1 What type of training is required to properly use the device, to obtain reliable and valid measurements DiaTecne s.r.l. provides the new Help/Tutorial that includes four sections: 1) Help: references to the various features of the software. 2) Quick Guide: tips and tricks on the use of PulsePen. 3) Tutorial: elements of theory and example videos. 4) User Manual: reference document for the installation and use of the instrument. It's included in the software package of the instrument but it can be also downloaded from the website. Our suggestion is to start using the PulsePen with all the information provided by the help/tutorial, which usually is enough combined with the steadiness and ability of the operator. In case the operator has some doubt, a brief training may be useful (4-5 hours of intensive training). On request DiaTecne s.r.l. provides training via video conference or at the Customer location. In any case, the Customer can obviously ask us by email if he/she has specific questions/doubts using the device, and we will reply in a short time. It is also possible to export and send us one or more examinations to obtain a valued opinion from tonometry experts about the signal quality. 2 Do laboratory personnel assigned to measure PWV using your device require a specific level of professional training or background? For example, carotid IMT requires a highly skilled ultrasound technician. A specific level of professional training is not required for the use of the PulsePen. As far as we know, not only a medical doctor but also nurses, students, biologists, and engineers use the PulsePen device in all the world in daily clinical practice. Actually, when the operator uses the PulsePen he/she should know what "want to find", i.e. he/she should know the pulse waveforms in different clinical conditions. In order to learn quickly the elements of hemodynamics, we suggest reading the book “Pulse waves: how vascular hemodynamics affects blood pressure” (author: P. Salvi, published by Springer). 3 How long does the measurement process take for each assessment? An expert operator may assess PWV in 5-8 minutes (included the insertion of patient’s data in the computer). During epidemiological studies, a single operator assessed up to 186 PWV a day (El Meniaa Study in Algeria). In our experience, it is not difficult to become a skilled operator after 20-30 PWV measurements. 4 What posture is the participant in during the measurement? PulsePen measures not only PWV but also central and peripheral blood pressure, thus the patient needs to stay lying down. 5 Is there any discomfort? No discomfort for the patient. 6 What is the reliability of the measurement? PulsePen has been validated versus invasive method (P. Salvi, et al. Validation of a new non-invasive portable tonometer for determining arterial pressure wave and pulse wave velocity: the PulsePen device. J Hypertens. 2004; 22:2285-2293) and versus MRI (L. Joly, et al. Pulse wave velocity assessment by external noninvasive devices and phase-contrast magnetic resonance imaging in the obese. Hypertension. 2009; 54:421-426). PulsePen was widely used in epidemiological and clinical studies. Actually, the normal values of PWV in children and adolescents currently used in all the world were acquired with the PulsePen device (G. Reusz, et al. Reference values of pulse wave velocity in healthy children and teenagers. Hypertension. 2010; 56:217-224). Also, reference values of PWV in the elderly age were acquired with the PulsePen device (A. Cosmin, et al. Reference values of aortic pulse wave velocity in the elderly. J Hypertens. 2008; 26:2207-2212.). Because of the proliferation of methods for measurement of aortic PWV, the international scientific society ARTERY published in 2010 guidelines for the validation of the instruments used for this purpose (Wilkinson IB, et al. on behalf of the ARTERY Society. Artery society guidelines for validation of non-invasive hemodynamic measurement devices: Part 1, arterial pulse wave velocity. Artery Research. 2010;4:34-40). Below is the conclusive judgment of these guidelines.   The PulsePen is the only device on the market, at the moment, that fully satisfies all the requirements suggested by ARTERY: sampling rate of 1 kHz; registration of 10 cardiac cycles (other devices record 10 seconds); use of arterial tonometer (some other devices use mechanotransducers), transit time determined from the waveforms using an intersecting tangent algorithm (other devices use other algorithms). Registration up to 24 hrs in ASCII format of tonometric signals. 7 Can you provide research references in which measurements taken with your device are related to other preclinical CVD markers or are used to predict CVD outcomes? Pls see “Support / Articles” 8 What age ranges are appropriate for these measurements? No limit of age exists for the use of PulsePen tonometer. PulsePen has been widely used in children (as highlighted above, the normal values of PWV in children and adolescents currently used in all the world were acquired with the PulsePen device) and in the elderly (as highlighted above, reference values of PWV in the elderly were acquired with the PulsePen device). The longitudinal multicenter “PARTAGE” study included prospectively 1130 elderly subjects aged older than 80 years living in nursing homes. 9 What sort of maintenance or service is required for the device? What is the number of measurements before service is required? No particular periodic maintenance or calibration operations are necessary on the instrument. In the case of prolonged non-use, remove the batteries. To clean the equipment, use a clean, dry cloth. Before each use with a new patient, it is necessary to clean the metal disk of the PulsePen probe and the plugs of the Patient's cable using a clean cloth dampened with alcohol. In the case normal cautions are applied during the instrument’s use (like avoiding that the probe falls down, correctly inserting the battery, … and all precautions listed in the user manual), thousands of measurements are possible with no service required. 10 How is service for the device handled? In case of problems with the device the Customer needs to contact DiaTecne s.r.l. by email and if necessary to send the apparatus following our instructions, using international express couriers (DHL, UPS, FedEx, ..). In few days the device will be repaired and sent back to the Customer. 11 How is training handled? Pls see point 1 12 How much does the device cost? Are there discounts for research uses (as opposed to clinical uses in revenue-generating health care settings)? Are there discounts for purchasing multiple units? Pls, ask for a quote. At the moment the main PulsePen device’s field of application is the research and our Customers are mainly Research Centers and Universities. Discounts are applied in the case of multiple purchasing units: ask for a special quote related to the number of the involved units. 13 Are there costs for service? Only the shipping costs during the Guarantee period (2 years) are applied. After this period the cost depends on the damaged parts. Normally in case of minor repair service, only the shipping costs are applied. 14 What is the guarantee? The guarantee period is 2 years.