® Warranty FloPoint Elite Uroflow System Warranty Warranty Verathon Medical® warrants the FloPoint® Elite Uroflow System against defects in material and workmanship as long as it is covered by the Premium Warranty Total Customer CareSM Plan. This warranty does not cover equipment sold as used. Damage or loss insurance is availability as part of the Total ReliabilitySM Plan.
® FloPoint Elite Uroflow System ® Contacting Verathon Medical Contacting Verathon® Contacting Verathon® The team at Verathon® is committed to modernizing healthcare delivery by putting patients first. Our products support healthcare professionals by providing the reliability, utility, and excellence. For additional product and company information, visit the Verathon® Web site at www.verathon.com.
® Clinical Application FloPoint Elite Uroflow System Clinical Application Clinical Application Definitions, Indications, and Output Definitions Uroflowmetry is a diagnostic test in which the patient urinates into a flow sensor connected to a recording device that produces a plot of urine flow rate versus time (the “uroflow curve”). Most Uroflow Systems measure urine flow rate by continuously weighing the urine as it fills a catch vessel and calculating the rate of increase in urine weight.
® FloPoint Elite Uroflow System Clinical Application FloPoint® Interpretation Limitations and Specific Clinical Applications A reduced urine flow rate can be caused by either a bladder outlet obstruction or by detrusor hypocontractility. In turn, bladder outlet obstruction can be due either to an anatomical abnormality (e.g., prostatic hypertrophy) or a neurological abnormality (e.g., detrusor-sphincter dyssynergia caused by multiple sclerosis).
® Clinical Application FloPoint Elite Uroflow System Figure 33. Measurements Taken From the FloPoint® Elite Curve A. Measurements of the continuous uroflow curve. Average flow rate (not shown) is calculated by divided total volume voided by flow time. B. Measurements of flow time and voiding time from an intermittent uroflow curve. A. B. Table 1.
® FloPoint Elite Uroflow System Clinical Application MEASUREMENTS DEFINITION NORMAL RESULTS Voiding Time Total duration of the micturition, including interruptions. Averages about 10 seconds with 100 ml voided volume and 25 seconds with 400 ml voided volume. No “normal limits” defined. Flow Time Total duration of measurable flow. Equal or nearly equal to voiding time. A flow time that is significantly shorter than the voiding time indicates an abnormal intermittent FloPoint® Elite pattern.
® Clinical Application FloPoint Elite Uroflow System Figure 34. Normal Uroflow Curve ♦ Superflow: Figure 35 shows an example of a “superflow” pattern. This pattern is characterized by a very high flow rate - usually greater 40 ml/sec. and a very short flow time. A superflow pattern is usually seen in females. It suggests decreased outlet resistance and/or detrusor instability, hence may be associated with urinary incontinence.2, 6 Figure 35.
® FloPoint Elite Uroflow System Clinical Application Figure 36. "Flat Top" Obstructive Flow Pattern The peak on the spike at the end of the trace might have been misinterpreted by the uroflowmetry as the peak flow. Figure 37. Rounded Top Obstructive Flow Pattern Irregular Patterns With the exception of an occasional terminal spurt (e.g., Figure 36) or one or two secondary voids in a normal man, irregular flow patterns are always either abnormal or artifactual.
® Clinical Application FloPoint Elite Uroflow System Figure 38. Fluctuating Pattern Caused by Abdominal Straining Figure 39.
® FloPoint Elite Uroflow System Clinical Application Figure 40. Artificial Fluctuating Pattern The patient creates this pattern by repeatedly moving his stream across the commode outlet. Figure 41. Artificial "Squeezing" Pattern The patient creates this pattern by repeatedly obstructing urine flow by squeezing his foreskin or penis.
® Clinical Application FloPoint Elite Uroflow System Table 2. Diagnostic Significance of FloPoint® Elite Results CURVE SHAPE Pattern Shape Continuous Flat PEAK FLOW TIME TO MAXIMUM VOID TIME CONCLUSION Low Shortened (Peak flow may be difficult to identify.
® FloPoint Elite Uroflow System Clinical Application Figure 42 shows examples of such a computer misinterpretation (solid arrow). In situations such as this, the clinician must override the computer’s interpretation and read the maximum manually from a smooth portion of the uroflow trace (open arrow in Figure 42). Figure 42. Artifactual uroflow peak produced by a spike The (black arrow) identifies an artifactual spike that the uroflowmetry reads as the flow peak.
Clinical Application ® FloPoint Elite Uroflow System Test Technique Incorporating the following into the FloPoint® Elite test procedure will materially enhance both the efficiency with which the test is done and the clinical utility of the test’s results: 1. The void should be performed with a comfortably full bladder.
® FloPoint Elite Uroflow System User’s Manual Clinical Application DIAGNOSIS CODE Bladder Neck Obstruction (acquired) 596.0 Hypertonicity of bladder 596.51 Low bladder compliance 596.52 Paralysis of bladder 596.53 Neurogenic bladder NOS 596.54 Detrusor sphincter dyssynergia 596.55 Other functional bladder disorder 596.59 Urethral stricture due to unspecified infection 598.00 Traumatic urethral stricture 598.1 Postoperative urethral stricture 598.
Clinical Application ® FloPoint Elite Uroflow System REFERENCES page 108 1. Abrams, P., Uroflowmetry, Urodynamics, 22nd ed. London, Springer-Verlag, 1997, pages 20-39. 2. Boone T.B. and Y. H. Kim, Chapter 4, Uroflowmetry, in Nitti, V. D. (ed), Practical Urodynamics, Philadelphia, W. B. Saunders, 1998, pages 28-37. 3. Chapple, C.A. and S. A. MacDiarmid, Urodynamics Made Easy, Chapter 3 Urodynamic Techniques: Flow Rate, New York, W.B. Saunders, 2000, pages 26-32. 4. Grino, P., B.
® FloPoint Elite Uroflow System Parts and Accessories Parts and Accessories Parts and Accessories FloPoint® Elite Uroflow System Components The following components are included with your FloPoint® Elite Uroflow System with ScanPoint® with QuickPrint system. Part and Part Number Name and Description FloSensor Measures urine volume and flow rate. The Handles suspend the FloSensor inside the toilet.
® Parts and Accessories Part and Part Number FloPoint Elite Uroflow System Name and Description ScanPoint® Remote: Acts as a remote control to start and stop the FloSensor, displays information on flow measurements and device status, and records voice annotation. 0570-0174 ScanPoint® Docking Station: Transmits data from the ScanPoint® Remote to the ScanPoint® host computer and recharges the Remote batteries.
® FloPoint Elite Uroflow System Part and Part Number Parts and Accessories Name and Description Box of Paper Funnels: Help direct the urine flow toward the FloSensor. Box contains 40 funnels. 0800-0297 Activation Tool: Use to press the Reset button on the ScanPoint® Remote if the Remote needs to be reactivated.
® Parts and Accessories Part and Part Number FloPoint Elite Uroflow System Name and Description FloPoint® Elite Mounting Bracket Template Aids in attaching the Mounting Bracket to the wall. 0900-1557 To order any of the above parts, contact your authorized Verathon Medical® Sales Representative or contact the Verathon Medical® Customer Care Department at 1.800.331.2313.
® FloPoint Elite Uroflow System Part and Part Number Parts and Accessories Name and Description USB Cable: Connects the ScanPoint® Label Writer to the ScanPoint® host computer. 0600-0233 Switching Power Adapter: Connects the Label Writer to the wall outlet. 0275-0002 Roll of Labels: Labels in roll format properly sized for the ScanPoint® Label Writer. 0125-0446 Power Cord: Connects the FloCharger to the wall outlet to charge the FloSensor battery.
® Specifications FloPoint Elite Uroflow System Specifications Specifications Symbol Directory The following table illustrates and explains the symbols that may appear on the FloPoint® Elite Uroflow System components and/or packaging. These symbols indicate the FloPoint® Elite system compliance with international and national standards and regulations.
® FloPoint Elite Uroflow System Specifications Specification Standard Electromagnetic compatibility standards IEC 60601-2, ICES-001 Safety Standard IEC 60601-1 Health Insurance Portability and Accountability Act (HIPAA)* *For details on Verathon® compliance with privacy rules, please refer to the information in the QuickPrint Help menu (select “Privacy Agreement”).
® Specifications FloPoint Elite Uroflow System regarding exposure in reasonably foreseeable environmental conditions to magnetic fields, pressure, or variations in pressure, acceleration, or thermal ignition sources.
® FloPoint Elite Uroflow System Specifications FloSensor Item Specification Sensory Type Spinning Disk Battery type Lithium Ion. 14.4 V, 2200 mAh Battery life A fully charged battery can perform approximately 30 exams within a 24-hour period. Charging Method Charge the FloSensor using the FloCharger installed on the Mounting Bracket. Charging Time No more than six hours from an empty battery to a full charge.
® Specifications FloPoint Elite Uroflow System Condition Specification Computer Regulatory Compliance The computer must minimally comply with the requirements of IEC 60950 and preferable with the requirements of IEC 60601-1. Computer Connection USB 1.1 Design Decoupled transformer at 200 mA at 4.2 V (25 kHz) Water Ingress IPX0 Accuracy Specifications The accuracy specifications assume the instrument is being used according to the instructions provided by Verathon®.
® FloPoint Elite Uroflow System Specifications Storage Conditions All components of the FloPoint® Elite Uroflow System are designed to withstand the following storage conditions: Condition Description Storage Indoor Ambient Temperature Range -10 - +35º Celsius (14 - 95º Fahrenheit) Atmospheric pressure range 50 kPa - 106 kPa Relative humidity 20% - 95% non-condensing Radio Specifications The FloSensor and ScanPoint® Remote communicate via a radio frequency that operates in the 2.
® Specifications FloPoint Elite Uroflow System Requirement Minimum Recommended USB Ports Two USB 1.1 ports Two USB 2.
® FloPoint Elite Uroflow System Specifications Condition Description Average print head life 2,000,000 linear inches (over 31 miles) / 50,800 linear meters Printer power requirements 24 VDC 1.75 A Regulatory approvals CE, FCC, cTUVus, GS and C-Tick Mounting Bracket and Related Equipment Specifications The ScanPoint® Label Writer meets the following specifications: User’s Manual Condition Description Mounting bracket material 16 guage 304 stainless steel Weight (mounting bracket alone) 6.
® Glossary FloPoint Elite Uroflow System Glossary Glossary page 122 Term Meaning Activate When the ScanPoint® Remote battery has been completely discharged, you may need to activate, or reset, the Remote before you can use it again. The Remote can be reactivated by pressing the recessed Reset button on the back of the unit using the supplied Activation Tool. Activation Tool The small tool used to depress the Reset button on the back of the Remote (see “Activate” above).
® FloPoint Elite Uroflow System Glossary Term Meaning Flow Interval Ends The end of a flow interval is identified by two consecutive samples with a flow rate less that 0.2 ml/s. Flow Interval Starts The start of a flow interval is identified by two consecutive samples with a flow rate greater than 0.5 ml/s. The actual start of the interval is selected to be the sample prior to the identifying samples where the flow rate is at least 0.2 ml/s.
® Glossary page 124 FloPoint Elite Uroflow System Term Meaning ScanPoint® Remote The remote control unit that receives exam data from the FloSensor via radio contact and transmits the exam data to the ScanPoint® host computer via ScanPoint® Remote Docking Station. ScanPoint® Imaging Technology The software and online service provided by Verathon® that prints exam results, maintains patient records, displays flow diagrams from exams, downloads software updates, and calibrates the FloPoint® Elite.
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