Bioness Neuromodulation A Bioness STRP-PP-V00 Patient Programmer User Manual
Bioness Neuromodulation ltd. A Bioness Inc Company Patient Programmer
user manual
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| Document Description | user manual |
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| Document Type | User Manual |
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| Date Submitted | 2012-06-29 00:00:00 |
| Date Available | 2012-07-02 00:00:00 |
| Creation Date | 2012-05-21 17:59:55 |
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| Document Title | user manual |
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| Document Author: | Eyal Kayton [Bioness Neuromodulation] |
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.com Rx Only StimRouter™, Bioness, the Bioness Logo® and LiveOn® are trademarks of Bioness Inc. in the United States or other countries. | www.bioness.com 612-00578-001 Rev. A 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. Registered Trademarks StimRouter™, Bioness, the Bioness Logo® and LiveOn® are trademarks of Bioness Inc. in the United States or other countries.| www.bioness.com Patents Pending This device is protected under one or more of the following U.S. Patents: U.S. Pat. No. 7,502,652. U.S. and foreign patents pending. Disclaimer Bioness Inc shall not be liable for any injury or damage suffered by any person, either directly or indirectly, as a result of the unauthorized use or repair of Bioness Inc products. Bioness does not accept any responsibility for any damage caused to its products, either directly or indirectly, as a result of use and/or repair by unauthorized personnel. Environmental Policy Service personnel are advised that when changing any part of the StimRouter system, care should be taken to dispose of those parts in the correct manner; where applicable, parts should be recycled. When the life cycle of a StimRouter component has been completed, the product should be discarded according to the laws and regulations of the local authority. For more information regarding these recommended procedures, please contact Bioness Inc. Bioness is committed to continuously seeking and implementing the best possible manufacturing procedures and servicing routines. 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 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.com Manufactured by Bioness Neuromodulation Ltd. 19 Ha’Haroshet Street PO Box 2500 Industrial Zone Ra’Anana 43654, Israel Conformity Certification ii 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 iv Clinician’s Guide Table of Contents List of Symbols ........................................................................................................................ iii Chapter 1: Introduction........................................................................................................ 1 Chapter 2: Warnings and Cautions .................................................................................. 3 Indications for Use .....................................................................................................................3 Contraindications ...................................................................................................................... 3 Implantation Setting .................................................................................................................. 4 Patient Screening .......................................................................................................................5 Warnings ................................................................................................................................... 5 Magnetic Resonance Imaging ............................................................................................. 5 Pregnancy ............................................................................................................................ 8 Long-Term Effectiveness of Neurostimulation...................................................................... 8 Programming ...................................................................................................................... 8 Device Components ........................................................................................................... 9 Flammable Fuel or Chemicals ............................................................................................. 9 Driving and Operating Machinery........................................................................................... 9 Electromagnetic Compatibility Warnings .................................................................................. 9 Medical Devices/Therapies ................................................................................................. 9 Electrosurgery Devices........................................................................................................ 10 High-Frequency Surgical Equipment ...................................................................................10 Body-Worn Device................................................................................................................10 Security Screening Devices .................................................................................................10 Cell Phones ......................................................................................................................... 11 Precautions ............................................................................................................................. 11 Clinician Training ................................................................................................................. 11 Post-Operative Care ........................................................................................................... 11 Implant Location.................................................................................................................. 11 For Single Patient Use Only ............................................................................................... 11 Postural Changes................................................................................................................ 11 Keep out of Reach of Children ............................................................................................ 12 Skin Abnormalities ...............................................................................................................12 Skin Irritation ....................................................................................................................... 12 Known or Suspected Heart Problems ................................................................................. 12 StimRouter Electrode Placement and Stimulation ............................................................... 12 Expiration Date ................................................................................................................... 13 Implant Failure..................................................................................................................... 13 Storage and Handling ......................................................................................................... 13 Adverse Effects ....................................................................................................................... 13 Risks Related to the Implant Procedure ...............................................................................13 RisksRelatedtoStimulation...................................................................................................14 Additional Risks Related to the StimRouter System ............................................................ 14 Chapter 3: Environmental Conditions that Affect Use................................................ 15 Storage and Handling............................................................................................................... 15 Radio Communication Information ...........................................................................................15 Conformity Certification ....................................................................................................... 16 Chapter 4: Clinician Kit...................................................................................................... 17 Description .............................................................................................................................. 17 Chapter 5: Device Description ........................................................................................ 19 Clinician Programmer with Software ........................................................................................ 19 Component Description....................................................................................................... 20 Operating Buttons............................................................................................................... 20 LEDs.................................................................................................................................... 20 SD Slot ............................................................................................................................... 20 Battery ................................................................................................................................ 20 Touchscreen Display ........................................................................................................... 20 24-Pin Connector Port ........................................................................................................ 21 Wireless Bluetooth Communication .................................................................................... 21 Clinician Programmer Memory Card ........................................................................................21 Clinician’s Programmer Charger................................................................................................21 Configuration Cradle ............................................................................................................... 22 vi Clinician’s Guide Connector Cable with Charger Adapter ...............................................................................22 Stylus .................................................................................................................................. 22 Tester ...................................................................................................................................... 23 Clinician’s Software Navigation................................................................................................ 23 OperatingModes...................................................................................................................23 Information Icon ...................................................................................................................24 Print Icon..............................................................................................................................25 Data Entry ........................................................................................................................... 25 Menu Bar and Menus .......................................................................................................... 25 Tabs .................................................................................................................................... 26 Buttons ............................................................................................................................... 27 Intensity Level Bar............................................................................................................... 28 Program Bar......................................................................................................................... 29 Search Bars......................................................................................................................... 29 Programming Parameters ................................................................................................... 30 Chapter 6: Set-Up Instructions ........................................................................................33 Programming Components and Software ............................................................................... 33 Connecting the Clinician Programmer and Cradle .............................................................. 33 Charging the Clinician Programmer .................................................................................... 34 Logging into the StimRouter Application ............................................................................. 34 Patient’s External Components ............................................................................................... 35 Connecting the Patient Programmer and Configuration Cradle............................................36 Connecting the StimRouter Electrode and EPT....................................................................37 Adhering the StimRouter Electrode to the Skin.................................................................... 38 Confirming Set-Up .............................................................................................................. 41 Removing the StimRouter Electrode ....................................................................................... 42 Testing the EPT.........................................................................................................................43 Chapter 7: Patient Records and History ....................................................................... 45 Patient Records........................................................................................................................ 45 Adding a Patient with an Unassigned System ..................................................................... 45 Copying a Record for an Existing Patient to an Unassigned System ................................... 47 Adding a Patient with an Assigned System ........................................................................ 48 vii Opening a Patient Record.................................................................................................... 49 Modifying a Patient Record ................................................................................................. 50 Removing a Patient Record ................................................................................................ 50 Searching for a Patient Record ........................................................................................... 51 Usage History .......................................................................................................................... 52 Viewing a Usage History ..................................................................................................... 52 Printing a Usage History....................................................................................................... 53 Session History........................................................................................................................ 53 Viewing a Session History.................................................................................................... 53 Printing a Session History.................................................................................................... 54 Printing Multiple Sessions......................................................................................................54 Chapter 8: Tools ................................................................................................................. 57 System Information and Component Reset ............................................................................. 57 Resetting the Patient Programmer and EPT ....................................................................... 57 User Administration.................................................................................................................. 58 Adding a User/Administrator................................................................................................ 59 Removing a User/Administrator........................................................................................... 60 Changing a User Password ................................................................................................ 61 Clinician Programmer Database Backup and Restore ............................................................ 62 Manually Backing Up the Database..................................................................................... 62 Enabling Automatic Database Backup ................................................................................ 62 Restoring the Database ...................................................................................................... 63 Chapter 9: Programming Instructions .......................................................................... 65 Stimulation and Time Settings ................................................................................................. 65 Programming Stimulation Settings ...................................................................................... 65 Programming Time Settings ................................................................................................ 67 Programs ................................................................................................................................. 68 Adding a Program................................................................................................................ 68 Viewing a Program ............................................................................................................. 68 Deleting a Program ............................................................................................................. 68 Printing a Program .............................................................................................................. 70 viii Clinician’s Guide Chapter 10: Maintenance and Cleaning .................................................................. 70 Battery Replacement ............................................................................................................... 71 Replacing the Clinician Programmer Battery ....................................................................... 71 Cleaning ...................................................................................................................................71 Disinfecting .............................................................................................................................. 71 Electronic Components........................................................................................................ 71 Clinician Kit Carrying Case ................................................................................................. 72 Chapter 11: Troubleshooting .......................................................................................... 73 Patient Forgets Patient Programmer ....................................................................................... 73 Using a Clinic Patient Programmer...................................................................................... 74 Registering the Patient Programmer/EPT ........................................................................... 75 Patient Forgets EPT ................................................................................................................ 76 Patient Loses EPT ................................................................................................................... 77 Patient Brings New EPT and New Patient Programmer ........................................................... 77 Copying Patient Data to New Components......................................................................... 77 Patient Forgets StimRouter Electrode .................................................................................... 78 Troubleshooting Wireless Technology .................................................................................... 78 Chapter 12: Technical Specifications .............................................................................. 83 Troubleshooting Wireless Technology ................................................................................... 85 Chapter 13: Appendix - EMI Tables ................................................................................ 87 Electromagnetic Emissions.................................................................................................... 87 Chapter 14: Bluetooth Printer Set-Up ............................................................................. 93 Enabling Bluetooth ................................................................................................................. 93 Device Pairing ....................................................................................................................... 97 ix x Clinician’s Guide 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. • Disposable StimRouter electrodes. This guide describes the external programming components of the StimRouter Neuromodulation System, which are provided in the StimRouter Clinician Kit. Refer to the StimRouter Procedure Manual for a description of the StimRouter Lead Kit, Insertion Tool Kit, package contents, device specifications and the StimRouter implant procedure. Refer to the StimRouter User’s Guide for a description of the StimRouter User Kit, including the StimRouter electrode, EPT, patient programmer, external accessories, package contents, device specifications and instructions for use. Chapter 1 - Introduction 2 Clinician’s Guide 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. The StimRouter programming system and patient-operated system should only be used under proper medical guidance and as described in this StimRouter Clinician’s Guide and in the StimRouter User’s Guide. Indications for Use The Bioness StimRouter Neuromodulation System is intended to provide electrical stimulation via an implanted lead to a target peripheral nerve, for aid in the management of adults that have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy (e.g. medications). The StimRouter is not intended to treat pain in the craniofacial region. Contraindications The Bioness StimRouter Neuromodulation System is contraindicated for: • Patients who have any active implanted device such as an implanted demand cardiac pacemaker or defibrillator, or any metallic implant in the immediate area intended for implant. Maintain a minimum safe separation distance of 15 cm (6 in.) between the SimRouter system and all other active implanted devices and metallic implants. A risk/benefit determination should be performed before using the StimRouter system for: • Patients exposed to diathermy. Shortwave, microwave and/or therapeutic ultrasound diathermy should not be used on patients who have a StimRouter Neuromodulation System. The energy generated by diathermy can be transferred through the StimRouter system components, causing tissue damage at the lead site and potentially resulting in severe injury. Diathermy may also damage the StimRouter system components, resulting in loss of therapy. Injury or damage can occur during diathermy treatment Chapter 2 - Warnings and Cautions 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. • Patients who are known or suspected to have a nickel allergy. The handles of the tunneling needle and tunneling needle stylet are nickel plated. • Patients with bleeding disorders or active anticoagulation that cannot be stopped for a few days close to the time of the surgical procedure. Implantation Setting The StimRouter should be implanted in an appropriately outfitted physician office, outpatient surgical center or hospital surgical center. Fluoroscopy and/or ultrasound should be available if deemed necessary and be used at the implanting physician’s discretion. Patient Screening Candidates for StimRouter therapy should be appropriately screened for selection and fully informed about the therapy risks and benefits, the surgical procedure, system operation and self-treatment responsibilities. Select patients carefully to ensure that: • Their symptoms are of an anatomical and/or physiological origin. • They are appropriate candidates for surgery. • They can properly operate the StimRouter system. Bioness highly recommends the following screening procedure prior to StimRouter lead implantation: • Nerve block using local anesthesia. • Psychological screening using techniques traditionally used for similar types of procedures and systems. Clinician’s Guide 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. Warnings Magnetic Resonance Imaging MRI Warnings and Precautions • Do not scan patients with a specific absorption rate (SAR) level exceeding 2 W/kg. A scan above 2 W/kg may increase the risk of MR-related heating. • Do not place a local RF transmit coil directly over the Bioness implanted lead. • The entire Bioness implanted lead must always be outside the MR coil and must not be exposed to any radio frequency field. StimRouter External Component Restrictions All external components of the StimRouter system are contraindicated for the MRI environment. Therefore, the StimRouter electrode, external pulse transmitter and patient programmer must be removed before the patient is allowed into the MRI environment. Chapter 2 - Warnings and Cautions 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. • Do not scan patients with a SAR level exceeding 2 W/kg. A scan above 2 W/kg may increase the risk of MR-related heating. • The entire StimRouter lead must be at least 50 cm from the center of the MR system’s bore (the iso-center of the bore) and at least 16 cm outside of the MR coil measured from the edge of the MR coil, to ensure patient safety relative to MRI-related heating. See Figure 2-1. Bore Table RF Coil Isocenter >50 cm >50 cm >16 cm >16 cm Lead Lead Figure 2-1. The entire StimRouter lead must be at least 50 cm from the center of the MR system’s bore (the iso-center) and at least 16 cm outside of the MR coil measured from the edge of the MR coil. Left: lead implanted in the forearm. Right: Lead implanted in the lower leg. Clinician’s Guide • 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. Patients must be screened for previously implanted (active or abandoned) medical devices, leads, lead extenders or lead adapters. MRI-Related Heating: Supplemental Information 1.5 T/64 MHz Temperature changes of the electrodes of the StimRouter lead were measured at 1.5 T/64 MHz according to ASTM F2182 (GE Signa, 46- 258170G1, whole body transmit radio frequency (RF) coil). With the lead in an orientation and a position in the phantom to produce worst-case heating, the greatest measured temperature rise scaled to a background local SAR of 1 W/kg was 3.9°C after six minutes of RF power application. This temperature change was with the lead in an elongated, “straight” configuration (i.e., no curves), which produced the highest temperature change. With the lead in curved or looped configurations, temperature changes were less. A computer simulation that incorporated the worst-case measured rise and a whole-body-averaged SAR of 2 W/kg predicts a worst case in the patient during MRI of less than 2°C provided that the entire StimRouter lead is at least 50 cm from the center of the bore of the MR system and at least 16 cm outside of the MR coil measured from the edge of the MR coil. 3 T/128 MHz Temperature changes of the electrodes of the StimRouter lead were measured at 3 T/128 MHz according to ASTM F2182 (GE Signa, 3T HDx, Software Version 15/LX/MR, 15.0.M4.0910a). With the lead in an orientation and a position in the phantom to produce worst-case heating, the greatest measured temperature rise scaled to a local background SAR of 2 W/kg was 2.9°C after six minutes of RF power application. This temperature change was with the lead in an elongated, “straight” configuration (i.e., no curves), which produced the highest temperature change. With the lead in curved or looped configurations, temperature changes were less. A computer simulation that incorporated the worst-case measured rise and a whole-body-averaged SAR of 2 W/kg predicts a worst case in the patient during MRI of less than 1°C provided that the entire StimRouter lead is at least 50 cm from the center of the bore of the MR system and at least 16 cm outside of the MR coil measured from the edge of the MR coil. Chapter 2 - Warnings and Cautions 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. The induced current will be less than the stimulation threshold if the StimRouter lead is at least 50 cm from the center of the bore and at least 16 cm outside of the MR coil measured from the edge of the MR coil. Potential Adverse Events Use of MRI could result in excessive heating of the lead if the MRI conditions of use are not followed. Induced voltages in the lead may occur, possibly causing uncomfortable levels of neurostimulation. Note: The StimRouter lead is not a life-sustaining device and could be explanted prior to an MRI procedure. Pregnancy The effects of electrical stimulation on pregnancy are unknown. Patients should avoid exposure to electrical stimulation for the entire duration of pregnancy. Long-Term Effectiveness of Neurostimulation The long-term effectiveness of neurostimulation is unknown. Programming The StimRouter components should only be programmed by the treating clinician and/or under proper medical guidance. Clinician’s Guide 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. Driving and Operating Machinery StimRouter stimulation should be off while driving and operating machinery. Electromagnetic Compatibility Warnings Medical Devices/Therapies The following medical therapies or procedures may turn stimulation off, may cause permanent damage to the external components and may injure the patient, particularly if used in close proximity to the system components: • Lithotripsy • Electrocautery • External defibrillation • Ultrasonic scanning • High-output ultrasound • Electromagnetic interference (EMI) from the following medical procedures is unlikely to affect the StimRouter system: • Computerized Axial Tomography (CT or CAT) scans • Diagnostic ultrasound (e.g., carotid scan, Doppler studies) • Diagnostic x-rays or fluoroscopy Note: Advise patients to remove the StimRouter electrode before undergoing medical therapies or procedures. Chapter 2 - Warnings and Cautions 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. High-Frequency Surgical Equipment Simultaneous connection of a patient to the StimRouter components and high-frequency surgical equipment may result in skin burns where the gel electrodes adhere to the skin and may damage the StimRouter EPT. Advise patients to remove the StimRouter electrode before medical treatment. Body-Worn Devices Although unlikely, body-worn medical devices may interfere with the RF communication used in the StimRouter system. Stimulation control may be delayed. Examples of a body-worn device are an insulin pump and a monitoring device. The patient programmer will emit visual alerts if interference occurs. To minimize interference, maintain a minimum safe separation distance of 15 cm (6 in.) between the SimRouter system and all other electronic devices. See the Troubleshooting section for help. See the Appendix for more information. The StimRouter system wireless technology may cause EMI to other body- worn medical devices. Refer to the instructions for use for those devices for information on recommended minimum separation distances. Security Screening Devices Certain types of security devices may affect stimulation. Examples include those used at the entrances and exits of public buildings such as libraries, airports and retail stores. Ask for help to bypass the device. Show your Medical Device Identification Card. If you must pass through the device: 10 • Turn off your StimRouter system. • Pass through the device quickly. • Stay as far from the emitter as possible. Walk, for example, in the center of a passthrough security gate. Clinician’s Guide 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. Precautions Clinician Training Bioness requires that clinicians involved with the use of the StimRouter system be formally trained by Bioness in the system’s operation and use. Post-Operative Care Clinicians should adequately observe the incision site and monitor for infection, possible device rejection or other possible adverse effects. If the patient notices excessive redness or discharge around the incision site, then the implant physician should be contacted immediately to check for infection and administer proper treatment following standard medical procedures. Implant Location Advise patients to never manipulate the StimRouter lead. If the lead is moved from the target stimulation point, then it may not function correctly or effectively. In some instances a lead can move from its original location, thus causing a loss of stimulation at the target stimulation point. If the lead moves, then the lead may need to be replaced. For Single Patient Use Only The StimRouter electrode is meant to be worn only by the patient for whom it is prescribed and in the location for which it is prescribed. The StimRouter electrode should not be adhered to any other person or any other place on the patient’s body. Postural Changes Changes in posture or abrupt movements may decrease or increase the perceived level of stimulation. Advise patients to turn off stimulation before making extreme posture changes or abrupt movements such as stretching, lifting of arms overhead or exercising. Chapter 2 - Warnings and Cautions 11 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. The redness should disappear in approximately one hour once the user patch is removed. However, some patients may experience skin irritation, an allergic reaction, or hypersensitivity to the electrical stimulation or the gel electrodes. Persistent redness, lesions or blisters are signs of irritation. Use of the StimRouter components should be temporarily halted until the irritation is resolved. In some cases, irritation can be avoided by removing the StimRouter electrode periodically to allow the skin to breathe and changing the stimulation parameters. Patients should consult their clinician if irritation persists. Known or Suspected Heart Problems Use caution when treating patients with suspected or diagnosed heart problems. StimRouter Electrode Placement and Stimulation 12 • Electrical stimulation should not be applied trans-thoracically or at the heart such that current may travel into or through the cardiac tissue, as such introduction of electrical current may cause heart rhythm disturbances. • Turn off stimulation before adhering, removing or handling the StimRouter electrode. • StimRouter electrode placement and stimulation settings should be determined by the implanting physician and/or treating clinician. • Do not apply the StimRouter electrode over any obstruction that would reduce the designated electrode surface area (for example, an adhesive bandage). A smaller electrode surface area could result in serious injury to the patient. • Do not apply the StimRouter electrode over skin folds, scarred tissue, irritated skin, uneven skin surfaces or broken skin. Clinician’s Guide • 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. Implant Failure Leads may fail at any time because of random component failure or lead breakage. If component failure or lead breakage occurs, then the lead may need to be replaced. Storage and Handling All StimRouter components and accessories should be handled with care. Components and accessories should not be dropped. Although reliability testing has been performed to ensure quality manufacturing and performance, dropping the components on hard surfaces, or other rough handling, can permanently damage the components. Refer to the HP product literature included in the Clinician Kit for storage temperatures for the Hewlett Packard iPAQ 210 Enterprise Handheld. Tester Storage Temperature Range: -20°C to +60°C. Adverse Effects In the unlikely event that any of the following occurs, patients should stop using their StimRouter components, remove the StimRouter electrode and immediately consult their clinician or their implant physician. Risks Related to the Implant Procedure Suboptimal lead placement may necessitate therapeutic adjustment and/or lead explant. Nerve injury is possible, although unlikely. Possible surgical complications include infection, cellulitis, abscess, fever, sepsis, bleeding and temporary pain at the implant site. Chapter 2 - Warnings and Cautions 13 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. If patients experience any pain or discomfort during stimulation, or notice any skin abnormalities, they should stop stimulation immediately, remove the StimRouter electrode and contact their clinician. Additional Risks Related to the StimRouter System • Migration of the lead may cause changes in stimulation effectiveness. • While very unlikely, a tissue reaction to any of the implanted materials may occur. • External electromagnetic interference may cause the StimRouter components to malfunction and may affect stimulation. • Patients may experience persistent pain at the implant site of the lead. • Although rare, the skin overlying the lead may erode. • Portable and mobile radio frequency communications equipment can affect medical electrical equipment. • The StimRouter external components could overheat if the components fail, which could cause burning. If patients experience any pain or discomfort during stimulation, or notice any skin abnormalities, they should stop stimulation immediately, cease contact with the StimRouter components and notify their clinician. 14 Clinician’s Guide Environmental Conditions that Affect Use 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. Do not store StimRouter components in a car or elsewhere where hot or cold temperatures could exceed the acceptable ranges of the components. Temperature extremes can damage the StimRouter components. To avoid condensation when transporting StimRouter components from hot to cold temperatures, place the components in an air-tight plastic bag first. Let them adjust slowly (for at least two hours) to the change in temperature before use. Radio Communication Information Several components of the StimRouter system communicate via radio communication and have been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 (Radio Frequency Devices) of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential environment. This equipment generates, uses and can radiate radio frequency energy and, if not operated and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular environment. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, then try to correct the interference by one or more of the following measures: • Reorient or relocate the receiving antenna. • Increase the separation between the equipment and receiver. • Consult the dealer or an experienced radio/television technician for assistance. Chapter 3 - Environmental Conditions that Affect Use 15 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. This device must accept any interference received, including interference that may cause undesired operation. 16 Clinician’s Guide 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. Your StimRouter Clinician Kit includes the following: • Clinician Programmer with Software • Clinician Programmer Memory Card • Clinician’s Programmer Charger • Configuration Cradle • Tester • Clinician’s Reference Card • HP product literature Clinician’s Programmer Charger Clinician Programmer EPT Tester Configuration Cradle Chapter 4 - Clinician Kit 17 18 Clinician’s Guide 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. Touchscreen Display SD Slot with Memory Card Installed On/Off Button 24-Pin Connector Port Reset Button Figure 5-1. The StimRouter clinician programmer. The clinician programmer is portable and comes with the StimRouter software installed, a memory (SD) card installed, a rechargeable Lithium- Ion battery installed and a clinician programmer charger. Chapter 5 - Device Description 19 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. Component Description Hewlett Packard iPAQ 200 Enterprise Handheld internally powered personal digital assistant with StimRouter proprietary software installed. Note: Refer to the HP web site for a description of the Hewlett Packard iPAQ 200 Enterprise Handheld, device specifications and instructions for use. Operating Buttons On/Off. Used to turn the clinician programmer on and off. Reset. Used to soft reset the clinician programmer. LEDs Power Indicator Light.YELLOW when the clinician programmer is charging; GREEN when the clinician programmer battery charge is complete. Bluetooth Enabled Indicator Light. BLUE when Bluetooth is ON. SD Slot Contains the clinician programmer memory (SD) card. Battery Removable/rechargeable 2200 mAh Lithium-Ion battery. CAUTION: Risk of explosion if battery is replaced by an incorrect type. Dispose of used batteries according to local regulation. Touchscreen Display Used to navigate the StimRouter application, read statuses and enter data. Use the pointed end of the stylus to make contact with the display screen. Use only the stylus. Do not use sharp objects such as pencils or pens on the touchscreen display. 20 Clinician’s Guide 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. WARNING: Use only the clinician programmer charger included in the StimRouter Clinician Kit (Manufacturer Model No. PHIHONG, PSC11R/PSM11R). Chapter 5 - Device Description 21 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. The configuration cradle with the clinician programmer and patient programmer connected. Connector Cable with Charger Adapter Connects the clinician programmer to the patient programmer and to the clinician’s programmer charger. Stylus A pen-shaped device used to input commands on the clinician programmer touchscreen display. 22 Clinician’s Guide 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. The StimRouter clinician programmer is online when connected to an operational StimRouter patient programmer and EPT. See Table 5-1. Offline. The StimRouter clinician programmer is offline when not connected to an operational StimRouter patient programmer and EPT. See Table 5-1. Chapter 5 - Device Description 23 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. Remove a patient record. View/print a patient’s history. View a patient’s programs. Back up the clinician programmer database. Restore the clinician programmer database. Add a new user. Remove a user. Change a user password. Table 5-1. StimRouter application operating modes and descriptions. Information Icon Used to communicate system status, error messages and troubleshooting solutions. When the icon is RED or YELLOW, press the icon with the stylus for more information. See Figure 5-5. Information Icon Figure 5-5. Location of the information icon. • 24 GREEN when the StimRouter is online; GRAY when no patient programmer is detected. Clinician’s Guide • 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. Used to enter characters in a field that requires alphanumeric input. The keyboard appears collapsed at the bottom right or center of most screens. To enlarge or reduce the keyboard, touch the keyboard with the stylus. To enter data, select each character using the stylus. Drop-Down Lists. Used to select a value. Press the down arrow to display the values. Use the stylus to select a value. See Figure 5-6. Figure 5-6. Illustrative drop-down lists for waveform, phase duration and pulse rate. Menu Bar and Menus The StimRouter application has five navigation menus, which appear on the menu bar. See Figure 5-7. Figure 5-7. Menu bar. Exit. Used to exit or logoff the StimRouter application. Patients. Used to open a patient record, add a new patient, modify a patient record or remove a patient record. Chapter 5 - Device Description 25 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. Tabs The StimRouter application has eight navigation tabs, or submenus, found under the five main menus. See Table 5-2. Menu Exit Tab No tabs Patients No tabs Programs Stim Settings History 26 Clinician’s Guide Function Descriptions • Exit the StimRouter application. • Log off the StimRouter application. • Open a patient record in online mode. • Open any patient record in offline mode. • Remove a patient record in offline mode. • Add a new patient in online mode. • Modify a patient name in online mode. • Program, test and save waveform, phase duration, pulse rate and intensity settings in online mode. • View stimulation settings for each program saved. • Add/delete programs in online mode. • Print the selected program. Time Settings • Program, test and save time on, time off, ramp up, total time and intensity settings in online mode. • View time settings for each program saved. • Add/delete programs in online mode. • Print the selected program. Usage • View/print a usage log. Sessions • View/print a session history. 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. StimRouter application navigation menus, navigation tabs and functions that can be performed from each menu/tab. Buttons When pressed, a navigation button will open a new screen or execute a command. See Figure 5-8. Depending on the operating mode, a button may be enabled or disabled. Disabled buttons are GRAY. For a list of commonly used buttons, see Table 5-3. Figure 5-8. Illustrative navigation buttons. Figure 5-8. Illustrative navigation buttons. Button Change Password Clear Exit Login Log Off Modify Function Descriptions • Open help screens. • Change a user password (enabled for administrators only). • Delete characters in a field. • Exit the StimRouter application. • Log into the StimRouter application. • Log off the StimRouter application. • Modify an existing patient record. Chapter 5 - Device Description 27 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). Resets the patient programmer so that it can be transferred from one EPT to another. Restore factory settings on the patient programmer and EPT. (When selected, all patient data on the patient programmer and EPT are erased.) Stop stimulation and save the stimulation and time settings. Test the current stimulation and time settings. View session details. Table 5-3. Selected navigation buttons and their accompanying functions. Intensity Level Bar Used to adjust stimulation intensity. Can be adjusted while stimulation is on or off. See Figure 5-9. Increase 5 mA Increase 1 mA Level Setting Decrease 5 mA Decrease 1 mA Figure 5-9. Intensity level bar. To adjust intensity, press the up or down arrows. 28 Clinician’s Guide 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.) Program Bar Arrows. Used to scroll through the saved programs. (Enabled when more than one program has been saved.) Search Bars Used to search the clinician programmer database. See Figure 5-11. Search Bars Figure 5-11. Search bars for usage log. Select a value from the drop-down lists or enter a value using the keyboard. Then press the double arrow to begin the search. Press the double arrow again to view additional matches found. Chapter 5 - Device Description 29 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 On Time Off Time Definition Time that stimulation is applied per cycle Time that stimulation is turned off per cycle Ramp Up Time to increase stimulation from zero to the set intensity Total Time Duration from the initiation to the end of a stimulation program Specification 1-60 seconds, 1-second resolution 0-60 seconds, 1 second resolution (0 seconds = constant stimulation) 0-10 seconds, but not more than “On time”, 1- second resolution 10 minutes- 12 hours Table 5-4. Timing parameters. Parameter Pulse Waveform Intensity* Maximum Voltage Maximum Output Maximum Charge Allowed Electrode Current Density Positive Phase Duration** Negative Phase Duration 30 Clinician’s Guide Specification Balanced biphasic (pulse is hardware balanced — no DC component exists) Symmetric or Asymmetric 0-30 milliamperes peak, 1-milliampere resolution (positive phase) 100 volts 7 milliamperes root mean square, 40 volts root mean square 10 microcoulombs per phase Less than 1 milliampere root mean square per centimeter2 70, 100, 150, 200, 250, 300, 350, 400, 450, 500 microseconds Symmetric: Identical to the positive phase duration. Asymmetric: Four times the positive phase duration. 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. ***Pulse repetition rate: The number of times per second a pulse is delivered. Table 5-5. Pulse parameters. Chapter 5 - Device Description 31 32 Clinician’s Guide 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. Clinician’s Programmer Charger Clinician Programmer Clinician Programmer Memory Card 24-Pin Connector Port Patient Programmer Connector Connector Cable Connector Cable with Charger Adapter Configuration Cradle Figure 6-1. The clinician programming system set-up configuration. Also shown is a patient programmer connected. 2. Plug the connector cable with charger adapter (on the configuration cradle) into the 24-pin connector port on the clinician programmer, with the arrows on the adapter facing up. Chapter 6 - Set-Up Instructions 33 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. When the clinician programmer is fully charged, the indicator light next to the On/Off button will be GREEN. Logging into the StimRouter Application To log into the StimRouter application: 1. Turn the clinician programmer on by pressing the on/off button on the lower right corner of the clinician programmer. See Figure 6-2. 2. If the login screen does not open automatically, then, using the stylus, press “Start” and then “StimRouter” to open the StimRouter application. Wait for the login screen to load. See Figure 6-2. Figure 6-2. The StimRouter application login screen. 34 Clinician’s Guide 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. The StimRouter User Kit also provides a system charger set to charge the patient programmer and EPT. When the clinician programmer is connected to an operational patient programmer and EPT, the clinician programmer is online and ready to program. Chapter 6 - Set-Up Instructions 35 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. Charging the patient programmer. WARNING: Use only the charger included in the StimRouter User Kit. (Refer to Manufacturer Model No. FRIWO FW7333SM/05 or FRIWO FW7333CM/05). 3. Plug the connector cable of the configuration cradle into the connector port of the patient programmer. The white arrow should be facing up. See Figure 6-5. Connector Cable Figure 6-5. Patient programmer connection configuration. 36 Clinician’s Guide 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. Snap the EPT into the StimRouter electrode. See Figure 6-6. 4. EPT StimRouter Electrode Figure 6-6. StimRouter electrode and EPT connection. Note: To ensure proper electrical stimulation, the EPT must be connected to the StimRouter electrode properly. If the EPT does not work properly, then remove it from the StimRouter electrode and reconnect it, or connect it to a new electrode. Chapter 6 - Set-Up Instructions 37 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. Locate the area where the receiver end of the lead is implanted. 2. Clean the skin above the receiver end of the lead with an alcohol swab or wet washcloth, and then dry. If the area has been treated with lotions or oils, then clean the skin with soap and water until all oils are removed, rinse well and dry. 3. If necessary, remove excess body hair from the skin area using scissors. Do not use a razor. A razor can irritate the skin. WARNING: Do not touch the gel electrodes with both hands while stimulation is turned on. Serious injury could result from electrical current passing across the chest cavity. Stimulation should be turned off before adhering, removing or handling the StimRouter electrode. WARNING: Do not apply the StimRouter electrode to anyone else or any other part of the body than that determined by the prescribing physician. The StimRouter electrode is for single patient use. 38 Clinician’s Guide 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. The gel should align with the contour of the StimRouter electrode and completely cover the base of the StimRouter electrode. Make sure the gel electrodes are not dry. Chapter 6 - Set-Up Instructions 39 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. The effectiveness of the stimulation is sensitive to the alignment and rotation of the StimRouter electrode in relation to the receiver end of the lead. If the alignment or rotation of the StimRouter electrode changes, the stimulation intensity may need to be adjusted. 6. Position the other end of the StimRouter electrode where it will minimize discomfort and avoid muscle contractions. CAUTION: Do not pinch or stretch the skin while adhering the StimRouter electrode. StimRouter Electrode EPT Skin Lead Receiver End of Lead Figure 6-10. Optimal stimulation, position of the StimRouter electrode. (Illustration not to scale.) 40 Clinician’s Guide 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. If the StimRouter electrode is not firmly adhered to the skin and moves, then stimulation may become uncomfortable or ineffective. 8. Make certain that the patient programmer is within 10 feet of the StimRouter electrode (with EPT attached). Confirming Set-Up If the clinician programmer, patient programmer, EPT are connected correctly, the clinician programmer information icon will be GREEN, confirming online mode. To confirm the clinician programmer is in online mode: 1. Check that the information icon on the clinician programmer is GREEN. 2. If the information icon is not GREEN, make certain that the StimRouter electrode with the EPT attached is within 10 feet of the patient programmer. 3. 4. If the information icon is still not GREEN, check all connections and charge the patient programmer and the EPT. Test the EPT using the tester. 5. See the “Troubleshooting” section of this guide. 6. Refer to the StimRouter User’s Guide for additional operational instructions for the StimRouter patient programmer, EPT and StimRouter electrode, including instructions on how to: • Turn on the patient programmer. • Charge the patient programmer. • Adjust the volume of audio alerts on the patient programmer. • Select a stimulation program using the patient programmer. • Turn stimulation on using the patient programmer. Chapter 6 - Set-Up Instructions 41 • 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. Then grasp the tab on the StimRouter electrode and gently pull away from the skin. See Figure 6-13. StimRouter Electrode Tab Figure 6-13. Removing the StimRouter electrode. 2. Obtain a StimRouter electrode liner to protect the gel electrodes from drying out. Attach the liner to the gel electrodes. 3. Store the StimRouter electrode with the liner attached in the StimRouter electrode carrying case. 42 Clinician’s Guide 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. Press the mode button briefly to start stimulation, you should hear a buzzing coming from the tester when stimulation is on and no buzzing when stimulation is off. En Chapter 6 - Set-Up Instructions 43 44 Clinician’s Guide Patient Records and History 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. Adding a Patient with an Unassigned System Follow these instructions when a patient does not have a record in the clinician programmer database and no patient data have been stored on the EPT or patient programmer, i.e., the patient’s system is unassigned and the patient is new. Note: “New” is only enabled in online mode when the clinician programmer is connected to an unassigned StimRouter patient programmer and EPT. To add a patient with an unassigned system to the clinician programmer database: 1. Make certain that the clinician programmer is connected to an operational patient programmer and EPT. See “Set-Up Instructions” section of this guide. 2. If the EPT and patient programmer are unassigned, then the application should automatically prompt that no patient data were found on the system. Press “OK.” See Figure 7-1. Chapter 7 - Patient Records and History 45 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. 46 Clinician’s 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. Make certain that the clinician programmer is connected to an operational patient programmer and EPT. See “Set-Up Instructions” section of this guide. 2. If the EPT and patient programmer are unassigned, the StimRouter application should automatically prompt that no patient data were found on the system. Press “OK.” See Figure 7-1. 3. If this prompt does not appear and the patient’s components are new, then reset the patient programmer and EPT. See “Tools” section of this guide. 4. Find the patient’s record on the Patient List, and then press “Open.” When the patient record opens, the patient data will automatically copy from the clinician programmer to the EPT and patient programmer. Chapter 7 - Patient Records and History 47 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. Make certain that the clinician programmer is connected to an operational patient programmer and EPT. See “Set-Up Instructions” section of this guide. 2. The StimRouter application will automatically prompt that a new patient was found and add the patient to the clinician programmer database. See Figure 7-3. 3. Proceed to “Programming Instructions” section of this guide. Figure 7-3. Adding a patient with an assigned system. 48 Clinician’s Guide 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. Select a patient from the Patient List, and then press “Open.” See Figure 7-4. Figure 7-4. Opening a patient record. Note: If a patient programmer and EPT are connected to the clinician programmer and have programs stored on them, then only the corresponding patient record can be opened. Chapter 7 - Patient Records and History 49 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. Removing a Patient Record Note: “Remove” is only enabled in offline mode. To remove 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, select the patient record to remove, and then press “Remove.” See Figure 7-7. 50 Clinician’s Guide 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. Using the search bar, select a search criterion from the “Search by” drop- down list, enter the search data in the accompanying field, and then press the double arrow to start the search. 4. The first match found (if any) will be highlighted on the Patient List. 5. Press the double arrow again to view any additional matches found. Chapter 7 - Patient Records and History 51 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.” See Figure 7-8. Figure 7-8. Sample usage log for program A. Note: Last Int. - Intensity in mA when the system was turned off the last time that interval. P. Duration - Program duration. How long that program was used in that interval. C. Duration - Cumulative duration. The total of the program durations. Average - Average of the program duration per interval. 4. In the “From,” “To” and “Interval” drop-down lists (top of screen), select a from date, a to date and an interval for viewing, and then press the double arrow. The usage history will open. 52 Clinician’s Guide 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. Viewing a Session History To view a session history: 1. From the PATIENTS MENU, select the patient on the Patient List, and then press “Open.” 2. From the HISTORY MENU, press the SESSIONS TAB, select a session to view, and then press “View.” See Figure 7-9. Figure 7-9. Viewing a session. Chapter 7 - Patient Records and History 53 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. Press the print icon. 3. When the Print Sessions screen opens, check the box next to each session to be printed, and then press “Print.” See Figure 7-11. 4. From the “Printer” drop-down list, select the installed printer or “Adobe PDF file,” and then press “Print.” 54 Clinician’s Guide 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.” Chapter 7 - Patient Records and History 55 56 Clinician’s Guide 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. Users can also reset the patient programmer and EPT, which restores the components to their factory settings. All patient data and logs are deleted. Resetting the Patient Programmer and EPT To reset the patient programmer: 1. Connect the patient programmer to the configuration cradle. 2. Press the TOOLS MENU, and then, on the INFO TAB, press “Reset Patient Programmer/EPT.” See Figure 8-1. Figure 8-1. Resetting the patient programmer and EPT. 3. Select “Reset the Patient Programmer,” and then press “Reset.” See Figure 8-2. Chapter 8 - Tools 57 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. Administrators can define automatic backup options, manually back up the clinician programmer database, manually restore the clinician programmer database, add and remove users/administrators, and change user passwords. 58 Clinician’s Guide 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. Chapter 8 - Tools 59 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.” 60 Clinician’s Guide 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. Chapter 8 - Tools 61 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. From the TOOLS MENU, press the BACKUP TAB, and then check “Enable automatic database backup.” The clinician programmer database will back up once per day and each time the application is exited. See Figure 8-7. 62 Clinician’s Guide 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.” Chapter 8 - Tools 63 64 Clinician’s Guide 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. Make sure that the StimRouter application is in online mode (the information icon should be GREEN). See “Confirming Set-Up” section of this guide. 2. From the PATIENTS MENU, press “Open” to view the STIM SETTINGS TAB. See Figure 9-1. Figure 9-1. Programming stimulation settings. 3. Adjust the stimulation settings using the drop-down lists next to “Waveform,” “Phase Duration” and “Pulse Rate.” Chapter 9 - Programming Instructions 65 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. Maximum charge level exceeded. 5. Slowly increase the intensity to a level that is tolerable for the patient and achieves the desired therapy. 6. Press “Stop & Save” to stop stimulation and save the stimulation settings to the clinician programmer, patient programmer and EPT. See Figure 9-3. Figure 9-3. Press “Stop & Save” to stop testing and save the current stimulation settings. 66 Clinician’s Guide 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. When “Constant Stim” is checked, “Time On” and “Time Off” are disabled; “Ramp Up” and “Total Time” can be adjusted. To change the duty cycle, uncheck “Constant Stim” and adjust “Time On” and “Time Off.” See Figure 9-5. Figure 9-5. Programming time settings. Chapter 9 - Programming Instructions 67 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. The program save date will appear on the Program Bar. Programs Delete Program Icon Back Program Arrow Add Program Icon Next Program Arrow Figure 9-7. Add a program icon, back program arrow, next program arrow, delete program icon, and print icon. 68 Clinician’s Guide Print Icon 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. After the program has been tested and “Stop & Save” pressed, the program will be saved to the clinician programmer database, the patient programmer and the EPT. The date the program was saved will appear in the center of the program bar. Note: The StimRouter can support up to eight programs, labeled A-H. Viewing a Program To view a program: 1. From the STIM SETTINGS TAB or the TIME SETTINGS TAB, press the left or right arrow on the Program Bar and scroll to the desired program. If only one program is saved, then the arrows on the Program Bar will be disabled. See Figure 9-7. Deleting a Program Note: The StimRouter application must be in online mode to delete a stimulation program. To delete a program: 1. From the STIM SETTINGS TAB or the TIME SETTINGS TAB, select a program to delete. 2. Press the delete program icon on the Program Bar. See Figure 9-7. Chapter 9 - Programming Instructions 69 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. 70 Clinician’s Guide 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. Use water. Do not use detergents or other cleaning agents. Do not clean the gel electrodes on the StimRouter electrode. StimRouter electronic components are not waterproof; do not immerse them in water. Disinfecting Electronic Components All StimRouter Clinician Kit electronic components may be cleaned and low-level disinfected using CaviWipes™ (Metrex, Orange, CA), or wipes or cloths saturated with 70% isopropyl alcohol (IPA) per the instructions below: 1. Use one saturated disinfectant wipe or cloth to thoroughly wet the component surface. 2. Use a second saturated disinfectant wipe or cloth to remove any surface contaminants. Soil, etc., will impede the disinfectant’s effectiveness, if not removed. Chapter 10 - Maintenance and Cleaning 71 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. Spray the entire surface of the Clinician Kit carrying case with CaviCide. 2. Use a clean towel to remove any surface contaminants. Soil, etc., will impede the disinfectant’s effectiveness, if not removed. 3. Spray the entire surface of the Clinician Kit carrying case again with CaviCide. 4. Keep spraying the entire carrying case surface as needed to keep it wet for 10 minutes. 70% IPA: 1. Wipe the entire surface of the Clinician Kit carrying case with a wipe or cloth saturated with 70% IPA. 2. Use a new wipe or cloth saturated with 70% IPA to remove any surface contaminants. Soil, etc., will impede the disinfectant’s effectiveness, if not removed. 3. Wipe the entire surface of the Clinician Kit carrying case again with a new wipe or cloth saturated with 70% IPA. 4. Use additional new wipes or cloths as needed to keep the entire surface of the carrying case wet with 70% IPA for 10 minutes. Note: Be sure to follow the Bioness instructions for the specified contact time to ensure an effective bacteria kill. Note: Do not use other cleaning/disinfecting agents such as a diluted bleach mixture, Lysol or Clorox wipes. Bioness has not tested these products’ effectiveness on the StimRouter components. Metrex products are sold through authorized dealers worldwide; 70% IPA is widely available. If you need assistance, please contact your local distributor. 72 Clinician’s Guide 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. • The patient forgets the StimRouter electrode. Patient Forgets Patient Programmer If a patient forgets to bring his or her patient programmer to a follow-up session, an alternate “clinic” patient programmer can be used. The clinic patient programmer must be reset and then registered to the patient’s EPT to proceed. Once the clinic patient programmer and patient’s EPT are registered, patient data stored on the EPT can be retrieved by the clinician programmer and new data can be stored on the EPT. The patient will need to re-register his or her EPT and patient programmer later. The new data stored on the EPT will overwrite the data stored on the patient programmer. Note: The information stored on an EPT will always overwrite the information stored on a patient programmer. Chapter 11 - Troubleshooting 73 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. The StimRouter application will detect the unregistered patient programmer and ask whether you want to register this patient programmer to an EPT now. See Figure 11-1. Figure 11-1. Unregistered patient programmer detected. 7. Press “Yes.” 8. Once the patient programmer and EPT are registered, press “OK.” 9. 10. From the Patient List, press “Open” to open the patient’s record. 74 Clinician’s Guide 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. Registering the Patient Programmer/EPT The patient programmer and EPT must be electronically registered to each other to operate. To register the patient programmer/EPT: 1. If necessary, charge the patient programmer. 2. Ensure that the patient programmer is turned off (the on/off button should not be FLASHING GREEN). See Table 11-1. Patient Programmer OFF Patient Programmer ON Flashing Green Table 11-1. Patient programmer on/off indicators. 3. Make sure the EPT is charged (if not, connect the EPT to a charger). 4. Place the patient programmer and the EPT close together on a table. Make sure the patient programmer and the EPT are no more than a few inches apart and not touching. 5. Make certain that any other EPT is at least 10 feet away from the components to be registered. 6. Simultaneously press and hold for three seconds the mode and minus buttons on the patient programmer to start the registration process. See Figure 11-2. The patient programmer will sound an audio alert, indicating the registration process has begun. 7. The patient programmer digital display should show two ALTERNATING GREEN ARCHES, indicating registration is in progress. Chapter 11 - Troubleshooting 75 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. If the problem persists, reconnect the charger to the EPT. If the error indication continues to appear, see Table 11-7. Patient Forgets EPT If a patient forgets to bring his or her EPT to a follow-up session, reschedule the programming session. Do not substitute a clinic EPT for the patient’s EPT; only the patient programmer can be substituted. The information stored on an EPT will always overwrite the information stored on a patient programmer. If a clinic EPT is used, then the patient’s EPT will overwrite any new information stored on the patient programmer. 76 Clinician’s Guide 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 Brings New EPT and New Patient Programmer If a patient receives a replacement EPT and patient programmer, then the patient will need to return to the clinic. The patient data stored on the clinician programmer database must be copied to the new EPT and patient programmer. Copying Patient Data to New Components To copy patient data to new components: 1. Connect the patient programmer to the clinician programmer and the configuration cradle. 2. Make sure the patient’s 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. The StimRouter application will detect the unregistered patient programmer and ask whether you want to register this patient programmer to an EPT now. 5. Press “Yes.” 6. Once the patient programmer and EPT are registered, press “OK.” 7. From the Patient List, select the patient’s record and press “Open.” Once the patient record is opened, all patient data except for history will copy to the patient’s new patient programmer and EPT. 8. Chapter 11 - Troubleshooting 77 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 solutions. Low Battery Detected: EPT or Patient Programmer • Press the information icon to view the error message and list of solutions. • Charge the patient programmer. • Charge the EPT. Software or Hardware Error • Press the information icon to view the error message and list of solutions. Contact your local distributor. Unexpected Error in the StimRouter Application Clinician Programmer Will Not Turn On • Press the clinician programmer reset button. • Charge the clinician programmer and verify that the amber LED is ON. If the light does not turn on, refer to the HP instructions for use. • Contact your local distributor. Table 11-2. Troubleshooting, clinician programmer. 78 Clinician’s Guide 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. On/Off Button Radio Frequency (RF) Icon EPT Icon Digital Display Patient Programmer Icon Figure 11-3. Patient programmer icons and digital display. Chapter 11 - Troubleshooting 79 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. EPT Icon FLASHES RED and Intensity Level FLASHES in the Digital Display Faulty Electrode Contact • Turn off the patient programmer. • Remove the StimRouter electrode from the skin. • Check to see that the protective covers were removed from the StimRouter electrode. • Check to see that the EPT is correctly attached to the StimRouter electrode. If necessary, reattach the EPT into the StimRouter electrode. • Make sure that nothing is on the gel electrodes or on the skin that would interfere with electrode contact with the skin. • Re-adhere the StimRouter electrode to the skin. • Replace the StimRouter electrode. • Clean the skin. EPT Malfunction • • Contact your local distributor. Table 11-5. Troubleshooting, patient programmer, EPT icon. 80 Clinician’s Guide 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. • Contact your local distributor. Patient Programmer Battery Charge Level is Patient Programmer Icon Low FLASHES YELLOW • Charge the patient programmer. Table 11-6. Troubleshooting, patient programmer, patient programmer icon. RF Icon Problems/Solutions Registration Failure; Unknown Reason RF Icon GLOWS RED and • Retry the process. “E” Appears in the Digital Display Immediately After the Registration Attempt RF Icon GLOWS RED, and “E” and then Registration Failure; More than One EPT Found “2” Appear in the Digital Display • Make sure only one EPT is within 10 feet of Immediately After the Registration Attempt the patient programmer. • Retry the process. RF Icon GLOWS RED, and “E” and then Registration Failure; No EPT Found “0” Appear in the Digital Display • Make sure the EPT is within inches of the Immediately After the Registration Attempt patient programmer but not touching. • Connect the EPT to the charger. • • Retry the process. Chapter 11 - Troubleshooting 81 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. EPT and Stimulation Solutions Stimulation Not As Effective As Usual • Check the orientation of the StimRouter electrode, it should be over the receiver end of the lead. • Make sure the StimRouter electrode is securely adhered to the skin. • Visually inspect the StimRouter electrode to make sure the gel is aligned with the contour of the electrode. • Review the skin care instructions. • Clean the skin with a damp cloth. • Change the StimRouter electrode, if the skin is dry. • Trim hair from the StimRouter electrode site. • Test the EPT using the tester. • Decrease the stimulation intensity level. • Check the placement of the StimRouter electrode. • Check the connection. • Check the Y cable (disconnect it and connect charger directly). • Check that the charger light turns on. • Contact your local distributor. Undesirable Motor Response EPT Charging Light Does Not Turn On Table 11-8. Troubleshooting, EPT and stimulation. 82 Clinician’s Guide 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., start/stop stimulation, change programs, adjust stimulation amplitude) • Display system status (e.g., battery charge level, error codes) • Retrieve patient stimulation session data Bluetooth communication is used between the clinician programmer and the HP printer to print stimulation parameters and use history. • Online Clinician Programmer mode (Clinician Programmer connected to patient programmer and EPT) EPT and patient programmer • Frequency band: 2.400 up to 2.4835 GHz • RF Frequency channels: 29 channels • Channel spacing: 580.810 kHz • Antenna type: Integrated chip antenna • Transceiver duplexing scheme: TDD • Frequency synthesizer settling time: < 1 msec • Modulation frequency: 0.5 Mbps • Modulation type: Minimum Shift Keying (MSK) • Transmit power (EIRP): EPT, -16 dBm; patient programmer, 4.1 dBm • Modulation baud rate: 500 kHz • Modulation bandwidth: 590 kHz Clinician Programmer • Bluetooth 2.0 Chapter 12 - Technical Specifications 83 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. • Delay in delivery of RF command of <1 second • Packet error rate of <1% Minimum Quality of Service Bluetooth Specifications Bluetooth Type Class 2, Bluetooth v2.0 2400 MHz to 2483.5 MHz (2.4 GHz Industrial Scientific Medical Band) Frequency Modulation GFSK, pi/4-DQPSK, 8-DPSK Scheme (automatically selected) Maximum Data 3 Mb/s Rate 4 dBm (2.5 mW) Maximum Power 10 m Maximum Range HP PDA iPAQ 210, -3 dBm (0.5 mW) Maximum Power 8 to128 bit encryption key Encryption HP bt500 Bluetooth USB 2.0 Wireless Adapter Maximum Power Encryption 84 4 dBm (2.5 mW) 8 to 128 bit encryption key Clinician’s Guide 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. • Use of randomized frequency channels (frequency hopping). • Use of whitening function (data randomizing). • Bluetooth communication is used exclusively in the clinician’s office. • Bluetooth serves for the communication between the Clinician’s Programmer System (CPS) and a HP printer using a paired HP bt500 wireless adapter. There is a risk of an interruption in the wireless communication resulting in the StimRouter system not responding to the user input. 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. Chapter 12 - Technical Specifications 85 86 Clinician’s Guide 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. There is potential for interference between electronic devices, including cell phones and other medical devices such as a body- worn insulin pump. Stimulation control may be delayed. Maintain a minimum safe separation distance of 15 cm (6 in.) between the StimRouter system and all other electronic devices. If interference is suspected or anticipated, distance yourself from the source of interference. Chapter 13 - Appendix - EMI Tables 87 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. Emissions Test RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations/ flicker emissions Compliance Electromagnetic Environment - Guidance Group 1 The StimRouter system uses RF energy for shortrange communications. Therefore, its RF emissions are very low, about 100 times lower than a commercially available cell phone. Though unlikely, portable and mobile RF communications equipment, such as the StimRouter patient programmer, EPT and clinician programmer, could affect medical electrical equipment. Class B The RF-enabled components of the StimRouter system are suitable for use in all establishments, including domestic establishments and those directly connected to the public low- voltage power supply network that supplies buildings used for domestic purposes. Class A Complies IEC 61000-3-3 88 Clinician’s Guide 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. Immunity Test Electrostatic discharge (ESD) IEC 60601 Test Level ±6 kV contact Compliance Level ±6 kV contact ±8 kV air ±8 kV air Electrical fast transient/ burst ±2 kV for Power supply lines ±2 kV for Power supply lines IEC 61000-4-4 ±1 kV for input/ output lines ±1 kV line (s) to line(s) Not applicable. No input/ output lines. ±1 kV line to line IEC 61000-4-2 Surge IEC 61000-4-5 Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 ±2 kV to earth Not applicable. No grounded interconnections. <5% UT Electromagnetic Environment - Guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. 70% UT Mains power quality should be that of a typical commercial or (>95% dip in UT) for hospital environment. 0.5 cycle The StimRouter system 40% UT continues operation during power mains interruptions, as (60% dip in UT) for it is normally powered by each 5 cycles component battery. 70% UT (30% dip UT) for 25 cycles (30% dip UT) for 25 cycles <5% UT <5% UT <5% UT (>95% dip in UT) for 0.5 cycle 40% UT (60% dip in UT) for 5 cycles (>95% dip in UT) for 5 sec Power frequency 3 A/m (50/ 60 Hz) magnetic field (>95% dip in UT) for 5 sec 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital IEC 61000-4-8 environment. NOTE: UT is the a.c.mains voltage prior to application of the test level. Chapter 13 - Appendix - EMI Tables 89 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 2.5 GHz 26 MHz to 1 GHz Radiated RF IEC 61000-4-3 3 V/m Electromagnetic Environment - Guidance Portable and mobile RF communications equipment should be used no closer to any part of the StimRouter system, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance (d) d = 1.2√P d = 0.4√P 80 MHz to 800 Mhz d = 2.3√P 800 MHz to 2.5 GHz 1 GHz to 2.5 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol: NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. 90 Clinician’s Guide 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. If the measured field strength in the location in which the StimRouter system is used exceeds the applicable RF compliance level above, the StimRouter system should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the StimRouter system. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the StimRouter System The StimRouter system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the StimRouter system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the StimRouter system as recommended below, according to the maximum output power of the communications equipment. Rated Maximum Output Power of Transmitter 0.01 0.1 10 100 Separation Distance According to Frequency of Transmitter 150 kHz to 80 MHz d = 1.2√P 80 MHz to 800 MHz d = 0.4√P 4.7 in. (0.12 m) 15 in. (0.38 m) 3 ft 11 in. (1.2 m) 12 ft 6 in. (3.8 m) 39 ft 4 in. (12 m) 1.6 in (0.04 m) 4.7 in. (0.12 m) 15.7 in. (0.4 m) 4 ft 2 in. (1.26 m) 13 ft 1 in. (4 m) 800 MHz to 2.5 GHz d = 2.3√P 9.1 in. (0.23 m) 2 ft 5 in. (0.73 m) 7 ft 7 in. (2.3 m) 24 ft 11 in. (7.3 m) 75 ft 6 in. (23 m) For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Chapter 13 - Appendix - EMI Tables 91 92 Clinician’s Guide 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.” Chapter 14 - Bluetooth Printer Set-up 93 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. 94 Clinician’s Guide 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.” Chapter 14 - Bluetooth Printer Set-up 95 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.” 96 Clinician’s Guide 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.) Chapter 14 - Bluetooth Printer Set-up 97 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.” 98 Clinician’s Guide 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.” Chapter 14 - Bluetooth Printer Set-up 99
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