Operator Guide
77 Pages
Preview
Page 1
52_052a EN
Operator’s Guide-Prometheus™ DUO™
Page 2 of 77
CONTENTS NOMENCLATURE SERVICE INFORMATION TECHNICAL SUPPORT INDICATIONS FOR USE Uroflow measurement Muscle activity measurement Warnings Cautions PARTS LIST ACCESSORIES CHAPTER 1: PHYSICAL-MECHANICAL OVERVIEW & SETUP The Prometheus DUO Device
Connecting the DUO Device
3 3 3 4 4 4 4 4 5 5 6 6
7
Uroflow Transducer Setup EMG Setup
7 8
Connecting Pathway™ cables to the DUO Device Connecting the DUO Patient Electrodes Powering the DUO Device CHAPTER 2: DUO SOFTWARE SETUP Introduction Initial Startup Process
8 8 10 11 11 11
The First Time Startup Opening Screen Create an Associate Create a Location Create Unique Identifiers
12 12 17 19
CHAPTER 3: USING DUO SOFTWARE Introduction Launching DUO Software DUO Tools
22 22 23 24
View System Setup Create/Edit/View Associates Create/Edit/View Locations View Associate Activities
25 26 30 32
Diagnostic Screening
37
Create a Patient Create a Patient Visit Attachments
38 42 43
Launching a Patient DUO EMG/Uroflow Test Modifying Test Parameters Opening Documents SOFTWARE LICENSE AGREEMENT STANDARD WARRANTY SERVICE AGREEMENT
55 63 71 76 77
© 2007 The Prometheus Group. All rights reserved. This document contains confidential and proprietary information that is the property of The Prometheus Group, Inc. 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 Duo are trademarks of The Prometheus Group, Inc., 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.
www.theprogrp.com
Operator’s Guide-Prometheus™ DUO™
Page 3 of 77
NOMENCLATURE In this Operator’s Guide, NOTES, CAUTIONS, and WARNINGS are included, which have the following implications: NOTE: A procedural emphasis - usually something regarding preparation for a process or a reminder that some bit of information recorded here will be used later for another purpose
CAUTION: A hazard to a piece of equipment or property – for example, potential for an electrical short, water damage, or some other danger to the equipment but not the operator or patient. Can also be a reference to HIPAA or other medical legal requirement.
[ [WARNING: A hazard to a person - a potential danger to the operator or patient such as electrical shock or some other potential danger.
SERVICE INFORMATION [ [ WARNING: There are no serviceable parts within this device. The user should not attempt to service the instrument beyond that described in the DUO Device Operator’s Guide. Refer all other servicing to qualified service personnel. Please call 1-800-272-8492 in the U.S.A. and Canada, or +1 (011) 603-742-6053 international, or e-mail [email protected]
[ [ The instrument should be serviced by qualified service personnel when: • Any cable, cord, or plug has been damaged. • The instrument does not appear to operate normally or exhibits a marked change in performance. • The instrument has been dropped, or the casing is damaged. • Fluid has been spilled on the instrument, or it has been immersed, and it appears that fluid has entered the housing.
TECHNICAL SUPPORT To contact The Prometheus Group Technical Support for assistance: Telephone: 800-272-8492 U.S.A. and Canada; +1 (011) 603-742-6053 international; e-mail: [email protected].
www.theprogrp.com
Operator’s Guide-Prometheus™ DUO™
Page 4 of 77
INDICATIONS FOR USE Uroflow measurement • Spontaneous uroflow • Non-invasive testing • Screening for bladder outlet obstruction • Therapeutic follow-up after surgery and drug treatment
Muscle activity measurement • Muscle re-education, strengthening, endurance building, and relaxation of skeletal muscles, specifically the pelvic floor muscles. • Assessment of pelvic floor dysfunctions, monitoring the muscle activity associated with the performance of Kegel exercises. • Assessment of conditions including stress incontinence, mixed incontinence, and urge incontinence.
Warnings
[ [This device is not intended for use with anesthetic gases mixed with air, oxygen or nitrous oxide. Danger of electrical ignition.
[ [Use only electrodes from The Prometheus Group with your Prometheus DUO system. Any other electrodes may not be compatible with the Prometheus DUO device.
[ [Do NOT immerse any part of this system in any fluid, with the exception of the Uroflow Funnel and Graduated Urine Beaker.
[ [To reduce the risk of electrical shock, do NOT connect any preamplifier, lead wire, electrode, or any other component to a wall outlet.
[ [Do NOT leave electrodes attached when device is not in use. [ [To reduce the risk of electrical shock, do NOT open the instrument’s housing. Refer servicing to qualified personnel only.
[ [Disassembly of equipment by unauthorized personnel will void the instrument’s warranty. [ [The following practices may be dangerous and void any guarantee(s) and obligations for The Prometheus Group: (1) The device is not used according to the enclosed manuals and other accompanying documentation; (2) The device is modified by persons other than The Prometheus Group Service Technicians.
Cautions Prior to using this device, be sure to read the DUO Device Operator’s Guide for installation, maintenance, cleaning, technical data, service, and warranty information. Federal law (USA) restricts this device for sale by or on the order of a licensed medical practitioners, licensed by law in the state in which they practice. Use only the approved power supply supplied with this device. Pulling the beaker plate may damage the Uroflow Transducer and void your warranty. Be sure that USB Serial Interface Cable is no longer than 3 meters.
www.theprogrp.com
Page 5 of 77
Operator’s Guide-Prometheus™ DUO™
HIPAA requires safeguards to protect patient privacy. Connecting this system to a network is done at your own risk.
PARTS LIST Before setting up the DUO system for the first time, carefully open the packing cartons and confirm that all Prometheus DUO equipment and accessories listed below are included. If there are questions about the contents or wish to order additional supplies, call Customer Service, Toll-Free: 1-800-4422325 in the U.S.A. and Canada, +1 (011) 603-749-0733 international, or Fax: 1-603-749-0511. Customer Service Representatives are on duty to take your order between 9:00 a.m. and 5:00 p.m., Eastern Time. (1) USB Serial Interface Cable
(1) DUO Device
(1) Uroflow Transducer Stand (Part# UTS)
(must be no longer than 3 meters)
(1) External DUO Power Supply
(1) DUO Software CD
(1) Power Cord
(1) Operator’s Guide
(1) Notebook Computer
(1) Uroflow Transducer
(1) Color Inkjet Printer
ACCESSORIES Part Number
(Quantity) Description
Illustration
2583E
(1) Extended Pathway™ Preamplifier
7300
(1) 6’ Adapter for Disposable Lead Wire Electrodes
6774
(5) DUO Patient Electrode Kit Sample Packets
UFN
(1) Uroflow Funnel
GUBA
(2) Graduated Urine Beaker
www.theprogrp.com
Operator’s Guide-Prometheus™ DUO™
Page 6 of 77
CHAPTER 1:
PHYSICAL-MECHANICAL OVERVIEW & SETUP The Prometheus DUO Device
Figure 1. (Top left) Complete DUO system. (Top right) Front panel of DUO Device. Note inputs designated EMG A and EMG B for Part # 7300 and Part # 2583E respectively; large, illuminated blue On-Off button; and an input designated UROFLOW for the Uroflow Transducer. (Bottom left) Electrodes and amplified cables. (Bottom center) A USB interface is located on the left side panel and (Bottom right) power input plug is on the right side panel. The DUO Device is powered by an external medical grade power supply. Units for use in the U.S.A. are configured for 115-120 V, 60 Hz AC.
Before using the DUO system, the DUO software must be configured and patient information entered into the system. See Chapter 2: DUO SOFTWARE SETUP for software configuration and Chapter 3: USING DUO SOFTWARE for entering patient information.
www.theprogrp.com
Operator’s Guide-Prometheus™ DUO™
Page 7 of 77
CONNECTING THE DUO DEVICE 1. Locate the USB interface at the rear of the left side panel. 2. Connect the USB Serial Interface Cable to the device. 3. Connect the other end of the cable to the notebook computer. U U S B US SB B iiin n p u np pu uttt O w h & O N O F F wiiitttccch h& & ON N---O OF FF F sssw iiin n d o g h nd diiicccaaattto orrr llliiig gh httt
C h n n A n u C p Ch haaan nn neeelll A A iiin np pu uttt
U R O F L O W U UR RO OF FL LO OW W p u t n p u t iin nput
C h n n B n u C p Ch haaan nn neeelll B B iiin np pu uttt
Figure 2. Connect notebook computer to the USB Serial Interface Cable on the left side panel of the DUO. Connect the Uroflow Transducer to the input plug on front panel. Plug Part # 7300, 6’ Adapter for Disposable Lead Wire Electrodes, into the EMG A Channel input and plug Part # 2583E, Extended Pathway Preamplifier, into the EMG B Channel Input. The patient electrodes will be connected to the EMG A Channel and the EMG B Channel cables shown in Figures 7 & 8.
Uroflow Transducer Setup 1. Place the Uroflow Transducer in the retaining ring as shown in Figure 3. Be careful to line up the cable outlet on the transducer with the notch in the ring. 2. Confirm that system power is OFF. 3. Connect the Uroflow Transducer to the DUO Device by inserting the circular plug on the end of the Uroflow Transducer cable into the input jack labeled UROFLOW on the front panel of the DUO Device (see Fig. 2). 4. Align the receptacle key with the connector key (see Fig. 4). 5. Push the plug into the receptacle until the locking tabs snap. 6.
To disconnect the transducer cable from the DUO Device, squeeze the circular plug on the transducer cable at the finger grips (located at the top and bottom of the connector). The locking tabs will deflect outward and unlock. Then pull back on the plug until it is fully disengaged.
www.theprogrp.com
Fig 3. Uroflow assembly.
Operator’s Guide-Prometheus™ DUO™
Page 8 of 77
Figure 4. Connecting (left) and disconnecting (right) the Uroflow Transducer to and from the DUO Device.
7. Place an empty Graduated Urine Beaker on the Uroflow Transducer (See Figure 3). 8. Adjust the height of the Uroflow Transducer Stand by turning the knob at the end of the Arm Assembly counterclockwise and sliding it up or down to the desired height. Turn the knob clockwise to tighten the Arm Assembly 9. Place the Uroflow Funnel in the ring above the Graduated Urine Beaker (See Figure 3). NOTE: Position the Graduated Urine Beaker before starting any procedure so that the automatic zeroing function in the DUO Software will set the voided volume and flow rate channel displays to zero, compensating for the weight of the empty Graduated Urine Beaker.
EMG Setup CONNECTING PATHWAY™ CABLES TO THE DUO DEVICE 1. Connect the 6’ Adapter for Disposable Lead Wire Electrodes (Part # 7300) to the EMG A Channel of the DUO Device (see Figure 2). 2. Connect the Extended Pathway Preamplifier (Part # 2583E) to the EMG B Channel of the DUO Device (see Figure 2).
CONNECTING THE DUO PATIENT ELECTRODES 3. Connect the 3 Disposable Lead Wire Electrodes, found in the DUO Patient Electrode Kit (Part # 6774), to the 6’ Adapter for Disposable Lead Wire Electrodes (Part # 7300) by pushing the sockets onto the pins, assuring the color of each electrode wire matches that of the 6’ Adapter for Disposable Lead Wire Electrodes (see Figure 5).
Figure 5. Disposable Lead Wire Electrodes with 6’ Adapter for Disposable Lead Wire Electrodes for EMG A Channel.
www.theprogrp.com
Operator’s Guide-Prometheus™ DUO™
Page 9 of 77
4. Attach a Pathway Electrode, found in the DUO Patient Electrode Kit (Part # 6774), to the Extended Pathway Preamplifier (Part # 2583E). Be sure that all 3 snaps fit tightly together (see Figure 6).
Figure 6. Pathway Electrode (left). Pathway Electrode with Extended Pathway Preamplifier (right).
5. EMG A Channel will be used for measurement of the primary muscle, using the Disposable Lead Wire Electrodes shown in Figure 5. The two red lead wires are connected to the “Active” electrodes, and should be placed at a 10:00 and 4:00 o’clock arrangement perianally. The green lead wire is connected to the “Reference” electrode, and should be placed at the Coccyx or Gluteal muscle.
Figure 7. Positioning the Patient Electrodes on the primary muscle.
6. EMG B Channel will be used for measurement of the accessory muscle, using the Pathway Electrode shown in Figure 6. Referring to Figure 8, place the Pathway Electrode on the patient’s right side of the abdomin, just above the pubic hairline.
Figure 8. Positioning the Patient Electrodes on the accessory muscle.
www.theprogrp.com
Operator’s Guide-Prometheus™ DUO™
Page 10 of 77
7. The DUO Device is now ready for EMG monitoring and for use with the Uroflow Transducer.
Powering the DUO Device 1. Connect the power supply (only use the approved power supply that was supplied with this device) to the power input on the DUO Device located at the rear of the right side panel. 2. Connect the power cord to the power supply. 3. Connect the power cord to an electrical outlet. NOTE: If an extension cord is required, it is recommended that a power strip NOT be used as some power strips can create electrical interference with the DUO Device operation. A heavy duty extension cord, with multiple outlets if necessary, should be used.
4. Turn the DUO Device ON by pushing the large blue button on the front panel. 5. When the DUO Device is ON, the blue light on the front panel will illuminate. This light indicates that the DUO Device is ready for operation. If the blue light does not turn on, push the large blue button again (turning it OFF), and follow these trouble-shooting steps: a. Be sure the power supply is firmly connected to the DUO Device by checking this connection. b. Be sure the power cord is plugged firmly into the power supply. c. Be sure the power cord is connected to the electrical outlet and that the electrical outlet is operational. d. Ensure that the green light on the power supply is illuminated. 6. As previously described, press the DUO Device ON button. NOTE: If the DUO Device still does not turn on, contact The Prometheus Group Technical Support for further assistance. Telephone: 800-272-8492 U.S.A. and Canada; +1 (011) 603-742-6053 international; email: [email protected].
www.theprogrp.com
Operator’s Guide-Prometheus™ DUO™
Page 11 of 77
CHAPTER 2:
DUO SOFTWARE SETUP Introduction The DUO software has been designed to be highly intuitive. However, it may be helpful for the user implementing the Initial Startup Process to have some Administrator-level procedural understanding. After the initial setup, users with access to DUO Tools, which is the administrative portion of the program, should have a general knowledge of typical Microsoft® Office program commands, and be able to enter information accurately on the keyboard. Some administrative tasks, such as database backup, will require some Administrator-level procedural understanding. Aspects of the DUO software used in the performance of DUO clinical functions, are launched via the Start Here button on the main screen and will be discussed in Chapter 3. Hands-on clinical operators will require a basic knowledge of Windows functions. For general assistance, contact The Prometheus Group Technical Support: Telephone: 800-272-8492 U.S.A. and Canada; +1 (011) 603-742-6053 international; e-mail: [email protected].
Initial Startup Process The DUO Software comes preloaded on the notebook computer supplied with the system. Before operating the system for the first time, the system administrator must configure the software by entering the Associate or Associates who will have access to the program and their level of access, the Location or Locations (if there are multiple clinics) of the practice, and how patients will be identified. To start, double-left-click the Launch DUO icon on the Windows Desktop. The window below will appear. (Note that only a partial screen is shown below in order to show a clearer view of the agreement). Read the Software License Agreement on Page 76 in this guide. If you agree, single-left-click on the OK button.
www.theprogrp.com
Operator’s Guide-Prometheus™ DUO™
Page 12 of 77
THE FIRST TIME STARTUP OPENING SCREEN
1. When the opening window (above) appears, single-left-click Next.
CREATE AN ASSOCIATE 2. The Create an Associate window (below) will then appear. The purpose of this section is to create an associate with login permissions. Additional associates can be added later. Single-leftclick Next to continue.
www.theprogrp.com
Operator’s Guide-Prometheus™ DUO™
3. The Associate Profile screen (below) will then appear:
www.theprogrp.com
Page 13 of 77
Operator’s Guide-Prometheus™ DUO™
Page 14 of 77
a. Complete the information requested by single-left-clicking on the fill-in boxes and keyboarding the information. All red entry fields must be completed to satisfy the minimum description requirements. All black entry fields are optional. b. In the entry field Is this profile a Provider, Office Staff or a Referring Physician? and other similar entry fields with drop-down lists, single-left-click on the small arrow at the right of the white entry box to open the list of options. Then single-left-click on the appropriate option. Note that only a Care Provider or Office Staff may have login privileges. In the example shown, Care Provider has been selected:
4. Scroll down and select Yes for DUO System login capability. This initial Associate MUST be given DUO System login capability and MUST be given a Username and Password. The program will not proceed until these steps are taken. The system will automatically assign “Admin” status to this initial Associate.
5. Single-left-click on the Set Username/Password button.
www.theprogrp.com
Operator’s Guide-Prometheus™ DUO™
Page 15 of 77
6. Enter the information and then single-left-click the OK button.
7. The Verify Password window will appear. Re-enter the password and single-left-click the OK button. If the password is not entered exactly as before, the program will prompt for the password to be re-entered correctly.
NOTE: It is strongly recommended that the Username and Password be recorded in a secure location for future reference. 8. OPTIONAL: Additional Associate information may be entered into the Contact Information and Additional Notes fields (this, and other optional information, can be added later). 9. OPTIONAL: The Associate Profile Edit History section contains profile edit data may be needed for compliance with HIPAA and other legal requirements. 10. There is now enough required information in the Associate Profile to satisfy the minimal Associate description for the DUO software to be launched. Single-left-click the Close button to exit the Associate Profile screen.
www.theprogrp.com
Operator’s Guide-Prometheus™ DUO™
Page 16 of 77
11. The Save the data that was updated window shown below will appear. Save the data by singleleft-clicking the YES button (when the cursor is positioned over this button, it will turn green as shown).
12. After single-left-clicking YES, the Associates List Screen will appear. Note that the Associate just entered is listed. Additional Associates may be entered at this time but are not required, single-left-click the Close button to continue the Initial Startup Process.
www.theprogrp.com
Operator’s Guide-Prometheus™ DUO™
Page 17 of 77
CREATE A LOCATION 13. The Create a Location window(below) will then appear. The purpose of this section is to create a location, a place of service. Additional locations, if necessary, can be added later. Single-left-click Next to continue.
NOTE: In the following example, the red entry field Business Name MUST be filled in. Metropolitan Urology Associates and some additional information has been entered in the example. While additional information may be entered later, entering the address and phone number of this location now will complete the header section of the reports in the software.
www.theprogrp.com
Operator’s Guide-Prometheus™ DUO™
Page 18 of 77
14. There is now enough required information in the Location Profile to satisfy the minimal location description for the DUO software to be launched. Single-left-click the Close button to exit the Location Profile screen. 15. The Save the data that was updated window shown below will appear. Save the data by singleleft-clicking the YES button.
16. After single-left-clicking YES, the Location List Screen will appear. Note that the Location just entered is listed. Additional Locations may be entered at this time but are not required, singleleft-click the Close button to continue the Initial Startup Process.
www.theprogrp.com
Operator’s Guide-Prometheus™ DUO™
Page 19 of 77
CREATE UNIQUE IDENTIFIERS 17. The Create Unique Identifiers window(below) will then appear. This is the method by which patients will be identified in the patient database. This feature ensures that the practice is compliant with HIPAA requirements for patient privacy. Single-left-click Next to continue.
www.theprogrp.com
Operator’s Guide-Prometheus™ DUO™
Page 20 of 77
18. Choose one or multiple Unique Patient Identifiers by single-left-clicking on the appropriate box or boxes. Note that by single-left-clicking on a box with a check mark (√) present removes the check mark and that method of identifying the patient. The example shows Unique ID checked. Single-left-click OK when complete.
19. A Congratulations window will appear. The Initial Startup Process is now complete single-leftclick Next to continue.
www.theprogrp.com