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Q-TECH Programmer User`s Manual

1. Figure 41 Sample ECG markers 51 Q TECH PROGRAMMER OPERATION S ECG Scale Settings To adjust the real time S ECG amplitude and display speed scale settings 1 Select the S ECG Display Settings icon located to the right of the Live S ECG 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 programmerdefaults to Full range for devices with an SO RX device gain setting of xand to Half range for devices with an SO RX device 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 Therapy 70 SSC ET 7 m red Display S attings PAN Mo ix Hi 12 5mm sec Vy Sweep Snead Figure 42 Adjusting Going and Sweep Speed Note Amplitude settings and display speed adjustments on scrolling real time S ECG and Captured S ECGs affect thedisplay screen settings only and have no impact on the SO RX device settings for sensing Capture and View S ECG Strips The programmer can display capture and store real time S ECG rhythm strips The programmer saves a maximum of fifteen 12 second Captured S ECG recordings comprised of 52 Q TECH PROGRAMMER OPERATION e 8 5 seconds before activation of th
2. Interference may occut in the vicinity of equipment marked with the following symbol Wa Note 1 Ar 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations forradio cell lar cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Q TECH Model 2020 is used exceeds the applicable RF compliance level above the Q TECH Model 2020 should be observed to verify normal operation If abnormal performances observed additional measures may be necessary such as reorienting or relocating the Q TECH Model 2020 Over the frequency range 150 kHz to 80 MHz field strengths should be lessthan 3 V m 69 Q TECH PROGRAMMER DECLARATIONS Table 7 Recommended Separation Distances Recommended separation distances between portable and mobile RF communications equipment and the Q TECH Model 2020 programmer The Q TECH Model 2020 programmer is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or
3. MN eg D Pe Che Neo d erre ZE 61 Additional Programmer FunctiOns cree crece ecce eee ee eee eee eee sere e Se eoe o ee eee ees se eee esso aae eee 61 REGED Shagek N er Nerone rne Ne een eere rennen Qe A 62 Sale D System Magnet Mod l 452QC X m lena Aere me eene neeeneetatononnus 63 MAINTENANCE A AEN rco quei ees senos vk et on NM eere bones 64 Chakgihg th PrograndMer ch Cheese eeneg CH rocccceggecccescnccce fa Neccesssscccccccscccccesssccss 64 Cleaning whd Ma ibten cg 4 Q2 7 eter Aie er eto ne erroe eroe erronee pr teer one oooo 64 ProgfammernEhd of EME 4 5 urgere eee ce D Beet ze eo oo e gooe sonno c qquf Marb eee eee eee eoe 64 TRQAJJSLESHOOTINGQ 2 4 2 MJ ees Dad aai eee op ona e oo eo ooo r eee e eene eee uen o none 65 TroubieShoqtilrg E e E oer ee Nee eere pen qe nae ooo eo aha V ooo e fupe un HA 65 mabilisMDb Prange 59 7 Ns e AER Qt a eene E EC BE 65 No Rater Available Qe A e PY Ne nr ENEE wt eec Denn e A 65 Doss of Carp unidatron ers Prints C ED usu s NL NN Nee 65 Inability to Communicate With the SQ RX Device 55 3 sss RR sss 66 COMPLIANCE SENT EMEQS S c AM ers Qe ese eee ee e Nuoto eoe ae goo o qp e eessen 67 Compliance StaLEMents x p e erp eoo pm Nennen oe ooo Deene REIN eee e eere e eee onos 67 Federal Communications Commission FCC COMPHIANCe 8 i deeesecesseacsescsecsssesesesssesseseseseseeceees 6
4. Ze m n ura 11 E d EGER Ji Figure 38 Stored Episodes screen Each selected Episode screen also displays the programmed parameters and the stored S ECG data at the time of episode declaration Select the Continue button to return to the Episodes pick list screen Q TECH PROGRAMMER OPERATION The following details are available for each episode Treated Episodes Up to 128 seconds of S ECG data is stored for each Treated Episode e Pre episode S ECG Up to 44 seconds e First shock Upto 24 seconds of pre shock S ECG and up to 12 seconds of post shock S ECG e Subsequent shocks 6 seconds of pre shock and 6 seconds post shock S ECG Untreated Episodes An Untreated Episode is defined as any high rate episode that spontaneously terminates during the charging process before a shock is delivered Up to 128 seconds of S ECG data is stored for each Untreated Episode e Pre episode S ECG 44 seconds of pre episode S ECG e a Episode S ECG Up to 84 seconds of tachycardia S ECG data Printing Reports from the Programmer Printing Reports Patient reports can be printed before or after a patient session is ended It isrecommended that a final report be printed immediately following the implant procedure There are three patient reports e Summary Report e Captured S ECGReport e Episode Reports 47 Q TECH PROGRAMMER OPERATION To print patient reports from either an Online or Offline session 1 Select the Main
5. As a fire precaution do not use rechargeable AAA batteries Insert only alkaline AAA batteries into the programmer Do not short circuit the battery by directly connecting any of the exposed terminals with metal objects Do not transport or store the battery together with metal objects such as necklaces hairpins etc Do notuse orleave the batter near a heat source such asa fire or heater Do not immerse the battery in water Do not crush puncture open dismantle or otherwise mechanically interfere with the batteries Donot directly solder the battery Do not put the battery into a microwave or pressurized container Do not usethe battery in combination with primary batteries such as dry cell batteries or batteries of different capacities or brands Immediately remove the battery fromthe programmer and stop use if the battery gives off an odor generates heat becomes discolored or deformed or in any way appears abnormal during use Do not continue charging the battery if it does not recharge within the specified charge time If the battery should leak do not allow the contents to come into contact with the skin or eyes If they do wash immediately with cold water and seek medical advice Do not store the battery in any location having temperatures outside of the 10 C to 55 C 14 F to 131 F storage range Exposure to high temperatures may cause the battery to overheat or ignite and may possibly reduce the performance a
6. General External defibrillation equipment should be available forimmediate use during the implantation procedure and follow up Placing amagnet over the SO RX Pulse Generator suspends arrhythmia detection and therapy response Removing the magnet resumes arrhythmia detection and therapy response Battery depletion will eventually cause the SO RX Pulse Generator to stop functioning Defibrillation and excessive numbers of charging cycles shorten the SQ RX Pulse Generator s battery longevity The SACD Systenrhas notbeen evaluated for pediatric use The S ICD System does not provideTong term bradycardia pacing Cardiac Resynchronization Therapy CRT or Anti Tachycardia Pacing ATP Use of Other Medical Therapies Diagnostic Procedures External defibrillation or cardioversion may damage the S ICD System Avoid placing the defibrillation paddles directly over the deviceor electrode Cardio Pulmonary Resuscitation CPR may temporarily interferewith sensing and may cause delay of therapy Do not expose patient with an implanted S ICD System to diathermy The interaction of diathermy therapy with an implanted SQ RX Pulse Generator can damage the SO RX Pulse Generator and cause patient injury Do not expose the patient to MRI scanning MRI scanning can damage the SO RX Pulse Generator and cause patient injury Electrical interference or noise from soutces such as electrosurgical and monitoring equipment can interfere with the c
7. Once Automatic Setup has been completed the SO RX device therapy parameters may be selected Note Data from clinical testing of the S ICD System demonstrated a significant reduction in inappropriatetherapy with the activation of the Conditional Shock Zone prior to hospital discharge To set the therapy parameters M Select the Main Menu button on the Navigation Bar 2 Selectthe Implant button Select the Device Settings button on the Navigation Bar to display the Device Settings screen Figure 31 KI decus Off x P d L dese Conditional Shack c ej Therapy Figure 31 Device Settings screen 39 40 4 5 Q TECH PROGRAMMER OPERATION Select the On Off Therapy switch to set the desired therapy mode Figure 32 Therapy On 3 Device Settings BPM E 180 190 pe NT 220 san ET NS Ji coanditienal shack Figure 32 Setting the On Off Therapy switch Select and drag the Conditional Shock Zone yellow and Shock Zone red Slider bars to set the desired zone configuration e The Shock Zone is programmable between 1 Z0 and 250 bom in steps of 10 bpm e 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 e When programming both the Shock Zone and Conditional Shock Zone maintain at least a 10 bpm difference between thetwo zones If the Conditional
8. 50 Hz Induction continues until the Hold To Induce button is released up to a maximum of 10 seconds per attempt e Arrhythmia detection andthe Live S ECG are suspended during AGinduction Once the Induction button is released the programmer displays the patient s rhythm e Upon detection and confirmation of an induced arrhythmia the S ICD System automaticallydelivers a shock at the programmed energy output and polarity e If the shock fails to convert the arrhythmia re detection occurs and subsequent shocks are delivered at the SO 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 43 Q TECH PROGRAMMER OPERATION arrhythmia a slight delay may be expected prior to capacitor charging or shock delivery Note The SO RX device can deliver a maximum of five shocks per episode At any time an 80 J rescue shock can be delivered by pressing the Rescue Shock button 7 At any time prior to therapy delivery the programmed energy may be aborted by selecting thered Abort button 8 Select the Exit button to exit the induction process and return to the Main Menu screen Performing an S
9. Shock Zone slider yellow is dragged over the Shock Zone slider red thectwo sliders will merge to create a single Shock Zone If post shock pacing is desired toggle the Post Shock Racing button ton Post shock bradycardia pacing occurs at a non programmable rate of 50 bpm for up to 30 seconds Pacing is inhibited ifthe intrinsic rate isygreater than 50 bpm Select the Program button Go permanently program the SO RX device A screen will appear to confirm that the SO RX devicessettings were programmed Figure 33 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 Q TECH PROGRAMMER OPERATION Therapy On 1 f Device Settings Figure 33 Confirmation of programming 8 Once programming is confirmed select the Continue button to proceed to the next operation Note fany ofthe SO RX devicesettings 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 Defibrillation Testing Once the SQ RX device is implanted and Automatic Therapy is programmed On defibrillation testing may be conducted Note Defibrillation testing is recommended at implant to confirm the ability of the S ICD System to sense and co
10. Suspend Mode whenever e The programmer is inactive for 15 minutes e The Power Off keys FN and ESC On Off are pressed e The touch screen display is closed e The Power Off button is selected from the Main Menu If the programmer enters Suspend Mode during active communication with the SO RX device the telemetry link will be disconnected When the programmer is resumed from suspend Mode the Startup screen is displayed Pressing the ESC On Off button or opening the touch screen from the folded down position ends Q TECH PROGRAMMER OPERATION Suspend Mode operation Using the Programmer Touch Screen The programmer is equipped with an LCD touch screen By using the stylus and keyboard the user can select on screen options and enter patient information Stylus The stylus is used to enter commands change parameters nd navigate through the programmer screens Note Donot substitute any type of ink pen forthe stylus this may causea permanent stain and damage to the display screen To use the stylus 1 Push the square stylus eject button on the right side of the programmer base The stylusis ejected from the holder Figure 5 Stylus release button Figure 5 Removing the stylus 2 Use the stylus to lightly tap the appropriate functions on the touch screen or press and hold the stylus to move a croll bar 3 Push the stylus back into its holder when finished Q TECH PROGRAMMER OPERATION Keyboard The com
11. The electrode model and serial numbers appear on the second line of the chart The implant date appears onthe third Tine of the chart Figure 25 Using the keyboard enter the following patient information e Patient Name up to 25 characters e Doctor Name up to 25 characters e Doctor Info up to 25 characters e Notes up to 100 characters Therapy On Electrode Moden 3010 Seria ai23456 Implant Date 04 43 2010 PA ea Figure 25 Patient Chart screen Note The Wotesfield will automatically wrap the text with the presence of a space between lt any characters within thefirst line Select the Save button to update the SO RX device with the patient information Note Failure to savethe new patient informationwill resultin loss of the entered data 35 Q TECH PROGRAMMER OPERATION Automatic Setup Before the SQ RX device can be activated it must go through an initial Automatic Setup Process at the time of the implant The Automatic Setup Process is initiated as follows 1 Select the Main Menu button 2 Select the Implant button 3 Select the Auto Setup button on the Navigation Bar The Automatic Setup screen appears Figure 26 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 ref r to the instructions for Manual Setup Therapy Off Tiy Pp EU f Automatic Setup T n d The Automatic Setup process will tailor the ELI to th
12. associated cables that may be interfering with the RF communication 65 66 Q TECH PROGRAMMER TROUBLESHOOTING Inability to Communicate With the SQ RX Device If the programmer is unable to communicate with the SO RX device follow the steps below 1 2 Attempt to reposition the wand Select Scan For Devices from the Main Menu or select Scan Again from the Device List screen to locate the desired device Move any equipment and associated cables that may be interfering with RF communication If available attempt to communicate using different programmer and or wand Apply a magnet to the SO RX device toelicit beeper tones Remove the magnet and re attempt communication Q TECH PROGRAMMER COMPLIANCE STATEMENTS Compliance Statements Federal Communications Commission FCC Compliance This transmitter is authorized by rule under the Medical Device Radiocommunication Service in part 95 of the FCC Rules and must not cause harmful interference to stations operating in the 400 150 406 00 MHz band in the Meteorological Aids 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 statiopns including interference that may cause undesired operation This transmitter shall De used only Ip accordance with the FCC Rules governing the Medical Device Radiocommunication Service Analog and digital vo
13. 7 1999 5 EC Compliance BEATE Dir amp Qtive QS AND ennen Nes he My ttresessessesssssrssssscecasessesersess 67 EMI RFI EE E qu S NER Za vats ae ES es tit cs So A 67 DECLARATIONS TABLES 3 p Qoo en NN Eee a es Mes i n Le 68 Declaration Electromagnetic EMISSIONS 5 5 5e Ae e eene sesenta enean intentos estatus 68 Declaration Electromagnetic Immunity Part Ra IET eee eee eee eese eeeeree enteros ta tonenentaests totos 68 Declaration Electromagnetic Immunity Dans pee decscssescscscssecscessesscsssesecscassscsesssesscacsesecseacseescees 69 Recommended Separation Distances A KJw m Werersessessscscsssrscscssesssssrsescasssesessersescavesesssrecscavsveseseers 70 SPECIFICATIONS 71 disset 71 Ki elei e E Ne EE 71 DEFINITION OF PACKAGE LABEL SYMBOLS wscsssssssccccscsssscsvecsesctesensvetecscesvassnsecnsasdacentscrnsetncenses 72 O Tech Programmer c D E A eter m EEN 72 Q Tech Programm Wand amp XN3 pr Coprercsccssscssrssssscsssssssssessesssssrecssscacssesseceesescesssserecscscesossssececsesvoseseers 73 WARRANTY E Nec A eme sacha N E WE 74 Cameron Health Q TECH Programmer Warranty ee eee eee aea ee eee e ee eee eee eee eese oos 74 Service e EE en E esM Meist ET sancinsa asas as sao a even UE pe0s 74 DISCIaIDIer Giu coo pte ceri S E a E ep NEE MA Be 74 Q TECH PROGRAMMER GENER
14. A COMPONENT OF THE S ICD SYS REF 2020EU Q TECH PROGRAMMER USER S MANUAL Copyright 2013 Cameron Health Inc San Clemente CA USA All rights reserved Limited Software License and Equipment Use S ICD SO RX and Q TRAK are all registered trademarks of Cameron Health Inc Q GUIDE and Q TECH are all trademarks of Cameron Health Inc Manuals or other written documentation may not be copied or distributed without Cameron Health Inc authorization ul ec rer In the United States In Europe Cameron Health Inc Cameron Health BV 905 Calle Amanecer World Trade Center Suite 300 Nieuwe Stationsstraat 10 San Clemente CA 92673 6811 KS Arnhem USA The Netherlands Tel 1 949 498 5630 Tel 31 26 3550260 Free 1 800 CARDIAC Free 800 SICD 4 YOU 1 800 227 3422 800 7423 4 968 Fax 1 949 498 5932 Fax 4 31 26 3550269 www cameronhealth com www cameronhealth com TABLE OF CONTENTS GENERAL DESCRIPTION gene Geet 1 MIO o a E d E o AN E WE 1 Indications for Use LL 3 eun tice rt Ego esa pr ko EESAN TOCA NENNEN NABERE RETEA TENERE ER ORANO 1 Eae DCL CN S EE E gt A 1 Programmer Warnings and Cautions 4 3 ccsecccccsesesssectossscccccccsscsccdadctsessccccccssccscccccsssssccssess 1 Generate No oq NN a Ned EA AN Mei E E M eoi EE Ne d W 1 SEI CC DEE AT EE A E Oh OOS E AT 3 E amp ctrostaqw Discharge ESI CC AN EE e NEE 4 S ICD System Warnings and Cautions Bee Genen peccceseathg eere eee
15. AL DESCRIPTION Description The Q TECH Programmer the programmer Model 2020 is a component of the Cameron Health 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 SO RX device Q TRAK Subcutaneous Electrode the electrode and the Q GUIDE Subcutaneous Electrode Insertion Tool the EIT The programmer communicates wirel ssly with the SO RX device to enable adjustment of programmable settings and data collection 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 Use The S ICD System is intended to provide defibrillation therapy forthe 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 Contraindications Unipolar pacemakers are contraindicated for use with the S ICD System Programmer Warnings and Cautions General e External defibrillation equipment sho ld be available for immediateuse during the implantation procedure and follow up e To avoid risk of electric shock the programme
16. Menu button to display the Main Menu screen 2 Select the Print Reports button 3 Select the desired reporttype A green checkmark will appear next to the selected report Report types are described below 4 Select the Print button to print the selected reports 5 Select the Cancel button to return to the previously accessed screen Summary Report The Summary Report includes the following information Patient Name Date of Current Follow Up Date of Last Follow Up Printed Report Date Device Model Serial Number Subcutaneous Electrode Model Serial Number Implant Date Therapy Parameters Programmed Gain Settings and Sensing Configuration Initial Shock Polarity Configuration Episode Summary Since Last Follow Up and Since Initial Implant Battery Status Subcutaneous Electrode Impedance Measurement Device Integrity Check if applicable Programmer Software Version To print a summary report select the Summary Report button on the Print Reports screen 48 Q TECH PROGRAMMER OPERATION Captured S ECG Report To print a Captured S ECG report 1 Select the Captured S ECG Report button from the Print Reports pick list screen A list of the captured S ECG strips is displayed Select the button next to the Captured S ECG s to be printed A gr en checkmark appears next to the selected Captured S ECG Figure 39 Therapy On Patient Name K K Print Reports d D S Current Printer A Cameron Heaith Figu
17. Q RX Follow up 44 Sensing Configuration and Automatic Setup Itisnot necessary to perform Automatic Setup at each follow up If Autom tic 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 duringphigh rate exercises can also be performed Acceptable sensing will yield S markers syrichronous to all QRS complexes If other markers are noted use the ManualSetup process to evaluate other sensing configurations Note lf Manual Setup was previously used to override a sensing configuration careful consideration should be taken when selecting A tomatic Setup If an update to the reference S EGG is desired dueto a change in the patient s resting ECG follow the Acquire Reference S ECG instructions found on page43 Viewing Device Status Once communication is established the programmer displays the Device Status screen with information regarding the current episodes and battery status of the SO RX device To view this information Select the Main Menu button Select the Follow Up button Select the Device Status button on theNavigation Bar The Device Status screen will appear showing an overview of all SQ RX device activity since the last communication session Figure 37 Se cum Q TECH PROGRAMMER OPERATION Therapy Off A p ate jd Intreated Episodes Ce KE n e Rema
18. Temperature Product stored with temperature limitations Radio Non ionizing electromagnetic radiation Risk Of Shock Indicates the risk of electric shock Fragile Handle with Care Transport and store with care Date of Manufacture Date device was manufactured Product Packaging Used to enclose and protect product for distribution Batteries AAA replaceable alkaline batteries Q TECH PROGRAMMER DEFINITION OF PACKAGE LABEL SYMBOLS Literature Written material included in Reference Number Catalog number packaging CL Geng plug Storage location of power Dior open ODER FCC ID SDYCHI2020 Federal Communications Commission Identifier serial number Table 11 Packaging Symbols Q TEGH Programmer Wand Wand An electronic accessory that Non Sterile Used to indicate the can read coded data product is not sterile Lot number Batch code 73 Q TECH PROGRAMMER WARRANT Y Cameron Health Q TECH Programmer Warranty Cameron Health Inc offers a full lifetime warranty on the Q TECH Programmer to the user or using facility Please contact your local Cameron Health ffice or local representative for details The warranty on the Q TECH Programmer does not extend to any product that has been tampered with altered or repaired by any person other than anjemployee of Cameron Health organization Service When requesting service please provide information concerning the nature of the failur
19. a particular installation If the device does cause harmful interference the user is encouraged to try and correct the interference by the following measures e Reorient or relocate the device e Increase the separation between the devices e Connect the equipment to an outlet oma different circuit e Contact your Cameron Health Representative or Cameron Health Customer Service 67 Q TECH PROGRAMMER DECLARATIONS Table 4 Declaration Electromagnetic Emissions The Q TECH Model 2020 programmer is intended for use in the electromagnetic environment specified below The customer or the user of the Q TECH Model 2020 should assure that it is used in such an environment RF Emissions CISPR 11 The Q TECH Model 2020 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 The Q TECH Model 2020 programmer is suitable for use in all establishments mum otherthan domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Table 5 Declaration Electromagnetic Immunity Part 1 The Q TECH Model 2020 programmer is intended foruse in the electromagnetic environment specified below The customer or the user of the Q TECH Model 2020 should assure that it is used in such an environment Immunity Test IEC 60601 Compliance Level Electromagnetic Environment Tes
20. any ofthe issues listed below The programmer can be reset by pressing and holding CTRE ALT DEL for 5 seconds Contact your local Cameron Health Representative or Customer Service Department for additional assistance Inability to Print If unable to print follow the steps below 1 y Ensure that the printer is turned On and that it contains paper and a sufficient ink supply Check printerfeed for paper jam Ensure thewireless printefcard is inserted into the programmer Ensure aS applicable the wireless function is enabled on the printer or the Cameron Health approved wireless adapter is fully inserted into theleft side of the printer No Printer Available The No Printer Available screen will appear if a printer was not setup Select the Try Again button or refer to the Printer Selection section for instructions Loss of Communication with Printer When communication between be programmer and the printer fails a Printing Error screen will appear witha message stating Error while printing reports Press Continue totry printing any remaining reports or Cancel to cancel the current print job If this occurs 1 Se Ge Select the Try Again button to reconnect to the printer Verify that the selected printer has as applicable the wireless f nction enabled or a Cameron Health approvedwirelessadapterinsertedin the left side of the printer Move the programmer closer to the printer Move any devices and the
21. cause clipping when the 2x gain is selected e 2xGain 2 mV 2xGain should be selected when the signalamplitude is small enough to allow use otamore sensitive setting without causing clipping of the captured signal The 2x gain selection amplifies the signal twice as much as the 1x gain selection To program the manually selected sense configuration 1 Select the Program button to save the sense vector and gain settings 59 60 Q TECH PROGRAMMER OPERATION 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 confirmation screen will appear wh n the captured reference S ECG is acquired Figure 50 Therapy Ya Reference S ECG acquisition successful Figure 50 Captured Reference S ECG confirmation 3 Select the Continue button Q TECH PROGRAMMER OPERATION Smart Charge Through the Smart Charge feature the SO 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 Select the Main Menu button 2 Select the Utilities button on th Main Men to display the Utilities Menu 3 Select the S
22. ccess the Utilities menu during an Online session 1 Select the Main Menu button to display the Main Menu screen 2 Select the Utilities button The Utilities screen appears Figure 45 F Therapy On enmm Figure Ab Utilities screen Acquire Reference S ECG To acquire a manual Reference S ECG 1 Select the Acquite Reference S ECG button on the Utilities menu to access the Acquire Reference S ECG screen 2 Select Continue to acquirea Reference S ECG The programmer will begin acquiring the Reference S ECG A message will appear requesting thatthe patient remain still Figure 46 The reference S ECG ORS template is recorded and stored in the SO RX device 3 Select the Continue button tocomplete 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 55 56 Q TECH PROGRAMMER OPERATION Therapy On M Acquire Reference 5 ECG Figure 46 The patientshould remain still while the Reference S ECG is acquired Q TECH PROGRAMMER OPERATION Beeper Control The 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
23. cludes setting the date and time format time zone language and printer Once these settings are configured during the initial setup process they will become the default parameters and will not normally need to be changed with each session Note lfpowerloss occurs and the battery is depleted these settings will need to bereconfigured To configur the programmer settings 1 Select the Programmer Settings button on the Startup screen Figure 7 to dis play the Programmer Settings screen Figures d D Programmer Settings S 72 a a 4 i th M WW ums 7 A start tena Figure 7 Startup screen Figure 8 Programmer Settings screen 2 Select the corresponding line to access each setting The settings that can be configured include e Date and time format e Timezone e Language e Printer Q TECH PROGRAMMER OPERATION Date and Time Format To set the date and time format 1 Select Set Date and Time Format on the Programmer Settings screen Figure 9 The Date and Time Settings screen appears Figure 10 B es 1 Date and Time Settings E Programmer Settings Sot Date and Time Format G CITED GL Es A mmide yyvy gt gt E 8 a e e e em ah ee mmm mmm o wm mmm e 2 m P e emm emm a y q BR Automatically Adjust for Daytight Savings Time en Ire e S E er EE dE A SE M A c ieee gt Figur 9 Programmer Settings screen Figure 10 Dateand Time Se
24. duction 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 Improperelectrode connection to the device Inability to communicate with the device Inability to defibrillate 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 Q TECH PROGRAMMER GENERAL DESCRIPTION e Subcutaneous emphysema e Syncope Surgical revision or replacement of the e Tissue redness irritation numbness or system necrosis If any adverse events occur invasive corrective action and or S ICD System modification 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 e Depression e Fear of shocks e Phantom shocks Q TECH PROGRAMMER OPERATION Setup of the Q TECH Programmer Packaging Programmer components include e Model 2020 Programmer with pre loaded software e Touch screen stylus e Lithium ion rechargeable battery e Noncrechargeable a
25. e Capture S ECG button e 3 5 seconds after activation of the Capture S ECG button If an additional recording is required then the oldest previous recording is replaced with the new recording To capture a new S ECG rhythm strip 1 Select the Capture S ECG button located to the eft 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 44 Captured S ECG rhythm strip 53 54 2 3 Q TECH PROGRAMMER OPERATION Select and move the calipers across the S ECG strip to measure intervals as desired Select the Continue button to return to the previously accessed screen To view a previously Captured S ECG lis 2 3 Select the Main Menu button Select the Follow Up button Select the Captured amp Stored Episode S ECG button The Captured S ECG pick list screen appears Select one Captured S ECG from the list TheGaptured S ECG Details screen appears Select and dragtthe calipers to view details Select the Continue button to return to the Captured S ECG listscreen Q TECH PROGRAMMER OPERATION Utilities Menu The programmer Utilities menu provides access to additional SQ RX device features These include Acquire Reference S ECG Beeper Control Man al Setup and Smart Charge To a
26. e Hospital Environment Exposure to EM or staticmagnetic fields may suspend tachycardia detection and possibly cause temporary inhibitionof therapy delivery EMl may also trigger delivery of a shockin the absence of a tachycardia Automatic sensing and detection of tachycardias will resume when the patient moves away from theEMbor static magnetic held source To minimize the risk advise patients to avoid sources of EMI or static magneticfields having strengths of gt 10 gauss orl mTesla e 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 Q TECH PROGRAMMER GENERAL DESCRIPTION Alternators on running engines in automobiles Communications equipment such as high power radio transmitters Sources of strong static magnetic fields may include the following Industrial transformers and motors Large stereo speakers Magnetic wands such as those used for airport security Patients should seek medical guidance from their physician before entering an area where a posted sign prohibits patients with an implantable cardioverter defibrillator or pacemaker Potential Adverse Events Potential adverse events related to implantation of the S ICD System may include but are not limited to the following Acceleration induction of atrial or ventricular arrhythmia Adverse reaction to in
27. e 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 Customer Service or yout local Cameron Health Representative for a Return Authorization number Disclaimer Every effort has been made to make the material in the Q TECH Programmer User s Manual complete accurate and up to date Cameron Health reserves the right to make changes without notice and shall not ber sponsiblefor any damages including butnot limited to consequential damages caused by reliance on the material presented including but not limited to typographical errors 74 In the United States Cameron Health Inc 905 Calle Amanecer Suite 300 San Clemente CA 92673 USA Tel 1 949 498 5630 Free 1 800 CARDIAC 1 800 227 3422 Fax 1 949 498 5932 www cameronhealth com ec RER In Europe Cameron Health BV World Trade Center Nieuwe Stationsstraat 10 6811 KS Arnhem The Netherlands Tel 31263550260 Free 4 800 SICD 4YQU 800 7423 4 968 Fax 31 26 3550269 www cameronhealth com C 0344 2008 PN 102099 010 en 2013 01
28. e patient s rhythm The patient will be required to lie at rest during this process Follaw th on screen directions for guidance Please ensure the patient s heart rate is FIT prior to continuing Figure 26 Automatic Setup screen oF Once started the Automatic Setup will e Perform the shock electrode integrity check Figure 27 to measure electrode impedance Normal sub threshold impedance range is 400 Ohms e Select the best sensing configuration The sense electrode configuration appears on the printed report and can be viewed via the Manual Setup process e Select the appropriate gain selection The selected sense gain appears on the Printed Report and can be viewed via the Manual Setup process 36 Q TECH PROGRAMMER OPERATION Therapy Off M Automatic Setup it ume ct exe re Ordre Figure 27 Measuring electrode impedance The progress of the Automatic Setup process is shown inthe status bar When each function is complete the arrow next to the function moves to a down position The Automatic Setup Sensing Optimization screen will be displayed The programmer will display amessage requesting that the patient sit up however this process can be omitted during the implantation procedure by selecting the Skip button Figure 28 Therapy off om gt md ay gt pationt to sit up hen press Optimize when ready to conmlinue If the patient is unable to change positions The device will n
29. eee eee eee de dee ee eee ee eoa 32 Entente Elec2Sefe Informiatigi y y A ccs SN sd see eere 32 GreaNng the Patiepge act D NL Lue NIA osea N erreen N ere AQ e be 34 Altomatet etus 4 4 num Nenne eoe oopa Neee f QI eoe AP n eene 36 ProgrammingMherapyP ram ters NN 4047 Q0 ANGE iei 29 DefibrillatiGyNTestiqMg NL Me Ite Ner eee rne 41 Performing an QGO RX FollQw up d5 2094 aree eee ee de eee eee Na ee eee e eer nee eeeeeeeeeeegeeeg 44 Sensing Configuration and Automatic Setup eene EEN 44 Viewing DeviceQNMt s O k Ene Ye A sees DEE N Neccscessssssssesscacacscscecsesssssecas 44 Viewing Stored Episgde9 Ch Nee et ALS EAR eee 46 Printing Reports from the Programmer cec Does eee e eee ee ee eee eoe ete ee eese eese osse tete eese eee e ooo 47 Printing eet NEIN TEE E ac E DEEN S E Mm 47 Summary Report RR Wren MO A S m 48 Captured S ECG RepbOFt cenae a AS NM org EE 49 Fpisodes BeDOPL EEN Masa ON cas A e 49 E duc ENEE 51 S ECG Rhythm SCI RE E 51 SECO Scale SEUNG cR m 52 Capture and View S ECG Stips NUTS ominis vrina iere Iz Viae rav eoi eve QUIM SEU Vasa Usa de 52 Utilities Menu etm WM o U BE 55 Acquire Reference amp mqVCG aN 2 Gerrscsscscsssssssssssseosscesosssssssssesscosoesscssassesscessosscososssssvessecscosossseavessecss 55 Beeper Control A EE FLATS OP 57 Manual Set fin MA NNUS r NT P 58 Smart Charyg
30. eee eoo ab eeeeeeeeeegeeeeeeeeeeeeg 5 EI AN o S E LC AT OE oA o A 5 Use of Other Medical Ther pies Diagnostic Procedures Lats eese tenens 5 Electromagnetic Interference EMI Outside the Hospital Environment sss 6 Poteltial 4ydy rse Eyehts 62 N e e E E O E ees 7 OPERATION M AMORE s RUNS AAT cs WEE MN REPERI Te Sum TE 9 Setup Of the QTECHPr ogrammer ges pe mee Se eo eel do peo ooo eoe it ee Bloe geeeeeeeeeeeeeeeg 9 PaekagWTWM m Ner eerte ee gage ON eor gm O i e eren V d EE 9 Inserat the Main Battery Pagice X 2 Lieu e Dal A sss SN esses USA 10 lo gyting HQeBaclafpy6atkeey Nerii m Na Ns e Nee ace ee ML 11 Charging the ReGOramrmpfle mm Rer EEN SIC ep Se lg enn 12 Using the Q TECH Pr grammqqtp 4 40 1 105 qe apre eee e poo ipfo ee erroe atero eoru 13 Turning eProg aNimesr OP en e NEE NEE e LEE Li E 13 Placing the Programmerin Suspend More GN NA Ngretressesesssrscscasssesesrers 13 Using the Programmer TOUGSNSTrE EA le n Me aa NATA eere Map Sisrsrssssssesesssrseseassvesesrers 14 SUV LS BET A A TET CAES E S E S c 14 CVO AE seo el ioa Wd E NC EEN e ER cer NOB diee atium n PRU 15 Using the Valdemoro et E E rete Ae E NR richer dba Eo deeds pr Teka 15 PV AU AAO ETERNA Pam coats m Ae d EE 6 m 16 Screen Header uus e Meri Ne Nemore A A d 16 Navigation Bal EMO Do EE i c E ETTA 17 Resetting the Programmer L mr neien NG r
31. ent complies with the International Special Committee on Radio Interference CISPR emission requirements Use of accessories other than those specified by Cameron Health may result in increased emissions or decreased functionality of the programmer and may cause unintended operational behavior of the programmer Do not attempt to remove the wireless communication card or wireless printer card Use of non approved Cameron Health components will voidsthe warranty and may cause unpredictable SO RX Pulse Generator operation No modification of the programmer is allowed Use only the Cameran Health programmer and appropriate softwareforcommunicating with and programming The SQ RX Pulse Generator Contact your local Cameron Health representative or Customer Service Department for assistance or a replacement part Q TECH PROGRAMMER GENERAL DESCRIPTION Batteries The following warnings pertain to safe handling of the batteries and power supply used with the programmer To prevent the battery fromdeaking generating heat or exploding observe the following precautions Use the battery only with an approved Cameron Health power adapter Do not discard the battery in a fire incinerate or subject battery cells to temperatures that exceed 100 C 242 F This may result in harmful emissions or explosion The battery incorporates built in safety devices To ensure their proper function do not disassemble or alter any partsof the battery
32. ess is complete 27 Q TECH PROGRAMMER OPERATION Connecting and Disconnecting from the SQ RX Device This section provides the information necessary for selecting connecting to and disconnecting from the SQ RX device Scanning For Devices 1 Select the Scan For Devices buttonOn the Startup Screen Figure 16 The Device List screen appears after the Scan Progress Bar displayed during the scanning process Select the Gancelutton at any time to end the scanning process Figure 16 Startup screen 2 Whenthe scanning process is complete list of all Cameron Health SO RX devices detected up to 16 will be displayed on the Device List Figure 17 The SQ RX devices that are in Shelf mode willbe displayed a 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 28 Q TECH PROGRAMMER OPERATION TE HN Device List Patient Name Model Serial E ee e i WM Patient name J ioro W 122456 M gt Figure 17 Device List screen E If the desired SQ RX devices not listed select tbe Scan Again button to re initiate the scanning process Select the Cancel button to return to the Startup screen Note Referto the Inability to Communicate with the SO RX Device section for further assistance Connecting to the SQ RX Device From the Device List screen selectthe desired SO RX device to initiate the communication session N
33. he programmer is not connected to an external power sourcepthe main battery pack is removed or the main battery pack charge supply is low The user can remove and replace the two AAA alkaline batteries as needed To install or replace the two internal batteries 1 Place the programmer in Suspend Mode by holding down the FN and ESC On Off keys simultaneously 2 Open the battery compartment Figure 3 The backup battery cover is located on the top left of the keyboard Angle the programmer screen forward to provide access to the cover Apply downward pressure tothe center of the battery cover and slide it toward the front of the programmer Backup Battery Cover Angle display slightly QO forward to access cover Figure 3 nserting backup batteries 3 Remove the depleted AAA alkaline batteries Insert two AAA batteries observing the polarity indication 5 Close the battery compartment bysliding th cover over the top of the batteries while applying downward pressure to the center of the cover P Q TECH PROGRAMMER OPERATION Charging the Programmer The programmer is primarily intended to be AC powered but can also be operated on battery power provided that the internal batteries are adequately charged When not in use it is recommended that the Q TECH programmer remain connected to AC power This will ensure stored programmer data is not lost in the event that the AAA batteries become depleted The main battery pac
34. ice 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 particulartransmission from this transmitter will be free from interference FCC ID SDYCHI2020 1999 5 EC Compliance R amp TTE Directive The S ICD System contains radio equipmentinthe frequency range 402 MHz to 405 MHz for ultra low power active medical implants The radio equipment in the S ICD System complies with the applicable harmonized standards and essential requirements of the R amp TTE Directive For additional information contact Cameron Health Inc direct by the telephone numbers listed onbe inside front cover or back page of this manual EMI RFI This equipment hasbeen tested and found tojcomply with the applicable limits for medical devices IEC 60601 1 2 2007 or Activedmplantable Medical Device Directive 90 385 EEC Table 3 EMI RFI Information Wireless Connection Frequency Bandwidth FCC Designation R amp TTE Class From Programmer Programmer Wireless 403 5 MHz 300 KHz CFR 47 Part 951 Class 1 Adapter and Pulse MICS Subdass 47 Generator Printer Adapter 2 400 2 4835 GHz 1000 KHz Maximum CFR AT Part 15 lass 2 Class B Subclass 21 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
35. ining Device Battery Life P fen Dk J D A S gt ev Ja Figure 37 Device Status screen The Device Status overview reports Date of the last follow up session Total Number of shocks delivered since the last follow up session Total number of treated episodes since the Jast follow up session Total number of untreated episodes since the last follow up session Remaining SO RX device battery life 45 46 Q TECH PROGRAMMER OPERATION Viewing Stored Episodes The 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 replacestthe oldest stored episode however the first treated episode will not be overwritten Note If a spontaneous episode occurs during a patient s follow up session while the SO RX device is wirelessly communicating withthe programmer the episode willnot be stored To view stored episodes Ur CW 6 s Select he Main Menu button Select the Follow Up button Select the Captured amp Stored Episodes S ECG icon from the Navigation Bar Select the Episodes toggle switch to access the episodes pick list Select an episode treated or untreated from the list Figure 38 The selected episode willbe downloaded from the device and displayed DES Therapy 0 tient N herapy On Patient Neme EA Episodes A H tm Description Date
36. k is recharged automatically whenever the programmer is powered using the AC adapter A battery pack is fully charged within 4 hours 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 e Allfourbars areilluminated green The battery is T0096 charged e Three bars are illuminated green The batteryis 7596 charged Two barsare illuminated yellow The battery is 5096 charged One bar is illaminated red The battery is 25 charged The programmer displays one ofthe following alert screens as battery power gets progressively lower Programmer Battery Low e Programmer Batter Critical e Qut Of Power To charge the programmer 1 Ensure that the main battery pack is inserted intothe programmer 2 Connect the AC adapter power cord to the programmer 3 Insert the power cord into an AC power outlet Q TECH PROGRAMMER OPERATION Using the Q TECH Programmer Turning the Programmer On The programmer can usually be started by simply opening the programmer lid If the programmer does not start press the ESC On Off key in the upper left corner of the keyboard Figure 4 ESC On Off Figure Turning the programmer On Off Placing the Programmer in Suspend Mode The programmer has a Suspend Mode whichisactivated automatically to conserve power When this mode is in effect the display will be blank The programmer enters
37. lkaline AAA backup batteries e Wireless printer card e Cameron Health Programmer wireless communication card with model 4510 telemetry wand e ACadapter power cord and power supply for battery charging Visually inspect the packaging to ensure the contents are complete Do not use if there is e Evidenceof damage or cracking e Evidence of battery leakageor corrosion Return the product to Cameron Health if am of these conditions exist Contact your local Cameron Health representative or Customer Service Department for instructions and return packaging Q TECH PROGRAMMER OPERATION Inserting the Main Battery Pack The programmer is powered by a rechargeabletithium ion battery pack or through AC power with the AC adapter power cord Note lfconnected to AC power make sure the programmer is in Suspend Mode before insertion of the battery pack See Placing the Programmer in Suspend Mode section The main battery islocated on the back of the programmer base To insert themain battery pack 1 Slide the battery so the outside latch istoward the rear of the programmer Figure 1 Main Battery Cover Figure 1 Main battery cover 2 Insert the battery packinto place Figure 2 Figure 2 nserting battery pack 3 Secure the battery pack with the slide cover by latching it in place Q TECH PROGRAMMER OPERATION Inserting the Backup Batteries Two internal AAA batteries serve as a backup power source for situations when t
38. mart Charge button The Reset Smart Charge screen appears Figure 51 Therapy On eset et SMART Char arge SMART Charge automatically extends detection following non sustained arrhythmias Figure 51 Reset Smart Charge screen 4 Select the Reset button to reset the Smart Charge to zero or press Gancel to return to the Utilities Menu without resetting the Smart Charge 5 A confirmation window will appear with the message Smart Charge successfully reset 6 Press the Continue button to return to the Utilities screen 61 Q TECH PROGRAMMER OPERATION Additional Programmer Functions Rescue Shock The Rescue Shock button is available on the programmer display when the SO 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 Button at the top of the programmer screen The Rescue Shock screen appears Figure 52 Th Ce On gt CEE Select SHOCK to deliver maximum energy rescue shock Figure 52 Rescue Shock screen 2 Select the Shock button to begimcharging the SQ RX device for a Rescue shock A red background screen with the word Charging will appear Alternatively selecting the Abort button will prevent delivery of arescue shock and will return to the Device Settings screen The shock can beyab
39. mber Figure 22 Suicide Gr Electr ER 1D Setup Please enter the ciectrode model and seria number before pressing proyram Figure 22 Entering electrode information Select the Program button to save the information A confirmation screen will appear during communication with the SO RX device Figure 23 Select Cancel to cancel information storage and return to the Automatic Setup screen 33 Q TECH PROGRAMMER OPERATION Therapy On Patient Name Electrode ID Setup m Please enter the electrode model and serial number before pressing program SSES 3010 mmm Communication in j ae O progress EPA Ramm A m YH gh ww fig 9 A e hb m 584 e L Can a gm d Bod usa A T P gt m y raft iy am fmc a bt eg Figure 23 Confirmation screen showing communication in progress Creating the Patient Chart This chart contains reference information for tHe patient To set up the patient chart 1 Select the Main Menu button on the Navigation Bar A Select the Implant button Figure 24 Therapy On Tn plant i Fallow Up wo EE 7 Cour Reports End Session tities iP Patient Test Figure 24 Select the Implant button fo create a patient chart 34 w Q TECH PROGRAMMER OPERATION Select the Patient View button to access the Patient Menu screen The SQ RX device model and serial numbers appear on the first line of the chart
40. ncy magnetic fields should Hz Magnetic Fields be at levels characteristic of a typical IEC 61000 4 8 location in a typical commercial or hospital environment NOTE U is the a c mains voltage prior to application of the test level 68 Q TECH PROGRAMMER DECLARATIONS Table 6 Declaration Electromagnetic Immunity Part 2 The Q TECH Model 2020 programmer is intended for use in the electromagnetic environment specified below The customer or the user of the Q TECH Model 2020 should assure that it is used in such an environment Immunity Test IEC 60601 Test Compliance Electromagnetic Environment Guidance Level Level Conducted RF 3 Vrms Portable and mobile RF communications equipment should be used no closer IEC 61000 4 6 150 kHz to to any part of the Q TECH Model 2020 programmer including cables than the 80 MHz recommended separation distance calculated from the equation applicable to the frequency ofthe transmitter Radiated RF 3V m IEC 61000 4 3 80 Mhz to Recommended Separation Distance 2 5 GHz dz SS P 150 KHz to 80 MHz 1 d 38 EP 80 MS ve 900 MHz Ve Ss 800 MHz to 2 5 GHz where P isthe maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range
41. nd service life of the battery Q TECH PROGRAMMER GENERAL DESCRIPTION e Batteries may be considered hazardous waste and are to be disposed of in accordance with the manufacturer s instructions deposited in the appropriate local battery recycling facility or returned to Cameron Health for proper disposal e Keep batteries out of the reachof children Note Ifthe programmer is not likely to be used for an extended period remove the main battery A reset of the Time Zone and Time Date format is required when the programmer returns to active communication Electrostatic Discharge ESD The programmer may be affected by ESD If ESD occurs and the programmer s functionality is affected attempt to reset the programmer or contactyour local Cameron Health representative or Customer Service Department for instructions e Do nottouch or connect the Wand to the programmer unless ESD precautionary procedures are used Q TECH PROGRAMMER GENERAL DESCRIPTION S ICD System Warnings and Cautions Before using the S ICD System read and follow all warnings and cautions provided in this manual Refer to the SO 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
42. nvert VF Note Episode data associated with rescue shocks manual shocks and induction testing is not stored in the SO RX device To induce VF and test the S ICD System LE Select the Programmer Main Menu button on the Navigation Bar to access the Main Menu 2 Select the Patient Test button to setup the induction test Figure 34 41 Q TECH PROGRAMMER OPERATION Therapy a On MEM IU TT Figure 34 Select the Patient Test Button to access the Main Menu 3 Select eitherstandard STD or reverse REV polarity 4 Select and drag the red marker to set the desired shock energy for the first delivered shock Figure 35 The shock energy may be programmed from 10 to 80 J A 15 J safety marginris recommended for defibrillation testing E SS sof 65 re 7 g LI Set Shock Energy Joules Shock Polarity Figure 35 Setting the desired first shock energy for defibrillation testing 42 Q TECH PROGRAMMER OPERATION 5 Select the Continue button to display the 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 36 Therapy On Figure 36 Induction Test screen Thefollowing functions occur during the test e The S ICD System induces ventricular fibrillation using 200 mA alternating current AC at
43. ommunication 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 Q TECH PROGRAMMER GENERAL DESCRIPTION lonizing radiation therapy such as radioactive cobalt linear accelerators and betatrons may adversely affect the S ICD System operation Therapeutic ionizing radiation cannot be immediately detected however it can damage the electronic components of the SO RX Pulse Generator To minimize the riskSof ionizing radiation Shield the SO 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 atthe SQ RX Pulse Generator Evaluate the S ICD System operation after each radiation treatment e Lithotripsy and other therapeutic forms of ultrasound can damage the SO RX Pulse Generator If required avoid direct flow of the pulse waves near the site of the implanted SO RX Pulse Generator e Usecaution during ablation procedures Program the S ICD System to Therapy Off Keep the current path electrode tip to ground as far away as possible from the implanted SQ RX Pulse Generator and electrode The programmeris not suitable for use in the presence of a fl mmable anesthetic mixture with air or with oxygen or nitrous oxide Electromagnetic Interference EMI Outside th
44. ons 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 SO RX device Screen Header When the programmer is Offline inactive communication the screen header displays the Battery Status Indicator When viewing Offline Stored Sessions the screen header displays e Patient name Therapy On Off e Battery status indicator When the programmer is online active communication the screen header displays e Therapy On Off e Patient name e Patient heart rate Programmer Battery and Telemetry status indicator e Screen title e Rescue shock icon Q TECH PROGRAMMER OPERATION Navigation Bar The Navigation Bar is the primary method for navigating the Online programmer screens The bar is located along the left side of the programmer screen and the corresponding screen appears with the selected icon highlighted Table 1 displays a list of the programmer iconsjand their corresponding descriptions Resetting the Programmer Periodically the programmer may need to be reset if e You cannot exita screen e Theoperating system stops responding e You are unable to turn the programmer On usingthe ESC On Off keys e You see a redaalert screen instructing you to press CTL AET DEE The programmer canbe reset by pressing andcholding CTL AET DEL for 5 seconds If the programme
45. orted by selecting the Abort button 3i A confirmation screen will appear with notification that the shock was delivered successfully along with the corresponding shock impedance Figure 53 62 Q TECH PROGRAMMER OPERATION Therapy On TETT Rescue Shock Shock delivered shock impedance 75 Ohms Figure 53 Confirmation of Rescue Shock delivery I for any reason the shock could not be delivered a red background screen will appear with a message stating TheShock could not be delivered Note Inthe event telemetry is lost SO RX device commands including Rescue Shocks will not be available until telemetry is reestablished S ICD System Magnet Model 4520 The Cameron HealthMagnet the magnet isa nonsterile accessory used to inhibitthe delivery of therapy from the device Apply the magnet flat against the skindirectly over the implanted SO RX device for aminimum of one 1 second to suspend arrhythmia detection Removal of the magnet will return the device to normal operation If the magnet is applied during an episode the episode will not be stored in the device memory Other behaviors of magnet pplication e Inhibit shock therapy delivery e Terminate post shock pacing therapy e Prohibit arrhythmia induction testing e Activate the device s beeper with each detected ORS complex for 60 seconds Note Aprogrammer commanded Rescue Shock can override the use of the magnet as long as the magnet was in place priorto
46. ot communicating with a selected SO RX device An Online session occurs when the programmer establishes a telemetry link with a specific SQ RX device Online and Offline display screens have a grey background appearance During active communication if the telemetry signal is lost between the programmer and the SQ RX device for more than five seconds a yellow alert screen is displayed notifying the user This may occur if the wand is moved out of the telemetry communications range or if noise orinterfering objects inhibit communication Programming commands including Rescue Shocks will not be available until telemetry is reestablished Telemetry reconnection may occurautomatically within one minute when the SO RX device and wand are withintelemetry range Offline Behavior When the programmer is notactivelycommunicating with an SO RX device itis Offline Stored patient sessions can be viewed and printed and programmer settings Can be accessed during Offline sessions Offline screens have a grey background 25 26 Q TECH PROGRAMMER OPERATION Stored Patient Sessions During a patient follow up visit the programmer will retrieve data from the SQ RX device s memory The programmer can store up to 15 patient sessions When the 16th 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 incl
47. ote Regardless of how many devices are located by ascan the user must select an SO RX device from the list to begin activecommunication 29 Q TECH PROGRAMMER OPERATION Connecting to an SQ RX Device in Shelf Mode 1 When the SQ RX device selection is made the programmer connects to the se lected SO RX device A window willappear indicating connection is in process 2 Once communication is established with the SO RX device the Device Identification screen appears Figure 18 Figure 18 Device Identification Screen Note lt The Device Identification screenisvisible only while connecting to an SO RX device in Shelf mode 3 The SQ RX device model and serial numbers are automatically acquired and displayed during the initial scannirig process Select Continue to remove the SO RX device from Shelf mode and prepare for implantation or select Cancel to return to the Devicetist screen 30 Q TECH PROGRAMMER OPERATION Ending a Patient Session To end an Online patient session and return the programmer to its Offline operation mode 1 Select the Main Menu button on the Navigation Bar The Main Menu screen ap pears 2 Select the End Session button Figure 19 Therapy Op Figure 19 Main Menu screen RT A warning message will be displayed to the user if any of the following conditions exists e AutomaticTherapy is programmed to Off e Reference S ECG has not been acquired e Automatic Setup or Op
48. ow optimize detection Instruct the at this time press Skip to proceed SLOSS ow ooo E est SS Ze EEE E OED EE a Figure 28 Automatic Setup screen 37 38 rp 8 Q TECH PROGRAMMER OPERATION Select the Continue button to finish the Automatic Setup process A confirmation screen will appear when Automatic Setup is complete Figure 29 Therapy OF Automatic 5 etup Automatic Satup completed successtully Figure 29 Confirmation of successful Automatic Setup Following the optional optimization process the Acquire Refer nce S ECG screen is displayed Figure 30 Select the Continue button to acquire a reference S ECG A Therapy or Q The following procedure will significantly improve rhythr diccrimination and raquircs acquisition of a reference 5 EC6 This process will take less than one minute Select Continua if the displayed S ECG is acceptable las Colin Lt TT W tancel Figure 30 Acquire Reference S ECG screen Q TECH PROGRAMMER OPERATION 9 Once the Reference S ECG acquisition process begins a status screen appears The process may take up to one minute during which the patient should remain still During this process a template of the patient s baseline QRS complex is stored in the SQ RX device Select Cancel at any time to end Reference S ECG acquisition When acquisition is complete select the Continue button Programming Therapy Parameters
49. pact computer keyboard with 58 full size keys is used to enter text and numeric data Using the Wand Use only the Cameron Health Model 4510 wand the wand to communicate with the SO RX device Note The wand i a non sterile device DO NOT STERILIZE The wand must be contained in a sterile barrier to be used in the sterile field To connect the wand to the programmer insert the wand cable connector possessing a green label into be communication card connector port Figure 6 located on the side of the programmer also marked with a green label Figure 6 Connecting the wand Q TECH PROGRAMMER OPERATION To obtain optimal telemetry the wand should be placed directly over the implanted SO RX device Although the programmer may receive S ECG telemetry at greater distances programming should be performed with the wand placed over the SO RX device When telemetry loss occurs the display screen will turn yellow and a message will appear with the text Communication Loss to alert the user Reposition the wand to establish communication The programmer will display a screen informing the user if the device was found and programming can continue Note lfcommunication cannot be reestablished the session should be ended and restarted by scanning for the SO RX device Navigation The programmer s graphic user interface GUI facilitatesmanagement and control of the S ICD System The Navigation Bar and oval on screen butt
50. r does not respond tothe reset process contact your local Cameron Health representative or Customer Service Department for assistance Q TECH PROGRAMMER OPERATION Table 1 con descriptions Main Menu Button Allows user to return to the main menu Auto Setup Button Allows user to access the auto setup menu Device Settings Button Allows user to access the SQ RX device settings screen Device Status Button open folder and dosed folder Allows user to access the SQ RX device status Screen User can view number of shocks delivered sincethe last update as well as the SQ RX device battery life Patient View Button Allows user to access the patientchartscreen Captured Episodes Allows user to access captured S ECGand stored episode screens S ECG Button Allows user to access induction screen Allows user to access the manual shock screen heft side of the meter allows user to view the programmer s battery status The right side of the meter allows viewing of telemetry signal Allows user to capture a live S ECG Allows user to modify the zoom and sweep speed on the live S ECG Allows user to view current heart rate Allows userto administer shock from any programmer screen c Y Toggle Switch Allows userto turn functions on or off Q TECH PROGRAMMER OPERATION Configuring the Q TECH Programmer Configuring Programmer Settings The programmer should be configured before communication with an SO RX device is attempted This in
51. r must only be connected to a supply mains with protective earth e Mains isolation is achieved by disconnecting the AC or DC connector of the power supply Do not position the programmer so that itis difficult to disconnect the power connections e The US power cord is for connection to 4 10 VAC supplymains All other power cords are for connection to 230 VAC supplymains e Confirm that the programmer is in communication with the intended implanted SO RX Pulse Generator Q TECH PROGRAMMER GENERAL DESCRIPTION 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 403 5 MHz and 2 5 GHz This may interfere with nearby equipment Closely monitor medical electrical equipment in the vicinity when using the programmer The presence of other devices inthe same frequency band 403 5 MHz forthe SQ RX Pulse Generator and 2 5 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 office equipment all equipment should be observed to verify normal operation Other equipment may interfere with the programmer even if that other equipm
52. re 39 Selecting Captured S ECG Reports for printing 2 Select Continue to return to the Print Reports pick list screen 3 Select the Print button to print the selected report 4 Select the Cancel button to return to the previously accessed screen Episodes Report To print an Episode Report 1 Select the Episodes Report button on the Print Reports pick ist screen The Episode List screen appears showing aist of the stored episodes Figure 40 Select the button next to the episode s to be printed Agreen checkmark appears next to the selected episode s 49 Q TECH PROGRAMMER OPERATION Therapy On Patient Name IN T EUG LE P Xu Treated E Episode 7 770hms 9 o7nsizees Ore f 030 Untreated Episode K omns2oos a NYa X c ETT Untreated d Episode Wo SA S nts Figure 40 Stored Episode List screen Select Continueto return to the Print Reports pick list screen Select the Print button to print the selected report Select the Cancel button to return to the previously accessed screen Q TECH PROGRAMMER OPERATION S ECG Features The programmer provides the capability to viewpadjust and capture the streaming S ECG from the SQ RX device S ECG Rhythm Strip Markers The system provides annotations to identify specific events on the S ECG These markers are shown in Table 2 and an example is shown in Figure 41 Table 2 S ECG Markers on Programmer Display Screens and Printed Reports Description
53. rogrammer Settings screen or select Cancel to return tocthe Programmer Settings Screen without saving the changes Printer Selection To select the printer to be usedwith 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 2 Select Printer Setup on the Programmer Settings screen A previously configured printer becomes the default printerand will be displayed at this time If a default printer has not already been selected and configured the programmer will scan the area to locate wireless printers A Scan Progress Bar will appear informing the user that the programmer is currently scanning for printers 21 Q TECH PROGRAMMER OPERATION 3i Select the printer of choice Figure 12 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 screenis displayed 4 Once the scan is complete the Printer Selection screen appears Figure 12 Note Refer to Troubleshooting section for printer problems Panter Model Name Printer Seria Number Figure 12 Printer Selection screen o Select the desired printername and enter the name using the keyboard upto 15 characters A unique printer identifier should appear with the printer selection Fig
54. 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 SO RX device is taken out of Shelf mode To reset the Beeper Control Note gt SCR The Beeper Control display screen is enabled only when an olert condition occurs If an alert condition is activated a notification screen will appear upon connection Select the Main Menu button to display the Main Menu Select the Utilities button to displ y the Utilities Menu Select the Beepe r Control button Select the Reset Beeper button to suspend audible beeping tones triggered by an alert condition Figure 47 df the alert condition is not corrected the audible beeping tones willbe re ctivated during the next automatic S ICD Systemiself check Select Reset Becper to stop the beeper for the current device alert Seloct Disable Beeper to disable the beeper warming for all error conditions including ERI and EOL Figure 47 Resetting the Beeper 57 Q TECH PROGRAMMER OPERATION 5 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 lfbeeperis disabled alert conditions will not trigger audible tones Manual Setup Manual Setup enables the user to perform the electrode integrity test and select
55. t Level Guidance Electrostatic Discharge 6 kV contact 6 kV contact Foors should be wood concrete or ESD 8KkV air 8kV air ceramictile If floors are covered IEC 61000 4 2 with synthetic material then the relative humidity should be at least 3096 Electrical Fast 2 kV for power supplylines 2 kV for power supply lines Mains powerquality should be that Transient Burst 1kVforinput output lines YKV for input output lines of a typical commercial or hospital IEC 61000 4 4 environment Surge 1kV line s to line s 1 kV line s to line s Mains power quality should be that of a IEC 61000 4 5 2 kV line S to earth 2 kV line s to earth typical commercial or hospital environment Voltage Dips Short 596 U 9596 dip in U for 0 5 cycles 596 U gt 95 dip in U for 0 5 cycles Mains power quality should be that of a interruptions and voltage 4096 U 6096 gp mm U for 5 cycles 4096 U 6096 dip in U for cycles typical commercial or hospital environment variations on power 70 U 30 dip in U or 25 Cydes 70 H 3096 dip in U for 25 cycles Ifthe user of the Q TECH Model 2020 supply input lines 596 U 79596 dip in U for 5 sec 596 U 79596 dip in U for 5 sec programmer requires continued operation IEC 61000 4 11 during power mains interruptions it is recommended that the Q TECH Model 2020 programmer be powered from an uninterruptible power supply or a battery Power Frequency 50 60 3 A m 3 A m Power freque
56. the user of the Q TECH Model 2020 programmer can help prevent electromagneticinterference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Q TECH Model 2020 programmer as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter Rated maximum output power of transmitter 150 KHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d NP ONE V For transmitters rated at a maximum output power not listed above the recommended separation distance d inmetres m can be estimated using the equation applicable to the frequency of the transmitter where pis the maximum output power rating of the transmitter Ip watt W according to the transmitter manufacturer Note 1 At SO MH and 800 MHz the separation distance for the higher frequency rarige applies Note 2 These guidelines may not apply in all situations Flectromagnetic propagationi is affected by absorption and reflection from structures objects anid people 70 Q TECH PROGRAMMER SPECIFICATIONS Table 8 Product Guidelines End Of Life Battery capacity has declined 50 of battery pack s initial capacity approximately 1000 charge discharge cycles Typical use is 4 years Back Up Batteries Two AAA alkaline batteries Power Supply Output 15 VDG 1 6 ee AR we EC 24W Manufacturer Model 57 EpacPowerStems Wii NO Po
57. the electrode sensing configuration and gain setting in the SO RX device 1 Fromthe Utilities Menu select the Manual Setup button The Impedance Test screen appears 2 Select the Test button to perform tbe electrode integrity test Figure 48 E Therapy On cons Impedance Press the Test button to check the Device impedance Ss 2 Figure 48 Impedance test screen 3 Select Continue to proceed or select Test to retry The sensing configuration can be evaluated by temporarily activating any of the vectors or gain settings The Live S ECG and markers will reflect the temporary selections for evaluation purposes 58 Q TECH PROGRAMMER OPERATION 4 There are three available sensing vectors that can be manually selected e Primary Sensing from the proximal electrode ring on the subcutaneous electrode to the surface of the active SO RX device e Secondary Sensing from he distal sensing electrode ring on the subcutaneous electrode to thesurfaceof the active SO RX device e Alternate Sensing from the distal sensing electrode ring to the proximal sensing electrode ring on the subcutaneous electrode The gain setting adjusts the sensed S ECG signal sensitivity Itay be manually selected via the Select Gain toggle button Figure 49 Therapy On Manual setup Select Sensing L L cation Figure 49 Gain adjustment e 1x Gain 4 mV 1x Gain should be selected when the signal amplitude is large enough to
58. the initiation of the programming 63 Q TECH PROGRAMMER MAINTENANCE command If the magnet is applied after the initial command the Rescue Shock will be terminated Note Magnet application does not affect wireless communication between the device and the programmer Charging the Programmer When not in use it isrecommended that the Q TECH programmer remain connected to AC power This will ensure stored programmer data is notlost in the event that AAA batteries become depleted Cleaning and Maintenance There are no user serviceable parts inthe programmer system With the exception of the wand and batteries To clean the programmer and wand as needed 1 Turn the Programmer Off by pressing the FN key and the ESC On Off key simultaneously A Gently wipe the screen andkeyboard with a soft clean dry cloth 3 Wipe the plastic portions of the programmer and the wand with an isopropyl alcohol moistened cloth 4 Dry the programmer immediately to remove residue Programmer End of Life The programmer andvaccessories are designed to provide years of service undertypical use To dispose of return or exchange a programmer contact your local Cameron Health representative or Customer Service Department for instructions and return packaging 64 Q TECH PROGRAMMER TROUBLESHOOTING Troubleshooting This section presents potential programmer issues and the possible solutions Of note resetting the programmer can often resolve m
59. timization has not been completed This message is typically displayed following the implant procedure as Setup Optimization was not performed Figure 20 31 Q TECH PROGRAMMER OPERATION 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 Therapy On Patient Name is NOT complete is NOT valid Select Continus to disconnect from the davice Figure 20 Session incomplete message Note Oncethe Continue button is selected the session is stored and communication isterminated Note norder toconfirm that Automatic Therapy isprogrammed On upon disconnection always use the End Session process and review all displayed warning messages Programming the SQ RX Device at Implant This section provides he information necessary f r programming the SO RX device during an implant setting Entering Electrode Information The programmer maintains information on the implanted electrode To record this information for a patient s new or replacement electrode Select the Main Menu button Select the Implant button Select the Automatic Setup button in the Navigation Bar Select Set Electrode ID button Figure 21 pope po 32 Q TECH PROGRAMMER OPERATION Therapy Off M Automatic Setup Figure 21 Selectthe Set Electrode ID button to enter electrode information Enter the electrode model and serial nu
60. ttings screen 2 Select the desired date format 3 Select the Automatically Adjust for Daylight Savings Time button ro initiate the daylight savings option A green checkmark will appear when thisfeature is active 4 Select the Save button to save the changes and return tothe Programmer Settings screen or select Cancel to return to the Programmer Settings screen without saving the changes Time Zone To set the time zone in which the programmer will be used iF Select Set Time Zone on the Programmer Settings screen The Set Time Zone screen appears 2 Select the country time zone button for the zone in which the programmer will be used A green checkmark will appear in the selected button Figure 11 The SQ RX device line frequency of 50 Hz or 60 Hz is automatically programmed based on the country time zone selected 20 Q TECH PROGRAMMER OPERATION Set Time Zone K L Me Standard Time A D e e X 6 00 Central Standard Time US amp Canada Ke WM a wm s o or Figure 11 TimeZone selection screen 3 Select the Save button to save the changes and return to the Programmer Settings screen or select Cancel to return to the Programmer Settings screen without saving the changes Language Preference To set the language preference 1 Select Set Language on theProgrammer Settings screen The Language Settings Screen appears 2 Selectithe Save button to save the changes and return to the P
61. uding any downloaded episodes Patient Data Programmed Device Settings To view stored patient sessions d From the Startup screen select Stored Patient Sessions Select the desired patient session Q TECH PROGRAMMER OPERATION Modes of Operation for the SQ RX Device The SQ RX device has three modes of operation Shelf e Therapy On e Therapy Off Shelf Mode The Shelf mode isa low power consumption state intended for storage only When communication is initiated between the SO 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 SO RX device is taken out of Shelf mode it cannotbe reprogrammed backinto Shelf mode Therapy On Mode The Therapy On modeisthe primary operating mode ofthe SO RX device allowing automatic detection of and response to ventricular tachyarrhythmias Note The SO RX device must be programmed out of Shelf mode before being programmed to Therapy On Therapy Off Mode The Therapy Off 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 Off mode when the SQ RX device is taken out of Shelf mode Note X Manual and rescue shock therapy are available once the initial Setup proc
62. ure 13 22 Q TECH PROGRAMMER OPERATION Enter a name for the new printer or sctect Cancel to select a different printer Ne Default Printer b Figure 13 Use the keyboard to enter a name for the selected printer Select the Save button to save the changes and return to the ProgrammerSettings Screen or select Cancelto return to the Programmer Settings screen without saving the changes A confirmation screen will appear when the printer setup is completed Figure 14 E printe Printer Setup Printer setup successfully complete 4 Figure 14 Printer Setup confirmation screen 23 Q TECH PROGRAMMER OPERATION Programmer Software Version To view the programmer s software version S 1 Select About Programmer on the Programmer Settings screen The Programmer Software Version Information screen appears Figure 15 hE e o al gt XS xO 7 o Q e ee Xo 9 OE QA M C 8 mmm mm Rp D 3S OU x ie mans D Q ad o o Seine Pr vet Ges Q i ot cum es 8 AN ue ont turn r Sett gt A W Ws H EE ep ajticon ersten programra oftware versi N OU MC QM RS e SE y OV d eA eg E LS S C RNC i se L o NI G4 V xS U O Gi N XO o S Qe SS NM A A gt Su NO Oo ON Q TECH PROGRAMMER OPERATION Modes of Operation for the Q TECH Programmer Online Behavior The programmer s interface variesaccording to whether the programmer is Online actively communicating or Offline n
63. vcssessscscsssrscscesesesssrsescasssescsserecscasesesssrscecassveseseers 17 Configuring the Q TECH Programmer eege Eug a EYE dp Eege EE EVE kN a ViRE EVE TT v Evo hY a ova 19 Configuring Seier de e GE 19 Dateand RN inet 20 MNE LONO eee ae enn Ac OMM os dM eae 20 Language Preference ng erases goes Wu E E 21 Printer Selection P qud 3 21 Programmer ge NIE SNR 24 Modes of Operation for the Q TECH Programmer creen e ee eee eee eee eee eee e n eee ee eese e eoo 25 Online Beha yor MN eed e WEE WEE Ce N T X TE 25 Offline Bahra vid N ADe S ME eee QN gt nnne nter tete tenus 25 Modes of Operation for the SQ RX Device 1 ee ecce eee eee eee o eee eee eese eee ee sete etes esee eoo 27 VRSIT MONS siemens esi Noo Nn Nasa user FG o b p poU 27 J hera On Mq Nue AW NEE ie eere Re eene e A 27 TheNipy Of amp Mibde 43 5 Ne Qr E teenteneneanos 27 Connecting and Disconnecting from the SQ RX Device 7 15 cere eere eee eee eee ee eee eeu 28 Scanno FareS viceswe M o c ECK A eem N eere eee nenen eene EE 28 CennectinQYXo thec4 RX BI Ce AQ eeu ww eem eere perenne G 29 Connecting to an SQ RX Device in Shelf Mode eelere gatecsseseseesesescseesesees 30 Endim a Patient Session GN NN ee NC EE N od eee NE TE 31 Programming the SQ RX Device at Implant 5 eoe L 1 Lee eee e ede p e
64. wer Systems MW2415 mag m CU CU Bboy WS ond LU Xv Temperature 15 Cto 38 C EL on 4 55 59 F to 100 F P14 F to 131 F Relative Humidity 5 to 93 maximum at 40 C 5 to 93 maximum at 40 C non condensing hon condensing Table 9 Specifications Dimensions 24 cem x 18 Cm x 4 0 cm Width x Depth x Height 9 3 inx 7 2 in x 1 4 in Weight 1 1 kg 3 0 lbs Includes 2200 mAh battery pack Standard Screen Display High Quality SVGA 600 x 800 pixels 16 bit color display with backlight stylus and touch screen sensitive 71 Q TECH PROGRAMMER DEFINITION OF PACKAGE LABEL SYMBOLS Table 10 Packaging Symbols Q TECH Programmer Symbol Specification Symbol Specification Type BF Applied Part Symbol Indicates connection of Type BF applied European Community Representative Authorized representative in the EU community Do Not Dispose Do not dispose of this product Ip the unsorted municipal waste KE stream Disposeof this product according to ocal regulations Serial Number Serial number of the device Conformit Europ enne Product fully complies with European Directive AIMD 90 385 EEC NS Keep Dry Ship and store in a dry place Electrostatic Discharge Identifies Geh a connector not tested for immunity to electrostatic discharge Product Drawing Used for visual Q identification of product 72 Manufacturer Name and address of the manufacturer Storage

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