OSYPKA PACE 203H Page 125 Instructions For Use Manual Download | Manualshive

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PACE 203H – Instructions for Use

5I-17-016X-B-20

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18 Appendix C: Conformity According to IEC 60601-1-2

Manufacturer guidelines and declarations:

Electromagnetic Radiation

Standard: IEC 60601-1-2: Table 1

PACE 203H is intended for use in an electromagnetic environment as described below.
The user should make sure that PACE 203H is used in such an environment.

Emissions Test

Compliance

Level

Guidelines for the Electromagnetic Environment

RF emissions
CISPR 11

Group 1

PACE 203H uses radio-frequency (RF) energy
exclusively for its own function. Therefore, the high-
frequency interference is very low and not likely to
cause any interference in nearby electronic
equipment.

RF emissions
CISPR 11

Class B

PACE 203H is suitable for use in all areas,
excluding residential areas and buildings that are
connected directly to the public power supply lines.

Harmonic
emissions
according to
IEC 61000-3-2

Not
applicable

Voltage
fluctuations
according to
IEC 61000-3-3

Not
applicable

Table 70: Guidance and manufacturer’s declaration – electromagnetic emission

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Summary of Contents for PACE 203H

Page 1: ...cemaker Distributor 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 M a n u f a c t u r e r 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 ...

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Page 3: ...ety 21 8 Electromagnetic Compatibility 21 9 Use and Application of PACE 203H 23 9 1 Design 23 9 2 Overview of the Display Dials and Keys 26 9 2 1 Upper Parameter Display 26 9 2 2 Lower Mode Menu Display 26 9 2 3 Dials 27 9 2 4 Fixed Labeled Keys 27 9 2 5 Softkeys and Menus 27 9 2 6 Display Backlight 28 9 2 7 LEDs for Sensing and Stimulation 28 9 2 8 Acoustic Indications 29 9 3 Powering On PACE 203...

Page 4: ...asic Rate 37 9 8 2 Adjustment of Stimulation Amplitude 38 9 8 3 Adjustment of Sensitivity 38 9 8 4 Adjustment of A V Delay 39 9 9 Using the Automatic Features 40 9 9 1 Automatic Setting of A V Delay with the Setting of Rate 40 9 9 2 Automatic Setting of PVARP with the Setting of Rate 41 9 9 3 Automatic Setting of MTR with the Setting of Rate 41 9 9 4 Automatic Adjustment of Sensitivity Auto Sense ...

Page 5: ... and Disable Alarms 64 9 12 5 3 Enable and Disable Atrial Trigger Function 65 9 12 5 4 Setting the User Language 66 9 12 5 5 Setting CTRL OUT Interface 66 9 13 Statistics 67 9 14 Emergency Stimulation 69 9 15 Pause Function 70 9 16 Connecting the Leads to PACE 203H 72 9 16 1 Lead Types 72 9 16 1 1 Lead Connection Terminals 72 9 16 2 Connection Configurations 72 9 16 3 Connecting the Leads 73 9 17 ...

Page 6: ...st Abnormal Settings 87 9 22 7 1 Possible Conflicts 88 9 22 7 2 Mode Switching 90 9 22 8 Effects from Therapeutic and Diagnostic Energy Sources 91 9 22 8 1 Defibrillation 91 9 22 8 2 RF Surgery 91 9 22 9 Summary of Text Messages 91 9 22 9 1 Warning Messages Related to Conflicting Parameter Settings 91 9 22 9 2 Warning Messages Related to Application Errors 95 9 22 9 3 Warning Messages Related to D...

Page 7: ...Appendix A Glossary 119 17 Appendix B Menu Tree 123 18 Appendix C Conformity According to IEC 60601 1 2 125 19 Appendix D List of Figures 131 20 Appendix E List of Tables 133 21 Appendix F PACE 203H Accessories 137 22 Appendix G Declaration of Conformity 139 ...

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Page 9: ...al Chamber DDD Temporary Cardiac Pacemaker External Pulse Generator 9 V Alkaline Battery User s Manual and Quick Reference Guide Please inform OSYPKA AG immediately if something is missing or damaged Claims that are filed afterwards will not 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 ope...

Page 10: ...for Use 10 139 5I 17 016X B 20 Helpful hints and notes on the usage of the device and for understanding the modes of operation will be intro duced by Notes Important facts and warnings to be observed are introduced by Warning ...

Page 11: ...he functional design of PACE 203H allows safe and easy operation for all requirements of DDD stimulation In addition PACE 203H offers the follow ing features During battery changes stimulation will be maintained for at least 30 seconds provided fully charged internal capacitors A non volatile memory keeps any desired stand by program ready for use even if the device is shut off An individualized s...

Page 12: ...nt s intrinsic heart activity PACE 203H is designed to protect against accidental liquid spills Insu lation between the upper and lower housing battery compartment lid and sealed dial mountings allow for a high level of spillage protection All further technical functions of PACE 203H will be described in detail in the following chapters ...

Page 13: ...ricular ectopic ar rhythmia Postoperatively after cardiac surgery Temporary application during implan tation or exchange of a permanent pacemaker Indication for atrial overdrive stimulation Supra ventricular tachycardia 4 Contraindication There are no contraindications with regards to the use of PACE 203H for temporary cardiac stimulation for therapy and prevention of arrhythmia The state of healt...

Page 14: ...tion 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 Si...

Page 15: ...possibility of a pace maker mediated tachycardia Overdrive stimulation in the atri um 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 compo nents Failure or change in the impulse emission changed or no sensing incorrect displays ...

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Page 17: ...tions a defibril lator should always be available in a ready to use state 6 ECG monitoring should be continued during all times PACE 203H is in use to signal possible complications of different reasons immediately to the medical staff 7 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 availa...

Page 18: ... when the stim ulation parameters are changed the user must make sure that no cross stimulation occurs If cross stimulation occurs one can try to eliminate the effect by adjusting the stimulation amplitudes or by ex 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 channe...

Page 19: ... a monitoring system 27 If the battery must be replaced while the device is being used on a patient ensure that PACE 203H was turned on and operated for at least one hour allowing sufficient time to re charge the internal capacitors which will maintain device operation for up to 30 s while the battery is being re placed If it is planned to replace the battery during use of the device on a patient ...

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Page 21: ...Electromagnetic Compatibility The temporary cardiac pacemaker PACE 203H meets all applicable international standards with respect to electromagnetic compatibility EMC IEC 60601 1 2 Medical electrical equipment Electromagnetic compatibility CISPR 11 Industrial scientific and medi cal radio frequency equip ment Electromagnetic dis turbances IEC 61000 Electromagnetic compatibility Some sources of rad...

Page 22: ... used no closer to any part of PACE 203H including patient cables and sensors than a recom mended separation distance of 10 m 30 ft B Floors should be wood concrete or ceramic tile If floors are covered with synthetic materials the relative hu midity should be at least 30 C Power frequency magnetic fields should be at levels characteristic of typical commercial or hospital envi ronments Please fin...

Page 23: ...ctions for Use 5I 17 016X B 20 23 139 9 Use and Application of PACE 203H 9 1 Design PACE 203H with its displays keys dials and terminals is shown in Figure 1 Figure 1 Temporary Cardiac Pacemaker PACE 203H Display Face ...

Page 24: ...tions 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 pace maker 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 pr...

Page 25: ...t the European WEEE1 guideline applies to the dis posal method of the device IP 43 IP Code Ingress Protection classifies the degree of protection provided against touching or intrusion of solid objects first digit 4 Protection against intrusion with a wire and against water second digit 3 Protection against spraying water Symbol for Conformité Européenne device and manufacturer meet all requiremen...

Page 26: ...ly when rele vant In VVI mode for instance the upper display will not show an atrial stimulation amplitude an atrial sensitivi ty or an A V Delay 9 2 2 Lower Mode Menu Display The lower display is used to show selec tion menus see section 9 2 5 Softkeys and Menus on page 27 and various messages These messages can be informative and alerting regarding errors and conflicts If the lower display is of...

Page 27: ...e V SENSE Adjusting the ventricu lar sensitivity Table 2 Dials and their functions 9 2 4 Fixed Labeled Keys Fixed labeled keys according to Table 3 are implemented Key Function ON Turning on the device OFF Turning off the device Emergency Setting emergency stimulation parameters Lock Unlock Unlocking Locking the dials and the keys Pause Disable stimulation as long as pressed Table 3 Fixed labeled ...

Page 28: ...easurement and further parameter settings and options can be accessed Note Pressing the softkey 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 batt...

Page 29: ...H is powered on by pressing the key labeled ON Subsequently PACE 203H performs a self test If the device was set to Stand by see chapter 9 5 it starts operation immedi ately with the last saved parameter set ting 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 PACE 203H indicates this ...

Page 30: ...sting after turning on 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 will appear in the lower display after 10 seconds 9 4 Locking Unlocking PACE 203H In order to prevent an accidental change of...

Page 31: ...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 atrioventricular 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 rat...

Page 32: ...cular event during which the atrial sensing circuit is refractory Thus any atrial event occurring during PVARP 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 pacing is the simplest of all pacing modes be cause there is no sensing and no mode ...

Page 33: ...ccurs during the A V Delay PACE 203H deliv ers a ventricular pacing stimulus upon termination of the A V Delay 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 intrinsic atrial and ventricular activity occur before the beat to beat interval terminates both channels are inhibited ...

Page 34: ...us P Tracking VAT Pacing In atrial synchronous P tracking VAT pacing mode 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 ventricular sensitivity to infinite Thus sensing in the ventricular channel is dis...

Page 35: ...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 Primary Mode Sensitivity Resulting Mode DDD A Sensitivity DVI DDD V Sensitivity DAI DDD A V Sensitivity D00 VVI V Sensitivity V00 AAI A Sensitivity A00 VDD A Sensitivity VVI VDD V Sens...

Page 36: ... mode change PACE 203H will make use of its Automatic setting feature to solve the problem see chapter 9 22 7 and 9 9 9 8 Adjustment of Rate Stimulation Amplitude Sensitivity 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 A STIM Atrial stimulation amplitude A V DLY Atrio ventricul...

Page 37: ... 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 display The intensity bar dia gram enlarges from left to right with rate increase ...

Page 38: ...ion Amplitude 0 1 0 1 2 0 2 0 0 2 6 0 6 0 0 5 12 0 12 0 1 0 18 0 V Table 14 Range and step width in parentheses for setting of stimulation amplitude 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 The actual sensitivity value and the pa rameter intensity bar diagra...

Page 39: ...e timely occurrence of the ven tricular event and is shifted right or left related to the increase or decrease the A V Delay respectively Parameter Range Step Width Unit A V Delay 5 10 10 400 ms Table 16 Range and step width in pa renthesis for setting of A V Delay The P V delay PVD is coupled with the A V Delay AVD Adjusting the AVD also sets the PVD By default the differ ence AVD PVD is equal to...

Page 40: ...e softkey labeled Auto AVD in the Auto Menu must be pressed The corresponding check box then becomes checked PACE 203H then adjusts the A V Delay depending on the basic rate according to the formula in Table 18 and rounds to the nearest manually adjustable 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 a...

Page 41: ...upper display The PVARP MTR setting menu appears showing the actual value which provides the opportunity to adjust a new value manually see chapter 9 12 1 Note PACE 203H divides the PVARP into two parts an absolute part and a relative part In the absolute part which is 100 ms long no atrial events are re cognized In the relative part the re maining atrial events are registered but not tracked This...

Page 42: ...ated from another parameter PACE 203H adapts the sensing value continuously 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 Figure 5 The Auto Sense function in creases sensitivity Figure 5 sh...

Page 43: ...nformative message in the lower display see also section 9 8 4 on page 39 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...

Page 44: ...e the acoustic indicator will automatically be enabled temporarily if it is not already switched on Because PACE 203H goes through an initializa tion algorithm individual intrinsic events may or may not be detected Auto Sense Menu Key No 1 Searching A Sense 2 Searching V Sense 3 hold 4 5 Table 23 Auto Sense Menu Searching If PACE 203H has found an intrinsic heart rhythm it will display the sensed ...

Page 45: ...bol Figure 13 is shown in the upper dis play Any P or R wave value determined by PACE 203H during interference is cleared off the display 2 seconds after 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 heart activity is sensed without interfer ence If no activity is sensed in a channel for...

Page 46: ...he re initialization the corre sponding interference symbol Figure 13 will be displayed in the upper dis play The sensitivity setting will remain unchanged and the measured frequency will be displayed because it may be a high frequency tachycardia This behav ior is different from Auto Sense initializa tion see above where the sensitivity value will be increased step by step in case of noise 9 9 4 ...

Page 47: ... or DDD 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 the time the Auto Sense function was disabled ...

Page 48: ...le 28 High Rate Menu 9 10 1 Atrial High Rate Standby The Atrial High Rate standby is accessed 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 automatically swit ched on temporarily if it is not already on Note Within the Atrial ...

Page 49: ...e and step width in pa renthesis for Atrial High Rate PACE 203H delivers atrial High Rate stimulation impulses upon pressing and holding the softkey labeled START Atrium The pacemaker switches to the A00 mode and stimulates with the set atrial High Rate showing the Atrial High Rate Running Menu Table 31 To return to the mode menu Table 9 on page 35 press the key _ Warning There is a risk of causin...

Page 50: ...chapter 9 22 2 on page 81 is enabled If no atrial lead is connected the error message Atrial lead disconnected will consequently appear Nevertheless the impulse emission with the atrial High Rate stimulation rate will be car ried out After releasing the softkey la beled START Atrium the previous state of the lead surveil lance will be restored The Pause function see chapter 1 1 on page 70 can be u...

Page 51: ...urning on PACE 203H the ventricular rapid pacing stimulation rate is set to the default value 180 ppm if the device had been powered off using the softkey labeled Off no storage If the device had been powered off with the softkey labeled Stand by store data then it will restore the rapid ventricular stimulation rate which was set before powering off Ventricular Rapid Pacing Standby Menu Key No STA...

Page 52: ...ventricular rapid pacing stimulation PACE 203H switches tem porarily as long as the START Ventricle key is pressed to V00 mode To prevent confusion the upper display remains un changed and does not reflect the V00 mode allowing the user to pre set nor mal pacing parameters Note Within the Ventricular Rapid Pac ing Standby Menu the pacemaker does not lock the key pad automatically Note For safety r...

Page 53: ...be carried out After releasing the softkey labeled START Ventricle the previous state of the lead surveil lance will be restored The Pause function see chapter 1 1 on page 70 can be used to measure the in trinsic 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 ...

Page 54: ...ard 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 Note Unlike the Turn On Parameter Set 9 11 5 a Standard Parameter Set must be recalled each time the device is turned off and on again 9 11 1 Parameters Stored in ...

Page 55: ...s Set Note Because the sensitivity and the options are also stored the pacing mode stored may also be one of the supple mentary modes D00 DVI VAT V00 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...

Page 56: ...rogram is answered with NO PACE 203H returns to the previous Standard Menu Pressing the softkey _ forces PACE 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 A...

Page 57: ...180 ppm Atrial Amplitude 5 5 V Atrial Sensitivity 1 1 0 5 mV Atrial Pulse Duration 1 1 ms Ventricular Amplitude 8 8 8 V Ventricular Pulse Duration 0 75 0 75 0 75 ms Ventricular Sensitivity 2 2 2 mV A V Delay AUTO i e 180 AUTO i e 180 ms PVARP AUTO i e 280 AUTO i e 280 ms MTR AUTO i e 106 AUTO i e 106 ms Automatic Sensing OFF OFF OFF OFF Atrial Trigger Option OFF OFF Table 38 Manufacturer s Default...

Page 58: ... Mode Menu If answered with NO PACE 203H returns to the previous Standard Menu Pressing the _ key forces PACE 203H to revert to the Mode Menu Note Upon the manufacturer s shipping of PACE 203H the Turn On Program parameters are set according to Table 40 Parameter Value Unit Mode DDD Basic Rate 60 ppm Start Rate Atrial Over drive Stimulation 240 ppm Start Rate Ventricular Rapid Pacing 180 ppm Atria...

Page 59: ...t should be provided with a therapeutic pacing program immediately after turning on 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 Setting PACE 203H provides the capability of setting additional stimulation parameters and enabling or disabling options To accompli...

Page 60: ...ll become effective with the next intervention interval Parameter Range Step Width Unit PVARP 100 10 500 ms Table 43 Range and step width in pa renthesis for manual setting of PVARP Note Changing the PVARP value man ually 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 increasi...

Page 61: ...and will become effective with the next intervention interval Parameter Range Step Width Unit MTR 80 2 230 ppm Table 45 Range and step width in pa renthesis for manual setting of MTR Note Changing the MTR value manually will also switch off the automatic setting if it was activated see chapter 9 9 3 Note The safety feature protection against abnormal settings see chapter 9 22 7 prevents decreasing...

Page 62: ... step widths in parenthesis for manual setting of Pulse Durations 9 12 4 Adjustment of Atrial ARP and Ventricular VRP Refractory Pe riod The atrial refractory period ARP and the ventricular refractory period VRP Firmware Version 1 24 and up of this pacemaker can be changed By pressing the softkey labeled ARP VRP in the Parameters Options Menu Table 41 on page 60 the ARP VRP Menu appears as shown i...

Page 63: ...ective 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 one can switch between Options Menu 1 and Options Menu 2 Options Menu 1 Key No Beep 1 Alarms 2 Atrial Trigger 3 more 4 _ 5 Table 51 Options Menu 1 By pressing the softkey labeled Options in the Parameters Options Menu th...

Page 64: ...isappears from the corresponding check box The loud speaker symbol disappears from the upper display as well Upon powering off 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 PACE 203H Upon the manufacturer s shipping of PACE 203H the acoustic indicator is disabled according to Table 48...

Page 65: ...e atrial sensing phase With the softkey labeled Atrial Trigger in the Options Menu the atrial trigger function can be enabled or disabled In case the atrial trigger function is ena bled the corresponding check box is checked Furthermore 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...

Page 66: ...ore toggles through the different language menus Language Menu Key No English 1 Deutsch 2 Français 3 more 4 _ 5 Table 53 Language Menu The manufacturer s default language setting 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 communicate with the Pacemaker Clinic PMC a feature of AESCULON and ICON Elec...

Page 67: ...es counted during Runtime and the percentage with respect to the Total Cycles Atrial Sensed Cycles AS Number of atrial sensed cycles counted during Runtime and the percentage with respect to the Total Cycles Page III Ventricular Sensed Cycles VS Number of ventricular sensed cycles counted during Run time and the percentage with respect to the Total Cycles Longest Series AP maxAP Largest series of ...

Page 68: ...reen auto matically alternates between the display of headers and their corresponding 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 Upon turning the device on the Runtime and all statistics event counters are reset The Runtime and the event counters are not reset if the d...

Page 69: ...defaults immediately to the emergency stimulation program with the parameter shown in Table 55 Note In case PACE 203H is locked it must be unlocked first by pressing the key Unlock Lock Note By pressing the emergency key PACE 203H irrevocably abandons the last parameter setting Note The pacer will give a warning if not both atrial and ventricular leads are connected However due to D00 pacing mode ...

Page 70: ...be sensed or the sensitivity is set to a value much smaller or much larger than the actual P or R wave amplitude PACE 203H will change the sensitivity temporarily PACE 203H will attempt to find intrinsic heart activity and to measure the ampli tudes optimally When the Auto Sense function is deactivated this change of sensitivity thresholds is only temporary Thus after releasing the key labeled Pau...

Page 71: ... due to the cross blanking which may result in a rate determination being of too low or unstable Thus if a precise measurement of the atrial frequency is desired the ventricular lead must be disconnected If frequencies higher than the noise frequency 270 ppm are detected while the key labeled Pause is pressed the corresponding interference symbol Figure 13 is displayed in the upper dis play The me...

Page 72: ...her directly or by means of an extension cable Warning All lead systems must be connected to type CF devices only be cause 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 For exact specifications of leads and patient cables please refer to our product catalog 9 16 1 1 Lead Connection Termin...

Page 73: ...ernal noise as compared to the bipolar configuration 9 16 3 Connecting the Leads PACE 203H must be turned off while the stimulation leads are connected to it Warning While the leads are being inserted into the patient and 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 device...

Page 74: ...the connections by manually turning the collets clockwise 4 If extension cables are used connect the leads to the extension cables 5 Turn on PACE 203H and set the de sired pacing mode 6 Determine the sensitivity threshold see chapter 1 1 7 Determine the cardiac capture thre shold see chapter 1 1 8 Control the proper functioning of PACE 203H with the assistance of an ECG monitor or recorder ...

Page 75: ...dy 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 PACE 203H will not sense intrinsic events in the atrium and ventricle respec tively Eventually PACE 203H operates in asynchronous pacing mode 5 Raise the sensitivity i e lower the sensitivity value again until stimulation is inhibited This sensitiv it...

Page 76: ...ion amplitude until the stimulus is no longer effective 2 In case PACE 203H is operating in a dual chamber mode the A V Delay must be set shorter than the patient s intrinsic A V interval 3 Raise the stimulation amplitude slowly 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...

Page 77: ...tion PACE 203H indicates AC operation with a green LED labeled Mains between the keys Off and On For connecting PACE 203H to AC power please adhere to the following instructions 1 Turn off 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 ...

Page 78: ... of a differential timing Intrinsic Event Upon sensing of an R wave PACE 203H provides a control signal whose processed R wave is de layed by approximately 5 ms assuming that the amplitude of the R wave meas ured is twice the value of the sensitivity set Paced Event Upon delivery of a ventricular stimulus PACE 203H pro vides a control signal whose processed R wave is delayed by approximately 35 ms...

Page 79: ...20 79 139 Options Menu 2 Key No Language 1 PMC BPI 2 3 more 4 _ 5 Table 57 Options Menu 2 BPI enabled Note The Terminal CTRL OUT is pro tected by a cap which will prevent pollu tion This cap should be in place when the CTRL OUT socket is not used ...

Page 80: ... at one end to the CTRL OUT terminal of PACE 203H and at the other end to the EC monitor Upon success ful communication PACE 203H para meter settings are transmitted to the EC monitor and both PACE 203H and the EC monitor are synchronized regarding timely occurrences of atrial and ventricular stimulation The combination of the pacemaker and the EC monitor provides a helpful tool for determining th...

Page 81: ...ry symbol blinks requesting an immediate change of the battery see chapter 11 2 This action is accompanied by the warning message Hurry up Change battery 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 109 the lifespan for 100 stimulation in two usual modes DDD VVI are given for alkaline and l...

Page 82: ... will be shown in the upper display with respect to the corresponding atrial and or ventricular channel Figure 12 Open Lead Symbol Additionally PACE 203H performs lead surveillance with an intelligent lead breakage warning function which oper ates independently in the atrial and ventricular channels PACE 203H enab les this function in a channel automati cally upon recognition that a lead is con ne...

Page 83: ...se of beginning operation 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 pace maker is not connected to the pacing leads However upon proper connection of PACE 203H to the pacing leads and thus the patient PACE 203H enables lead breakage surveillance after three successfully sensed or pa...

Page 84: ...erence in Ventricular Channel Interference in Atrial Channel 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 Interference Note Interference is not recognized and indicated If the sensitivity of the corresponding channel is set to infinite or If the corresponding channel is refrac tory...

Page 85: ...s interval of 40 ms is referred to as the crosstalk sensing window and the ventricular response to as ventricular safety pacing This ventricular pacing stimulus is delivered early that is 100 ms after the atrial event This cor responds 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 ventricular asys...

Page 86: ...lin Electrophysiol 1982 5 486 489 4 Den Dulk K Lindemans FW Bar FW Wellens HJ Pacemaker related tachycardias Pacing Clin Electrophysiol 1982 5 476 485 Despite the extended PVARP the dur ation 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 b...

Page 87: ...s a consequence ventricular respon ses caused by premature atrial contra ctions are not counted as extrasystoles 9 22 6 Runaway Protection 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 stimulation rates for example due to a defect in the frequency generator is limited by an independent safety function to a maxi...

Page 88: ...ge and prevent abnormal setting d PVD PVARP URI with URI 1 MTR To guarantee Wenckebach behavior DDD VDD DAI VAT DAT Transient warning message and prevent abnormal setting e ARP 20 ms LRI To guarantee mini mum atrial sensing phase AAI AAT Transient warning message and prevent abnormal settings Table 60 Abnormal Settings 9 22 7 1 Possible Conflicts Conflicts can occur in the process of changing para...

Page 89: ...ase Rate to decrease MTR Table 61 Conflicts Type a Basic Rate AVD PVARP Message M M Decrease PVARP or AVD to increase Rate A M Decrease PVARP to increase Rate M A Decrease AVD to increase Rate A M Decrease PVARP to decrease Rate M A Decrease AVD to decrease Rate M M or A Decrease PVARP or Rate to increase AVD M M or A Decrease AVD or Rate to increase PVARP Table 62 Conflicts Type b Basic Rate AVD ...

Page 90: ...Decrease Rate to increase ARP Table 65 Conflicts Type e 9 22 7 2 Mode Switching PACE 203H avoids conflicts as a result of mode switching by selecting appropri ate parameter values according to the rules set for the automatic modes A V Delay PVARP and MTR independent of whether these automatic modes for the respective parameters are enabled or disabled The basic rate is the deter mining parameter a...

Page 91: ...s can also dam age the pacemaker 9 22 8 2 RF Surgery When using RF electrocautery and RF surgery instruments very strong electri cal and magnetic interference is gener ated which can influence or even dam age electronic instruments like PACE 203H Fibrillation currents can also be generated by crosstalk into the leads and cables If simultaneous use of PACE 203H and electro surgical instruments is r...

Page 92: ...e rate This led to a conflict type b or d because the sum of PVARP and A V Delay is exces sively high Decrease PVARP and or A V Delay or set to Auto PVARP and Auto AVD before further increase of rate Alternatively in case of an implicit conflict type d be tween PVARP plus A V Delay and automatically set MTR manually set MTR to a lower value 9 22 7 Decrease A V Delay to increase Rate The user has a...

Page 93: ...further increase of PVARP 9 22 7 Decrease PVARP or A V Delay to increase MTR The user has attempted to increa se MTR This led to a conflict type d because the sum of PVARP and P V delay is too long Decrease PVARP and or A V Delay before further increase of MTR 9 22 7 Decrease Rate to decrease MTR The user has attempted to de crease MTR This led to a conflict type a because rate is set to an excess...

Page 94: ...ase MTR to decrease Rate The user has attempted to decrease the rate This led to a conflict type d because the MTR is too high with respect to the sum of PVARP and A V Delay Decrease MTR or set to Auto MTR before further decrease of rate Alternatively manual set PVARP or A V Delay to a lower value 9 22 7 Decrease A V Delay or MTR to decrease Rate The user attempted to decrease the rate This led to...

Page 95: ... unlocks PACE 203H The warn ing message is now visible A second press of the key Unlock Lock then con firms 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 Unlock Lock switches the backlight on and unlocks PACE 203H A second press of the key Unlock then confirms the error message The message except the change battery...

Page 96: ...confirmation even if the disconnection persists The open output is only indicat ed by the open lead symbol see Figure 12 Note Surveillance can only occur if the stimulation amplitude is set to a value 2 0 V and if the pulse duration is 0 15 millisec onds If the lead was not discon nected intentionally there is a possibility that lead breakage or a disconnection of the connector cable exists Check ...

Page 97: ...act that the error is 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 PACE 203H A second press of the key Unlock Lock then confirms the error message If the error persists the warning mes sage will...

Page 98: ...H must be sent to the manufacturer for inspection and service Stored data lost Manufacturer s defaults will be used The memory for the Stand by data the standard programs and or or other non volatile data has lost its data content The manufacturer s standard turn on program see section 1 1 1 has been reset and standard programs may have been reset to their manufactur er s defaults Attempt to switc...

Page 99: ...AVD turned off The automatic A V Delay setting has been turned off because the A V DLY dial has been turned If the automatic A V Delay setting is to remain enabled activate it again via the Auto Menu and avoid turning the A V DLY dial 9 9 1 Atrial Auto Sense turned off The automatic atrial sensing adjustment has been turned off because the A SENSE SENSE dial has been turned If the automatic atrial...

Page 100: ...o resolve a parameter conflict during mode switching the A V Delay has been changed i e adapted to the current Basic Rate OR A V Delay has been increased to the minimum value of 30 ms when atrial Auto Sense has been activated N A conflict resolved by the device Please check if the altered A V Delay is appropriate for the patient 9 22 7 PVARP adapted To resolve a parameter conflict during mode swit...

Page 101: ...en 10 C 50 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 zatio...

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Page 103: ... be cleaned disinfected and sterilized after each use Single use cables must not be re used 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 depends implicitly on the...

Page 104: ...n Open the battery com partment lid see Figure 15 Make certain that the inserted battery 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 not important 5 Close the battery compartment lid until it is audibly latched in place Rotate the protection cover over the battery compartment rele...

Page 105: ...plitude pulse width in the atrial and ventricular channels Measuring the stimulation rate Measuring the sensitivity in the atrial and ventricular channel Inspecting the battery surveillance and measuring the power mainte nance time after removal of battery Inspecting the lead surveillance Inspecting the runaway protection Warning A repair or calibration made by anyone except the manufacturer or a ...

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Page 107: ...e 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 ...

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Page 109: ...nflammable mixtures of anesthesia supplies and air oxygen or nitrous oxide N2O According to European Directives 93 42 EWG and 2007 47 EC Class IIb Continuous operation Active therapeutical medical device According to U S Regulations for medical devices Cardiac Pacemaker Number 21 CFR 870 3600 Name External Pacemaker Pulse Generator Regulatory Class 3 Product Code 74DTE Extension cable Number 21 CF...

Page 110: ...1000 ppm 5 Ventricular rapid pacing Firmware version 1 24 and up 70 220 ppm 2 Output pulse Cathodic biphasic asymmetric capacitive coupled passive discharge Nominal pulse amplitude 500 Ω 0 1 18 V 10 0 05V Nominal pulse amplitude 200 Ω 2000 Ω 0 1 18 V 20 0 05V Pulse duration 0 05 ms 1 50 ms 10 0 01 ms Atrial sensitivity 0 2 20 mV 20 0 1 mV Ventricular sensitivity 1 0 20 mV 20 0 1 mV Input impedance...

Page 111: ...DD DAI VAT DAT Ventricular Refractory Period VRP 250 ms 500 ms 5 Firmware version 1 24 and up 250 ms 5 otherwise PVARP 100 ms 500 ms 5 absolute portion 90 ms 5 relative portion PVARP 90 ms 5 Extended PVARP after PVC 500 ms 5 or maximum possible period Blanking period in atrial channel 85 ms 5 2 ms 6 ms after atrial as well as ventricular stimulation and sensing Ventricular blanking period in ventr...

Page 112: ...fety Interference detection frequency 4 5 Hz 5 270 ppm Interference rate Basic Rate 10 ppm 2 max MTR and max 220 ppm Defibrillation protection According to IEC 60601 2 31 Runaway protection 238 ppm 3 ppm Lead surveillance Message in case of short circuit or inter ruption in the stimulation circuit for a set stimulation amplitude equal or higher 2 0 V and a set pulse duration equal or higher 0 15 m...

Page 113: ...g the empty depletion symbol and acoustic warning when an imme diate battery change is required 5 5 0 5 V Power maintenance during battery change assuming fully charged internal capacitors Minimum 30 s Operating Environment Operating temperature 10 C 50 F 45 C 113 F Relative humidity 30 75 non condensing Atmospheric pressure 700 hPa 1060 hPa Storage temperature w o battery 20 C 4 F 60 C 140 F Oper...

Page 114: ...ed terminals collets for plugs with 0 9 mm 2 0 mm diameter Other interfaces Port for connection to Intra Aortic Balloon Pump IABP interface BPI 202 and Electrical Cardiometry EC monitors w Pacemaker Clinic 5 We reserve the right to make changes without notice 5 Electrical Cardiometry EC and Pacemaker Clinic are trademarks of Osypka Medical ...

Page 115: ... 203H is delivered in a carrying case with the following content PACE 203H DDD Temporary Cardiac Pacemaker 9V Battery PACE 203H User s Manual PACE 203H Quick Reference Guide See Appendix F PACE 203H Accessories on page 137 for accessories such as exten sion cables and adaptors ...

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Page 117: ...tial damages including but not limited to medical expenses caused by a defect or mal function whether your claim is based on warranty contract tort or otherwise 2 damage from accident abuse misuse or introduction of foreign objects 3 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 o...

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Page 119: ...cular 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 ventricular depolarization A V crosstalk Detection of the atrial output pulse by the ventricular sensing amplifier which may result in ventricular output inhibition A V Delay AVD Programmed delay between an atrial pulse and the subsequent non tr...

Page 120: ...s that as interference Lower rate interval LRI The longest period between consecutive paced or sensed events occurring in the relevant chamber In absence of sensed cardiac or other electrical influ ence equal to basic pulse interval Maximum tracking rate upper rate MTR Maximum ventricular pacing rate in response to sensed atrial activity Expressed differently it is the maximum pulse rate at which ...

Page 121: ...nt not preceded by a sensed atrial event Also named extrasystole Pulse Monophasic electrical output of a pulse generator intended to stimulate the myocardium Pulse amplitude Magnitude of the pulse expressed in volts or milli amperes Pulse duration Duration of the pulse Pulse interval Time interval between identical points of two consec utive pulses expressed in milliseconds Pulse rate Number of pu...

Page 122: ... sensed events while still maintaining 1 1 atrioventricular synchrony equal to 60 MTRppm V A Delay VAD 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 depolarization ...

Page 123: ...PACE 203H Instructions for Use 5I 17 016X B 20 123 139 17 Appendix B Menu Tree Figure 17 Map of Menu Tree Part 1 ...

Page 124: ...PACE 203H Instructions for Use 124 139 5I 17 016X B 20 Figure 18 Map of Menu Tree Part 2 ...

Page 125: ...gnetic Environment RF emissions CISPR 11 Group 1 PACE 203H uses radio frequency RF energy exclusively for its own function Therefore the high frequency interference is very low and not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B PACE 203H is suitable for use in all areas excluding residential areas and buildings that are connected directly to the p...

Page 126: ...y lines should be that of typical commercial or hospital environment 1 kV for input output lines Not applicable lines have a length of less than 3 m Surge voltages surges according to IEC 61000 4 5 1 kV differential mode 1 kV differential mode Quality of power supply lines should correspond to levels typical of commercial or hospital environments 2 kV common mode 2 kV common mode Voltage drops bri...

Page 127: ...onment Portable and mobile radio frequency RF communication equipment are not used closer to any part of PACE 203H including cables and leads than the recommended safety distance Recommended safety distance Conducted RF interferences according to IEC 61000 4 6 10 Vrms 150 kHz to 80 MHz outside of ISM bandsa 10 Vrms 150 kHz to 80 MHz outside of ISM bandsa P d 35 0 10 Vrms 150 kHz to 80 MHz inside o...

Page 128: ...26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz b The compliance level in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz is intended to reduce the likelihood that mobile portable communications devices cause interference if they are unintentionally brought into patient areas For this reason greater safety distance is recommended separation dista...

Page 129: ...is not specified in the table above the safety can be calculated using the specified formula for the corresponding frequency Here P is the rated output power of the transmitter in watts W and d the safety distance in meters m Note 1 At 80 MHz and 800 MHz the safety distance for the higher frequency range applies Note 2 The ISM bands for industrial scientific and medical applications between 150 kH...

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Page 131: ...tivity 42 Figure 7 Acoustic Indicator Symbol for a Loudspeaker 64 Figure 8 Alarms Off Crossed Bell Symbol 65 Figure 9 Displays of Statistics automatically alternating 68 Figure 10 Lead Connection Terminals 72 Figure 11 Battery Symbol 81 Figure 12 Open Lead Symbol 82 Figure 13 Symbol for Interference 84 Figure 14 Symbol for Extrasystole Premature Ventricular Contraction PVC 86 Figure 15 Battery Com...

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Page 133: ...plitude 38 Table 15 Ranges and step widths in parenthesis for sensitivity settings 39 Table 16 Range and step width in parenthesis for setting of A V Delay 39 Table 17 Auto Menu 40 Table 18 Formula for automatic setting of A V Delay 40 Table 19 Formula for automatic setting of PVARP 41 Table 20 Formula for automatic setting of MTR 41 Table 21 Auto Sense Menu 43 Table 22 Auto Sense Menu channels se...

Page 134: ... 62 Table 47 Ranges and step widths in parenthesis for manual setting of Pulse Durations62 Table 48 ARP VRP Menu 62 Table 49 Range and step width in parenthesis for manual setting of ARP 63 Table 50 Range and step width in parenthesis for manual setting of VRP 63 Table 51 Options Menu 1 63 Table 52 Options Menu 2 64 Table 53 Language Menu 66 Table 54 Statistical Parameters 67 Table 55 Emergency St...

Page 135: ...ssages 100 Table 70 Guidance and manufacturer s declaration electromagnetic emission 125 Table 71 Guidance and manufacturer s declaration electromagnetic immunity I 126 Table 72 Guidance and manufacturer s declaration electromagnetic immunity II 128 Table 73 Safety distances between portable and mobile RF communication equipment129 ...

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Page 137: ...pendix F PACE 203H Accessories Please contact OSYPKA AG address on title page for accessories available for PACE 203H such as various types of extension cables adapters and the BPI 202 interface for an intra aortic balloon pump Figure 19 Pacing Extension Cables ...

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Page 139: ...al 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 is applicable to all aforementioned devices which are la belled with the CE mark This Declaration of Conformity is based on the Full Quality Assurance System certification with the registrat...

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