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2 Table of Contents PharmaSmart Intro & Program Biography Getting Started... 8 Product Replacement... 9 Kiosk Functionality Storage and Smart Card How to Change Paper Clinical Accuracy Clinical Accuracy Statement Blood Pressure Cuff Accuracy Q & A Accuracy Skit (Staff Member to Patient) Frequently Asked Questions Blood Pressure Fluctuates Pharmacy Services POS Placement Order Replenishment/Reorder How to Relocate Kiosk Special Instructions (Signs) Blood Pressure Tracker How to Use Online Blood Pressure Tracker French Manual start on Page 31 Page 1 of 49

3 PharmaSmart Health Screening Program - Introduction and Program Biography PharmaSmart is proud to introduce a full service, out of office health management blood pressure program. It is designed as an easy-to-use clinical screening solution for employees, patients and customers. PharmaSmart is committed to developing progressive patient care programs supported by clinical accuracy, accreditation and premium service. For over 20 years our service program has delivered excellence by maintaining a focus on efficiency, integrity and simplicity for all customers. This booklet was designed to familiarize you and your staff with your new blood pressure screening program. References throughout this training manual may vary based on the equipment type that you have either leased or purchased. PharmaSmart blood pressure programs and equipment types vary in description and functionality. If you are unsure about the equipment type that you have received, please contact your account representative with any questions. *Please keep this training manual in a safe and secure area so that any onsite representative from your site can review all of the important facts and information provided. Our customer support center is always available 24/7 by calling 1 (800) and selecting Option 3. Page 2 of 49

4 Health IT is changing the face of Pharmacy. Don t wait to provide your patients with an accurate, automated biometric blood pressure screening tool. Contact PharmaSmart today! PharmaSmart s Program Offers: Interoperability MTM Health IT & Data Analytics Valid and Accurate Alert Notification PharmaSmart 43 Co 5 tor 1 33 Com t 5 2 Com t tor 3 33 I conducted a survey of the seven leading North American manufacturer websites and found only one of the companies provided clinical validation data on their website. I then sent a questionnaire, by registered mail, to the Regulatory Directors of the seven manufacturers, only one company provided a complete and satisfactory response (PharmaSmart) Clinically Validated Peer Reviewed Model PS2000 With Connectivity Dr. Bruce Alpert, M.D. Are Kiosks Blood Pressure Readings Trustworthy? November 15, 2012 Android ipad iphone BPT Mobile Powered by BPT One Page 3 of 49

5 Benefits & Advantages of the PharmaSmart Blood Pressure Program The program focuses on five core areas: Technology, Clinical Validation, Services, Revenue (if applicable) & Branding (if applicable) Technology - The PS2000 kiosk is HIPPA/PIPEDA compliant and clinically validated. This blood pressure monitor utilizes Smart Card technology, which conveniently tracks the patient s individual readings over time. By using the Smart Card, the patient will also be provided a detailed, printed report when they measure their blood pressure on the kiosk. PharmaSmart s commitment to a one-button operation ensures ease of use, maximizing consumer usage. Connectivity - The PS2000 kiosk utilizes wireless, wired or M2M internet technology, and a patented Smart ID protocol to communicate patient results from the kiosk to our HIPAA TM TM (privacy) compliant PS DataSmart server. From the PS DataSmart server, patient data is made available to patients and their healthcare providers though the PharmaSmart Blood TM Pressure Tracker health portal, providing a comprehensive, historical report from any computer or mobile device. In many instances, patient data is made available to the pharmacist or physician directly from within their clinical system. Ask PharmaSmart if your clinical system vendor is an integrated partner Clinical Validation - PharmaSmart kiosk technology meets AAMI /ANSI /ISO standards 4 and it has achieved an A rating for accuracy per the BHS device standard. Additionally, the kiosk s patented cuff design fits 97% of all arm circumferences including small, medium and large arm sizes. Visit our website at and view all accreditations, news and articles validating the PharmaSmart model PS2000 technology. Branding - All elements (software, Blood Pressure Management Smart Cards, printed tickets, signs, online portal, etc.) can be fully branded to support your brand identity and marketing objectives, increasing the reach of your brand both inside and outside the pharmacy. PharmaSmart offers retail pharmacies a distinct competitive advantage with the high value hypertensive patient. Page 4 of 49

6 Revenue - PharmaSmart provides the program and tools that create added value for the hypertensive patient, and converts them into a new and recurring revenue opportunity. By empowering your staff to become Experts in Hypertension, the PharmaSmart program will drive significant and sustainable profits from multiple sources. Service - Our technical support and Customer Service Advisors are available 24/7 by calling 1 (800) , Option 3. 1AAMI Association for the Advancement of Medical Instrumentation a non-profit organization that is a primary source of consensus in the development,management and use of safe and effective medical instrumentation and technology. 2ANSI American National Standards Institute a private non-profit organization that oversees the creation, dissemination and use of guidelines impacting businesses of every sector. The organization is active in accrediting programs that assess conformance to standards. 3 International Standards Organization - ISO (International Organization for Standardization) is the world s largest developer of voluntary International Standards. International Standards give state of the art specifications for products, services and good practice, helping to make industry more efficient and effective. 4 BHS British Hypertension Society a forum comprising of medical professionals working in the hypertension and cardiovascular disease fields, specializing in the delivery of care and research. Page 5 of 49

7 Becoming an Expert in Blood Pressure Management Your kiosk program is equipped with the tools and support necessary to transition your site into an advanced blood pressure screening and health management resource center. The program will allow you to place emphasis on critical blood pressure management screening, information, advice, and therapeutic support. *PharmaSmart offers a diverse set of services designed to support your blood pressurprogram, which are outlined below. Doctor Detailing (Pharmacy site only): Doctor detailing is available to retail pharmacy. The program educates your top prescribing physicians on the unique benefits of the PharmaSmart program for critical between visit and out of office blood pressure testing and monitoring. Our retailer branded detailing program reinforces your position, the pharmacy, as a leader and a true partner in community blood pressure monitoring. By providing a practical solution for managing the hypertensive patient, the PharmaSmart program will drive hypertensive and diabetic patients to your pharmacies for between visit hypertension management. The program will help drive new prescription business, and increase your collaborative care opportunities with local physicians. Workshops (Pharmacy/Worksites sites): Workshops help program participants gain a strong understanding of effective blood pressure management, including education on device validity, proper measurement technique, uses of the Smart Card and online portal, and the importance of a personal, historical record of the blood pressure results. PharmaSmart is qualified to assist with the preparation and administration of your workshop experience (costs may apply). Certified Education (Pharmacy/Worksite/Medical Professional): PharmaSmart is building a Continuing Education (CE) platform designed to provide the latest advancements in key topic related protocol. We are always updating our educational and clinical research and documentation. For the latest news and offerings that may impact you directly please visit *Model PS2000 Classic and Select customers qualify for upgraded premium support services. Please contact your account representative for details. Page 6 of 49

8 Conclusion Hypertension is the leading cause of death and disability worldwide. Studies have shown that 1 in 4 people worldwide have hypertension (including 1 in 3 Americans), and 9 out of 10 people will become hypertensive at some point in their life. PharmaSmart is committed to help reduce the impacts of high blood pressure. With your PharmaSmart program in place, you can encourage every hypertensive, pre-hypertensive, and diabetic patient, employee and/or customer at your site to measure their blood pressure, track it over time, and share their results with their healthcare provider. PharmaSmart provides the tools and support to position your site as a front line resource in the effective management of hypertension, providing a lasting impact to your staff, patients, customers and/or employees. The program can also serve as a new source of revenue. Our experienced team knows that every program implementation is unique and important. We look forward to working with you to develop a turnkey, customized program that supports your existing corporate priorities and brand identity. If you have questions or concerns, please contact PharmaSmart at 1 (800) , Option 3 or visit our website at Page 7 of 49

9 Getting Started with PharmaSmart Blood Pressure Management Program watch training VIDEO on DVD or access video by visiting area throughout the primary kiosk region. 1. Staff and participants must be able to see the signs in order for them to know this service is available. Place signage throughout common areas or if a pharmacy, reference your Rx Services POS placement guide that is part of your introductory package. a. Lost your Rx Services POS Placement Guide? For a new one, contact our Customer Service Department at 1 (800) , Option All store personnel should tell patients and customers about the new blood pressure management program and service available at the site. If you are a pharmacy or worksite offering the Smart Card program, then offer the option to enroll in the Smart Card program to each person who brings in a prescription for a hypertension and/or diabetes related medication. a. Please note this is a tracking tool for all blood pressure readings and can be made available to anyone who is interested in this option. 2. Place the bag stuffers (if applicable) inside all patient, customer and employee bags and/or mailboxes. You can also circulate an notification and conduct regular staff trainings. a. You may be eligible for onsite training. Contact your account representative for details. specialists and family physicians in your area, as well as potential employees, customers and patients. Inform them about this new and innovative blood pressure monitoring service you are offering. Getting the word out will build awareness for the types of hands on services and out of office services offered at your site Page 8 of 49

10 PharmaSmart Blood Pressure Machine Product Replenishment & Ordering Information 1. To order by phone: please call 1 (800) , Option 3 2. To order by fax: 1 (585) To place an order online: us at: * Prior to ordering, please consult with your program administrator as some sites may be subject to special ordering instructions, or you may contact PharmaSmart directly for further information. **There is no minimum order required. All orders received before 2:00pm (EST) will be shipped that day. All orders received after 2:00pm (EST) will be shipped the next day. If an order is needed by the next day, we will gladly ship it overnight. All costs associated with sending a package will be included on the invoice. Shipping/handling charges may apply. Page 9 of 49

11 Blood Pressure Kiosk Model PS2000 with Connectivity Basic Program Details: 1. Key & Storage Compartment (Figure A) keep the key from getting lost. a. The key will unlock both the head of the unit and the storage compartment. 2. Smart Cards (Figure B). and carrier should register a retail value. If you are experiencing issues please consult your program administrator. Figure A - PharmaSmart Kiosk Storage and Key NOTE Storage Compartment is located underneath seat. Things to keep in the storage compartment at all times: all paper, recharge card/instructions, connectivity card/instructions, BP logs. Figure B - PharmaSmart Smart Cards UPC Barcode Customer UAC Page 10 of 49

12 How to Change Paper & Fix a Paper Jam Instructions - PS2000 * Release Lever Step 1: Kiosk Head - Unlock the Kiosk Head with the same key used for the storage compartment. Lift the door and pull out gently to lock the door in place. Step 2: Release Lever - On the printer, push the red release lever back to open the metal door. Note: Do NOT Pull on the printer. This will cause it to be misaligned. Step 3: Load Paper - Insert paper roll. Load paper in the designated area. Be sure that the paper is coming under the roll. Loading incorrectly will cause paper to print out blank. Step 4: Close Door Pull out enough paper so when the metal door is shut, you will have about one inch of paper showing. Make sure that the paper is straight before closing metal door. *Release Lever Step 5: Fixing Paper Jam/Clear Error - Open Kiosk Head, push the red release lever back to open metal door. Remove any excess paper that may be causing the paper jam. To clear any errors, reset the kiosk by unplugging the power. Upon restart the kiosk will print a startup report. This will ensure printer is working. Page 11 of 49

13 PharmaSmart Clinical Accuracy PharmaSmart Accuracy Statement PharmaSmart PS2000 Proven Accuaracy The PharmaSmart PS2000 blood pressure monitor is designed to measure blood pressure in 5 accordance with AHA guidelines for general screening: seated, brachial artery measurement at the level of the heart. The model PS2000 oscillometric technology and unique cuff design has been clinically evaluated for compliance with The Association for the Advancement of Medical Instrumentation s standard 6 (AAMI) and to a modified British Hypertension Society (BHS) Protocol. The clinical study was performed at the University of Tennessee, and the results were published in the technical research journal Blood Pressure Monitoring (vol 9, no 1). Subjects tested ranged in age from 18 to 74, with the average age of 40. Arm size ranged from 22 to 38 cm in circumference. Resting systolic BP ranged from 91 to 252 mmhg, and resting diastolic pressure ranged from 57 to 160 mmhg. There were 44 males, and 41 females. For each subject the readings obtained by the PS2000 were compared with auscultatory readings obtained by two clinicians, blinded to the results of each other and the device. The manual reference measurements were alternated with the readings obtained by the device. The study concluded: "The PharmaSmart PS2000 met the AAMI (FDA) requirements for accuracy Most notably, the mean difference between well-trained clinicians and the device readings were very small (0.07 systolic and 0.3 diastolic). Further, when analyzed in accordance to the BHS evaluation protocol, the PS2000 achieved the highest grade - an 'A'. It is well suited for its role 7 as a high volume, self-administered BP screening device." To view the full text of the published clinical study, visit our website at 5Association for the Advancement of Medical Instrumentation, American National standard: Manual, electronic or automated sphygmomanometers. Arlington, Virginia: AAMI; O Brien E, Petrie J, Littler WA, DeSwiet M, Padfield PL, Altman D, et al. The British Hypertension Society protocol for the evaluation of blood pressure measuring devices. J Hypertens 1993;11(suppl 2):S43-S63 7Alpert BS. Validation of the Pharma-Smart PS-2000 public use blood pressure monitor. Blood Pressure Monitoring 2004, 9:19-23 Page 12 of 49

14 Clinical Cuff Design Patented BP Cuff Technology (US Patent #: 7,166,077) The PharmaSmart non-invasive cuff incorporates a breakthrough design that enables accurate readings for the full range of adult arm sizes, achieving accuracy that would traditionally require small, medium, and large cuff sizes. The cuff uniquely maintains the ideal contact width for different arm circumferences. This eliminates the problems caused by improper selection or application of the cuff. The PharmaSmart cuff also swivels on two planes to provide maximum user comfort, and allow correct posture. Cross Section Cuff US Patent #: 7,166,077 Page 13 of 49

15 PharmaSmart Accuracy Q & A 1. PharmaSmart kiosk readings are inconsistent (some high, some low). Blood Pressure Fluctuates It is normal for blood pressure (BP) to fluctuate significantly as much as 15 or more points from breath to breath. Many users will misinterpret high or low readings as inaccurate readings, when in fact they are seeing normal fluctuations in their BP. Some patients will see wide fluctuations in their BP, while others will be more consistent. BP is affected significantly by many variables, such as exercise, coffee, smoking, illness, etc. The average of multiple readings over a period of time is the best indication of a patient s BP. 2. PharmaSmart kiosk readings taken sequentially vary too much. Even sequential measurements made by a doctor using a stethoscope often result in measurements differing by 15 or more points. Also, it is proven that blood pressure will vary each second, from breath to breath. 3. PharmaSmart kiosk readings are higher/lower than clinic, or home readings. It is expected that a patient s BP will be different in the store/worksite than it is in the doctor s office or at home. BP fluctuates dramatically in response to the body s demands, even in a healthy person. Because of the fluctuating nature of BP, an average of readings over a period of time is the best indication of a patient s true BP. 4. PharmaSmart Kiosk readings are higher/lower than manual (nurse readings taken in the store. Keep in mind that even sequential measurements made by a trained clinician using a stethoscope often result in measurements differing by 15 or more points. This fact makes it extremely difficult to validate device readings against manual readings. Also, a pharmacy and worksite environment includes activity and ambient noise. This environment is not well-suited for assessing BP with a stethoscope. While manual BP readings are compromised by such an environment (as studies have shown); it has no detrimental effect on the PharmaSmart blood pressure kiosk. Even for a trained professional, taking an accurate measurement with a stethoscope is difficult due to complicating variables. These include: The PharmaSmart Blood Pressure kiosk has been designed to minimize the errors that are caused by these and many other adverse conditions. Page 14 of 49

16 5. PharmaSmart kiosk readings are higher/lower than other BP Device readings taken in the store. Keep in mind that even sequential measurements made by a doctor using a stethoscope often result in measurements differing by 15 or more points. This fact makes it extremely difficult to validate device readings against manual readings. Also, note that the PharmaSmart Blood Pressure Unit has a number of advantages over home devices. Most home use devices use a single cuff to measure BP in arms of any size this causes accuracy concerns with large and small arms. The PharmaSmart Blood Pressure Unit has a self-adapting cuff to allow accurate measurement on arms of differing sizes. In addition, the PharmaSmart Blood Pressure Unit is designed to provide consistent elevation of the arm with respect to the heart and to support the arm without user effort. Home-use devices do not provide this consistency. Essential Information: A. PharmaSmart Accuracy PharmaSmart technology has been validated through independent, published clinical trials. Research has determined that PharmaSmart equipment conforms to leading standards for device accuracy. This means that readings taken on the PharmaSmart machine are equivalent to those obtained by a well-trained blood pressure technician. Clinical research is available on PharmaSmart s website: B. Proper Usage Technique For any method of BP measurement (home unit, kiosk, manual, etc), proper technique is very important for accuracy. When using the PharmaSmart BP Kiosk, the patient should rest seated at the unit for a full minute prior to commencing the test. This will allow them to return to a resting pulse. Also ensure the patient uses the proper arm position. A diagram on the instruction panel indicates the correct arm position. It is also very important that the patient remains quiet and still for the duration of the test. It is OK to take multiple readings at one sitting, and it is normal for sequential readings to differ, even significantly. C. Encourage Blood Pressure Management Smart Card Tracking The Blood Pressure Management Smart Card allows patients and their pharmacists to determine their average blood pressure from multiple readings taken over a period of time. Clinically, this information provides a more accurate picture of a patient s true BP, and allows for improved professional consultation and patient management. Page 15 of 49

17 PharmaSmart Accuracy Script Pharmacy/Worksite Member to Patient Patient: Hello, I just took my Blood Pressure on your Kiosk and it appears to provide me inaccurate results. Is your blood pressure kiosk accurate? Pharmacy/Worksite Staff Member Answer: Thanks for letting us know about your concern. Yes, it is accurate. May I ask you a few questions? 1. What makes you question the accuracy of your readings? 2. Did you remove all heavy layers of clothing (coat/sweater)? 3. Did you use the proper arm position (per the diagram on the machine)? 4. Were you careful to remain still and not talk during the test? 5. Did you take three tests at least one minute apart? Here are some important facts about blood pressure, and blood pressure kiosk: 1. It is normal for your blood pressure to fluctuate as much as 15 or more points from minute to minute. Blood pressure is affected by many things, such as coffee, smoking, illness, medication, or food. Some people also suffer from white coat effect, which means their blood pressure is higher in a doctor s office or perhaps even at the pharmacy. 2. The blood pressure kiosk meets world leading standards for equipment accuracy This means that the PharmaSmart kiosk readings are equivalent to those obtained by a well-trained blood pressure clinician (nurse, doctor, and pharmacist). 3. If you would like to learn more about the accuracy of the PharmaSmart kiosk, please visit and click the Clinical Validation hot button. PharmaSmart is the only blood pressure kiosk manufacturer that can provide published clinical validation. 4. The best indication of your blood pressure is an average of readings taken over a period of time. The Smart Card helps track your readings and helps us counsel you better. Page 16 of 49

18 Blood Pressure Fluctuates Education Blood pressure fluctuation can be a very difficult principle for your customers and your personnel to understand. As an aid to explaining this concept to them, we suggest that you refer them to the chart below. The chart graphically illustrates just how much blood pressure can fluctuate over the course of a single day. The information displayed was gathered by a 24 hour ambulatory BP monitor worn by a single person for one entire day. This person s average BP is about 144/87, but the systolic varied from 118 to 184, and the diastolic ranged from 70 to 120. Many factors affect blood pressure, and these types of fluctuations should be expected. Please encourage users of the Blood Pressure Kiosk to take the average of 8 to 10 readings over a period of time. Only then will they have a good indication of their average blood pressure. For more information: PharmaSmart Customer Service Call: 1 (800) , Option 3 Page 17 of 49

19 Frequently Asked Questions for Smart Cards (FAQ) Q: How does the smart card work? A: Insert the card into the blood pressure kiosk with the chip facing down. Press start within 10 seconds of inserting card. The card should remain in the machine for the duration of the test. Q: How do I know if the smart card recorded my BP reading? A: The printed receipt will show up to the last 10 BP readings and pulse, as well as an average. The card must stay in the machine during the entire test in order for a reading to be recorded. Q: A patient s card is reading expired. Is there a way to recharge the card or do they need to purchase a new card? A: Smart cards can be recharged by using a PharmaSmart Recharge Card. This card will allow the pharmacy staff to recharge a patient s card for an additional 365 days. The recharge card is located in a packet underneath the seat of the kiosk, in an envelope attached to the door. If unable to locate, call PharmaSmart customer service. Q: Why is a smart card reading invalid or obsolete? A: If this is happening for one patient, ensure the card is being inserted correctly. If this is happening for multiple cards, reset the machine by unplugging the power cord for 30 seconds. If the problem persists, contact PharmaSmart customer service. Q: Why are my readings not displaying on the internet? A: Not all kiosks are connected to the internet. If you know that your kiosk has connectivity, it may require a reset (unplug power for 30 seconds then plug in), this may restore connection. For questions about connectivity, call PharmaSmart customer service. Q: How can I print all of the readings that are stored on the smart card? A: Locate the recharge card, typically stored underneath the seat of the kiosk, and insert this into the unit. Follow the onscreen directions to navigate to Print Card Readings. Q: Why is my patient receiving Unauthorized Access when trying to log in to the Blood Pressure Tracker? A: This error is most commonly seen when a birth date being entered differs from the one used to originally log in. If the error continues, contact PharmaSmart customer service. Customer service will need the Unique Access Code (back of the card) and the patient s birth date. Q: What if a patient loses his or her smart card? A: All data collected on smart cards or through our blood pressure tracker is anonymous. Therefore, the only way data can be transferred from one card to another is if both the old and new Unique Access Codes are available. To have this performed contact PharmaSmart customer service. PharmaSmart Customer Service Call: 1 (800) , Option 3 Page 18 of 49

20 Pharmacy Services POS Guide Receiving a Pharmacy Service Package Pharmacy Services - Field - Setting Up a Pharmacy & Training Rx Staff Not Pictured: Buttons = All Pharmacy Personal to wear buttons during promo period Window Clingers = Placed at Drive Thru Window or Consultation Window Page 19 of 49

21 Marketing Material Placement Guide Marketing Material Placement Guide Pharmacy Services POS Execution Model Be Smart! TRACK YOUR BLOOD PRESSURE ASK OUR PHARMACIST! Test yourself on the blood pressure kiosk simple and easy. Test Regularly The card will store 30 readings and the ticket will print the average of your last 10 results and pulse rate. Share the printed results with our pharmacist to help manage your health! Go online at to track your blood pressure All Rights Reserved. Poster - Display Waiting Room Consultation Area Pick Up & Drop Off Counter Pharmacy Area Be Smart! TRACK YOUR BLOOD PRESSURE! ASK OUR PHARMACIST! All Rights Reserved All Rights Reserved. TRACK YOUR BLOOD PRESSURE! Be Smart! TRACK YOUR BLOOD PRESSURE! ASK OUR PHARMACIST! Test yourself on the blood pressure kiosk simple and easy. Test Regularly The card will store 30 readings and the ticket will print the average of your last 10 results and pulse rate. Share the printed results with our pharmacist to help manage your health! Be Smart! ASK OUR PHARMACIST! Test yourself on the blood pressure kiosk simple and easy. Test Regularly The card will store 30 readings and the ticket will print the average of your last 10 results and pulse rate. Share the printed results with our pharmacist to help manage your health! All Rights Reserved. Be Smart! TRACK YOUR BLOOD PRESSURE! ASK OUR PHARMACIST! Shelf Talker - Display OTC Aisles - i.e. Hypertension and cardio medications Heart - Hypertension - Glucose Healthy Food Aisles Place them at or below eye level in the above mentioned areas Communicate to store manager Tent Sign - Display Pick up & Drop Off Counter Consultation area Waiting Room Table Visit your local highest prescribing hypertension and diabetes specialists or general practitioners/family doctors and tell them how you can better manage patient blood pressure Window Clinger - Display Drive Thru Window Front-end Store Entrance Pharmacy Area - window separation between pharmacy & patient Coat Button - Display Pharmacist White Coat Tech White Coat Front-end or Rx Clerk shirt or coat Be Smart! TRACK YOUR BLOOD PRESSURE! Page 20 of 49

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