OSYPKA PACE 203H User manual

5I-17-016X-B-20 Osypka Medical 2013©
Instructions for Use
P A C E 2 0 3 H
Dual-Chamber (DDD) Temporary Pacemaker
Distributor
OSYPKA AG
Earl-H.-Wood-Strasse 1
D-79618 Rheinfelden, Germany
Phone: [phone] - 0
Fax: [phone] - 160
E-Mail: [e-mail]
M a n u f a c t u r e r
Osypka M edical GmbH
Albert
-Einstein-Strasse 3
D-12489 Berlin, Germany
Phone: [phone]
Fax: [phone]
E-Mail: [e-mail]

PACE 203H – Instructions for Use
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Table of Contents
1 Preface 9
1.1 General 9
1.2 Checking the Delivery 9
1.3 Optional Accessories 9
1.4 Writing Conventions of this Manual 9
2 Product Description 11
3 Indication 13
4 Contraindication 13
5 Possible Complications 14
6 Precautionary Measures and Warnings 17
7 Patient Safety 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 203H 29
9.4 Locking/Unlocking PACE 203H 30
9.5 Powering Off PACE 203H 31
9.6 Modes of Operation 31
9.6.1 Ventricular Asynchronous (V00) Pacing 32

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9.6.2 Atrial Asynchronous (A00) Pacing 32
9.6.3 A-V Sequential Asynchronous (D00) Pacing 32
9.6.4 Ventricular Inhibited (VVI) Pacing 32
9.6.5 Atrial Inhibited (AAI) Pacing 33
9.6.6 Atrial Synchronous (P-Tracking) (VDD) Pacing 33
9.6.7 Dual-Chamber Pacing and Sensing with Inhibition and Tracking (DDD) 33
9.6.8 The A-V Sequential, Atrial Inhibited (DAI) Pacing 33
9.6.9 The A-V Sequential, Ventricular Inhibited (DVI) Pacing 34
9.6.10 Atrial Sensing Atrial Synchronous (P-Tracking) (VAT) Pacing 34
9.6.11 Non-Pacing Mode 0D0 (Pause) 34
9.6.12 Atrial Trigger Modes AAT, DDD+AT and DAT 34
9.7 Changing the Mode of Operation 35
9.8 Adjustment of Rate, Stimulation Amplitude, Sensitivity and A-V Delay 36
9.8.1 Adjustment of Basic 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) 42
9.9.4.1 How the Auto Sense Function Works 42
9.9.4.2 Important Notes Using the Auto Sense Function: 43
9.9.4.3 Activation of Auto Sense 43
9.9.4.4 Notes for the Initialization of the Auto Sense function 45
9.9.4.5 Re-Initialization of Auto Sense 46
9.9.4.6 Deactivation of Auto Sense 46
9.10 High-Rate / Overdrive Stimulation 48
9.10.1 Atrial High-Rate Standby 48
9.10.1.1 Atrial High-Rate Stimulation with Ramp Function 50
9.10.2 Ventricular Rapid Pacing Standby 51
9.10.2.1 Ventricular Rapid Pacing with Ramp Function 53
9.11 Standard Programs 54

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9.11.1 Parameters Stored in a Standard Program 54
9.11.2 Store Standard Programs 56
9.11.3 Recall Standard Programs 56
9.11.4 Recall Manufacturer’s Defaults 56
9.11.5 Changing the Turn-On Program 58
9.12 Parameters/Options Setting 59
9.12.1 Adjustment of PVARP 60
9.12.2 Adjustment of MTR 61
9.12.3 Adjustment of Pulse Duration 61
9.12.4 Adjustment of Atrial (ARP) and Ventricular (VRP) Refractory Period 62
9.12.5 Setting Options 63
9.12.5.1 Enable and Disable Acoustic Indicator 64
9.12.5.2 Enable 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 Determining the Sensitivity Threshold 75
9.18 Determining the Cardiac Capture Threshold 76
9.19 AC Power Supply (Option) 77
9.20 Controlling an Intra-Aortic Balloon Pump (Option) 78
9.21 Interfacing with Electrical Cardiometry™ Monitors (Option) 80
9.22 Internal Surveillance and Safety Features 81
9.22.1 Battery Surveillance 81
9.22.2 Lead Surveillance 82

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9.22.2.1 Short Circuit in Pacing System 82
9.22.2.2 Interruption in Pacing System 82
9.22.3 Interference and Mode Switching 83
9.22.4 Crosstalk and Ventricular Safety Pacing 84
9.22.4.1 Ventricular Blanking Period 85
9.22.4.2 Crosstalk Sensing Window and Ventricular Safety Pacing 85
9.22.5 Premature Ventricular Contraction (PVC) 85
9.22.5.1 Isolated PVC, or Initial PVC 86
9.22.5.2 Subsequent PVCs 86
9.22.5.3 Absolute and relative PVARP 87
9.22.6 Runaway Protection 87
9.22.7 Protection Against 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 Device Errors 97
9.22.9.4 Informative Messages 99
10 Storage 101
11 Care and Maintenance 103
11.1 Care and Cleaning 103
11.2 Changing the Battery 103
11.3 Safety Check-Ups of the Pacemaker 105
11.4 Product Return Policy 105
12 Customer Service 107
13 Technical Data 109
14 Delivery Unit 115
15 Conditions of Guarantee and Liability Restrictions 117

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16 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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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: [phone] - 0
The product may only be placed in
service when its proper use can be
assured.
According to U.S. Standards,
PACE 203H is a Class III device
(21 CFR 862-892 [807.87(c)]).
According to European Standards,
PACE 203H is a Class IIb medical
product (Council Directive 93/42/EEC of
14 June 1993 (‘Medical Device
Directive’), Annex IX).
1.2 Checking the Delivery
Unpack the product and carefully check
to see if any damage has occurred
during shipment. Check to see if every-
thing was delivered as listed on the
shipping list. This includes:
•PACE 203H Dual-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 operation of
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
otherwise 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:
•Fixed labeled keys and dials are
marked with bold style:
ON, OFF, Pause,
Unlock/Lock
•Texts in the upper display are
marked with bold style:
AUTO, A-TRIG.
•Text in the lower display and soft-
labeled keys are marked in italics:
Main Menu, START

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•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: …

PACE 203H – Instructions for Use
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2 Product Description
PACE 203H is a dual chamber external
cardiac pacemaker with atrial controlled
timing for routine temporary heart stimu-
lation. 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.
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
supply option is not available in USA and
Japan.)
The 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 standard program
is available for each primary pacing
mode.
•An emergency program can be “cal-
led up” by pressing the emergency
key.
•A burst- and a ramp function are
available for atrial overdrive-stimu-
lation.
•An Unlock/Lock button protects
against accidental change of the set
parameters.
•The set parameters and (error) mes-
sages are shown on a liquid crystal
display.
•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.
•System malfunctions that occur are
indicated optically and acoustically.
•A lead surveillance system indicates
interruptions and short circuits.
•When a battery change is required,
optical and acoustic alerts are pro-
vided.
•During dual chamber pacing, an
automatic mode for adapting A-V De-
lay, maximum tracking rate (MTR),
and PVARP is available.
•An automatic mode for adjusting the
sensitivity in both the atrium and ven-
tricle may be chosen.

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•A Pause function is available for
easy determination and measure-
ment of the patient’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.

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3 Indication
The PACE 203H DDD Temporary Cardi-
ac Pacemaker is designed to be used
with cardiac stimulation lead systems for
temporary atrial, ventricular or A-V se-
quential stimulation. PACE 203H has ap-
plications where such stimulation modes
are indicated for therapeutic, prophylac-
tic, or diagnostic purposes.
Specific indications include, but are not
limited to, the following:
•Sick sinus syndrome;
•Bradycardia with congestive heart
failure;
•Complete heart block;
•Acute myocardial infarction compli-
cated with heart block;
•Sinus bradycardia;
•Cardiac arrest with ventricular
asystole;
•Atrial and/or ventricular 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 health of the patient, 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 the excessive and chaotic fre-
quency 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.

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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-
bolism
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).
Abnormal pacemaker settings Erratic rhythm. Compromise in stroke volume / cardi-
ac output

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Complication Result
Inappropriately high sensitivity
setting. Sensing of R or T waves
in the atrium or P waves in the
ventricle. Detection of interfer-
ence (noise, electromagnetic
interference).
Ventricular tachycardia, ventricular fibrillation, and
death, if not recognized immediately.
Time mismatch between
intracardiac conduction and
pacemaker settings.
Pacemaker mediated tachycardia.
(In order to prevent this, some decision overrides are
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-
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. 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
of PACE 203H with defibrillators or electro-surgical
instruments.
Table 1: Possible Complications

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6 Precautionary Measures
and Warnings
The following list presents important
precautionary measures and warnings.
Additional important precautionary
measures and warnings will be found in
the following chapters.
1. In order to prevent unnecessary
complications, PACE 203H should
only be applied and used by medical
personnel with extensive experience
in cardiac stimulation therapy. Addi-
tionally, the person using the device
should be thoroughly familiar with the
contents of this instruction manual.
2. 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.
3. Make sure that all devices in the
vicinity of the patient are properly
grounded.
4. 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.
5. While the lead is being inserted and
connected to the pacemaker, contin-
uous ECG monitoring is mandatory.
For emergency situations, 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 available.
8. Error messages and conflict warn-
ings of PACE 203H do not replace
an ECG monitoring.
9. During atrial overdrive-stimulation an
accidental conduction into the ventri-
cle is possible and may cause ven-
tricular tachycardia. Therefore, con-
tinuous ECG-monitoring is mandato-
ry. A defibrillator should always be
available in a ready-to-use state.
10. If PACE 203H operates in an asyn-
chronous mode, the pacing pulses
may occur during the vulnerable
phase of the patient’s intrinsic activity
(corresponds approximately in the
ECG to the T-wave); and may cause
ventricular fibrillation and ventricular
flutter.
11. It is mandatory to continuously moni-
tor the patient and to be prepared for
a possible failure or malfunctioning of
the pacemaker when PACE 203H is
used in conjunction with electro-
surgical instruments or defibrillators.
12. To protect the patient and the pace-
maker from current passing through
the pacemaker/lead-circuitry caused
by defibrillation discharges, the stim-
ulation circuit should always be
opened during defibrillation if possi-
ble. Current flows caused by defibril-
lator discharges can endanger the

PACE 203H – Instructions for Use
18 / 139 5I-17-016X-B-20
patient. High current amplitudes can
also damage the pacemaker.
13. If PACE 203H is to be used for a
long 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.
14. 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.
15. 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. PACE 203H is designed in such
a way that this cross-talk is mini-
mized. Furthermore, the distance be-
tween atrial and ventricular lead sys-
tem should be not less than 4 cm.
16. Due to differences in the anatomy,
electro-physiological conditions and
the location of the electrodes, cross-
stimulation cannot be completely
prevented. Therefore, when the de-
vice is switched on or 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
channel.
17. PACE 203H prevents abnormal set-
tings (see chapter 9.22.7).
18. 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).
19. 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.
20. In case that PACE 203H is not used
for long periods of time, the battery
must be removed in order to prevent
damage from possible battery acid
leakage. (Such damage will not be
compensated under the guarantee).
21. 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.
22. The device must not be sterilized in
an autoclave. Sterilization with plas-
ma, ultrasound or gamma radiation is
also not allowed. PACE 203H can be
damaged by such procedures.
23. Connector cables, intended for single
use, cannot be re-sterilized and rein-
serted into a patient.
24. Only the manufacturer, or facilities
authorized by the manufacturer, can
perform repairs or calibration of
PACE 203H.

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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.
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.
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, then prior use PACE 203H
must be checked for sufficient battery
backup time.
28. Use only 9 V primary batteries for
PACE 203H. Re-chargeable batter-
ies (accumulators) should not be
used (possibly low capacity and un-
stable charge condition may cause a
malfunction of the pacemaker).
29. When used as intended, PACE 203H
does not contain any parts which are
subject to wear and tear.