Ultroid Technologies, Inc.

Ultroid Technologies, Inc.
6023 South 2nd Street
Tampa, FL 33611-4707
Ultroid® Hemorrhoid
Management System
(3053)
ULTROID® MODEL 3053
OPERATING & MAINTENANCE
MANUAL
0470
CAUTION: Federal law restricts this medical device to sale by or on order of a licensed
physician.
Ultroid Technologies, Inc.
www.Ultroid.com
1
Rev 10.5.2010a
Contents
Service Policy
System Usage and Scope of Application
Product Description
Product Specification and UHMS Components
Product Safety Information
Ratings Label
Warranty
Ultroid® Product List
Contraindications
Cautions
Instructions for Pre-treatment Exam
Assembly and Use of the UHMS Operational Testing
Proper Patient Pad Placement Procedure
Treatment Time Recommendations
Review
Cleaning Instructions for UHMS:
Ultroid® Single-use Patient Probe
Ultroid® Control Handle
Ultroid® System Generator Contraindications for Use
Anatomy
Sample Patient Consultation
Sample New Patient Questionnaire
Grading of Hemorrhoids
User Agreement
Physician Marketing Tool Kit
Rev 10.5.2010a
2
3
3
3
4
5
6
7
8
9
9
10
11
14
15
15
17
18
19
19
19
19
20
21
22
23
24
28
To Ultroid Technologies, Inc. Licensed Physician Clients:
Ultroid® Technologies, Inc. requires that you read and follow the instructions
in this manual and view the instructional segments of the resource CD, to
ensure maximum performance of your Ultroid® System.
maintenance will extend the life of your equipment.
Proper care and
Should you have any
questions regarding care or operation of the Ultroid® System, contact a
customer service representative at www.Ultroid.com or obtain a contact
number from your local distributor.
Service Policy:
If equipment is in need of repair please contact your local distributor or
Ultroid® customer service at 1 (877) 858-0555 or info@ultroid.com.
System Usage and Scope of Application:
Ultroid®
Hemorrhoid
Management
System
Term:
Electrotherapeutic
direct
current system.
Intended Use/ Scope of Application: Elimination of all grades of internal
hemorrhoids.
Statement
of
Intended
Use:
The
Ultroid®
Hemorrhoid
Management
System is intended for physician use only. It is intended for coagulative
hemostatic therapy of internal hemorrhoids grades I, II, III, IV.
Product Description:
The
Ultroid®
Hemorrhoid
electrotherapeutic
devices
Management
designed
to
System
apply
a
is
an
assembly
galvanic
direct
of
current
to the mucosal tissue surface of symptomatic internal hemorrhoids for their
elimination. It consists of a main electricity (AC-powered) generator which
produces direct current in milliamperes (mA) passed via a patient pad,
through the body, to a probe (an electrode) applied to the hemorrhiodal
tissue, a hand piece, and electrical cables. The tissue is subjected to
mild
electrical
current
creating
a
biochemical
reaction
that
interrupts
the hemorrhoid vasculature and shrinks the hemorrhoids. It may also be
battery powered. The system is constituted of plastic, steel and metal.
Rev 10.5.2010a
3
UHMS Product Specifications:
Ultroid Hemorrhoid Management System primary components consisting
of the Ultroid System Generator, Ultroid Control Handle, Ultroid Reusable
Patient Pad, & Ultroid Single-use Procedure Kit. The Procedure Kit contains
the following items: Ultroid Single-Use Probe, Ultroid Single-use Patient Pad
Sponge, and an Ultroid Single-use Anoscope.
UHMS System Components:
Ultroid Reusable Patient Pad: The patient pad is a non-active, positive
conductor that is connected to a hemorrhoid management system generator to create a circuit for the flow of direct current in milliamperes (mA)
to the negative electrode (a hand-held probe contacting the hemorrhiodal tissue) allowing direct galvanic current to pass through internal
hemorrhoidal tissue. The pad is placed under the patient’s body where
the greatest surface area can be covered, (e.g., the thigh) and is connected to the generator via an electrical connection cord. It requires the
insertion of a Single-use Patient Pad Sponge soaked with saline solution
for conduction. This is a reusable device that can be disinfected after
each procedure. The pad is not intended to be sterile. The Ultroid Patient
Pad dimensions are 17.145 cm by 8.89 cm. The Pad is constituted of metal,
plastic and rubber.
Ultroid Hemorrhoid Management System Procedure Kit: A collection of non-sterile and
sterile devices to be used in conjunction with the system to facilitate the procedure of
electrically eliminating all grades of internal hemorrhoids. It includes a tissue contact
electrode (a hand-held probe), a Patient Pad Sponge, and a disposable anoscope. This
is a single-use package. The Procedure Kit is constituted of plastic, synthetic sponge,
and stainless steel.
Ultroid Single-use Probe: a sterile, probe-like, electrode designed with two monopolar
electrical conductors (negative electrodes) at the terminal end intended to conduct
direct current to the mucosal surface of symptomatic internal hemorrhoids. This device
is inserted into the hand piece of the hemorrhoid management system and connected
to the generator via an electrical connection cord. The Probe is a single-use device. It is
made of stainless steel, plastic and thermal plastic for insulation of its extended shaft.
Ultroid Single-use Patient Pad Sponge: a non-sterile, absorbent, device
used to facilitate conduction of direct current from a hemorrhoid management system Patient Pad (the positive conductor) through the patient’s body to a probe (the negative electrode) applied to the hemorrhoid. It is inserted into a dedicated slot in the Patient Pad, moistened with
normal saline solution, and applied directly to the patient’s skin surface
where there is no therapeutic effect intended, (e.g., under the thigh). The
Patient Pad Sponge is a single use device constituted of synthetic sponge.
Ultroid Single-use Anoscope: An endoscope with a rigid inserted portion
that is used for the visual examination and treatment of the anus and
rectum. It is inserted into the body through the anus during the procedure
called an anoscopy. The inserted portion is quite short in length, though
longer than a sphincteroscope, and larger in diameter, and an obturator
is typically inserted into its lumen to assist the insertion. This is a single-use
device measuring 90 mm in length by 18mm in diameter, constituted of
plastic.
Rev 10.5.2010a
4
Ultroid Technologies, Inc.
6023 South 2nd Street
Tampa, FL 33611-4707
Phone: 001.877.858.0555
Product Safety Information:
Ultroid Hemorrhoid Management System
: 3053
Electrical Class:
Class II
Degree of Protection:
BF
0470
Voltage: 100 - 240 V
Frequency: 50/60 Hz
Power: 25 VA MAX 5.1 Volts DC
Ambient Temperatures: Room Temperature
Fuse: T1A, 250V (X2)
IEC 60601-1
CAUTION !
TO REDUCE THE RISK OF ELECTRIC SHOCK,
DO NOT OPEN THE UNIT.
REFER SERVICING TO QUALIFIED SERVICE PERSONNEL.
WARNING !
DANGER!
HAZARDOUS ELECTRICAL
RISK OF EXPLOSION IF
OUTPUT. THIS EQUIPMENT
USED IN THE PRESENCE OF
IS FOR USE ONLY BY
FLAMMABLE ANESTHETICS.
QUALIFIED PERSONNEL.
PATIENT CONNECTION IS
ELECTRONICALLY
ISOLATED.
Rev 10.5.2010a
5
Ultroid® Technologies, Inc.
Tampa, FL 33611
Ratings Label
DO NOT REMOVE LABEL
Reference Number
Serial Number
Electrical Class
Protection Class
Voltage In
IEC 60601-1
0470
Voltage Out
Symbol Key:
: Symbol for “MANUFACTURER”
(the person placing the device on the market)
: Symbol for “CAUTION”
: Symbol for “PROTECTION CLASS”
(special attention to be paid to instructions for use)
: Symbol for “CATALOGUE NUMBER”
(the manufacturer’s catalogue number for the device or part)
: Symbol for “SERIAL NUMBER”
(the manufacturer’s unit tracking number)
: Symbol for “ELECTRICAL CLASS”
(Electrical Class II Device)
(Protection Class BF Device)
: Symbol for “VOLTAGE IN”
(100-240V , 50/60 Hz , 25 VA)
: Symbol for “VOLTAGE OUT”
(5.1VDC _ _ _, 0.25A)
Rev 10.5.2010a
6
ONE YEAR MANUFACTURER WARRANTY:
Important:
Evidence of original purchase is required for warranty
service including the return of the executed User Agreement as set forth
on page 24, herein. WARRANTOR: Ultroid Technologies, inc. (“Ultroid®”)
ELEMENTS OF WARRANTY: Ultroid® warrants for one year, to the original
retail owner/End-User, the Ultroid® System Generators - 110/220 Volt
and the Ultroid® System Generator - Battery-powered (the “Product”)
only, to be free from defects in materials and workmanship with only
the limitations or exclusions set out below. WARRANTY DURATION: This
warranty to the original retail owner/End-User shall terminate and be
of no further effect 12 months after the date of original retail sale. The
warranty is invalid if the Product is (A) damaged or not maintained as
reasonable or necessary, (B) modified, altered or used as a part of any
other product or subsystem or configuration not sold by Ultroid®, (C)
improperly used or configured, (D) serviced or repaired by someone
other than an authorized Ultroid® service center for a defect or
malfunction covered by this warranty, (E) used in any conjunction
with equipment or parts or as part of any system not manufactured
by Ultroid®, or (F) installed or programmed by anyone other than as
detailed in the Ultroid® Hemorrhoid Management System Operating
and Maintenance Manual for the Product. STATEMENT OF REMEDY: In
the event that the Product does not conform to this warranty at any
time while this warranty is in effect, warrantor will either, at its option,
repair or replace the defective unit and return it to you without charge
for parts, service, or any other cost (except shipping and handling)
incurred by the warrantor or its representatives in connection with
performance of this warranty.
Warrantor, at its option, may replace
the unit with a new or refurbished unit. THE LIMITED WARRANTY SET
FORTH ABOVE IS THE SOLE AND ENTIRE WARRANTY PERTAINING TO THE
PRODUCT AND IS IN LIEU OF AND EXCLUDES ALL OTHER WARRANTIES OF
ANY NATURE WHATSOEVER, WHETHER EXPRESSED, IMPLIED OR ARISING
BY OPERATION OF LAW, INCLUDING, BUT NOT LIMITED TO ANY IMPLIED
WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE. THIS WARRANTY DOES NOT COVER OR PROVIDE FOR THE
REIMBURSEMENT OR PAYMENT OF INCIDENTAL OR CONSEQUENTIAL
DAMAGES.
Some states do not allow this exclusion or limitation of
incidental or consequential damages so the above limitation or
exclusion may not apply to you. LEGAL REMEDIES: This warranty gives
you specific legal rights, and you may also have other rights which
vary from state to state. This warranty is NOT void outside the United
States of America. If you are outside of the United States of America
you must seek replacement through your distributor.
PROCEDURE
FOR OBTAINING PERFORMANCE OF WARRANTY:
If, after following the
instructions in the Ultroid® Hemorrhoid Management System Operating
and Maintenance Manual, you are certain that the Product is defective,
pack the Product carefully (preferably in its original packaging).
The Product should include all parts and accessories originally
packaged with the Product.
Include evidence of original purchase
and a note describing the defect that has caused you to return it.
7
Rev 10.5.2010a
Ultroid® Technologies, Inc.
Product List:
Primary Components:
Ultroid® System Generator
Ultroid® Control Handle
Ultroid® Reusable Patient Pad
Patient Pad Connection Cord
Ultroid® Control Handle Connection Cord
Power Cord (110, 220, Etc.)
Ultroid® Single-use Procedure Kit
Procedure Kit Components:
Ultroid® Single-use Probe
Ultroid® Single-use Patient Pad Sponge
Ultroid® Single-use Anoscope
Media Materials:
Ultroid® Operation Manual
For pricing on any of these products,
please contact your local distributor.
Rev 10.5.2010a
8
INDICATIONS FOR USE:
Coagulative Hemostatic Therapy of Internal Hemorrhoids,
Grades I, II, III, IV.
CONTRAINDICATIONS:
• Pregnancy
• Pacemaker and/or defibrillator implant
• Bleeding disorder
• Anticoagulant therapy
• Active anorectal infection
• Inflammatory bowel disease
• Lower abdominal/lower quadrant transplant patients
• Purely external hemorrhoids
CAUTIONS:
The following cautions apply to the use, care and/or maintenance of the Ultroid®
Hemorrhoid Management System (UHMS.)
1. Study this manual, and other accompanying instructions, carefully and thoroughly before handling the Ultroid® System(UHMS) and any of its accessories. Keep this manual in a convenient and
accessible location for reference. Prior to contacting Ultroid Technologies, Inc. or your local distributor, please re-read this manual for possible solutions.
2. The Ultroid® Hemorrhoid Management System should be handled with care by
informed personnel who are familiar with its assembly, operation and disassembly. It
is a precision medical device which can be damaged by misuse or abuse.
3. The operational safety test must be performed prior to each patient treatment.
This testing will assure proper performance and allow diagnosis of any technical malfunctions prior to patient treatment.
4. Follow all labeling instructions for the safe handling and storage of the UHMS. Improper storage will damage components.
5. View the physician instructional video on the Ultroid® In-service Presentation prior to the firstuse of the UHMS.
6. Inability to obtain adequate milliamperage is often a result of:
a. A failure to completely soak the Patient Pad; and/or
b. A failure to use 0.9% normal saline solution to soak the
Patient pad.
NOTE: Inadvertent failure to comply with any of the procedures outlined in the the
Ultroid® Operation Manual may result in poor conduction and an inability to achieve
a current greater than 4-6 mA.
7. The Single-use Probe is not for reuse or attempted sterilization. Reuse of the probe
will cause patient to patient disease transmission. Attempting to clean or sterilize the
probe will cause a breakdown of the polymer and result in bacterial contamination
as well as an unstable connection between the male end of the probe and the female insertion site on the control handle.
Rev 10.5.2010a
9
INSTRUCTIONS FOR PRE-TREATMENT EXAM:
1. Correct HD diagnosis is made by a comprehensive internal and external
anal examination.
Wearing gloves, first perform a standard external anal
exam looking for redundant anal tissue, active inflammation, infection and
abscess formation or other pathology.
Palpate the perianal area during
this process.
2. Next, perform a digital examination using lubrication or *Xylocaine®
jelly. Feel for the presence of any mass, lesions or other pathology. Use
the disposable anoscope with the operative port for the anoscopic exam.
When the obturator is removed from the anoscope, a small area of tissue
protrudes into the visual field for treatment. Surrounding tissue is protected.
3. Each of the four quadrants of the anal canal can be divided into two
equal areas to help localize the hemorrhoid. By rotating the speculum, the
entire anal canal is viewed and the position of pathology is noted.
4.
Slowly insert the lubricated anoscope into the anal canal.
introduction fosters patient comfort.
Slow
5.
Remove the obturator slowly to avoid a vacuum effect and examine
the area protruding through the operative port. 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.
a. Grade I hemorrhoids will project into the lumen. They may or
may not show signs of active bleeding.
b. Grade II hemorrhoids will prolapse through the operative port
and spontaneously retract into the anal canal when the patient
stops straining.
c. Remove the anoscope if the hemorrhoid tissue remains
prolapsed. Determine if you can manually reduce the tissue into
the anal canal. Ability to manually reduce indicates a grade III
hemorrhoid.
d. If the tissue is not reducible and is prolapsed with anal rectal
mucosa 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.
6. In addition to determining hemorrhoid grade and position, examine the
hemorrhoids for signs of inflammatory changes, bleeding, hypertrophied
anal papilla and other pathology.
Determine and note the grade of
hemorrhoid for each anal segment. In most instances, it is appropriate to
treat the highest grade of hemorrhoid first.
7.
Replace the obturator to move the involved tissue out of the operative
port before rotating the anoscope to the next area. Continue in this manner
to examine the entire circumference of the anal canal.
8. Be sure to examine each segment separately.
10
Rev 10.5.2010a
ASSEMBLY:
ULTROID® HEMORRHOID MANAGEMENT SYSTEM
Assemble Ultroid Reusable Patient Pad
1. Place the Ultroid® Single-use Patient Pad Sponge into the Ultroid® Patient
Pad.
SOAK 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.)
2. 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.
3. Insert the other end of the Patient Pad Connection Cord into the “PATIENT
PAD” socket of the Ultroid® System Generator.
PATIENT PAD
HANDLE
Rev 10.5.2010a
11
4. Plug Control Handle Connection Cord 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.
5. Plug the Handle Connection Cord into the “HANDLE” Socket of the
Ultroid® System Generator by aligning the white placement dots on the
“HANDLE” Socket and Connection Cord.
Rotate clockwise to lock and
secure the connection.
PATIENT PAD
HANDLE
Rev 10.5.2010a
12
6.
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.
7. Plug the Power Cord into the Power Socket of the Ultroid® System
Generator. 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.
8. 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.
PATIENT PAD
HANDLE
13
Rev 10.5.2010a
OPERATIONAL TESTING:
Prior to each patient treatment, the
to ensure proper performance and
functions. To perform the Operational
is established by placing the probe
saline soaked patient pad.
operational test should be performed
allow for diagnosis of technical malTesting on the UMHS, a closed circuit
tips firmly against a connected and
1. Place the probe tips firmly against the saline soaked Ultroid® Patient Pad
Sponge
2. Press “TEST”
button while touching the probe to the Patient Pad
Sponge. If the sponge is not thoroughly soaked with saline or the resistance is too high, an error state occurs which forces all time digits to (88.88)
and prohibits the start of a procedure. This state will persist until the test is
passed. If there is no error, 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.
3. If the “TEST” passes, you may procede with the procedure.
You are now ready to perform the Ultroid® Procedure.
Rev 10.5.2010a
14
INSTRUCTIONS FOR PERFORMING THE ULTROID® PROCEDURE:
PROPER PLACEMENT OF THE ULTROID® Patient Pad:
1. 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).
2. Ultroid® Technologies, Inc. recommends the lateral position for patient
comfort and to ensure complete Patient Pad contact.
PROCEDURE:
1. Be sure the Patient Pad is adequately saturated and placed. Following anoscopic examination, isolate the hemorrhoid to be treated in the side viewing
slot of the anoscope.
2. 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
In this example, patient is in
the right lateral position.
right (R) locations.
3. 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. It is NOT necessary
to penetrate the tissue with the probe tips.
4. 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.
5. To initiate current, press the “UP”
crease 1mA with each depression.
increments of 2 mA per bar.
button and the current applied will inThe mA bar indicates current increases in
If the user lifts the probe from the tissue, the current terminates; however, the
handle timer will continue to count. To restart the current, reposition the probe
tips and then press the “UP”
button until desired current level is reached.
NOTE: Be sure to monitor the mA bar indicator and not the handle timer, as the
timer will continue to increase even in the absence of current.
IMPORTANT: Pressing the “DOWN”
button until the mA indicator lights disappear (i.e. mA 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, as described on page 14 of this manual.
Rev 10.5.2010a
15
5. Increase the milliamperes slowly to a maximum setting of sixteen
(16) milliamperes, or until the patient experiences any discomfort.
Each patient will have a different tolerance level to the treatment.
A gradual increase of current over one to two minutes is tolerated
best.
6. 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 (see treatment time recommendation chart on page
17).
7. During the treatment, you may note a color change of the treated
area. Occasionally, popping noises will be heard, indicating the
release of hydrogen gas.
8. 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 (Chart A P.17).
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.
NOTE:
Treatment time increases or decreases depending on
milliamperage tolerated by the patient. As a general rule, the
higher milliamperage applied, the shorter the procedure, and the
less milliamperage applied, the longer the procedure.
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. Remove the Ultroid® Single-use Patient Probe from the
hemorrhoid tissue.
DISCARD THE PROBE IN AN APPROPRIATE
BIOHAZARD CONTAINER AFTER USE.
10. The treated hemorrhoid segment should be re-examined
approximately 10-14 days post treatment. If the treated hemorrhoid
segment is improved but not resolved, an additional treatment may
be warranted.
Rev 10.5.2010a
16
Treatment Time Recommendations:
Effective treatment is a function of the maximum current used and
the duration of the treatment, known as the milliampere-minute
(mA x min) product. 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.
These tables are intended serve as a guide and should be used in
conjunction with the visual clues outlined above.
* 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
Rev 10.5.2010a
17
REVIEW:
Key points to remember when treating internal hemorrhoids with the Ultroid®
Hemorrhoid Management System:
1. First, complete a digital and anoscopic examination. Identify and document
all hemorrhoids and their grade.
2. Setup the UMHS and test the unit following the “Assembly” and “Operational
Testing” protocols.
3. Properly place the Ultroid® Patient PAD: Place the Ultroid® Patient pad with
the saturated sponge (0.9% normal saline solution) surface touching the patient’s skin under the dependent thigh (weight bearing thigh).
NOTE: The lateral position is recommended for patient comfort and to ensure
complete Patient Pad contact.
4. Isolate the hemorrhoid to be treated in the viewing slot of the ansocope.
5.
Introduce the Ultroid® single-use Patient Probe into the anoscope, making
sure to angle it towards the operative slotted section. Place the probe tips on
the base of the tissue, (the feeding vasculature of the hemorrhoid.) The probe
tips should be placed above the dentate line at all times.
6. Activate the current to the probe tips by depressing the “START”
then the “UP” button on the handle.
button,
7. Increase the milliamps slowly up to a maximum of sixteen (16) milliamps, or
until the patient begins to feel discomfort. Each patient will tolerate different
levels of mA current. A gradual increase of direct current over a period of one
to two minutes is tolerated best. If a patient experiences discomfort, decrease
the current by 2mA. After one to two minutes, reattempt increase of current.
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 (Chart A P.17).
8. Once treatment is complete, gradually decrease current to zero.
9.
Complete a follow-up patient examination 10 to 14 days post procedure.
Treat remaining symptomatic hemorrhoids following the recommended protocol. The most severe hemorrhoids may require more than one treatment.
10. If the procedure is carefully performed as outlined in this manual, Ultroid
is a safe, effective, and painless outpatient procedure for the treatment and
management of ALL Grades of HD (hemorrhoidal disease).
Rev 10.5.2010a
18
CLEANING INSTRUCTIONS FOR THE ULTROID® HEMORRHOID MANAGEMENT SYSTEM (UHMS):
ULTROID® SINGLE-USE PATIENT PROBE:
The single-use patient probe is intended for single-use only. As such, Ultroid
Technologies, Inc. recommends proper disposal of the probe into a biohazard
waste receptacle at the conclusion of an Ultroid® treatment with the clear protective sleeve placed back on the probe. This will eliminate the chance of infectious disease transmission.
ULTROID® CONTROL HANDLE:
At the conclusion of an Ultroid® treatment, carefully wipe the control handle 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.
ULTROID® SYSTEM GENERATOR:
The Ultroid® System Generator 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.
CONTRAINDICATIONS FOR USE:
Ultroid® is contraindicated for patients with the following
conditions:
• Pregnancy
• Pacemaker and/or defibrillator implant
• Bleeding disorder
• Anticoagulant therapy (relative contraindication)
• Active anorectal infection
• Inflammatory bowel disease
• Lower abdominal/lower quadrant transplant patients
• Purely external hemorrhoids
Rev 10.5.2010a
19
ANATOMY:
Internal Hemorrhoidal Plexus
Dentate Line
External Hemorrhoidal Plexus
Right Posterior
Left Lateral
Right Anterior
Usual position of internal
hemorrhoids, or anal cushions.
Origin below dentate line (external
plexus)
External Hemorrhoid
Origin above dentate line (internal
plexus)
Internal Hemorrhoid
Rev 10.5.2010a
20
Origin
above and
below
dentate line
(internal
and external
plexus)
Mixed Hemorrhoid
SAMPLE PATIENT CONSULTATION:
This is a suggested patient chart. It is not intended as a substitute
for taking and recording a complete medical history and conducting a thorough investigation.
Rev 10.5.2010a
21
SAMPLE NEW PATIENT PACKET ADDENDUM:
This is a suggested patient chart. It is not intended as a substitute
for taking and recording a complete medical history and conducting a thorough investigation.
Rev 10.5.2010a
22
GRADING OF HEMORRHOIDS:
Grading is based on history and physical exam. If the patient
is unsure whether prolapse is present, the physician may ask
the patient to Valsalva (strain).
Grade 1:
• Mildest
• Bulge into the anal canal and often bleed but
do not prolapse beyond the anal verge (does
not go outside of the anus)
Grade 2:
• May prolapse beyond the anal verge with
straining but reduce spontaneously when strain
ing ceases (goes back into anal canal without
assistance)
Grade 3:
• Prolapses beyond the anal verge spontaneous
ly or with straining and requires manual reduc
tion (must be pushed back into anal canal)
Grade 4:
• Chronically prolapsed and cannot be reduced
(pushed back inside anal canal)
• Most severe
Rev 10.5.2010a
23
USER AGREEMENT:
THIS USER AGREEMENT (“Agreement”) is signed this _____________ day
of ____________, 20__, by ________________________, a _______________
(corporation)(professional
association)(other)
with
(its)(his)(her)
principal place of business in ___________________ (“USER”).
RECITALS
A. Ultroid® is in the business of manufacturing a medical device recognized by
the Food and Drug Administration (“FDA”) with its related procedures for the
treatment of hemorrhoids known as the Ultroid® Hemorrhoid Management
System (“3053”).
B. The System uses a single-use patient probe which has been recognized by the United States Food and Drug Administration (FDA)
for “Single-use Only”.
C. USER has fully acquainted itself with the use of the System and is
in full and complete understanding of the guidelines, representations, warranties, FDA product approvals acquired, established and
promulgated by Ultroid®.
D. USER desired to use the System in the medical/osteopathic practice.
E. Ultroid® agrees to permit and provide to USER the System for use
in USER’s practice, and USER agrees to strictly abide by the Ultroid®
Hemorrhoid
Management
System’s
Operating
&
Maintenance
Manual and this User Agreement in USER’s use of the System. NOW,
THEREFORE, for good and valuable consideration, the receipt and
sufficiency of which are hereby acknowledged, the USER, intending
to be legally bound, hereby agrees as follows:
1. USER’S RESPONSIBILITY AND COMMITMENT. USER understands and
agrees that certain duties and responsibilities shall govern such arrangement and that it shall:
a. Strictly abide by the Ultroid® Hemorrhoid Management System
Operating & Maintenance Manual, a copy of which is attached
hereto and made a part hereof;
b. Comply with the FDA approved 510K filed for the System as it
relates to the use of the sterile, single-use patient probe (the
“Probe”).
c. Dispose of the Probe after each single-use into a biohazard
waste receptacle at the conclusion of an Ultroid® treatment.
d. Not attempt to clean or re-sterilize or re-use the Probe on the
patient or subsequent patients following the single-use of the
Probe.
Rev 10.5.2010a
24
2. REQUIRED DISCLOSURES. USER shall notify Ultroid® in writing within
three days after any of the following events occur:
a. USER’s license to practice medicine in the State or any other jurisdiction lapses or is denied, suspended, revoked, terminated, relinquished or made subject to terms of probation or other restriction;
b. USER’s medical staff privileges at any health care facility are denied, suspended, revoked, terminated, relinquished (under threat
of disciplinary action), or made subject to terms of probation or
other restriction;
c. USER’s professional liability policy is canceled or non-renewed
and another policy with the same or similar coverage is not issued
within 3 days of cancellation or non-renewal;
d. USER is required to pay damages in any malpractice action by
way of judgment or settlement;
e. USER becomes the subject of an investigatory, disciplinary or
other proceeding or action before any governmental, professional,
licensing board, medical staff, or peer review body;
f. USER’s Drug Enforcement Agency number is revoked, suspend
ed, terminated, relinquished, placed on terms of probation, or restricted in any way;
g. An event occurs that substantially interrupts all or a portion
of USER’s professional practice or that materially adversely affects
USER’s ability to perform USER’s obligations hereunder;
h. USER’s conviction of an offense related to health care or
USER’s listing by a federal agency as being debarred, excluded or
otherwise ineligible for federal program participation; or,
i. USER seeks protection as a debtor pursuant to the U.S. Bank
ruptcy Code.
USER understands and agrees that upon the occurrence of any one
or more of the matters 2. a. through i. herein, Ultroid® has the right to
termi¬nate its relationship with USER, revoke USER’s right to use the
System, and demand and receive the return of all Ultroid® equipment which is a part of the System.
3. CONFIDENTIAL INFORMATION. USER shall hold all confidential information
in the strictest confidence and shall not, during or subsequent to the term of
this Agreement, use Ultroid®’s confidential information for any purpose whatsoever other than the performance of its duties and responsibilities hereunder
or disclose Ultroid®’s confidential information to employees of USER except on
a need to know basis or to third parties, and it is understood that such confidential information shall remain the sole property of Ultroid®. USER will abide
by Health Insurance Portability and Accountability Act of 1996, Public Law 104191 (“HIPPA”) and Title 45, Sections 164.502(e) and 164.504(e) of the Code of
Federal Regulations (“CFR”).
Rev 10.5.2010a
25
4. INDEMNITY BY USER FOR MISUSE OR ALTERATION OF PRODUCT OR
PROCEDURE. USER agrees to indemnify and hold Ultroid® harmless
from any claims, suits, proceedings, losses, liabilities, damages, costs
and expenses (inclusive of Ultroid®’s reasonable attorneys’ fees)
made against or incurred by Ultroid® arising out of or in connection
with any activities of the USER arising from USER’s misuse or alteration of the product which allegedly results in an injury to a patient
by USER or an agent of the USER. USER shall be solely responsible for,
and shall indemnify and hold Ultroid® harmless from, any claims,
warranties or representations made by the USER or the USER’s employees or agents which differ from the warranty provided by Ultroid® in its limited warranty agreement.
5.
LIMITATION OF LIABILITY.
Limitation of Liability and No
Consequential Damages.
Ultroid®’S TOTAL LIABILITY TO USER OR
ANY THIRD PARTY HEREUNDER SHALL BE LIMITED TO CONTRACT
DAMAGES INCURRED BY USER AND SHALL NOT INCLUDE INCIDENTAL
OR CONSEQUENTIAL DAMAGES AS SET FORTH IN THE ONE YEAR
LIMITED WARRANTY CONTAINED HEREIN.
USER ACKNOWLEDGES
THAT THIS LIMITATION OF LIABILITY AND CONSEQUENTIAL DAMAGES
IS A FUNDAMENTAL ASPECT OF THE AGREEMENT AND THAT IN ITS
ABSENCE, THE ECONOMIC TERMS SET FORTH IN THE AGREEMENT
WOULD BE SUBSTAINTIALLY DIFFERENT.
6.
TERMINATION.
Either party may terminate this Agreement by
providing thirty (30) days written notice to the other party. Either
party may terminate this Agreement immediately without providing
notice to the other party in the event of: (a) material breach of
the Agreement by the other party; (b) the insolvency of the other
party; (c) the institution of any proceeding in relation to the credit
standing of the other party, such as bankruptcy, reorganization,
rehabilitation or composition, by or against the other party; or (d)
the appointment of any receiver or trustee for the other party.
7. RELATIONSHIP OF USER AND Ultroid®. The relationship between
Ultroid® and USER established by this Agreement is of a vendor to
its vendee. USER is an independent contractor and shall have and
retain complete management and operation of its practice and
business. All expenses that may be incurred by USER in connection
with this Agreement shall be borne wholly and completely by USER,
and Ultroid® shall not be in any way responsible or liable therefore.
Neither USER, nor any person whose wages are paid by USER, shall
be deemed a servant, agent (actual or apparent), joint venture,
or employee of Ultroid® for any purpose whatsoever.
No agency,
employment, partnership, joint venture, or other joint relationship is
created hereby, it being understood that USER and Ultroid®
are
independent contractors vis-à-vis one another and that neither has
any authority to bind the other in any respect whatsoever.
26
Rev 10.5.2010a
8. ASSIGNMENT. USER may not assign this Agreement or any of its
rights, duties or obligations under this Agreement to any third party
without Ultroid®’s prior written consent.
9. SEVERABILITY AND WAIVER. In the event any provision of this
Agreement is held to be invalid or unenforceable, the valid or
enforceable portion thereof and the remaining provisions of this
Agreement will remain in full force and effect. Any waiver (express
or implied) by any party of any default or breach of this Agreement shall not constitute a waiver of any other or subsequent
default or breach.
10. NOTICES. All notices required to be given in connection with
this Agreement shall be sent by certified mail, return receipt required and addressed to:
Ultroid Technologies, Inc.
6023 South 2nd Street
Tampa, FL 33611-4707
877-858-0555
info@ultroid.com
If to USER:
________________________________________________
________________________________________________
________________________________________________
IN WITNESS WHEREOF, the USER has hereunto caused this User
Agreement to be duly executed on the day and date first above
written.
USER:
By: _________________________________________
(physician’s signature required)
Print Name: __________________________________
USER COPY. To be retained in your files.
27
Rev 10.5.2010a
If you did not receive the Ultroid Physician Marketing Tool kit with
your UHMS, please contact your local distributor or the Ultroid home
office at the following:
Ultroid Technologies, Inc.
Marketing Department
6023 South 2nd Street
Tampa, FL 33611-4707
or
1 (877) 858-0555
or
info@ultroid.com
or
Materials can also be downloaded for print at www.Ultroid.com in the physician
section under physician toolkit. All material requests will be mailed to the
address given by the physician office.
Rev 10.5.2010a
28