Verathon 0570-0175, 0570-0174 User Manual

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 Care

Damage or loss insurance is availability as part of the Total Reliability
this warranty, a service center authorized by Verathon
prove to be defective during the warranty period.

This warranty does not apply if the unit was misused or modified by anyone other than a
service center authorized by Verathon

The unit must be used in accordance with the instructions contained in this man ual.
Consumable items are not covered in this warranty and should be used in conformance
with Verathon

For further details, consult your Premium Warranty Total Customer Care
Warranty conditions may differ in some countries outside the United States. Contact your
local distributor for warranty terms.

Disclaimer of Additional Warranties

There are no understandings, agreements, representations of warranties expressed or
implied (including warranties of merchantability or fitness for a particular purpose) other
than those set forth in the preceding Warranty section. The contents of this manual do
not constitute a warranty.

SM

Plan. This warranty does not cover equipment sold as used.

®

product specifications.

SM

®

will repair or replace units that

®

.

Plan. Pursuant to

SM

Plan.

Some states disallow certain limitations on applied warranties. The purchaser, user, and
patient should consult state law if there is a question regarding this disclaimer. This
information, descriptions, recommendations, and safety notations in this manual are
based upon Verathon

®

experience and judgment with FloPoint® Elite as of July 2007. The
contents of this manual should not be considered to be all-inclusive, or to cover all
contingencies.

The physician who directs the use of the FloPoint

®

Elite Uroflow System at the institution

where it is in use is responsible for keeping current with clinical research in uroflowmetry.
Please direct any questions or problems concerning uroflowmetry, using the instrument,

or the interpretation of data to the responsible physician.

page 94 User’s Manual

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
Verathon

Corporate Headquarters (USA)

Verathon Incorporated
20001 North Creek Parkway
Bothell, WA 98011
USA

Verathon Medical B. V. (Europe)

Boerhaaveweg 1
3401 MN IJsselstein
The Netherlands

Verathon Medical Sarl (France)
Office Address:

Espace Europeen de l'Entreprise
2 allée d'Oslo
67300 Schiltigheim
France

®

Web site at www.verathon.com. If you have any questions or comments about

®

products and services, please contact us at:

Toll free: 800.331.2313 (US & Canada Only)

Tel: [phone]
Fax: [phone]
Web: www.verathon.com
Email: [e-mail]

Tel: [phone]

Fax: [phone]
Web: http://www.verathon.eu/
Email: [e-mail]

Postal Address:
BP 10039
F-67012 Strasbourg Cedex
France

Tel: [phone]
Fax: [phone]
Email: [e-mail]

Verathon Medical Ltd.
(United Kingdom)

The Granary Manor Farm Courtyard
Aston Sandford, Aylesbury

Tel: [phone]

Fax: [phone]
Web: www.verathon.co.uk/

Email: [e-mail]
Buckinghamshire, HP17 8JB
United Kingdom

Verathon Medical K. K. (Japan)

Executive Tower Azabudai 7F
1-4-3 Azabudai

Tel: [phone]

Fax: [phone]

Email: [e-mail]
Minato-ku
Tokyo, Japan 106-0041

User’s Manual page 95

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. By
contrast, the FloPoint
When a flow of urine hits the disk, the motor must work harder to maintain the disk
spinning at that same speed with the added weight of the urine. The FloSensor measures
the amount of power needed to maintain the disk’s original speed and uses that
measurement to calculate the urine flow rate. The FloSensor also records the total
amount of urine discharged by the patient.

Indications

In general, uroflowmetry is used as a screening test to determine which patients with
symptoms or clinical conditions involving the lower urinary tract should be referred for
further workup (e.g., urodynamics, cystography). The most common clinical application of
uroflowmetry is to provide an objective indication of a low urine flow rate caused by
bladder outflow obstruction – especially in males with symptoms suggestive of benign
prostatic hypertrophy. Uroflowmetry is also often included in the workup of females with
urinary incontinence.

®

Elite FloSensor contains a disk that spins at a constant speed.

Clinical Condition or History Suggestive Of:

 High bladder outlet resistance. Examples include prostatism (the most

common indication), lower urinary tract infection and previous lower urinary
tract surgery.

 A decompensated bladder or weak detrusor contraction.
 Neurologic impairment of voiding. Examples include multiple sclerosis and

spinal cord injury.

Specific Signs and Symptoms:

 Prolonged or interrupted voiding.
 High residual urine.
 Manually assisted voiding (e.g., by applying pressure to the lower abdomen).
 Excessive straining required to void.

FloPoint

The FloPoint
seconds. Several measurements are taken from the FloPoint

®

Elite Output

®

Elite Uroflow System plots urine flow rate in ml/second versus time in

®

Elite curve, either

manually by the clinician, or automatically by a digital processor.

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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). Therefore, by itself,
uroflowmetry cannot determine the cause of a reduced flow rate.

However, many clinicians with uroflowmetry experience contend that uroflowmetry can
provide useful clinical information by itself, particularly in men. For example, Boone and

2

Kim

state that if a patient complains of a reduced flow of urine, but there are no other
signs or symptoms of voiding dysfunction and uroflowmetry is normal, it is unlikely that
further urodynamic testing will reveal an abnormality. Chapple and MacDiarmid
“Simple uroflowmetry by itself is adequate investigation for uncomplicated prostate­mediated bladder outflow obstruction in over 60% of patients. McLoughlin, et al
that an abnormally reduced maximum urine flow rate is a reliable indicator of obstruction
in over 90 percent of men with prostatic symptoms. Also, Abrams
Ostergard

7

state that in female patients with urinary incontinence an abnormally high flow

1

and Sand and

rate and short duration void sometimes provides a useful suggestion of detrusor
instability and/or abnormally reduced outlet resistance.

3

state:

5

found

Quantitative Measurements

Figure 33 diagrams the measurements taken from the FloPoint

®

Elite curve. Table 1

summarizes the definitions and normal results of these measurements.

Flow Rates

Both maximum and average urine flow rates are strongly dependent on voided volume
and the patient's age and sex.

NOTE: In subsequent FloPoint Elite Report Charts (Figure 33 through Figure 42 ), flow
rate is represented by the letter Q.

User’s Manual page 97

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 b y

divided total volume voided by flow time. B. Measurements of flow time and voiding time from an
intermittent uroflow curve.

A.

B.

Table 1. Measurements from the FloPoint® Elite Curve (see Figure 33)
MEASUREMENTS DEFINITION NORMAL RESULTS

Peak Flow Rate Maximum measured flow

rate excluding dribble­produced or other spikes.

Depends on age, sex and
voided volume. Rarely
exceeds 40 ml/sec.
Clinical significance is
questionable with
irregular flow patterns.

Average Flow Rate Voided volume divided by

flow time.

Typically is about half of
Peak Flow.

page 98 User’s Manual

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.

Time to Peak Flow Time from flow onset to

peak flow.

About 30 percent of
voiding time. Has no
clinical significance with
irregular flow pattern.

Measurements Related to FloPoint

®

Elite Curve Patterns

Time to peak flow rate, flow time and voiding time do not provide the same quantitative
“normal” versus “abnormal” results as do flow rates. However, as discussed in the next
section, these measurements can provide useful indications of the FloPoint

®

Elite curve’s

shape.

Continuous/Regular Patterns:

 Normal: A normal FloPoint® Elite pattern is a smooth unbroken, bell-shaped

curve with peak flow occurring relatively early. (Time to peak flow averages
about 30% of total flow time.) Figure 34 shows an example of a normal
uroflow curve.

User’s Manual page 99

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. Superflow Pattern

 Obstructive:

Patterns suggestive of bladder outlet obstruction (BOO) are characterized by
a prolonged flow time during which a large part of the total voided volume is
voided at a constant low flow rate. Figure 36 and Figure 37 show examples
of “obstructive” flow patterns.

page 100 User’s Manual

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. There are two types of irregular flow patterns: a “fluctuating” flow
pattern, in which the repeated downward deflections do not fall below a measurable
flow rate, and an “intermittent” flow pattern characterized by the occurrence of
interruptions of varying durations between voiding episodes. Figure 38 shows an
example of a fluctuating flow pattern caused by abdominal straining: Figure 39 shows
an example of an intermittent flow pattern caused by detrusor-sphincter dyssynergia.

User’s Manual page 101

Clinical Application FloPoint® Elite Uroflow System

Figure 38. Fluctuating Pattern Caused by Abdominal Straining

Figure 39. Abnormal Intermittent Pattern, Caused By Detrusor Sphincter Dyssynergia

Clinical Significance

Whether an irregular uroflow pattern or urethral sphincter relaxation are lost cau sing the
detrusor to push intermittently against a contracted urethral sphincter, irregular traces can
also be caused by fluctuating or poorly sustained detrusor contractions, which are
generally seen in patients with a neurological abnormality – most commonly multiple
sclerosis.

1

Artifactual Causes

As discussed previously, irregular traces can be caused by a male patient moving his
stream across to the collecting funnel (“cruising”) or intermittently squeezing the tip of the
penis or foreskin during voiding.

1

Figure 40 and Figure 41 show examples of these two
types of artifactual irregular patterns. Anxiety, as might be caused by the unfamiliar
laboratory environment, can also cause an irregular trace in normals.

page 102 User’s Manual

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.

Using Flow Time and Voiding Time to Help Identify the Curve Pattern

A long time to peak and a long flow time can help confirm a subjective impression of an
“obstructive” flow pattern.

Comparing flow time with total voiding time provides a quantitative indication of an
interrupted flow pattern’s severity – the greater the difference between voiding and flow
times, the more severe the interruption.

Summary of Diagnostic Significance

Table 2 summarizes the diagnostic significance of abnormal FloPoint

®

Elite test results.

User’s Manual page 103