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PACE203H - Instructions for Use

1. eccceeeceeseeeeeeeeeeeeeseeeeeseeeseeeeseees IEC 60601 1 IEC 60601 2 31 Type CF protection against electric shock EM amp standards u er ee IEC 60601 1 2 IEC 6100 4 2 IEC 61000 4 3 CISPR 11 class B European Classification ersseersnensnnensnnennnenennn Class IIb according EC directive 93 42 ECC US Classification ccccccsssccceesseeeeesseeeesseeeeessneeees Class III according 513 FD amp C 21 CFR 862 892 807 87 c Product code 74DTE according 21 CFR 870 3600 We reserve the right to make changes without notice E Option not available in USA and Japan 104 129 51 17 016X B 18 PACE 203H Instructions for Use 14 Delivery Unit The PACE 203H is delivered in a carrying case with the following content e PACE 203H DDD Temporary Cardiac Pacemaker e 9V Battery e PACE 203H User s Manual e PACE 203H Quick Reference Guide See Appendix F PACE 203H Accessories on page 127 for accessories such as exten sion cables and adaptors 51 17 016X B 18 105 129 PACE 203H Instructions for Use 15 Conditions of Guarantee and Liability Restrictions OSYPKA AG warrants each new PACE 203H excluding batteries to be free from defects in materials and workman ship for a period of two 2 years follow ing delivery of the unit to the original purchaser If our examination of the PACE 203H discloses a defect to our reasonable satisfaction then we will repair or replace the defective parts
2. The equipment is intended for use in an electromagnetic environment in which radiated RF distur bances are controlled The customer or user of the PACE 203H can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the PACE 203H as recommended below according to the maximum output power of the communications equipment Rated Separation distance according to frequency of transmitter maximum m output 150 KHz to 80 MHz 150 KHz to 80 MHz 80MHzto 800 800MHzto25 power of outside ISM bands in ISM bands MHz GHz transmitter TE a 2 We d l2WP d 23WP Vi 2 0 01 0 04 0 12 0 12 0 23 0 1 0 11 0 38 0 38 0 73 1 0 35 1 2 1 2 2 3 10 1 1 3 8 3 8 7 3 100 3 5 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distances din meters m can be determined 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 The ISM industrial scientific and medical bands between 150 KHz and 80 MHz are 6 765 MHz to 6 798 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz NOTE 3 An additional factor of 10 3 is
3. one can switch between Options Menu 1 and Options Menu 2 51 17 016X B 18 PACE 203H Instructions for Use Options Menu 1 Key No Beep oO 1 Alarms M 2 Tage O s more 4 T 5 Table 51 Options Menu 1 By pressing the softkey labeled Options in the Parameters Options Menu the Option Menu 1 for enabling and disabl ing acoustic signals beep alarms and atrial trigger appears as shown in Table 51 The user language can be set via the Options Menu 2 by pressing the softkey labeled Language as shown in Table 52 The meaning of the second line in Op tions Menu 2 is explained in sections 9 20 page 70 and 9 21 page 72 The statistic feature from the third line is explained in section 9 13 on page 58 51 17 016X B 18 Options Menu 2 Key No Language 1 PMC O BPI 2 Statistics 3 more 4 Tt 5 Table 52 Options Menu 2 9 12 5 1 Enable and Disable Acoustic Indicator With the softkey labeled Beep in the Options Menu 1 the acoustic indicator can be enabled or disabled The corres ponding check box then gets checked or unchecked respectively If the acoustic indicator is enabled the symbol for a loudspeaker see Figure 7 appears in the upper display Figure 7 Acoustic Indicator Symbol for a Loudspeaker With the acoustic indicator enabled the delivery of a stimulus is indicated by a high pitched tone beep whereas sens ing of a P or R wave will be signaled by a beep of low
4. IEC 61000 4 6 150 KHz to 80 MHz 150 KHz to 80 MHz outside ISM bands outside ISM bands Recommended separation distance 10 Vrms 10 Vrms 150 KHz to 80 MHz 150 KHz to 80 MHz 3 5 in ISM bands in ISM bands d NP RadiatedRF 10 V m 10 V m LV IEC 61000 4 3 80 MHz to 2 5 GHz a 2 P vz d l1 2VP 80 MHz to 800 MHz d 2 3 VP 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W 51 17 016X B 18 117 129 PACE 203H Instructions for Use according to the transmitter manufacturer and dis the recommended separation distance in meters m Field strength from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol Kp NOTE 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 affected by absorption and reflection from structures objects and people a The ISM industrial scientific and medical bands between 150 KHz and 80 MHz are 6 765 MHz to 6 798 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz b The compliance levels in the ISM frequency bands between 150 KHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz are intended
5. The VAT mode may be useful in situa tions where no ventricular sensing is possible for instance because of inter ference or when A V synchrony must be maintained upon a complete A V block 9 6 10 Non Pacing Mode 0DO Pause In this mode sensing is enabled in all channels but not pacing The PACE 203H is listening to intrinsic atrial and ventricular events only The ODO mode is utilized to check the patient s intrinsic activity see chapter 9 15 or to get initial values for the Auto Sense feature see chapter 9 9 4 It must be used with great caution on patients depending on a pacemaker 9 6 11 Atrial Trigger Modes DDD AT and DAT If Atrial Trigger option see chapter 9 12 5 3 is activated an atrial stimulus is delivered any time an atrial activity is sensed and with the atrial channel not being refractory The Atrial Trigger is enabled when either AAI gt AAT or DDD gt DDD AT or DAI gt DAT modes are set 27 129 PACE 203H Instructions for Use 9 7 Changing the Mode of Op eration If the lower display is switched on it always displays the Mode Menu first Each of the primary modes DDD VVI AAI VDD can now be selected by the touch of the corresponding softkey Table 9 If the lower display is off it can be turned on pressing the key Unlock Lock In the event that another menu is displayed pressing the t_ softkey will switch to the mode menu immediately Mode Menu K
6. 1 5 x Rate ppm 50 250 ms Table 18 Automatic Setting Equation for A V Delay If the A V DLY dial has been rotated to deactivate Auto A V delay the transient message Auto AVD turned off appears in the lower display accompa nied by a short beep and AUTO disap pears from the upper display To deactivate Auto A V Delay in the Auto menu the softkey labeled Auto AVD must be pressed again This causes the check mark to disappear from the cor responding check box and AUTO from the upper display 9 9 2 Automatic Setting of PVARP with the Setting of Rate If this feature is enabled the PACE 203H automatically adjusts the post ventricular atrial refractory period PVARP with the setting of the basic rate To activate Auto PVARP the softkey labeled Auto PVARP in the Auto Menu must be pressed The corresponding check box then gets checked The PACE 203H now adjusts the PVARP depending on the basic rate according to the formula in Table 19 and rounded to the nearest manually adjust able value see chapter 9 12 1 In the 33 129 PACE 203H Instructions for Use upper display the label AUTO PVARP indicates that the Auto PVARP feature is activated Automatic PVARP Range Unit PVARP 100 50 ns 330 0 75 x Rate ppm 0 Table 19 Automatic setting formula for PVARP To deactivate Auto PVARP the softkey labeled Auto PVARP in the Auto menu must be pressed again Thi
7. DDD standard parameter Plus 1 day reserve after first appear ance of the battery change message Continuous displaying of battery depletion symbol blinking of last segment and acoustic warning when the time to charge lev el is reached 7 2 0 2 V blinking the empty depletion symbol and acoustic warning when an immediate battery change is required 5 5 0 5 V Minimum 30 s 103 129 PACE 203H Instructions for Use Mains operation vant ier batted Sie tateitieeiets with battery inserted indication by LED Operating temperature unnsessseessnnnnnnnnnnennnnnnnnnnn 10 C 50 F 45 C 113 F Storage temperature w o battery u 20 C 4 F 60 C 140 F Operation in explosion hazard areas The device may not be used in areas where flammable agents are present Housing dimensions LXWXxD uunzennenersnnnnennenenen een Approx 200 mm x 96 mm x 38 mm Overall dimensions LXWxD 20 nenn Approx 212 mm x 96 mm x 51 mm with terminals and dials Weight without battery ueessnenersennnnensnnnennnnnnnenennennn Approx 445 g Weight with battery uusnneerssnenersennnnen ernennen nennen Approx 490 g Lead connections 2244400unnnnnnnnnnnnnnnnnnnnnnnnnnnn Protected terminals collets for plugs with 0 9 mm 2 0 mm diameter Otherinterface 2 c sects ieee ran Intra aortic balloon pump interface Safety standards
8. The sensitivity is adjustable in the range and with the steps shown in Table 15 Parameter Adjustable Values Unit 0 2 0 1 2 0 2 0 0 2 5 0 Atrial ial 5 0 0 5 10 0 um Sensitivity 10 0 1 0 20 0 no sensing 1 0 0 1 2 0 2 0 0 2 5 0 Ventricular icul 5 0 0 5 10 0 my Sensitivity 10 0 1 0 20 0 no sensing Table 15 Adjustable Values for Sensi tivity step width in parenthesis Warning Increasing the mV values indicates decreasing the sensitivity An atrial value of 0 2 mV and a ventricular value of 1 0 mV represent the highest sensitivity in the respective channels The value infinite results in an asyn chronous mode for the corresponding 31 129 PACE 203H Instructions for Use channel An inhibition of the stimulation pulse in this channel is not possible 9 8 4 Adjustment of A V Delay By rotating the A V DLY dial clockwise the A V delay will become extended within the range shown in Table 16 The actual A V delay and the parameter intensity bar diagram can be observed in the upper display The parameter inten sity bar diagram corresponds to the A V delay The leftmost bar represents the timely occurrence of the atrial event and is always displayed A second bar represents the timely occurrence of the ventricular event and is shifted right or left related to the increase or decrease the A V delay respectively Adjustable Parameter Vaides Unit
9. 14 Delivery Unit 15 Conditions of Guarantee and Liability Restrictions 16 Appendix A Glossary 6 129 75 76 77 77 77 78 79 79 79 79 80 81 83 83 83 83 84 84 87 89 91 93 95 95 95 96 97 99 101 105 107 109 51 17 016X B 18 PACE 203H Instructions for Use 17 18 19 20 21 22 Appendix B Menu Tree Appendix C EMC Guidance and Manufacturer s Declaration Appendix D List of Figures Appendix E List of Tables Appendix F PACE 203H Accessories Appendix G Declaration of Conformity 51 17 016X B 18 113 115 121 123 127 129 7 129 PACE 203H Instructions for Use 1 Preface 1 1 General Read these instructions carefully before using the product described within Should you have any questions about these instructions or the use of this product please contact the customer service department before using the product Phone 49 7623 7405 0 The product may only be placed in ser vice when its proper use can be assured According to U S Standards the PACE 203H is a Class Ill device 21 CFR 862 892 807 87 c According to European Standards the PACE 203H is a Class IIb medical prod uct Council Directive 93 42 EEC of 14 June 1993 Medical Device Direc tive Annex IX 1 2 Checking the Delivery Unpack the product and carefully check to see if any damage has occurred in shipment Check to see if everything was delivered as listed on the shipping
10. Instructions for Use 9 19 AC Power Supply Op tion Option not available in USA and Japan Although operation of the PACE 203H always requires a 9 V battery with suffi cient charge a medical grade AC power supply PACE 203H accessory can be used While the PACE 203H is powered by the AC power supply the 9 V battery inside the PACE 203H is not discharged It is for safety reasons that the battery must stay inside the PACE 203H during AC operation The PACE 203H indicates AC operation with a green LED labeled Mains be tween the keys Off and On For connecting the PACE 203H to AC power please adhere to the following instructions 1 Turn off the PACE 203H 2 Lift the cap that protects the terminal CTRL OUT see Figure 2 3 Insert the connector of the AC Power Supply into the terminal CTRL OUT Secure the connection by manually turning the collets clockwise 4 Insert the wall power supply into a mains socket 5 Control the proper lighting of the green Mains LED 6 Turn on the PACE 203H in the usual way Warning If the green LED Mains does not light the PACE 203H operates bat tery powered with the specified battery lifespan 51 17 016X B 18 69 129 PACE 203H Instructions for Use 9 20 Controlling an Intra Aortic Balloon Pump Op tion Option not available in USA and Japan In combination with the optional BPI 202 Balloon Pump Interface the PACE 203H can control the triggering of an in
11. Longest Series VP Largest series of consecutive ventricular paced cycles maxVP during Runtime and the percentage with respect to the Total Cycles Cycles with Extrasystoles Number of premature ventricular contractions PVC PVC during runtime and the percentage with respect to the Total Cycles Page IV Artifacted Cycles Number of distorted cycles during runtime and the per XC centage with respect to the Total Cycles These are for example cycles with disconnected or shorted pacing leads or cycles with distortions from noise 58 129 Table 54 Statistical Parameters 51 17 016X B 18 PACE 203H Instructions for Use Runtime Statistics Ah AB mir Runtime Settings Uncharged Pacer Settings Cycles 42 Total Cycles Statistics Screen WS BBB 2 Ventricular 4 Senged Cycles masAP 166 88 Longest Series 42 AF mar F 106 00 3 Longest Series 42 up Statistics Screen III AP 106 00 Atrial 42 Paced Cycles VP 166 88 3 Ventricular 42 Paced Cycles AS 6 88 Atrial Sensed Cycles Statistics Screen II PUG AAR 4 Cycles with 4 Extrasystoles HE A B K Artifacted Cycles Reset Statistics Statistics Screen IV Figure 9 Displays of Statistics automatically alternating Repeated pressing of the softkey labeled more toggles between the four differ ent statistics screens IV see Figure 9 The content of each statistics screen automatically alternates between the display of heade
12. Manufacturer s Default Programs Turn On program when the question Overwrite Turn on program is ans wered with YES Table 39 9 11 5 Changing the Turn On Pro gram By pressing the softkey Save as Turn on in the Standard Menu Table 35 the actual setting will become the permanent 51 17 016X B 18 49 129 PACE 203H Instructions for Use Turn on Saving Key No Confirmation Overwrite Turn on program 2 YES 3 NO 4 te 5 Table 39 Turn on Saving Confirmation After storing the user defined Turn on Program the PACE 203H abandons the Turn On Menu and returns to the Mode Menu is answered with NO the PACE 203H returns to the previous Standard Menu Pressing the t_ key forces the PACE 203H to revert to the Mode Menu Note Upon the manufacturer s shipping of the PACE 203H the Turn On Pro gram parameters are set according to Table 40 50 129 Parameter Value Unit Mode DDD Basic Rate 60 ppm Overdrive Stimulation Start Rate 240 ppm Atrial Amplitude 5 V Atrial Sensitivity 0 5 mV Atrial Pulse Duration 1 ms Ventricular Amplitude 8 V Ventricular Pulse Duration ae ns Ventricular Sensitivity 1 mV AUTO A V Delay i e 200 ms AUTO PVARP i e 280 ms AUTO MIR i e 100 Pen Automatic Sensing OFF Atrial Trigger Option OFF Table 40 Manufacturer s Turn on Pro gram Warning The Manufacturer s Turn on program is intended to provide a safe and conservative pac
13. Warning The PACE 203H must not be submerged in either water or in any other cleaning solution Do not use any scrubbing powder liquid on the device The device must not be sterilized in an autoclave Sterilization with ultrasound or gamma rays is also not permitted The PACE 203H can be damaged by such procedures The PACE 203H can be sterilized with gas The battery has to be removed A temperature of 55 C and a relative hu midity of 90 must not be exceeded The pressure must not exceed atmos pheric pressure The procedure given in the instructions for use of the sterilization equipment shall be followed For valida tion approved methods must be used Re usable cables must be cleaned disinfected and sterilized after each use Single use cables must not be re used 51 17 016X B 18 11 2 Changing the Battery While the device is in use the battery should be changed when the battery depletion symbol shows only one blink ing segment and the warning message Change battery appears The amount of time remaining from this moment until the battery is completely drained de pends implicitly on the type of battery used and therefore cannot be predicted with absolute certainty Typically one day of reserve energy can be expected with the recommended battery if the PACE 203H is set to a mode with stan dard parameters During a battery change the PACE 203H is capable of maintaining conti nuous operation for at least 3
14. for Ventricular Rapid Pacing 44 Menu while Ventricular Rapid Pacing RUNNING cceeseeeeeseneeeeeeneeeeeneeeees 44 Standard Menis scs cst weet Hallen Be ee eee 46 Standard Programs Set uncut nn 47 Standard Saving Confirmation ccccccceeseeeeeeeeeeeeeneeceeeeeeeeeeeeseeeeeeeseneeeeaes 48 Manufacturer s Default Programs uuu 2444444Hnnnn ne nnnnnnnnnnnnnnennnnn nennen ernennen 49 Turn on Saving Confirmation 20u4s44ersnnnsnnennnnennnnnnnnnnnnnnnnnnnennnnnnnnennnnnnnnn 50 Manufacturer s Turn on Program uuezeesserssnenensennnnerennnnnnennnnennennnnn nennen nnnnnnn nen 50 Parameters Options Menu 1 2404s2444nnsnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nenn 51 PVARP amp MTR Menu 2 einsehen 51 Manually Adjustable Values for PVARP step width in parenthesis 52 PVARP amp MTR Menutwis2a tates nite Raced hen ened dbin dated 52 Manually Adjustable Values for MTR step width in parenthesis 53 PulseiDuration Menu v 35 aici helene le ee oc aes 53 Manually Adjustable Values for Pulse Duration step width in parenthesis 53 ARP e VRP MENU maineira e hie ii ie ei 54 Manually Adjustable Values for ARP AAI AAT seeren 54 Manually Adjustable Values for VRP ssssessssssesesrsesrrreerrrssrirrssrirnerrrnsrrrrsernnse 54 Options Menu EAEEREN 55 Options Menu 2 an tele a eon eee Aes 55 Language Menu eA ee Ae 57 Statist
15. of the PACE 203H with defibrillators or electro surgical instruments Table 1 Possible Complications 12 129 51 17 016X B 18 PACE 203H Instructions for Use 6 Precautionary Measures The following and Warnings list presents important precautionary measures and warnings Further important precautionary meas ures and warnings will be found in the following chapters 1 In order to prevent unnecessary complications the PACE 203H should only be applied and used by medical personnel with extensive ex perience in cardiac stimulation thera py Additionally the person using the device should be thoroughly familiar with the contents of this instruction manual All lead systems are to be connected to type CF devices only because of the danger of current being diverted to the heart Devices that are con nected to a main supply pose in creased danger for current diversions to the heart Make sure that all devices in the vicinity of the patient are properly grounded The stimulation leads provide a di rect low resistance current path to the heart Therefore it is absolutely necessary that the connector plug is not touched with bare hands or come in contact with electrically conductive or wet surfaces All possible static electricity sources must be kept away from the stimulation system While the lead is being inserted and connected to the pacemaker conti nuous ECG monitoring is mandatory F
16. or when A V synchrony must be maintained upon a complete A V block 9 6 8 The A V Sequential Ventricular Inhibited DVI Pacing A V sequential ventricular inhibited DVI pacing provides pacing in both the atrium and the ventricle but sensing only in the ventricle This mode is implicitly selected by setting first the DDD mode and second the atrial sensitivity to infi nite Thus sensing in the atrial channel is disabled Note With the DVI mode implicitly set the following exceptions are taking place 1 The PACE 203H specific algorithm for determining extrasystoles is dis abled In DVI mode the PACE 203H cannot differentiate between high in trinsic rates and occurrences of extrasystoles because the atrial sensing is disabled 2 If another R wave is detected during the V A delay the V A delay will be initiated with a value equal to the dif ference between the beat to beat in terval and the A V delay 9 6 9 Atrial Sensing Atrial Synchron ous P Tracking VAT Pacing In atrial synchronous P tracking VDD pacing mode the PACE 203H stimulates only in the ventricle but senses in the atrium only If intrinsic atrial activity oc curs a ventricular stimulus is delivered after the P V delay This mode is implicitly selected by first setting the VDD mode and second the 51 17 016X B 18 ventricular sensitivity to infinite Thus sensing in the ventricular channel is disabled
17. stored may also be one of the supple mentary modes D00 DVI VAT VOO A00 AAT and DDD AT Warning Because the automatic condi tion of the sensitivity adjustment is also stored recalling a standard setting with Auto Sense ON is followed by the request to search for initial sensitivity values as described in chapter 9 9 4 3 Therefore storing a standard program 51 17 016X B 18 with Auto Sense activated is only rec ommended for experienced users Note Upon the manufacturer s shipping of the PACE 203H the user standard settings are identical with the manufac turer s defaults see chapter 9 11 4 9 11 2 Store Standard Programs By pressing the softkey labeled Save as XXX standard in the Standard Menu Table 35 the actual setting will become the standard for the current primary 47 129 PACE 203H Instructions for Use mode XXX stands for one of the primary modes DDD VVI AAI or VDD upon answering the question Overwrite stan dard XXX program With YES Table 37 Standard Saving Confirmation Key No 4 Overwrite standard XXX program 2 YES 3 NO 4 1_ 5 Table 37 Standard Saving Confirmation After storing the user defined Standard Program the PACE 203H abandons the Standard Menu and returns to the Mode Menu If the question Overwrite standard XXX program If answered with NO the PACE 203H returns to the previous Standard Menu 48 129 Pressing the softkey t_ forces the PACE
18. te 5 Table 29 Atrial High Rate Standby Menu The atrial high rate stimulation frequency can be adjusted by using the RATE dial This means that the RATE dial defaults into a HIGH RATE dial for adjustment of the atrial high rate stimulation frequency as long as the Atrial High Rate Standby Menu is present This is indicated by a blinking symbol HI in front of the label RATE together this forms HI RATE in the upper display The atrial high rate stimulation frequency can be changed in 10 ppm increments between 7O ppm and 1000 ppm as shown in Table 30 Adjustable Values Unit Parameter Atrial High Rate 70 10 1000 ppm Table 30 Range and step width in pa renthesis for Atrial High Rate 51 17 016X B 18 The PACE 203H delivers atrial high rate stimulation impulses upon pressing and holding the softkey labeled START The pacemaker switches to the A00 mode and stimulates with the set atrial high rate stimulation frequency showing the Atrial High Rate Running Menu Table 31 To return to the mode menu Table 9 on page 28 please press the key _ Warning There is a risk of causing ventricular tachycardia during atrial high rate stimulation Continuous ECG moni toring of the patient is therefore manda tory A defibrillator should always be available and ready to use Note During atrial high rate stimulation the PACE 203H switches temporarily as long as the START Atrium key is pr
19. 016X B 18 PACE 203H Instructions for Use 9 22 7 1 Possible Conflicts Conflicts can occur in the process of changing parameter settings In the tables below all possible cases are listed together with the transient conflict warning message which will be dis played on the lower display In case of a conflict the parameter to be changed is limited to a value still permissible The acronyms in the tables have the following definitions A Value to be increased a Value to be decreased A Parameter is set to Automatic Setting M Parameter is set to Manual Setting Basic Rate MTR Message Increase MTR to increase Rate Decrease Rate to decrease MTR Table 61 Conflicts Type a Basic Rate AVD PVARP Message M M Decrease PVARP or AVD to increase Rate a A M Decrease PVARP to increase Rate a M A Decrease AVD to increase Rate a A M Decrease PVARP to decrease Rate a M A Decrease AVD to decrease Rate M a MorA_ Decrease PVARP or Rate to increase AVD M MorA a Decrease AVD or Rate to increase PVARP 51 17 016X B 18 Table 62 Conflicts Type b 81 129 PACE 203H Instructions for Use Basic Rate AVD Message a M Decrease AVD to increase Rate M a Decrease Rate to increase AVD Table 63 Conflicts Type c Basic Rate AVD PVARP MTR Message PVD a A A
20. 203H to revert to the Mode Menu 9 11 3 Recall Standard Programs By pressing the softkey labeled Recall XXX standard in the Standard Menu Table 35 the stored standard program for the current primary mode XXX stands for one of the primary modes DDD VVI AAI or VDD becomes the actual setting After pressing the softkey labeled Recall XXX standard the PACE 203H aban dons the Standard Menu and returns to the Mode Menu 9 11 4 Recall Manufacturer s Defaults By pressing the softkey Manufacturer s default in the Standard Menu Table 35 the manufacturer s default for the current primary mode as shown in Table 38 becomes the actual setting After pressing the softkey Manufacturer s default the PACE 203H abandons the Standard Menu and returns to the Mode Menu 51 17 016X B 18 PACE 203H Instructions for Use Parameter DDD VVI AAI VDD Unit Basic Rate 72 72 72 72 ppm Atrial Overdrive Stimulation 240 240 u ppm Start Rate Ventricular Rapid Pacing 180 180 180 ppm Start Rate Atrial Amplitude 5 Ze 5 u V Atrial Sensitivity 1 1 0 5 mV Atrial Pulse Duration 1 1 ms Ventricular Amplitude 8 8 5 8 V Ventricular Pulse Duration 0 75 0 75 0 75 ms Ventricular Sensitivities 2 2 2 mV A V Delay AUTO u AUTO ms i e 180 i e 180 PVARP AUTO AUTO ms i e 280 i e 280 MTR AUTO AUTO ms i e 106 i e 106 Automatic Sensing OFF OFF OFF OFF Atrial Trigger Option OFF OFF Table 38
21. A V Delay 5 10 10 400 ms Table 16 Adjustable Values of A V De lay step width in parenthesis The P V delay PVD is coupled with the A V delay AVD Adjusting the AVD also sets the PVD By default the difference AVD PVD is equal to 30 ms that is PVD is 30 ms shorter than AVD Note When atrial Auto Sense is enabled the A V delay and P V delay are limited to a minimum of 30 ms This is because Auto Sense requires a speci fied time to measure the intrinsic atrial activity In case the atrial Auto Sense is enabled and the A V delay was set to a value smaller than 30 ms then the A V delay will be automatically extended to 30 ms This action is indicated by a tran 32 129 sient informative message in the lower display see also chapter 9 9 4 Note Because of its safety feature pro tection against abnormal settings see chapter 9 22 7 the PACE 203H pre vents increasing the A V delay to a val ue which would not guarantee a mini mum atrial sensing phase in dual cham ber demand modes or a minimum V A interval in the DOO mode respectively The limitation of the A V delay value will be indicated by a transient warning mes sage in the lower display 9 9 Using the Automatic Fea tures The PACE 203H offers the capability for automatic setting of A V delay PVARP and maximum tracking rate MTR with the setting of rate as well as for automat ic adjustment of sensitivity To enable these f
22. Deutsch Zyklen mit Extrasystolen l 3 o Sprache PMCO BPI Statistische Daten 3 oja Atrial Trigger Laufzeit Laufzeit der AP 100 00 Atriale stimu Ventrikul re PVC 0 00 O h 00 min Statistik 42 lierte Zyklen wahrg Zyklen 0 Einstellungen Schrittmacher VP 100 00 Ventrikul re 00 L ngste stimu unver ndert Einstellungen 4 stim Zyklen 42 lierte A Serie Gest rte Zyklen Atriale wahrg La i Statistik Statistik Zyklen zur cksetzen zur cksetzen lt Statistikbil schirm Statistikbildschirm I Statistikbildschirm Ill Statistikbildschirm IV Figure 17 Graphical Schema of Menu Tree Part 2 114 129 51 17 016X B 18 PACE 203H Instructions for Use 18 Appendix C EMC Guidance and Manufacturer s Declaration The PACE 203H needs like every medical electrical device special precautions regarding electromagnetic compatibility EMC This section is intended to give the user guidance and information about all aspects to ensure that the PACE 203H operates as intended in an electromagnetic environment Guidance here given must be followed for putting PACE 203H into service The user must be aware that the use of leads and patient cables other than those specified in the instruction for use may result in increased electromagnetic emissions or decreased electromagnetic immunity The PACE 203H should not be used adjacent to or stacked with other equipment If adja cent or stacked use is ne
23. F and 25 C 77 F Keep out of direct light If damage to the package is detected before use the cable must be repacked in a gas permeable container and re sterilized with ethylene oxide gas at a maximum temperature of 50 C 122 F and a maximum overpressure of 1 7 bar Sterilization must be accomplished in accordance with the instructions of the gas sterilizer manufacturer After sterili zation aerate the items before use to permit escape of residual ethylene oxide Warning Connector cables intended for single use must not be re sterilized after use 51 17 016X B 18 Warning In case the PACE 203H is not to be used for longer periods of time the battery must be removed in order to prevent damage from possible battery acid leakage Damage because of a leaking battery is not covered by the manufacturer s guarantee 93 129 PACE 203H Instructions for Use 11 Care and Maintenance 11 1 Care and Cleaning As a precision electronic device the PACE 203H must be handled with cor responding care Although the device is robustly constructed it can be damaged by heavy mechanical stress for exam ple by dropping on a hard surface The enclosure and the keypad of the PACE 203H are protected against acci dental liquid spills To clean the device use a towel or sponge moistened with water or alcohol For disinfection the enclosure of the PACE 203H can be cleaned with alhy dex cydex or with detergicide
24. Message Conflict Error Chapter Decrease The user has attempted to PVARP and or rate must be de 9 22 7 PVARP or increase A V delay This led creased before A V delay can be Rate to conflict type b because further increased to increase there is inadequate time for a A V Delay long A V delay in the pres ence of a high rate and a long PVARP Decrease The user has attempted to The rate must be decreased before 9 22 7 Rate increase A V delay This led A V delay can be further increased to increase to conflict type c because A V Delay there is inadequate time for a long A V delay in the pres ence of high rate Decrease The user has attempted to PVARP and or MTR must be de 9 22 7 PVARP or increase A V delay This led creased before A V delay can be MTR to conflict type d because further increased to increase there is inadequate time for a A V Delay long A V delay in the pres ence of a high MTR and a long PVARP Decrease The user has attempted to A V delay and or rate must be 9 22 7 A V Delay increase PVARP This led to decreased before PVARP can be or Rate conflict type b because further increased to increase there is inadequate time for a PVARP long PVARP in the presence of a high rate and a long A V delay Decrease The user has attempted to A V delay and or MTR must be 9 22 7 A V Delay increase PVARP This led to a decreased before PVARP can be or MTR conflict type d because further increased t
25. activity ventri cular or atrial stimulation impulses will be given with the set basic rate The recog nition of a P wave in AAI mode in the pacemaker s sensing phase inhibits the delivery of the next stimulation impulse resets the timing of the pacemaker to the beginning of the beat to beat interval and starts the refractory period 9 6 6 Atrial Synchronous P Tracking VDD Pacing In atrial synchronous P tracking VDD pacing mode the PACE 203H stimulates only in the ventricle senses in both atrium and ventricle and responds both by inhibition of ventricular output by intrinsic ventricular activity and by ventri cular tracking of P waves A sensed P wave initiates the P V delay During the P V delay the atrial channel is refractory At the end of the P V delay a ventricular stimulus is delivered if no intrinsic ventricular activity has been sensed that is P wave tracking Ventri cular activity paced or sensed initiates the PVARP and the V A delay If no P wave activity occurs during the V A delay the A V delay is initiated During the A V delay the atrial channel is re fractory If no R wave activity occurs during the A V delay the PACE 203H delivers a ventricular pacing stimulus upon termination of the A V delay 26 129 9 6 7 Dual Chamber Pacing and Sensing with Inhibition and Tracking DDD This pacing mode provides dual chamber pacing and sensing with inhibi tion and atrial tracking If intri
26. again via the has been turned Auto Sense Menu and avoid turning the V SENSE dial Switch Atrial Atrial Auto Sense and Atrial Act according to the message 9 9 4 Auto Sense Trigger cannot be enabled at the 9 12 5 3 off to enable same time because the trig Atrial Trigger gered stimulation prevents proper measurement of the intrinsic atrial activation 51 17 016X B 18 91 129 PACE 203H Instructions for Use PACE 203H Meaning Cause Measures to Eliminate See Message the Problem Chapter Switch Atrial Atrial Auto Sense and Atrial Act according to the message 9 9 4 Trigger off to Trigger cannot be enabled at the 9 12 5 3 enable same time because the trig Atrial Auto Sense gered stimulation prevents proper measurement of the intrinsic atrial activation Switch Atrial If atrial Auto Sense is activated If a shorter A V delay is neces 9 9 4 Auto Sense off a minimum of 30 ms P V delay sary atrial Auto Sense cannot be to decrease AVD is required to allow proper mea employed and must be deacti surement of the intrinsic atrial vated activation Because A V delay cannot be shorter than P V delay it is also limited to 30 ms AVD To resolve a parameter conflict N A conflict resolved by the 9 22 7 adapted during mode switching the A V device delay has been changed i e Please check if the altered adapted to the current rate A V delay is appropriate for the OR patient A V delay has been incr
27. basic rate amp atrial overdrive rate atrial sensi tivity atrial pulse amplitude A V delay ventricular pulse amplitude and ventricu lar sensitivity are adjustable by rotating these dials see Table 2 When the dials are rotated there is both a tactile notched click and acoustic response beep Dial Function HI RATE Adjusting the basic rate and the overdrive stimula tion rate A SENSE Adjusting the atrial sensi tivity A STIM Adjusting the atrial pulse amplitude A V DELAY Adjusting the A V delay V STIM Adjusting the ventricular pulse amplitude V SENSE Adjusting the ventricular sensitivity Table 2 Dials and their functions 9 2 4 The Fixed Labeled Keys Fixed labeled keys according to Table 3 are implemented 20 129 Key Function ON Turning on the device OFF Turning off the device Emergency Setting emergency stimulation parameters Unlocking Locking the Lock Unlock dials and the keys Disable stimulation Pause as long as pressed Table 3 Fixed labeled keys and their functions 9 2 5 The Softkeys and the Menus For setting of the pacing mode and other parameters and functions five additional keys so called softkeys are implemented These keys are used in conjunction with and located next to the lower display Each softkey selects the option that is displayed adjacent to it in different menus show
28. be judged as intrinsic heart signals and lead to an inhibition or according to the pacing mode to a triggering of stimulation Signals with a frequency above 273 bpm about 4 5 Hz will be judged as interfer ence and force the PACE 203H to an asynchronous stimulation If the PACE 203H recognizes interfe rence in a channel the basic rate will be increased by 10 ppm but not above the MTR only in the case the MTR is appli cable and the MTR set to a value less than 10 ppm above the basic rate and not above 220 ppm The PACE 203H displays the symbol for interference see 51 17 016X B 18 PACE 203H Instructions for Use Figure 13 in the upper display atrium and or ventricle gt Figure 13 Symbol for Interference Additionally the pacemaker changes to the pacing mode due to interference Table 59 shows the corresponding reac tion The pacemaker will switch to the following mode during Basic Interference in Interference in Mode Ventricular Chan Atrial Channel nel DDD D00 DVI D00 No change No change VVI V00 No change V00 No change No change AAI No change A00 A00 No change No change VDD V00 VVI Table 59 Mode Switching Due to Interfe rence Note Interference is not recognized and indicated If the sensitivity of the corresponding channel is set to infinite or If the corresponding channel is refractory because sensing is turned off in
29. by defibrillation discharges the sti mulation circuit should always be opened during defibrillation if possi ble Current flows caused by defibril lator discharges can endanger the 13 129 PACE 203H Instructions for Use 13 14 15 16 patient High current amplitudes can also damage the pacemaker If the PACE 203H is to be used for a longer period of time on a patient the stimulation threshold should be checked from time to time the first time after a few hours then daily since an increase of the threshold may occur An unnecessarily high sensitivity small sensitivity value increases the probability that proper pacemaker functioning will be affected by exter nal interference and the device will switch to asynchronous stimulation see also chapter 9 22 3 If there are strong electromagnetic fields caused by telecommunication devices like mobile phones or other sources an asynchronous mode should be set with a higher than the patient s intrin sic rate During dual chamber pacing there is an inherent potential risk of cross stimulation which is a cross talk of an atrial stimulation or depolarization impulse into the ventricle or vice ver sa The PACE 203H is designed in such a way that this cross talk is mi nimized Furthermore the distance between atrial and ventricular lead system should be not less than 4 cm Due to differences in the anatomy electro physiological conditions and t
30. however can restrict the choice of operational mode and stimulation parameters For example a mode of operation with atrial sensing is not suitable or appropri ate when atrial fibrillation occurs This is due to excessive and chaotic frequency of detected fibrillation waves Overdrive stimulation therapy must only be used in the atrium Overdrive stimulation in the ventricle could cause life threatening ventricular fibrillation 51 17 016X B 18 PACE 203H Instructions for Use 5 Possible Complications When using an external pacemaker such as PACE 203H the following complica tions can arise bolism Complication Result Infection Sepsis Thrombosis and pulmonary em Death Perforation of the heart Hemopericardiu Hemothorax Cardiac tamponade Muscle and nerve stimulation Patient discomfort Dislocation of lead System malfunction Failure to stimulate Disconnection or breakage of lead contact problems at connec tion sites Insufficient tightening of the collets Intermittent or complete failure of effective stimulation and or sensing Dislocation of ventricular lead near atrium Atrial oversensing and ventricular inhibition Significant rise in the stimulation threshold Loss of effectiveness of the stimulation exit block Significant drop of the ECG signal amplitude after lead dis location or ingrown lead Loss of sensing entrance block Abn
31. imme diately with the last saved parameter setting If the device was OFF the key Lock Unlock which is located to the right of the softkeys must be pressed and released to indicate that it is func tioning properly The PACE 203H indi cates this by the schematized key sym bol shown in the lower display Table 6 and Table 7 22 129 Press Lock Unlock key re quest Press Version n nn yyyy mm dd Table 6 Press Lock Unlock Key Request Release Lock Unlock key request Release Version n nn yyyy mm dd Table 7 Release Lock Unlock Key Re quest Note Version n nn indicates the hard ware and or software version of the device and yyyy mm dd the correspond ing release date Year Month Day 51 17 016X B 18 PACE 203H Instructions for Use When the key Unlock Lock has been pressed and released the PACE 203H begins to function with the Turn on pro gram see chapter 9 11 5 Upon ship ping from the manufacturer a DDD mode with high sensitivity and moderate stimulation amplitudes is preset This setting provides safe therapy for most pacing situations see Table 40 The Turn on program however may be customized according to the physician s preferences The language setting see chapter 9 12 5 4 and acoustic indication of sens ing and stimulation see chapter 9 2 8 will remain unchanged during power off Note If the indication to press and re lease the key Unlock Lock is n
32. immunity test and compliance level for electrostatic discharge and power frequency magnetic fields and describes the electromagnetic environment that the PACE 203H is intended to operate in Guidance and manufacturer s declaration electromagnetic immunity The PACE 203H is intended in the electromagnetic environment specified below The customer and the user of the PACE 203H should assure that it will be used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 15 kV air 6 kV contact 8 15 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic materials the relative hu midity should be at least 30 Electrical fast 2 kV for power 2 kV for power Mains power quality should be that of 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur for 5 sec transient burst supply lines supply lines typical commercial or hospital envi IEC 61000 4 4 1 kV for in Not applicable for ronment put output lines input output lines Surge 1 kV differential 1 kV differential Mains power quality should be that of IEC 61000 4 5 mode mode typical commercial or hospital envi 2 kV common 2 kV common ronment mode mode Voltage dips lt 5 Ur Not applicable No applicable short interrup gt 95 dip i
33. interference symbol Figure 13 is displayed in the upper display The measured frequency is displayed nevertheless because it may be a high frequency tachycardia Accor dingly for the same reason the setting of the sensitivity threshold remains un changed unlike during initialization of the Auto Sense function When no intrinsic activity is sensed in any channel for 3 seconds while the key 51 17 016X B 18 labeled Pause is pressed any measured values already displayed are erased Note As long as the key labeled Pause is pressed all other keys and dials are disabled 63 129 PACE 203H Instructions for Use 9 16 Connecting the Leads to the PACE 203H 9 16 1 Lead Types For temporary stimulation of the heart with the PACE 203H temporary trans venous leads or permanent leads re gardless of whether they are of bipolar or unipolar configuration can be used The use of myocardial leads up to 6 elec trodes and VDD single pass leads is also permissible Temporary transvenous pacing leads These leads are advanced into the heart via a vein and are connected to the PACE 203H either directly or by means of an extension cable Heart wires myocardial pacing leads Heart wires myocardial leads are af fixed to the heart during open heart surgery when it is expected that the patient may need stimulation for a limited period of time after surgery The heart wires are connected to the PACE 203H by means o
34. least 30 seconds provided fully charged internal capacitors e A non volatile memory keeps any desired stand by program ready for use even if the device is shut off e A standard program which can be individualized is available for each primary pacing mode e An emergency program can be called up by pressing an emergen cy key e A burst and a ramp function are available for atrial overdrive stimu lation e An Unlock Lock button protects against accidental change of the set parameters e The set parameters and error mes sages are shown on a liquid crystal display e The detection of the intrinsic heart activity as well as the emission of stimulation impulses are shown sep arately by blinking LEDs for both atri um and ventricle Additionally a beep tone can be switched on when ever desired e System malfunctions that occur are indicated optically and acoustically e A lead surveillance system indicates interruptions and short circuits 9 129 PACE 203H Instructions for Use e When a battery change is required optical and acoustic alerts are pro vided e During dual chamber pacing an automatic mode for adapting A V de lay maximum tracking rate MTR and PVARP is available e An automatic mode for adjusting the sensitivity in both the atrium and ven tricle may be choosen e A Pause function is available for easy determination and measure ment of the patient s intrinsic hea
35. of these functions the Standard Menu must first be entered via the softkey labeled Main Menu and then via the softkey labeled Standard If the lower display is off then pressing the key Unlock Lock turns the display on The Standard Menu appears as shown in Table 35 9 11 1 Parameters Stored in a Stan dard Program The parameters stored in each of the four sets are marked with in Table 36 The parameters marked with are not stored in the set and will remain unchanged if a stored program is re called 46 129 Standard Menu Save as Turn on Save as XXX standard Recall XXX standard Manufacturer s default E Key No 5 Table 35 Standard Menu 51 17 016X B 18 PACE 203H Instructions for Use Parameter DDD VVI AAI VDD Unit Basic Rate ppm Atrial Amplitude u V Atrial Sensitivity incl Automatic state mV Atrial Pulse Duration ms Ventricular Stimulation Ventricular Amplitude V Ventricular Pulse Duration ms Ventricular Sensing Ventricular Sensitivity incl Automatic state mV A V Delay incl Automatic state ms PVARP incl Automatic state ms MTR incl Automatic state E ppm Atrial Trigger Option Table 36 Standard Programs Set Note Because the sensitivity and the options are also stored the pacing mode
36. power saving This occurs in parallel upon locking the dials and keys If the battery voltage decreases below a specified battery depletion level the backlight is automatically deactivated and will not be turned on again until the battery has been replaced 9 2 7 LEDs for Sensing and Stimula tion To the left of the upper display there are four LEDs for indicating atrial and ventri cular sensing and stimulation events The LEDs for indicating sensing flash green and those for indicating stimula tion flash yellow All LEDs appear brightly shortly after turning on the PACE 203H to verify that they are operational 21 129 PACE 203H Instructions for Use 9 2 8 Acoustic Indications Key pressing results in a high frequency acoustic signal beep Warnings are acoustically indicated by three successive short high frequency acoustic signals beeps whereas errors are indicated by one long high frequency signal long beep If the Beep feature is enabled see chap ter 9 12 5 1 sensing and stimulation events are acoustically indicated beep Sensing and stimulation are indicated by a different high frequency signal beep Specifically sensing occurs with a lower frequency signal than stimulation 9 3 Powering On the PACE 203H The PACE 203H is powered on by pressing the key labeled ON Subsequently the PACE 203H performs a self test If the device was set to Stand by see chapter 9 5 it starts operation
37. softkey Table 28 shows the High Rate Menu Note Remember to press the key Un lock Lock in case the PACE 203H key pad is locked In case the lower display was turned off it is then turned on High Rate Menu Key No Atrial 1 High Rate 2 Ventricular Rapid Pacing 3 4 tT 5 Table 28 High Rate Menu 40 129 9 10 1 Atrial High Rate Standby The Atrial High Rate standby is ac cessed by pressing the softkey labeled Atrial High Rate in the High Rate Menu Table 28 The Atrial High Rate Standby Menu appears as shown in Table 29 The atrial high rate stimulation is now at standby The acoustic indicator is auto matically switched on temporarily if it is not already on Note Within the Atrial High Rate Stand by Menu the pacemaker continues to operate in the set mode Any previously selected atrial high rate stimulation frequency and the corres ponding beat to beat interval are dis played Note After turning on the PACE 203H atrial high rate stimulation frequency is set to the default value 240 ppm if the device has been powered off using the softkey labeled Off no storage If the device has been powered off with the softkey labeled Stand by store data then it will restore the high rate frequen cy which was set before powering off 51 17 016X B 18 PACE 203H Instructions for Use Atrial High Rate Key No Standby Menu START Atrium 1 240 ppm 250 ms 2 Use RATE Dial 3 to change High Rate 4
38. the A STIM dial or the V STIM dial clockwise the stimulation am plitude will be increased in the range shown in Table 14 The actual stimulation amplitude value and the intensity bar diagram can be seen in the upper dis play The intensity bar diagram enlarges from left to right with amplitude increase Parameter Adjustable Values Unit 0 1 0 1 2 0 Stimulation 2 0 0 2 6 0 T Amplitude 6 0 0 5 12 0 12 0 1 0 18 0 Table 14 Adjustable Values for Stimula tion Amplitude step width in parenthes es 9 8 3 Adjustment of Sensitivity By rotating the A SENSE dial or the V SENSE dial clockwise the sensitivity value mV value increases This indi cates that the sensitivity will decrease 51 17 016X B 18 The actual sensitivity value and the pa rameter intensity bar diagram can be seen in the upper display The parame ter intensity bar diagram diminishes from left to right when the sensitivity value is increased sensitivity is decreased If the minimum sensitivity is reached the value infinite is indicated by in the display and a mode change occurs This is indicated by the pacing mode code visible in the upper display see chapter 9 7 By rotating the A SENSE dial or the V SENSE dial counterclockwise the sensi tivity value mV value decreases This indicates that the sensitivity value in creases The parameter intensity bar diagram expands from the right to left side
39. the rules for abnormal settings see 9 22 7 After subsequent PVCs the V A delay is calculated to VA Delay AVD Basic Rate 9 22 5 3 Absolute and relative PVARP If the patient s heart is beating at a rela tively high intrinsic rate an extended PVARP could have the consequence that after the recognition of a single extrasystole subsequent extrasystoles are determined only because within the atrial channel the PVARP takes up most of the V A delay The PACE 203H avoids this effect by dividing the PVARP in two periods the absolute PVARP and the relative PVARP Within the absolute PVARP 90 ms no atrial events are sensed Within the relative PVARP equals the remaining 400 ms atrial events are sensed but not tracked by the ventricu lar channel Thus the PACE 203H inter prets a ventricular sensed event follow ing an intrinsic atrial event occurred within the relative PVARP as a regular beat and not as an extrasystole As a consequence ventricular respon ses caused by premature atrial contrac tions are not counted as extrasystoles 9 22 6 Runaway Protection The PACE 203H can stimulate the heart with a maximum basic rate of 220 ppm or a maximum tracking rate MTR of 230 ppm The output of higher stimula tion rates for example due to a defect in the frequency generator is limited by an independent safety function to a maxi 79 129 PACE 203H Instructions for Use mum of 238 ppm This sa
40. the stimulus and the occurrence of ventricular depolarization Please see the instruction manual for the IABP interface device for further informa tion Warning Because the ventricular intra cardiac electrogram is processed to control the IABP the output at the ter minal CTRL OUT is only enabled if a pacing mode with sensing and or stimu lation in the ventricle is chosen The output at the terminal is disabled any time the PACE 203H operates in a pac ing modes using atrial sensing and or pacing AAI A00 AAT Enable the balloon pump interface com munication by selecting the radio button assigned to BPI manufacturer s default in the Options Menu 2 Table 57 Press ing the PMC BPI softkey in the will tog gle between selection of the radio button assigned to PMC for Pacemaker Clin ic a program view of the AESCU LON and the radio button assigned to BPI for Balloon Pump Interface Bal loon pump interface communication is default 51 17 016X B 18 PACE 203H Instructions for Use Options Menu 2 Key No Language 1 PMC O BPI 2 3 more 4 Te 5 Table 57 Options Menu 2 BPI enabled Note The Terminal CTRL is protected by a cap which will prevent pollution This cap should be in place when the CTRL OUT socket is not used 51 17 016X B 18 71 129 PACE 203H Instructions for Use 9 21 Interfacing with Electrical Cardiometry Monitors Option As an option the PACE 203H int
41. used in calculating the recommended separation distance for transmitters in the ISM frequency bands between 150 KHz and 80 MHz and in the frequency range 80 MHZ to 2 5 GHz to decrease the likelihood that mobile portable communications equipment could cause interference if it is inadvertently brought into patient areas NOTE 4 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Table 73 Distances between portable and mobile RF communication equipment 51 17 016X B 18 119 129 PACE 203H Instructions for Use 19 Appendix D List of Figures Figure 1 PACE 203H Display Face ccceeseeceneeeeeeeeeeeeseeeseaeeseneeseaeeseneeseaeeseaeeseaeeseaeenea 17 Figure 2 Re r View a e a a a i 18 Figure 3 Upper Display aisimi a e Een 19 Figure 4 Lock Symb Oh a 3224 28er a a Ea EEEE 23 Figure 5 The Auto Sense function increases sensitivity ursseensneensnnnnnnnensnnnnnnnennnnnn nen 35 Figure 6 The Auto Sense function decreases sensitivity ueersseensseensnnnnsnnensnnnnnnnnnnnnnn nen 35 Figure 7 Acoustic Indicator Symbol for a LoUdSpeaker ceceeeeeeeeeeeeeeeeeeneeeeeeteeeeeee 55 Figure 8 Alarms Off Crossed Bell Symbo rsursnsensnnensnnensnnnnnnnennnnnnnnennnnnnnnnn 56 Figure 9 Displays of Statistics automatically alternating z4 urmn0en nen ennensnennnnn 59 Figure 10
42. 0 seconds Typically this duration is even longer The battery change should therefore be quick but does not require haste Warning In order to provide continuous operation of the PACE 203H during a battery change the battery must not remain in the PACE 203H until it is com pletely drained During operation of the PACE 203H the user must not permit the critical depletion level to occur indi cated by battery symbol shown empty and blinking and the warning message Hurry up Change battery and then being forced to replace the depleted battery with a new one with great haste If the PACE 203H is switched off or to stand by mode after the request to change the battery appears the battery must be changed before the PACE 203H is turned on again Note After inserting a new battery the PACE 203H requires 30 minutes to 95 129 PACE 203H Instructions for Use recharge its internal power capacitor in order to be able to perform the bridging function again Button Cover Battery 4 Release Open Button Battery Compartment Lid Figure 15 Battery Compartment For battery replacement please adhere to the following instructions 1 Have a new 9 V battery 6LR61 on hand 2 On the bottom of the PACE 203H turn the protection cover of the bat tery compartment release button and push the battery compartment release button Open the battery compartment lid see Figure 15 Make certain that th
43. 19 20 20 20 21 21 22 22 23 24 24 25 3 129 PACE 203H Instructions for Use 9 6 2 9 6 3 9 6 4 9 6 5 9 6 6 9 6 7 9 6 8 9 6 9 9 6 10 9 6 11 9 7 9 8 9 8 1 9 8 2 9 8 3 9 8 4 9 9 9 9 1 9 9 2 9 9 3 9 9 4 9 9 4 1 9 9 4 2 9 9 4 3 9 9 4 4 9 9 4 5 9 9 4 6 9 10 9 10 1 9 10 1 1 9 10 2 9 10 2 1 9 11 9 11 1 4 129 Atrial Asynchronous A00 Pacing A V Sequential Asynchronous D00 Pacing Ventricular Inhibited VVI Pacing Atrial Inhibited AAI Pacing Atrial Synchronous P Tracking VDD Pacing Dual Chamber Pacing and Sensing with Inhibition and Tracking DDD The A V Sequential Ventricular Inhibited DVI Pacing Atrial Sensing Atrial Synchronous P Tracking VAT Pacing Non Pacing Mode ODO Pause Atrial Trigger Modes DDD AT and DAT Changing the Mode of Operation Adjustment of Rate Stimulation Amplitude Sensitivity and A V Delay Adjustment of Basic Rate Adjustment of Stimulation Amplitude Adjustment of Sensitivity Adjustment of A V Delay Using the Automatic Features Automatic Setting of A V Delay with the Setting of Rate Automatic Setting of PVARP with the Setting of Rate Automatic Setting of MTR with the Setting of Rate Automatic Adjustment of Sensitivity Auto Sense How the Auto Sense Function Works Important Notes Using the Auto Sense Function Activation of Auto Sense Notes for the Initialization of the Auto Sense function Re Initialization of Auto Sense Deactivation o
44. 203H Fibrillation currents can also be generated by crosstalk into the leads and cables If simultaneous use of the PACE 203H and electro surgical instruments is re quired the PACE 203H should be set to an asynchronous pacing mode without any sensing 83 129 PACE 203H Instructions for Use Warning In any case it is mandatory to continuously monitor the patient and to be prepared for a possible failure or malfunctioning of the PACE 203H 9 22 9 Summary of Text Messages The PACE 203H differentiates between conflicts application related and device related errors and warning messages These are documented in the following sub sections 9 22 9 1 Warning Messages Related to Conflicting Parameter Set tings Conflict warnings alert the user that he or she must adjust unusual conflicting parameter settings Such settings can result in improper pacing therapy for the patient The PACE 203H blocks conflict ing parameter settings as long as the Alarms functions are not disabled see chapter 9 22 7 and 9 12 5 2 When the PACE 203H determines a conflict it displays a warning message in the lower display accompanied by an acoustic warning signal The warning message alerts the user about the prob lem and how to solve it Warning mes sages appear after the recognition of conflicts Depending on the warning message it disappears automatically after a few seconds or after confirmation by the user The user
45. 9 X Figure 8 Alarms Off Crossed Bell Symbol To reactivate the lead surveillance fea ture and the protection against abnormal settings the Alarms key must be pressed again This causes the check mark to appear in the corresponding check box and the crossed bell symbol in the upper display disappears Note If previously disabled Alarms are enabled the PACE 203H will solve poss ible conflicts caused by abnormal set tings using its Automatic setting feature The fact that a parameter has been adapted according see chapter 9 22 7 and 9 9 9 12 5 3 Enable and Disable Atrial Trigger Function When the atrial trigger function is enabled the PACE 203H delivers an atrial stimulus immediately after an atrial sensing within the atrial sensing phase With the softkey labeled Atrial Trigger in the Options Menu the atrial trigger func tion can be enabled or disabled In case the atrial trigger function is enabled the corresponding check box is checked Furthermore the PACE 203H indicates the label A TRIG in the atrial stimulation section of the upper display Note The atrial trigger function is avail able in the primary modes AAI and DDD To turn the atrial trigger function off the softkey labeled Atrial Trigger must be pressed again The check mark disap pears from the corresponding check box 51 17 016X B 18 PACE 203H Instructions for Use and the label A TRIG disappears from the upper display as well
46. 9 3 Note The safety feature protection against abnormal settings see chapter 9 22 7 prevents decreasing the MTR to a value smaller than the basic rate In creasing the MTR will be limited to a value that still guarantees Wenckebach behavior The limitation of the MTR value will be indicated by a transient warning message in the lower display 9 12 3 Adjustment of Pulse Duration The pulse durations can be adjusted by pressing the softkey labeled Pulse dura tion in the Parameters Options Menu The Pulse Duration Menu appears as shown in Table 46 51 17 016X B 18 Pulse Duration Menu Key No A 1 1 00 ms 2 V 3 0 75 ms 4 tT 5 Table 46 Pulse Duration Menu The pulse duration can be changed with the softkey labeled T or the softkey la beled J in increments decrements of 0 05 ms between 0 05 ms and 1 50 ms respectively as shown in Table 47 The parameter change appears imme diately in corresponding line of the lower display and will become effective with the next intervention interval Manually Zst Adjustable Values Unit Atrial Pulse Duration 0 05 0 05 1 50 ms Ventricular 0 05 0 05 1 50 Pulse Duration Table 47 Manually Adjustable Values for Pulse Duration step width in parenthe sis 53 129 PACE 203H Instructions for Use 9 12 4 Adjustment of Atrial ARP and Ventricular VRP Refractory Pe riod The atrial refractory period ARP and the ventricu
47. A first press of the key Unlock Lock 51 17 016X B 18 switches the lower display and the back light on and unlocks the PACE 203H The error warning message is now visi ble This is despite the fact that the error no longer present A second press of the key Unlock Lock then confirms the error message If an error is detected when the lower display is switched on but the device is locked a first press of the key Un lock Lock switches the backlight on and unlocks the PACE 203H A second press of the key Unlock Lock then confirms the error message If the error persists the warning mes sage will reappear after confirmation Table 68 lists the possible warning mes sages 89 129 PACE 203H Instructions for Use PACE 203H Meaning Cause Measures to eliminate the See Warning Message Conflict Error Chap ter Unexpected Most of the device related errors Attempt to switch the PACE 203H device error are reported by this warning off and on waiting after a few no message seconds on again The error number can give If this doesn t solve the problem Restart the manufacturer a helpful hint as remove the battery while the device or to locating the cause of the error device is switched on wait for a ieee Note The PACE 203H attempts minimum of 10 minutes and then pection F reinsert to continue its operation with the current parameter set or if this is Note The patient must not
48. AD Other expression for atrial escape interval Ventriculoatrial interval VAI Delay between a ventricular pulse or the sensing of a ventricular depolarization and the subsequent atrial pulse or the sensing of an atrial depolariza tion 112 129 51 17 016X B 18 PACE 203H Instructions for Use 17 Appendix B Menu Tree Menu Tree Part 1 D00 DVI DAI voo VDD V00 VVI VAT ojo Press PAUSE to go to the measurement screen 50 bpm A 1200 ms 2 3mV 50 bpm v 1200 ms 8 0 mV AVI 90 ms Press EMERGENCY to start V00 emergency stimulation en O VDD V00 VVI VAT Turn OFF Menu Stand by Store Data Figure 16 Graphical Schema of Menu Tree Part 1 5l 17 016X B 18 High Rate Options Atrial START High Rate Ventricle oer 333 ms Rapid Pacing to change Rate Auto Auto Auto Auto Sense Turn on Turn on Save as VVI Program Standard Manufacturer s Default Overwrite see Menu Tree Part 2 Standard VVI Program Atrial Auto Sense m Ventricular Auto Sense oO 113 129 PACE 203H Instructions for Use Men baum Teil 2 PVARP 270 ms MTR 114 ppm siehe ARP Men baum AALAAT Teil 1 English O VRP Francais 8 2 3 3 a I I1 1 RE k PVARP amp MTR W ara AA an vob Vvivar_O Optionen Optionen italiano O Espanol oO ojojo Svensk O 0 75 ms lt 8 gt a
49. Atrial Trigger is also disabled when the primary mode is changed to VVI or VDD because these modes do not provide atrial stimulation Atrial Trigger must be activated again after changing back to the primary modes AAI or DDD Note Atrial Trigger cannot be used together with Atrial Auto Sense because the triggered stimulation prevents proper measurement of the intrinsic atrial acti vation see also 9 9 4 Note A sensed atrial event in the rela tive PVARP see chapter 9 12 1 is nev er followed by a triggered atrial stimula tion even if atrial trigger is enabled because it may be a ventricular echo 9 12 5 4 Setting the User Language By pressing the softkey labeled Lan guage in the Options Menu 2 the Lan guage Menu appears as shown in Table 53 The activated user language is marked By pressing the corresponding key the language can be selected The softkey labeled more toggles through the different language menus 51 17 016X B 18 Language Menu Key No English 1 Deutsch O 2 Fran ais O 3 more 4 tT 5 Table 53 Language Menu The manufacturer s language setting default is English 9 12 5 5 Setting CTRL OUT Interface By pressing the softkey labeled PMC BPI in the Options Menu 2 the CTRL OUT port is set to either commu nicate with the Pacemaker Clinic PMC a feature of AESCULON and ICON Electrical Cardiometry monitors or with the optional BPI 202 intra aortic balloon pump
50. D WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE THE RE MEDIES SET FORTH IN THIS WAR RANTY SHALL BE THE ONLY REME DIES AVAILABLE TO ANY PERSON NO PERSON HAS ANY AUTHORITY TO BIND US TO ANY REPRESENTA TION OR WARRANTY EXCEPT AS SPECIFICALLY SET FORTH HEREIN This Warranty including its terms condi tions limitations exceptions and exclu sions contains our entire obligation to you and replaces any other representa tions made to you or understanding you may have about our obligation You may also have additional rights that vary from state to state 107 129 PACE 203H Instructions for Use 16 Appendix A Glossary Atrial escape interval Time between ventricular sensed beat or a ventri cular pulse and the succeeding non triggered atrial pulse of a pulse generator i e the time when the pacemaker waits for a P wave Atrial tracking In an atrioventricular mode a ventricular stimulus tracks a detected atrial P wave after P V delay up to the programmed maximum tracking rate This results in an atrial controlled timing of the pace maker Atrial triggering A detected P wave causes an atrial stimulus Atrioventricular interval AVI Delay between an atrial pulse or the sensing of an atrial depolarization and the subsequent ventricular pulse or the sensing of a ventricular depolarization The actual AVI can be shorter than the adjusted A V delay or P V delay in case of a spontaneous ventricul
51. Decrease AVD to increase Rate a A M A Decrease PVARP to increase Rate a M M A Decrease PVARP or AVD to increase Rate a M A A Decrease AVD to increase Rate a A M A Decrease PVARP to decrease Rate a A A M Decrease MTR to decrease Rate a M A M Decrease AVD or MTR to decrease Rate a A M M Decrease PVARP or MTR to decrease Rate M a MorA MorA Decrease PVARP or MTR to increase AVD M MorA a MorA Decrease AVD or MTR to increase PVARP M MorA MorA a Decrease PVARP or AVD to increase MTR Table 64 Conflicts Type d Basic Rate ARP Message a M Decrease ARP to increase Rate M a Decrease Rate to increase ARP 82 129 Table 65 Conflicts Type e 51 17 016X B 18 PACE 203H Instructions for Use 9 22 7 2 Mode Switching The PACE 203H avoids conflicts as a result of mode switching by selecting appropriate parameter values according to the rules set for the automatic modes A V delay PVARP and MTR inde pendent of whether these automatic modes for the respective parameters are enabled or disabled The basic rate is the determining parameter and will never be altered If a conflict type b Table 60 must be solved and both PVARP and A V delay are set to manual the PACE 203H will first set the PVARP to the automatic value see chapter 9 9 2 If this does not solve the conflict the A V delay will be reset to the automatic value see chapter 9 9 1 The PACE 203H acknowledges that a parameter has been change
52. IABP interface 57 129 PACE 203H Instructions for Use 9 13 Statistics By pressing the softkey labeled Statistics in the Options Menu 2 see Table 52 on Please refer to Table 54 Statistical Pa rameters and to Figure 9 page 55 the user can review statistical data obtained by the PACE 203H pre sented in four different statistics screens Page Parameter Explanation Statistics Runtime Time since last reset of statistics counters power on or Runtime manual reset Page Pacer Settings Indicates if during the Runtime any of the pacemaker 9 Unchanged Changed settings mode or parameter were changed or not Total Cycles Number of cardiac cycles counted during Runtime Cycles Atrial Paced Cycles Number of atrial paced cycles counted during Runtime AP and the percentage with respect to the Total Cycles Page II Ventricular Paced Cycles Number of ventricular paced cycles counted during Run 9 VP time and the percentage with respect to the Total Cycles Atrial Sensed Cycles Number of atrial sensed cycles counted during Runtime AS and the percentage with respect to the Total Cycles Ventricular Sensed Cycles Number of ventricular sensed cycles counted during Run VS time and the percentage with respect to the Total Cycles Longest Series AP Largest series of consecutive atrial paced cycles during maxAP Runtime and the percentage with respect to the Total Page Ill Cycles
53. Instructions for Use sponse is different in case of isolated PVC or the initial PVC of a series and subsequent PVCs 9 22 5 1 Isolated PVC or Initial PVC After detection of a PVC the PVARP is extended to 500ms Therefore any sensed intrinsic atrial events are not tracked by the ventricle After termination of the extended PVARP the atrial chan nel is alert and sensing begins again Despite the extended PVARP the dura tion of the sensing phase or the width of the crosstalk sensing window is set to at least 350 ms independent of set basic rate and A V delay The duration of the sensing phase may be even longer if the difference between VA delay and extended PVARP i e AVD 500 ms Sensing Phase g Basic Rate where AVD means the A V delay re veals a value exceeding 350 ms A sensing phase of at least 350 ms allows atrioventricular synchronization If the sensing phase terminates without an atrial event sensed the PACE 203H delivers an atrial stimulus unless a further ventricular extrasystole has been detected 9 22 5 2 Subsequent PVCs If a PVC is followed by another PVC without intermediate atrial sensed or paced event the behavior is adapted for subsequent PVCs ensuring appropriate pacing at higher basic rates After subsequent PVCs the PVARP is extended up to 500 ms but not exceed ing PVARP ya AVD 20 ms Basic Rate 51 17 016X B 18 The maximum PVARP is in agreement with
54. Instructions for Use CZ OSYPKA PACE 203H Dual Chamber Temporary Pacemaker Dea DVI DAI wiIo ee AAI oO nee AAT VDD o vee WI VAT Ma in Menu Manufacturer Distributor Osypka Medical GmbH OSYPKA AG Albert Einstein Strasse 3 Earl H Wood Strasse 1 D 12489 Berlin Germany D 79618 Rheinfelden Germany Phone 49 30 6392 8300 Phone 49 7623 7405 0 Fax 49 30 6392 8301 Fax 49 7623 7405 160 E Mail mail osypkamed com E Mail mail osypka de 51 17 016X B 18 01 23 PACE 203H Instructions for Use Table of Contents 1 1 1 1 2 1 3 1 4 oN ODO Oo fF 9 9 1 9 2 9 2 1 9 2 2 9 2 3 9 2 4 9 2 5 9 2 6 9 2 7 9 2 8 9 3 9 4 9 5 9 6 9 6 1 Preface General Checking the Delivery Optional Accessories Writing Conventions of this Manual Product Description Indication Contraindication Possible Complications Precautionary Measures and Warnings Patient Safety Electromagnetic Compatibility Use and Application of the PACE 203H Design Overview of the Display Dials and Keys The Upper Parameter Display The Lower Mode Menu Display The Dials The Fixed Labeled Keys The Softkeys and the Menus Display Backlight LEDs for Sensing and Stimulation Acoustic Indications Powering On the PACE 203H Locking Unlocking the PACE 203H Powering Off The PACE 203H Modes of Operation Ventricular Asynchronous V00 Pacing 51 17 016X B 18 oO 0 10 11 13 15 15 17 17 19 19
55. Lead Connection Terminals rs40ursnsnsnnennnnensnnnnnnnensnnnnnnnennnnnnnnnnnnnnnnnn 64 Figure 11 Battery Symbol 2 2 2 es iR 74 Figur 12 Open Lead Symbol 2 as aaa 75 Figure 13 Symbol for Interference 2 240444004nnBnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnennnnnnnann 77 Figure 14 Symbol for Extrasystole Premature Ventricular Contraction PVC 78 Figure 15 Battery Compartment 20rs40unnnsennnnnnnnnennnnnnnnnennnnnnnnnnnnnnnnnnennnnnnnnnnnnnnnnnnn 96 Figure 16 Graphical Schema of Menu Tree Part 1 nen nnnennnnnnnnnnnnnnnnn 113 Figure 17 Graphical Schema of Menu Tree Part 2 eecceseseeeeeeseeeeeeeeeeeeeeeeeeeeneeeneees 114 Figure 19 Pacing Extension Cables uurs40unnnnennnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn 127 51 17 016X B 18 121 129 PACE 203H Instructions for Use 20 Appendix E List of Tables Table 1 Possible Complications ccccceeeceeseeeeeeeeeeeeeeeeeeeeeeeeeeeeseaeeeeeeessaeeeeeeessaeeneneeeea 12 Table 2 Dials and their functions 2z u4s0um44440R ne nnnannenennonennnnonnennnnnennnnonnnnnnnnnenenanen 20 Table 3 Fixed labeled keys and their functions 44444000nnnsnnnnnnnnnnnnnnnnennnnnnn 20 Table M de Menu 2 2 4 28er 22ER idise apaia 21 kable 5 MainiMenu 2 4 2842 802er ahnen 21 Table 6 Press Lock Unlock Key Request uuesssnnnnesennnnensnnnnnnnennnnn nen
56. acing is the simplest of all pacing modes be cause there is no sensing and no mode of response The ventricular pacing stimuli occur at the programmed rate regardless of any intrinsic cardiac event 9 6 2 Atrial Asynchronous A00 Pac ing Atrial asynchronous A00 pacing be haves exactly like V00 but the pacing stimuli occur in the atrium The atrial pacing stimuli occur at the programmed rate regardless of any intrinsic cardiac event 9 6 3 A V Sequential Asynchronous D00 Pacing Dual chamber or A V sequential asyn chronous D00 pacing provides atrial and subsequent ventricular stimuli with a fixed programmed delay The pacing stimuli occur at the programmed rate regardless of any intrinsic atrial or ventri cular events 9 6 4 Ventricular Inhibited VVI Pac ing Ventricular inhibited VVI pacing incor porates sensing on the ventricular chan nel and pacemaker output is inhibited by a sensed ventricular event In VVI mode the PACE 203H is refractory for a period after a paced or sensed ventricular event the ventricular refractory period Any ventricular event occurring within 25 129 PACE 203H Instructions for Use the ventricular refractory period is not sensed Any ventricular event occurring outside the ventricular refractory period is sensed and resets the timing of the pacemaker to the beginning of a new beat to beat interval 9 6 5 Atrial Inhibited AAI Pacing In the absence of intrinsic
57. after confirmation every 2 minutes Release A key is pressed while the Release all keys during the 9 3 all keys PACE 203H is turning on power on process of the device to allow a proper self test Key A key is pressed for more In case no cause is apparent timeout than 120 seconds There is and the error message pers a possibility that something ists this indicates that a key is heavy is pressing on the malfunctioning and the device PACE 203H or it is being must be sent to the manufac abutted against an edge of turer for inspection and ser some sort vice Atrial The atrial lead or ventricu If the lead was not discon 9 22 2 lead lar lead has been discon nected intentionally there is a disconnected nected The last stimulation possibility that lead breakage or could not be properly car or a disconnection of the Ventricular ried out connector cable exists ad Note This error message Check all connections con disconnected will not be repeated after confirmation even if the disconnection persists The open output is only indi cated by the open lead symbol see Figure 12 Note Surveillance can only occur if the stimulation amplitude is set to a value 22 0V and if the pulse duration is 20 15 millise conds nection cables and leads 88 129 51 17 016X B 18 PACE 203H Instructions for Use PACE 203H Meaning Cause Measures to Eliminate the See Warning Message Co
58. all these cases 51 17 016X B 18 9 22 4 Crosstalk and Ventricular Safety Pacing In dual chamber pacing modes an atrial stimulus could be sensed on the ventri cular channel and inhibit ventricular stimulation This is known as crosstalk or A V crosstalk In a pacemaker dependent patient inhibition of ventricu lar output by crosstalk results in asys tole For a better understanding how the PACE 203H prevents or operates in the presence of crosstalk the A V delay should be considered as an interval with three periods The ventricular blanking period the ventricular triggering period also known as the crosstalk sensing window and the remaining period of the A V delay in which a sensed event inhibits the ventricular output This re maining period may be not extant if the sum of ventricular blanking period and crosstalk sensing equals the A V delay 9 22 4 1 Ventricular Blanking Period To prevent crosstalk the PACE 203H initiates after an atrial stimulus a brief ventricular blanking period As a conse quence any possible crosstalk from the atrial pacing stimulus is masked or blanked with respect to the ventricular sensing circuitry The blanking period is of short duration because it is important for the ventricular sensing circuit to be returned to the alert state relatively early during the A V delay so that intrinsic ventricular activi ty can inhibit the ventricular output 9 22 4 2 Crosstalk Se
59. ameter set will be comple mented from the standard program of the new mode The enabling of the atrial trigger function in the AAl and DDD modes is described in chapter 9 12 5 3 A non pacing mode 0DO is accessible by pressing the key labeled Pause see chapter 9 15 Note A standard program can be stored for each primary mode These standard programs may be defined by the user see chapter 9 11 Note If conflicts because of abnormal settings occur as a result of a mode change the PACE 203H will make use of its Automatic setting feature to solve the problem see chapter 9 22 7 and 9 9 51 17 016X B 18 9 8 Adjustment of Rate Stimu lation Amplitude Sensi tivity and A V Delay One rotary dial is assigned to each of the parameters Table 11 shows the function of each dial Dial Function RATE Basic rate A SENSE Atrial sensitivity Atrial stimulation ASTIM amplitude A V DLY Atrio ventricular delay V STIM Ventricular stimulation amplitude V SENSE Ventricular sensitivity Table 11 Rotary Dial functions listed in order from top to bottom The actual values of the parameters and the corresponding bar diagrams indicat ing signal intensity or magnitudes are located in the upper display which is always turned on These bar diagrams indicate the set value within its range In order to change a parameter or pa rameters the dials must be unlocked by pressing the
60. aning Cause Measures to Eliminate the See Warning Message Conflict Error Chapter Decrease The user attempted to de A V delay and or MTR must be 9 22 7 A V Delay crease the rate This led to a decreased or set to Auto AVD and or MTR conflict type d because the Auto MTR before the rate can be to decrease sum of PVARP P V delay further decreased Rate and V V delay is too long with Alternatively manual setting of the respect to the MTR PVARP to a lower value is sug gested Decrease The user attempted to de PVARP and or MTR must be de 9 22 7 PVARP crease the rate This led to a creased or set to Auto PVARP and or MTR conflict type d because the Auto MTR before the rate can be to decrease sum of PVARP and A V delay further decreased Rate is too long with respect to the Alternatively manual setting of the MTR A V delay to a lower value is sug gested Table 66 Warning Messages Related to Conflicting Parameter Settings 9 22 9 2 Warning Messages Related to Application Errors Generally if the problem is identified any application related errors can be solved by the user Application related errors result in a warning message in the lower display accompanied by an acous tic warning signal which will be repeated periodically The warning message alerts the user about the problem It appears after recognition of the error and disap pears after the problem has been solved or after confirm
61. ar depolarization A V crosstalk Detection of the atrial output pulse by the ventricu lar sensing amplifier which may result in ventricular output inhibition A V delay AVD Programmed delay between an atrial pulse and the subsequent non triggered ventricular pulse under the condition that no sensing of a ventricular depo larization was detected by the pulse generator Basic rate short rate Pulse rate of a pulse generator either atrial or ventricular unmodified by sensed cardiac or other electrical influence Basic pulse interval Pulse interval unmodified by sensed cardiac or other electrical influence Basic pulse interval 1 basic rate Blanking period Period during which a sensing function of a pulse generator is disabled 51 17 016X B 18 109 129 PACE 203H Instructions for Use Cross blanking period Escape interval External pacemaker Inhibition Interference pulse rate Lower rate interval LRI Maximum tracking rate upper rate MTR Non implantable pulse generator Patient Cable 110 129 Period during which the sensing function of the pulse generator is disabled in one channel because of an event in the other channel Time between a sensed beat or a pulse and the succeeding non triggered pulse of a pulse genera tor Non Implantable pulse generator and patient cables if used The effect of the pulse suppression in a demand pacemaker at sensing of a cardiac de
62. ation V00 A00 rate 80 ppm all amplitudes 12 V or set value when higher pulse duration atrium 1 0 ventricles 0 75 ms or set value when longer AVD 170 ms AUTO 51 17 016X B 18 PACE 203H Instructions for Use Standard setting ss iienaa ee Lead surveillance 0 0 eeeeeccccceeceeesseeeeeeeeeneeseeeeeeees EENEN EEEE AETA Life span of recommended battery Alkaline Life span of recommended battery Lithium Battery Power Reserve uunnessnennsennnnenennnnnnennnnnnee Battery depletion indication uu 22444r seen nenne Power maintenance during battery change 51 17 016X B 18 Standard parameter set for each primary mode plus one turn on parameter set Different for stimulation sensing and warnings stimulation and sensing in dication can be turned on or off gt 4 5 Hz 5 gt 273 bpm Basic rate 10 ppm 2 max MTR and max 220 ppm According to IEC 60601 2 31 238 ppm 3 ppm Message in case of short circuit or interruption in the stimulation circuit for a set stimulation amplitude equal or higher 2 0 V and a set pulse dura tion equal or higher 0 15 ms 9 Volt identification per IEC 86 6LR61 Recommended types Duracell Alkaline MN1604 Sonnenschein Lithium SLM minimal 10 days VVI standard parameter minimal 8 days DDD standard parameter minimal 19 days VVI standard parameter minimal 15 days
63. ation by the user The user can confirm the error message by pressing the key Unlock Lock Confir mation causes the warning message to disappear and the acoustic signal to cease If an error is detected when the lower display is switched off the acoustic 51 17 016X B 18 signal is then the only available warning A first press of the key Unlock Lock switches the lower display and the back light on and unlocks the PACE 203H The warning message is now visible A second press of the key Unlock Lock then confirms the error message If an error is detected when the lower display is switched on but the device is locked a first press of the key Un lock Lock switches the backlight on and unlocks the PACE 203H A second press of the key Unlock then confirms the error message The message except the change battery and the lead disconnected messages will reappear a few seconds after confirmation if the error persists Table 67 shows these messages 87 129 PACE 203H Instructions for Use PACE 203H Meaning Cause Measures to Eliminate the See Warning Message Conflict Error Chapter Change battery The battery change level is Insert a new battery 9 22 1 reached 11 2 Note This message will be repeated after confirmation every 10 minutes Hurry up The critical battery change Insert a new battery 9 22 1 level is reached 11 2 Change Note This message will be battery repeated
64. be not possible with the emergency connected to the PACE 203H mode during this maneuver If the error repeats itself this may If the error persists despite of lead to an erratic rhythm these maneuvers the PACE 203H must be sent to the manu facturer for inspection and ser vice Stored data The memory for the Stand by data In case this error repeats itself lost and the standard programs has the PACE 203H must be sent to Manufacturer s lost its data The manufacturer s the manufacturer for inspection defaults standard turn on program see and service will be used 9 11 5 has been set and all standard programs have been reset to their manufacturer s defaults Keyboard While turning on the device a key Releasing all keys during the 9 3 error was pressed constantly for more power on process of the device is than 10 seconds despite of the message Release all keys necessary to allow a proper self check In case all keys were released and the error message persists this implies that a key is malfunc tioning and the PACE 203H must be sent to the manufacturer for inspection and service Table 68 Warning Messages Related to Device Errors 90 129 51 17 016X B 18 PACE 203H Instructions for Use 9 22 9 4 Informative Messages The PACE 203H displays various infor mative messages on the lower display which alert the user that certain actions must be taken These messages are accompa
65. cessary the PACE 203H should be observed to verify normal operation in the configuration in which it will be used Electromagnetic Emission Table 70 states the compliance classification for electromagnetic emissions and describes the general electromagnetic environment that the PACE 203H is intended to operate in Guidance and manufacturer s declaration electromagnetic emissions The PACE 203H is intended in the electromagnetic environment specified below The customer and the user of the PACE 203H should assure that it will be used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions Group 1 The PACE 203H uses RF energy only for its internal CISPR 11 function Therefore its RF emissions are very low and are not likely to cause any interference in near by electronic equipment RF emissions Class B The PACE 203H is suitable for use in all establish CISPR 11 ments including domestic establishments and those Harmonic emis Not directly connected to the public low voltage power sions applicable supply network that supplies buildings used for IEC 61000 3 2 domestic purposes Voltage fluctua Not tions applicable Flicker emis sions IEC 61000 3 3 Table 70 Guidance and manufacturer s declaration electromagnetic emission 51 17 016X B 18 115 129 PACE 203H Instructions for Use Electromagnetic Immunity Table 71 states the
66. confirms the warn ing message by pressing the key Un lock Lock Confirmation causes the warning message to disappear Table 66 shows a list of these warning messages PACE 203H Meaning Cause Measures to Eliminate the See Warning Message Conflict Error Chapter Increase The user has attempted to MTR must be increased or set to 9 22 7 MTR to increase the rate This led to a Auto MTR before the rate can be increase conflict type a because further increased Rate MTR is set at an excessively low value Decrease The user has attempted to PVARP and or A V delay must be 9 22 7 PVARP or increase the rate This led to a decreased or set to Auto PVARP A V Delay conflict type b or d because and Auto AVD before the rate can to increase the sum of PVARP and A V be further increased Rate delay is excessively high Alternatively in case of an implicit conflict type d between PVARP plus AVD and automatically set MTR the manual setting of the MTR to a lower value is suggested Decrease The user has attempted to A V delay must be decreased or set 9 22 7 A V Delay increase the rate This led to to Auto AVD before the rate can to increase conflict type b or c because be further increased Rate the A V delay is excessively high 84 129 51 17 016X B 18 PACE 203H Instructions for Use PACE 203H Meaning Cause Measures to Eliminate the See Warning
67. cular pulse amplitude ven tricular sensitivity as well as the pacing mode code NBG code and additional symbols are continuously displayed as shown in Figure 3 Figure 3 shows the upper parameter display in DDD mode Please refer to the indicated paragraphs for detailed infor mation about the symbols Parameters are shown only when rele vant In VVI mode for instance the upper display will not show an atrial OOD ee Kee 9 22 3 N e BE m ee mV 9 22 2 SD vo AUTO 0 ee O V S BO E SENSE gt fl Q AUTO mV see 9 10 Ara X 6 a ee 9 13 6 1 see 9 13 6 2 stimulation amplitude an atrial sensitivi ty or an A V delay 9 2 2 The Lower Mode Menu Display The lower display is used to show selec tion menus see section 9 2 5 The Soft keys and the Menus on page 20 and various messages These messages can be informative as well as alerting the user regarding errors and conflicts If the lower display is off then pressing the key Lock Unlock turns the display on After 2 3 min without any user op eration turn of dials or pressing of keys the lower display disappears for battery power saving MAMA Be 7 RATE ICa Figure 3 Upper Display 51 17 016X B 18 19 129 PACE 203H Instructions for Use 9 2 3 The Dials There are six dials corresponding to the parameter segments in the upper para meter display The six parameters
68. d appropriately with re gards to the basic rate given by a short warning message in the lower display Example AVD adapted In this example the PACE 203H changed the A V delay Note Because of this maneuver the PACE 203H does not switch to an auto matic mode The PACE 203H simply determines and sets one or more para meters similar to what the correspond ing automatic mode would have deter mined 51 17 016X B 18 9 22 8 Effects from Therapeutic and Diagnostic Energy Sources 9 22 8 1 Defibrillation The PACE 203H is designed in a man ner such that it withstands defibrillation discharges according to ISO 14708 1 Warning Any protection against defibril lation discharges is limited due to the low resistance required by the pacemak er output circuitry In any case it is man datory to monitor the patient for a period of time after defibrillation and to be prepared for a possible failure or mal functioning of the pacemaker To protect the patient and the pacemak er from current passing through the pacemaker lead circuit caused by de fibrillation discharges the stimulation circuit should always be opened if poss ible Excessively high currents can also dam age the pacemaker 9 22 8 2 RF Surgery When using RF electrocautery and RF surgery instruments very strong elec trical and magnetic interference is gen erated which can influence or even damage electronic instruments like the PACE
69. dicated by a transient warning message in the lower display Note The PVARP of the PACE 203H is divided in two parts an absolute part and a relative part In the absolute part 90 ms no atrial events are recognized In the relative part the remaining atrial events are registered but not tracked This algorithm prevents misinterpretation of ventricular events after premature atrial events as extrasystoles PVCs as described in chapter 9 22 5 52 129 9 12 2 Adjustment of MTR The maximum tracking rate MTR can be adjusted by pressing the softkey labeled PVARP amp MTR in the Parame ters Options Menu The PVARP amp MTR Menu appears as shown in Table 44 PVARP amp MTR Menu Key No PVARP T 1 280 ms 2 MTR F 3 106 ppm 4 K 5 Table 44 PVARP amp MTR Menu The MTR can be changed with the soft key labeled 7 or the softkey labeled J in increments decrements of 2 ppm be tween 80 ppm and 230 ppm respective ly as shown in Table 45 The parameter change appears imme diately in the fourth line of the lower display and will become effective with the next intervention interval 51 17 016X B 18 PACE 203H Instructions for Use Manually Barameisr Adjustable Values Unit MTR 80 10 230 ppm Table 45 Manually Adjustable Values for MTR step width in parenthesis Note Changing the MTR value manually will also switch off the automatic setting if it was activated see chapter 9
70. e maker Clinic PMC to define a range for the atrio ventricular AV delay a step width for stepping through the aforementioned range and a waiting period applied between a change of the AV delay and a period of hemodynamic measurements Upon a key stroke the PACE 203H automatically applies the 51 17 016X B 18 PACE 203H Instructions for Use various pacing parameter permutations for a limited time one after the other while the obtaining and recording the corresponding hemodynamic measure ments At the end of this scan the EC monitor presents the results in a matrix and suggests the optimal pacing parameter permutation which can be accepted by the user or ignored Please refer to the instructions for use of the AESCULON or ICON monitor for more detailed information 51 17 016X B 18 73 129 PACE 203H Instructions for Use 9 22 Internal Surveillance and Safety Features 9 22 1 Battery Surveillance The PACE 203H is powered by a stan dard 9 V battery The PACE 203H continuously monitors the battery voltage The battery symbol see Figure 11 located in the upper display continuously indicates the re maining battery voltage The time to change battery level is reached when only one segment the rightmost triangu lar one remains and is blinking Addi tionally the warning message Change battery will appear approximately every 10 min in the lower display accompanied by an aco
71. e impulse emission with the atrial high rate stimulation frequency will be carried out After releasing the softkey labeled START Atrium the previous state of the lead surveillance will be restored The Pause function see chapter 9 15 on page 62 can be used to measure the intrinsic rate of atrial tachycardia up to rates of about 700 bpm Thus the Pause function assists in determining the optimal atrial high rate stimulation fre quency Please note that the atrial fre quency measurement can be affected by cross blanking after ventricular senses As long as the softkey labeled START Atrium is pressed all other keys and dials are disabled 9 10 1 1 Atrial High Rate Stimulation with Ramp Function The PACE 203H provides a function allowing the application of atrial high rate stimulation with a ramp function While the atrial high rate stimulation is running Atrial High Rate Running Menu Table 31 is shown turning the HIGH RATE dial changes the atrial high rate stimula tion rate This feature allows the user to manually set a ramp function for atrial high rate stimulation Note The PACE 203H ignores any rotation of the HIGH RATE dial beyond the defined minimum or maximum set tings 51 17 016X B 18 PACE 203H Instructions for Use 9 10 2 Ventricular Rapid Pacing Standby The Ventricular Rapid Pacing standby is accessed by pressing the softkey la beled Ventricular Rapid Pacing The Ventricular Rapid Pac
72. e inserted bat tery does not drop on the floor 3 Remove the battery from the battery compartment 4 Place a new battery in the com partment The orientation of the bat tery polarity is irrelevant 5 Close the battery compartment lid until it is audibly latched in place 96 129 Rotate the protection cover over the battery compartment release button 6 It is mandatory to dispose of the battery in an environmentally friend ly legal manner Warning Avoid handling with spillage if the battery compartment is open Warning Only insert a 9 V battery 6LR61 produced by a respected and reliable battery manufacturer 11 3 Safety Check Ups of the Pacemaker In order to assure safe operation of the PACE 203H the following check ups must be carried out on a regular basis Before each use Visual inspection e Inspect the device and accessories for visible damage e Inspect the connections for visible damage Function test e Inspect all connections to see if they affix and function properly e Inspect all operating elements and displays for perfect function After each use e Clean the device and its accessories according to the instructions provided in chapter 1 51 17 016X B 18 PACE 203H Instructions for Use Annual Functional and Safety Check e Measuring the auxiliary currents e Measuring the stimulation parame ters amplitude pulse width in the atrial and ventricular channels e M
73. e limits 51 17 016X B 18 8 Electromagnetic Compa tibility The temporary cardiac pacemaker PACE 203H meets all applicable interna tional standards with respect to electro magnetic compatibility EMC IEC Medical electrical equipment 60601 Electromagnetic compatibility 1 2 CISPR Industrial scientific and medi 11 cal radio frequency equip ment Electromagnetic distur bances IEC Electromagnetic compatibility 61000 Some sources of radiated emissions may impact the proper function of PACE 203H e Electrosurgical instruments operating with radio frequency e Devices for diathermy therapy e Magnetic resonance imaging MRI e Medical telemetry systems Special electromagnetic compatibility EMC precautions should be taken when using electrical medical equipment such as the PACE 203H 15 129 PACE 203H Instructions for Use A Portable and mobile RF communica tions equipment such as mobile phones can affect the function of the PACE 203H Mobile phones with a rated maximum output power of 2 Watt and a transmitter frequency up to 2 5 GHz should be used no closer to any part of the PACE 203H including patient cables and sensors than a recommended separation distance of 10 m 80 ft Floors should be wood concrete or ceramic tile If floors are covered with synthetic materials the relative hu midity should be at least 30 Power frequency magnetic
74. eads or unipo lar leads with indifferent electrode Bipolar When using a bipolar trans venous stimulation lead the distal pole of the lead is connected to the different 51 17 016X B 18 PACE 203H Instructions for Use black terminal of the corresponding channel on the PACE 203H The prox imal pole is then connected to the indiffe rent red terminal When using heart wires the connection is arbitrary since both electrodes are affixed in the myocardium The connec tion may be selected to obtain the best sensing and stimulation parameters When a stimulus is delivered the current flows from the negative to the positive electrode and causes a myocardial depolarization and in turn leads to a heart muscle contraction Unipolar When using a unipolar lead it is connected to the different black terminal of the corresponding channel of the PACE 203H In order to close the circuit and allow a stimulus an indiffe rent electrode must be connected to the indifferent red terminal of the corres ponding channel of the PACE 203H This electrode must have a large surface and must be attached subcutaneously If unipolar stimulation is given in the atrium as well as in the ventricles one indifferent electrode is sufficient The indifferent terminals of all channels can be connected to each other Warning The unipolar configuration is more susceptible to external noise as compared to the bipolar confi
75. eased to the minimum value of 30ms when atrial Auto Sense has been activated PVARP To resolve a parameter conflict N A conflict resolved by the 9 22 7 adapted during mode switching the device PVARP has been changed i e Please check if the altered adapted to the current rate PVARP is appropriate for the patient MTR To resolve a parameter conflict N A conflict resolved by the 9 22 7 adapted during mode switching the device maximum tracking rate has been changed i e adapted to the current rate Please check if the altered MTR is appropriate for the patient Table 69 Informative Messages Sometimes only a combination of adaptations resolves the conflict completely In this case the message reports all adapted parameters 92 129 51 17 016X B 18 PACE 203H Instructions for Use 10 Storage The storage temperature range of the PACE 203H is 20 C 4 F 60 C 140 F Note that the device must be within the operational temperature range before use 10 C 50 F 45 C 113 F The enclosed connector cables are sterilized prior to shipment They are packed in double transparent sterile packages The sterilization method is ethylene oxide gas The sterility is guaranteed as indicated by the expiration date if the package is not damaged and properly stored The sterile connection cables must be stored in a dry cool place at tempera tures between 10 C 50
76. easuring the stimulation rate e Measuring the sensitivity in the atrial and ventricular channel e Inspecting the battery surveillance and measuring the power mainten ance time after removal of battery e Inspecting the lead surveillance e Inspecting the runaway protection Warning A repair or calibration made by anyone except the manufacturer or a manufacturer authorized designee voids the warranty of the PACE 203H 11 4 Product Return Policy In the event that a PACE 203H and or its accessories are defective and or are beyond repair the user customer must obtain a Return to Manufacturer Auth orization RMA number from the manu facturer and then return these items to the manufacturer for repair or proper disposal 51 17 016X B 18 97 129 PACE 203H Instructions for Use 12 Customer Service If you have any questions the customer service can be reached at OSYPKA AG Earl H Wood Strasse 1 D 79618 Rheinfelden Germany Phone 49 7623 7405 0 Fax 49 7623 7405 160 E Mail mail osypka de For service and repair please contact the manufacturer Osypka Medical GmbH Albert Einstein Strasse 3 D 12489 Berlin Germany Phone 49 30 6392 8300 Fax 49 30 6392 8301 E Mail mail osypkamed com 51 17 016X B 18 99 129 PACE 203H Instructions for Use 13 Technical Data PACE 203H Dual Chamber DDD Temporary Cardiac Pacemaker Measurement conditions uuusrssnenerssnnnnee nennen
77. eatures the Auto Menu must first be entered by pressing the softkey labeled Main Menu and then the softkey labeled Auto If the lower display is off then pressing the key Unlock Lock turns it on The Auto Menu appears as shown in Table 17 Then with the corresponding keys one or more of the automatic features can be enabled or disabled individually 51 17 016X B 18 PACE 203H Instructions for Use Auto Menu Key No avo 1 PVARP M 2 MR M 3 Rais a tT 5 Table 17 Auto Menu 9 9 1 Automatic Setting of A V Delay with the Setting of Rate If this feature is enabled the PACE 203H automatically adjusts the A V de lay with the setting of the basic rate To activate Auto A V Delay the softkey labeled Auto AVD in the Auto Menu has to be pressed The corresponding check box then gets checked The PACE 203H then adjusts the A V delay depending on the basic rate ac cording to the formula in Table 18 and rounded to the nearest manually adjust able value see chapter 9 8 4 In the corresponding A V DLY segment in the upper display the label AUTO indicates that the Auto A V delay feature is acti vated The calculated value for the A V delay is also indicated numerically Auto A V Delay can be deactivated ei ther via the Auto menu or simply by rotating the unlocked A V DLY dial a few clicks approximately a quarter of one revolution 51 17 016X B 18 Automatic A V Delay Range Unit A V Delay 290
78. ect the atrial pacing leads or the corresponding extension cable to the atrial output terminals of the PACE 203H Make sure the polarity is correct 3 Secure the connections by manually turning the collets clockwise 4 If extension cables are used connect the leads to the extension cables 5 Turn on the PACE 203H and set the desired pacing mode 6 Determine the sensitivity threshold see chapter 9 17 7 Determine the cardiac capture thre shold see chapter 9 18 8 Control the proper functioning of the PACE 203H with the assistance of an ECG monitor or recorder 66 129 51 17 016X B 18 PACE 203H Instructions for Use 9 17 Determining the Sensitivi ty Threshold Determining the sensitivity threshold can be accomplished by using the Auto Sense function see chapter 9 9 4 or manually Both methods require that the patient has intrinsic heart activity For manual determination of the sensitiv ity threshold the patient must have heart activity with a rate that is hemodynami cally tolerated over a longer period of time a few minutes The manual determination of the sensi tivity threshold is performed as follows 1 Set the stimulation amplitude in dual chamber mode both channels to the smallest value so that any asynchronous stimulation which oc curs during the procedure remains ineffective 2 Set the basic rate 10 ppm below the patient s intrinsic rate 3 If the PACE 203H is operating i
79. eeeeeeeeeeeeeseeeeeeeeecnaeeeeeeessaeeneneeee 37 Table 24 Auto Sense Menu intrinsic rhythm fOUNC eceeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeetee 37 Table 25 Auto Sense Menu finished 244442404nnn0ennnnnnnnnennnnnnnnnnnnnnnnnennnnnn nn 37 Table 26 Auto Sense Menu no R wave fOUnd cccceececeeeeeeeeeeeeeeeeeeteeeeeeeeestaeeneeeeeee 38 Table 27 Auto Sense Menu one channel initialization request 38 Table 28 High Rate Menu 2222000susssssnsnsnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn 40 Table 29 Atrial High Rate Standby Menu 224s42404nnnnennnnnnnnennnnnnnnnnnnnnnnnnennnnnnnnn 41 Table 30 Range and step width in parenthesis for Atrial High Rate 41 Table 31 Menu while Atrial High Rate is running 22u44s44eer rennen ne nnnnnn ernennen nenn 42 Table 32 Ventricular Rapid Pacing Standby Menu 2244422044200ensnennnnnennnnnnnnennnnnn nn 43 51 17 016X B 18 123 129 PACE 203H Instructions for Use Table 33 Table 34 Table 35 Table 36 Table 37 Table 38 Table 39 Table 40 Table 41 Table 42 Table 43 Table 44 Table 45 Table 46 Table 47 Table 48 Table 49 Table 50 Table 51 Table 52 Table 53 Table 54 Table 55 Table 56 Table 57 Table 58 Table 59 Table 60 Table 61 Table 62 Table 63 Table 64 Table 65 Table 66 Table 67 124 129 Range and step width in parenthesis
80. er frequency Once enabled the acoustic indicator is disabled by pressing the softkey labeled Beep 55 129 PACE 203H Instructions for Use The check mark disappears from the corresponding check box The louds peaker symbol disappears from the upper display as well Upon powering off the PACE 203H it retains the enabled disabled status of the acoustic indicator Thus the enabled disabled status of the last usage is restored again upon powering on the PACE 203H Upon the manufacturer s shipping of the PACE 203H the acoustic indicator is disabled according to Table 48 Note The warning and error signals are not influenced whether or not the acous tic indicator is enabled or disabled Warning and error signals are always accompanied by acoustic signals 9 12 5 2 Enable and Disable the Alarms With the softkey labeled Alarms in the Options Menu the lead surveillance feature see chapter 9 22 2 and the protection against abnormal settings see chapter 9 22 7 can be enabled or disabled Warning Alarms should only be dis abled in a controlled environment spe cifically where medical professionals continuously monitor the patient Upon turning on the PACE 203H the alarms are always enabled With alarms enabled pressing the soft key labeled Alarms causes the check mark to disappear from the correspond ing check box In the upper display the crossed bell symbol see Figure 8 is shown 56 12
81. erfaces with the Electrical Cardiometry EC monitors AESCULON ICON of fered by Cardiotronic La Jolla CA USA and Osypka Medical Berlin Ger many These monitors can synchronize with the PACE 203H and record the pacemaker settings with the correspond ing results of the hemodynamic mea surements The PACE 203H interface to EC moni tors is enabled by selecting the radio button assigned to PMC in the Options Menu 2 Table 57 Pressing the PMC BPI softkey in the Options Menu 2 Table 57 will toggle between the radio button assigned to PMC for Pacemaker Clinic an EC monitor feature and the radio button assigned to BPI for Balloon Pump Inter face 72 129 Options Menu 2 Key No Language 1 PMC BPI O 2 3 more 4 tT 5 Table 58 Options Menu 2 PMC enabled The communication between the PACE 203H and the EC monitor is estab lished via a custom interface cable con nected at one end to the CTRL OUT terminal of the PACE 203H and at the other end to the EC monitor Upon successful communication the PACE 203H parameter settings are transmitted to the EC monitor and both PACE 203H and the EC monitor are syn chronized regarding timely occurrences of atrial and ventricular stimulation The combination of the pacemaker and the EC monitor provides a helpful tool for determining the hemodynamically optimal pacing parameters The user utilizes the EC monitor feature Pac
82. essed to A00 mode To prevent con fusion the upper display remains merely unchanged and does not reflect the A00 mode allowing the user to pre set nor mal pacing parameters Note Within the Atrial High Rate Stand by Menu the pacemaker does not lock the key pad automatically 41 129 PACE 203H Instructions for Use Menu when Atrial High Rate is running Key No Running 1 240 ppm 250 ms 2 3 Use RATE Dial to change High Rate 4 i 5 Table 31 Menu while Atrial High Rate is running After releasing the softkey labeled START Atrium now labeled Run ning the PACE 203H abandons the delivery of atrial high rate stimulation impulses and returns to Atrial High Rate standby If the atrial high rate stimulation frequency has been changed during Atrial High Rate running the basic rate prior the start of the high rate stimulation is restored Thus a rate change during running overdrive stimulation is only temporary This allows a ramp stimula tion to always be started with the same rate The atrial high rate mode is abandoned by pressing the softkey t_ which forces the PACE 203H to return to the Mode Menu Table 9 on page 28 After the start of an atrial high rate stimu lation the lead surveillance in the atrial channel see chapter 9 22 2 on page 74 is enabled If no atrial lead is connected the error message 42 129 Atrial lead disconnected will consequently appear Nevertheless th
83. ey No sani ae 1 wm O 2 Mae O 3 NAi O 4 Main Menu 5 Table 9 Mode Menu The modes DOO V00 A00 DVI DAI and VAT are set by selecting the primary mode DDD VVI AAI VDD and setting the sensitivity in the respective chan nel s to infinite which will be displayed as Table 10 shows the resulting supplementary modes if the sensitivity is set to infinite 28 129 Primary AE Resulting Mode Sensitivity Mode DDD A SensItVIy gt DVI DDD V Sensitivity gt DAI DDD A V Sensitivity gt D00 eu eee voo AAI A Se gt A00 VDD ERENS VI VDD NZ VAT VDD A V Sensitivity gt voo Table 10 Supplementary Mode The selected mode is indicated with its NBG code in the upper display In the new mode the PACE 203H continues to 1 Bernstein AD Camm AJ Fletcher RD et al The NASPE BPEG generic pacemaker code for antibradyarrhythmia and adaptive rate pacing and antitachyarrhythmia devices Pacing Clin Electrosphysiol 1987 10 794 799 51 17 016X B 18 PACE 203H Instructions for Use work with the parameters set before the mode change Note In case of a change from a single to a dual chamber mode or from one chamber mode to another chamber mode for instance VVI AAI the last used parameters are adopted If the Turn on program see chapter 9 11 5 has been re defined to a single chamber mode in case of a first change of such kind the par
84. f Auto Sense The High Rate Overdrive Stimulation Atrial High Rate Standby Atrial High Rate Stimulation with Ramp Function Ventricular Rapid Pacing Standby Ventricular Rapid Pacing with Ramp Function Standard Programs Parameters Stored in a Standard Program 25 25 25 26 26 26 27 27 27 27 28 29 30 31 31 32 32 33 33 34 35 35 35 36 37 38 39 40 40 42 43 45 46 46 51 17 016X B 18 PACE 203H Instructions for Use 9 11 2 9 11 3 9 11 4 9 11 5 9 12 9 12 1 9 12 2 9 12 3 9 12 4 9 12 5 9 12 5 1 9 12 5 2 9 12 5 3 9 12 5 4 9 12 5 5 9 13 9 14 9 15 9 16 9 16 1 9 16 1 1 9 16 2 9 16 3 9 17 9 18 9 19 9 20 9 21 9 22 9 22 1 9 22 2 9 22 2 1 Store Standard Programs Recall Standard Programs Recall Manufacturer s Defaults Changing the Turn On Program Parameters Options Setting Adjustment of PVARP Adjustment of MTR Adjustment of Pulse Duration Adjustment of Atrial ARP and Ventricular VRP Refractory Period Setting Options Enable and Disable Acoustic Indicator Enable and Disable the Alarms Enable and Disable Atrial Trigger Function Setting the User Language Setting CTRL OUT Interface Statistics Emergency Stimulation Pause Function Connecting the Leads to the PACE 203H Lead Types Lead Connection Terminals Connection Configurations Connecting the Leads Determining the Sensitivity Threshold Determining the Cardiac Capture Threshold AC Power Supply Option Controlling a
85. f an extension cable Permanent pacing leads Prior to im plantation of a permanent pacemaker or during a pacemaker change stimulation may be properly maintained with the assistance of the PACE 203H The per manent lead is connected to the PACE 203H either directly or by means of an extension cable Warning All lead systems must be connected to type CF devices only because of the danger of current being diverted to the heart Devices that are connected to a mains supply pose in creased danger for current diversions to the heart 64 129 For exact specifications of leads and patient cables please refer to our prod uct catalog 9 16 1 1 Lead Connection Terminals At the top of the pacemaker are pro tected terminals collets located for plugs with a diameter of 0 9mm to 2 0 mm Viewing the display face of the PACE 203H the atrial connections are located to the left and the ventricular connections to the right see Figure 1 Viewing the top of the PACE 203H as shown in Figure 10 the ventricular con nections are located to the left and the atrial connections to the right The indifferent terminals are colored red while the different terminals are colored black Ventricular Atrial Terminals Terminals Figure 10 Lead Connection Terminals 9 16 2 Connection Configurations Various connection configurations exist depending on the leads used One may choose between bipolar l
86. f higher if longer Table 55 Note In case the PACE 203H is locked it must be unlocked first by pressing the key Unlock Lock Warning If the device is operating in an atrial mode AAI AAT A00 it defaults first to the VOO mode with the above mentioned values upon pressing the emergency key However if the lead surveillance determines that no ventricu 60 129 lar lead is connected the device switch es to A00 mode Note By pressing the emergency key the PACE 203H irrevocably abandons the last parameter setting 51 17 016X B 18 PACE 203H Instructions for Use Emergency Stimulation Program Atrium Operation Mode 00 A00 Rate 80 ppm Amplitude 12V Atrium or set value if higher Amplitude 12V Ventricle or set value if higher Pulse Duration 1 00 ms or set value if higher if longer Puls Duration Ventricle 0 75 ms or set value if higher if longer Table 55 Emergency Stimulation 51 17 016X B 18 61 129 PACE 203H Instructions for Use 9 15 Pause Function The PACE 203H allows the user to tem porarily interrupt the current stimulation therapy in order to monitor the patient s intrinsic cardiac activity This function also referred to as PAUSE function is activated by pressing and holding the key labeled Pause The pause function is implemented as the pacing mode ODO see also chapter 9 6 10 In case any intrinsic atria
87. fety function is referred to as runaway protection 9 22 7 Protection Against Abnormal Settings The PACE 203H continuously monitors the setting of parameters so that abnor mal settings as shown in Table 60 can be detected and avoided Such settings can cause danger for the patient Note All conflicts are avoided when Auto A V Delay Auto PVARP and Auto MTR are activated see chapter 9 9 Note The protection against abnormal settings warning and limitation can be turned off using the Alarms on off op tion see 9 12 5 2 If Alarms are off it is the responsibility of the user to set ap propriate parameter combinations Abnormal Settings Reason for Mode Action Preventing a Basic Rate gt MTR Basic Rate must not DDD Transient warning message and be larger than MTR VDD prevent abnormal setting DAI VAT DAT b AVD PVARP 20ms To guarantee mini DDD Transient warning message and gt LRI mum atrial sensing VDD prevent abnormal setting phase DAI VAT DAT c AVD 60ms gt LRI To guarantee mini DOO Transient warning message and mum VA delay DVI prevent abnormal setting d PVD PVARP gt URI To guarantee DDD Transient warning message and with URI 1 MTR Wenckebach VDD prevent abnormal setting behavior DAI VAT DAT e ARP 20 ms gt LRI To guarantee mini AAI Transient warning message and mum atrial sensing AAT prevent abnormal settings phase 80 129 Table 60 Abnormal Settings 51 17
88. fields should be at levels characteristic of typical commercial or hospital envi ronments Please find further information and guidance regarding EMC in chapter 8on page 15 16 129 51 17 016X B 18 PACE 203H Instructions for Use 9 Use and Application of the PACE 203H 9 1 Design The PACE 203H with its displays keys dials and terminals is shown in Figure 1 Terminals Upper parameter display Lower mode menu displa Fixed labeled keys Figure 1 PACE 203H Display Face 51 17 016X B 18 17 129 PACE 203H Instructions for Use Terminals Button cover CTRL OUT Figure 2 Rear View On the rear side of the device see Figure 2 there is a metal hanger This hanger deploys in three snap in positions Thus it can be used as a hanger as a table top stand or it can be folded away To adjust the hanger grasp it from the sides and pull away from the pa cemaker frame The rear side features a battery compartment release button which opens the battery compartment The battery compartment is located at the bottom of the device A button cover prevents the release button from being unintentionally pressed see chapter 11 2 18 129 51 17 016X B 18 PACE 203H Instructions for Use 9 2 Overview of the Display Dials and Keys 9 2 1 The Upper Parameter Display The six parameters basic rate atrial sensitivity atrial pulse amplitude A V delay ventri
89. finished 9 9 4 4 Notes for the Initialization of the Auto Sense function If the user continues to press the softkey labeled Initiate the PACE 203H will continue to search for intrinsic activity and find the optimal value If the PACE 203H detects frequencies higher than the noise frequency 273 bpm during the Auto Sense initiali zation the corresponding interference symbol is shown in the upper dis play Any P or R wave value determined by the PACE 203H during interference is cleared off the display 2 seconds after the PACE 203H determines interference with the Auto Sense function enabled the sensitivity setting will be doubled in order to find a sensitivity level where the 37 129 PACE 203H Instructions for Use heart activity is sensed without interfe rence If no activity is sensed in a channel for 3 seconds a previously determined P or R wave will be cleared off the display If no activity is sensed in a channel for 3 seconds a previously determined P or R wave will be cleared off the display Table 26 shows an example were an atrial rhythm could be found but no ventricular rhythm Auto Sense Menu Key No Sensed 1 A 2 3 mV 2 No V Sense 3 Finished release key 4 5 Table 26 Auto Sense Menu no R wave found If no intrinsic rhythm is detected in one or both channels the respective check mark continues blinking after returning to the previous menu The initialization request persists as
90. guration 51 17 016X B 18 9 16 3 Connecting the Leads The PACE 203H must be turned off while the stimulation leads are con nected to it Warning While the leads are being inserted into the patient and the PACE 203H is connected continuous ECG monitoring is mandatory For emergency situations a defibrillator must always be in a ready to use state The user must ensure that all devices in the vicinity of the patient are properly grounded Warning Before handling the pacemak er the patient cable or the indwelling stimulation lead the electrostatic poten tial between user and patient must be equalized The stimulation leads provide a direct low resistance current path to the heart Therefore it is absolutely mandatory that the connector plug is not touched with bare hands or can come in contact with electrically conductive or wet surfaces All possible static electricity sources must be kept away from the stimulation system The user must follow the steps described below when connecting a stimulation lead to the PACE 203H 1 Turn off the PACE 203H Open the collets see Figure 10 2 If a patient cable is used this cable must be connected first to the PACE 203H before the stimulation lead is connected to the patient cable Con nect the ventricular pacing leads or the corresponding extension cable to the ventricular output terminals of 65 129 PACE 203H Instructions for Use the PACE 203H Conn
91. he difference between the set beat to beat interval and the A V interval Atrial triggering means that a detected P wave causes an atrial stimulus The programmable options for atrial trigger ing are OFF or ON The blanking period is defined as the time during and after a sensed or paced event when the sensing channel and or the opposite channel of an atrioventricu lar pacemaker are insensitive The pur pose is to avoid sensing of late poten tials and sensing the event of one chan nel in the opposite channel crosstalk Thus during the blanking period no events are recognized Refractory period is a set time in the pacemaker in which a signal in the re spective channel will be recognized but not tracked or does not cause inhibition Sensing phase is the period of time in which a signal that occurred in the re spective channel will be recognized interpreted as intrinsic and tracked Thus this is the period outside blanking or refractory periods The post ventricular atrial refractory period or PVARP a pacemaker para meter is the period after a sensed or paced ventricular event during which the atrial sensing circuit is refractory Thus any atrial event occurring during PVARP 51 17 016X B 18 will not be sensed by the atrial sensing circuit In biventricular stimulation the PVARP starts after the second ventricu lar stimulus 9 6 1 Ventricular Asynchronous V00 Pacing Ventricular asynchronous V00 p
92. he location of the electrodes cross stimulation can however not be completely prevented Therefore when the device is switched on or when the stimulation parameters are changed the user must make sure that no cross stimulation occurs If this should happen one can try to eliminate the effect by adapting the stimulation amplitudes or by ex 14 129 17 18 19 20 21 22 23 24 changing the polarity of the leads If this is not possible the pacemaker must in this special case be used in a single chamber mode without con nection of the leads of the other channel The PACE 203H prevents abnormal settings see chapter 9 22 7 In order to provide continuous opera tion of the pacemaker during battery changes the battery must not be left in the device until it is completely drained see also 9 22 1 If the device is switched off or to stand by after the request to change the battery appears the battery must be changed before the pacemaker is turned on again In case that the PACE 203H is not used for long periods of time the bat tery must be removed in order to prevent damage from possible bat tery acid leakage Such damage cannot be compensated under the guarantee The pacemaker must not be sub merged in either water or any other cleaning solution Do not use any scrubbing powder liquid on the de vice The device must not be sterilized in an autoclave Sterilization with plas
93. ical Paramelers u 2 24H 22 sn ee ee eld 58 Emergency Stimulation 2 0c6 ated aa n a a E a aa 61 Pause Menu with example values uusnesennnersennnnennnnnnennennnnn nennen ernennen 62 Options Menu 2 BPI enabled riiseni iiiaae kenesone ieaie iidr 71 Options Menu 2 PMC enabled 24444244nnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn 72 Mode Switching Due to Interference 244440ennnennnnennnnnsnnennnnnnnnnnnnnnnn 77 Abnormal Settings Zu es nich lat estate 80 Eonflicts Typea 4 2 Basta rennen 81 Conflicts Type B at Schalen cada 81 Conflicts TYPE C nn 2 ae nn Ahan 82 Conflicts Typ d srei iaa a Giles 82 Contlicts Type i6 ic handedatstonhin stain datal ni dated 82 Warning Messages Related to Conflicting Parameter Settings 87 Warning Messages Related to Application Errors uuersnnenersennneenennnnen ernennen 89 51 17 016X B 18 PACE 203H Instructions for Use Table 68 Warning Messages Related to Device Errors Table 69 Informative Messages 0 0 0 eeeeeeeseneeeeeeneeeeeeaeeeeeeaeeeeeeaeeeeeeaeeeessaeeeeeenneeesenaees Table 70 Guidance and manufacturer s declaration electromagnetic emission 115 Table 71 Guidance and manufacturer s declaration electromagnetic immunity 116 Table 72 Guidance and manufacturer s declaration electromagnetic immunity Il 118 Table 73 Distances between portable and mobi
94. ing Standby Menu appears as shown in Table 32 The ventricular rapid pacing is now at stand by The acoustic indicator is automatical ly switched on temporarily if it is not already on Note Within the Ventricular Rapid Pac ing Standby Menu the pacemaker con tinues to operate in the set mode Any previously selected ventricular rapid pacing stimulation frequency and the corresponding beat to beat interval are displayed Note After turning on the PACE 203H the ventricular rapid pacing stimulation frequency is set to the default value 180 ppm if the device has been powered off using the softkey labeled Off no storage If the device has been powered off with the softkey labeled Stand by store data then it will restore the rapid ventricular pacing frequency which was set before powering off 51 17 016X B 18 Ventricular Rapid Key No Pacing Standby Menu START Ventricle 1 180 ppm 333 ms 2 Use RATE Dial 3 to change Rapid Pacing Rate 4 ft 5 Table 32 Ventricular Rapid Pacing Standby Menu The ventricular rapid pacing stimulation frequency can be adjusted by using the RATE dial This means that the RATE dial defaults into a HIGH RATE dial for adjustment of the ventricular rapid pac ing rate as long as the Ventricular Rapid Pacing Standby Menu is present This is indicated by a blinking symbol HI in front of the label RATE together this forms HI RATE in the upper display The ventricular rapid pacing
95. ing therapy for the patient A change of this program is only recommended for experienced users Note Because the sensitivity and the options are also stored the pacing mode 51 17 016X B 18 PACE 203H Instructions for Use stored may also be one of the supple mentary modes D00 DVI VAT DAT V00 A00 AAT and DDD AT Note Because the automatic state of the sensitivity adjustment is also stored turning on a pacemaker with a Turn on program with Auto Sense ON is fol lowed by the request to search for initial sensitivity values as described in chap ter 9 9 4 3 Because the patient should be provided with a therapeutic pacing program immediately after turning on the PACE 203H storing a Turn On Program with Auto Sense enabled is NOT rec ommended Note The Turn on Program also stores a changed Overdrive Stimulation Start Rate 9 12 Parameters Options Set ting The PACE 203H provides the capability of setting additional stimulation parame ters and enabling or disabling options To accomplish this the Parame ters Options Menu must be entered via the softkey labeled Main Menu and then via the softkey labeled Parame ters Options If the lower display is off then pressing the key Unlock Lock turns the display on The Parameters Options Menu appears as shown in Table 41 At this point the corresponding softkeys for the menu setting PVARP amp MTR pulse duration difference AVD PVD ARP or further opt
96. ion the PACE 203H first disables the lead breakage surveillance Thus the user is able to set up the patient without being bothered by lead breakage warnings while the pacemaker is not connected to the pacing leads However upon proper connection of the PACE 203H to the pacing leads and thus the patient the PACE 203H enables lead breakage surveillance after three successfully sensed or paced events Note The lead surveillance can be turned off using the Alarms on off option see Chapter 9 12 5 2 However it is not recommended to disable the lead surveillance function 76 129 Warning The lead surveillance function should only be disabled if a medical professional continuously monitors the patient 9 22 3 Interference and Mode Switch ing The PACE 203H is designed for optimal sensing characteristics and filtering suppression of possible noise and inter ference of frequencies beyond the range of intrinsic and paced frequencies How ever there are types of interference whose frequencies hardly differ from those of intracardiac signals for exam ple noise from mains supply and strong muscle potentials and are of such magnitude that complete suppression cannot be achieved As a consequence the PACE 203H implements an algorithm which decides by means of a rate analysis of the ob served signal whether the intrinsic events or interference is sensed Signals with a frequency below 273 bpm about 4 5 Hz will
97. ions can be chosen 51 17 016X B 18 Parame Key No ters OptionsMenu PVARP amp MTR 1 ARP amp VRP 2 Pulse Duration 3 Options 4 1 5 Table 41 Parameters Options Menu 1 9 12 1 Adjustment of PVARP The post ventricular atrial refractory period PVARP can be adjusted by pressing the softkey PVARP amp MTR in the Parameters Options Menu The PVARP amp MTR Menu appears as shown in Table 42 PVARP amp MTR Menu Key No PVARP i 1 280 ms 2 MTR tT 3 106 ppm l 4 tT 5 Table 42 PVARP amp MTR Menu 51 129 PACE 203H Instructions for Use The PVARP can be changed with the softkey labeled T or the softkey labeled J in increments decrements of 10 ms between 100 ms and 500 ms respec tively as shown in Table 43 The parameter change appears imme diately in the second line of the lower display and will become effective with the next intervention interval Manually Parameter Adjustable Values Unit PVARP 100 10 500 ms Table 43 Manually Adjustable Values for PVARP step width in parenthesis Note Changing the PVARP value ma nually will also switch off the automatic setting if it was activated see chapter 9 9 2 Note The safety feature protection against abnormal settings see chapter 9 22 7 prevents increasing the PVARP to a value which would not guarantee a minimum atrial sensing phase or Wenckebach behavior Any limitation of the PVARP setting will be in
98. key Unlock Lock if the PACE 203H is not yet unlocked Rotating the rate amplitude or A V delay dials clockwise increases the pa rameter value In contrast counter clockwise rotation decreases the para meter value Rotating a sensitivity dial clockwise in creases the sensitivity value i e de 29 129 PACE 203H Instructions for Use crease the sensitivity In contrast coun terclockwise rotation decreases the sen sitivity value i e increases the sensitivity If a maximum or minimum value is reached further rotation of the dial is disregarded Each parameter change is visualized on the upper display both as a number and as a bar diagram Any change of the parameters will be come effective after the next sensing or stimulation event Several parameters are allowed to change simultaneously If a parameter has no pacing function in the mode selected for example A Sense in the VVI mode the correspon ding section in the upper display is blanked If a dial belonging to parameter without pacing function in the mode selected is set the respective previous ly blanked section will be switched on A numeric value will be briefly displayed whereupon it will disappear in approxi mately two seconds 9 8 1 Adjustment of Basic Rate Rotating the RATE clockwise will in crease the basic rate in the range shown in Table 12 The actual rate value and the intensity bar diagram can be seen in the upper disp
99. l or ventricular cardiac activity is sensed e the atrial rate measured in beats per minute bpm the corresponding PP interval ms and the P wave amplitude mV e the ventricular rate measured in beats per minute bpm the corres ponding RR interval ms and the R wave amplitude mV and e the atrio ventricular interval AVI measured in ms are shown on the lower display as shown in Table 56 The parameter val ues are displayed after the second in trinsic sensed event These events are detected up to frequencies of about 700 bpm If no cardiac activity can be sensed or the sensitivity is set to a value much smaller or much larger than the actual P or R wave amplitude the PACE 203H will change the sensitivity temporarily The PACE 203H will attempt to find intrinsic heart activity and to measure the amplitudes optimally When the Auto Sense function is deactivated this change of sensitivity thresholds is only 62 129 temporary Thus after releasing the key labeled Pause the previous sensitivity threshold is restored When the Auto Sense function is activated in one or in both channels the changed sensitivity setting will be taken as new start value for the Auto Sense algorithm see 9 9 4 Thus the Auto Sense function is reinitia lized with the determined sensitivity threshold The display is shown as long as the key labeled Pause is pressed plus for ap proximately an additional second after relea
100. lar refractory period VRP of this pacemaker can be changed By pressing the softkey labeled ARP amp VRP in the Parameters Options Menu Table 41 on page 51 the ARP amp VRP Menu appears as shown in Table 48 The ARP amp VRP Menu can be used to change the setting for ARP and VRP ARP amp VRP Menu Key No ARP a 1 250 ms 2 VRP 7 3 250 ms 4 TL 5 Table 48 ARP amp VRP Menu The ARP can be changed with the soft key labeled ARP T or the softkey labeled ARP J in increments decrements of 10 ms between 250ms and 400 ms respectively as shown in Table 49 The manufacturer s defaults setting is 250 ms refer to section 9 11 4 on page 48 54 129 Manually 3 Parameter Adjustable Values Unit ARP 250 10 400 ms Table 49 Manually Adjustable Values for ARP AAI AAT The VRP can be changed with the soft key labeled VAP T or the softkey labeled VRP J in increments decrements of 10 ms between 250 ms and 500 ms re spectively as shown in Table 50 Manually A Parameter Adjustable Values Unit VRP 250 10 500 ms Table 50 Manually Adjustable Values for VRP The parameter changes appear imme diately in the corresponding line of the lower display see Table 48 and will become effective with the next interven tion interval 9 12 5 Setting Options The Options Menu consists of two parts It appears as shown in Table 51 and Table 52 By pressing the softkey more
101. lay The intensity bar dia gram enlarges from left to right with rate increase 30 129 Adjustable Parameter Values Unit Rate 30 2 220 ppm Table 12 Adjustable Values for Rate step width in parenthesis In order to avoid unintentional settings of high stimulation rates the desire to in crease the stimulation rate from 150 ppm Table 13 and then from 180 ppm must be confirmed Confirmation Message Key No Rate i gt 150 ppm 2 YES gt 3 NO 4 5 Table 13 Confirmation message when increasing the rate higher than 150 ppm Each time the stimulation rate is in creased by rotating the dial RATE clockwise higher than 150 ppm the message Rate gt 150 ppm appears and must be confirmed with YES in order to increase the rate from 150 ppm NO abandons the intention to increase the stimulation rate and the message dis 51 17 016X B 18 PACE 203H Instructions for Use appears Once the threshold of 150 ppm is passed increases of the stimulation rate in the range beyond 150 ppm and less or equal than 180 ppm require no confirmation Note The safety feature protection against abnormal settings see chapter 9 22 7 prevents increasing the basic rate to a value larger than the MTR in DDD VDD DAI VAT and DAT mode Limiting the basic rate value is accom panied by a transient warning message in the lower display 9 8 2 Adjustment of Stimulation Am plitude By rotating
102. le RF communication equipment 119 51 17 016X B 18 125 129 PACE 203H Instructions for Use 21 Appendix F PACE 203H Accessories Please contact OSYPKA AG address on title page for accessories available for the PACE 203H such as various types of extension cables adapters and the BPI 202 interface for an intra aortic balloon pump Figure 18 Pacing Extension Cables Pacing Verlangerungskabel Pacing Extension Cables Lange for alle Kabel auf dieser Seite 25m Artikol Baz Astikol Ne Length of all cables on this page 25m Product name _ Articlo no 2mm 2mm DZT KK S gt D2TKK 81806 0 9 2mm DA4T SP ml p ki D4TSP 81808 en I schwarz black cana 0 9 2 mm D 27 SP rot red Bere e schwarz black 2mm D2sP rot red TU D2 sP s1e73 J I schwarz black 2mm 0 9 2 mm u D2P sp ar rotred D2P SP s1ossBL e1886WS WS weisswhite __ jack 2mm VH C 2 0 9 1 mm vic 2 sseis 2mm VH C 2Hir 53816 Y2 SP 82101 2G 2D 81820 2G 4D 81823 Dio Lisforung der Vort ngsrungan arfoigt EO gas starilsient F r Einmalgabeauch bestimmt Extreion cables supped EO ge ai trad For onetime ums oriy Andarungen dio dem tachnischen Fortschritt danan blabon verbahahon Dia Lisforung der Adapter orfolgt richt storil Adaptors zuppkod non sterio The night to maka technical mprovaments without notice amp reserved Dr YM13100517DA1_Kahoi_Paang TME GmbH Medizin Eart H Wood S
103. list This includes e PACE 203H Dual Chamber DDD Temporary Cardiac Pacemaker Ex ternal Pulse Generator e 9V Alkaline Battery e Users Manual and Quick Reference Guide 8 129 Please inform OSYPKA AG immediately if something is missing or damaged Claims that are filed afterwards cannot be considered 1 3 Optional Accessories Not available in USA and Japan The optionally available medical grade AC power supply 100 240 V 50 60 Hz allows the operation of the PACE 203H while conserving battery power The optionally available BPI 202 intra aortic balloon pump interface provides reliable ECG synchronization for intra aortic balloon pumps IABP which oth erwise rely on a surface ECG obtained from three ECG electrodes 1 4 Writing Conventions of this Manual In this instruction manual certain con ventions are used Keys and displays are represented in the text as follows e Fixed labeled keys and dials are marked with bold style ON OFF Pause Unlock Lock e Texts in the upper display are marked with bold style AUTO A TRIG e Text in the lower display und soft labeled keys are marked in italics Main Menu START 51 17 016X B 18 PACE 203H Instructions for Use e Helpful hints and notes on the usage of the device and for understanding the modes of operation will be intro duced by Notes e Important facts and warnings to be observed are introduced by Warni
104. ma ultrasound or gamma radiation is also not allowed The PACE 203H can be damaged by such proce dures Connector cables intended for single use cannot be re sterilized and rein serted into a patient Only the manufacturer or facilities authorized by the manufacturer can 51 17 016X B 18 PACE 203H Instructions for Use perform repairs or calibration of the PACE 203H 25 All automatic settings provided by the PACE 203H are only a guide to as sist the user in finding the appropri ate settings It is the responsibility of the operator to determine if these settings are correct 26 All battery powered devices can lose their function due to normal dis charge of the battery It must also be considered that the pacemaker can stop operating as a result of an un predictable component failure The patient should not be left unattended by the medical staff and should al ways be supervised by a monitoring system 7 Patient Safety The temporary cardiac pacemaker PACE 203H meets all applicable interna tional standards for patient safety IEC Medical electrical equipment 60601 1 General requirements for safety IEC Medical electrical equipment 60601 Electromagnetic compatibility 1 2 IEC Medical electrical equipment 60601 External cardiac pacemakers 2 31 In the event that the patient is connected to multiple electrical devices the sum of leakage currents may exceed the allow abl
105. malfunctions Exit Block the PACE 203H checks during each delivery of a stimulus whether an interruption or a short circuit of the pacing system has occurred Warning The lead surveillance is enabled only if the pacing amplitude is set greater than or equal to 2 0 V and if the pulse duration is set to a value greater than or equal to 0 15 ms 51 17 016X B 18 PACE 203H Instructions for Use 9 22 2 1 Short Circuit in Pacing System A short circuit in the pacing system can occur for example because of defective insulation An interruption of the stimula tion system can be caused by lead or cable breakage or an incorrectly made connection A short circuit will be indicated by the warning messages Atrial output short or Ventricular output short see chap ter 9 22 9 located in the lower display Each warning message will also be accompanied by an acoustic warning signal Only pressing the key Un lock Lock will discard the warning mes sages for a few seconds but will reap pear if the failure persists 9 22 2 2 Interruption in Pacing System In case of an interruption of the stimula tion circuit which is defined as 3 suc cessive stimulations not properly carried out the open lead symbol see Figure 12 will be shown in the upper display with respect to the corresponding atrial and or ventricular channel 0 Figure 12 Open Lead Symbol Additionally the PACE 203H performs lead surveillance wi
106. n Intra Aortic Balloon Pump Option Interfacing with Electrical Cardiometry Monitors Option Internal Surveillance and Safety Features Battery Surveillance Lead Surveillance Short Circuit in Pacing System 51 17 016X B 18 47 48 48 49 51 51 52 53 54 54 55 56 56 57 57 58 60 62 64 64 64 64 65 67 68 69 70 72 74 74 74 75 5 129 PACE 203H Instructions for Use 9 22 2 2 Interruption in Pacing System 9 22 3 Interference and Mode Switching 9 22 4 Crosstalk and Ventricular Safety Pacing 9 22 4 1 Ventricular Blanking Period 9 22 4 2 Crosstalk Sensing Window and Ventricular Safety Pacing 9 22 5 Premature Ventricular Contraction PVC 9 22 5 1 Isolated PVC or Initial PVC 9 22 5 2 Subsequent PVCs 9 22 5 3 Absolute and relative PVARP 9 22 6 Runaway Protection 9 22 7 Protection Against Abnormal Settings 9 22 7 1 Possible Conflicts 9 22 7 2 Mode Switching 9 22 8 Effects from Therapeutic and Diagnostic Energy Sources 9 22 8 1 Defibrillation 9 22 8 2 RF Surgery 9 22 9 Summary of Text Messages 9 22 9 1 Warning Messages Related to Conflicting Parameter Settings 9 22 9 2 Warning Messages Related to Application Errors 9 22 9 3 Warning Messages Related to Device Errors 9 22 9 4 Informative Messages 10 Storage 11 Care and Maintenance 11 1 Care and Cleaning 11 2 Changing the Battery 11 3 Safety Check Ups of the Pacemaker 11 4 Product Return Policy 12 Customer Service 13 Technical Data
107. n Ur PACE 203H has an uninterruptible tions and vol for 0 5 cycle power system tage variations 40 Ur on power 60 dip in Ur supply lines for 5 cycles IEC 61000 4 11 70 Ur Power frequen 3 A m 3A m Power frequency magnetic fields cy magnetic should be at levels characteristic of a field typical commercial or hospital envi ronment NOTE Uris the AC voltage prior to application of the test level Table 71 Guidance and manufacturer s declaration electromagnetic immunity 116 129 51 17 016X B 18 PACE 203H Instructions for Use The following Table 72 states the immunity test and compliance level for radiated RF elec tromagnetic fields Guidance is given for the electromagnetic environment regarding those fields Guidance and manufacturer s declaration electromagnetic immunity The PACE 203H is intended in the electromagnetic environment specified below The customer and the user of the PACE 203H should assure that it will be used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environ ment guidance Conducted RF 10 Vrms 10 Vrms Portable and mobile RF communications equipment should be used no closer to any part of the PACE 203H including cables and leads than the recommended separation distance calcu lated from the equation appli cable to the frequency of the transmitter
108. n a dual chamber mode the A V delay must be set longer than the patient s intrinsic A V interval 4 In case the pacemaker already senses intrinsic heart activity in the atrial or ventricular channel set the sensitivity at a low level i e raise the sensitivity value such that the PACE 203H will not sense intrinsic events in the atrium and ventricle respectively Eventually the PACE 203H operates in asynchronous pac ing mode 5 Raise the sensitivity i e lower the sensitivity value again until stimula tion is inhibited This sensitivity set 51 17 016X B 18 equals the sensitivity threshold In order to create a safety cushion the sensitivity must be raised further The set value should be a 1 2 to 1 3 of the sensitivity threshold value 6 In case a dual chamber mode is chosen the procedure must be re peated for the other channel Warning An unnecessarily high sensi tivity i e smaller sensitivity value in creases the probability that the proper pacemaker function will be affected by external interference and the pacemak er will switch to asynchronous stimula tion see also chapter 9 22 3 Note When setting the sensitivity thre shold it is very helpful to turn on the acoustic signal of the PACE 203H be cause it emits a different pitched tone for stimulation and for sensing see chapter 9 12 5 1 67 129 PACE 203H Instructions for Use 9 18 Determining the Cardiac Capture Thre
109. n in the lower dis play The Mode Menu Table 4 appears first when the lower display is turned on The mode selection is located in the top menu level to allow a quick access 51 17 016X B 18 PACE 203H Instructions for Use Mode Menu Key No denn ain 1 voo O 2 oan O 3 UNINA O 4 Main Menu 5 Table 4 Mode Menu All other functions are placed in the second third or even forth menu level To access these features the Main Menu must first be entered by pressing the softkey labeled Main Menu If the lower display is off then pressing the key Unlock Lock turns the display on The Main Menu consists of two parts It appears as shown in Table 5 Main Menu 1 Key No High Rate 1 Auto 2 Standard 3 Parameters Options 4 tT 5 Table 5 Main Menu 51 17 016X B 18 From here the High Rate overdrive stimulation the general parame ter options settings the parameters of the cardiac resynchronization therapy CRT the automatic settings feature the recall of standard programs the lead impedance measurement and further parameter settings and options can be accessed Note Pressing the softkey J in any menu always returns to the Main Menu 9 2 6 Display Backlight Both the upper and lower displays are backlit The backlight is deployed as long as the device is unlocked After 30 seconds without any user op eration rotation of dials or pressing keys the backlight is automatically turned off for battery
110. nen nnnnnen nennen rn 22 Table 7 Release Lock Unlock Key Request 22u42s2nnensnnnnen nennen nennen ernennen nennen 22 Table 8 Turn off Menu mina 2 RER ER 24 Fable 9 Mode Menu since cietiin bea leer een 28 Table 10 Supplementary Mode i cts 0 eke herd ie A ee A ennnen nnne 28 Table 11 Rotary Dial functions listed in order from top to bottom uuerssseerrennnen nennen 29 Table 12 Adjustable Values for Rate step width in parenthesis 4umrr nn nenn 30 Table 13 Confirmation message when increasing the rate higher than 150 ppm 30 Table 14 Adjustable Values for Stimulation Amplitude step width in parentheses 31 Table 15 Adjustable Values for Sensitivity step width in parenthesis 31 Table 16 Adjustable Values of A V Delay step width in parenthesis 32 Table 1 72 Auto Me nuisty si i Siete ite Sede Heil 33 Table 18 Automatic Setting Equation for A V Delay u 20urs00snsnnensnnnnnnnennnnnnnennnnnn nn 33 Table 19 Automatic setting formula for PVARP uunssseserssnenersennnnnnennnnnnennnnne nennen nenn 34 Table 20 Automatic setting formula for MTR uu eeseceeeeseeeeeeneeeeeeneeeeesaeeeeeseeeeesnaeeeeeaees 34 Table 21 Auto Sense Menu iiris esta 36 Table 22 Auto Sense Menu channels selected initialization request 36 Table 23 Auto Sense Menu Searching ccccceeecceseeeeee
111. nflict Error Chapter Atrial The atrial or ventricular Check all connections con 9 22 2 output output respectively is nection cables and leads and short short circuited or low identify the short or resistance bridged The PACE 203H was unable to a deliver the last stimulation ulse properly short p propery Note Surveillance can only occur if the stimulation amplitude is set to a value 22 0 V and if the pulse duration is 20 15 millise conds Table 67 Warning Messages Related to Application Errors 9 22 9 3 Warning Messages Related to Device Errors Device related errors are those which are probably caused by a malfunction of the pulse generator itself Some may also have external reasons Errors of this kind result in a warning message in the lower display accompanied by an acoustic error signal which will be re peated periodically The warning mes sage alerts the user about the problem It appears after recognition of the error and disappears only after confirmation by the user i e device related error messages must be confirmed The acoustic error signal will however cease when the error is no more present The user must confirm the error message by pressing the key Unlock Lock Confir mation causes the text message to dis appear and the acoustic signal to cease If an error is detected when the lower display is switched off the acoustic signal is then the only available warning
112. ng 2 Product Description The PACE 203H is a dual chamber external cardiac pacemaker with atrial controlled timing for routine temporary heart stimulation All the usual modes of stimulation are available for treatment of acute brady arrhythmia and for pre intra and post operative stimulation of the heart The stimulation parameters are easily adjustable by rotating dials through a wide range of values The PACE 203H offers the possibility for atrial overdrive stimulation or rapid atrial pacing for terminating supra ventricular tachycardia The rate of the overdrive stimulation is adjustable within a wide range and is independent of the selected stimulation rate The overdrive rate can be determined before and changed during overdrive therapy If required overdrive stimulation can be initiated with the touch of a button The overdrive stimulation is indicated optically and acoustically A medical grade AC power supply allows AC operation of the pacemaker while preserving the battery energy During AC operation a fully charged battery must be in the battery compartment as a backup for AC power failure The AC power 51 17 016X B 18 supply option is not available in USA and Japan The functional design of the PACE 203H allows safe and easy operation for all requirements of DDD stimulation The PACE 203H offers further the follow ing features e During battery changes stimulation will be maintained for at
113. nhibition will not occur The PACE 203H indicates ventricular safety pacing after A V crosstalk through a short time interval between the blinking of the LEDs corresponding to ventricular sensing and pacing respectively 78 129 9 22 5 Premature Ventricular Con traction PVC The PACE 203H assumes an extrasys tole or premature ventricular contraction PVC if it detects two ventricular events without an atrial event in between The detection of a PVC is indicated in the ventricular section of the upper display by the symbol for an extrasystole see Figure 14 9 Figure 14 Symbol for Extrasystole Premature Ventricular Contraction PVC For patients with retrograde conduction the sensing of a ventricular event con ducted retrograde to the atrium can lead to pacemaker mediated tachycardia Note Pacemaker mediated tachycardia has been defined as a reentry arrhyth mia in which the dual chamber pace maker acts as the antegrade limb of the tachycardia and the natural pathway acts as the retrograde limb 23 The PACE 203H prevents pacemaker mediated tachycardia by implementation of a specific PVC algorithm The re 2 Furman S Fisher JD Endless loop tachy cardia in an AV universal DDD pace maker Pacing Clin Electrophysiol 1982 5 486 489 3 Den Dulk K Lindemans FW Bar FW Wel lens HJ Pacemaker related tachycardias Pacing Clin Electrophysiol 1982 5 476 485 51 17 016X B 18 PACE 203H
114. nied by an acoustic warning signal and require no confirmation They disappear automatically after a short period of time or after confirmation by the user The user can confirm an infor mative message by pressing the key Unlock Lock Confirmation causes the message to disappear PACE 203H Meaning Cause Measures to Eliminate See Message the Problem Chapter Startup Timeout The key Unlock Lock was not In order to turn on the pacemaker 9 3 Press Unlock pressed within 30 sec after the key Unlock Lock must be turning on the pacemaker pressed within 30 sec after press Note The PACE 203H will turn ing the key labeled ON itself off after this message Auto AVD The automatic A V delay setting If the automatic A V delay setting 9 9 1 turned off has been turned off because is to remain enabled activate it the A V DLY dial has been again via the Auto Menu and turned avoid turning the A V DLY dial Atrial The automatic atrial sensing If the automatic atrial sensing 9 9 4 Auto Sense adjustment has been turned off adjustment is to remain enabled turned off because the A SENSE SENSE activate it again via the Auto dial has been turned Sense Menu and avoid turning the A SENSE dial Ventricular The automatic ventricular sens If the automatic ventricular sens 9 9 4 Auto Sense ing adjustment has been turned ing adjustment is to remain turned off off because the V SENSE dial enabled activate it
115. nn Environment temperature 20 2 C Voltage supply 9 0 5 V Load resistance 500 Q 1 Test impulse as specified in ISO 14702 8 Triangle 2 ms 13 ms Pacing modes nel primary DDD VVI AAI VDD supplementary DOO V00 A00 DVI DAI DDD AT DAT Stimulation indicators ccsccceceeeeeeeeeteeeeeesteeeeeeees Yellow LEDs blink synchronous to emission of stimulation pulses Sensing indicators eee eeeeeeeeeeeeeeeteeeteeeeeeeeeseaeetenees Green LEDs blink synchronous to sensing of P R waves Basic rale u en e E a ease eats 30 220 ppm 2 Maximum tracking rate MTR neee 80 230 ppm 2 Atrial overdrive stimulation 22uuu44 nennen 70 1000 ppm 5 Ventricular overdrive stimulation 0 0 00 eeeeeeeeeeees 180 220 ppm 2 Outputpulsei zn Ken See ee Cathodic biphasic asymmetric capacitive coupled passive discharge Nominal pulse amplitude 500 Q nunersennneenenenenn nn 0 1 18 V 10 0 05V V Nominal pulse amplitude 200 Q 2000 Q 0 1 18 V 20 0 05V V Pulse duration u a 0 05 ms 1 50 ms 10 0 01 ms Atrial sensitivity eesssensssennnnnnnnennnsnnnnnnnnnnnnnnnnnn 0 2 20 mV 20 0 1 mV Ventricular S NSitivity cccccceeeeeeeeeeeeeeeeeteeeeeeees 1 0 20mV 20 0 1 mV Input impedance ee eeeeeeeeseeeeeeeseceeeneneeeeeseeeeteseenenes 22 kQ 20 Output impedance usrssensneennnnennnnennnnn
116. nnnnnnnnnnn nn lt 10Q Load impedance range unneerenennnennnnnensnnnnnnn ernennen 200 2 2000 Q AeV delay AVD 2 enced en ence 5ms 400 ms 5 2 ms minimum 30 ms when atrial Auto Sense is activated 51 17 016X B 18 101 129 PACE 203H Instructions for Use P V delay PVD u Atrial escape interval V A delay c e Extended atrial escape interval s e V A delay after first PVC 0 0 eeececeeeeeeeeeseeeteneeennees Extended PVARP after PVC neeese Ventricular refractory period seeen Non physiologic A V delay eeen Emergency mode ccceseceeeeseeeeteseeeeeeeseeeeseseeeenes 102 129 Determined by A V delay 30 ms minimum 5 ms when atrial Auto Sense is not activated minimum 30 ms when atrial Auto Sense is acti vated may be prolonged depending on MTR Determined by basic rate 5 Determined by basic rate and A V interval 5 Determined by basic rate and A V delay minimum 850 ms 5 250 ms 400 ms 5 AAI AAT A V interval plus PVARP DDD VDD DAI VAT DAT 250 ms 500 ms 5 100 ms 500 ms 5 90 ms 5 PVARP 90 ms 5 500 ms 5 or maximum possible period 250 ms 5 85 ms 5 2 ms 6 ms after atrial as well as ventricular stimula tion and sensing 85 ms 5 2ms 6msafter ventricular stimulation and sensing 55ms 5 2ms 6ms after atrial stimulation 45ms 5 2ms 40 ms 100 ms 5 2 ms for ventricular safety stimul
117. nsic atrial and ventricular activity occur before the beat to beat interval terminates both channels are inhibited and no pacing occurs If a P wave is sensed before the V A interval is completed output from the atrial channel is inhibited The A V delay is initiated If no ventricular activity is sensed before the A V delay terminates a ventricular pacing stimulus is deli vered that is P synchronous ventricular pacing If no atrial activity is sensed before the V A delay is completed an atrial pacing stimulus is delivered which initiates the A V delay If intrinsic ventricular activity occurs before the termination of the A V delay the ventricular output from the PACE 203H is inhibited that is atrial pacing If no intrinsic ventricular activity occurs before the termination of the A V delay a ventricular pacing stimulus is delivered that is A V sequential dual chamber pacing The A V Sequential Atrial Inhibited DAI Pacing A V sequential atrial inhibited DAI pacing provides pacing in both the atrium and the ventricle but sensing only in the atrium This mode is implicitly selected by setting first the DDD mode and second the ventricular sensitivity to infinite Thus sensing in the ven tricular channel is disabled The DAI mode may be useful in situa tions where no ventricular sensing is possible for instance because of inter 51 17 016X B 18 PACE 203H Instructions for Use ference
118. nsing Window and Ventricular Safety Pacing The crosstalk sensing window follows the ventricular blanking period From 77 129 PACE 203H Instructions for Use then on the PACE 203H cannot differen tiate crosstalk from intrinsic ventricular activity To prevent ventricular systole the PACE 203H delivers a ventricular stimulus if either crosstalk or intrinsic ventricular activity is sensed within 40 ms after the termination of the blanking period This interval of 40 ms is referred to as the crosstalk sensing window and the ven tricular response to as ventricular safety pacing This ventricular pacing stimulus is delivered early that is 100 ms after the atrial event This corresponds to an abbreviated A V delay of 100 ms If the signal sensed is indeed crosstalk the paced ventricular stimulus at the abbreviated A V delay prevents ventricu lar asystole If on the other hand intrinsic ventricular activity occurs during this 40 ms window the safety mechanism results in delivery of a ventricular pacing stimulus within or immediately after the intrinsic beat This delivery is safe because the ventricle is refractory Consequently no depolariza tion results from the ventricular stimulus Furthermore the stimulus is too early to coincide with ventricular repolarization or a vulnerable period Crosstalk window and safety pacing are designed to supplement the ventricular blanking function to ensure that crosstalk i
119. o 30 ms This action will be indicated by a transient informative message in the lower display see also 9 8 4 9 9 4 3 Activation of Auto Sense Because the Auto Sense algorithm re quires sensed intrinsic atrial or ventricu lar events to become operational an initial appropriate sensing value is re quired to enable the Auto Sense feature The following procedure has been estab lished to obtain this initial value To enter the Auto Sense Menu the soft key labeled Auto Sense in the Auto Menu must be pressed see Table 21 Auto Sense Menu Key No 1 AS Pie O 2 Aussee E 3 4 fe 5 Table 21 Auto Sense Menu The softkey labeled Atrial Auto Sense and or Ventricular Auto Sense must be in order to enable or disable the Auto 36 129 Sense feature for the atrial and or ventri cular channel Table 21 If Auto Sense is being enabled in a channel where it was not activated be fore a check mark appears in the re spective checkbox The checkbox then starts blinking and the request to press and hold the softkey labeled Initiate is indicated in the lower display Table 22 illustrates this scenario if Auto Sense is enabled in both channels Auto Sense Menu Key No 1 Atrial Auto Sense M 2 Ventricular Auto Sense M 3 Initiate Press amp Hold 4 tT 5 Table 22 Auto Sense Menu channels selected initialization request When the softkey labeled Initiate is pressed the PACE 203H stops pacing as long as this key i
120. o increase there is inadequate time for a PVARP long PVARP in the presence of a high MTR and long A V delay Decrease The user has attempted to PVARP and or A V delay must be 9 22 7 PVARP or increase MTR This led to a decreased before MTR can be A V Delay conflict type d because the further increased to increase sum of PVARP and P V delay MTR is too long 51 17 016X B 18 85 129 PACE 203H Instructions for Use PACE 203H Meaning Cause Measures to Eliminate the See Warning Message Conflict Error Chapter Decrease The user has attempted to Rate must be decreased before the 9 22 7 Rate decrease MTR This led to a MTR can be further decreased to decrease conflict type a because rate MTR is set to an excessively high value Decrease The user has attempted to PVARP must be decreased or setto 9 22 7 PVARP increase the rate This led to a Auto PVARP before the rate can to increase conflict type b because the be further increased Rate sum of PVARP and A V delay Alternatively manual setting of the is too long with respect to the A V delay or in case of a conflict rate or MTR type d MTR to a lower value is suggested Decrease The user has attempted to A V delay must be decreased or set 9 22 7 A V Delay increase rate This led to a to Auto AVD before the rate can to increase conflict type b or d because be further increased Rate the sum of PVARP and A V Alternatively man
121. or unit at our discretion If it is not possible to repair or replace the PACE 203H we will substitute a functionally equivalent device or refund your original purchase price at our discretion For Warranty claims the defective unit must be returned within thirty 80 days after discovery of the defect postage or shipping prepaid and the RMA number displayed to OSYPKA AG Earl H Wood Strasse 1 D 79618 Rheinfelden Germany If you mail or ship your PACE 203H to us we recommend that you insure and or track your shipment since we will not be liable for loss or damage during shipment This warranty does not cover 1 inci dental or consequential damages in cluding but not limited to medical ex penses caused by a defect or malfunc tion whether your claim is based on warranty contract tort or otherwise 2 damage from accident abuse misuse or introduction of foreign objects 3 51 17 016X B 18 unauthorized modifications alterations or repairs 4 failure to follow the manu facturer s instructions 5 third party actions fire vandalism theft etc 6 the elements or acts of God 7 acces sories 8 preventative maintenance 9 damage that is not reported with 30 days after expiration of the Warranty 10 external electrical interference 11 shipping and mailing costs 12 batte ries THIS WARRANTY IS ESPRESSLY IN LIEU OF ANY OTHER WARRANTY EXPRESSED OR IMPLIED INCLUD ING ANY IMPLIE
122. or emergency situations a defibril lator should always be available in a ready to use state 51 17 016X B 18 10 11 12 ECG monitoring should be continued during all times the PACE 203H is in use for the patient to signalize possi ble complications of different reasons immediately to the medical staff In either case it is necessary to moni tor the patient and to be prepared for a failure of the pacemaker function A back up device for the pacemaker must be available Error messages and conflict warn ings of the PACE 203H do not re place an ECG monitoring During atrial overdrive stimulation an accidental conduction into the ven tricle is possible and may cause ven tricular tachycardia Therefore conti nuous ECG monitoring is mandatory A defibrillator should always be available and ready to use If the PACE 203H operates in an asynchronous mode the pacing pulses may occur during the vulner able phase of the patient s intrinsic activity corresponds approximately in the ECG to the T wave and may cause ventricular fibrillation and ven tricular flutter respectively It is mandatory to continuously moni tor the patient and to be prepared for a possible failure or malfunctioning of the pacemaker when the PACE 203H is used in conjunction with electro surgical instruments or defi brillators To protect the patient and the pace maker from current passing through the pacemaker lead circuitry caused
123. or simply by rotating the respective unlocked A SENSE or V SENSE dial a few clicks approx a quarter of one revolution lf a SENSE dial has been turned to deactivate Auto Sense the transient message Atrial Ventricular Auto Sense or Auto Sense turned off turned of appears in the lower display accompa nied by a short beep The label AUTO disappears from the upper display Using the Auto menu the Auto Sense function is disabled by pressing the cor responding softkey As a consequence the corresponding check box is un checked The label AUTO disappears from the upper display Note Upon a mode change for instance VVI gt AAI or DDD gt VVI that disables a channel the Auto Sense function enabled in this particular channel is disabled The Auto Sense function is not reactivated upon enabling the particular channel because the EGM amplitudes could have changed significantly during 51 17 016X B 18 the time the Auto Sense function was disabled 39 129 PACE 203H Instructions for Use 9 10 The High Rate Overdrive Stimulation The PACE 203H provides a function for atrial high rate stimulation also known as atrial overdrive stimulation or rapid atrial pacing and a function for ventricu lar rapid pacing Both functions become accessible by entering the main menu via the softkey labeled Main Menu and then by selecting either Atrial High Rate or Ventricular Rapid Pacing via the cor responding
124. ormal pacemaker settings Erratic rhythm Compromise in stroke volume car diac output Inappropriately high sensitivity setting Sensing of R or T waves in the atrium or P waves in the ventricle Detection of interfe rence noise electromagnetic interference Ventricular tachycardia ventricular fibrillation and death if not recognized immediately 51 17 016X B 18 11 129 PACE 203H Instructions for Use Complication Result Time mismatch between intra cardiac conduction and pace maker settings Pacemaker mediated tachycardia In order to prevent this some decision overrides are implemented in the PACE 203H However it is not possible to completely prevent the possibility of a pacemaker mediated tachycardia Overdrive stimulation in the atrium rapid atrial pacing Accidental conduction into the ventricle can create ventricular arrhythmia Battery failure or exhaustion Failure of impulse emission Failure to stimulate Technical defect in the PACE 203H failure of components Failure or change in the impulse emission changed or no sensing incorrect displays Failure to stimu late Undetected programming errors Chaotic rhythm Erroneous lead connection Device does not function properly Chaotic rhythm Failure to stimulate as intended Influence of defibrillation and RF surgery See chapter 8 for the effects while simultaneous use
125. ot fol lowed within 30 sec an error message Startup timeout Press Unlock will appear and the device will switch off This prevents discharge of the bat tery if the key labeled ON has been pressed accidentally Note Please do not press any key dur ing the self testing after turning on the PACE 203H Among other tests a key check is performed during this period If a key is pressed a request will be indi cated as follows Release all keys If the operator is not in compliance with this request or if a key is stuck the message Keyboard error 51 17 016X B 18 will appear in the lower display after 10 seconds 9 4 Locking Unlocking the PACE 203H In order to prevent an accidental change of pacing parameters the device will be locked automatically if no control has been turned or no key has been pressed for 30 sec If the device is locked pressing the key Lock Unlock performs an unlock func tion If the device is unlocked pressing the key Lock Unlock disables any dials and menu operation ofthe PACE 203H Whether the device is locked or un locked these conditions will be conti nuously indicated by the lock symbol Figure 4 in the upper display a ft Figure 4 Lock Symbol If a key is pressed or a dial is rotated while the device is locked a warning beep will be emitted and the lock symbol will blink for 2 seconds Note For High Rate Stimulation Stand by see chapter 9 10 the time of o
126. ous ventricular pac ing is disabled regardless of any atrial event The PVARP of the PACE 203H is divided in two periods an absolute period and a relative period In the absolute period 90 ms no atrial events are recognized In the relative period the remaining atrial events are registered but not tracked This algorithm prevents misinterpretation of ventricular events after premature atrial events as extrasys toles PVCs sensed ventricular event not preceded by a sensed atrial event Also named extrasystole Monophasic electrical output of a pulse generator intended to stimulate the myocardium Magnitude of the pulse expressed in volts or mil liamperes Duration of the pulse Time interval between identical points of two con secutive pulses expressed in milliseconds Number of pulses per minute 1 ppm 1 60 s Delay between the sensing of an atrial depolariza tion and the subsequent non triggered ventricular pulse under the condition that no sensing of a ventricular depolarization was detected by the pulse generator Period during which a pulse generator will not respond to a beat Minimum signal expressed in millivolts required to consistently control the function of the pulse gene rator The shortest period allowable between paced or sensed events while still maintaining 1 1 atrioven tricular synchrony equal to 60 MTRppm 111 129 PACE 203H Instructions for Use V A delay V
127. perat ing freedom is 60 seconds after last operation 23 129 PACE 203H Instructions for Use 9 5 Powering Off The PACE 203H The PACE 203H is powered off by pressing the key labeled OFF In order to prevent powering off the de vice by mistake a menu Table 8 ap pears in the lower menu with the soft keys labeled Off and Stand by Power Off Menu Key No Off no storage 1 2 Stand by store data 3 4 Tt 5 Table 8 Turn off Menu Upon selecting Off no storage by pressing the corresponding softkey the PACE 203H switches off without storage of the actual settings prompting the message Off no storage Upon selecting Stand by store data by pressing the corresponding softkey the PACE 203H stores the actual set tings prompting the message Stand by store data and then switches off The PACE 203H does not consume any battery power in the Stand by mode When the PACE 203H is powered on from the Stand by mode it will after switching on function with these prior 24 129 settings and not with the Turn on pro gram The PACE 203H switches off with a short acoustic signal beep 9 6 Modes of Operation The following terms are defined The beat to beat interval a pacemaker parameter is the programmed interval of a complete pacing cycle measured in milliseconds ms It is determined as the inverse of the basic rate Wenckebach behavior is always acti vated in atrio
128. polarization or other electrical influence in the same chamber Pulse rate with which the pulse generator responds when it senses electrical activity other than that from the myocardium and recognizes that as inter ference The longest period between consecutive paced or sensed events occurring in the relevant chamber In absence of sensed cardiac or other electrical influence equal to basic pulse interval Maximum ventricular pacing rate in response to sensed atrial activity Expressed differently it is the maximum pulse rate at which the non implantable pulse generator will respond on a 1 1 basis to a triggering signal Medical electrical equipment with an internal elec trical power source which is intended for use out side the body and which produces a periodic elec trical pulse intended to stimulate the heart through a lead or combination of lead and patient cable Device attached to the terminals of a non implantable pulse generator so that the distance between it and the pacing lead can be increased 51 17 016X B 18 PACE 203H Instructions for Use Post ventricular atrial refractory period PVARP Premature ventricular contraction PVC Pulse Pulse amplitude Pulse duration Pulse interval Pulse rate P V delay PVD Refractory period Sensitivity Upper rate interval URI 51 17 016X B 18 Period after a ventricular event whether sensed or paced during which synchron
129. rate can be changed in 2 ppm increments between 180 ppm and 220 ppm as shown in Table 33 43 129 PACE 203H Instructions for Use Adjustable Values ol Parameter Ventricular Rapid Pacing Rate 180 12 220 ppm Table 33 Range and step width in parenthesis for Ventricular Rapid Pacing The PACE 203H delivers ventricular rapid pacing stimulation impulses upon pressing and holding the softkey labeled START Ventricle The pacemaker switches to the V00 mode and stimulates with the set ventricular rapid pacing rate showing the Ventricular Rapid Pacing Running menu Table 34 To return to the mode menu Table 9 on page 28 please press the key _ Warning There is a risk of causing ventricular tachycardia during ventricular rapid pacing stimulation Continuous ECG monitoring of the patient is there fore mandatory A defibrillator should always be available and ready to use Note During ventricular rapid pacing stimulation the PACE 203H switches temporarily as long as the START Ven tricle key is pressed to VOO mode To prevent confusion the upper display remains merely unchanged and does not reflect the VOO mode allowing the user to pre set normal pacing parameters Note Within the Ventricular Rapid Pac ing Standby Menu the pacemaker does not lock the key pad automatically 44 129 Note For safety reasons the ventricular rapid pacing function does not offer a higher stim
130. rs and their correspond ing measurements The softkey labeled Reset Statistics provided exclusively in statistics screen IV allows a manual reset of Runtime and thus all event counters of the statistics 51 17 016X B 18 Upon turning the device on the Runtime and all statistics event counters are reset The Runtime and the event coun ters are not reset if the device was put into stand by with Stand by store data and then activated again Refer to sec tion 9 5 on page 24 for turning off with Stand by store data Note It is theoretically possible that some percent values in the statistics are larger than 100 for example if there would be more than one extrasystole per cycle 59 129 PACE 203H Instructions for Use 9 14 Emergency Stimulation In case heart stimulation becomes inef fective with the set parameters in place the PACE 203H provides an emergency stimulation program This emergency program can be quickly and easily acti vated from all operational states by pressing the key EMERGENCY The PACE 203H defaults immediately to the emergency stimulation program with the parameter shown in Emergency Stimulation Program Operation Mode 00 A00 Rate 80 ppm Amplitude 12V Atrium or set value if higher Amplitude 12V Ventricle or set value if higher Pulse Duration 1 00 ms Atrium or set value if higher if longer Puls Duration 0 75 ms Ventricle or set value i
131. rt activity e The PACE 203H is designed to pro tect against accidental liquid spills Insulation between upper and lower housing and the battery compartment lid as well as sealed dial mountings allow for a high level of spillage pro tection All further technical functions of the PACE 203H will be described in detail in the following chapters 3 Indication The PACE 203H DDD Temporary Car diac Pacemaker is designed to be used with cardiac stimulation lead systems for temporary atrial ventricular or A V se quential stimulation The PACE 203H has applications where such stimulation modes are indicated for therapeutic prophylactic or diagnostic purposes Specific indications include but are not limited to the following e Sick sinus syndrome e Bradycardia with congestive heart failure 10 129 e Complete heart block e Acute myocardial infarction compli cated with heart block e Sinus bradycardia e Cardiac arrest with ventricular asys tole e Atrial and or ventricular ectopic arr hythmia e Postoperatively after cardiac surgery e Temporary application during implan tation or exchange of a permanent pacemaker Indication for atrial overdrive stimulation e Supra ventricular tachycardia 4 Contraindication There are no contraindications with regards to the use of the PACE 203H for temporary cardiac stimulation for therapy and prevention of arrhythmia The state of health of the patient
132. s an example in which the sensitivity is increased i e sensitivity value is decreased to maintain an ap propriate safety margin when the EGM amplitude drops Decrease Sensitivityuntil upper margin is no more exceeded Figure 6 The Auto Sense function de creases sensitivity Figure 6 shows an example in which the sensitivity is decreased i e sensitivity value is increased when the EGM am plitude goes up An appropriate safety margin is kept without working with un necessarily high sensitivity which may promote noise detection 9 9 4 2 Important Notes Using the Auto Sense Function Because the intrinsic activity of the pa tients heart determines the sensitivity value the Auto Sense feature can of course only be used in a patient who has such intrinsic activity Auto Sense cannot be used together with Atrial Trigger because the triggered stimulation prevents proper measure ment of the intrinsic activation see also 9 12 5 3 Auto Sense requires a specific time to measure the intrinsic atrial activity P V 35 129 PACE 203H Instructions for Use delay is therefore limited to a minimum of 30 ms when atrial Auto Sense is acti vated Because A V delay cannot be shorter than P V delay it is also limited to 30 ms In case atrial Auto Sense is enabled and the A V delay was set to a value smaller than 30 ms then the A V delay will be automatically extended t
133. s causes the check mark to disappear from the cor responding check box and AUTO PVARP from the upper display The PVARP amp MTR setting menu appears showing the actual value which provides the opportunity to adjust a new value manually see chapter 9 12 1 Note The PVARP of the PACE 203H is divided in two parts an absolute part and a relative part In the absolute part which is 100 ms long no atrial events are recognized In the relative part the remaining atrial events are registered but not tracked This algorithm prevents the misinterpretation of ventricular events after premature atrial events as extrasystoles PVCs as described in chapter 9 22 5 34 129 9 9 3 Automatic Setting of MTR with the Setting of Rate If this feature is enabled the PACE 203H automatically adjusts the Maxi mum Tracking Rate MTR with the set ting of the basic rate To activate Auto MTR the softkey la beled Auto MTR in the Auto Menu must be pressed The corresponding check box then gets checked The PACE 203H then adjusts the MTR to a value 34 ppm higher than the basic rate but with a minimum of 100 ppm and a maximum of 230 ppm according to the formula and the range in Table 20 In the upper display the label AUTO MTR indi cates that the Auto MTR feature is acti vated Automatic MTR Range Unit MTR Rate 34 100 230 ppm Table 20 Automatic setting formula for MTR To deactivate Auto MTR the
134. s held down How ever the PACE 203H continues to sense and attempts to detect a regular intrinsic activation of the patient s heart While doing this the lower display appears as shown in Table 23 A flashing heart symbol indicates each detected event Furthermore the acoustic indicator will automatically be enabled temporarily if it is not already switched on Because the PACE 203H goes through an initializa 51 17 016X B 18 PACE 203H Instructions for Use tion algorithm individual intrinsic events may or may not be detected Auto Sense Menu Key No 1 Searching A Sense y 2 Searching V Sense y 3 hold 4 5 Table 23 Auto Sense Menu Searching If the PACE 203H has found an intrinsic heart rhythm it will display the sensed EGM amplitude as shown in Table 24 Auto Sense Menu Key No Sensed 1 A 2 3 mV 2 V 8 0 mV 3 Finished release key 4 5 Table 24 Auto Sense Menu intrinsic rhythm found The softkey labeled nitiate can now be released An appropriate sensitivity val ue will be automatically selected and set 51 17 016X B 18 which will be visible in the upper display Furthermore the sign AUTO will be shown in the respective section s of the upper display The lower display will return to the Auto Sense Menu with the boxes checked blinking ceases as shown in Table 25 Auto Sense Menu Key No 1 Atrial Auto Sense M 2 Ventricular Auto Sense M 3 4 Tt 5 Table 25 Auto Sense Menu
135. se the PACE 203H ceases the lead breakage warning message upon the users confirmation but continues to display the open lead symbol if the mal function remains present If the disconnection is detected when the lower display is switched off only the acoustic signal is enabled A first press of the key Unlock Lock switches on the lower display and the backlight and unlocks the device Then the warning message is displayed A second press on the key Unlock Lock confirms the error message 75 129 PACE 203H Instructions for Use If the disconnection is detected when the lower display is switched on but the device is locked a first press of the key Unlock Lock switches the backlight on and unlocks the device The user con firms the warning message with a second press of the key Unlock Lock Once the leads are connected and func tioning appropriately the lead breakage warning function is enabled automatical ly after three sensed or paced events Note As long as the stimulation ampli tude is set to less than 2 0 V or the pulse duration is set less than 0 15 ms the lead breakage surveillance remains in the previously held status enabled or disabled When the PACE 203H resumes opera tion from the stand by mode the lead breakage surveillance is always acti vated The PACE 203H assumes that the pacemaker is already connected to the pacing leads and thus to the patient In any other case of beginning operat
136. shold Warning If the patient has a sufficient intrinsic heart rate the determination of the sensitivity threshold must be carried out before the cardiac capture threshold can be determined This is done in order to make certain that no asynchronous superimposition of intrinsic rhythm and stimulation occurs To determine the cardiac capture thre shold the following steps should be taken 1 Set the basic rate at least 10 ppm above the patients own rate If the PACE 203H is already effectively stimulating lower the stimulation amplitude until the stimulus is no longer effective 2 In case the PACE 203H is operating in a dual chamber mode the A V de lay must be set shorter than the pa tient s intrinsic A V interval 3 Raise the stimulation amplitude slow ly until the stimulus is effective again The amplitude set equals the cardiac capture threshold 4 In order to create a safety cushion the stimulation amplitude must be raised further The set value should be from two to three times the car diac capture threshold 5 In case a dual chamber mode is chosen the procedure must be re peated in the other channel Warning If the PACE 203H is to be used for a longer period of time on a patient the stimulation threshold should be checked from time to time the first time after a few hours then daily be 68 129 cause an increase in the capture thre shold can occur 51 17 016X B 18 PACE 203H
137. shown in Table 27 38 129 Auto Sense Menu Key No 1 Atrial Auto Sense M 2 Ventricular Auto Sense M 3 Initiate press amp hold 4 tT 5 Table 27 Auto Sense Menu one chan nel initialization request The user can decide if another attempt shall be made to find an intrinsic rhythm or if the procedure shall be terminated using the t_ key In the previous exam ple the Auto Sense feature will then be enabled only in the atrial channel 9 9 4 5 Re Initialization of Auto Sense Once activated the Auto Sense feature can be easily re initialized by just press ing and holding the key PAUSE see 9 15 However this is only necessary if the amplitude of the intrinsic activity has decreased so dramatically and rapidly such that the Auto Sense algorithm could not follow this change Warning If frequencies higher than the noise frequency 273 bpm are detected during the re initialization the corres ponding interference symbol will be displayed in the upper display The sen sitivity setting will remain unchanged and 51 17 016X B 18 PACE 203H Instructions for Use the measured frequency will be dis played because it may be a high 6frequency tachycardia This behavior is different from Auto Sense initialization see above where the sensitivity value will be increased step by step in case of noise 9 9 4 6 Deactivation of Auto Sense The Auto Sense function can be dis abled either via the Auto Menu
138. sing the key The acoustic indicator will automatically be enabled temporarily if not already enabled Pause Menu Sensed 50 bpm A 1200 ms 2 3 mV 50 bpm V 1200 ms 8 0 mV AVI 90 ms Table 56 Pause Menu with example values The pause function is activated for up to 10 seconds Subsequently the PACE 203H resumes pacing independent if the user continues to hold the key la beled Pause 51 17 016X B 18 PACE 203H Instructions for Use Warning Because pacing is interrupted the user must be aware that the patient receives no stimulation therapy and support by the pacemaker as long as the key labeled Pause is pressed The PAUSE function is always opera tional except during application of atrial overdrive stimulation It does deploy however during High Rate standby and can be used to measure the frequency of the atrial tachycardia which assists in finding the optimal overdrive stimulation rate The determination of the intrinsic atrial rate can be influenced by the cross blanking after ventricular sensing Thus sensing of atrial activations can get lost due to the cross blanking which may result in a rate determination being of too low or unstable Thus if a precise mea surement of the atrial frequency is de sired the ventricular lead must be dis connected If frequencies higher than the noise frequency 273 bpm are detected while the key labeled Pause is pressed the corresponding
139. softkey labeled Auto MTR in the Auto Menu must be pressed again This causes the check mark to disappear from the cor responding check box and the label AUTO MTR in the upper display The MTR setting menu appears showing the actual value which provides the opportu nity to input a new value manually see chapter 9 12 2 51 17 016X B 18 PACE 203H Instructions for Use 9 9 4 Automatic Adjustment of Sensi tivity Auto Sense 9 9 4 1 How the Auto Sense Function Works The Auto Sense function automatically adjusts the PACE 203H sensitivity to maintain an approximate 3 1 sensing safety margin potentially reducing the number of under over sensing episodes This feature may also reduce the need to manually determine the sensitivity thre shold see chapter 9 17 The Auto Sense function is different from the other automatic functions in that the automatic sensing value is not calculated from another parameter The PACE 203H adapts the sensing value conti nuously to the patient s intrinsic heart activity For this intrinsic activity which is detected in the sensing phase of the respective channel the amplitude is measured and the sensitivity value of the pacemaker is adapted to maintain the 3 1 sensing safety margin safet margi 4 sensitivi Es gt Increase Sensitivityntil lower margin is exceeded Figure 5 The Auto Sense function in creases sensitivity 51 17 016X B 18 Figure 5 show
140. tate of the lead surveillance will be restored The Pause function see chapter 9 15 on page 62 can be used to measure the intrinsic ventricular rate Thus the Pause function may assists in determining the optimal ventricular rapid pacing rate As long as the softkey labeled START Ventricle is pressed all other keys and dials are disabled 9 10 2 1 Ventricular Rapid Pacing with Ramp Function The PACE 203H provides a function allowing the application of ventricular rapid pacing with a ramp function While the ventricular rapid pacing is running Ventricular Rapid Pacing Running Menu Table 34 is shown turning the HIGH RATE dial changes the ventricular rapid pacing rate This feature allows the user to manually set a ramp function for ventricular rapid pacing stimulation 51 17 016X B 18 Note The PACE 203H ignores any rotation of the HIGH RATE dial beyond the defined minimum or maximum set tings 45 129 PACE 203H Instructions for Use 9 11 Standard Programs The PACE 203H provides the capability of storing and recalling a user defined standard set of parameters a so called standard program for each primary mode of operation DDD VVI AAI VDD That is four different standard programs can be stored Alternatively the user can reset each primary mode to the manufacturer s default settings In addition the initial mode and parameter settings can be configured in the Turn on program To perform one
141. th an intelligent lead breakage warning function which oper ates independently in the atrial and ven tricular channels The PACE 203H enables this function in a channel auto matically upon recognition that a lead is connected According to the definition of the function a lead is connected upon 51 17 016X B 18 three sensed or paced events In case an atrial or ventricular lead or any part of the circuit fractures accidentally or on purpose identified by three failed deliveries of pacing stimuli the open lead symbol In case an atrial or ventricular lead or any part of the circuit fractures acciden tally or on purpose identified by three failed deliveries of pacing stimuli the open lead symbol see Figure 12 ap pears in the respective section of the upper display accompanied with an acoustic warning signal The warning signal is repeated as long as the inter ruption persists In addition the warning messages Atrial lead disconnected or Ventricular lead disconnected appear in the lower display only if the lower dis play is switched on Once the problem for the malfunction is resolved the warn ing message disappears automatically and the acoustic warning signal ceases The user can confirm the error message by pressing the key Unlock Lock Con firmation causes the warning message to disappear and the acoustic signal to cease despite the fact for example that the lead remains disconnected In this ca
142. to decrease the likelihood that mo bile portable communications equipment could cause interference if it is inadvertently brought into patient areas For this reason an additional factor of 10 3 is used in calculat ing the recommended separation distance for transmitters in these frequency range c Field strength from fixed 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 fixed RF transmitters an electromagnetic site survey should be consi dered If the measured field strength in the location in which the PACE 203H is used ex ceeds the applicable RF compliance level above the PACE 203H should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the PACE 203H d Over the frequency range 150 KHz to 80 MHz field strengths should be 10 V m Table 72 Guidance and manufacturer s declaration electromagnetic immunity II 118 129 51 17 016X B 18 PACE 203H Instructions for Use Table 73 lists minimum separation distances between PACE 203H and portable mobile RF communication equipment that should be maintained to avoid interference Recommended separation distances between portable and mobile RF communication equipment
143. tr 1 79618 izintechnik EE OSYPKA 51 17 016X B 18 127 129 PACE 203H Instructions for Use 22 Appendix G Declaration of Conformity my OSYPKA MEDICAL Berlin Germany San Diego California USA Osypka Medical GmbH Albert Einstein Strasse 3 12489 Berlin Germany declare under our sole responsibility that the medical device Dual chamber External Pacemaker PACE 203 including Power Supply PACE and accessories is in conformity with the act on Medical Devices the Medical Device Directive 93 42 EEC amended by 2007 47 EC with reference to Directive 2006 42 EC on Machinery and the applicable medical device standards IEC 60601 1 and IEC 60601 2 31 This Declaration of Conformity covers all in our company manufactured loads of the above mentioned device which are labelled with the CE mark This Declaration of Conformity is based on the Full Quality Assurance System certification with the registration number G1 10 04 39212 013 issued by the Notified Body Nr 0123 the TUV Product Service GmbH in Munich Berlin 2010 06 21 r vr IR fy a Plant Manager Quality Manager 51 17 016X B 18 129 129
144. tra aortic balloon pump IABP The BPI 202 obtains a signal from the PACE 203H indicating a either a ventricular intrinsic depolarization or a stimulus and provides a corresponding signal to the IABP which resembles a surface QRS com plex The PACE 203H utilizes the intracardiac electrogram obtained from the ventricu lar channel The ventricular signal is processed in such a way that its charac teristics shape impulse amplitude base width are similar to a signal obtained from surface electrodes Setup Connect the BPI 202 and PACE 203H via the CTRL OUT terminal of the PACE 203H see Figure 1 and Figure 2 Attach the clips of the 3 leads provided by the IABP which usually are attached to 3 surface ECG electrodes to the 3 pins provided at the front of the BPI 202 The PACE 203H accomplishes the syn chronization of the IABP with the heart activity in both intrinsic and paced ventri cular events by application of a differen tial timing Intrinsic Event Upon sensing of an Rwave the PACE 203H provides a control signal whose processed R wave is delayed by approximately 5 ms assuming that the amplitude of the R wave measured is twice the value of the sensitivity set 70 129 Paced Event Upon delivery of a ventri cular stimulus the PACE 203H provides a control signal whose processed R wave is delayed by approximately 35 ms accounting for the latency period that is the time between actual delivery of
145. ual setting of the delay is too long with respect pyaRP or in case of a conflict the rate or MTR type d the MTR to a lower value is suggested Decrease The user has attempted to PVARP must be decreased or setto 9 22 7 PVARP decrease the rate This led to Auto PVARP before the rate can to decrease a conflict type b because be further decreased Rate the sum of PVARP and A V Alternatively manual setting of the delay is too long with respect A V delay or in case of a conflict to rate or MTR type d the MTR to a lower value is suggested Decrease The user has attempted to The A V delay must be decreased 9 22 7 A V Delay decrease the rate This led to or set to Auto AVD before the rate to decrease a conflict type b or d be can be further decreased Rate cause the sum of PVARP and Alternatively manual setting of the A V delay is too long with pyaRP or in case of a conflict respect to the rate type d the MTR to a lower value is suggested Decrease The user has attempted to The MTR must be decreased or set 9 22 7 MTR decrease the rate This led to to Auto MTR before the rate can to decrease a conflict type d because be further decreased Rate the MTR is too high with respect to the sum of PVARP and A V delay Alternatively manual setting of the PVARP or of A V delay to a lower value is suggested 86 129 51 17 016X B 18 PACE 203H Instructions for Use PACE 203H Me
146. ulation rate than would also available in normal operation Menu when Key No Ventricular Rapid Pacing is Running Running 180 ppm 2 333 ms Use RATE Dial 3 to change Rapid Pacing Rate 4 t 5 Table 34 Menu while Ventricular Rapid Pacing Running After releasing the softkey labeled START Ventricle now labeled Run ning the PACE 203H abandons the delivery of ventricular rapid pacing stimu lation impulses and returns to Ventricu lar Rapid Pacing Standby If the ventricu lar rapid pacing rate has been changed during Ventricular Rapid Pacing Run ning the basic rate prior the start of the ventricular rapid pacing is restored Thus a rate change during running ven tricular rapid pacing is only temporary This allows a ramp stimulation to always be started with the same rate The ventricular rapid pacing mode is abandoned by pressing the softkey _ 51 17 016X B 18 PACE 203H Instructions for Use which forces the PACE 203H to return to the Mode Menu Table 9 on page 28 After the start of an ventricular rapid pacing stimulation the lead surveillance in the corresponding channel is enabled see chapter 9 22 2 on page 74 If no ventricular lead is connected the error message Ventricular lead disconnected will consequently appear Nevertheless the impulse emission with ventricular rapid pacing rate will be carried out After releasing the softkey labeled START Ventricle the previous s
147. ustic warning signal Note The text message Change battery disappears only upon the user pressing the key Unlock Lock Figure 11 Battery Symbol If the time to change battery warning is disregarded and the voltage falls below a critical value then the empty battery symbol blinks requesting an immediate change of the battery see chapter 11 2 This action is accompanied by the warn ing message Hurry up Change battery 74 129 and the acoustic warning signals every 2 minutes The lifespan of the battery depends on the set stimulation parameters In chap ter Technical Data on page 101 the lifespan for 100 stimulation in two usual modes DDD VVI are given for alkaline and lithium batteries During a battery change the PACE 203H is capable of providing continuous operation for at least 30 seconds Warning In order to provide continuous operation of the pacemaker during bat tery changes it is recommended that the battery will be replaced before being completely drained see also chap ter 11 2 If the PACE 203H is switched off or to the stand by state after the first request to change the battery has appeared the battery must be replaced before the pacemaker is turned on again The bat tery can be changed without losing the stored settings The battery surveillance cannot be turned off with the Alarms on off option see chapter 9 12 5 2 9 22 2 Lead Surveillance In order to prevent system
148. ventricular modes incorpo rating atrial sensing In case of high spontaneous intrinsic atrial rates the P V delay will be prolonged in order to prevent high ventricular stimulation rates This function limits the ventricular rate to the so called Maxi mum Tracking Rate MTR As a con sequence Wenckebach behavior inter mittently blocks the conduction of intrin sic atrial beats to the ventricular cham ber The A V delay a pacemaker parameter is the programmed atrioventricular pac ing interval initiated by an atrial stimu lus The P V delay a pacemaker parameter is the programmed time interval between atrial sensing P wave and the ventricu lar stimulus The P V delay can be inter preted as a programmable conduction delay window It is determined by the A V delay and by the Maximum Tracking Rate MTR The A V interval is the measured time interval between a sensed or paced atrial event and the subsequent ventricu lar sensed or paced event In case of 51 17 016X B 18 PACE 203H Instructions for Use spontaneous ventricular depolarization the A V interval is shorter than the pro grammed A V delay The V A delay a pacemaker parameter is the programmed ventriculoatrial inter val initiated by a sensed or paced ven tricular event Known also as the Atrial Escape Interval it is the interval from a sensed or paced ventricular event to an atrial paced event Every cycle the V A delay is calculated as t

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