Boston Scientific CRM70514 Bluetooth Module User Manual

Boston Scientific Corporation Bluetooth Module Users Manual

Users Manual

Q-TECH™ PROGRAMMERA COMPONENT OF THE S-ICD® SYSTEMUSER’S MANUAL Model 3200Physician must be trained or experienced in device implant and follow-up procedures.
© Copyright 2014 Boston Scientic or its aliates.All rights reserved.Limited Software License and Equipment Use.S-ICD®, SQ-RX®, and Q-TRAK® are all registered trademarks of Cameron Health, Inc. Q-GUIDE™ and Q-TECH™ are all trademarks of Cameron Health, Inc. The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks is under license.microSD is a trademark or registered trademark of SD-3C, LLC.Manuals or other written documentation may not be copied or distributed without Cameron Health, Inc. authorization.Cameron Health, Inc.4100 Hamline Avenue NorthSt. Paul, MN 55112-5798 USA1.800.CARDIAC (227.3422)+1.651.582.4000www.cameronhealth.comThis literature is intended for use by professionals trained or experienced in device implant and/or follow-up procedures.
TABLE OF CONTENTSGENERAL DESCRIPTIONDescription ................................................................................................................................1Indications for Use ....................................................................................................................1Intended Use .............................................................................................................................1Contraindications .....................................................................................................................1Programmer Warnings and Cautions ......................................................................................1General .................................................................................................................................................................... 1Electrostatic Discharge (ESD) ..........................................................................................................................3S-ICD System Warnings and Cautions .....................................................................................3General .................................................................................................................................................................... 3Use of Other Medical Therapies/Diagnostic Procedures ......................................................................4Electromagnetic Interference (EMI) Outside the Hospital Environment ........................................5S-ICD System Clinical Investigation ..............................................................................................................5Potential Adverse Events ..................................................................................................................................6OPERATIONSetup of the Q-TECH Programmer ...........................................................................................7Packaging ...............................................................................................................................................................7Programmer Controls and Connections .....................................................................................................7Charging the Programmer ...............................................................................................................................8Using the Q-TECH Programmer................................................................................................9Turning the Programmer On ........................................................................................................................... 9Changing the Programmer Volume Level ............................................................................................... 10Placing the Programmer in Suspend Mode ............................................................................................ 10Turning the Programmer O........................................................................................................................ 11Using the Programmer Touch Screen ....................................................................................................... 11Using the Wand ................................................................................................................................................. 12Navigation .......................................................................................................................................................... 13Screen Header ................................................................................................................................................... 13Navigation Bar ................................................................................................................................................... 14Restarting the Programmer .......................................................................................................................... 14
Conguring the Q-TECH Programmer .................................................................................. 16Conguring Programmer Settings ............................................................................................................. 16Date and Time Format .................................................................................................................................... 18Time Zone ........................................................................................................................................................... 18Language Preference ...................................................................................................................................... 19Printer Selection ............................................................................................................................................... 19Programmer Software Version .................................................................................................................... 22Modes of Operation for the Q-TECH Programmer ............................................................... 22Online Behavior ................................................................................................................................................ 22Oine Behavior ................................................................................................................................................ 23Modes of Operation for the SQ-RX Device ........................................................................... 24Shelf Mode .......................................................................................................................................................... 24Therapy On Mode ............................................................................................................................................ 24Therapy O Mode ............................................................................................................................................ 24Connecting and Disconnecting from the SQ-RX Device ..................................................... 25Scanning For SQ-RX Devices ........................................................................................................................ 25Connecting to the SQ-RX Device ................................................................................................................ 27Connecting to an SQ-RX Device in Shelf Mode: .................................................................................... 27Ending a Patient Session ............................................................................................................................... 28Programming the SQ-RX Device at Implant ........................................................................ 30Entering Electrode Information .................................................................................................................. 30Creating the Patient Chart ............................................................................................................................ 32Automatic Setup ............................................................................................................................................... 34Programming Therapy Parameters ............................................................................................................ 37Debrillation Testing ....................................................................................................................................... 40Performing an SQ-RX Follow-up ........................................................................................... 43Sensing Conguration and Automatic Setup ........................................................................................ 43Viewing SQ-RX Device Status ...................................................................................................................... 43Viewing Stored Episodes ............................................................................................................................... 44Printing Reports from the Programmer ............................................................................... 46Printing Reports ................................................................................................................................................ 46Summary Report .............................................................................................................................................. 47Captured S-ECG Report .................................................................................................................................. 48OPERATION (continued)
Episodes Report ................................................................................................................................................ 49S-ECG Features ....................................................................................................................... 50S-ECG Rhythm Strip Markers ........................................................................................................................ 50S-ECG Scale Settings ....................................................................................................................................... 52Capture and View S-ECG Strips .................................................................................................................... 53Utilities Menu ......................................................................................................................... 54Acquire Reference S-ECG ............................................................................................................................... 55Capture All Sense Vectors.............................................................................................................................. 56Beeper Control .................................................................................................................................................. 57Manual Setup..................................................................................................................................................... 58Smart Charge ..................................................................................................................................................... 61Additional Programmer Functions ....................................................................................... 63Rescue Shock ..................................................................................................................................................... 63Manual shock ..................................................................................................................................................... 65S-ICD System Magnet Model 4520 ............................................................................................................ 65MAINTENANCE Charging the Programmer ............................................................................................................................66Cleaning the Programmer............................................................................................................................. 66Service .................................................................................................................................................................. 66Maintenance Check ......................................................................................................................................... 67Safety Measurements ..................................................................................................................................... 67Programmer End of Life ................................................................................................................................ 67TROUBLESHOOTINGInability to Print ................................................................................................................................................ 68No Printer Available ......................................................................................................................................... 68Touch Screen Inactive while Connected to AC Power ........................................................................ 68Loss of Communication with Printer .........................................................................................................68Inability to Communicate With the SQ-RX Device ............................................................................... 69COMPLIANCE STATEMENTSFederal Communications Commission (FCC) US .................................................................................. 70Essential Performance .................................................................................................................................... 70EMI/RFI ................................................................................................................................................................. 71
DECLARATIONS TABLESDeclaration Electromagnetic Emission .................................................................................................... 72Declaration Electromagnetic Immunity Part 1 ...................................................................................... 72Declaration Electromagnetic Immunity Part 2 ...................................................................................... 73Recommended Separation Distances ...................................................................................................... 74EMI/RFI Information: Programmer–to–pulse generator .................................................................... 74EMI/RFI Information: Programmer–to–printer (Bluetooth®) ............................................................... 74SPECIFICATIONSProduct Guidelines .......................................................................................................................................... 75Specications ..................................................................................................................................................... 75Nominal Specications .................................................................................................................................. 76DEFINITION OF PACKAGE LABEL SYMBOLSPackaging Symbols: Q-TECH Programmer .............................................................................................. 77Packaging Symbols: Q-TECH Programmer Wand ................................................................................. 77WARRANTYLimited Warranty .............................................................................................................................................. 78
1QTECH™ PROGRAMMER: GENERAL DESCRIPTIONDescriptionThe Q-TECH Programmer (the “programmer”), Model 3200, is a component of the Cameron Health/Boston Scientic 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 “SQ-RX device”), Q-TRAK Subcutaneous Electrode (“electrode”) and the Q-GUIDE Subcutaneous Electrode Insertion Tool (“EIT”). The programmer is a non–sterile, non–implantable, tablet computer controlled by a graphic user interface (GUI) displayed on a touchscreen. The programmer is powered by either AC line power or an internal lithium ion battery pack. The programmer uses a connected RF telemetry wand to communicate wirelessly with the SQ-RX device to enable adjustment of programmable settings as well as collection of data. The S-ICD System is designed for ease of use and simplicity of patient management. The S-ICD System has a number of automatic functions designed to reduce the amount of time required for implantation, initial programming and patient follow-up.Indications for UseThe S-ICD System is intended to provide debrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing. Intended UseThe programmer is intended to communicate with the SQ-RX device. The programmer software controls all SQ-RX device communication functions. ContraindicationsUnipolar pacemakers are contraindicated for use with the S-ICD System.Programmer Warnings and CautionsGeneral• External debrillation equipment should be available for immediate use during the implantation procedure and follow-up.• Use the programmer only with the external power supply packaged with the programmer. Using other accessories may cause damage to the programmer.
2QTECH™ PROGRAMMER: GENERAL DESCRIPTION• 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. Do not position the programmer or the external power supply in a manner that would make it dicult to disconnect that cord.• Never use a damaged external power supply or a damaged programmer.• The programmer is not waterproof or explosion-proof and it cannot be sterilized. Do not use it in the presence of ammable gas mixtures, including anesthetic mixtures containing air, oxygen, or nitrous oxide.• Conrm that the programmer is in communication with the intended implanted SQ-RX Pulse Generator.• The programmer is intended for use by healthcare professionals only. The programmer may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as reorienting or relocating the programmer or shielding the location.• By design, the programmer emits radio frequencies in the 402-405 MHz and 2.4 GHz bands. This may interfere with nearby equipment. Closely monitor medical electrical equipment in the vicinity when using the programmer.• The presence of other equipment in the same frequency bands (402-405 MHz for the SQ-RX Pulse Generator and 2.4 GHz for the printer) may interfere with communication. If communication problems occur, refer to the Troubleshooting section of this manual.• If the programmer is used near other medical or oce equipment, all equipment should be observed to verify normal operation. Other equipment may interfere with the programmer, even if that other equipment complies with the International Special Committee on Radio Interference (CISPR) emission requirements.• Use of non-Cameron Health/Boston Scientic-approved accessories may result in increased emissions or decreased functionality of the programmer and may cause unintended operational behavior of the programmer.• No modication of the programmer is allowed.• Use only the Cameron Health/Boston Scientic S-ICD programmer and appropriate software to communicate with and program the SQ-RX Pulse Generator.• Do not discard the programmer in a re, incinerate, or subject it to temperatures that exceed 100° C (212° F). This could cause the programmer to explode.
3Q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 Scientic. Do not attempt to dry the programmer in an oven, microwave, or dryer because this poses a risk of overheating or explosion.• Do not subject the programmer to temperatures outside of the -10° C to 55° C (14° F to 131° F) storage range. Exposure to high temperatures may cause the programmer to overheat or ignite, and may possibly reduce its performance and service life.• Mishandling (such as dropping or crushing) could damage the programmer. If you suspect damage to the programmer, contact your Cameron Health/Boston Scientic representative or the customer service department for instructions and return packaging.• The display on the programmer is made of glass or acrylic and could break if the programmer is dropped or if it receives signicant impact. Do not use if screen is broken or cracked as this could cause injury .• Do not use the programmer adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, check the programmer for normal operation in that conguration.• Contact your Cameron Health/Boston Scientic representative or the customer service department for assistance or a replacement part.Electrostatic Discharge (ESD)The programmer may be aected by ESD. If ESD occurs and the programmer’s functionality is aected, attempt to reset the programmer or contact your Cameron Health/Boston Scientic representative or the customer service department for instructions.• Do not touch or connect the telemetry wand to the programmer unless ESD precautionary procedures are used.S-ICD System Warnings and CautionsBefore using the S-ICD System, read and follow all warnings and cautions provided in this manual. Refer to the SQ-RX Pulse Generator, Q-TRAK Electrode or Q-GUIDE Electrode Insertion Tool User’s Manuals for information on implanting and explanting the S-ICD System.The S-ICD System contains sterile products for single use only. Do not resterilize. Handle the components of the S-ICD System with care at all times and maintain proper sterile technique.General• External debrillation equipment should be available for immediate use during the implantation procedure and follow-up.
4Q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. Debrillation 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.• The S-ICD System does not provide long-term bradycardia pacing, Cardiac Resynchronization Therapy (CRT) or Anti-Tachycardia Pacing (ATP).Use of Other Medical Therapies/Diagnostic Procedures• External debrillation or cardioversion may damage the S-ICD System. Avoid placing the debrillation paddles directly over the SQ-RX device or electrode.• Cardio Pulmonary Resuscitation (CPR) may temporarily interfere with sensing and may cause delay of therapy.• Do not expose a patient with an implanted S-ICD System to diathermy. The interaction of diathermy therapy with an implanted SQ-RX Pulse Generator can damage the SQ-RX Pulse Generator and cause patient injury.• Do not expose the patient to MRI scanning. MRI scanning can damage the SQ-RX Pulse Generator and cause patient injury.• Electrical interference or “noise” from sources such as electrosurgical and monitoring equipment can interfere with the communication between the programmer and SQ-RX Pulse Generator or cause inappropriate therapy. If interference occurs, move and reposition the programmer or wand away from the source of the interference.• Ionizing radiation therapy, such as radioactive cobalt, linear accelerators, and betatrons may adversely aect the S-ICD System operation. Therapeutic ionizing radiation cannot be immediately detected; however, it can damage the electronic components of the SQ-RX Pulse Generator. To minimize the risks of ionizing radiation: » Shield the SQ-RX Pulse Generator with a radiation-resistant material, regardless of the distance between the SQ-RX Pulse Generator and the radiation beam. » Do not project the radiation port directly at the SQ-RX Pulse Generator. » Evaluate the S-ICD System operation after each radiation treatment.• Lithotripsy and other therapeutic forms of ultrasound can damage the SQ-RX Pulse Generator. If required, avoid direct ow of the pulse waves near the site of the implanted SQ-RX Pulse Generator.
5QTECH™ PROGRAMMER: GENERAL DESCRIPTION• Use caution during ablation procedures. Program the S-ICD System to Therapy O. 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 ammable anesthetic mixture with air or with oxygen or nitrous oxide.Electromagnetic Interference (EMI) Outside the Hospital EnvironmentExposure to EMI or static magnetic elds may suspend tachycardia detection and possibly cause temporary inhibition of therapy delivery. EMI may also trigger delivery of a shock in the absence of a tachycardia. Automatic sensing and detection of tachycardias will resume when the patient moves away from the EMI or static magnetic eld source.To minimize the risk, advise patients to avoid sources of EMI or static magnetic elds having strengths of >10 gauss or 1 mTesla.• Sources of EMI include, but are not limited to: » High-voltage power lines » Arc welding equipment » Electrical smelting furnaces » Large radio-frequency transmitters (such as radar) » Alternators on running engines in automobiles » Communications equipment (such as high-power radio transmitters)• Sources of strong static magnetic elds may include the following: » Industrial transformers and motors » Large stereo speakers » Magnetic wands, such as those used for airport securityPatients should seek medical guidance from their physician before entering an area where a posted sign prohibits patients with an implantable cardioverter debrillator or pacemaker.S-ICD System Clinical InvestigationA summary of the S-ICD System Clinical Investigation, including observed adverse events is provided in the SQ-RX® Pulse Generator User’s Manual.
6QTECH™ PROGRAMMER: GENERAL DESCRIPTIONPotential Adverse EventsPotential 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/or breakage• Electrode insulation failure• Erosion/extrusion• Failure to deliver therapy• Fever• Hematoma• Hemothorax• Improper electrode connection to the pulse generator• Inability to communicate with the pulse generator• Inability to debrillate or pace• Inappropriate post-shock pacing• Inappropriate shock delivery• Infection• Keloid formation• Migration or dislodgement• Muscle stimulation• Nerve damage• Pneumothorax• Post-shock/post-pace discomfort• Premature battery depletion• Random component failures• Stroke• Subcutaneous emphysema• Surgical revision or replacement of the system• Syncope• Tissue redness, irritation, numbness or necrosisIf any adverse events occur, invasive corrective action and/or S-ICD System modication or removal may be required.Patients who receive an S-ICD System may also develop psychological disorders that include, but are not limited to, the following:• Depression• Fear of shocks• Phantom shocks
7QTECH™ PROGRAMMER: OPERATIONSetup of the Q-TECH ProgrammerPackagingProgrammer components include:• Model 3200 Programmer with pre-loaded software• Model 3203 Telemetry Wand• External power supply and AC power cordVisually 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 Scientic. Contact your local representative or the Cameron Health/Boston Scientic customer service department for instructions and return packaging.Programmer Controls and ConnectionsFigure 1: microSD™ slot (for technical support use)Power buttonVolume controlTelemetry wand connector portExternal power supply portControls and external connections
8QTECH™ PROGRAMMER: OPERATIONCharging the ProgrammerThe 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.Note: Current session data may be lost if a 45 minute period of inactivity occurs during an active telemetry session and the programmer is not connected to AC power.Typical charge time for a fully discharged battery is 5 hours. However, more time may be required if the programmer is in use while being recharged. The Battery Status indicator located on the upper right corner of the screen displays the status of the main battery power when the unit is in use:• All four bars are illuminated (green) - The battery is 100% charged• Three bars are illuminated (green) - The battery is 75% charged• Two bars are illuminated (yellow) - The battery is 50% charged• One bar is illuminated (red) - The battery is 25% chargedThe programmer displays one of the following alert screens as battery power gets progressively lower.• Programmer Battery Low• Programmer Battery Critical• Out Of PowerTo charge the programmer:1. Connect the external power supply cable to the programmer (Figure 2). 2. Plug the external power supply cord into an AC power outlet.
9QTECH™ PROGRAMMER: OPERATIONFigure 2: Connecting the external power supplyUsing the Q-TECH ProgrammerTurning the Programmer OnThe 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).External power supply port
10QTECH™ PROGRAMMER: OPERATIONFigure 3: Turning the programmer On/O and changing the volume levelNote: If the programmer cannot be turned on while it is connected to AC power via the external power supply, rst 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.Changing the Programmer Volume LevelThe volume level of programmer-generated sounds may be temporarily adjusted using the volume control (Figure 3). This level is automatically reset when the programmer is restarted.Placing the Programmer in Suspend ModeThe programmer has a Suspend Mode which is activated automatically to conserve power. The display will be blank when this mode is in eect.The programmer enters Suspend Mode whenever:• The power button (Figure 3) is momentarily pressed and released• The programmer is not connected to the external power supply, it is not in active communication with an SQ-RX pulse generator, and no user activity has occurred for 15 minutesMomentarily pressing the power button will resume normal operation.Power On/O Volume Control
11QTECH™ PROGRAMMER: OPERATIONTurning the Programmer OThere are two ways to turn the programmer o:1. Press and hold the power button (Figure 2) until the System shutdown menu appears. Select Power o from the popup and conrm by pressing OK.2. From the on-screen Main Menu, press the Power O button and select OK at the conrmation prompt.Using the Programmer Touch ScreenThe programmer is equipped with an LCD touch screen. The screen can be adjusted to the desired viewing angle by using the kick-stand located on the back of the programmer. All interaction with the programmer is conducted using the ngers to touch the appropriate areas on the screen. Scroll on-screen lists by sliding a nger up and down the list (Figure 4). An on-screen keyboard is presented whenever text entry is required. Figure 4: Scrolling on-screen lists
12QTECH™ PROGRAMMER: OPERATIONUsing the WandModel 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 eld.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). To disconnect the wand, grasp the wand cable connector and gently pull it straight o the communication connector port.Note: Do not pull or yank on the cable to disconnect the wand from the programmer. Such action could cause hidden damage to the cable. A damaged cable might reduce wireless communication capabilities and require a replacement wand. Figure 5: Connecting the wandTo obtain optimal telemetry, the wand should be placed directly over the implanted SQ-RX device. Although the programmer may receive S-ECG telemetry at greater distances, programming should be performed with the wand placed over the SQ-RX device.
13QTECH™ PROGRAMMER: OPERATIONWhen 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.NavigationThe programmer’s graphic user interface (GUI) facilitates management and control of the S-ICD System. The Navigation Bar and on-screen icons at the top of the screen allow the user to navigate programming software screens. In addition, a continuous subcutaneous electrocardiogram (S-ECG) is displayed along the bottom of the screen during Online (active) communication with the SQ-RX device.Screen HeaderWhen the programmer is Oine (inactive communication), the screen header displays the Battery Status Indicator.When viewing Oine Stored Sessions, the screen header displays:• Patient name• Therapy On/O• Battery status indicatorWhen the programmer is online (active communication), the screen header displays:• Therapy On/O• Patient name• Patient heart rate• Programmer Battery and Telemetry status indicator• Screen title• Rescue shock icon
14QTECH™ PROGRAMMER: OPERATIONNavigation BarThe 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.Restarting the ProgrammerThe programmer’s operating system is self-monitoring and is generally able to sense many system error conditions and automatically initiate a restart sequence in response. Follow the on-screen instructions to complete the programmer-initiated restart sequence.The programmer may need to be manually restarted if:• You cannot exit a screen• The operating system stops respondingA manual restart is accomplished by pressing and holding the power button until the system shutdown menu appears on the screen. Select Restart from the popup and conrm by pressing OK. If the programmer does not respond to a restart process, contact your Cameron Health/Boston Scientic representative or the customer service department for assistance.
15QTECH™ PROGRAMMER: OPERATIONTable 1: Icon descriptionsIcon 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. User can view number of shocks delivered since the last update as well as the SQ-RX device battery life. Patient View Icon Allows user to access the patient chart screen. Captured and Stored Episodes S-ECG Icon Allows user to access captured S-ECG and stored episode screens. Induction Test Icon Allows user to access induction screen. Manual Shock Icon Allows user to access the manual shock screen. Battery & Telemetry Meter Left side of the meter allows user to view the programmer’s battery status. The right side of the meter allows viewing of telemetry signal. Capture S-ECG Allows user to capture a live S-ECG. S-ECG Display Settings Allows user to modify the zoom and sweep speed on the live S-ECG. Heart Rate Icon Allows user to view current heart rate. Rescue Shock Icon Allows user to administer a rescue shockOption Selection Slider Switch Allows user to select one of two options, e.g. A or B
16QTECH™ PROGRAMMER: OPERATIONConguring the Q-TECH ProgrammerConguring Programmer SettingsThe programmer should be congured 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 congured during the initial setup process they become the default parameters and will not normally need to be changed with each session.To congure the programmer settings:1. Select the Programmer Settings button on the Startup screen (Figure 6) to display the Programmer Settings screen (Figure 7).Figure 6: Startup screen
17QTECH™ PROGRAMMER: OPERATIONFigure 7: Programmer Settings screen2. Select the corresponding line to access each setting. The settings that can be congured include:• Date and time format• Time zone• Language• Printer
18QTECH™ PROGRAMMER: OPERATIONDate and Time FormatTo 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.Figure 8: Date and Time Settings screenTime ZoneTo set the time zone in which the programmer will be used:1. Select Set Time Zone on the Programmer Settings screen. The time zone selec-tion screen appears (Figure 9).2. Select the country/time zone button for the zone in which the programmer will be used. A checkmark will appear in the selected button. The SQ-RX device line frequency of 50 Hz or 60 Hz is automatically programmed based on the country/time zone selected.
19QTECH™ PROGRAMMER: OPERATIONFigure 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 PreferenceTo set the language preference:1. Select Set Language on the Programmer Settings screen. The Language Settings screen appears.2. Select the Save button to save the changes or select Cancel to return to the Programmer Settings screen without saving the changes. If the language is changed the programmer will automatically restart and return to the Startup screen.Printer SelectionThe programmer communicates with the printer wirelessly via Bluetooth® technology. Only Cameron Health/Boston Scientic-approved printers can be used with the programmer. To select the printer to be used with the programmer:1. Ensure the printer is on and, as applicable, the wireless function is enabled or the wireless adapter is in the printer’s USB port.
20QTECH™ PROGRAMMER: OPERATION2. Select Printer Setup on the Programmer Settings screen. A previously congured printer becomes the default printer and will be displayed at this time. If a default printer has not already been selected and congured, 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). If no printers are found, a window will appear stating that there are no printers. Select the Scan Again button or the Cancel button to return to the Programmer Settings screen. If a printer was selected during another session, the Printer Setup screen is displayed.Figure 10: Printer Selection screen4. Once the scan is complete, the Printer Selection screen appears (Figure 10).Note: Refer to “Troubleshooting” section for printer problems.5. Select the desired printer name and enter the name using the on-screen keyboard (up to 15 characters). A unique printer identier should appear with the printer selection (Figure 11).
21QTECH™ PROGRAMMER: OPERATIONFigure 11: Use the on-screen keyboard to enter a name for the selected printer6. 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 conrmation screen will appear when the printer setup is completed (Figure 12).Figure 12: Printer Setup conrmation screen
22QTECH™ PROGRAMMER: OPERATIONProgrammer Software VersionTo 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 screen2. This screen displays the current version of the programmer software. Select the Continue button to return to the Programmer Settings screen.Note: The patient printed report contains the programmer software version.Modes of Operation for the Q-TECH ProgrammerOnline BehaviorThe programmer’s interface varies according to whether the programmer is Online (actively communicating) or Oine (not communicating) with a selected SQ-RX device.An Online session begins when the programmer establishes a telemetry link with a specic SQ-RX device. A yellow alert screen is displayed if the telemetry signal is lost between the programmer and the SQ-RX device for more than ve seconds during active communication. This may occur if the
23QTECH™ PROGRAMMER: OPERATIONwand 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.Note: Whenever the programmer is in active communication with an SQ-RX device, charging of the pulse generator in preparation for delivering a shock (whether commanded or in response to a detected arrhythmia) is indicated by an audible notication. The notication continues until the shock is delivered or aborted.Oine BehaviorWhen the programmer is not actively communicating with an SQ-RX device it is Oine. During Oine sessions, programmer settings can be accessed, and stored patient sessions can be viewed and/or printed.Stored Patient SessionsDuring a patient follow-up visit, the programmer will retrieve data from the SQ-RX device’s memory. The programmer can store up to 50 patient sessions. When the 51st session occurs, the programmer will automatically replace the oldest stored session with the new data. A stored session includes the following information:• Captured S-ECG Reports• Episode History (including any downloaded episodes)• Patient Data• Programmed Device SettingsTo view stored patient sessions:1. From the Startup screen, select Stored Patient Sessions.2. Select the desired patient session.
24QTECH™ PROGRAMMER: OPERATIONModes of Operation for the SQ-RX DeviceThe SQ-RX device has three modes of operation:• Shelf• Therapy On• Therapy OShelf ModeThe 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. Once the SQ-RX device is taken out of Shelf mode, it cannot be reprogrammed back into Shelf mode.Therapy On ModeThe Therapy On mode is the primary operating mode of the SQ-RX device, allowing automatic detection of, and response to, ventricular tachyarrhythmias.Note: The SQ-RX device must be programmed out of Shelf mode before being programmed to Therapy On.Therapy O ModeThe Therapy O mode disables automatic therapy delivery and enables manual control of shock delivery. Programmable parameters may be viewed and adjusted via the programmer. Also, the subcutaneous electrogram (S-ECG) may be displayed or printed.The SQ-RX device automatically defaults to Therapy O mode when the SQ-RX device is taken out of Shelf mode.Note: Manual and rescue shock therapy are available once the initial Setup process is complete.
25QTECH™ PROGRAMMER: OPERATIONConnecting and Disconnecting from the SQ-RX DeviceThis section provides the information necessary for selecting, connecting to, and disconnecting from the SQ-RX device.Scanning For SQ-RX Devices1. 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.Figure 14: Startup screen
26QTECH™ PROGRAMMER: OPERATION2. 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. If the desired SQ-RX device is not listed, select the Scan Again button to re-initiate the scanning process. Select the Cancel button to return to the Startup screen.Note: Refer to the Inability to Communicate with the SQ-RX Device section for further assistance.
27QTECH™ PROGRAMMER: OPERATIONConnecting to the SQ-RX DeviceFrom 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.2. Once communication is established with the SQ-RX device, the Device Identication screen appears (Figure 16).Figure 16: Device Identication screenNote: The Device Identication screen is visible only while connecting to an SQ-RX device in Shelf mode.3. The SQ-RX device model and serial numbers are automatically acquired and displayed during the initial scanning process. Select Continue to remove the SQ-RX device from Shelf mode and prepare for implantation, or select Cancel to return to the Device List screen.
28QTECH™ PROGRAMMER: OPERATIONEnding a Patient SessionTo end an Online patient session and return the programmer to its Oine 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 screen3. A warning message will be displayed to the user if any of the following conditions exists:• Automatic Therapy is programmed to O• Reference S-ECG has not been acquired• Automatic Setup or Optimization has not been completed. This message is typically displayed following the implant procedure as Setup Optimization was not performed (Figure 18).4. Select the Continue button to end the patient session and return to the Startup Menu screen, or select Cancel to remain online and return to the Main Menu screen.
29QTECH™ PROGRAMMER: OPERATIONFigure 18: Session incomplete messageNote: 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 o during a session, either automatically or manually, session data will not be saved.Note: In order to conrm that Automatic Therapy is programmed On upon disconnection, always use the End Session process and review all displayed warning messages.
30QTECH™ PROGRAMMER: OPERATIONProgramming the SQ-RX Device at ImplantThis section provides the information necessary for programming the SQ-RX device during an implant setting.Entering Electrode InformationThe 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. The Automatic Setup screen appears (Figure 19).4. Select Set Electrode ID button.Figure 19: Select the Set Electrode ID button to enter electrode informationNote: ECG and heart rate information is not present on the Automatic Setup and Electrode ID setup screens until the electrode has been connected to the SQ-RX device.5. Enter the electrode model and serial number (Figure 20).
31QTECH™ PROGRAMMER: OPERATIONFigure 20: Entering electrode information6. Select the Program button to save the information. A conrmation 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.Figure 21: Conrmation screen showing communication in progress
32QTECH™ PROGRAMMER: OPERATIONCreating the Patient ChartThis 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 chart3. Select the Patient View icon to access the Patient View screen.4. The SQ-RX device model and serial numbers appear on the rst line of the chart. The electrode model and serial numbers appear on the second line of the chart. The implant date appears on the third line of the chart (Figure 23). Using the on-screen keyboard, enter the following patient information:• Patient Name: up to 25 characters• Doctor Name: up to 25 characters• Doctor Info: up to 25 characters• Notes: up to 100 characters
33QTECH™ PROGRAMMER: OPERATIONFigure 23: Patient Chart screenNote: The Notes eld will automatically wrap the text with the presence of a space between any characters within the rst line.5. 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.
34QTECH™ PROGRAMMER: OPERATIONAutomatic SetupBefore 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. For rates greater than 130 bpm, select the Cancel button and refer to the instructions for Manual Setup.Figure 24: Automatic Setup screen5. Once started the Automatic Setup will:• Perform the shock electrode integrity check to measure electrode impedance (Figure 25). Normal sub-threshold impedance range is < 400 Ohms.• Select the best sensing conguration. The sense electrode conguration appears on the printed report and can be viewed via the Manual Setup process.• Select the appropriate gain selection. The selected sense gain appears on the Printed Report and can be viewed via the Manual Setup process.
35QTECH™ PROGRAMMER: OPERATIONFigure 25: Measuring electrode impedanceThe 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).Figure 26: Automatic Setup screen
36QTECH™ PROGRAMMER: OPERATION7. Select the Continue button to nish the Automatic Setup process. A conrmation screen will appear when Automatic Setup is complete (Figure 27).Figure 27: Conrmation of successful Automatic Setup8. 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.Figure 28: Acquire Reference S-ECG screen
37QTECH™ PROGRAMMER: OPERATION9. 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.Programming Therapy ParametersOnce Automatic Setup has been completed, the SQ-RX device therapy parameters may be selected.Note: The IDE Study demonstrated a signicant reduction in inappropriate therapy with the activation of the Conditional Shock Zone prior to hospital discharge (see SQ‐RXPulse Generator User’s Manual, Section: S‐ICD System Clinical Investigation).To set the therapy parameters:1. Select the Main Menu icon on the Navigation Bar.2. Select the Implant button.3. Select the Device Settings icon on the Navigation Bar to display the Device Settings screen (Figure 29). Figure 29: Device Settings screen
38QTECH™ PROGRAMMER: OPERATION4. Select the On/O Therapy switch to set the desired therapy mode (Figure 30).Figure 30: Setting the On/O Therapy switch5. Select and drag the Conditional Shock Zone (yellow) and Shock Zone (red) slider bars to set the desired zone conguration.• 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. Enhanced detection criteria are automatically enabled when the Condi-tional Shock Zone is programmed.• When programming both the Shock Zone and Conditional Shock Zone, maintain at least a 10 bpm dierence between the two zones. If the Conditional Shock Zone slider (yellow) is dragged over the Shock Zone slider (red), the two sliders will merge to create a single Shock Zone.6. If post-shock pacing is desired, slide the Post Shock Pacing switch to the On position. (Post-shock bradycardia pacing occurs at a non-programmable rate of 50 bpm for up to 30 seconds. Pacing is inhibited if the intrinsic rate is greater than 50 bpm.)7. Select the Program button to apply the changes and program the SQ-RX device. A screen will appear to conrm that the SQ-RX device settings were programmed (Figure 31). If the SQ-RX device does not accept the SQ-RX device programming, a Program Device alert screen will appear. Select the Try Again button to return to the Device Settings screen.
39QTECH™ PROGRAMMER: OPERATIONFigure 31: Conrmation of programming8. Once programming is conrmed, 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.
40QTECH™ PROGRAMMER: OPERATIONDebrillation TestingOnce the SQ-RX device is implanted and Automatic Therapy is programmed On, debrillation testing may be conducted.Note: Debrillation testing is recommended at implant to conrm 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. Select the Main Menu icon on the Navigation Bar to access the Main Menu.2. Select the Patient Test button to setup the induction test (Figure 32).Figure 32: Select the Patient Test Button to access the Induction Test screen.3. Select either standard (STD) or reverse (REV) polarity (Figure 33).4. Select and drag the red marker to set the desired shock energy for the rst delivered shock. The shock energy may be programmed from 10 to 80 J. A 15 J safety margin is recommended for debrillation testing.
41QTECH™ PROGRAMMER: OPERATIONFigure 33: Setting the desired rst shock energy for debrillation testing5. Select the Continue button to display the next Induction Test screen.Note: 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.6. Select and hold the Hold To Induce button for the desired duration (Figure 34).Figure 34: Induction Test screen
42QTECH™ PROGRAMMER: OPERATIONThe following functions occur during the test:• The S-ICD System induces ventricular brillation 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: If necessary, the induction can be terminated by disconnecting the wand from the programmer.• 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.• Upon detection and conrmation of an induced arrhythmia, the S-ICD System automatically delivers a shock at the programmed energy output and polarity.Note: Whenever the programmer is in active communication with an SQ-RX device, charging of the pulse generator in preparation for delivering a shock (whether commanded or in response to a detected arrhythmia) is indicated by an audible notication. The notication continues until the shock is delivered or aborted.• If the shock fails to convert the arrhythmia, re-detection occurs and subsequent shocks are delivered at the SQ-RX device’s maximum energy output (80 J).Note: Following the release of the Hold To Induce button, evaluate the sensing markers during the induced rhythm. The S-ICD System uses a lengthened rhythm detection period. Consistent tachy “T” markers indicate that tachyarrhythmia detection is occurring, and that capacitor charging is imminent. If a high degree of amplitude variation is noted during the arrhythmia, a slight delay may be expected prior to capacitor charging or shock delivery.Note: The SQ-RX device can deliver a maximum of ve shocks per episode. At any time, an 80 J rescue shock can be delivered by pressing the Rescue Shock icon.7. At any time prior to therapy delivery, the programmed energy may be aborted by selecting the red Abort button.8. Select the Exit button to exit the induction process and return to the Main Menu screen.
43QTECH™ PROGRAMMER: OPERATIONPerforming an SQ-RX Follow-upSensing Conguration and Automatic SetupIt 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. If other markers are noted, use the Manual Setup process to evaluate other sensing congurations.Note: If Manual Setup was previously used to override a sensing conguration, careful consideration should be taken when selecting Automatic Setup.If an update to the reference S-ECG is desired due to a change in the patient’s resting ECG, follow the Acquire Reference S-ECG instructions.Viewing SQ-RX Device StatusOnce communication is established, the programmer displays the Device Status screen with information regarding the current episodes and battery status of the SQ-RX device.To view this information:1. Select the Main Menu icon.2. Select the Follow Up button.3. Select the Device Status icon on the Navigation Bar.4. The Device Status screen will appear showing an overview of all SQ-RX device activity since the last communication session (Figure 35).
44QTECH™ PROGRAMMER: OPERATIONFigure 35: Device Status screenThe 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 sessionNote: Choosing the “View” button in the Treated Episodes row allows navigation directly to the list of stored episodes (Figure 36).• Total number of untreated episodes since the last follow-up session• Remaining SQ-RX device battery lifeViewing Stored EpisodesThe SQ-RX device stores up to 25 treated and 20 untreated tachycardia episodes, which can be viewed during a patient’s follow-up session. When the maximum number of episodes is exceeded, the most recent episode replaces the oldest stored episode; however, the rst treated episode will not be overwritten.Note: If a spontaneous episode occurs during a patient’s follow-up session while the SQ-RX device is wirelessly communicating with the programmer, the episode will not be stored.
45QTECH™ PROGRAMMER: OPERATIONTo 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.Note: In order to be available for printing, episodes must be individually selected and viewed from the Stored Episodes Screen (Figure 36).Figure 36: Stored Episodes screen (scrollable list)6. Each selected episode screen also displays the programmed parameters and the stored S-ECG data at the time of episode declaration.7. Select the Continue button on the selected episodes screen to return to the Episodes screen.
46QTECH™ PROGRAMMER: OPERATIONThe following details are available for each episode:Treated EpisodesUp 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-ECGUntreated EpisodesAn Untreated Episode is dened as any high-rate episode that spontaneously terminates during the charging process, before a shock is delivered.Up to 128 seconds of S-ECG data is stored for each Untreated Episode:• Pre-episode S-ECG: 44 seconds of pre-episode S-ECG• Episode S-ECG: Up to 84 seconds of tachycardia S-ECG dataPrinting Reports from the ProgrammerPrinting ReportsPatient reports can be printed before or after a patient session is ended. It is recommended that a nal report be printed immediately following the implant procedure. There are three patient reports:• Summary Report• Captured S-ECG Report• Episode ReportsTo print patient reports from either an Online or Oine session:1. Select the Main Menu icon to display the Main Menu screen.2. Select the Print Reports button to display the Print Reports screen (Figure 37).
47QTECH™ PROGRAMMER: OPERATIONFigure 37: Print Reports screen3. 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 ReportTo print a summary report, select the Summary Report option on the Print Reports screen and press the Print button. The report will print for either the current active session (if the programmer is online) or for the chosen stored session (if the programmer is oine.)The Summary Report includes the following information:• Patient Name• Date of Current Follow-Up• Date of Last Follow-Up• Printed Report Date• SQ-RX Device Model/Serial Number• Electrode Model/Serial Number• Implant Date
48QTECH™ PROGRAMMER: OPERATION• Therapy Parameters• Programmed Gain Settings and Sensing Conguration• Initial Shock Polarity Conguration• 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 VersionCaptured S-ECG ReportTo print a Captured S-ECG report:1. Select the Captured S-ECG Report option from the Print Reports screen (Figure 37). 2. A list of the captured S-ECG strips is displayed (Figure 38). Select the Captured S-ECG(s) to be printed. A checkmark appears next to the selected Captured S-ECG.Figure 38: Captured S-ECG selection screen (scrollable)
49QTECH™ PROGRAMMER: OPERATION3. 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 ReportTo 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. A checkmark appears next to the selected episode(s). Note: In order to be available for printing, episodes must have been individually selected and viewed from the Stored Episodes Screen (Figure 36).Figure 39: Stored Episode List screen (scrollable)
50QTECH™ PROGRAMMER: OPERATION3. 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 screen4. Select the Print button to print the selected report.5. Select the Cancel button to return to the previously accessed screen.S-ECG FeaturesThe programmer provides the capability to view, adjust and capture the streaming S-ECG from the SQ-RX device.S-ECG Rhythm Strip MarkersThe system provides annotations to identify specic events on the S-ECG. These markers are shown in the S-ECG Markers on Programmer Display Screens and Printed Reports table (Table 2) and an example is shown in the Sample ECG Markers illustration (Figure 41).
51QTECH™ PROGRAMMER: OPERATIONTable 2: S-ECG Markers on Programmer Display Screens and Printed ReportsDescription MarkerCharging aCSensed Beat SNoisy Beat NPaced Beat PTachy Detection TDiscard Beat •Return to NSRaShockEpisode data compressed or not available a Marker present on printed report but not on programmer display screen. Figure 41: Sample ECG markers
52QTECH™ PROGRAMMER: OPERATIONS-ECG Scale SettingsTo 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 win-dow. 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. The programmer defaults to Full Range for SQ-RX devices with a gain setting of x1 and to 1/2 Range for SQ-RX devices with a gain setting of x2. The Sweep Speed slider controls the display speed of the scrolling Live S-ECG. The nominal sweep speed setting is 25 mm/sec.Figure 42: Adjusting Gain and Sweep SpeedNote: Amplitude settings and display speed adjustments on scrolling real-time S-ECG and Captured S-ECGs aect the display screen settings only and have no impact on the SQ-RX device settings for sensing.
53QTECH™ PROGRAMMER: OPERATIONCapture and View S-ECG StripsThe programmer can display, capture and store real-time S-ECG rhythm strips. The programmer saves a maximum of fteen, 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 buttonIf 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. Select the Capture S-ECG button located to the left of the Live S-ECG window (Figure 43). The S-ECG will scroll across the display screen. Calipers appear below the Captured S-ECG rhythm strip (Figure 44). Each 12-second recording is date and time stamped according to the programmer’s date and time setting.Figure 43: Select the Capture S-ECG buttonFigure 44: Captured S-ECG rhythm strip
54QTECH™ PROGRAMMER: OPERATION2. 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. Select the Captured and Stored Episode S-ECG icon. The Captured S-ECG screen appears.4. Select one Captured S-ECG from the list. The Captured S-ECG Details screen appears.5. Select and drag the calipers to view details.6. Select the Continue button to return to the Captured S-ECG list screen.Utilities MenuThe programmer Utilities menu provides access to additional SQ-RX device features. These include Acquire Reference S-ECG, Capture All Sense Vectors, Beeper Control, Manual Setup and Smart Charge.To access the Utilities menu during an Online session:1. Select the Main Menu icon to display the Main Menu screen.2. Select the Utilities button. The Utilities screen appears (Figure 45).
55QTECH™ PROGRAMMER: OPERATIONFigure 45: Utilities screenAcquire Reference S-ECGTo 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). The reference S-ECG QRS template is recorded and stored in the SQ-RX device.3. Select the Continue button to complete the process and return to the Utilities screen. The Cancel button can be used at any time to end S-ECG acquisition and return to the Utilities screen.
56QTECH™ PROGRAMMER: OPERATIONFigure 46: The patient should remain still while the Reference S-ECG is acquiredCapture All Sense VectorsThe Capture All Sense Vectors button on the Utilities screen congures 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 conguration after all S-ECGs have been captured.To capture the three sense vectors:1. From the Utilities screen (accessible from the Main Menu screen), select the Capture All Sense Vectors button.2. The Capturing 12 Second S-ECG screen will appear and display the status of the sense vector capture process (Figure 47).
57QTECH™ PROGRAMMER: OPERATIONFigure 47: Capture all sense vectorsOnce 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 ControlThe SQ-RX device has an internal alert system that emits an audible beeping tone when an alert condition occurs. Alert conditions may include Elective Replacement Indicator (ERI), End of Life (EOL), electrode impedance out of range, prolonged charge times, failed Device Integrity Check and irregular battery depletion. Beeper Control allows activation or suppression of the beeper.Once an alert condition is triggered, audible tones beep for 16 seconds every nine hours until the alert condition is resolved. Beeper Control is automatically enabled when the SQ-RX device is taken out of Shelf mode.To reset the Beeper Control:Note: Access to the Beeper Control display screen is enabled only when an alert condition occurs. If an alert condition is activated, a notication screen will appear upon connection.1. From the Utilities screen (accessible from the Main Menu screen), select the Beeper Control button.
58QTECH™ PROGRAMMER: OPERATION2. 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 Beeper3. 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.Note: If beeper is disabled alert conditions will not trigger audible tones.Manual SetupManual Setup enables the user to perform the electrode integrity test and select the electrode sensing conguration and gain setting in the SQ-RX device.1. From the Utilities screen (accessible from the Main Menu screen), select the Manual Setup button. The Impedance Test screen appears (Figure 49).2. Select the Test button to perform the electrode integrity test.
59QTECH™ PROGRAMMER: OPERATIONFigure 49: Impedance test screen3. Select Continue to proceed or select Test to retry. The sensing conguration can be evaluated by temporarily activating any of the vectors or gain settings. The Live S-ECG and markers will reect the temporary selections for evaluation purposes.4. There are three available sensing vectors that can be manually selected:• Primary: Sensing from the proximal electrode ring on the subcutaneous electrode to the surface of the active SQ-RX device• Secondary: Sensing from the distal sensing electrode ring on the subcutaneous electrode to the surface of the active SQ-RX device• Alternate: Sensing from the distal sensing electrode ring to the proximal sensing electrode ring on the subcutaneous electrodeThe gain setting adjusts the sensed S-ECG signal sensitivity. It may be manually selected via the Select Gain slider switch (Figure 50).
60QTECH™ PROGRAMMER: OPERATIONFigure 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 amplies the signal twice as much as the 1x gain selection.To program the manually selected sense conguration:1. Select the Program button to save the sense vector and gain settings.2. The Acquire Reference S-ECG process is automatically enabled during the Manual Setup Process. Select the Continue button to acquire a reference S-ECG. A conrmation screen will appear when the captured reference S-ECG is acquired (Figure 51).3. Select the Continue button.
61QTECH™ PROGRAMMER: OPERATIONFigure 51: Captured Reference S-ECG conrmationSmart ChargeThrough 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. To reset the Smart Charge feature:1. From the Utilities screen (accessible from the Main Menu screen), select the Smart Charge button. The Reset Smart Charge screen appears (Figure 52).
62QTECH™ PROGRAMMER: OPERATIONFigure 52: Reset Smart Charge screen2. 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 conrmation window will appear with the message: “Smart Charge successfully reset.”4. Press the Continue button to return to the Utilities screen.
63QTECH™ PROGRAMMER: OPERATIONAdditional Programmer FunctionsRescue ShockThe 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. The Rescue Shock screen appears (Figure 53).Figure 53: Rescue Shock screen2. Select the Shock button to begin charging the SQ-RX device for a Rescue shock. A red background screen with the word “Charging” will appear (Figure 54). Selecting the Abort button will prevent delivery of a rescue shock and will return to the Device Settings screen.
64QTECH™ PROGRAMMER: OPERATIONFigure 54: Abort Rescue Shock3. A conrmation screen will appear with notication that the shock was delivered successfully along with the corresponding shock impedance (Figure 55).Figure 55: Conrmation of Rescue Shock delivery
65QTECH™ PROGRAMMER: OPERATIONIf 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 shockManual Shock allows the user to deliver a synchronized shock during a sinus rhythm, an atrial rhythm or a ventricular rhythm. The shock energy level is user-congured in the 10 to 80 joule range (Figure 56). Manual shock may also be utilized at a low energy to assess system impedance/integrity either at implant or as warranted by patient condition. A manual shock may be administered with the S-ICD detection zone(s) either ON or OFF.Figure 56: Manual shockS-ICD System Magnet Model 4520Model 4520 Magnet (the “magnet”) is a nonsterile accessory used to inhibit the delivery of therapy from the SQ-RX device. Apply the magnet at against the skin directly over the implanted SQ-RX device for a minimum of one (1) second to suspend arrhythmia detection. Removal of the magnet will return the SQ-RX device to normal operation. If the magnet is applied during an episode, the episode will not be stored in the SQ-RX device memory.
66Q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 secondsNote: 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. If the magnet is applied after the initial command, the Rescue Shock will be terminated.Note: Magnet application does not aect wireless communication between the SQ-RX device and the programmer.MAINTENANCE Charging the ProgrammerWhen not in use, it is recommended that the programmer remain connected to the external power supply. This will ensure that the internal battery is adequately charged.Cleaning the ProgrammerKeep the programmer away from dust and dirt. Do not use harsh chemicals, cleaning solvents, or strong detergents to clean the programmer and wand.To clean the programmer and wand as needed:1. Turn the Programmer O.2. Gently wipe the programmer screen with a soft, clean, dry cloth.3. Clean the programmer plastic case and the wand by wiping them with an isopropyl alcohol-moistened cloth.4. Dry the programmer immediately to remove residue.ServiceThere are no user-accessible or user-serviceable parts or components in the programmer. If any service, repair, or replacement of internal components is needed, the programmer must be returned to Cameron Health/Boston Scientic. Contact your Cameron Health/Boston Scientic Representative or the customer service department for instructions and return packaging.
67Q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 Scientic customer service or your local representative for a Return Authorization number. Maintenance CheckPrior to each use, you should perform a visual inspection and verify the following:• Mechanical and functional integrity of the programmer, cables, and accessories.• Legibility and adherence of the programmer labels.• Startup screen appears a few seconds after you turn on the programmer. (The normal power-up process veries that the programmer has passed its internal checks and is ready for use.)Safety MeasurementsNational regulations may require that the user, manufacturer, or manufacturer representative periodically perform and document safety tests of the programmer. If such testing is required in your country, follow the testing interval and extent of testing as regulated in your country. If you do not know the national regulations in your country, please contact your Cameron Health/Boston Scientic representative. If IEC/EN 62353 is a required standard in your country, but no specic testing or interval is specied, it is recommended that you perform these safety tests using the direct method as specied in IEC/EN 62353 at an interval of every 24 months. Test values are shown in the Nominal Specications table (Table 11). Programmer End of Life The programmer and accessories are designed to provide years of service under typical use. To dispose of, return, or exchange a programmer, contact your Cameron Health/Boston Scientic representative or the customer service department for instructions and return packaging. Do not dispose of the programmer in the trash or at electronics recycling facilities.
68QTECH™ PROGRAMMER: TROUBLESHOOTINGTROUBLESHOOTINGThis 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 Scientic representative or the customer service department for additional assistance.Inability to PrintIf unable to print, follow the steps below:1. Ensure that the printer is turned On and that it contains paper and a sucient ink supply.2. Check printer feed for paper jam.3. Ensure, as applicable, that the wireless function is enabled on the printer or that the Cameron Health/Boston Scientic approved wireless adapter is fully inserted into the left side of the printer.No Printer AvailableThe No Printer Available screen will appear if a printer was not set up. Select the Try Again button or refer to the Printer Selection section for instructions.Touch Screen Inactive while Connected to AC PowerIf the touch screen does not function while the programmer is connected AC power via the external power supply, disconnect and reconnect the external power supply and restart the programmer.Loss of Communication with PrinterWhen communication between the programmer and the printer fails, a Printing Error screen will appear with a message stating “Error while printing reports. Press “Continue” to try printing any remaining reports, or “Cancel” to cancel the current print job.”
69QTECH™ PROGRAMMER: TROUBLESHOOTINGIf 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.Inability to Communicate With the SQ-RX DeviceIf the programmer is unable to communicate with the SQ-RX device, follow the steps below:1. Attempt to reposition the wand.2. Select Scan For Devices from the Main Menu or select Scan Again from the Device List screen to locate the desired SQ-RX device.3. Move any equipment and associated cables that may be interfering with RF communication.4. If available, attempt to communicate using a dierent S-ICD System programmer and/or wand.5. Apply a pulse generator magnet to the SQ-RX device to elicit beeper tones. Remove the magnet and re-attempt communication.
70QTECH™ PROGRAMMER: COMPLIANCE STATEMENTSFederal Communications Commission (FCC) USThis 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., transmitters and receivers used to communicate weather data), the Meteorological Satellite, or the Earth Exploration Satellite Services and must accept interference that may be caused by such stations, including interference that may cause undesired operation. This transmitter shall be used only in accordance with the FCC Rules governing the Medical Device Radiocommunication Service. Analog and digital voice communications are prohibited. Although this transmitter has been approved by the Federal Communications Commission, there is no guarantee that it will not receive interference or that any particular transmission from this transmitter will be free from interference. The Bluetooth® module contained within the Model 3200 programmer complies with Title 47, Part 15 of the FCC rules. Operation is subject to the following two conditions:• This device may not cause harmful interference, and• This device must accept any interference received, including interference that may cause undesired operation.FCC ID SDYCHI2020Contains: FCC ID ESCCRM70514CAUTION: Changes or modications not expressly approved by Cameron Health / Boston Scientic could void the user’s authority to operate the equipment.Essential PerformanceIn order for the Model 3200 Programmer to meet its intended use, it must interrogate and maintain a communications link with a supported pulse generator as well as being able to appropriately detect touch screen button presses. Therefore those functions that pertain to communications with the implanted cardioverter debrillator and detection of touch screen presses are considered essential performance.COMPLIANCE STATEMENTS
71QTECH™ PROGRAMMER: COMPLIANCE STATEMENTSEMI/RFIThis 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. If the device does cause harmful interference the user is encouraged to try and correct the interference by the following measures:• Reorient or relocate the device• Increase the separation between the devices• Connect the equipment to an outlet on a dierent circuit• Contact your Cameron Health/Boston Scientic representative or customer service.
72QTECH™ PROGRAMMER: DECLARATIONS TABLESTable 4: Declaration Electromagnetic Immunity Part 1Table 3: Declaration Electromagnetic EmissionThe Q-TECH Model 3200 programmer is intended for use in the electromagnetic environment specied below. The customer or the user of the Q-TECHModel 3200 should assure that it is used in such an environment.Emissions Test Compliance Electromagnetic Environment GuidanceRF Emissions CISPR 11 Group 1 The Q-TECH Model 3200 programmer uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.RF Emissions CISPR 11 Class A The Q-TECH Model 3200 programmer is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.Harmonic Emissions IEC 61000-3-2 Class AVoltage Fluctuations/Flicker Emissions IEC 61000-3-3 Complies The Q-TECH Model 3200 programmer is intended for use in the electromagnetic environment specied below. The customer or the user of the Q-TECH Model 3200 should assure that it is used in such an environment.Immunity Test IEC 60601 Test LevelCompliance Level Electromagnetic Environment GuidanceElectrostatic Discharge(ESD)IEC 61000-4-2± 6 kV contact ± 8 kV air± 6 kV contact ± 8 kV airFloors should be wood, concrete, or ceramic tile. If oors are covered with synthetic material, then the relative humidity should be at least 30%.Electrical Fast Transient/BurstIEC 61000-4-4± 2 kV for power supply lines ± 1 kV for input/output lines ± 2 kV for power supply lines ± 1 kV for input/output linesMains power quality should be that of a typical commercial or hospital environment.SurgeIEC 61000-4-5 ± 1 kV line(s) to line(s) ± 2 kV line(s) to earth ± 1 kV line(s) to line(s) ± 2 kV line(s) to earthMains power quality should be that of a typical commercial or hospital environment.Voltage Dips, Short interruptions, and voltage variations on power supply input linesIEC 61000-4-11<5% UT (>95% dip in UT) for 0.5 cycles 40% UT (60% dip in UT) for 5 cycles 70% UT 30% dip in UT) or 25 cycles <5% UT (>95% dip in UT) for 5 sec<5% UT (>95% dip in UT) for 0.5 cycles 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles <5% UT (>95% dip in UT) for 5 secMains power quality should be that of a typical commercial or hospital environment. If the user of the Q-TECH Model 3200 programmer requires continued operation during power mains interruptions, it is recommended that the Q-TECH Model 3200 programmer be powered from an uninterruptible power supply or a battery.Power Frequency (50/60 Hz) Magnetic FieldsIEC 61000-4-83 A/m 3 A/m Power frequency magnetic elds should be at levels characteristic of a typical location in a typical commercial or hospital environment. NOTE: UT is the a.c. mains voltage prior to application of the test level.
73QTECH™ PROGRAMMER: DECLARATIONS TABLESTable 5: Declaration Electromagnetic Immunity Part 2The Q-TECH Model 3200 programmer is intended for use in the electromagnetic environment specied below. The customer or the user of the Q-TECH Model 3200 should assure that it is used in such an environment.Immunity Test IEC 60601 Test LevelCompliance LevelElectromagnetic Environment GuidanceConducted RFIEC 61000-4-63 Vrms150 kHz to80 MHz3 V Portable and mobile RF communications equipment should be used no closer to any part of the Q-TECH Model 3200 programmer, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.Recommended Separation Distance3,5V1√ Pd = []3,5E1√ Pd = []7E1√ Pd = []80 MHz to 800 MHz800 MHz to 2.5 GHz150 KHz to 80 MHzwhere 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 xed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.bInterference may occur in the vicinity of equipment marked with the following symbol:Radiated RFIEC 61000-4-33 V/m80 MHz to2.5 GHz3 V/mNote 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 aected by absorption and reection from structures, objects and people.a Field strengths from xed 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 xed RF transmitters, an electromagnetic site survey should be considered. If the measured eld strength in the location in which the Q-TECH Model 3200 is used exceeds the applicable RF compliance level above, the Q-TECH Model 3200 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Q-TECH Model 3200.b Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m
74QTECH™ PROGRAMMER: DECLARATIONS TABLESTable 8: EMI/RFI Information: Programmer–to–printer (Bluetooth®)Specication Bluetooth® 4.0 wireless technologyFrequency band 2.402-2.480 GHzModulation type GFSK, π/4-DQPSK, 8DPSKRadiated power <100 mWBandwidth < 1 MHzTable 6: Recommended Separation Distances Recommended separation distances between portable and mobile RF communications equipment and the Q-TECH Model 3200 programmerThe Q-TECH Model 3200 programmer is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Q-TECH Model 3200 programmer can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Q-TECH Model 3200 programmer as recommended below, according to the maximum output power of the communications equipment.Rated maximum output power of transmitter WSeparation distance according to frequency of transmitter m150 KHz to 80 MHz 3,5V1√ Pd = []80 MHz to 800 MHz 3,5E1√ Pd = [] 800 MHz to 2.5 GHz 0.01 0.117 0.117 0.2330.1 0.369 0.369 0.7381 1.17 1.17 2.3410 3.69 3.69 7.38100 11.7 11.7 23.3For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (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 aected by absorption and reection from structures, objects and people.7E1√ Pd = []Table 7: EMI/RFI Information: Programmer–to–pulse generatorSpecication Medical Implant Communications Service (MICS)Frequency band 402-405 MHzModulation type FSKRadiated Power <25 μWBandwidth < 300 KHz
75QTECH™ PROGRAMMER: SPECIFICATIONSTable 9: Product GuidelinesComponent RequirementDC PowerBattery pack type 4000 mAh 3.7 volt lithium-ion battery packCharge time Approximately 5 hoursPower SupplyInput 100 – 240 VAC, 50 - 60 Hz, 0.5AOutput 5.5 VDC, 3.64APower: 20 WManufacturer/Model Elpac Power Systems MWA020005AEnvironment Operating StorageTemperature 15° C to +38° C(+59° F to +100° F)-10° C to +55° C(+14° F to +131° F)Relative humidity 5% to 93% maximum at 40° C, non-condensing5% to 93% maximum at 40° C, non-condensingAtmospheric pressure 50 kPa to 106 kPa (7.252 psi to 15.374 psi)50 kPa to 106 kPa (7.252 psi to 15.374 psi)Table 10: SpecicationsComponent SpecicationDimensionsWidth x Depth x Height24.0 cm x 12.7 cm x 2.6 cm 9.4 in x 5.0 in x 1.0 inWeight .6 kg, 1.3 lbsStandard Screen Display WVGA, 1024 x 600 pixels, 16M TFT
76QTECH™ PROGRAMMER: SPECIFICATIONSTable 11: Nominal SpecicationsCharacteristic NominalElectrical Safety Testing – IEC 60601-1:2005 / ANSI/AAMI ES60601-1:2005 allowed values Earth resistance 100 mΩEarth leakage current 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 valuesEarthbond testing (Groundbond testing) 300 mΩ including power cable not exceeding 3 metersEquipment leakage — direct method 500 μAPatient leakage current — direct method (Wand, BF)<= 5000 μASafety FeaturesDebrillator protection to 5000 V, 400 J
77QTECH™ PROGRAMMER: DEFINITION OF PACKAGE LABEL SYMBOLSTable 12: Packaging Symbols: Q-TECH ProgrammerSymbol Specication Symbol SpecicationType BF Applied Part Symbol – Indicates connection of Type BF applied partManufacturer – Name and address of the manufacturerReference Number - Catalog number Storage Temperature - Product stored with temperature limitationsPart Number - Component number Radio – Non-ionizing electromagnetic radiationDo Not Dispose – Do not dispose of in trash Follow instructions for useSerial Number – Serial number of the programmerRisk Of Shock – Indicates the risk of electric shockKeep Dry - Ship and store in a dry place Fragile: Handle with Care - Transport and store with careElectrostatic Discharge – Identies a connector not tested for immunity to electrostatic dischargeDate of Manufacture – Date programmer was manufacturedTable 13: Packaging Symbols: Q-TECH Programmer WandSymbol Specication Symbol SpecicationLot number – Batch code Non-Sterile – Used to indicate the product is not sterile
78QTECH™ PROGRAMMER: WARRANTYLimited WarrantyA limited warranty may apply to this programmer. For warranty eligibility and to obtain a copy of the limited warranty, contact Boston Scientic / Cameron Health using the information on the back cover.
Cameron Health, Inc 4100 Hamline Avenue NorthSt. Paul, MN 55112-5798 USA1.800.CARDIAC (227.3422)+1.651.582.4000www.cameronhealth.com PN 104749-204 EN US 2014-08

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