Morpheus Anorectal Manometry W Paradoxical EMG Operator's Guide
Morpheus Anorectal Manometry W Paradoxical EMG Operator's Guide
Copyright © 2015
The Prometheus Group®
One Washington Street, Suite 303
Dover, New Hampshire 03820
FOR ASSISTANCE, CALL YOUR LOCAL SALES REPRESENTATIVE, DISTRIBUTOR, OR THE PROMETHEUS GROUP® AT
800.442.2325 IN THE U.S. AND CANADA OR 603.749.0733 INTERNATIONAL. FOR TELEPHONE TECHNICAL SUPPORT CALL
800.272.8492 IN THE U.S. AND CANADA OR 603.742.6053 INTERNATIONAL.
WEBSITE: www.theprogrp.com E-MAIL: [email protected]
52_067.01EN
Morpheus® Anorectal Manometry w/Paradoxical EMG Operator’s Guide Page 2 of 37
CONTENTS
Anorectal Manometry w/Paradoxical EMG 3
Create a Patient 3
Select an Existing Patient 5
Create a Patient Visit 6
Attachments 7
Launch Anorectal Manometry w/ Paradoxical EMG 9
Study Protocols 10
A – EMG A 10
B – Anorectal Manometry 13
Dependency Attachments 21
Diagnosis and Recommendation 21
Physiology Inputs 22
Opening Documents 24
Review Current Visit 26
Review Previous Visits 27
Review Patients By Date 27
Active Study Screen Changes Addendum 29
Modify Protocol 29
Colors 30
Timing/Smoothing 31
Markers 32
Utilities 33
MORPHEUS® CONTROL MODULE ANORECTAL MANOMETRY 35
WITH PARADOXICAL EMG SPECIFICATIONS 35
SOFTWARE LICENSE AGREEMENT 36
STANDARD WARRANTY SERVICE AGREEMENT 37
2015 The Prometheus Group®. All rights reserved. This document contains confidential and proprietary information that is the property of The
Prometheus Group® and is protected by the copyright laws of the United States, international copyright treaties, and all other applicable national laws.
Any unauthorized use, reproduction or transfer of any information in this document is strictly prohibited. This document contains information regarding
technology that is protected under one or more United States patents and other pending United States and foreign patents. The Prometheus Group®
logo and combinations thereof, Prometheus®, Pathway®, and Morpheus® are registered trademarks of The Prometheus Group®, One Washington
Street, Suite 303, Dover, NH 03820. All other brand and product names are used for identification only and are the property of their respective holders.
Specifications are subject to change without notice. Printed in U.S.A.
Do NOT use accessories, consumables and components not supplied or approved by The
Prometheus Group®. Using these items may result in inaccurate readings, misdiagnosis, or possible
damage to the unit and void the unit’s warranty.
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CREATE A PATIENT
1. Click Create New Patient to establish a new patient record. Go to the following section (page 5)
SELECT AN EXISTING PATIENT to select an existing patient.
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2. Enter the patient data. Red entries MUST be completed. The provider selected should be the
patient’s primary provider. Click …Add New Provider and create an Associate Profile if the provider
does NOT appear on the list. Click Save New Patient. The Patient Selection Screen is now
populated with the new information.
NOTE: Red entries will vary depending on what is specified as the Unique Patient Identifiers. In the
example below, Full Name was specified and Unique ID, Social Security Number and Date of Birth
were NOT specified.
3. Click Create New Patient and repeat Step 2 to create additional new patients.
4. To edit/review patient information click Edit/Review Additional Patient Information. The Patient
Information Screen will open.
5. Patient information can be edited/reviewed as necessary. Click Print and Print Preview to print the
patient information.
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7. Save the data that was updated will appear. Click YES to exit and save the changes. Click NO to
exit without saving the changes. Click Cancel to make additional changes. Click YES.
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4. To place a patient on the inactive list, populate the Patient Selection screen with the patient and
click Edit/Review Additional Patient Information. Click the drop down arrow in the Active/InActive
Status box and click InActive. Click the Show InActive Patients box on the Patient Selection
screen to show the inactive patient list. Follow the same steps from the inactive patient list to return a
patient to the active list clicking Active in the Active/InActive Status box.
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ATTACHMENTS
1. Three Attachments are available: Medical Issues, Histories, and Wexner Score Sheet.
2. Medical Issues
a. Double click Medical Issues.
b. Entry box for Select an Associate will appear. Click the drop down arrow to expand the list. Click
the correct associate. Click OK.
NOTE: Be sure to select the associate who is actually administering the patient care.
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4. Issues and Histories provided this visit will appear. Enter the written description of chief
complaint by keying in the window. Complete the remainder by clicking on the drop down arrow and
clicking an option adding detail by keying in the window.
5. Click Close.
6. Click Yes.
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Note: Attachments can be completed prior to or after Anorectal Manometry w/ Paradoxical EMG or at a
future time.
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5. Click the drop down list arrow under Study Protocols. Five studies are available:
A – EMG A is used to assess the role of the paradoxical puborectalis contraction during mocked
defecation. This study is performed noninvasively by either surface electrodes or a rectal sensor placed in
the anal canal.
B – Anorectal Manometry evaluates a number of important parameters: 1) A structured 6cm, 5cm, 4cm,
3cm, 2cm and 1cm Stationary Pull-through study incorporating Rest/Squeeze and optional Push
pressures to determine the High Pressure Zone (HPZ); 2) Once the HPZ is determined, the Presence or
Absence of a Recto Anal Inhibitory Reflex (RAIR); 3) Rectal Volume Sensory Thresholds and; 4) Balloon
Expulsion (Defecation Dynamics) Test.
C – Anorectal Manometry Freestyle incorporates the same studies as B with the additional flexibility of
choosing which cm depths and which pressures (Rest/Squeeze/Push) to incorporate in the depth test.
D – EMG A, Anorectal Manometry combines A and B as a single study.
E – EMG A, Anorectal Manometry Freestyle combines A and C as a single study.
Study Protocols
A – EMG A
1. Click A – EMG A.
2. Place patient on their left side with knees slightly bent. Place active surface electrodes (red) at the 3
and 9 o’clock positions on either side of the anus. Electrodes should be placed close to the anus.
Place the ground electrode (green) on the hip (ileac crest) directly over the bone.
3. Instruct the patient to relax.
4. The screen will be active and begin data collection. Click PAUSE to freeze the display (PAUSE will
now read CONTINUE). Click CONTINUE to resume the display. Click RESET to restart the display.
Click STOP COLLECTING DATA to stop a study.
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5. Custom Markers appear at the bottom of the screen and will become active as required.
6. Markers include Rest, Squeeze, Push and Artifact. Artifact marker can be accessed during both
the study and study review.
8. Instruct patient to squeeze as Squeeze is clicked. Wait until the timed countdown is over and instruct
patient to relax.
9. Instruct patient to push or bear down as Push is clicked. Wait until the timed countdown is over and
instruct patient to relax.
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11. If needed, the EMG (µV) Range can be changed by clicking the Up Arrow to increase the range or
the Down Arrow to decrease the range.
13. End Session and Save Data? Select YES, NO or CANCEL will appear.
14. Click Yes and a Review Screen will appear with color bars at the top delineating study segments.
15. While in the review window another study may be launched. The user may launch, complete, save,
review and edit up to SIX studies of any combination within a single session.
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B – ANORECTAL MANOMETRY
1. Click B – Anorectal Manometry.
2. Patient Preparation - The patient’s bowel should be empty prior to the test. An enema may be
necessary for complete emptying.
3. Position patient lying on their left side with knees bent, pillow under head.
4. Connect the ARM 4 channel catheter.
5. The screen will be active and begin data collection. Click PAUSE to freeze the display
(PAUSE will now read CONTINUE). Click CONTINUE to resume the display. Click RESET
to restart the display. Click STOP COLLECTING DATA to stop a study.
6. Verify the unit of measurement (mm HG or cm H2O) desired. Default is set to mm HG. Click cm
H2O to change. This is a toggle button.
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7. Insert catheter into rectum (after lubricating it) to the 6cm mark at the anal verge.
8. Click Start Here/Zero Pressure. This will zero pressure to baseline.
9. Zero pressure prior to selecting 6cm or Catheter pressure must be zeroed will appear.
10. Click CONTINUE if the display was paused during patient preparation or RESET to restart.
11. Depth and other markers below the display will become active as required.
12. The active 6cm button indicates the first depth position of the study. Rest, Squeeze and optional
Push will appear in sequential order. Artifact and Custom can be used at any time during the study.
Click 6cm.
13. Encourage the patient to relax. Click Rest while instructing the patient to rest during the rest time
frame. The countdown in seconds appears on the lower left of the screen. Rest will turn white once
the countdown is completed and activate Squeeze.
14. Click Squeeze while instructing the patient to squeeze until the countdown is completed. Instruct the
patient to relax once the countdown is completed. Squeeze will turn white and activate 5cm, Rest
and Push.
15. Rest will generate a second Rest and Squeeze test at the 6cm position. Push enables the optional
Push test at the 6cm position. 5cm completes the 6cm depth position and activates the 5cm depth
position.
Note: Rest/Squeeze and optional Push can be used up to three times for each depth. Artifact and
Custom can be used up to three times for each depth.
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16. Click Push while instructing the patient to push until the countdown is completed. Instruct the patient
to relax once the countdown is completed. Push will turn white and activate the 5cm depth.
17. Pull the catheter out to the 5cm marking at the anal verge.
18. Click 5cm. Repeat the previous (Rest, Squeeze and optional Push) at each centimeter depth marker
as required.
19. When performing the stationary pull-through depth test, watch for the “High Pressure Zone” (HPZ).
There will be a rise in resting pressure around the 3-1 cm depth. Make a mental note because the
RAIR (Recto-Anal Inhibitory Reflex Test) is to be performed at this level. RAIR is the portion of the
study that tests the involuntary reaction of the intestinal smooth muscle to comply with increases in
stool volume or distension of the rectum.
20. Once the first set of Rest/Squeeze and optional Push studies at 1cm have been completed, the
Rest, Push and RAIR Status will be available. Continue to perform additional Rest/Squeeze and
optional Push studies or proceed to RAIR Status.
21. Position the catheter at the HPZ, usually at the 2-3 cm marker.
22. Inflate 30 ml of air into the compliance balloon channel of the catheter. Hold the air in place
approximately three seconds and then withdraw or aspirate all of the air quickly. Observe the tracing.
If a response is noted, click RAIR Status. Marker Auto Popup Edit & Control will appear. Enter the
RAIR/Sensation Depth (cm) and Balloon Volume (ml). Increase the balloon volume by 10 ml of air
and repeat the above if no response is noted. Click RAIR Absent in Marker Auto Popup Edit &
Control if RAIR is absent. Click OK.
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23. Rectal volume sensory thresholds will be recorded once the RAIR is completed. First Sensation,
First Urge and Maximum Tolerated will now be active.
24. The compliance balloon channel is inflated with increasing volumes. The patient’s awareness to this
distension will be noted by their response to a feeling of sensations. Once the patient feels the first
awareness of distension click First Sensation. Marker Auto Popup Edit & Control will appear.
Enter the Balloon Volume(ml). Click OK.
25. Continue to inflate the balloon with increasing volume. Click First Urge and enter the Balloon
Volume (ml).
26. Continue to inflate the balloon until Maximum Tolerated is noted. Click Maximum Tolerated and
enter the Balloon Volume (ml).
27. Quickly release the air out of the balloon so the patient is relieved of the pressure.
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28. An (optional) expulsion study may be performed upon completion of the sensation study. Click
Custom. If this study is not required proceed to step# 35.
30. With the compliance balloon still inserted (in the rectal vault above the sphincter mechanism) and the
patient in the left lateral or knee-chest position, inflate the compliance balloon with a maximum of 60
ml of water/air.
31. Click OK.
32. The patient is questioned regarding their first sensation and the need to evacuate.
33. Click Custom and click Expulsion End to conclude the expulsion study. Click OK.
34. The patient is escorted to the restroom and given instructions for expulsion of the balloon.
35. Click STOP COLLECTING DATA.
36. End Session and Save Data? Select YES, NO or CANCEL will appear.
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37. Click Yes and a Review Screen will appear with color bars at the top delineating study segments
38. Now that two studies have been saved, the previous study may be reviewed by clicking on the
Review Previous green arrow. A Review Next green arrow is provided as well. In the REVIEW
STUDY area the Generate Report On This Study has a check mark. Click the check mark to
remove this study from inclusion in generated documents. Click to restore the check mark.
a. Place the cursor on the graph at the beginning point (must be just past the 0 ordinate). Hold down
the left mouse button. The cursor will change to a magnifying glass. Drag the magnifying glass to
the desired right most position and release. The selected portion of the graph will fill the window.
Repeat to expand this area further.
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b. A scroll bar now appears at the bottom of the graph. The entire study may be viewed in the
zoomed mode by using the scroll bar.
40. To add an artifact marker click Artifact. Marker Auto Popup Edit & Control box will appear. Click
the desired marker. Click OK. The cursor inside the graph will change to a pointing finger. Move the
pointing finger to the desired marker location and click.
a. To move an Artifact marker, place the cursor over the marker line. The cursor will change to a
pointing finger. Click. The line will change from a solid to a dotted line. Move the pointing finger and
the marker line will also move. Move the pointing finger to the desired location and click.
b. To delete an Artifact marker click the marker line then press the Delete key on the keyboard.
41. Click QUICK PRINT if a printed screen copy is needed. QUICK PRINT will also print the STUDY
RESULTS.
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43. Click EXIT once all reviews and changes are complete.
44. The Patient Selection Screen will appear. In the Current Patient Visit, Diagnosis and
Recommendation and Physiology Inputs attachments have been added.
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Dependency Attachments
DIAGNOSIS AND RECOMMENDATION
1. Double click Diagnosis and Recommendation.
2. Procedures Administered this Visit will open. Complete Diagnosis by clicking the appropriate
option(s). Use the scroll bar if necessary. Click on a selected option(s) to deselect.
3. Recommendation: Enter Additional Note allows the input of commonly used terms or phrases
which, after entered and clicked on, appear in the Additional patient notes for follow-up visit
section for further editing.
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4. Enter Additional Note terms and phrases automatically carry forward for use with all subsequent
tests.
5. Click Close.
6. Click YES.
PHYSIOLOGY INPUTS
1. Double click Physiology Inputs.
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2. Procedures Administered this Visit will open. Complete the Physiology Inputs by scrolling,
selecting from drop down menus or keying in findings, etc.
3. Click Close.
4. Click YES.
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Opening Documents
1. The program automatically compiles patient and provider information, Attachments and study results
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to generate documents in Adobe Acrobat PDF or Word™ (Editable) file format. Documents can
be viewed, edited, printed and saved to another location. To open Documents, click View/Print/Save
Documents.
2. Save the data that was updated will appear. Click YES. This will move all Attachments from a
Cached to a Created status.
3. A Documents window will appear. Choose View/Edit, Print or Save in a PDF or Word™ (Editable)
format. Only the Word™ (Editable) format will activate the Edit function for the View/Edit option.
Then click Chart Note, Narrative or Anorectal Physiology Narrative Report. Chart Note,
Narrative and Anorectal Physiology Narrative Report can be accessed at the same time by
highlighting all three. If all three are highlighted and only one is required, click on the two that are not
needed to deselect.
4. In this example Chart Note, View/Edit and PDF have been selected. Click OK.
5. Report Menu will appear. Click on the provided options. Click OK.
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7. The Chart Note will be generated. To print, click on the printer icon on the top toolbar or click File on
the top toolbar and click Print. The Chart Note can also be printed directly from the Program
generated Documents.
NOTE: Exit the PDF document by clicking on the in the upper right hand corner of the screen.
8. All the information imputed in the Attachments is included in a comprehensive format for Chart
Note, Narrative and Anorectal Physiology Narrative Report along with the graph and statistical
information gathered during the session.
9. Clicking Save from Program generated Documents brings up Browse for Folder to Save and
transfer documents to another location.
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2. If there are multiple studies, toggle between studies to review or edit by selecting Review Previous
or Review Next. All studies, whether Generate Report On This Study is checked or not, are shown
for edit/review. Full review screen edit capabilities are active.
3. Click EXIT when the review/edit of these studies is complete. Patient Selection Screen will appear.
4. Attachments can be created, edited and added to the current session. To create or edit an
attachment double click on that attachment. Enter the needed information. Refer to the Attachments
section for further information.
5. Click Close. Select Yes to accept or No to NOT accept the changes/additions made.
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2. The Patient Visit List Screen will appear. To review a specific visit, double click on that visit. The
Patient Selection Screen will appear.
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2. Click a specific modality or All from the drop down menu under Select Modality.
3. Click All Dates or Custom Selection. Custom Selection activates Begin Date and End Date
calendars
5. Search Results can be sorted. Clicking Patient Name, Associate Name and Modality will organize
these categories in alphabetical order. Clicking on Date of Visit will organize by either ascending or
descending date.
6. Double click on a record, launch the edit/review from the Patient Selection Screen with the same
capabilities as described in the Review Current Visit section. The edit/review functions depend on
the modality selected.
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Note: Two new buttons appear beside Review Patients By Date: Review Previous Patient and
Review Next Patient.
7. Clicking Review Previous Patient or Review Next Patient will advance to the previous or next
patient record.
Note: Create New Visit appears when accessing either Review Previous Visits or Review Patients By
Date for other than the current date.
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COLORS
1. Click Colors.
2. Color Selection will appear. Click EMG A. Click Post, Right, Anterior, Left or the Screen
Background to modify its color. Click OK.
3. Color will appear. Set EMG A to be a basic color by clicking on one of the Basic colors. Select a
Custom color by clicking and holding on the bull’s-eye in the color spectrum window. Drag the
bull’s eye over the color spectrum until the desired color appears in Color|Solid. Both Basic and
Custom colors can be adjusted lighter or darker. Click, hold, and drag the color saturation bar up or
down. To add an adjusted color to Custom colors, click Add to Custom Colors.
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TIMING/SMOOTHING
1. Click Timing/Smoothing.
3. Change Screen Sweep Time (s): seconds by clicking the drop down arrow and clicking on the new
sweep time.
4. Change EMG Smoothing: value by clicking in the cell and keying in the value desired. Enter an
integer between 0-15. Note: A setting of 3 yields the best performance numbers and has therefore
been set as the default value.
5. Change Catheter Smoothing value by clicking in the cell and keying in the value desired. Enter an
integer between 0-50. Note: A setting of 3 yields the best performance numbers and has therefore
been set as the default value.
6. Change Pre-Test Begin Offset (s): seconds by clicking in the cell and keying in the value desired.
Enter an integer between 0-300. Note: A setting of 4 seconds yields the best performance numbers
and has therefore been set as the default value.
7. Change Rest/Squeeze/Push Time (s): seconds by clicking in the appropriate cell and keying in the
value desired. Enter an integer between 0-20. Note: A setting of 10 seconds yields the best
performance numbers and has therefore been set as the default value.
8. Click OK.
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MARKERS
1. Click Markers.
Note: Color is the only option which can be changed for Depth, Artifact and Custom markers.
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5. Text on graph can be changed for Rest, Squeeze, Push, RAIR Status, First Sensation, First Urge
and Maximum Tolerated. Click on a marker name. Click Use Name and key in a maximum of 3
letters.
6. The marker Description can be changed. Click on the marker name and key in the Description box.
7. Click OK.
9. Save Protocol will appear. Place a check in the box Check to enable saving Application Protocol.
Remember to change the name in Save As… to save as a new protocol. If the protocol name is NOT
changed the original protocol will be overwritten with any and all changes made. Click OK.
Utilities
NOTE: The Launch Anorectal Manometry w/ Paradoxical EMG is set to Live mode by default. There is
a Simulation mode which will run the test with preloaded data for demonstration purposes. This is a
limited feature set NOT meant for clinical use.
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2. A popup window will appear stating the Morpheus® is about to stop collecting data and display a
popup window. Would you like to continue? Click Yes.
4. Utilities also contains information about the Morpheus® Serial Number and Morpheus® Unlock
Keycode.
5. If Simulation has been selected, Simulation Mode will flash in the lower left hand corner of the
study screen.
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Electromyography:
Number of Channels: 2
Range: 1 - 800 µV
Accuracy: 2% ±2 Microvolts (Less than 500 Microvolts)
Sampling Rate: 10 Hz
Display: Linear or Logarithmic
Signal Processing: True RMS Conversion
20 to 500 Hz Bandpass
60 Hz Notch Filter
Input Common Mode Rejection greater than 100dB
Input Noise Level of less than 1 µV
Internal Active Electrode Preamplifier on both channels
Active Electrode Impedance of 10 gigohms
Pressure Manometry:
Number of Channels: 4 catheter channels
Range: 0 - 300 Millimeters of Mercury (mmHG)
0 - 400 Centimeters of Water (cmH2O)
Accuracy: 5% ±2 Millimeters of Mercury (mmHG)
5% ±2.72 Centimeters of Water (cmH2O)
Sampling Rate: 10 Hz
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The Prometheus Group® grants to the purchaser of the Anorectal Manometry w/Paradoxical EMG
Software the right to use one copy of Anorectal Manometry w/Paradoxical EMG Software on one
computer within one business entity. Anorectal Manometry w/Paradoxical EMG Software cannot be
shared among or between multiple business entities; for example, a satellite clinic affiliated with a hospital
operating as a separate business entity. Each business entity is required to have its own original copy of
the Anorectal Manometry w/Paradoxical EMG Software.
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The Prometheus Group® warrants equipment of its own manufacture to be free from defects in material
and workmanship as follows:
One (1) year from the date of shipment to the original purchaser, subject to the terms, conditions,
limitations, and exclusions specified herein.
1. Service: The Prometheus Group® of New Hampshire, Ltd., hereafter “The Prometheus Group®”,
shall provide, for the term of this warranty, repair of defective Prometheus Group® units. This
warranty shall include all parts and labor charges. The purchaser must obtain a Return Authorization
Number and must return the defective unit, at the purchaser’s own expense to The Prometheus
Group®. The Prometheus Group® may, at its option, repair and return the unit or provide a
replacement unit. Should The Prometheus Group® elect to provide a replacement unit, then this
warranty is automatically transferred to the replacement unit. The Prometheus Group® shall return, at
The Prometheus Group’s™ own expense, the repaired or replacement Prometheus Group® unit.
2. Exclusions: The following conditions are excluded from service under this warranty:
A. Preventative maintenance. Preventative maintenance, defined as maintenance performed for the
purpose of preventing a malfunction, is excluded from service under this warranty.
B. Repair of damage or malfunction of Prometheus Group® equipment resulting from abuse,
accident, modification, usage of accessories, consumables and components not supplied or
approved by The Prometheus Group®, or other cause other than normal usage, including but not
limited to operator error, failure of other user-supplied equipment, and equipment operation in
excess of design specifications is excluded from service under this warranty.
C. Loss due to fire, flood, robbery, burglary, theft, vandalism, radioactive contamination, or other
natural disasters or Acts of God is excluded from service under this warranty
D. Replacement of batteries, accessories and expendables such as electrodes, are excluded from
service under this warranty.
E. Commercial Equipment made by others, such as computers and printers.
NOTE: The Prometheus Group® provides no warranty on these items, and any service required must be obtained
from the original manufacturer.
3. Optional Warranty Extension: This warranty may be renewed or extended by written agreement and
acceptance of both parties. The price for such extension shall be the price in effect at the time the
extension is put in force. The Prometheus Group® shall waive any inspection and conditional repair
requirements for uninterrupted warranty extensions.
4. Limitation of Remedy: The Prometheus Group® shall not be liable for any damages caused by the
delay in furnishing warranty services or other performance under this warranty. The service warranty
expressed in paragraph 1 represents the sole and exclusive remedy for any warranty claims under
expressed or implied warranties, including without limitation any warranty of merchantability or
fitness. This warranty specifically limits the liability of The Prometheus Group®, including liability for
negligence claims by users and disclaiming any other claims of non-performance by The Prometheus
Group®. In no event shall The Prometheus Group® be held liable for any incidental or consequential
damages of any kind.
5. Assignment: This warranty shall not be assigned by the purchaser without prior written consent of
The Prometheus Group®. The warranty shall be binding upon all of the parties and their successors
and assigns.
52_076bEN
®
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