Liberty Ammunition Inc.

Ultroid®
In-Service
REV UIS 4.20.2010a
Our duty
At Ultroid, we are committed to educating
providers and patients of the world about
Hemorrhoidal Disease (HD)
and
The Painless Solution to HD
Training = Success
Proper training
Effective treatment
Happy
Patients
Happy
Doctors
New Standard of care for treatment of HD
Win, win, win, win!!!
• Patients
• Providers
• Health Care System Costs
• Employers
Ultroid® In-Service
In-Service
Objectives
Objectives for In-service:
1. Create a satisfied, loyal Ultroid Provider Base
2. Mastery of the Ultroid procedure
3. Facilitating communication between the Ultroid
Provider and Patient
4. Encourage staff involvement: increase
procedure volumes and patient referrals
Objective 1:
Satisfied and Loyal Ultroid Provider
• Well trained providers, including PA’s and
ARNP’s, are confident performing the Ultroid
Procedure
• Confident, well-trained providers create optimal
results and positive patient experience
Objective 2: Mastery of the
Ultroid ®Procedure
• Improve patient outcomes
• Increase patient satisfaction
• Improve treatment success rate
• Instill confidence in the Ultroid® Provider
• Increase utilization
• Increase non-invasive treatments: grades III & IV
• Prevent under treatment
Objective 3: Facilitating Patient
Communication
Recognize the Obstacles:
•
Embarrassment
•
Fear of the unknown
•
Knowledge of pain associated with other
treatment modalities
Address the obstacles
• Ask about HD on new patient questionnaires
• Ask patients about HD symptoms at each visit
• Market the product in your office
• Encourage the staff to inform your patients of the
addition of Ultroid to your practice
• Offer patients the Ultroid Solution
Connecting to the Patient
Educate Patients
• “You are not alone, HD affects millions…”
• “This condition can be easily treated…”
Communicate
• Address patient concerns
• Educate patients on the benefits of Ultroid
• Address misconceptions
Offer a Solution
• Ultroid
The In-Service Protocol
The In-Service Protocol
• Ultroid® Overview
• Ultroid® Hemorrhoid Management System (UHMS)
• Patient Examination
• Ultroid® Procedure
Ultroid ® Overview
• Indications
• Contraindications
• What is Ultroid®?
• How does Ultroid® work?
Review the Indications:
• Ultroid® is indicated for the treatment of INTERNAL
HEMORRHOIDS, Grades I-IV.
• Ultroid® may be used to treat the INTERNAL portion
of a MIXED hemorrhoid.
• Ultroid® is NOT to be used to treat EXTERNAL
hemorrhoids.
Review the Contraindications:
• Pregnancy
• Pacemaker/defibrillator implant
• Bleeding disorder
• Anticoagulant therapy
• Active anorectal infection
• Inflammatory Bowel Disease
• Lower abdominal/lower quadrant transplant patients
• Purely external hemorrhoids
What is Ultroid®?
• Ultroid® is a quick, easy, painless and proven
solution for HD
• An office-based treatment for all grades of
internal hemorrhoids.
• Ultroid® is a medical device which applies a very
low direct current to the base of the hemorrhoid
via a hand-held probe.
How does Ultroid® work?
• Ultroid delivers a very low (negative galvanic)
direct current to the hemorrhoid via the probe tips
• Ultroid® causes a reaction in tissues which
results in regression of the hemorrhoid.
• In theory, the effect of Ultroid® is a chemical
reaction which results in thrombosis of the
feeding vessel.
The Ultroid® System
• Unit components
• Unit assembly
• Operational Safety Test
• Exam Room Set Up
Components
• Ultroid® System Converter
• Ultroid® Control Handle
• Ultroid® Reusable Patient Pad
• Patient Pad Connection Cord
• Ultroid® Control Handle Connection Cord
• Power Cord (Converts AC to Low DC Current)
• Ultroid® Single-use Procedure Kit
Procedure Kit Components
• Single-use sterile probe
• Single-use anoscope
• Single-use sponge for grounding pad
FAQ: why are there 2 probe tips?
The current only flows to the patient it does
not flow between the tips, each tip has a
2.5mm area of affect together they cover a
surface are of .5cm
Assembly of the Ultroid®
Reusable Patient Pad
• Place the Ultroid® Single-use
Patient Pad Sponge into the
Ultroid® Reusable Patient Pad
• Saturate the Patient Pad Sponge with 0.9% NORMAL
SALINE
• Do not use sterile water, distilled water, tap water, etc.
The unit will not conduct properly without normal saline
solution.
Assembly of the Ultroid®
Reusable Patient Pad
• Insert either end of the Patient Pad Connection Cord into
the Ultroid® Reusable
Patient Pad.
• Confirm a secure connection between Patient Pad
Connection Cord and the receiving bracket of the Patient
Pad
• Insert the other end of the Patient Pad Connection
Cord into the socket of the Ultroid® System Converter.
Assembly of Ultroid® Control Handle
• Plug Control Handle Connection into the Ultroid® Control
Handle by aligning the white placement dots on the
Control Handle and Connection Cord.
• Rotate clockwise to lock
and secure the connection .
• Plug the Handle Connection Cord into the “HANDLE”
Socket of the Ultroid® System Converter by aligning the
white placement dots on the “HANDLE” Socket and
Connection Cord. Rotate clockwise to lock and secure the
connection
Assembly of Ultroid® Control Handle
• Without removing the clear plastic
probe sleeve, insert the Ultroid®
Single-use Probe into the
corresponding receptacle of the
Ultroid® Control Handle.
NOTE: Probe may be inserted with tips in the vertical or
horizontal position, depending upon the location of the
hemorrhoid.
Assembly of Ultroid® System Converter
• Plug the Power Cord into the power socket of the Ultroid®
System Converter.
• Ensure that the unit power switch is set to OFF prior to
plugging the unit into a wall outlet.
• Ensure that the plug component fits with the appropriate
wall socket configuration.
• Plug the power cord into the appropriate wall outlet.
Operational Testing
• Prior to patient treatment, the operational test should be
performed to ensure proper performance and allow
diagnosis of technical malfunctions.
• To perform the Operational Testing on the Ultroid®
System, a closed circuit must be established.
• To initiate power, set the power switch to ON.
• The Ultroid® Control Handle will illuminate, indicating
power has been established.
• Remove the clear plastic probe sleeve. The UHMS is now
ready for Operational Testing.
Operational Testing
• Place the probe tips firmly against the saline soaked
Ultroid® Patient Pad Sponge
• Press “TEST” button while touching the probe to the
Patient Pad Sponge.
“TEST”
Operational Testing
• The timer display and mA bar graph will be blank and a
blinking dot will appear in the timer display indicating the
operational test is complete.
If the “TEST” passes, you may proceed with the procedure.
Troubleshooting:
If the timer display reads “88.88”, the test has FAILED.
Check the following:
1. The grounding pad sponge is thoroughly saturated
with SALINE.
2. The grounding pad sponge is in direct contact with the
patient’s skin.
3. The grounding pad cord is securely connected to
grounding pad bracket and converter.
Operational Testing Failure
• If the test FAILS, “88.88” will appear in the time
display
• Test failure prohibits the start of a procedure.
• This state will persist until the test is passed.
Reasons for Failure of Operational Test:
1. Sponge is not thoroughly soaked with saline or if
the resistance is too high
2. Poor contact of grounding pad sponge and patient
3. Poor connection of grounding pad connection cord
and grounding pad or converter
Exam Room Set Up
• Set up the exam room to facilitate provider comfort. The
provider will be holding the probe in one position for
several minutes.
• The importance of provider and patient comfort cannot be
underestimated.
Exam Room Set Up
Ensuring Provider Comfort
• Choose a chair with adjustable seat height for the
provider.
• Position the chair to a height at which the provider can
comfortably visualize the treatment area.
• Position the patient so the provider can rest his/her
arm/elbows on the exam table.
• Adequate lighting is necessary for optimal visualization
(i.e. gooseneck lamp, headlight, etc.)
Patient Positioning
• When possible, the patient should
be in the lateral position
(i.e. lying on his or her side) with their buttocks toward the
edge of the table.
• The patient may bring their knees toward their chest, to
provide optimal position for insertion of the anoscope and
visualization of the treatment area.
• The assistant may also help the patient to position his or
her legs. Additionally a pillow may be placed between the
legs.
Nursing or Medical Staff Assistance
• The provider may choose to have an assistant in the
procedure room to hold the anoscope in place and assist
with patient positioning.
• The optimal position for the assistant is to stand in front of
the patient facing the doctor. The assistant places his or
her gloved hands on the plastic winged tips of the
anoscope.
Grounding Pad Placement
• The grounding pad is placed
under the weight bearing thigh.
• The pad should be between
the table and the patient’s thigh.
• There should be direct contact with the saline soaked
sponge and the patient’s skin.
Grounding Pad Placement -continued
• Ensure the connecting plug is visible and not under the
thigh.
• In the event the plug becomes disconnected it will be in
plain view of the provider and his/her staff.
• The sponge MUST be completely and thoroughly
saturated with SALINE solution.
Management of Patient Expectations
PAIN vs. DISCOMFORT
The Anoscope:
• The anoscope is uncomfortable, but should not be painful.
• The patient should be warned that the anoscope may
cause discomfort.
• The provider may use a lubricant that contains 2%
Lidocaine as it is more comfortable for the patient and will
not alter the treatment outcome.
• The patient may also feel the need to defecate.
• Reassurance is most helpful.
Management of Patient Expectations
The Ultroid® Procedure:
• The procedure should NOT be painful.
• The PATIENT IS THE GUIDE when determining the
current level to be used.
• Communication and patient feedback is essential!
• If the patient experiences pain, this is an indication that
the treatment is too close to the dentate line. Reposition
the probe tips to a more PROXIMAL position on the
hemorrhoid.
• The more gradual the increase of current, the more
tolerable the procedure will be for the patient.
Patient Examination
• Correct diagnosis is made by a comprehensive internal
and external anal examination.
• Anorectal evaluation consists of three parts: inspection,
digital rectal examination and anoscopy.
Three Part Examination
• External exam
• Digital exam
• Anoscopic exam
External Examination/Inspection
• The external examination involves visual inspection of the
area.
• With the patient in the lateral recumbent position, wearing
gloves, use gentle traction to separate the glutei.
• Perform a standard external anal exam looking for
redundant anal tissue, hypertrophied anal papillae,
abscesses, anal fissures, fistulae, perianal dermatitis,
masses, external hemorrhoids, thrombosed hemorrhoids,
rectal prolapse, condyloma, or other pathology.
Digital Rectal Examination
• Digital rectal examination
is necessary to palpate for
masses, hemorrhoids,
or other pathology.
• In men, the prostate
should be examined as well
• While wearing gloves, use lubrication or Xylocaine® jelly
to perform a 360 degree finger sweep to feel for the
presence of any masses or other pathology.
Anoscopic Examination
• An anoscopic exam is
performed to visualize the
entire circumference of the
anal canal.
Anoscopic Examination
1. Use a lubricated anoscope with the operative port (sideviewing slot) for the anoscopic exam.
2. SLOWLY insert the lubricated anoscope into the anal
canal. Slow introduction fosters patient comfort!
3. Remove the obturator slowly to avoid a vacuum effect
and examine the area protruding through the operative
port.
Grading Internal Hemorrhoids
4. If hemorrhoids are present, determine the grade. To do
this, ask the patient to “strain.”
• Determine if the protruding hemorrhoids are prolapsing
down the anal canal.
• Grade and map any internal hemorrhoids present
NOTE: Grading is based on the degree of prolapse and
cannot be done with the anoscope in place. The
preferred method is performed with the patient
standing slightly bent over and straining.
Grading Internal Hemorrhoids
• Grade I hemorrhoids will project into the lumen, but do not
prolapse with straining and may or may not show signs of
active bleeding
• Grade II hemorrhoids will prolapse through the operative
port and spontaneously retract into the anal canal when
patient stops straining.
Grading Internal Hemorrhoids
• Remove the anoscope. If the hemorrhoid tissue remains
prolapsed, determine if the hemorrhoid can be manually
reduced into the anal canal. Ability to manually reduce
indicates a grade III hemorrhoid.
• If the tissue is not reducible and is affixed to the outside of
the anal canal, it is a grade IV hemorrhoid. Generally
these are noted on the external examination and can be
confirmed during the retraction of the anoscope.
Anoscopic Examination -continued
5. In addition to determining hemorrhoid grade and
position, examine the hemorrhoids for signs of
inflammatory changes, bleeding, hypertrophied anal
papilla and other pathology.
6. Replace the obturator to move the involved tissue out
of the way of the operative port before rotating the
anoscope to the next segment.
7. Continue in this manner to examine the entire
circumference of the anal canal.
Anoscopic Examination -continued
8. Determine and note the grade of each
segment.
• Each of the four quadrants of the anal
canal can be divided into two equal
areas to help localize the hemorrhoid.
• By rotating the anoscope, the entire anal canal is viewed
and the position of pathology is noted.
• Be sure to examine each segment separately.
Documentation
9. Map segment location and
grade of hemorrhoid
Segment Location
1_______________
2_______________
3_______________
4_______________
• Be sure to note patient’s
position (i.e. right or left lateral)
5_______________
6_______________
7_______________
Hemorrhoid Grade
This information is useful at
follow up visit.
0 – Normal
1 – Grade I
2 – Grade II
3 – Grade III
4 – Grade IV
8_______________
_
The Ultroid® Procedure
Prior to treatment
As previously outlined, the following steps MUST be
completed prior to the start of the Ultroid® Procedure:
1. Assemble Ultroid® Hemorrhoid Management System.
2. Place the Ultroid® Reusable Patient Pad with the
saturated (0.9% normal saline solution) sponge surface
in direct contact with the patient’s skin under the
dependent thigh (weight bearing thigh).
3. Perform Operational Safety Test.
4. Complete an anorectal examination.
5. Document segment location and grade.
The Ultroid® Procedure
1. Isolate the hemorrhoid to be treated in the side-viewing
slot of the anoscope.
•
In most instances, it is appropriate to treat the highest
grade of hemorrhoid first.
The Ultroid® Procedure
Probe Orientation
•
•
Probe is placed in the control handle so tips are
vertical
for hemorrhoids in the anterior (A) and
posterior (P) locations.
Probe tips are horizontal
for hemorrhoids in the left
(L) and right (R) locations.
In this example, patient is in
the right lateral position.
Left (L)
Right
Posterior
Right Anterior
The Ultroid® Procedure
Probe Positioning
2. Place the Ultroid® Single-use Patient Probe tips onto
the hemorrhoid at the base of the feeding vessel and not
on the body.
• Be sure the probe tips are applied to the hemorrhoidal
tissue above the dentate line to avoid causing pain to
the patient. Penetration should be avoided.
The Ultroid® Procedure
Starting the Procedure
3. Press “START” button to begin the timer. The handle
timer will increase every second up to 99.59.
NOTE: there is NO current generated at this point.
“START”
Troubleshooting:
If depressing the “START”
button does not start
clock, the operational test
must be repeated. See
Operational Testing slides
The Ultroid® Procedure
Increasing the current
4. To initiate current, press the “UP” button and the
current applied will increase 1mA with each
depression.
mA indicator bar
Each click of “UP”
Increases current
by 1mA
Each bar represents 2mA
The mA bar indicates current increases in increments of
2 mA per bar.
The Ultroid® Procedure
5. GRADUALLY increase the current slowly to a maximum
setting of sixteen (16) milliamperes, or until the patient
experiences any discomfort.
• A gradual increase of current over one to two minutes
is tolerated best.
• Each patient will have a different tolerance level, the
patient is the guide for treatment level.
The Ultroid® Procedure
•
If a patient does not tolerate the next level, reduce the
current by depressing the “DOWN” button. Remain at
tolerated current for 30-60 seconds, then reattempt
current increase by pressing the “UP” button.
Each click of
“DOWN”
decreases
current by 1mA
•
If the patient experiences sharp pain or increased
discomfort with the start of a treatment or at any time
during treatment, reposition the probe tips proximally
and start again.
The Ultroid® Procedure
BREAKING TISSUE CONTACT:
If the user lifts the probe from the tissue,
the current terminates; however, the
timer display will continue to count. Timer
mA indicator bar
• To restart the current after breaking tissue contact,
simply reposition the probe tips and then press the “UP”
button until desired current level is reached.
• NOTE: Be sure to monitor the mA indicator and not the
clock, as the timer will continue to count even in the
absence of current.
The Ultroid® Procedure
• IMPORTANT: Pressing the “DOWN” button until the mA
indicator lights disappear (i.e. current is zero) and the
handle timer display indicates 00.00 will terminate the
procedure. In order to restart the procedure the
operational test must be repeated.
Troubleshooting:
The current will not increase and the timer display
indicates 00.00. If depressing the “START” button
does not start clock, and depressing the “UP” button
does not initiate current, the operational test must be
repeated. See Operational Testing slides
The Ultroid® Procedure
Identifying treatment is working
6. During the treatment, you may note a color change of
the treated area. Occasionally, popping sounds will be
heard and foaming is often seen.
The Ultroid® Procedure
Length of treatment
7. There are several ways to determine when to stop the
treatment.
• Continue treating the hemorrhoid until it has darkened
in color, the popping sounds cease, and/or until you
reach the recommended treatment time for the specific
hemorrhoid Grade (See “Treatment Time
Recommendations” slide).
• NOTE: color change and the popping sound of gas
release at the probe tip are present with significant
variability and become more useful as indicators of a
successful treatment after experience by the practitioner
is gained.
The Ultroid® Procedure
Length of treatment
8. Length of treatment is a function of the hemorrhoid
grade and the current tolerated.
• The treatment time is clearly indicated on the Ultroid®
Control Handle in minutes and seconds (00.00).
• Successful treatment is dependent upon maximum
current used and duration of treatment
• Treatment time increases or decreases depending on
milliamperage tolerated by the patient.
• As a general rule, the higher the current applied, the
shorter the procedure. Conversely, the lower the current
applied, the longer the procedure.
The Ultroid® Procedure
Length of treatment
• Effective treatment is a function of the maximum current
used and the duration of the treatment, known as the
milliampere-minute product (mA x min).
• The milliampere-minute product is directly correlated with
disease grade.
• Using the average milliampere-minute product necessary
for hemorrhoid resolution*, treatment times were
calculated for each grade and maximum current applied.
• Maximum current applied is determined by the patient’s
tolerance.
* Norman, Daniel A. et al. Direct Current Electrotherapy of Internal Hemorrhoids; An Effective, Safe,
and Painless Outpatient Approach. Am J Gastroenterol. 1989 May; 84(5):482-7
Treatment Time Recommendations
NOTE: These tables are intended serve as a guide and should be
used in conjunction with the visual clues previously outlined.
Treatment Time Recommendations
NOTE: These tables are intended serve as a guide and should be
used in conjunction with the visual clues previously outlined.
The Ultroid® Procedure
Termination of treatment
9. When treatment is complete, depress the “DOWN”
button on the Ultroid Control Handle until the mA indicator
disappears (all milliamperage indication lights are off) and
the handle timer reads 00.00.
10. Lift the Ultroid® Single-use Patient Probe from the
hemorrhoid tissue.
11. Remove and dispose of Single-use anoscope.
12. DISCARD THE PROBE IN AN APPROPRIATE
BIOHAZARD CONTAINER AFTER USE.
13. Remove and dispose of Single-use grounding pad
sponge.
Cleaning Reusable Components
12. Clean reusable parts.
• At the conclusion of an Ultroid® treatment, carefully wipe
the control handle and reusable patient pad with alcohol
solution.
• NOTE: Do not allow any liquid to enter the nose piece of
the control handle. Do not immerse any of the Ultroid®
Hemorrhoid System’s components into liquid.
• The Ultroid® System Converter can be wiped down with
alcohol solution. NOTE: Do not allow any liquid to enter
any of the plugs, connectors, or openings on the unit.
Patient Re-examination
• The treated hemorrhoid segment should be re-examined
approximately 10-14 days post treatment.
• If the treated hemorrhoid segment is improved but not
resolved, additional treatment(s) may be warranted.
• Global billing periods may apply.