OSYPKA PACE 203H Instructions For Use Manual
  1. Manuals
  2. Brands
  3. OSYPKA Manuals
  4. Medical Equipment
  5. PACE 203H
  6. Instructions for use manual

OSYPKA PACE 203H Instructions For Use Manual

Dual-chamber ddd temporary pacemaker
Hide thumbs Also See for PACE 203H:
Table of Contents

Advertisement

Quick Links

M a n u f a c t u r e r
Os ypka M edical GmbH
Albert-Einstein-Strasse 3
D-12489 Berlin, Germany
Phone: +49 (30) 6392 8300
Fax:
+49 (30) 6392 8301
E-Mail: mail@osypkam ed.com
5I-17-016X-B-20
Instructions for Use
P A C E 2 0 3 H
Dual-Chamber (DDD) Temporary Pacemaker
Distributor
OSYPKA AG
Earl-H.-W ood-Strasse 1
D-79618 Rheinfelden, Germ any
Phone: +49 (7623) 7405 - 0
Fax:
+49 (7623) 7405 - 160
E-Mail: mail@osypka.de
Osypka Medical 2013©

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the PACE 203H and is the answer not in the manual?

Questions and answers

Related Manuals for OSYPKA PACE 203H

Summary of Contents for OSYPKA PACE 203H

  • Page 1 Earl-H.-W ood-Strasse 1 D-12489 Berlin, Germany D-79618 Rheinfelden, Germ any Phone: +49 (30) 6392 8300 Phone: +49 (7623) 7405 - 0 Fax: +49 (30) 6392 8301 Fax: +49 (7623) 7405 - 160 E-Mail: mail@osypkam ed.com E-Mail: mail@osypka.de 5I-17-016X-B-20 Osypka Medical 2013©...

  • Page 3: Table Of Contents

    PACE 203H – Instructions for Use Table of Contents 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 PACE 203H...
  • Page 4 PACE 203H – Instructions for Use 9.6.2 Atrial Asynchronous (A00) Pacing 9.6.3 A-V Sequential Asynchronous (D00) Pacing 9.6.4 Ventricular Inhibited (VVI) Pacing 9.6.5 Atrial Inhibited (AAI) Pacing 9.6.6 Atrial Synchronous (P-Tracking) (VDD) Pacing 9.6.7 Dual-Chamber Pacing and Sensing with Inhibition and Tracking (DDD) 9.6.8...
  • Page 5 PACE 203H – Instructions for Use 9.11.1 Parameters Stored in a Standard Program 9.11.2 Store Standard Programs 9.11.3 Recall Standard Programs 9.11.4 Recall Manufacturer’s Defaults 9.11.5 Changing the Turn-On Program 9.12 Parameters/Options Setting 9.12.1 Adjustment of PVARP 9.12.2 Adjustment of MTR 9.12.3...
  • Page 6 PACE 203H – Instructions for Use 9.22.2.1 Short Circuit in Pacing System 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...
  • Page 7 PACE 203H – Instructions for Use Appendix A: Glossary Appendix B: Menu Tree Appendix C: Conformity According to IEC 60601-1-2 Appendix D: List of Figures Appendix E: List of Tables Appendix F: PACE 203H Accessories Appendix G: Declaration of Conformity...

  • Page 9: Preface

    ECG According to U.S. Standards, obtained from three ECG electrodes. PACE 203H is a Class III device (21 CFR 862-892 [807.87(c)]). According to European Standards, 1.4 Writing Conventions of PACE 203H is a Class IIb medical...
  • Page 10 PACE 203H – Instructions for Use • 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: Product Description

    A non-volatile memory keeps any 2 Product Description desired stand-by program ready for use, even if the device is shut off. PACE 203H is a dual chamber external • An individualized standard program cardiac pacemaker with atrial controlled is available for each primary pacing timing for routine temporary heart stimu- mode.
  • Page 12 All further technical functions of PACE 203H will be described in detail in the following chapters. 12 / 139 5I-17-016X-B-20...

  • Page 13: Indication

    The PACE 203H DDD Temporary Cardi- There are no contraindications with ac Pacemaker is designed to be used regards to the use of PACE 203H for with cardiac stimulation lead systems for temporary cardiac stimulation for therapy temporary atrial, ventricular or A-V se- and prevention of arrhythmia.

  • Page 14: Possible Complications

    PACE 203H – Instructions for Use 5 Possible Complications When using an external pacemaker such as PACE 203H, the following complica- tions can arise: Complication Result Infection Sepsis Thrombosis and pulmonary em- Death bolism Perforation of the heart Hemopericardiu. Hemothorax, Cardiac tamponade...
  • Page 15 (In order to prevent this, some decision overrides are pacemaker settings. implemented in PACE 203H. However, it is not pos- sible to completely prevent the possibility of a pace- maker mediated tachycardia.) Overdrive stimulation in the atri-...

  • Page 17: Precautionary Measures And Warnings

    PACE 203H – Instructions for Use 6. ECG monitoring should be continued during all times PACE 203H is in use 6 Precautionary Measures to signal possible complications of and Warnings different reasons immediately to the The following list presents important medical staff.
  • Page 18 13. If PACE 203H is to be used for a a single-chamber mode without con- long period of time on a patient, the...
  • Page 19 PACE 203H – Instructions for Use 25. All automatic settings provided by 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.

  • Page 21: Patient Safety

    PACE 203H – Instructions for Use 7 Patient Safety 8 Electromagnetic Compatibility The temporary cardiac pacemaker PACE 203H meets all applicable The temporary cardiac pacemaker international standards for patient safety: PACE 203H meets all applicable international standards with respect to electromagnetic compatibility (EMC).
  • Page 22 PACE 203H – Instructions for Use Portable and mobile RF communica- tions equipment, such as mobile phones, can affect the function of PACE 203H. Mobile phones with a rated maximum output power of 2 Watt and a transmitter frequency up to 2.5...

  • Page 23: Use And Application Of Pace 203H

    PACE 203H – Instructions for Use 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 5I-17-016X-B-20 23 / 139...
  • Page 24 PACE 203H – Instructions for Use Figure 2: Temporary Cardiac Pacemaker PACE 203H 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.
  • Page 25 The internationally recognized pictograms have the following meaning: Classification: CF (cardiac floating) applied part, defibrillation protected Symbol: Follow instruction for use. PACE 203H is marked with the symbol of a crossed-out garbage. The symbol indicates that the European WEEE guideline applies to the dis- posal method of the device.

  • Page 26: Overview Of The Display, Dials And Keys

    PACE 203H – Instructions for Use stimulation amplitude, an atrial sensitivi- ty, or an A-V Delay. 9.2 Overview of the Display, Dials and Keys 9.2.2 Lower Mode / Menu Display The lower display is used to show selec- 9.2.1 Upper Parameter Display tion menus (see section 9.2.5 “Softkeys...

  • Page 27: Dials

    PACE 203H – Instructions for Use 9.2.4 Fixed Labeled Keys 9.2.3 Dials Fixed labeled keys according to Table 3 There are six dials corresponding to the are implemented. parameter segments in the upper pa- rameter display. The six parameters basic rate (& atrial overdrive rate), atrial...

  • Page 28: Display Backlight

    The LEDs for indicating sensing flash green and those for indicating stimula- Parameters tion flash yellow. Options All LEDs appear bright shortly after turn- ing on PACE 203H to verify that they are ↑_ operational. Table 5: Main Menu 28 / 139 5I-17-016X-B-20...

  • Page 29: Acoustic Indications

    Specifically, sensing occurs with a lower frequency signal than stimulation. Table 6: Press Lock/Unlock Key Request 9.3 Powering On PACE 203H Release Lock/Unlock key PACE 203H is powered on by pressing request the key labeled ON Subsequently, PACE 203H performs a Release self-test.

  • Page 30: Locking/Unlocking Pace 203H

    PACE 203H. Among other tests, a key will blink for 2 seconds. check is performed during this period. If...

  • Page 31: Powering Off Pace 203H

    PACE 203H – Instructions for Use 9.5 Powering Off PACE 203H 9.6 Modes of Operation PACE 203H is powered off by pressing the key labeled OFF. The following terms are defined: In order to prevent powering off the de- The beat-to-beat interval (a pacemaker...

  • Page 32: Ventricular Asynchronous (V00) Pacing

    PVARP (a pacemaker pa- a sensed ventricular event. In VVI mode, rameter), is the period after a sensed or PACE 203H is refractory for a period paced ventricular event during which the after a paced or sensed ventricular atrial sensing circuit is refractory.

  • Page 33: Atrial Inhibited (Aai) Pacing

    Inhibited (DAI) Pacing refractory. If no R-wave activity occurs A-V sequential, atrial inhibited (DAI) during the A-V Delay, PACE 203H deliv- pacing provides pacing in both the atri- ers a ventricular pacing stimulus upon um and the ventricle but sensing only in termination of the A-V Delay.

  • Page 34: The A-V Sequential, Ventricular Inhibited (Dvi) Pacing

    DDD mode, In this mode, sensing is enabled in all and second, the atrial sensitivity to infi- channels but not pacing. PACE 203H is nite ("–.–"). Thus, sensing in the atrial ‘listening’ to intrinsic atrial and ventricular channel is disabled.

  • Page 35: Changing The Mode Of Operation

    PACE 203H – Instructions for Use Primary Resulting 9.7 Changing the Mode of Sensitivity Mode Mode Operation If the lower display is switched on, it A-Sensitivity → always displays the Mode Menu first. "–.–" Each of the primary modes (DDD, VVI, AAI, VDD) can now be selected by the V- Sensitivity →...

  • Page 36: Adjustment Of Rate, Stimulation Amplitude, Sensitivity And A-V Delay

    Note: If conflicts (because of abnormal order from top to bottom settings) occur as a result of a mode change, PACE 203H will make use of its Automatic setting feature to solve the The actual values of the parameters and problem (see chapter 9.22.7 and 9.9).

  • Page 37: Adjustment Of Basic Rate

    PACE 203H – Instructions for Use counterclockwise rotation decreases the Parameter Range (Step Width) Unit parameter value. Rotating a sensitivity dial clockwise in- Rate 30 (2) 220 creases the sensitivity value, i.e. de- crease the sensitivity. In contrast, coun- Table 12: Range and step width...

  • Page 38: Adjustment Of Stimulation Amplitude

    PACE 203H – Instructions for Use threshold of 150 ppm is passed, increas- 9.8.3 Adjustment of Sensitivity es of the stimulation rate in the range By rotating the A-SENSE dial or the V- beyond 150 ppm and less or equal than SENSE dial clockwise, the sensitivity 180 ppm require no confirmation.

  • Page 39: Adjustment Of A-V Delay

    PACE 203H – Instructions for Use Parameter Range (Step Width) Unit Parameter Range (Step Width) Unit 0.2 (0.1) 2.0 A-V Delay 5, 10 (10) 400 2.0 (0.2) 5.0 Atrial Table 16: Range and step width (in pa- 5.0 (0.5) 10.0...

  • Page 40: Using The Automatic Features

    The corresponding check Features box then becomes checked. PACE 203H offers the capability for PACE 203H then adjusts the A-V Delay automatic setting of A-V Delay, PVARP, depending on the basic rate according to and maximum tracking rate (MTR), with...

  • Page 41: Automatic Setting Of Pvarp With The Setting Of Rate

    The corresponding check Automatic PVARP Range Unit box then becomes checked. PACE 203H then adjusts the MTR to a PVARP = value 34 ppm higher than the basic rate, 100…500 330 – (0.75 x Rate/ppm) but with a minimum of 100 ppm and a...

  • Page 42: Automatic Adjustment Of Sensitivity (Auto Sense)

    PACE 203H – Instructions for Use To deactivate Auto MTR, the softkey labeled Auto MTR in the Auto Menu safety margin must be pressed again. This causes both the check mark to disappear from sensitivity the corresponding check box and the label AUTO MTR in the upper display.

  • Page 43: Important Notes Using The Auto Sense Function

    PACE 203H – Instructions for Use 9.9.4.2 Important Notes Using the Auto Sense Menu Key No. Auto Sense Function: Because the intrinsic activity of the pa- tient’s heart determines the sensitivity Atrial value, the Auto Sense feature can, of Auto Sense...
  • Page 44 Table 22: Auto Sense Menu Table 23: Auto Sense Menu (Searching) (channels selected, initialization request) If PACE 203H has found an intrinsic When the softkey labeled Initiate is heart rhythm, it will display the sensed pressed, PACE 203H stops pacing as EGM amplitude as shown in Table 24.

  • Page 45: Notes For The Initialization Of The Auto Sense Function

    PACE 203H – Instructions for Use shown in the respective section(s) of the If no activity is sensed in a channel for upper display. The lower display will 3 seconds, a previously determined P or return to the Auto Sense Menu with the R wave will be cleared off the display.

  • Page 46: Re-Initialization Of Auto Sense

    PACE 203H – Instructions for Use Warning: If frequencies higher than the Auto Sense Menu Key No. noise frequency (270 ppm) are detected during the re-initialization, the corre- sponding interference symbol (Figure 13) will be displayed in the upper dis- Atrial play.
  • Page 47 PACE 203H – Instructions for Use Note: Upon a mode change (for instance VVI → AAI or DDD → VVI) that disables a channel, the Auto Sense function, enabled in this particular channel, is disabled. The Auto Sense function is not...

  • Page 48: High-Rate / Overdrive Stimulation

    9.10 High-Rate / Overdrive The Atrial High-Rate standby is Stimulation accessed by pressing the softkey labeled PACE 203H provides a function for atrial High-Rate stimulation, also known as Atrial High-Rate atrial overdrive stimulation, or rapid atrial in the High-Rate Menu (Table 28). The...
  • Page 49 PACE 203H – Instructions for Use PACE 203H delivers atrial High-Rate Atrial High-Rate Key No. stimulation impulses upon pressing and Standby Menu holding the softkey labeled START START (Atrium). (Atrium) The pacemaker switches to the A00 240 ppm mode and stimulates with the set atrial...

  • Page 50: Atrial High-Rate Stimulation With Ramp Function

    31 is shown), turning the HIGH-RATE by pressing the softkey , which forces ↑_ dial changes the atrial High-Rate stimu- PACE 203H to return to the Mode Menu lation rate. This feature allows the user (Table 9 on page 35). 50 / 139 5I-17-016X-B-20...

  • Page 51: Ventricular Rapid Pacing Standby

    This is indicated by a blinking symbol HI- in front of the label RATE (together this Note: After turning on PACE 203H the forms HI-RATE) in the upper display. ventricular rapid pacing stimulation rate The ventricular rapid pacing rate can be...
  • Page 52 PACE 203H – Instructions for Use Note: Within the Ventricular Rapid Pac- Range Parameter Unit ing Standby Menu, the pacemaker does (Step Width) not lock the key pad automatically. Ventricular Rapid 70 (2) 220 Pacing Rate Note: For safety reasons the ventricular...

  • Page 53: Ventricular Rapid Pacing With Ramp Function

    Rapid Pacing Running Menu, Table 34 is abandoned by pressing the softkey ↑_ shown), turning the HIGH-RATE dial which forces PACE 203H to return to the changes the ventricular rapid pacing Mode Menu (Table 9 on page 35). rate. This feature allows the user to ma-...

  • Page 54: Standard Programs

    PACE 203H – Instructions for Use 9.11.1 Parameters Stored in a 9.11 Standard Programs Standard Program The parameters stored in each of the PACE 203H provides the capability of four sets are marked with "+" in Table storing and recalling a user defined stan- 36.
  • Page 55 Note: Because the sensitivity and the Note: Upon the manufacturer’s shipping options are also stored, the pacing mode of PACE 203H, the user standard set- stored may also be one of the supple- tings are identical with the manufactur- mentary modes (D00, DVI, VAT, V00, er’s defaults (see chapter 9.11.4).

  • Page 56: Store Standard Programs

    Pressing the softkey forces actual setting will become the standard ↑_ PACE 203H to revert to the Mode Menu. for the current primary mode (XXX stands for one of the primary modes DDD, VVI, AAI or VDD) upon answering 9.11.3 Recall Standard Programs...
  • Page 57 PACE 203H – Instructions for Use Parameter Unit Basic Rate Atrial Overdrive Stimulation – – Start Rate Ventricular Rapid Pacing – Start Rate Atrial Amplitude – – Atrial Sensitivity – Atrial Pulse Duration – – Ventricular Amplitude – Ventricular Pulse Duration 0.75...

  • Page 58: Changing The Turn-On Program

    PACE 203H – Instructions for Use Note: Upon the manufacturer’s shipping 9.11.5 Changing the Turn-On of PACE 203H, the Turn-On Program Program parameters are set according to Table By pressing the softkey Save as Turn-on Parameter Value Unit in the Standard Menu (Table 35), the Mode –...

  • Page 59: Parameters/Options Setting

    PACE 203H – Instructions for Use Warning: The Manufacturer's Turn-on program is intended to provide a safe 9.12 Parameters/Options and conservative pacing therapy for the Setting patient. A change of this program is only PACE 203H provides the capability of recommended for experienced users.

  • Page 60: Adjustment Of Pvarp

    PACE 203H – Instructions for Use The PVARP can be changed with the Parameters / Key No. softkey labeled ↑ or the softkey labeled Options Menu ↓ in increments / decrements of 10 ms PVARP & MTR between 100 ms and 500 ms, respec- tively, as shown in Table 43.

  • Page 61: Adjustment Of Mtr

    PACE 203H – Instructions for Use events as extrasystoles (PVCs) as de- Parameter Range (Step Width) Unit scribed in chapter 9.22.5. 80 (2) 230 Table 45: Range and step width (in pa- 9.12.2 Adjustment of MTR renthesis) for manual setting of MTR...

  • Page 62: Adjustment Of Atrial (Arp) And Ventricular (Vrp) Refractory Period

    PACE 203H – Instructions for Use 9.12.4 Adjustment of Atrial (ARP) and Pulse Duration-Menu Key No. Ventricular (VRP) Refractory Pe- riod ↑ The atrial refractory period (ARP) and the ventricular refractory period (VRP; 1.00 ms ↓ Firmware Version 1.24 and up) of this pacemaker can be changed.

  • Page 63: Setting Options

    PACE 203H – Instructions for Use Parameter Range (Step Width) Unit 9.12.5 Setting Options The Options Menu consists of two parts. 250 (10) 400 It appears as shown in Table 51 and Table 52. By pressing the softkey Table 49: Range and step width (in pa- renthesis) for manual setting of ARP more...

  • Page 64: Enable And Disable Acoustic Indicator

    The loud- speaker symbol disappears from the upper display, as well. Statistics Upon powering off PACE 203H, it retains the enabled / disabled status of the acoustic indicator. Thus, the more … enabled/disabled status of the last usage is restored again upon powering on ↑_...

  • Page 65: Enable And Disable Atrial Trigger Function

    Alarms When the atrial trigger function is ena- causes the check mark to disappear bled, PACE 203H delivers an atrial stim- from the corresponding check box. In the ulus immediately after an atrial sensing upper display, the crossed bell symbol within the atrial sensing phase.

  • Page 66: Setting The User Language

    PACE 203H – Instructions for Use AESCULON™ and ICON™ Electrical 9.12.5.4 Setting the User Language Cardiometry™ monitors) or with the By pressing the softkey labeled optional BPI 202™ intra-aortic balloon Language pump (IABP) interface (not available in the U.S.). in the Options Menu 2, the Language Menu appears as shown in Table 53.

  • Page 67: Statistics

    PACE 203H – Instructions for Use data obtained by PACE 203H presented in four different statistics screens. 9.13 Statistics Please refer to Table 54: Statistical By pressing the softkey labeled Parameters and to Figure 9. Statistics in the Options Menu 2 (see Table 52 on...
  • Page 68 PACE 203H – Instructions for Use Statistics Screen I Statistics Screen II Statistics Screen III Statistics Screen IV Figure 9: Displays of Statistics (automatically alternating) Repeated pressing of the softkey labeled The softkey labeled more ... Reset Statistics toggles between the four different statis- provided exclusively in statistics screen tics screens I - IV, see Figure 9.

  • Page 69: Emergency Stimulation

    EMERGENCY. PACE 203H 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.

  • Page 70: Pause Function

    Thus, after releasing the key labeled Pause, the previous sensitivity threshold 9.15 Pause Function is restored. When the Auto Sense PACE 203H allows the user to tempo- function is activated in one or in both rarily interrupt the current stimulation channels, the changed sensitivity setting therapy in order to monitor the patient’s...
  • Page 71 PACE 203H – Instructions for Use Warning: Because pacing is interrupted, labeled Pause is pressed, any measured the user must be aware that the patient values already displayed are erased. receives no stimulation therapy and sup- port by the pacemaker as long as the key labeled Pause is pressed.

  • Page 72: Connecting The Leads To Pace 203H

    (up to 6 electro- connections to the right (see Figure 1). des) and VDD single pass leads is also Viewing the top of PACE 203H, as permissible. shown in Figure 10, the ventricular Temporary, transvenous pacing...

  • Page 73: Connecting The Leads

    (–, black) terminal of the corresponding 9.16.3 Connecting the Leads channel on PACE 203H. The proximal PACE 203H must be turned off while the pole is then connected to the indifferent stimulation leads are connected to it. (+, red) terminal.
  • Page 74 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 PACE 203H and set the de- sired pacing mode. 6. Determine the sensitivity threshold (see chapter 1.1).

  • Page 75: Determining The Sensitivity Threshold

    2. Set the basic rate 10 ppm below the lation and for sensing (see chapter patient’s intrinsic rate. 9.12.5.1). 3. If PACE 203H is operating in a dual chamber mode, the A-V Delay must be set longer than the patient’s intrinsic A-V interval.

  • Page 76: Determining The Cardiac Capture Threshold

    PACE 203H is already effectively stimulating, lower the stimulation 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.

  • Page 77: Ac Power Supply (Option)

    4. Insert the wall power supply into a mains socket. 5. Control the proper lighting of the green Mains LED. 6. Turn on PACE 203H in the usual way. Warning: If the green LED Mains does not light, PACE 203H operates battery powered with the specified battery lifespan.

  • Page 78: Controlling An Intra-Aortic Balloon Pump (Option)

    BPI (manufacturer’s 203H via the CTRL.OUT terminal of default) in the Options Menu 2 (Table PACE 203H (see Figure 1 and Figure 2). 57). Pressing the PMC/BPI softkey will Attach the clips of the 3 leads provided...
  • Page 79 PACE 203H – Instructions for Use Options Menu 2 Key No. Language more … ↑_ 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: Interfacing With Electrical Cardiometry™ Monitors (Option)

    Cardiometry™ Monitors nected at one end to the CTRL.OUT (Option) terminal of PACE 203H and at the other As an option, PACE 203H interfaces with end to the EC™ monitor. Upon success- the Electrical Cardiometry™ (EC™) ful communication, PACE 203H para- monitors (AESCULON™, ICON™)

  • Page 81: Internal Surveillance And Safety Features

    (see also chapter Change battery! 11.2). will appear approximately every 10 min If PACE 203H is switched off, or to the in the lower display, accompanied by an stand-by state after the first request to acoustic warning signal.

  • Page 82: Lead Surveillance

    PACE 203H – Instructions for Use with respect to the corresponding atrial 9.22.2 Lead Surveillance and/or ventricular channel. In order to prevent system malfunctions (Exit-Block), PACE 203H checks, during each delivery of a stimulus, whether an interruption or a short circuit of the Figure 12: Open Lead Symbol pacing system has occurred.

  • Page 83: Interference And Mode Switching

    PACE 203H – Instructions for Use user’s confirmation, but continues to leads. However, upon proper connection display the open lead symbol if the mal- of PACE 203H to the pacing leads and, function remains present. thus, the patient, PACE 203H enables lead-breakage surveillance after three If the disconnection is detected when the successfully sensed or paced events.

  • Page 84: Crosstalk And Ventricular Safety Pacing

    PACE 203H – Instructions for Use Signals with a frequency above 270 ppm The pacemaker will switch to the (about 4.5 Hz) will be judged as interfer- following mode during ence and force PACE 203H to an asyn- Basic Interference in Interference in chronous stimulation.

  • Page 85: Ventricular Blanking Period

    PACE 203H – Instructions for Use the ventricular triggering period, also responds to an abbreviated A-V Delay of known as the crosstalk sensing window, 100 ms. and the remaining period of the A-V If the signal sensed is indeed crosstalk,...

  • Page 86: Isolated Pvc, Or Initial Pvc

    PACE 203H – Instructions for Use 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 Figure 14: Symbol for Extrasystole rate and A-V Delay.

  • Page 87: Absolute And Relative Pvarp

    PVARP takes up most Note: All conflicts are avoided, when of the V-A delay. "Auto A-V Delay", "Auto PVARP" and PACE 203H avoids this effect by dividing "Auto MTR" are activated (see chapter the PVARP in two periods, the absolute 9.9).

  • Page 88: Possible Conflicts

    PACE 203H – Instructions for Use Abnormal Settings Reason for Mode Action Preventing Basic Rate must not Transient warning message and Basic Rate > MTR be larger than MTR prevent abnormal setting AVD + PVARP + 20ms To guarantee mini-...
  • Page 89 PACE 203H – Instructions for Use The acronyms in the tables have the following definitions: " " Value to be increased " " Value to be decreased "A" Parameter is set to "Automatic Setting" "M" Parameter is set to "Manual Setting"...

  • Page 90: Mode Switching

    Table 65: Conflicts Type e) must be solved and both PVARP and A- 9.22.7.2 Mode Switching V Delay are set to ”manual”, PACE 203H will, first, set the PVARP to the automatic PACE 203H avoids conflicts as a result value (see chapter 9.9.2). If this does not...

  • Page 91: Effects From Therapeutic And Diagnostic Energy Sources

    If simultaneous use of PACE 203H and and sets one or more parameters, simi- electro-surgical instruments is required, lar to what the corresponding automatic PACE 203H should be set to an asyn- mode would have determined. chronous pacing mode (without any sensing).
  • Page 92 PACE 203H – Instructions for Use lower display, accompanied by an after a few seconds, or after confirmation acoustic warning signal. The warning by the user. The user confirms the warn- ing message by pressing the key Un- message alerts the user about the prob- lock / Lock.
  • Page 93 PACE 203H – Instructions for Use PACE 203H Meaning / Cause Measures to Eliminate the Warning Message Conflict / Error Chapter Decrease The user has attempted to increa- Decrease PVARP and/or MTR 9.22.7 PVARP or se A-V Delay. This led to conflict...
  • Page 94 PACE 203H – Instructions for Use PACE 203H Meaning / Cause Measures to Eliminate the Warning Message Conflict / Error Chapter Decrease The user has attempted to decrea- Decrease PVARP or set to 9.22.7 PVARP se the rate. This led to a conflict "Auto PVARP"...

  • Page 95: Warning Messages Related To Application Errors

    9.22.9.2 Warning Messages Related to Application Errors ches the lower display and the backlight on and unlocks PACE 203H. The warn- Generally, if the problem is identified, ing message is now visible. A second any application related errors can be press of the key Unlock/Lock then con- solved by the user.
  • Page 96 PACE 203H – Instructions for Use PACE 203H Meaning / Cause Measures to Eliminate the Warning Message Conflict / Error Chapter A key is pressed for more In case no cause is apparent, timeout than 120 seconds. There is and the error message per-...

  • Page 97: Warning Messages Related To Device Errors

    Device related errors are those which switches the lower display and the back- are probably caused by a malfunction of light on, and unlocks PACE 203H. The the pulse generator itself. (Some may error warning message is now visible. also have external reasons.) Errors of...
  • Page 98 PACE 203H – Instructions for Use PACE 203H Meaning / Cause Measures to eliminate the Warning Message Conflict / Error Chapter Unexpected Most of the device related Attempt to switch the device off, device error errors are reported by this and after waiting after a few no.

  • Page 99: Informative Messages

    PACE 203H – Instructions for Use pear automatically after a short period of 9.22.9.4 Informative Messages time or after confirmation by the user. The user can confirm an informative PACE 203H displays various informative message by pressing the key Un- messages on the lower display, which lock/Lock.
  • Page 100 PACE 203H – Instructions for Use PACE 203H Meaning / Cause Measures to Eliminate 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...

  • Page 101: Storage

    The storage temperature range of use. PACE 203H is -20° C (-4° F)…+60° C (+140° F). Warning In case PACE 203H is not to Note that the device must be within the be used for longer periods of time, the operational temperature range before battery must be removed in order to use (+10°...

  • Page 103: Care And Maintenance

    For valida- If PACE 203H is switched off or to stand- tion approved methods must be used. by mode after the request to change the battery appears, the battery must be...
  • Page 104 For battery replacement, please adhere to the following instructions: Have a new 9 V-battery (6LR61) on hand. On the bottom of PACE 203H, turn the protection cover of the battery compartment release button, and push the battery compartment re- lease button. Open the battery com- partment lid (see Figure 15).

  • Page 105: Safety Check-Ups Of The Pacemaker

    (WEEE directive) applies to the return to the manufacturer and disposal • Inspect the connections for visible method of the PACE 203H as indicated damage. by the pictogram located on its back (Figure 16). Function test •...

  • Page 107: Customer Service

    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...

  • Page 109: Technical Data

    PACE 203H: non-sterile Extension cables connecting to pacing electrodes / wires: sterile No protection against inflammable PACE 203H must not be used in the presence of anesthesia supplies: inflammable mixtures of anesthesia supplies and air, oxygen or nitrous oxide (N...
  • Page 110 PACE 203H – Instructions for Use Parameter Measurement conditions: Environment temperature: 20 ± 2° C Voltage supply: 9 ± 0.5 V Load resistance: 500 Ω ± 1% Test impulse: as specified in ISO 14702-8 (Triangle 2 ms / 13 ms)
  • Page 111 PACE 203H – Instructions for Use Parameter (minimum 5 ms when atrial Auto Sense is not activated; minimum 30 ms when atrial Auto Sense is activated); may be prolonged depending on MTR Escape interval: Determined by Basic Rate ± 5 %...
  • Page 112 PACE 203H – Instructions for Use Parameter Basic rate 80 ppm, Amplitude 18 V (atrium and ventricle), Pulse duration 1.5 ms (atrium and ventricle), AVD 170 ms (auto) Standard setting: Standard parameter set for each primary mode, plus one turn-on parameter set...
  • Page 113 PACE 203H – Instructions for Use Battery (Alkaline): minimal 8 days (DDD, standard parameter) Life span of recommended battery minimal 19 days (VVI, standard parameter) (Lithium): minimal 15 days (DDD, standard parameter) Battery Power Reserve: Plus 1 day reserve after first appearance of...
  • Page 114 Port for connection to Intra-Aortic Balloon Pump (IABP) interface BPI 202™ and Electrical Cardiometry™ (EC™) monitors w/ Pacemaker Clinic™ We reserve the right to make changes without notice. 5 Electrical Cardiometry, EC and Pacemaker Clinic are trademarks of Osypka Medical. 114 / 139 5I-17-016X-B-20...

  • Page 115: Delivery Unit

    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. 5I-17-016X-B-20 115 / 139...

  • Page 117: Conditions Of Guarantee And Liability Restrictions

    If you mail or ship your PACE 203H to tions made to you or understanding you us, we recommend that you insure may have about our obligation. You may...

  • Page 119: Appendix A: Glossary

    PACE 203H – Instructions for Use 16 Appendix A: Glossary Atrial escape interval Time between ventricular sensed beat or a ventricular pulse and the succeeding non-triggered atrial pulse of a pulse generator, i.e. the time when the pacemaker waits for a P-wave.
  • Page 120 PACE 203H – Instructions for Use Cross blanking period Period during which the sensing function of the pulse generator is disabled in one channel because of an event in the other channel. Escape interval Time between a sensed beat or a pulse and the succeeding non-triggered pulse of a pulse generator.
  • Page 121 PACE 203H divides the PVARP into 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 regis- tered, but not tracked.
  • Page 122 PACE 203H – Instructions for Use Upper rate interval (URI) The shortest period allowable between paced or sensed events, while still maintaining 1:1 atrioventricular synchrony (equal to 60 / MTR V-A Delay (VAD) Expression for atrial escape interval. Ventriculoatrial Interval (VAI)

  • Page 123: Appendix B: Menu Tree

    PACE 203H – Instructions for Use 17 Appendix B: Menu Tree Figure 17: Map of Menu Tree (Part 1) 5I-17-016X-B-20 123 / 139...
  • Page 124 PACE 203H – Instructions for Use Figure 18: Map of Menu Tree (Part 2) 124 / 139 5I-17-016X-B-20...
  • Page 125 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 Guidelines for the Electromagnetic Environment...
  • Page 126 PACE 203H – Instructions for Use Electromagnetic Immunity Standard: IEC 60601-1-2: Table 2 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. Testing the Test Level Compliance...
  • Page 127 Electromagnetic Immunity for External Cardiac Pacemakers Standard: IEC 60601-1-2: Table 3 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. Testing the Test Level...
  • Page 128 If the measured field strength exceeds the HF compliance level at the location where PACE 203H is used, PACE 203H must be observed to ensure correct functioning. Additional measures may be necessary, such as reorienting or relocating PACE 203H.
  • Page 129 RF communication equipment (transmitters) – depending on the output power of the communication equipment. as described below. The user should make sure that PACE 203H is used in such an environment.

  • Page 131: Appendix D: List Of Figures

    PACE 203H – Instructions for Use 19 Appendix D: List of Figures Figure 1: Temporary Cardiac Pacemaker PACE 203H Display Face ........ 23 Figure 2: Temporary Cardiac Pacemaker PACE 203H Rear View ........24 Figure 3: Upper Display ..................... 26 Figure 4: Lock Symbol .......................

  • Page 133: Appendix E: List Of Tables

    PACE 203H – Instructions for Use 20 Appendix E: List of Tables Table 1: Possible Complications ..................15 Table 2: Dials and their functions ..................27 Table 3: Fixed labeled keys and their functions ..............27 Table 4: Mode Menu......................28 Table 5: Main Menu ......................
  • Page 134 PACE 203H – Instructions for Use Table 33: Range and step width (in parenthesis) for Ventricular Rapid Pacing ....52 Table 34: Menu while Ventricular Rapid Pacing Running ..........52 Table 35: Standard Menu ....................54 Table 36: Standard Programs Set ..................55 Table 37: Standard Saving Confirmation ................
  • Page 135 PACE 203H – Instructions for Use Table 68: Warning Messages Related to Device Errors ............ 98 Table 69: Informative Messages ..................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 –...

  • Page 137: Appendix F: Pace 203H Accessories

    21 Appendix 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...

  • Page 139: Appendix G: Declaration Of Conformity

    PACE 203H – Instructions for Use 22 Appendix G: Declaration of Conformity Osypka Medical GmbH Albert-Einstein-Strasse 3 12489 Berlin Germany declare under our sole responsibility, that the medical device Dual-Chamber Temporary Cardiac Pacemaker PACE 203H including Medical Grade Power Supply PACE and accessories...

Table of Contents