FREEDOM SPINAL CORD STIMULATION SYSTEM WAVECREST PROGRAMMER USER MANUAL

Transcription

1 FREEDOM SPINAL CORD STIMULATION SYSTEM WAVECREST PROGRAMMER USER MANUAL Caution: Federal law restricts this device to sale by or on the order of a physician. WAVECREST APPLICATION SOFTWARE VERSION 2.0

2 TABLE OF CONTENTS HOW TO USE THIS MANUAL... 3 SAFETY INFORMATION... 3 INDICATIONS FOR USE... 3 CONTRAINDICATIONS... 4 WARNINGS... 6 PRECAUTIONS ADVERSE EVENT SUMMARY SOFTWARE INFORMATION CONNECTING TO WEARABLE ANTENNA ASSEMBLY OPENING WAVECREST APPLICATION PATIENT SELECTION ADDING A NEW PATIENT PATIENT INFORMATION SETTING STIMULATION PARAMETERS CURRENT SETTINGS SETTING ELECTRODE POLARITY SETTING PULSE RATE SETTING PULSE WIDTH SETTING PULSE AMPLITUDE SETTING THE TRANSMIT POWER SETTING A PROGRAM CAPTURING AN IMAGE PROGRAM CYCLE PULSE PATTERN DOSAGE TIME DAILY THERAPY TIME TROUBLESHOOTING CONTACT INFORMATION English 2

3 HOW TO USE THIS MANUAL This user manual shall be used to program the Wearable Antenna Assembly (WAA) WaveCrest Application. The WaveCrest Application connects via Bluetooth to the WAA. Only a trained clinical representative may use the WaveCrest Application. This manual also provides the warnings and precautions for the Freedom Spinal Cord Stimulator (SCS) System. SAFETY INFORMATION INDICATIONS FOR USE The Freedom Spinal Cord Stimulator (SCS) System is intended as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or lower limbs, including unilateral or bilateral pain. The Freedom- 8A Trial Lead Kit is only used in conjunction with the Freedom- 8A Stimulator Receiver Kit, and the Freedom- 4A Trial Lead Kit is used for either the Receiver Kit Freedom- 4A Stimulator or the Receiver Kit Freedom- 8A Stimulator. The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device. English 3

4 CONTRAINDICATIONS Poor surgical risks Spinal cord stimulators should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. This includes patients who need anticoagulation therapy that cannot be temporarily halted to accommodate the implantation procedure. Pregnancy Safety and effectiveness of the Freedom SCS System for use during pregnancy and nursing have not been established. Inability to operate System Spinal cord stimulators should not be used on patients who are unable to understand or operate the System. Exposure to shortwave, microwave, or ultrasound diathermy Diathermy should not be operated within the vicinity of a patient implanted with a Freedom Stimulator or when wearing the Wearable Antenna Assembly (WAA). The energy from diathermy can be transferred through the stimulator or WAA and cause tissue damage, resulting in severe injury. Occupational exposure to high levels of non- ionizing radiation that may interfere with therapy Patients who regularly work in environments with elevated levels of non- ionizing radiation should not be implanted with the device. The energy in high- level areas can be transferred through the device and cause tissue damage, resulting in severe injury. Examples of environments having high level non- ionizing radiation includes the following: o Radio or cell phone transmission stations o Facilities using radiofrequency heat sealers or induction heaters English 4

5 o Electric power infrastructure controlled environments (i.e. step down transformers or high voltage power lines) Implanted cardiac or other neurostimulation systems Patients who have implanted cardiac or other neurostimulation systems should not use the Freedom SCS System. Electrical pulses from the device may interact with the sensing operation of an implanted cardiac or neurostimulation system, causing inappropriate responses. English 5

6 WARNINGS Electromagnetic interference (EMI) EMI is a field of energy generated by equipment found in the home, work, medical or public environments. EMI that is very strong can interfere with System. The device includes features that provide protection from EMI. Most electrical device and magnets encountered in a normal day will not affect the operation of the System. However, strong sources of EMI could result in the following: Serious patient injury resulting from heating of the implanted device and damage to surrounding tissue. System damage, resulting in a loss of, or change in, symptom control and requiring additional surgery. Operational changes to the WAA. This may cause either external device to turn on, turn off, or to reset to factory settings. If this occurs, the WAA need to be reprogrammed. Unexpected changes in stimulation, causing a momentary increase in stimulation or intermittent stimulation. Some patients have described as a jolting or shocking sensation. Although the unexpected change in stimulation could feel uncomfortable, it does not damage the device or cause a patient direct injury. In rare cases, as a result of the unexpected changes in stimulation, patients have fallen down and been injured. If you suspect that equipment is interfering with device function: Move the equipment or object away from the patient. Remove the external generator/transmitter (the Wearable Antenna Assembly (WAA)) from the vicinity of the patient. English 6

7 Electromagnetic equipment/environments Avoidance of high electromagnetic equipment radiators or environments is highly encouraged. Examples of equipment and/or environments include the following: High- power amateur transmitters/antennas or citizen band (CB) radio or Ham radio used for private recreation, communication, and wireless experimentation Electric arc welding or resistance welding equipment used for melting and joining metals or plastics Industrial electric induction furnace/heater or electric arc furnace/heater used for melting metals and plastics High- voltage areas identified by fenced areas, restricted access signs, and caution signs (safe if outside the fenced area) Microwave transmitters identified by fenced areas, restricted access signs, and caution signs (safe if outside the fenced area) Television and radio towers identified by fenced areas, restricted access signs, and caution signs (safe if outside the fenced area) Linear power amplifiers used for increasing the power output of radio transmitters, wireless communication applications, audio equipment or other electronic equipment Radio telemetry equipment used for tracking location of vehicles, equipment or animals Machinery or heavy equipment Machinery and heavy equipment (including vehicles) should not be operated while using the Freedom SCS System. Malfunction of the system could English 7

8 result in loss of body control, body function, or a feeling that could render the patient incapable of controlling the system. Stimulator fracture If the Stimulator insulation is ruptured or pierced due to extensive forces, unexpected changes in stimulation could result. Electrocautery If electrocautery tools are used near the device then the insulation can be damaged. The device may fail or conduct induced currents. Induced electrical currents can cause heating of the stimulator that results in tissue damage. When electrocautery is necessary, these precautions must be followed: The WAA should be taken off. Bipolar cautery should be used. If unipolar cautery is necessary: o Only low- voltage modes should be used. o The lowest possible power setting should be used. o The current path (ground plate) should be kept as far away as possible from the implanted device. o Full- length operating room table ground pads should not be used. After electrocautery, confirm that the device is working as intended. Active Implantable or Body Worn Medical Devices Safety has not been established for patients who use the Freedom SCS System with other active implantable or body worn medical devices. These devices include other neurostimulation systems, insulin pumps, automated external defibrillators (AED), cochlear implants, and wearable medical sensors. Malfunction and/or English 8

9 damage could occur to either system that could result in harm to the patient or other people nearby. Magnetic Resonance Imaging (MRI) The receiver stimulator is MR Conditional. An MRI examination with the receiver stimulator may be safety performed under certain conditions. The trial lead is MR Unsafe due to the lack of fixation of the device during the trial period. Refer to the Product Safety Sheet for specific MRI guidelines. The WAA component is MR Unsafe; ensure that the WAA does not enter the MR system room. Since the WAA is MR Unsafe, the strong magnetic field of the MR system could attract or otherwise damage the WAA, and in the process cause serious harm to the patient or other people or damage to the MR system. Computed Tomography (CT) Scanning Safety has not been established for CT scanning of patients with an implanted stimulator. X- rays from the scan could cause unintended shocks or malfunctions of the stimulator. The CT operator should use CT scout views to determine if implanted medical devices are present and their location relative to the programmed scan range. For CT procedures in which the device is in or immediately adjacent to the programmed scan range, the operator should: Remove the WAA from the CT scan range. Minimize X- ray exposure to the implanted device by: o Using the lowest possible X- ray tube current consistent with obtaining the required image quality. o Making sure that the X- ray beam does not dwell over the device for more than a few seconds. English 9

10 After CT scanning directly over the implanted device: Place the WAA and turn on stimulation. Check for proper stimulation, and that indicator lights are operating as expected. Shut off the WAA if it is suspected that the device is not functioning properly. Radiofrequency (RF) ablation Safety has not been established for radiofrequency (RF) ablation in patients with a stimulator. RF ablation may cause induced electrical currents that result in heating and tissue damage. Do not use RF ablation anywhere near the stimulator. If RF ablation is used, ensure that ablation is not performed over or near the stimulator. Theft detectors, electronic article surveillance (EAS) systems, and radiofrequency identification systems Tests have been performed with a limited number of security systems, and have demonstrated that the Freedom SCS System (implanted device and WAA) are not affected by close proximity of the security systems. Any security system may temporarily interrupt spinal cord stimulation, or cause elevated levels of stimulation. It is recommended that if a patient feels an increase in stimulation near a security system, they promptly move away from the area and remove the WAA from the body. When possible, it is best to avoid these security systems or to remove the WAA off while passing through security systems. Patients with an implanted device should inform the attendant who may be able to assist them in bypassing the security system. If unavoidable, the patient should walk through the security system and promptly move away from the area. Patients should not lean on scanners or linger in the area of the security system. English 10

11 Psychotherapeutic procedures Safety has not been established for psychotherapeutic procedures using equipment that generates electromagnetic interference (e.g., electroconvulsive therapy, transcranial magnetic stimulation) in patients who have spinal cord stimulators. Induced electrical currents can cause heating that may result in tissue damage. High- output ultrasonics / lithotripsy Safety has not been established for high- output ultrasonics or lithotripsy when implanted with the Freedom SCS System. Use of lithotripsy may result in damage to the device or harm to the patient. Bone growth stimulators Safety has not been established for bone growth stimulator systems within the vicinity of the Freedom SCS System. Use of a bone growth stimulator may result in damage to the device or harm to the patient. Dental drills and ultrasonic probes Safety has not been established for dental drills or ultrasonic probes within the vicinity of the Freedom SCS System. Use of dental drills or ultrasonic probes may result in damage to the device or harm to the patient. Electrolysis Safety has not been established for electrolysis within the vicinity of the Freedom SCS System. Use of electrolysis may result in damage to the device or harm to the patient. Laser procedures Safety has not been established for lasers within the vicinity of the Freedom SCS System. Use of lasers may result in damage to the device or harm to the patient. Radiation therapy Safety has not been established for high radiation sources such as cobalt 60 or gamma radiation at the device. Use of radiation therapy could cause damage to the device or harm to the patient. English 11

12 Transcutaneous electrical nerve stimulation Safety has not been established for use of transcutaneous electrical nerve stimulation (TENS) when implanted with the Freedom SCS System. Use of TENS could cause the device to turn off or intermittent/increased stimulation. Other medical procedures EMI from the following medical procedures is unlikely to affect the device: Diagnostic ultrasound (e.g., carotid scan, Doppler studies) Diagnostic x- rays or fluoroscopy Magnetoencephalography (MEG) Positron emission tomography (PET) scans Therapeutic magnets (e.g., magnetic mattresses, blankets, wrist wraps, elbow wraps) Keep the magnet away from the stimulator site. Magnetic fields will generally not affect the stimulator. WAA Skin Contact Do not place the WAA directly on the skin. Direct skin contact may cause irritation and/or sensitivity to the materials. The WAA must be placed overtop a thin layer of clothing at all times. Painful Stimulation If the patient experiences painful stimulation, the amplitude on the WAA should be decreased immediately and/or removed from the patient s body. Contact your clinician if this continues to occur. English 12

13 PRECAUTIONS Physician training Prescribing clinicians should be experienced in the diagnosis and treatment of chronic intractable pain and should be familiar with using the Freedom SCS System. Implanting clinicians should be experienced in spinal procedures and should review the procedures described in the Instructions for Use. Keep the WAA dry The WAA is not waterproof. Keep it dry to avoid damage. Do not use the WAA when engaging in water activities. Storage temperatures The Freedom SCS System should be kept within the storage temperatures listed on product packaging. Exceeding the storage temperature could cause harm to you or the component. Please contact Stimwave if a storage temperature is surpassed. Freedom Stimulator Storage Temperature Wearable Antenna Assembly Storage Temperature Clean the WAA Clean the outside of the WAA with a damp cloth when needed to prevent dust and grime. Mild household cleaners will not damage the device or labels. Handle the WAA with care The WAA is a sensitive electronic device. Avoid dropping the device onto hard surfaces. Keep the WAA out of the reach of children and pets. English 13

14 Medical tests and procedures Before undergoing medical tests or procedures, contact the clinician to determine if the procedure will cause damage to the patient or to the System. Physician instructions Always follow the programs and therapy instructions established by the clinician. Failure to do so may cause the therapy to be less effective in providing pain relief. Airline policies - Follow airline policies for use of medical spinal cord stimulation systems and electronic equipment during flights. Refer all questions to airline personnel. Use the WAA as directed Use the WAA only as explained by the clinician or as discussed in the User Manual. Using the WAA in any other manner could result in harm. Do not dismantle the WAA Do not dismantle or tamper with the device. Tampering with the device could result in harm. If the device is not working properly, contact the clinician for help. Flammable or Explosive Environments Do not use the WAA in flammable or explosive environments. Using the WAA in one of these environments could result in harm. Use of another patient s WAA - Never use another patient s WAA. The therapy programmed is a unique prescription for each patient. Use of another patient s WAA could result in overstimulation. Activities requiring excessive twisting or stretching Avoid activities that potentially can put undue stress on the device. Activities that include sudden, excessive, or repetitive bending, twisting, bouncing, or stretching can cause your stimulator to English 14

15 fracture or migrate. This can result in a loss of stimulation, intermittent stimulation, and additional medical procedures. Scuba diving or hyperbaric chambers Do not dive below 13 meters (45 feet) of water or enter hyperbaric chambers above 1.5 atmospheres absolute (ATA). These conditions can damage the device. Before diving or using a hyperbaric chamber, discuss the effects of high pressure with the clinician. Skydiving, skiing, or hiking in the mountains High altitude should not affect the System. However, take care to not put undue stress on the device. During skydiving, the sudden jerking that occurs when the parachute opens can dislodge or fracture the device. This can result in a loss of stimulation, intermittent stimulation, and additional medical procedures. Unexpected changes in stimulation Electromagnetic interference, changes in posture, and other activities can cause a perceived increase in stimulation. Some patients have described this as a jolting or shocking sensation. You should reduce your amplitude to the lowest setting and turn OFF your System before engaging in activities that could become unsafe. Discuss these activities with your clinician. Interference during programming - If interference is suspected during programming of the WAA, the clinician should confirm that the Bluetooth data transmission is operating properly. Bluetooth data communication is confirmed by the blue light indicator on the WAA blinking. If during the programming session the light indicator is not blinking then the clinician should do the following: Terminate the current programming session and shut down the WaveCrest application; English 15

16 Check for sources of Bluetooth interference in the surrounding area; Remove or turn off the source of interference; Re- establish the Bluetooth link with the WAA through pairing; Resume programming by opening the WaveCrest application; Confirm the light indicator is now blinking. ADVERSE EVENT SUMMARY Implantation of a spinal cord stimulation system is similar to any surgical procedure. Risks include the following: Allergic or immune system response to implanted material. Infection. Leakage of cerebrospinal fluid. Epidural hemorrhage, hematoma, or paralysis. Therapeutic use of the Freedom SCS System incurs the following risks: Undesired change in stimulation, including uncomfortable chest wall stimulation. Device migration, erosion through the skin, or fracture leading to loss of therapeutic effect. Electromagnetic interference leading to change in System performance. Loss of therapeutic effect despite a functioning system. Adverse events that could occur with the Freedom SCS System: Device migration, resulting in altered stimulation therapy that may be uncomfortable. English 16

17 Device fracture, resulting in loss of stimulation. Infection, resulting in tissue sensitivity, redness and swelling. Adverse effects of stimulation are usually mild and go away when stimulation is turned off. Patients should be instructed to contact their clinician immediately if they experience any problem or if they experience a change in stimulation. Over time there could be changes in the level of pain control. SOFTWARE INFORMATION The WaveCrest Application runs on Apple ipad mini, ipad 2, ipad (3 rd and 4 th generation), and ipad Air running ios 6.0 or greater. The software is not available through main Apple App Store. The software is distributed privately through Stimwave. Notes: Always notify the patient when stimulation is about to begin. CONNECTING TO WEARABLE ANTENNA ASSEMBLY The ipad communicates with the WAA via an encrypted Bluetooth connection. An ipad pre- loaded with the WaveCrest App is required. Once connected, the clinician can program the WAA. This is accomplished by first pairing the WAA with the ipad via the ios operating System. Steps: 1. Power on the ipad and the WAA. 2. Select Settings from the ipad (Figure 1). 3. Select Bluetooth from the list of Settings. 4. Confirm that Bluetooth is turned on. English 17

18 5. Wait for the ipad to identify Bluetooth devices within range. Select the WAA unique identification number from the list of available devices. 6. Connection is made and secure when the ipad identifies the device as Paired (Figure 2). 7. You are now ready to open the WaveCrest Application. Figure 1 English 18

19 Figure 2 OPENING WAVECREST APPLICATION The WaveCrest App must be running in order to program settings. The application cannot be opened unless a WAA has first been paired to the ipad. The application cannot be opened unless the correct password is entered into the WaveCrest App. Steps: 1. Connect to the WAA via Bluetooth (previous section). 2. Navigate ipad screens to locate the WaveCrest icon. 3. Select the icon. 4. When prompted, enter the administrator password for the specific ipad. 5. You are now ready to communicate with the WAA. PATIENT SELECTION The Patients tab allows you to select a patient from the available list or search by the Patient ID number. Steps: 1. Select the Patients (Figure 3). English 19

20 2. Select the desired Patient ID from the list provided or search by Patient ID number. 3. When prompted, the patient information will appear. Confirm that the information is correct before moving to configure the patient s system or review usage history. Figure 3 English 20

21 ADDING A NEW PATIENT The Patients tab allows you to add a new patient. Steps: 1. Select the Patients tab. 2. Select +Add Patient to add a new patient. 3. A new Patient Information Form is created. PATIENT INFORMATION Notes: Patient ID is an automatically randomly generated value by the application. The patient is meant to remain anonymous. The generated Patient ID should be stored with the patient s medical files at the Physician s office. WaveCrest does not store any identity sensitive information. The Patient Information Form is displayed on screen when you select Add in the upper right corner or after a Patient ID is selected. The information can be viewed or updated from this screen. Steps: 1. Select the desired field to enter data or edit a previous entry. 2. Use the onscreen keyboard or picker view. 3. Continue entering data as needed. 4. Select Save before moving to another tab. English 21

22 Figure 4 English 22

23 SETTING STIMULATION PARAMETERS WARNING: Confirm that you are paired to the correct WAA unit before setting a program. Do not program a device unless you can confirm the serial number and password of the device. The Program tab allows you to modify and set programs. Steps: 1. Select the Configure tab. 2. Click in the upper right hand corner Connect to toggle the pop- up window with a list of WAA devices (listed by serial number) that are currently active and ready to connect. 3. Select the desired WAA to be programmed. 4. Use your finger to click on the desired new parameter or move the slider carriage(s) to the new parameter(s). 5. To select a different range of parameter values for Pulse Rate and Width, click the rectangular box next to the Title to reveal a drop down list. This list will show you the range of options available. Selecting a new range will NOT change the parameter until you tap on the desired new parameter. 6. Set the Electrode Polarities and Pulse Current for the desired Channel (A or B). Once the Stimulator is configured, Press Send A or Send B to send the parameters to the WAA. 7. After the patient has validated the parameters, press the Set I button to store the new parameters to the WAA. 8. The WAA program I has now been set. English 23

24 Figure 5 The WaveCrest App uses a reference table for allowable output current amplitude selection based on the combinations of pulse width and pulse rate selected. For each combination of pulse width and rate, the app will display the allowable output current English 24

25 amplitude corresponding to that combination in the table. A visual representation of the limits is presented in Figure 6 for the Freedom 8A/4A SCS System. Figure 6 CURRENT SETTINGS When paired with a WAA device, the current stimulation program and settings are displayed at the top of the application. These settings are changed when the device is programmed via the application or when the user presses either the increase or decrease amplitude key. Pulse Amplitude will always default to zero when selecting a new program and following a power cycle. This holds true whether the program is selected on the WAA or the WaveCrest App. English 25

26 SETTING ELECTRODE POLARITY Notes: Electrode polarity defaults to off whenever an electrode is added to a configuration. Electrodes can only be Off, Positive or Negative. You must have at least one Positive and one Negative electrode for a configuration per stimulator. The stimulator channel cannot be changed on the implant. Refer to the Patient Registration Form to confirm the channel of the stimulators implanted. There are only two (2) channels to select from. Steps: 1. Select the Configure tab. 2. Press the Add Stimulator button to add an additional stimulator to the configuration. 3. Select the stimulator Channel as either A or B. 4. Press the desired electrodes to cycle it through the option of Off, Positive and Negative polarities. SETTING PULSE RATE Steps: 1. Pulse rate is adjusted using the drop down menu and horizontal selection bar. 2. Select the desired pulse rate range using the drop down menu. 3. Select the specific pulse rate using the horizontal selection bar. English 26

27 SETTING PULSE WIDTH Steps: 1. Pulse width is adjusted using the drop down menu and horizontal selection bar. 2. Select the desired pulse width range using the drop down menu. 3. Select the specific pulse width using the horizontal selection bar. SETTING PULSE AMPLITUDE Notes: If you have more than one pair programmed on a single stimulator, then each individual pair will be assigned the same pulse amplitude. Steps: 1. Pulse width is adjusted using the vertical slider and selection arrows. 2. Pressing the desired value on the vertical slider can make large changes in pulse amplitude with 1.0 ma resolution. 3. Pressing the selection arrows on the edges of the view can make small changes in pulse amplitude (+0.1 ma). English 27

28 SETTING THE TRANSMIT POWER Notes: The transmit power is the amount of power the device is using to communicate with the stimulator. The transmit power does not affect the stimulation therapy. Patients who have lots of scar tissue or have a device implanted deep in the skin will require a higher transmit power. The transmit power should be adjusted if the patient is reporting intermittent stimulation or no stimulation. Steps: 1. Transmit power is adjusted using the horizontal slider bar. 2. Slid the selection carriage to the desired transmit power. 3. Increase the transmit power if the patient reports intermittent stimulation or no stimulation. 4. Decrease the transmit power to a level where the patient reports consistent stimulation. SETTING A PROGRAM Notes: Each Wearable Antenna Assembly has 3 programs that can be set. Steps: 1. Select the desired pulse rate, pulse width and pulse amplitude. 2. Select the Set I button to assign the values to Program I. 3. Select the Set II button to assign the values to Program II. 4. Select the Set III button to assign the values to Program III. English 28

29 CAPTURING AN IMAGE An image can be captured and saved to the patient s entry. Notes: Confirm that the WaveCrest Application has access to the device s camera and to the Camera Roll. Steps: 1. Select the Capture Image icon to access the device s camera. 2. Use the Camera application to capture an image. 3. The image is saved to the patients file. 4. You may search through images by swiping left or right on the pictures bar at the bottom of the screen. 5. You may enlarge a single picture by pressing on the picture. English 29

30 Figure 7 English 30

31 PROGRAM CYCLE Notes: The Cycle Sequence allows for a single program to run for a determined amount of time, and then switch to the next program. After the list of programs has been complete, the Cycle Sequence will return to the first program in the least and repeat. The clinician dictates the amount of time each program runs for. Steps: 1. Toggle Program Cycle on using the switch (Figure 8). 2. Select Add to add a new program to they Cycle Sequence. 3. Select the desired program. 4. Select the desired amount of time. 5. Select Start Therapy PULSE PATTERN Notes: The Pulse Pattern specifies how long to run the program before turning program back on. This allows for fine- tuning of pulse patterns over the span of one second. Steps: 1. Toggle Pulse Pattern on using the switch (Figure 8). 2. Select Set Timer next to On in order to specify the length of each individual dose. 3. Select Set Timer next to Off in order to specify the length of time between each individual dose. English 31

32 DOSAGE TIME Notes: The Dosage Time allows for the stimulation to be applied in periodic doses, automatically switching on and off as specified by the On and Off timers. This allows for limiting pulse patterns over the span of several minutes, hours, and up to one day. Steps: 1. Toggle Dosage Time on using the switch (Figure 8). 2. Select Set Timer next to On in order to specify the length of each individual dose. 3. Select Set Timer next to Off in order to specify the length of time between each individual dose. DAILY THERAPY TIME Notes: Daily Therapy Time allows the clinician to limit the patient to the number of hours in a day that stimulation may be used. Steps: 1. Toggle Daily Therapy Time on using the switch (Figure 8). 2. Select Set Total Therapy Time. 3. Select the desired therapy time allowed to run in 24 hours. 4. Select Start Therapy. English 32

33 Figure 8 English 33

34 TROUBLESHOOTING This information can help you solve problems that may arise with the WaveCrest App. If a problem is not solved after several attempts, or if a problem is not described here, review the connecting device s user manual or contact Stimwave. Problem Application is not connecting to the WAA. Cannot connect to the WAA with Bluetooth. Cannot maintain a Bluetooth connection with the WAA. Possible Solution Turn ipad s Bluetooth setting off and back on. Check to ensure WAA is turned on. The Programmer is not recognizing the WAA. Open Bluetooth menu and turn Bluetooth off. If WAA has been previously connected it will show up under My Devices. Remove from My Devices by selecting the info icon corresponding to the WAA. Select Forget this Device. Turn WAA OFF and wait 5 seconds before turning the power back ON. Attempt to re- pair with the device. The WAA is not in range. Make sure the WAA is within 4-5 meters of the Programmer. Move Programmer closer to the WAA. Make sure there is a direct line of sight between the WAA and the Programmer. WAA has low battery and is not connecting. Place WAA on Charging Pad and wait for battery to become fully charged. English 34

35 Problem Cannot see the WAA in the Bluetooth devices. The WaveCrest Application exits unexpectedly or crashes. Application is operating erratically. Possible Solution ipad is not recognizing the WAA. Open Bluetooth menu and turn Bluetooth off. If WAA has been previously connected it will show up under My Devices. Remove from the My Devices by selecting the icon corresponding to the WAA. Select Forget this Device. Turn WAA OFF and wait 5 seconds before turning the power back ON. Attempt to re- pair with the device. The ios device is not operating correctly. Restart the ios device. Turn off ios device by pressing and holding the ON/OFF button. Wait 30 seconds. Turn on ios device by pressing and holding the ON/OFF button. Try WaveCrest Application again. The WaveCrest Application is not operating correctly. Reinstall the application. From home screen, touch and hold WaveCrest app icon until it jiggles. Press the X icon that appears in the upper left corner to delete the app. Reinstall the app. Ensure no nearby equipment is generating EMI. EMI may interfere with device function Turn WAA OFF and wait 5 seconds before turning the power back ON. Attempt to re- pair with the device. English 35

36 Problem Application is not changing the stimulation parameters or The programs are not retaining the stimulation parameters set. Application is not saving a configuration. Patient reports that stimulation is uncomfortable or too high. The patient does not report stimulation but stimulation should be on. Possible Solution Check that a Bluetooth connection has been made Confirm the serial number of the WAA matches that which is displayed by the Application Power cycle the WAA Power cycle the Application Confirm that there is at least one positive and one negative electrode polarity The selected parameter settings are not suitable for the patient. Reduce the amplitude on the WAA. Remove the WAA from the patient. Transmit power is too low to communicate with the stimulator. Increase the Transmit Power. Stimulation is off. Turn the WAA OFF and wait 5 seconds before turning the WAA back ON. WAA is not placed over the stimulator. Place the antenna directly over the stimulator. Amplitude of the WAA is set too low to feel. Increase the amplitude. WAA is not functioning correctly. Check the operation of the WAA and confirm indicator lights are functioning. English 36

37 Problem Patient reports stimulation only some of the time. When do I need to change the stimulation parameters? WAA is unresponsive: The indicator light does not turn on. The stimulation amplitude keys do not respond. What are stimulation parameters programmed on WAA? How do I know that the amplitude is increasing? Possible Solution WAA may have a poor connection with the stimulator. Increase the Transmit Power. The WAA may not be placed over the area of the receiver. Place the WAA directly over the stimulator. Move the WAA up and down, then side to side to determine the best position. Stimulation parameters are changed when the patient s paresthesia coverage is not overlapping their pain. Ask the overseeing clinician when the parameters need changed and to what settings. The WAA is not powered on. Turn the power ON. The WAA system has frozen. Turn the power OFF and wait 5 seconds before turning the power back ON. The battery is not charged. Recharge the battery by placing the WAA on the charger. The WaveCrest Application displays the current settings at the top of the screen in a grey colored ribbon. When using the WaveCrest Application: The amplitude status display correlates to the WAA amplitude. English 37

38 CONTACT INFORMATION MANUFACTURER Stimwave Technologies Incorporated 901 East Las Olas Boulevard, Suite 201 Fort Lauderdale, FL United States Telephone: Fax: Internet: Published August 2015 EUROPEAN AUTHORIZED REPRESENTATIVE Emergo Europe Molenstraat BH, The Hague Netherlands AUSTRALIAN SPONSOR Emergo Australia Level 20 Tower II, Darling Park 201 Sussex Street Sydney, NSW 2000 Australia