Clinician’s Guide DRAFT
Worldwide Corporate Office Bioness Inc 25103 Rye Canyon Loop Valencia, CA 91355 USA Telephone: 800.211.9136 Email: info@bioness.com Website: www.bioness.com Manufactured by Bioness Neuromodulation Ltd. 19 Ha’Haroshet Street PO Box 2500 Industrial Zone Ra’Anana 43654, Israel European Authorized Representative NESS Europe B.V. Stationsweg 41 3331 LR Zwijndrecht, The Netherlands Telephone: +31.78.625.6088 Email: international@nl.bioness.com Website: www.bioness.
Neuromodulation System Clinician’s Guide DRAFT Rx Only
Copyright ©2012 by Bioness Inc. All Rights Reserved. No part of this publication may be reproduced, transmitted, transcribed, stored in a retrieval system or translated into any language or any computer language, in any form or by any third party, without the prior written permission of Bioness Inc. Guarantees Bioness Inc reserves the right to modify, without prior notice, information relating to its products to improve their reliability or operating capacity.
List of Symbols Caution or Warning Double Insulated (Equivalent to Class II of IEC 536) Type BF Applied Part(s) Non-Ionizing Radiation Date of Manufacture Manufacturer This Product Must Not Be Disposed of with Other Household Waste Consult Instructions for Use Re-Order Number Lot Number Serial Number Complies with United States and Canadian Product Safety Standards Single Patient Use Storage Temperature Complies with the European Union Medical Device Directive Quantity iii
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Table of Contents List of Symbols ........................................................................................................................ iii Chapter 1: Introduction........................................................................................................ 1 Chapter 2: Warnings and Cautions .................................................................................. 3 Indications for Use ....................................................................................
Keep out of Reach of Children ............................................................................................ 12 Skin Abnormalities ...............................................................................................................12 Skin Irritation ....................................................................................................................... 12 Known or Suspected Heart Problems ................................................................................
Connector Cable with Charger Adapter ...............................................................................22 Stylus .................................................................................................................................. 22 Tester ...................................................................................................................................... 23 Clinician’s Software Navigation............................................................................
Opening a Patient Record.................................................................................................... 49 Modifying a Patient Record ................................................................................................. 50 Removing a Patient Record ................................................................................................ 50 Searching for a Patient Record ...........................................................................................
Chapter 10: Maintenance and Cleaning .................................................................. 70 Battery Replacement ............................................................................................................... 71 Replacing the Clinician Programmer Battery ....................................................................... 71 Cleaning ...................................................................................................................................
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1 Introduction The Bioness StimRouter Neuromodulation System consists of the following components and accessories: • An implantable multi-electrode lead with integrated receiver in loader. • Surgical tools for implantation of the StimRouter lead. • An external programming system with a clinician programmer, a clinician programmer cradle and charger, a tester and accessories. • A patient-operated system with a rechargeable EPT, an external patient programmer, a system charger and accessories.
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2 Warnings and Cautions Clinicians and patients should know the limitations, warnings and precautions associated with the StimRouter Neuromodulation System. Clinicians should review the warnings and precautions and instructions for use with the patient. If at any time the clinician or patient is concerned about the safety or effectiveness of the StimRouter system, then call your local distributor.
whether neurostimulation is turned on or off. All patients are advised to inform their health-care professionals that they should not be exposed to diathermy. • Patients exposed to therapeutic ultrasound. • Patients who are unable to operate the StimRouter system. • Patient who are high surgical risks or poor surgical candidates in general. • Patients who have a cancerous lesion present near the target stimulation point or near to where the StimRouter electrode will adhere.
Bioness recommends the following optional screening procedure prior to StimRouter lead implantation: • Transcutaneous electrical nerve stimulation (TENS) to determine the patient’s tolerance of stimulation near the anticipated site for the StimRouter electrode. Please note that some individuals are very sensitive to the sensation to electrical stimulation applied to the skin.
MRI Information Non-clinical testing has demonstrated that the StimRouter lead is MR Conditional. Patients with an implanted StimRouter lead can be scanned safely, immediately after implantation, on MRI cylindrical bore systems that meet the following conditions: • Static magnetic field of 1.5 Tesla (T) or 3 T. • Highest spatial magnetic gradient of 2500 gauss/cm or less. • MR system reported, whole-body-averaged SAR does not exceed 2 W/kg at 1.5 T and 2 W/kg at 3 T.
• Communication is maintained with the patient so that the scan can be promptly terminated in the event of painful nerve stimulation or other adverse event. Information regarding the position of the lead is necessary for routine MRI procedures. Review of the patient’s Medical Device Identification Card, direct communication with the implanting physician or obtaining an x-ray is recommended to determine the location of the implanted lead.
Image Artifacts MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the StimRouter lead. Therefore, optimization of MR imaging parameters to compensate for the presence of the StimRouter lead may be necessary. Induced Currents The electric fields induced in the patient with the StimRouter lead by the pulsed gradient fields were calculated.
Device Components The use of non-Bioness components with the StimRouter system may result in damage to the system and increased risk to the patient. Flammable Fuel or Chemicals Advise patients to turn the StimRouter system (patient programmer and stimulation) off when near a refueling point, flammable fuel, fumes or chemicals. The operation of the StimRouter could cause the chemicals or fumes to ignite, causing severe burns, injury or death.
Electrosurgery Devices Electrosurgery devices should not be used in close proximity to an implanted StimRouter lead. Contact between an active electrode of the electrosurgery device and the implanted lead can cause direct stimulation of the target stimulation point and severe injury to the patient.
Cell Phones There is potential for interference between electronic devices, including cell phones. Stimulation control may be delayed. If interference is suspected or anticipated, distance yourself from the source of interference. To minimize interference, maintain a minimum safe separation distance of 15 cm (6 in.) between the StimRouter system and all other electronic devices.
Keep out of Reach of Children The StimRouter components should be kept out of the reach of children. Skin Abnormalities Do not adhere the StimRouter electrode to sites that are swollen, infected or inflamed, or that have skin eruptions such as phlebitis, thrombophlebitis and varicose veins. Do not adhere the StimRouter electrode to skin that is breached. Skin Irritation It is normal for the skin under the StimRouter electrode to become red.
• Always inspect the gel electrodes before use. Do not apply the StimRouter electrode if the gel electrodes appear dried out, worn, dirty or irregular. • Make sure the gel electrode liners are removed before applying the user patch. • Do not handle the StimRouter electrode with both hands while stimulation is on; serious injury can result from current passing through the cardiac tissues. Expiration Date Do not use a StimRouter electrode with a “Use by” date that has expired.
Risks Related to Stimulation • Operation of the StimRouter components may cause increased pain in an area other than the lead site. This pain may be caused by stimulation of the tissue surrounding the stimulation electrodes (e.g., skin, fascia and muscle). • Patients may also experience an undesirable motor response during stimulation.
Environmental Conditions that Affect Use 3 Storage and Handling All StimRouter components should be kept dry and protected from extreme changes in temperature and humidity. Do not use or store components where they could come in contact with water, such as by sinks, bathtubs and shower stalls. Do not expose components to weather conditions such as rain or snow, or to any other source of water.
The antenna for each transmitter must not be located near to or operating in conjunction with any other antenna or transmitter. Changes or modifications to components not expressly approved by Bioness could void the user’s authority to operate the equipment. Conformity Certification The StimRouter complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: 1. This device may not cause harmful interference, and 2.
4 StimRouter Clinician Kit Description The StimRouter Clinician Kit contains the clinician programming components of the StimRouter Neuromodulation System, used to program the StimRouter EPT and Patient Programmer.
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5 Device Description Clinician Programmer with Software The StimRouter clinician programmer is used to program, test and save stimulation parameters and programs on the StimRouter EPT and patient programmer. See Figure 5-1. All stimulation parameters and programs are stored on the clinician programmer as well. When connected to the StimRouter clinician programmer cradle and patient programmer, the clinician programmer can wirelessly communicate with the EPT.
WARNING: The clinician programmer should only contain the installed Windows Mobile® operating system and Bioness Inc proprietary StimRouter software. Do not use the clinician programmer for any purpose other than that described in this manual. Third-party software packages are not supported and may interfere with proper operation of the StimRouter components, thus voiding the warranty.
24-Pin Connector Port For use with the connector cable on the clinician programmer cradle. Wireless Bluetooth Communication Used for high-speed, low-power, short-range wireless communication with a Bioness-approved Bluetooth printer. Clinician Programmer Memory Card Used to back up and restore the clinician programmer database. The memory card is supplied installed in the SD slot of the clinician programmer. Clinician’s Programmer Charger Used to recharge the clinician programmer battery.
Configuration Cradle Used to connect the clinician programmer to the patient programmer and to the clinician’s programmer charger. The configuration cradle is designed to house the patient programmer and the clinician programmer in a convenient, portable unit. See Figure 5-2. Charger Charger Adapter Clinician Programmer Stylus (not shown) Connector Cable Patient Programmer Connector Cable Configuration Cradle Figure 5-2.
Tester Used to confirm that the EPT is working properly. See Figure 5-3. Figure 5-3. The tester. The tester is used to diagnose stimulation problems in the EPT. It provides audio feedback when connected and stimulation is applied. Clinician’s Software Navigation The StimRouter clinician’s software is provided installed on the clinician programmer. Operating Modes The StimRouter application has two operating modes: online and offline. Online.
Operating Mode Online Function Descriptions • Add a new patient. • Modify a patient name. • Open a patient record. • View/print a patient’s history. • Program stimulation settings. • Program time settings. • Add or remove a stimulation program. • View the system information. • Reset the EPT and patient programmer. • Back up the database. • Restore the clinician programmer database. • Add a new user. • Remove a user. • Change a user password. Offline • • • • • • • • • Open any patient record.
• FLASHING RED with “i” in the center when a patient programmer is connected and a correctable error has occurred (for example, RF communication failure). • CONSTANT RED with “i” in the center when a patient programmer is connected and an error has occurred. • FLASHING YELLOW with “i” in the center when the StimRouter patient programmer or EPT battery charge level is low. Print Icon Used to print patient reports. Data Entry Keyboard.
Programs. Used to program, test and save a set of stimulation and time settings. (Enabled when a patient record is open.) History. Used to view or print a patient’s usage log or session history. (Enabled when a patient record is open.) Tools. Used to view system information and to reset the patient programmer and EPT. Users with administrator privileges can also add and remove users, change a user password, and back up and restore the clinician programmer database.
Menu Tools Tab Info Users Backup Restore Function Descriptions • View system information in online mode. • Reset the patient programmer and EPT in online mode. • Add a new user. • Remove a user. • Change a user password. • Back up the clinician programmer database. • Enable/disable automatic database backup. • Restore the clinician programmer database from automatic backup. • Restore the clinician programmer from manual backup. Table 5-2.
New New User Open Print • • • • Remove Remove User Reset Patient Programmer • • • Reset Patient Programmer/EPT • Stop & Save Test View • • • Add a new patient record. Add a new user (enabled for administrators only). Open an existing patient record. Print the specified report to a Bioness-approved Bluetooth printer or to a PDF file on the memory (SD) card. Remove an existing patient record. Remove a user (enabled for administrators only).
Program Bar Used to add, delete and view up to eight clinician-set stimulation programs, labeled A-H. See Figure 5-10. Add Program Icon Back Program Arrow Next Program Arrow Delete Program Icon Figure 5-10. Program bar and icon definitions. Add Program Icon. Used to add a new stimulation program. (Enabled in online mode when fewer than eight programs have been saved.) Delete Program Icon. Used to delete a stimulation program. (Enabled in online mode when more than one program has been saved.
Programming Parameters Patients require tailored stimulation patterns to help control their pain. The StimRouter system features eight programmable parameters and can store up to eight stimulation programs on the clinician programmer, patient programmer and EPT. Timing parameters are specified in Table 5-4. Pulse parameters are specified in Table 5-5.
Parameter Total Pulse Duration Maximum Load Typical Load Minimum Load Pulse Repetition Rate*** Specification Up to 2550 microseconds (depends on waveform) 5000 ohms (subject to max voltage limitation) in parallel to 80 nanofarads 2700 ohms in parallel to 22 nanofarads 100 ohms in parallel to 1 nanofarad 1, 2, 5, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 120, 140, 160, 180, 200 hertz *Intensity: A measure of strength of the stimulation. **Positive phase duration: A measure of the duration of a pulse.
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6 Set-Up Instructions Programming Components and Software This section describes how to connect the clinician programmer and cradle, charge the clinician programmer and launch the StimRouter application. Connecting the Clinician Programmer and Cradle To connect the clinician programmer and cradle: 1. Orient the clinician programmer in the configuration cradle with the touchscreen facing up and the 24-pin connector port facing left. See Figure 6-1.
Charging the Clinician Programmer To charge the clinician programmer: 1. Insert the connector on the clinician’s programmer charger into the charger adapter on the connector cable. See Figure 6-1. WARNING: Use only the clinician’s programmer charger included in the StimRouter Clinician Kit (Manufacturer Model No. PHIHONG, PSC11R/PSM11R). 2. Plug the charger into a power socket. 3. Allow the clinician programmer to charge. The clinician programmer can take two to four hours to charge.
3. To log in, enter a user name and password, and then press “Login.” Note: Always log off the StimRouter application before leaving the clinician programmer unattended. Patient’s External Components The patient-operated components of the StimRouter system are: the patient programmer, EPT and StimRouter electrode. See Figure 6-3. StimRouter Electrode EPT Patient Programmer Figure 6-3. The StimRouter patient programmer, StimRouter electrode and EPT.
Connecting the Patient Programmer and Configuration Cradle To connect the patient programmer and configuration cradle: 1. Open the flexible cover on the patient programmer. 2. If necessary, charge the patient programmer using the system charger set provided in the User Kit. Insert the Y cable connector into the charging socket; plug the charger into a power socket. See Figure 6-4. Patient Programmer Charging Socket Flexible Cover Connection Port Charger Cable Connector Figure 6-4.
4. Insert the patient programmer into the configuration cradle. Connecting the StimRouter Electrode and EPT To connect the StimRouter electrode and EPT: 1. Obtain an operational StimRouter electrode. Electrodes can be reused for as long as the gel electrodes can fully adhere to the skin. 2. Do not remove the the reusable StimRouter electrode liner from the gel electrodes at this time. Set the StimRouter electrode on a flat surface with the gel electrodes facing down. 3.
Adhering the StimRouter Electrode to the Skin The StimRouter electrode with EPT attached should be placed on the skin directly over the receiver end of the lead. For optimal stimulation, the skin where the StimRouter electrode will adhere should be clean and dry. This section describes how to prepare the skin, and how to adhere and remove the StimRouter electrode. Note: Transfer the EPT to a new StimRouter electrode when the gel electrodes adherence to the skin decreases.. To prepare the skin: 1.
To adhere the StimRouter electrode: 1. Protective Covers 2. Remove the reusable StimRouter electrode liner and store it in the StimRouter electrode carrying case. The StimRouter electrode liner is larger than the electrode and is marked with the Bioness logo. See Figure 6- 8. Do not bend, break or soil the StimRouter electrode liner. Figure 6-8. Remove the StimRouter electrode liner. 3. Visually inspect the gel electrodes. Make sure the gel is smooth and attached to the StimRouter electrode.
4. Using the index finger and thumb, grasp the edges of the StimRouter electrode so that the gel electrodes face away from the palm. See Figure 6-9. EPT Figure 6-9. Grasp the edges of the EPT attached to the StimRouter electrode. 5. Align one end of the StimRouter electrode with EPT attached directly over the receiver end of the lead. If the StimRouter electrode is not directly over the receiver end of the lead, then stimulation may be uncomfortable or ineffective. See Figure 6-10.
CAUTION: Make certain the adhesion site is free of obstructions (for example, bandages, clothing, etc.) before adhering the StimRouter electrode. If the StimRouter electrode is placed partially or wholly over a bandage or other obstruction, then skin irritation or tissue damage could occur during stimulation. 7. Firmly adhere the StimRouter electrode to the skin, making sure that the electrode is in full contact with the skin.
• Adjust stimulation intensity using the patient programmer. • Save a new stimulation intensity level on the patient programmer. • Turn stimulation off using the patient programmer. Removing the StimRouter Electrode from the Skin/Body It may be necessary during set up to remove the StimRouter electrode to reposition it or test the EPT. To remove the StimRouter electrode: 1. To remove the StimRouter electrode, make certain that stimulation is turned off.
Testing the EPT The tester is used to test the functionality of an EPT. Before connecting the EPT to the tester, make sure the EPT is charged. Using the patient programmer or clinician programmer, stimulation can be turned on. Using the tester: 1. Connect the Tester snaps to the EPT plug holes. See Figure 6-14. Figure 6-14. Connecting the tester to the EPT. 2. Press the patient programmer on/off button to turn on the system. 3.
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Patient Records and History 7 Patient Records This section reviews how to add, copy, open, modify, remove and search for a patient record; and how to view and print a patient’s session and usage history. Definition of Terms Unassigned System: No patient data are stored on the EPT or patient programmer. Assigned System: Patient data are stored on either the EPT or patient programmer.
Figure 7-1. Unassigned system detected. 3. If this prompt does not appear and the patient’s components are new, then reset the patient programmer and EPT. See “Resetting the Patient Programmer and EPT” section of this guide. 4. Press “New” to create a new patient record. 5. When the New Patient screen opens, enter the patient’s first and last names and a patient ID. See Figure 7-2. Figure 7-2. Adding a patient with an unassigned system. 6. Proceed to “Programming Instructions” section of this guide.
Copying a Record for an Existing Patient to an Unassigned System Follow these instructions when a patient has a record stored in the clinician programmer database and no patient data have been stored on the EPT or patient programmer, i.e., the patient is not new but the patient’s system is unassigned. This patient may have purchased replacement components, or the patient’s components may have been reset. To copy a record for an existing patient to an unassigned system: 1.
Adding a Patient with an Assigned System Follow these instructions when a patient does not have a record in the clinician programmer database but data are stored on the patient’s EPT and patient programmer, i.e., the patient’s system is assigned. This patient may be a referral from another clinic or from a clinician using a different clinician programmer. To add a patient with an assigned system to the clinician programmer database: 1.
Opening a Patient Record Note: When the clinician programmer is in online mode and connected to a patient programmer and an EPT that contain programs, only the patient record corresponding to those components can be opened. If the components do not contain programs, then any patient record can be opened and the patient data copied to the patient programmer and EPT. In offline mode, any patient record can be opened and viewed. To open a patient record: 1. Press the PATIENTS MENU to open the Patient List. 2.
Modifying a Patient Record Note: “Modify” is only enabled in online mode, when the clinician programmer is connected to a working patient programmer and EPT. To modify a patient record: 1. Press the PATIENTS MENU to view the Patient List. 2. From the Patient List, press “Modify.” 3. Enter changes to the patient’s first or last name, and then press “OK.” See Figure 7-6. Patient ID cannot be modified. Figure 7-6. Modifying a patient record.
Figure 7-7. Removing a patient record. Searching for a Patient Record To search for a patient record: 1. Make certain that the clinician programmer is not connected to an operational patient programmer and EPT, i.e., that the clinician programmer is in offline mode. The information icon should not be GREEN. 2. Press the PATIENTS MENU to open the Patient List. 3.
Usage History The patient usage history is stored on the EPT and is automatically retrieved when the clinician programmer is connected to an operational patient programmer and EPT. Viewing a Usage History To view a usage history: 1. From the PATIENTS MENU, select the patient on the Patient List, and then press “Open.” 2. From the HISTORY MENU, press the USAGE TAB to open the Usage Log. 3. In the “Display” drop-down list (bottom right of screen), select a program to view or select “All Programs.
Printing a Usage History To print a usage history: 1. Press the print icon on the Usage Log screen. 2. From the “Printer” drop-down list, select the installed printer or “Adobe PDF file,” and then press “Print.” Note: Selecting “Adobe PDF file” saves the usage history as a PDF file on the clinician programmer memory (SD) card. Session History Session history can be viewed and printed from the SESSIONS TAB under the HISTORY MENU. Open a patient record to enable the HISTORY MENU.
3. The session detail will open. See Figure 7-10. Figure 7-10. Session detail. Printing a Session History To print a session history: 1. With the session detail open, press the print icon. 2. From the “Printer” drop-down list, select the installed printer or “Adobe PDF file,” and then press “Print.” Note: Selecting “Adobe PDF file” saves the session as a PDF file on the clinician programmer memory (SD) card. Printing Multiple Sessions To print multiple sessions: 1. Open the SESSIONS TAB. 2.
Note: Selecting “Adobe PDF file” saves the session as a PDF file on the clinician programmer memory (SD) card. Figure 7-11. Printing multiple sessions. Check which sessions to print, and then press “Print.
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8 Tools Both users and administrators have access to the INFO TAB of the TOOLS MENU. Only administrators have access to the USERS, BACKUP and RESTORE tabs of the TOOLS MENU. System Information and Component Reset System information can be found on the INFO TAB of the TOOLS MENU. From the INFO TAB, users can also reset the patient programmer, if, for example, a clinic patient programmer is to be used.
Figure 8-2. Select a reset option, and then press “Reset.” To reset the patient programmer and EPT: 1. Make certain the clinician programmer is in online mode. Select “Reset the System (Patient Programmer and EPT),” and then press “Reset.” See Figure 8-2. User Administration The StimRouter application supports two levels of users: users and administrators. Administrators have extended authorizations.
Adding a User/Administrator To add a user/administrator: 1. From the TOOLS MENU, press the USERS TAB and then “New User.” See Figure 8-3. Figure 8-3. Adding a user/administrator. 2. Enter a user name and password, confirm the password, select either “Users” or “Administrators” from the “Group” drop-down list, and then press “Add.” See Figure 8-4. Figure 8-4. Adding a user/administrator.
Removing a User/Administrator To remove a user/administrator: 1. From the TOOLS MENU, press the USERS TAB, select a user name, and then press “Remove User.” Confirm “Yes” or “No” when prompted. See Figure 8-5. (The administrator who is logged on cannot be removed.) Figure 8-5. Removing a user. Select the user, and then press “Remove.
Changing a User Password To change a user password: 1. From the TOOLS MENU, press the USERS TAB, select a user name, and then press “Change Password.” 2. Enter and confirm the new user password, and then press “OK.” See Figure 8-6. Figure 8-6. Changing a user password. Note: Bioness recommends that passwords be changed at least every three months.
Clinician Programmer Database Backup and Restore Manually Backing Up the Database Note: Only administrators have access to the BACKUP TAB. To manually back up the clinician programmer database: 1. From the TOOLS MENU, press the BACKUP TAB. See Figure 8-7. Figure 8-7. Backing up the clinician programmer database. 2. From the “Back up to” drop-down list, select “SD Card,” and then press “Start Backup.” Enabling Automatic Database Backup To enable automatic database backup: 1.
Restoring the Database Note: Only administrators have access to the RESTORE TAB. To restore the clinician programmer database: 1. From the TOOLS MENU, press the RESTORE TAB. 2. From the “Restore from” drop-down list, select “SD Card.”See Figure 8-8. Figure 8-8. Restoring the clinician programmer database. 3. Select “From automatic backup” or “From manual backup,” and then choose a backup date and time from the drop-down lists. 4. Press “Start Restore.
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9 Programming Instructions The programming session can begin once the StimRouter electrode with EPT attached is adhered, the clinician programmer and patient programmer are set up, and the patient’s record is added and opened. This section describes how to program stimulation and time settings, and how to add a program, view a program, delete a program and print a program. Stimulation and Time Settings Programming Stimulation Settings To program stimulation settings: 1.
Note: The stimulation settings have a constant ramp-up of 1 second, during which the patient may not feel any stimulation. Account for ramp-up time during the adjustment process. 4. Press “Test” to test the stimulation settings; stimulation will turn on. Note: If the combination of parameters exceeds the maximum charge level allowed (10 microcoulombs per phase), then a warning will appear with directions to reduce the total charge. “Test” will be disabled. See Figure 9-2. Figure 9-2.
7. The program save date will appear on the Program Bar. Note: If an intensity adjustment during testing causes the maximum charge level to be reached, then a notification will appear. No further increase will be allowed. See Figure 9-4. Figure 9-4. Maximum charge level reached. Programming Time Settings To program time settings: 1. From the STIM SETTINGS TAB, press the TIME SETTINGS TAB. 2. The default time setting is constant stimulation.
3. Press “Test” to test the time settings; stimulation will turn on. 4. Fine-tune the intensity level (using the up/down arrows). Note: If an intensity adjustment during testing causes the maximum charge level to be reached, then a notification will appear. No further increase will be allowed. See Figure 9-6. Figure 9-6. Maximum charge level reached. 5. Press “Stop & Save” to stop stimulation and save the time settings to the clinician programmer, patient programmer and EPT. 6.
Adding a Program Note: The StimRouter application must be in online mode to add a new stimulation program. To add a program: 1. From the STIM SETTINGS TAB or TIME SETTINGS TAB press the add program icon on the Program Bar. See Figure 9-7. 2. The new program will open with default settings. The new program label (A-H) will appear in the Program Bar. 3.
Printing a Program To print a program: 1. Open the selected program and press the print icon. See Figure 9-7. 2. Select a printer or “Adobe PDF file” from the drop-down list, and then press “Print.” See Figure 9-8. Figure 9-8. Select a printer (or “Adobe PDF file”) from the drop-down list, and then press “Print.” 3. If the page does not print, then verify that the printer is within 30 feet of the clinician programmer, is turned on, has paper in the paper tray and is not displaying an error message.
Maintenance and Cleaning 10 Battery Replacement Replacing the Clinician Programmer Battery During extended periods of nonuse, remove the battery from the clinician programmer. Refer to the iPAQ product instructions for information on battery removal and replacement. CAUTION: Risk of explosion if battery is replaced by an incorrect type. Dispose of used batteries according to local regulation. Cleaning All StimRouter Clinician Kit components may be cleaned by carefully wiping them with a damp cloth.
3. As needed, use additional saturated disinfectant wipes or cloths to keep the component surface wet for 10 minutes. Note: Be sure to follow the Bioness instructions for the specified contact time to ensure an effective bacteria kill. Clinician Kit Carrying Case The StimRouter Clinician Kit carrying case may be cleaned and low-level disinfected using CaviCide® (Metrex, Orange, CA) or 70% isopropyl alcohol (IPA) per the instructions below: CaviCide: 1.
11 Troubleshooting The tables at the end of this section describe the visual indicators that may appear on the clinician programmer and patient programmer, and possible solutions for troubleshooting. In addition, this section describes solutions for the following scenarios that may arise during a programming session: • The patient forgets to bring the patient programmer. • The patient forgets to bring or has lost the EPT. • The patient brings a new patient programmer and EPT.
Using a Clinic Patient Programmer To use a clinic patient programmer: 1. Connect the clinic patient programmer to the clinician programmer cradle. 2. Make sure the EPT and the patient programmer are charged (if not, connect them to a charger). 3. Make sure the patient programmer and the EPT are no more than a few inches apart and not touching. 4. From the TOOLS MENU, press “Reset Patient Programmer/EPT.” 5. Select “Reset the Patient Programmer” and press “Reset.” 6.
Note: The patient Usage Log is stored on the EPT and is automatically retrieved when the patient programmer and EPT are connected. 11. Proceed with the programming session. Programming changes will be automatically saved to the EPT. 12. Before the session ends, remind the patient to re-register his or her EPT and patient programmer at home. Review with the patient the following instructions for RF registration.
On/Off Button Mode Button Volume Buttons Plus/Minus Buttons Unregistered In Process Complete Error Figure 11-2. StimRouter Patient Programmer operating buttons and RF registration status indicators. 8. When the digital display shows the letter “C” and the RF icon turns GREEN for a few seconds, the registration procedure is complete. Note: If the digital display shows the letter “E” and the RF icon turns RED for a few seconds, then an error has occurred and the procedure must be repeated.
Patient Loses EPT When a patient loses an EPT, he or she will need to electronically register the patient programmer and new EPT. See “Registering the Patient Programmer/EPT” section of this guide. All data stored on the patient programmer will copy to the new EPT. However, since the usage history is stored on the EPT, any usage history that was not copied to the clinician programmer database is lost with the lost EPT.
Patient Forgets StimRouter Electrode If a patient forgets to bring his or her StimRouter electrode to a follow-up session, use a clinic StimRouter electrode or reschedule the programming session Troubleshooting Wireless Technology Clinician Programmer FLASHING RED Information Icon FLASHING YELLOW Information Icon RED Information Icon Problems/Solutions A User-Correctable Error such as Faulty Electrode Contact, Radio Communication Failure • Press the information icon to view the error message and list of
Tester Tester Will Not Buzz • Check to see if EPT is charged. • Replace the tester. Table 11-3. Troubleshooting, tester. Patient Programmer Indicator Patient Programmer Will Not Turn On Problems/Solutions Battery Failure; Charger Failure; Patient Programmer Failure • Charge the patient programmer. • Change the battery in the patient programmer. • Contact your local distributor. Table 11-4. Troubleshooting, patient programmer.
EPT Icon Problems/Solutions EPT Icon FLASHES YELLOW EPT Icon GLOWS RED and “E” appears in the Digital Display EPT Battery Charge Level is Low • Charge the EPT. EPT Icon FLASHES RED and “E” FLASHES in the Digital Display EPT Temperature Error • The EPT is either too hot or too cold and will cease activity until its working temperature range is restored. Restore the EPT to its working temperature range.
Patient Programmer Icon While Charging, Patient Programmer Icon GLOWS RED and “E” Appears in the Digital Display Problems/Solutions Charging Error • Reconnect the charger cable to the patient programmer. • Replace the battery in the patient programmer. Patient Programmer Malfunction Patient Programmer Icon • Turn the patient programmer off and then back GLOWS RED and “E” on. Appears in the Digital Display • Check to see if one of the buttons is stuck and, if so, try to release it.
RF Icon Problems/Solutions RF Icon FLASHES RED Radio Communication Failure or EPT Battery Failure • Make sure the patient programmer and EPT are within 10 feet of each other. • If the components are within range, then turn the patient programmer off and back on. • Connect the EPT to the charger.• Re-register the components. • Contact your local distributor Table 11-7. Troubleshooting, patient programmer, RF icon.
12 Technical Specifications Wireless (RF) Communications Specifications Capabilities Functions Modes Characteristics • Communication between the patient programmer and EPT • Communication between the Clinician Programmer and Bluetoothenabled printer RF Communication is used between the EPT and patient programmer, enabling the Clinician Programmer to perform the following functions: • Define stimulation parameters and programs (e.g., pulse width, amplitude) • Control stimulation (e.g.
Locations and Ranges The patient programmer and EPT communicate when an object-free line of sight is available, up to 7 m distance between them. The communication range will be shortened if conductive objects, such as metal or the human body, are in the communication path between the patient programmer and EPT. The patient programmer alerts visually when loss of communication with the registered EPT occurs. Intermittent RF communication may also cause some delay in user-controlled operations.
Troubleshooting Wireless Technology The patient programmer will emit audio and visual alerts if RF communication fails. See below. Report problems your local distributor. Privacy of StimRouter Wireless Communication While the frequency band used by the StimRouter wireless system can be used by other users of the band, the privacy of the StimRouter wireless system is ensured by: • The unique ID of paired components. • Proprietary communication protocol.
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Appendix - EMI Tables 13 Electromagnetic Emissions The StimRouter system is medical electrical equipment and was tested for electromagnetic compatibility (EMC) in accordance with International Electrotechnical Committee (IEC) 606011-2. The following tables provide information regarding the EMC testing and guidance for safe use of the system. The StimRouter system should be configured and used in accordance with the instructions provided in this manual.
Guidance and Manufacturer’s Declaration Electromagnetic Emissions The StimRouter system is intended for use in the electromagnetic environment specified below. The customer or the user of the StimRouter system should assure that it is used in such an environment.
Guidance and Manufacturer’s Declaration Electromagnetic Immunity The StimRouter system is intended for use in the electromagnetic environment specified below. The user of the StimRouter system should assure that it is used in such an environment.
Guidance and Manufacturer’s Declaration Electromagnetic Immunity The StimRouter system is intended for use in the electromagnetic environment specified below. The customer or the user of the StimRouter system should assure that it is used in such an environment. Immunity Test IEC 60601 Test Level Compliance Level Conducted RF 3 Vrms 3 Vrms IEC 61000-4-6 150 kHz to 80 MHz 3 V/m 150 kHz to 80 MHz 10 V/m 80 Mhz to 2.
Guidance and Manufacturer’s Declaration Electromagnetic Immunity a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered.
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14 Bluetooth Printer Set-Up The StimRouter clinician programmer and a Bluetooth printer are Bluetooth-enabled devices. To communicate, the clinician programmer and the printer must be within 30 feet of each other and turned on. Enabling Bluetooth To set up a Bluetooth printer: 1. Turn the clinician programmer on, press “Start” and then “Settings.” See Figure 14-1. Figure 14-1. Press “Start” and then “Settings.
2. The Settings screen will open. Press the CONNECTIONS TAB and then the Bluetooth icon. See Figure 14-2. Figure 14-2. Press the Bluetooth icon. 3. From the GENERAL TAB, press “Turn on” (under “Bluetooth status”) and then the “Bluetooth Manager” hyperlink. See Figure 14-3. Figure 14-3. Press “Turn on.” 4. The Bluetooth Manager screen will open. Press “New.” See Figure 14-4.
Figure 14-4. Press “New.” (Your screen icons may vary.) 5. The Connection Wizard will open. Press “Explore a Bluetooth device.” See Figure 14-5. Figure 14-5. Press “Explore a Bluetooth device.
6. Wait for the application to process, press “Officejet H470” and then “Next.” See Figure 14-6. Figure 14-6. Press “Next.” 7. Press “Serial Port” under “Service Selection” and then “Next.” See Figure 14-7. Figure 14-7. Press “Serial Port” and then “Next.
8. Press “Finish.” See Figure 14-8. Figure 14-8. Press “Finish.” Device Pairing To pair the clinician programmer with a Bluetooth printer: 1. Return to the Bluetooth manager screen, and then press “Menu.” See Figure 14-9. Figure 14-9. Press “Menu.” (Your screen icons may vary.
2. From the pop-up menu, press “Paired Devices” and then “Add.” 3. Under “Bluetooth: Device Pairing” press the lookup icon (right of the “Device” field). See Figure 14-10. Figure 14-10. Press the lookup icon. 4. From the Bluetooth Browser, select “Officejet H470” and press “View.” See Figure 14-11. Figure 14-11. Select the Officejet H470 icon and then “View.
5. Enter “0000” in the “Passkey” field and press “ok.” See Figure 14-12. Figure 14-12. Enter “0000” in the “Passkey” field. Press “ok.
