plan to PainTrace® around this time, please contact Tech Support so we can ensure you do not experience any interruptions of service. Thank you. Contact Information: techsupport@biotraceit.com www.paintrace.com
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