Q-TECH™ PROGRAMMER A COMPONENT OF THE S-ICD® SYSTEM USER’S MANUAL Model 3200 Physician must be trained or experienced in device implant and follow-up procedures.
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TABLE OF CONTENTS GENERAL DESCRIPTION Description ��������������������������������������������������������������������������������������������������������������������������������1 Indications for Use ��������������������������������������������������������������������������������������������������������������������1 Intended Use �����������������������������������������������������������������������������������������������������������������������������1 Contraindications ������������������������������������
OPERATION (continued) Configuring the Q-TECH Programmer ���������������������������������������������������������������������������������� 16 Configuring Programmer Settings ������������������������������������������������������������������������������������������������������������� 16 Date and Time Format ������������������������������������������������������������������������������������������������������������������������������������ 18 Time Zone ����������������������������������������������������������
Episodes Report ������������������������������������������������������������������������������������������������������������������������������������������������ 49 S-ECG Features ����������������������������������������������������������������������������������������������������������������������� 50 S-ECG Rhythm Strip Markers ������������������������������������������������������������������������������������������������������������������������ 50 S-ECG Scale Settings ��������������������������������������
DECLARATIONS TABLES Declaration Electromagnetic Emission ���������������������������������������������������������������������������������������������������� 72 Declaration Electromagnetic Immunity Part 1 �������������������������������������������������������������������������������������� 72 Declaration Electromagnetic Immunity Part 2 �������������������������������������������������������������������������������������� 73 Recommended Separation Distances ��������������������������������������������������
Q-TECH™ PROGRAMMER: general description Description The Q-TECH Programmer (the “programmer”), Model 3200, is a component of the Cameron Health/ Boston Scientific S-ICD System, which is prescribed for patients when cardiac arrhythmia management is warranted. The other components of the S-ICD System include the SQ-RX Pulse Generator (the “SQRX device”), Q-TRAK Subcutaneous Electrode (“electrode”) and the Q-GUIDE Subcutaneous Electrode Insertion Tool (“EIT”).
Q-TECH™ PROGRAMMER: general description • • • • • • • • • • • • • • 2 The US power cord is for connection to 110 VAC supply mains. All other power cords are for connection to 230 VAC supply mains. Outside North America, use the supplied power cord that exactly matches your AC electrical outlet. To avoid risk of electric shock, the programmer must only be connected to a supply mains with protective earth. Mains isolation is achieved by disconnecting the AC power cord.
Q-TECH™ PROGRAMMER: general description • • • • • • • Do not disassemble or alter any parts of the programmer. Do not immerse the programmer in liquid of any kind. If the programmer does get wet, contact customer service for information about returning the programmer to Cameron Health/Boston Scientific. Do not attempt to dry the programmer in an oven, microwave, or dryer because this poses a risk of overheating or explosion.
Q-TECH™ PROGRAMMER: general description • • • • Placing a magnet over the SQ-RX Pulse Generator suspends arrhythmia detection and therapy response. Removing the magnet resumes arrhythmia detection and therapy response. Battery depletion will eventually cause the SQ-RX Pulse Generator to stop functioning. Defibrillation and excessive numbers of charging cycles shorten the SQ-RX Pulse Generator’s battery longevity. The S-ICD System has not been evaluated for pediatric use.
Q-TECH™ PROGRAMMER: general description • • Use caution during ablation procedures. Program the S-ICD System to Therapy Off. Keep the current path (electrode tip to ground) as far away as possible from the implanted SQ-RX Pulse Generator and electrode. The programmer is not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.
Q-TECH™ PROGRAMMER: general description Potential Adverse Events Potential adverse events related to implantation of the S-ICD System may include, but are not limited to, the following: • • • • • • • • • • • • • • • • • Acceleration/induction of atrial or ventricular arrhythmia Adverse reaction to induction testing Allergic/adverse reaction to system or medication Bleeding Conductor fracture Cyst formation Death Delayed therapy delivery Discomfort or prolonged healing of incision Electrode deformation and/
Q-TECH™ PROGRAMMER: Operation Setup of the Q-TECH Programmer Packaging Programmer components include: • Model 3200 Programmer with pre-loaded software • Model 3203 Telemetry Wand • External power supply and AC power cord Visually inspect the packaging to ensure the contents are complete. Do not use if there is evidence of damage. In case of damage return the product to Cameron Health/Boston Scientific.
Q-TECH™ PROGRAMMER: Operation Charging the Programmer The programmer is primarily intended to be operated while connected to the AC-powered external power supply, but may also be operated on battery power provided that the internal battery is adequately charged. The programmer is recharged whenever it is connected to the AC-powered external power supply. When not in use, it is recommended that the programmer remain connected to the external power supply in order to maintain an adequate battery charge.
Q-TECH™ PROGRAMMER: Operation External power supply port Figure 2: Connecting the external power supply Using the Q-TECH Programmer Turning the Programmer On The programmer power button is located in the recess above and behind the left corner of the screen. Press and hold the button until the display screen is active (Figure 3).
Q-TECH™ PROGRAMMER: Operation Power On/Off Volume Control Figure 3: Turning the programmer On/Off and changing the volume level Note: If the programmer cannot be turned on while it is connected to AC power via the external power supply, first unplug the external power supply cord from the programmer. Press and hold the programmer power button until the display screen is active (Figure 3). AC power via the external power supply can then be reconnected.
Q-TECH™ PROGRAMMER: Operation Turning the Programmer Off There are two ways to turn the programmer off: 1. Press and hold the power button (Figure 2) until the System shutdown menu appears. Select Power off from the popup and confirm by pressing OK. 2. From the on-screen Main Menu, press the Power Off button and select OK at the confirmation prompt. Using the Programmer Touch Screen The programmer is equipped with an LCD touch screen.
Q-TECH™ PROGRAMMER: Operation Using the Wand Model 3203 wand (“the wand”) makes it possible for this programmer to communicate with the SQ-RX device. Note: The wand is a non-sterile device. DO NOT STERILIZE the wand or the programmer. The wand must be contained in a sterile barrier before use in the sterile field. To connect the wand to the programmer, slide the wand cable connector over the communication connector port located on the rear edge of the programmer (Figure 5).
Q-TECH™ PROGRAMMER: Operation When telemetry loss occurs, the display screen will turn yellow and a message will appear with the text “Communication Loss” to alert the user. Reposition the wand to establish communication. The programmer will display a screen informing the user if the SQ-RX device is found and programming can continue. Note: If communication cannot be reestablished, the session should be ended and restarted by scanning for the SQ-RX device.
Q-TECH™ PROGRAMMER: Operation Navigation Bar The Navigation Bar is the primary method for navigating the Online programmer screens. The bar is located along the top edge of the programmer screen and chosen screens appear with their selection icon highlighted. Table 1 displays a list of the programmer icons and their corresponding descriptions.
Q-TECH™ PROGRAMMER: Operation Table 1: Icon descriptions Icon Description User Application  Main Menu Icon Allows user to return to the main menu.  Automatic Setup Icon Allows user to access the automatic setup menu.  Device Settings Icon Allows user to access the SQ-RX device settings screen.  Device Status Icon (open folder and closed folder) Allows user to access the SQ-RX device status screen.
Q-TECH™ PROGRAMMER: Operation Configuring the Q-TECH Programmer Configuring Programmer Settings The programmer should be configured before communication with an SQ-RX device is attempted. This includes setting the date and time format, time zone, language and printer. Once these settings are configured during the initial setup process they become the default parameters and will not normally need to be changed with each session. To configure the programmer settings: 1.
Q-TECH™ PROGRAMMER: Operation Figure 7: Programmer Settings screen 2. Select the corresponding line to access each setting.
Q-TECH™ PROGRAMMER: Operation Date and Time Format To set the date and time format: 1. Select Set Date and Time Format on the Programmer Settings screen (Figure 7). The Date and Time Settings screen appears (Figure 8). 2. Select the desired date format. 3. Select the Save button to save the changes and return to the Programmer Settings screen, or select Cancel to return to the Programmer Settings screen without saving the changes.
Q-TECH™ PROGRAMMER: Operation Figure 9: Time Zone selection screen (scrollable list) 3. Select the Save button to save the changes and return to the Programmer Settings screen, or select Cancel to return to the Programmer Settings screen without saving the changes. Language Preference To set the language preference: 1. Select Set Language on the Programmer Settings screen. The Language Settings screen appears. 2.
Q-TECH™ PROGRAMMER: Operation 2. Select Printer Setup on the Programmer Settings screen. A previously configured printer becomes the default printer and will be displayed at this time. If a default printer has not already been selected and configured, the programmer will scan the area to locate wireless printers. A Scan Progress Bar will appear informing the user that the programmer is currently scanning for printers. 3. Select the printer of choice (Figure 10).
Q-TECH™ PROGRAMMER: Operation Figure 11: Use the on-screen keyboard to enter a name for the selected printer 6. Select the Save button to save the changes and return to the Programmer Settings screen, or select Cancel to return to the Programmer Settings screen without saving the changes. A confirmation screen will appear when the printer setup is completed (Figure 12).
Q-TECH™ PROGRAMMER: Operation Programmer Software Version To view the programmer’s software version: 1. Select About Programmer on the Programmer Settings screen. The Programmer Software Version information screen appears (Figure 13). Figure 13: Programmer Software Version information screen 2. This screen displays the current version of the programmer software. Select the Continue button to return to the Programmer Settings screen.
Q-TECH™ PROGRAMMER: Operation wand is moved out of the telemetry communications range or if noise or interfering objects inhibit communication. Programming commands, including Rescue Shocks, will not be available until telemetry is reestablished. Telemetry reconnection may occur automatically within one minute when the SQ-RX device and wand are within telemetry range.
Q-TECH™ PROGRAMMER: Operation Modes of Operation for the SQ-RX Device The SQ-RX device has three modes of operation: • Shelf • Therapy On • Therapy Off Shelf Mode The Shelf mode is a low power consumption state intended for storage only. When communication is initiated between the SQ-RX device and the programmer, a full-energy capacitor reformation is automatically performed and the SQ-RX device is prepared for set-up.
Q-TECH™ PROGRAMMER: Operation Connecting and Disconnecting from the SQ-RX Device This section provides the information necessary for selecting, connecting to, and disconnecting from the SQ-RX device. Scanning For SQ-RX Devices 1. Select the Scan For Devices button on the Startup Screen (Figure 14). The Device List screen appears after the Scan Progress Bar displayed during the scanning process. Select the Cancel button at any time to end the scanning process.
Q-TECH™ PROGRAMMER: Operation 2. When the scanning process is complete, a list of all SQ-RX devices detected (up to 16) will be displayed on the Device List (Figure 15). The SQ-RX devices that are in Shelf mode will be displayed as “Not Implanted.” Any SQ-RX devices that were previously taken out of Shelf mode are displayed either as “Implanted” or with the stored patient name. Figure 15: Device List screen (scrollable list) 3.
Q-TECH™ PROGRAMMER: Operation Connecting to the SQ-RX Device From the Device List screen, select the desired SQ-RX device to initiate the communication session. Note: Regardless of how many SQ-RX devices are located by a scan, the user must select an SQ-RX device from the list to begin active communication. Connecting to an SQ-RX Device in Shelf Mode: 1. When the SQ-RX device selection is made, the programmer connects to the selected SQ-RX device. A window will appear indicating connection is in process.
Q-TECH™ PROGRAMMER: Operation Ending a Patient Session To end an Online patient session and return the programmer to its Offline operation mode: 1. Select the Main Menu icon on the Navigation Bar. The Main Menu screen appears. 2. Select the End Session button (Figure 17). Figure 17: Main Menu screen 3. 4.
Q-TECH™ PROGRAMMER: Operation Figure 18: Session incomplete message Note: Once the Continue button is selected, the session is stored and communication is terminated. Note: A telemetry session must be terminated using the End Session process as described in steps 1 through 4 above in order for data obtained during that session to be saved. If the programmer is powered off during a session, either automatically or manually, session data will not be saved.
Q-TECH™ PROGRAMMER: Operation Programming the SQ-RX Device at Implant This section provides the information necessary for programming the SQ-RX device during an implant setting. Entering Electrode Information The programmer maintains information on the implanted electrode. To record this information for a patient’s new or replacement electrode: 1. Select the Main Menu icon. 2. Select the Implant button. 3. Select the Automatic Setup icon in the Navigation Bar.
Q-TECH™ PROGRAMMER: Operation Figure 20: Entering electrode information 6. Select the Program button to save the information. A confirmation screen will appear during communication with the SQ-RX device (Figure 21). Select Cancel to cancel information storage and return to the Automatic Setup screen.
Q-TECH™ PROGRAMMER: Operation Creating the Patient Chart This chart contains reference information for the patient. To set up the patient chart: 1. Select the Main Menu icon on the Navigation Bar. 2. Select the Implant button (Figure 22). Figure 22: Select the Implant button to create a patient chart 32 3. Select the Patient View icon to access the Patient View screen. 4. The SQ-RX device model and serial numbers appear on the first line of the chart.
Q-TECH™ PROGRAMMER: Operation Figure 23: Patient Chart screen Note: 5. The Notes field will automatically wrap the text with the presence of a space between any characters within the first line. Select the Save button to update the SQ-RX device with the patient information. Note: Failure to save the new patient information will result in loss of the entered data.
Q-TECH™ PROGRAMMER: Operation Automatic Setup Before the SQ-RX device can be activated, it must go through an initial Automatic Setup Process at the time of the implant. The Automatic Setup Process is initiated as follows: 1. Select the Main Menu icon. 2. Select the Implant button. 3. Select the Automatic Setup icon on the navigation bar. The Automatic Setup screen appears (Figure 24). 4. Select Continue if the patient’s heart rate is less than 130 bpm.
Q-TECH™ PROGRAMMER: Operation Figure 25: Measuring electrode impedance The progress of the Automatic Setup process is shown in the status bar. When each function is complete, the arrow next to the function moves to a down position. 6. The Automatic Setup Sensing Optimization screen will be displayed. The programmer will display a message requesting that the patient sit up; however, this process can be omitted during the implantation procedure by selecting the Skip button (Figure 26).
Q-TECH™ PROGRAMMER: Operation 7. Select the Continue button to finish the Automatic Setup process. A confirmation screen will appear when Automatic Setup is complete (Figure 27). Figure 27: Confirmation of successful Automatic Setup 8. Following the optional optimization process, the Acquire Reference S-ECG screen is displayed (Figure 28). Select the Continue button to acquire a reference S-ECG.
Q-TECH™ PROGRAMMER: Operation 9. Once the Reference S-ECG acquisition process begins, a status screen appears. The process may take up to one minute, during which the patient should remain still. During this process, a template of the patient’s baseline QRS complex is stored in the SQ-RX device. Select Cancel at any time to end Reference S-ECG acquisition. When acquisition is complete, select the Continue button.
Q-TECH™ PROGRAMMER: Operation 4. Select the On/Off Therapy switch to set the desired therapy mode (Figure 30). Figure 30: Setting the On/Off Therapy switch 5. Select and drag the Conditional Shock Zone (yellow) and Shock Zone (red) slider bars to set the desired zone configuration. • • 6. 7. 38 The Shock Zone is programmable between 170 and 250 bpm in steps of 10 bpm. The Conditional Shock Zone is programmable between 170 and 240 bpm in steps of 10 bpm.
Q-TECH™ PROGRAMMER: Operation Figure 31: Confirmation of programming 8. Once programming is confirmed, select the Continue button to proceed to the next operation. Note: If any of the SQ-RX device settings are changed from the Device Settings screen and not subsequently programmed, the Pending Program Changes screen will appear. You may select Cancel to return to the Device Settings screen or select Continue to cancel all SQ-RX device setting changes.
Q-TECH™ PROGRAMMER: Operation Defibrillation Testing Once the SQ-RX device is implanted and Automatic Therapy is programmed On, defibrillation testing may be conducted. Note: Defibrillation testing is recommended at implant to confirm the ability of the S-ICD System to sense and convert VF. Note: Episode data associated with rescue shocks, manual shocks, and induction testing is not stored in the SQ-RX device. To induce VF and test the S-ICD System: 1.
Q-TECH™ PROGRAMMER: Operation Figure 33: Setting the desired first shock energy for defibrillation testing 5. Select the Continue button to display the next Induction Test screen. Note: 6. Ensure that noise markers (“N”) are not present on the S-ECG prior to induction. The presence of noise markers may delay detection and therapy delivery. Select and hold the Hold To Induce button for the desired duration (Figure 34).
Q-TECH™ PROGRAMMER: Operation The following functions occur during the test: • The S-ICD System induces ventricular fibrillation using 200 mA alternating current (AC) at 50 Hz. Induction continues until the Hold To Induce button is released (up to a maximum of 10 seconds per attempt). Note: • Arrhythmia detection and the Live S-ECG are suspended during AC induction. Once the Induction button is released, the programmer displays the patient’s rhythm.
Q-TECH™ PROGRAMMER: Operation Performing an SQ-RX Follow-up Sensing Configuration and Automatic Setup It is not necessary to perform Automatic Setup at each follow-up. If Automatic Setup is performed, resulting in a vector change, sensing should be reevaluated. After the setup process is complete, evaluate the streaming S-ECG during a pectoral exercise. Sensing performance during high rate exercises can also be performed. Acceptable sensing will yield “S” markers synchronous to all QRS complexes.
Q-TECH™ PROGRAMMER: Operation Figure 35: Device Status screen The Device Status overview reports: • Date of the last follow-up session • Total number of shocks delivered since the last follow-up session • Total number of treated episodes since the last follow-up session Note: Choosing the “View” button in the Treated Episodes row allows navigation directly to the list of stored episodes (Figure 36).
Q-TECH™ PROGRAMMER: Operation To view stored episodes: 1. Select the Main Menu icon. 2. Select the Follow Up button. 3. Select the Captured and Stored Episodes S-ECG icon from the Navigation Bar. 4. Select the Episodes option to access the Episodes screen. 5. Select an episode (treated or untreated) from the list (Figure 36). The selected episode will be downloaded from the SQ-RX device and displayed.
Q-TECH™ PROGRAMMER: Operation The following details are available for each episode: Treated Episodes Up to 128 seconds of S-ECG data is stored for each Treated Episode: • Pre-episode S-ECG: Up to 44 seconds • First shock: Up to 24 seconds of pre-shock S-ECG and up to 12 seconds of post-shock S-ECG • Subsequent shocks: 6 seconds of pre-shock and 6 seconds post-shock S-ECG Untreated Episodes An Untreated Episode is defined as any high-rate episode that spontaneously terminates during the charging proces
Q-TECH™ PROGRAMMER: Operation Figure 37: Print Reports screen 3. Select the desired report type. A checkmark will appear next to the selected report. Report types are described below. 4. Select the Print button to print the selected report. 5. Select the Cancel button to return to the previously accessed screen. Summary Report To print a summary report, select the Summary Report option on the Print Reports screen and press the Print button.
Q-TECH™ PROGRAMMER: Operation • Therapy Parameters • Programmed Gain Settings and Sensing Configuration • Initial Shock Polarity Configuration • Episode Summary: Since Last Follow-Up and Since Initial Implant • Battery Status • Electrode Impedance Measurement • SQ-RX Device Integrity Check, if applicable • Programmer Software Version • SQ-RX Device Software Version Captured S-ECG Report To print a Captured S-ECG report: 1.
Q-TECH™ PROGRAMMER: Operation 3. Select Continue to return to the Print Reports screen. 4. Select the Print button to print the selected report. 5. Select the Cancel button to return to the previously accessed screen. Episodes Report To print an Episode Report: 1. Select the Episodes Report option on the Print Reports screen (Figure 37). 2. The Episode List screen appears showing a list of the stored episodes (Figure 39). Select the episode(s) to be printed.
Q-TECH™ PROGRAMMER: Operation 3. Select Continue to return to the Print Reports screen (Figure 40). Either 12 seconds or 44 seconds of pre-episode S-ECG data may be selected using the radio buttons below the Episode Reports row. The default value for Episode Report Onset is 12 seconds. Figure 40: Print Reports screen 4. Select the Print button to print the selected report. 5. Select the Cancel button to return to the previously accessed screen.
Q-TECH™ PROGRAMMER: Operation Table 2: S-ECG Markers on Programmer Display Screens and Printed Reports Description Marker Charging a C Sensed Beat S Noisy Beat N Paced Beat P Tachy Detection T Discard Beat • Return to NSRa Shock Episode data compressed or not available a Marker present on printed report but not on programmer display screen.
Q-TECH™ PROGRAMMER: Operation S-ECG Scale Settings To adjust the real-time S-ECG amplitude and display speed scale settings: 1. Select the S-ECG Display Settings icon located to the right of the Live S-ECG window. The S-ECG Settings screen is displayed. 2. Select and drag the Gain or Sweep Speed Scale bars as desired (Figure 42). The S-ECG scale will change according to the selected setting. The gain setting controls the visual gain.
Q-TECH™ PROGRAMMER: Operation Capture and View S-ECG Strips The programmer can display, capture and store real-time S-ECG rhythm strips. The programmer saves a maximum of fifteen, 12-second, Captured S-ECG recordings comprised of: • 8.5 seconds before activation of the Capture S-ECG button • 3.5 seconds after activation of the Capture S-ECG button If an additional recording is required, then the oldest previous recording is replaced with the new recording. To capture a new S-ECG rhythm strip: 1.
Q-TECH™ PROGRAMMER: Operation 2. Select and move the calipers across the S-ECG strip to measure intervals as desired. 3. Select the Continue button to return to the previously accessed screen. It is also possible to capture S-ECGs corresponding to all three sense vectors (Primary, Secondary, and Alternate) by using the Capture All Sense Vectors button on the Utilities screen (Figure 45). To view a previously captured S-ECG: 1. Select the Main Menu icon. 2. Select the Follow Up button. 3.
Q-TECH™ PROGRAMMER: Operation Figure 45: Utilities screen Acquire Reference S-ECG To acquire a manual Reference S-ECG: 1. From the Utilities screen (accessible from the Main Menu screen), select the Acquire Reference S-ECG button to access the Acquire Reference S-ECG screen. 2. Select Continue to acquire a Reference S-ECG. The programmer will begin acquiring the Reference S-ECG. A message will appear requesting that the patient remain still (Figure 46).
Q-TECH™ PROGRAMMER: Operation Figure 46: The patient should remain still while the Reference S-ECG is acquired Capture All Sense Vectors The Capture All Sense Vectors button on the Utilities screen configures temporary programmer settings that allow you to capture S-ECGs generated from each of the three sense vectors (Primary, Secondary, and Alternate). This process takes approximately one minute. The programmer returns to its original settings configuration after all S-ECGs have been captured.
Q-TECH™ PROGRAMMER: Operation Figure 47: Capture all sense vectors Once captured, the three S-ECGs can be viewed by following the steps outlined in “To view a previously captured S-ECG” on page 54. Beeper Control The SQ-RX device has an internal alert system that emits an audible beeping tone when an alert condition occurs.
Q-TECH™ PROGRAMMER: Operation 2. Select the Reset Beeper button to suspend audible beeping tones triggered by an alert condition (Figure 48). If the alert condition is not corrected, the audible beeping tones will be reactivated during the next automatic S-ICD System self-check. Figure 48: Resetting the Beeper 3. The disable Beeper feature is enabled when ERI is reached or EOL occurs. If desired, select disable Beeper when ERI or EOL occurs. Beeper tones are permanently disabled.
Q-TECH™ PROGRAMMER: Operation Figure 49: Impedance test screen 3. Select Continue to proceed or select Test to retry. The sensing configuration can be evaluated by temporarily activating any of the vectors or gain settings. The Live S-ECG and markers will reflect the temporary selections for evaluation purposes. 4.
Q-TECH™ PROGRAMMER: Operation Figure 50: Gain adjustment • 1x Gain (± 4 mV): 1x Gain should be selected when the signal amplitude is large enough to cause clipping when the 2x gain is selected. • 2x Gain (± 2 mV): 2x Gain should be selected when the signal amplitude is small enough to allow use of a more sensitive setting without causing clipping of the captured signal. The 2x gain selection amplifies the signal twice as much as the 1x gain selection.
Q-TECH™ PROGRAMMER: Operation Figure 51: Captured Reference S-ECG confirmation Smart Charge Through the Smart Charge feature, the SQ-RX device charge initiation sequence adapts to the occurrence of non-sustained ventricular arrhythmia episodes by delaying capacitor charging. This conserves battery longevity and may prevent unnecessary shocks for non-sustained arrhythmias. Smart Charge is enabled automatically when an untreated ventricular arrhythmia episode is recorded.
Q-TECH™ PROGRAMMER: Operation Figure 52: Reset Smart Charge screen 62 2. Select the Reset button to reset the Smart Charge to zero or press Cancel to return to the Utilities Menu without resetting the Smart Charge. 3. A confirmation window will appear with the message: “Smart Charge successfully reset.” 4. Press the Continue button to return to the Utilities screen.
Q-TECH™ PROGRAMMER: Operation Additional Programmer Functions Rescue Shock The Rescue Shock icon is available in the navigation bar on the programmer display when the SQ-RX device Setup Process is complete and an SQ-RX device is actively communicating with the programmer. During active communication, a maximum (80 J) rescue shock can be delivered upon programmer command. To deliver a rescue shock: 1. Select the red Rescue Icon at the top of the programmer screen.
Q-TECH™ PROGRAMMER: Operation Figure 54: Abort Rescue Shock 3. A confirmation screen will appear with notification that the shock was delivered successfully along with the corresponding shock impedance (Figure 55).
Q-TECH™ PROGRAMMER: Operation If for any reason the shock could not be delivered, a red background screen will appear with a message stating “The Shock could not be delivered.” Note: In the event telemetry is lost, SQ-RX device commands, including Rescue Shocks, will not be available until telemetry is reestablished. Manual shock Manual Shock allows the user to deliver a synchronized shock during a sinus rhythm, an atrial rhythm or a ventricular rhythm.
Q-TECH™ PROGRAMMER: OPERATION / MAINTENANCE Other behaviors of magnet application: • Inhibit shock therapy delivery • Terminate post-shock pacing therapy • Prohibit arrhythmia induction testing • Activate the SQ-RX device’s beeper with each detected QRS complex for 60 seconds Note: A programmer commanded Rescue Shock can override the use of the magnet as long as the magnet was in place prior to the initiation of the programming command.
Q-TECH™ PROGRAMMER: MAINTENANCE When requesting service, please provide information concerning the nature of the failure and the manner in which the equipment was used when the failure occurred. The model number and serial number should also be provided. Before returning any products to the factory, call Cameron Health/ Boston Scientific customer service or your local representative for a Return Authorization number.
Q-TECH™ PROGRAMMER: TROUBLESHOOTING TROUBLESHOOTING This section presents potential programmer issues and the possible solutions. Of note, restarting the programmer can often resolve many of the issues listed below. The programmer can be restarted by pressing and holding the power button until the system shutdown menu appears and then choosing the “Restart” option. Contact your Cameron Health/Boston Scientific representative or the customer service department for additional assistance.
Q-TECH™ PROGRAMMER: TROUBLESHOOTING If this occurs: 1. Select the Try Again button to reconnect to the printer. 2. Verify that the selected printer has, as applicable, the wireless function enabled or a Cameron Health-approved wireless adapter inserted in the left side of the printer. 3. Move the programmer closer to the printer. 4. Move any devices and the associated cables that may be interfering with the RF communication.
Q-TECH™ PROGRAMMER: Compliance statements COMPLIANCE STATEMENTS Federal Communications Commission (FCC) US This transmitter is authorized by rule under the Medical Device Radiocommunication Service (in part 95 of the FCC Rules) and must not cause harmful interference to stations operating in the 400.150 406.00 MHz band in the Meteorological Aids (i.e.
Q-TECH™ PROGRAMMER: Compliance statements EMI/RFI This equipment has been tested and found to comply with the applicable limits for medical devices, IEC 60601-1-2:2007 or Active Implantable Medical Device Directive 90/385/EEC. Although this testing shows the device to provide reasonable protection against harmful interference in a typical medical installation, there is no guarantee that interference will not occur in a particular installation.
Q-TECH™ PROGRAMMER: Declarations tables Table 3: Declaration Electromagnetic Emission The Q-TECH Model 3200 programmer is intended for use in the electromagnetic environment specified below. The customer or the user of the Q-TECH Model 3200 should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment Guidance RF Emissions CISPR 11 Group 1 The Q-TECH Model 3200 programmer uses RF energy only for its internal function.
Q-TECH™ PROGRAMMER: Declarations tables Table 5: Declaration Electromagnetic Immunity Part 2 The Q-TECH Model 3200 programmer is intended for use in the electromagnetic environment specified below. The customer or the user of the Q-TECH Model 3200 should assure that it is used in such an environment. Immunity Test Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3 IEC 60601 Test Level 3 Vrms 150 kHz to 80 MHz Compliance Level 3V 3 V/m 80 MHz to 2.
Q-TECH™ PROGRAMMER: Declarations tables Table 6: Recommended Separation Distances Recommended separation distances between portable and mobile RF communications equipment and the Q-TECH Model 3200 programmer The Q-TECH Model 3200 programmer is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
Q-TECH™ PROGRAMMER: Specifications Table 9: Product Guidelines Component Requirement DC Power Battery pack type 4000 mAh 3.7 volt lithium-ion battery pack Charge time Approximately 5 hours Power Supply Input 100 – 240 VAC, 50 - 60 Hz, 0.5A Output 5.5 VDC, 3.
Q-TECH™ PROGRAMMER: Specifications Table 11: Nominal Specifications Characteristic Nominal Electrical Safety Testing – IEC 60601-1:2005 / ANSI/AAMI ES60601-1:2005 allowed values Earth resistance Earth leakage current 100 mΩ 5 mA Normal Condition (NC) 10 mA Single Fault Condition (SFC) Patient leakage current 100 μA Normal Condition (NC) 500 μA Single Fault Condition (SFC) (mains on applied parts) Electrical Safety Testing – IEC 62353:2008 allowed values Earthbond testing (Groundbond testing) 300 mΩ i
Q-TECH™ PROGRAMMER: Definition of package label symbols Table 12: Packaging Symbols: Q-TECH Programmer Symbol Specification Symbol Specification Type BF Applied Part Symbol – Indicates connection of Type BF applied part Manufacturer – Name and address of the manufacturer Reference Number - Catalog number Storage Temperature - Product stored with temperature limitations Part Number - Component number Radio – Non-ionizing electromagnetic radiation Do Not Dispose – Do not dispose of in trash Follow
Q-TECH™ PROGRAMMER: Warranty Limited Warranty A limited warranty may apply to this programmer. For warranty eligibility and to obtain a copy of the limited warranty, contact Boston Scientific / Cameron Health using the information on the back cover.
Cameron Health, Inc 4100 Hamline Avenue North St. Paul, MN 55112-5798 USA 1.800.CARDIAC (227.3422) +1.651.582.4000 www.cameronhealth.
