Related Manuals for Boston Scientific Freelink
Summary of Contents for Boston Scientific Freelink
- Page 1 Freelink™ Remote Control Directions for Use 91171771-02 CAUTION: Federal law restricts this device to sale, distribution and use by or on the order of a physician. Content ID: 92089552 REV A...
- Page 2 Clinician Remote Control Directions for Use Guarantees Boston Scientific Corporation reserves the right to modify, without prior notice, information relating to its products in order to improve their reliability or operating capacity. Drawings are for illustration purposes only. Trademarks All trademarks are the property of their respective holders.
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Page 3: Table Of Contents
Table of Contents Description ...............................1 Cautions ................................1 Remote Control Features ........................1 Basic Operation ............................2 Unlocking the RC .............................2 Turning Therapy On/Off ............................2 Selecting Your Language/Screen Preference ....................2 The Home Screen ............................3 Adjusting Stimulation Amplitude from the Home Screen ..................4 The Main Menu ............................4 Accessing the Main Menu ..........................4 Program Selection and Activation ........................5 Selecting Stimulation Areas to Modify Programs....................6... -
Page 4: Description
Clinician Remote Control Directions for Use Description The Freelink™ Remote Control (RC) is a handheld device that allows you to communicate with and control the Stimulators. Cautions • Keep the RC dry. It should not be exposed to moisture. • Do not connect the RC USB port to any other device except to the RC charger provided with it. -
Page 5: Basic Operation
The RC communicates with the Stimulator through a radio frequency (RF) telemetry link. The RC has an effective communication range of up to 91.4 cm (36 inches) with the Boston Scientific rechargeable Stimulator, and a nominal effective communication range of 55.9 cm (22 inches) with the Boston Scientific non-rechargeable Stimulators. -
Page 6: The Home Screen
Clinician Remote Control Directions for Use The Home Screen The Remote Control (RC) Home screen displays information for the specific stimulator and stimulation therapy programmed. If a program is running, the Home Screen will display the following information: • Name of the Program •... -
Page 7: Adjusting Stimulation Amplitude From The Home Screen
The Main Menu Adjusting Stimulation Amplitude from the Home Screen 1. Press the Home button on the left side of the RC to view the Home screen. Note: When the RC connects to a non-rechargeable Stimulator, the RC will not display the Stimulator battery icon in the upper right corner of the home screen. -
Page 8: Program Selection And Activation
Clinician Remote Control Directions for Use Program Selection and Activation The Programs Menu allows patients to change to another program, save modifications to Programs, restore programs to clinic settings, and delete programs. 1. Press the button on the left side of the RC to display the Programs screen. Note: You can also navigate to the Programs menu from the Main Menu. -
Page 9: Selecting Stimulation Areas To Modify Programs
The Main Menu Selecting Stimulation Areas to Modify Programs Each Program can include settings for up to four Stimulation Areas. Each Stimulation Area is identified by a letter and a name. These Stimulation Areas control Amplitude, Pulse Width, and Rate. Main Menu: From the 1. - Page 10 Clinician Remote Control Directions for Use 2. Press the Minus button to decrease the Amplitude (level) of stimulation. 3. Press the Plus button to increase the Amplitude (level) of stimulation. Pulse Width From the Area screen: 1. Select Pulse Width. 2.
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Page 11: Saving Modified Programs
The Main Menu Saving Modified Programs If the stimulation amplitude, pulse width, or rate have been changed, the new settings can be saved as the default stimulation for that Program. The new settings will remain until a new change is saved or the Program is restored to its Clinic Settings. -
Page 12: Restoring Programs
Clinician Remote Control Directions for Use Restoring Programs Restoring Programs removes saved changes to a Program and resets the Program to the original Clinic Settings. 1. Press the button on the left side of the RC. From the Main Menu screen, select Programs. -
Page 13: Copying Programs
The Main Menu Copying Programs You can copy an existing Program to a new Program. 1. Press the button on the left side of the RC. From the Main Menu screen, select Programs. 2. Select Copy to..3. Select the Program that you want to copy the current Program to. 4. -
Page 14: Deleting Programs
Clinician Remote Control Directions for Use Deleting Programs 1. Press the button on the left side of the RC. From the Main Menu screen, select Programs. 2. Select Delete. 3. Select the Program to delete. 4. Select Yes to Delete the selected program. Select No to cancel the action. -
Page 15: Managing Schedules
The Main Menu Managing Schedules Schedules allows patients to select and change to a different schedule, exclude programs from a schedule, or advance to the next program in a schedule. Note: Depending on the stimulator configurations, some selections may be unavailable. Main Menu: From the 1. - Page 16 Clinician Remote Control Directions for Use 2. Press the Up or Down Arrow buttons to navigate to the desired Schedule. 3. Press the Right Arrow button to Select the Schedule. Exclude Program from a Schedule Schedules Main Menu: From the 1.
- Page 17 The Main Menu 5. If No is selected, the program will not be excluded and you will be redirected to the Schedules Menu: Advance Program within a Schedule Schedules Menu: From the 1. Press the Down Arrow button to navigate to Next Program. 2.
- Page 18 Clinician Remote Control Directions for Use 4. If Yes is selected, the Program Advanced screen displays: 5. If No is selected, the program will not be advanced and you will be redirected to the Schedules Menu: Clinician Remote Control Directions for Use 91171771-02 15 of 35...
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Page 19: Entering A Therapy Rating
The Main Menu Entering a Therapy Rating The Therapy Rating is a way for the patient to communicate real time preferences to different therapy types. Their preferences are recorded on a five star rating scale. Note: Depending on stimulator configurations, some selections may be unavailable. Main Menu: From the 1. -
Page 20: Accessing System Settings
Clinician Remote Control Directions for Use Accessing System Settings From the Main Menu: 1. Select System Settings. The System Settings screen displays. When using the Precision Montage MRI Stimulator, the Lead Check icon will also appear on the System Settings screen: Remote Settings The Remote Settings option allows you to adjust the Alert Volume, Screen Brightness, and to select your language preference. - Page 21 The Main Menu Alert Volume From the Remote Settings menu: 1. Select Alert Volume. 2. Press the Minus button to decrease the Alert Volume 3. Press the Plus button to increase the Alert Volume. Screen Brightness From the Remote Settings menu: 1.
- Page 22 Clinician Remote Control Directions for Use Languages The RC allows you to configure your system to display one the following: • Text screen in one of the languages provided • Iconic screen From the Remote Settings menu: 1. Select Languages. 2.
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Page 23: System Info
The Main Menu System Info The System Info menu gives you the option of viewing information regarding the RC or the Stimulator. From the System Settings menu: System Info. 1. Select Remote Info 2. Select Remote Info to view the Remote Info screen. Serial Number Model Number Boot Version... - Page 24 Clinician Remote Control Directions for Use Select More to view additional Remote Info. LCD Boot Version LCD Firmware The Remote Info screen displays the following additional information: • LCD Boot Version • LCD Firmware Stimulator Info 1. Select Stimulator Info to view the Stimulator Info screen. Serial Number Model Number Boot Version...
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Page 25: Accessing The Clinician Menu
Accessing the Clinician Menu Accessing the Clinician Menu The Clinician Menu allows you to link to a Stimulator, clear the link to a Stimulator, check impedances, and reset the Stimulator. It also allows you to use the Remote Control without any of the lockouts that may have been programmed by the Clinician Programmer (e.g., Main Menu, Programs, Pulse Width, Rate). - Page 26 Clinician Remote Control Directions for Use Stimulator Search The Clinician Menu allows you to search for a Stimulator and link to it. From the Clinician Menu: 1. Select Stimulator Search. The Stimulator Search screen displays. 2. If the desired Stimulator has not been located, select Rescan.
- Page 27 Accessing the Clinician Menu Clear Link If the RC is linked to a Stimulator, the Clear Link option displays on the Clinician Menu. From the Clinician Menu: 1. Select Clear Link. The Clear Link to Stimulator? screen displays. 2. Select Yes to clear the link to the Stimulator.
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Page 28: Impedances
Clinician Remote Control Directions for Use Impedances You can use the RC to check impedances. From the Clinician Menu: Impedances. The Impedances screen displays. Select 1450 1450 1000 1450 1450 1450 1000 1450 1450 1200 1450 1450 1000 8000 2. Select Measure to check impedances. -
Page 29: Lead Check (Precision Montage Mri Stimulator Only)
Accessing the Clinician Menu Lead Check (Precision Montage MRI Stimulator Only) For the Precision Montage MRI Stimulator, you can use the Remote Control to test lead integrity. From the Systems Settings menu: Select Lead Check Clinician Remote Control Directions for Use 91171771-02 26 of 35... -
Page 30: Recharging The Rc
Clinician Remote Control Directions for Use Recharging the RC icon at the top left of the Home screen indicates the charge level of the RC battery. The RC will display messages reminding you to recharge the RC or the Stimulator if the battery power is low. - Page 31 Recharging the RC External Trial Stimulator or Rechargeable Stimulator Only Note: The following is not applicable to the Precision Novi Stimulator. icon at the top right of the Home screen indicates the charge level of the Stimulator battery. The RC will display messages reminding you to recharge the Stimulator if the battery power is low. Charge Stimulator Press...
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Page 32: Troubleshooting
Troubleshooting Telemetry Help The RC has an effective communication range of up to 91.4 cm (36 inches) with the Boston Scientific rechargeable Stimulator, and a nominal effective communication range of 55.9 cm (22 inches) with the Boston Scientific non-rechargeable Stimulator. Common sources of interference, such as televisions and computer monitors, can affect wireless communication. -
Page 33: No Program To Run Screen
Troubleshooting The telemetry bars indicate the strength of wireless communication. The number of bars will change depending on the distance and orientation of the RC from the Stimulator. This tool will continue to measure the strength of communication for 30 seconds or until is pressed. -
Page 34: Unsupported Stimulator Screen
Clinician Remote Control Directions for Use Unsupported Stimulator Screen This screen is displayed when the RC detects an incompatible Stimulator. Unsupported Stimulator Press continue. Press to continue System Settings Reset Screen This screen is displayed when the RC experiences an error and a reset of the RC is required. Press to continue. -
Page 35: Remote Error Screen
Remote Error Screen This screen is displayed when there is a critical error on the RC which causes the RC to be unusable. Advise the patient to contact Boston Scientific or their healthcare provider to order a replacement RC. Remote... -
Page 36: Non-Rechargeable Ipg Battery Status
Clinician Remote Control Directions for Use Non-rechargeable IPG Battery Status ERI (Elective Replacement Indicator) Screen The implanted non-rechargeable Stimulator is nearing end of service. Changes made to the stimulation will not be saved, and stimulation will not be available soon. Advise the patient to contact their healthcare provider to report this message. -
Page 37: Icon Description And Index
Icon Description and Index Icon Description and Index Languages 2, 19 Alert Volume 17, 18 Lead Check 17, 26 Amplitude 4, 6 A B ... Areas 4 Main Menu 22 Change Program 5 Navigation 1, 22 Change Schedule 12 No 8, 9, 10, 11, 23, 24, 25 Clinician Menu 22, 24, 25 Copy to 10 Program 4, 8, 9, 10, 11... - Page 38 Clinician Remote Control Directions for Use Save Program 8 Schedules 3, 4, 12 Screen Brightness 17, 18 Stimulation Area 6 Stimulator 2, 23, 25, 27, 28, 31 Stimulator Battery 4, 28 Stimulator Information 21 System Info 20 System Settings 4, 17, 22, 31 Therapy OFF 2 Therapy ON 2 Therapy Rating 4, 16...
- Page 39 Legal Manufacturer Australian Sponsor EU Authorised Address Representative Boston Scientific Neuromodulation Boston Scientific (Australia) Pty Ltd Boston Scientific Limited Corporation PO Box 332 Ballybrit Business Park 25155 Rye Canyon Loop BOTANY Galway, Ireland Valencia, CA 91355 USA NSW 1455 T: +33 (0) 1 39 30 97 00...