P-STIM Placement and HRV Training! For Treatment of Chronic Pain!

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1 P-STIM Placement and HRV Training! For Treatment of Chronic Pain! November 2011

2 Presentation Overview! BEFORE patient arrives! Preparation of materials DURING patient visit! HRV Testing & Monitoring P-STIM Placement Documentation Patient instructions Scheduling follow-up appointment AFTER patient leaves! Follow-up

3 BEFORE Patient Arrives!

4 Supplies Needed! P-STIM! ANSiscope! Snap Electrodes! Tac Gel Adhesive! Prep Nʼ Stay! Stylus! Patient Tracking Sheet! Items in red supplied by DyAnsys Alcohol Pads! Scissors! Sharp Prong! Patient Table! Blood Pressure Cuff! Sterile surface drop sheet, ~18 square! Burnisher! Cotton Tip Applicator! Sterile Tweezers! Items in black supplied by clinician

5 Items Provided in the P-STIM Package! Package Insert! P-STIM Device! Protective Cap! Three sterile needles! Replacement stylus end cap! Three oval adhesives! Tegaderm adhesive tape x 2! Alcohol prep pad!

6 Preparing the Stylus! Unscrew rear end plug! Remove outer housing! Insert battery! Reassemble! Press tip against finger, red light should activate to indicate it is working! Clean stylus tip with alcohol pad! Add end cap! Turn the end cap ¼ turn clockwise! (always remove end cap between uses to prolong battery life)!

7 Laying out the Supplies! Place all items, except ANSiscope, on a sterile surface! Open the P-STIM Package and place contents on the sterile surface! Remove the white serial number label on the back of the P-STIM! Place this white label onto the Patient Tracking Sheet!

8 Activating and Testing the P-STIM! Remove protective tabs! Gently push batteries into place! Attach protective cover! Peel back cover off ½ way! Ground device by placing finger behind cover! Insert Stylus into one of the needle tips! Listen for tapping sound behind the high pitch sound!

9 Preparing P-STIM for Placement! Using scissors, trim off extra adhesive backing, being sure not to cut the wires! Attach wires to the needles, making sure they are perpendicular to the adhesive strips! Set aside!

10 DURING Patient Visit!

11 Patient Information & Tracking Sheet! Fill out patient information including a description of their pain and where it is on the body! Take patient blood pressure and note on the Patient Tracking Form! For each treatment week, note their pain level and other issues as indicated! Use this form to track weekly needle placement and balans Activity!

12 ANSiscope Autonomic Dysfunction Test! Obtain a baseline reading at the patientʼs first visit! Patient should fast at least two hours prior to the test! This includes no smoking or excessive exercise To monitor patient improvements, subsequent Autonomic Dysfunction Tests should be taken, minimally at the middle and end of the treatment process! Leave electrodes on the patient after the dysfunction test, as they will be used for monitoring the patientʼs Sympathovagal Balance to optimize P-STIM placement!

13 The ANSiscope Function: Sympathovagal Balance Monitoring! Attach electrodes to the patientʼs inner wrists and ankles (if not already attached from the Autonomic Dysfunction Test)! Select the ANSiscope function, enter patient information and begin the balans testing! Leave electrodes attached and ANSiscope running during the entire P-STIM placement procedure!

14 Preparing the Patient! Clean entire ear with alcohol pad, including behind the ear! This will remove any dirt or oils that may decrease adhesive strength Using a cotton tip applicator, apply Prep Nʼ Stay to the area just cleaned (both on top and behind the ear)!

15 Placing the P-STIM! Apply thin layer of Tac Gel to the back of the P-STIM device! Place device behind the ear, away from the hairline! Hold for 30 seconds, such that the Tac Gel holds it in place!

16 Placing the P-STIM: Optimizing Needle Location! Locate appropriate needle placement using the Stylus! Stylus sounds! Low pitch (indicates high resistance and is NOT conducive to P-STIM placement) High pitch (indicates low resistance and is conducive to P-STIM placement) Refer to the placement guide to find the appropriate areas for placement of the three needles!

17 Placing the P-STIM: Needle Location! Mentally note the Sympathetic value (Sym) line location! Locate the first insertion point with the Stylus, looking for the high pitched sound! Gently insert the needle! Ask patient if that location is painful, if so find another location: feeling the needle temporarily is o.k.!

18 Placing the P-STIM: Noting Sym Line! After needle insertion,mentally note the Sympathetic value (Sym) and line location again! The Sympathetic line should rise and then drop closer to the original value! It not, the needle is not optimally placed! Using the Stylus, locate a different location and repeat above!

19 Finishing P-STIM Placement! After all needles have been placed, cover each with one oval adhesive! Pat adhesive in place using a burnisher by pushing tape down around the needle!

20 Placing the P-STIM: Taping the Wires! Using a piece of Tegaderm tape, secure the wires to the patientʼs neck! IMPORTANT! Using a sharp prong, create a small air hole near the wire insertion point of the device!

21 Using the Patient Tracking Form! Draw the patientʼs final balans trajecatory on the patient tracking form! Also note the balans value on the form!

22 Using the Patient Tracking Form! Note the final needle placement on the ear diagram of the patient tracking form!

23 Final Patient Notes! Have patient wait at least 15 minutes! Ensures they are experiencing no pain or other side affects as a result of the placement! Instruct patient to be careful when showering! They should not wash their hair when P-STIM is in place! Instruct patient to remove the device on day four! Example: if placed on Monday at 10:00 a.m., have them remove it on Friday at 10:00 am! Schedule the patientʼs appointment for the following week and ideally, subsequent weeks!

24 AFTER Patient Leaves!

25 AFTER Patient Leaves! Follow-up with the patient by phone the next day! Particularly during the first few placements! If, during the four days, the patient experiences any discomfort, such as nausea or more pain than usual, instruct them to call the office.! Any discomfort means they are receiving too much stimulation! Have the patient remove one or two of the three needles! Remove the vagus nerve location first! If no vagus needle location, then the top needle! If the discomfort continues, remove a second needle!

26 AFTER Patient Leaves: Follow-up! The emotional and physical aspects of the ANS are intertwined! It is important that the patient has a positive attitude during the treatment process and not get discouraged! Let the patient know that this treatment process can take time! On average, most treatments take ~10-12 weeks However, some cases can take longer, such as 20 weeks Continue to reassure the patient! Let them know that their symptoms can be significantly improved with this new process!!

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