OSYPKA PACE 203H Quick start guide

User Notes PACE 203H
Displays, Dials and Keys
Display Symbols
BATTERY (FULL CHARGED)
INTERFERENCE (ATRIUM / VENTRICLE)
OPEN LEAD (ATRIUM / VENTRICLE)
EXTRASYSTOLE (PVC)
ALARMS DISABLED
ACOUSTIC INDICATOR ENABLED
LOCKED / UNLOCKED
User Notes PACE 203H
Rear Side
Hanger snaps in two positions for hanging up or standing up the
device.
The battery release button opens the battery compartment.
A button cover protects the battery release button.
These User Notes do not replace the Instruction for Use (IfU).
Read the IfU carefully before using the product.
Osypka Medical
5I-17-017X-B-18 P1
These User Notes do not replace the Instruction for Use (IfU).
Read the IfU carefully before using the product.
Osypka Medical
5I-17-017X-B-18 P2
OFF ON
ATRIUM VENTRICLE
INDIFF(+) DIFF(-) INDIFF(+) DIFF(-)
BASIC RATE
A-SENSITIVITY
A-AMPLITUDE
A-V DELAY
V-AMPLITUDE
V-SENSITIVITY
EMERGENCY
STIMULATION
UNLOCKING/
LOCKING
STIM. PAUSE
SOFTKEYS
(menu keys)
UPPER
DISPLAY
A-SENSE
A-STIM.
V-STIM.
V-SENSE
LOWER
DISPLAY
VENTRICLE ATRIUM
DIFF(-) INDIFF(+) DIFF(-) INDIFF(+)
HANGER
BUTTON COVER
CTRL.OUT

User Notes PACE 203H
Lead Connection Terminals
Connecting Extension Cable/Leads
Warning: While the PACE 203H is connected, continuous ECG-
monitoring is mandatory. A defibrillator must always be present in
the ready-to-use state.
The electrostatic potential between user and patient must be
equalized before using the PACE 203H, including the extension
cable or the indwelling leads.
The connector plug must not be touched with bare hands or come
in contact with electrically conductive or wet surfaces.
•Open the collets counterclockwise
after powering off the PACE 203H.
•Connect the extension cable to the output terminals, Make
sure the chamber atrium (A) / ventricle (V) and the polarity is
correct: different (-) pole black, indifferent (+) pole red.
•Secure the connections by rotating the connectors clockwise.
•Connect the leads to the extension cable.
User Notes PACE 203H
Powering On/Off, Lock/Unlock
Powering On
•Press ON key
If the device was powered off to Stand-by, it begins operating
immediately with the previously set parameters.
•Press key
only if the pacemaker was powered off. The PACE 203 H
begins operation with the Turn-on program. After shipping
from the manufacturer, the default pacing mode is DDD. It is
set with relatively low frequency, high sensitivity and medium
stimulation amplitudes. This default setting provides
conservative pacing therapy.
The Turn-on program may be customized according to the
user's preferences.
Lock/Unlock
The lock symbol in the upper display continuously indicates
whether the pacemaker is locked or unlocked.
•Press key
The PACE 203H is locked if it was previously unlocked.
The PACE 203 H is unlocked, if it was previously locked.
In order to prevent an accidental change of parameters, the
PACE 203H is locked automatically, if no dial has been rotated
and no key has been pressed for 30 sec.
Powering Off
•Press OFF key. A menu appears in the lower display with the
options Off and Stand-by.
•Select Off, if the actual settings are not to be stored or
•Select Stand-by, if the actual settings are to be stored.
The PACE 203 H does not consume any battery power in
the Stand-by mode.
These User Notes do not replace the Instruction for Use (IfU).
Read the IfU carefully before using the product.
Osypka Medical
5I-17-017X-B-18 P3
These User Notes do not replace the Instruction for Use (IfU).
Read the IfU carefully before using the product.
Osypka Medical
5I-17-017X-B-18 P4
DIFF(-) INDIFF(+) DIFF(-) INDIFF(+)
VENTRICLE AT
RIUM

User Notes P
ACE 203H
Select the Pacing Mode
Setting DDD, VVI, AAI, VDD
•Select the "primary" mode by
pressing the corresponding key
next to the lower display. (If the
lower display is off or the
PACE 203H is locked, then first
press key.)
DDD
D00 DVI DAI

VVI
V00

AAI
A00 AAT

VDD
V00 VVI VAT

Main Menu
Setting D00, V00, A00
•First select "primary" pacing mode (see above),
then set sensitivity to infinite (displayed as "-.-").
Primary
Mode
Change of Sensitivity
Resulti
ng
Mode
DDD A- and V- Sensitivity →"–.–" D00
VVI V- Sensitivity →"–.–" V00
AAI A- Sensitivity →"–.–" A00
VDD A- and V- Sensitivity →"–.–" V00
•The resulting pacing mode is indicated in the upper display.
Recalling/Saving standard programs
•Press the softkey labeled Main Menu
key, then the softkey labeled
Standard.
•Follow hints in menu.
Save as
Turn on
Save as XXX
standard
Recall XXX
standard
Manufacturer's
default
↑_
User Notes PACE 203H
Adjustment of Stimulation Parameters
Adjustment
•Adjust rate, stimulation amplitude, sensitivity and A-V delay
by rotating the corresponding dials.
•To be able to change a parameter the dials must be
unlocked by pressing the yellow key.
•Clockwise rotation of the rate, amplitude or A-V delay dial
increases the value.
Counterclockwise rotation decreases the value.
•Clockwise rotation of a sensitivity dial increases the sensitivity
value, i.e. decreases the sensitivity, and vice versa.
Using the Automatic Functions
•If the related automatic function are enabled, the PACE 203H
automatically adjusts A-V delay (AVD), PVARP and maximum
tracking rate (MTR) with setting of the basic rate.
•Enabling the automatic functions:
Press the Main Menu key first and then the Auto key.
Enable (or disable) the automatic functions individually.
Note: For detailed
description of the auto-
matic adjustment of
sensitivity (Auto Sense
function) please refer to
the instructions for use
manual.
Auto
AVD

Auto
PVARP

Auto
MTR

Auto
Sense
↑_
Starting Emergency Stimulation
•Unlock by pressing the key, then press the red
EMERGENCY key. The mode D00, rate 80 ppm and
stimulation amplitude 18 V (max) will be set.
These User Notes do not replace the Instruction for Use (IfU).
Read the IfU carefully before using the product.
Osypka Medical
5I-17-017X-B-18 P5
These User Notes do not replace the Instruction for Use (IfU).
Read the IfU carefully before using the product.
Osypka Medical
5I-17-017X-B-18 P6

User Notes
PACE 203H
Determining the Sensitivity Threshold Manually
The sensitivity threshold can also be determined by means of the
Pause function (see User Notes "Pause Function").
Warning: For manual determination of the sensitivity threshold,
the patient must have heart activity with a rate that is
hemodynamically tolerated over a longer period of time (a few
minutes).
•Set stimulation amplitude (in dual chamber both channels) to
the smallest value so that asynchronous stimulation remains
ineffective.
•Set basic rate 10 ppm below the patient's intrinsic rate.
•In a dual chamber mode, the A-V delay must be set to a value
longer than the patient's own delay.
•In case the PACE 203H already detects heart signals, set the
sensitivity low enough (i. e. increase the sensitivity value), so
that no more sensing takes place. Thus the PACE 203H
stimulates asynchronously in the corresponding channel.
•Increase the sensitivity (decrease the sensitivity value) again
until stimulation is inhibited. This is the sensitivity threshold. In
order to create a safety cushion, the sensitivity must be further
increased. The set value should be a 1/2 to a 1/3 of the
sensitivity threshold value.
•In case a dual chamber mode is chosen the procedure must
be repeated for the other channel.
Warning: An unnecessarily high sensitivity (i.e. small sensitivity
value) increases the probability that external interference affects
the operation of the PACE 203H, which then may switch to
asynchronous stimulation.
Note: When setting the sensitivity threshold, enabling the acoustic
signal of the PACE 203H is recommended. Beeps of different
frequency distinguish acoustically between stimulation and
sensing.
User Notes PACE 203H
Determining the Cardiac Capture Threshold
Attention: If the patient has a satisfactory intrinsic heart rate, the
determination of the sensitivity threshold must be carried out
before the cardiac capture threshold is determined. This maneuver
makes certain that no asynchronous superimposition of intrinsic
rhythm and stimulation occurs.
•Set the basic rate at least 10 ppm above the patient’s own rate.
If the PACE 203H is already effectively stimulating, lower the
stimulation amplitude until the stimulus is no longer effective.
•In case the PACE 203H is operating in a dual chamber mode,
the A-V delay must be set to a value less than the patient’s own
delay.
•Increase the stimulation amplitude slowly until the stimulus is
effective again. This is the cardiac capture threshold.
•In order to create a safety cushion, the stimulation amplitude
must be further increased. The set value should be 2 to 3 times
of the cardiac capture threshold.
•In case a dual-chamber mode is chosen, the procedure must
be repeated in the other channel.
Warning: If the PACE 203 H is to be used for a longer period of
time on a patient, the stimulation threshold should be checked
from time to time (the first time after a few hours, then daily),
because an increase in the threshold may occur.
These User Notes do not replace the Instruction for Use (IfU).
Read the IfU carefully before using the product.
Osypka Medical
5I-17-017X-B-18 P7
These User Notes do not replace the Instruction for Use (IfU).
Read the IfU carefully before using the product.
Osypka Medical
5I-17-017X-B-18 P8

User Notes PACE 203H
Pause Function
To check the patient's intrinsic heart activity, stimulation can be
interrupted temporarily. With the pause function the determination
of sensitivity threshold and intrinsic rate can be simplified
considerably.
•Press and hold the Pause key.
Stimulation is interrupted for maximum 10 seconds.
•If heart activities are sensed, atrial and ventricular rates as
well as the measured EGM amplitudes are displayed in the
pause menu.
Sensed:
A 230 bpm
(261 ms)
2.3 mV
V 50 bpm
(1200 ms)
8.0 mV
AVI 90 ms
•If a reasonable and stable EGM amplitude is displayed, a
sensitivity value should be set which is between a 1/2 and a
1/3 of the displayed amplitude.
•The atrioventricular interval (AVI) shows the time distance
between atrial and ventricular sense event.
•To repeat the pause function release and press the Pause
key again.
Warning: Because pacing is interrupted, the patient receives no
support by the pacemaker as long as the Pause key is pressed.
User Notes PACE 203H
Atrial High Rate Stimulation (Overdrive)
•Press Main Menu soft-key and then High-Rate soft-key.
•Select the Atrial High-Rate soft-key
•The Atrial High-Rate Standby Menu appears.
But the PACE 203H still continues operation in the set mode.
START
(Atrium)
240 ppm
(250 ms)
Dial RATE
to change
High-Rate!
↑_
•The rate magnitude of the tachycardia may be determined by
means of the pause function.
•Rotate the RATE dial, if the displayed atrial high-rate stimula-
tion rate is to be changed.
•Press and hold START key to deliver atrial high-rate stimula-
tion impulses (A00 mode).
running...
240 ppm
(250 ms)
Dial RATE
to change
High-Rate!
↑_
Warning: There is a risk of causing ventricular tachycardia during
atrial overdrive stimulation. Continuous ECG monitoring of the
patient is mandatory. A defibrillator should be at hand in the ready-
to-use state.
These User Notes do not replace the Instruction for Use (IfU).
Read the IfU carefully before using the product.
Osypka Medical
5I-17-017X-B-18 P9
These User Notes do not replace the Instruction for Use (IfU).
Read the IfU carefully before using the product.
Osypka Medical
5I-17-017X-B-18 P10

User Notes PACE 203H
Adjustment of Pacer Timing Parameters
PVARP & MTR
The post ventricular atrial refractory period (PVARP) and the
maximum tracking rate (MTR) can be adjusted automatically with
the setting of the basic rate (see User Notes "Adjustment of
Stimulation Parameters"), or manually.
•Press Main Menu, Parameter/-
Options and PVARP & MTR in this
order.
•Use Increase and Decrease keys for
changing PVARP & MTR.
Note: Manually changing PVARP &
MTR will also disable the automatic
function if it was enabled. It can be
reactivated again with the softkey
adjacent to the checkbox.
PVARP
280 ms
↑
↓
MTR
106 ppm
↑
↓
↑_
Pulse Duration
•Press softkeys Main Menu, Parameters/Options and Pulse
Duration key in this order. The Pulse Duration Menu is
displayed.
•Use keys adjacent to the arrows for changing atrial (A) and
ventricular (V) pulse duration.
ARP & VRP
The atrial (default 250ms) and ventricular (default 250ms)
refractory period can be extended up to 400ms respective 500ms:
•Press softkeys Main Menu, Parameter&Options and
ARP&VRP in this order.
•Use arrow soft-keys to change ARP and/or VRP.
User Notes PACE 203H
Setting Options
•Press softkeys Main Menu, Parameters/Options and Options
in this order.
•The Options Menu consists of two parts. First the left one
appears. The key more-.. toggles to the right one.
Beep Language
Alarms PMC BPI

Atrial
Trigger Statistics
more … more …
↑_ ↑_
•The Beep key enables or disables the acoustic indicator.
•The Alarms key enables or disables the lead surveillance
feature and the protection against abnormal settings.
Warning: The alarms should only be disabled in a controlled
environment where the patient is continuously monitored by a
medical professional, e.g. in an operating room environment.
•The Language key switches to the Language (selection)
Menu.
•The option PMC/BPI chooses the mode for the CTRL.OUT
interface. Please refer to the instructions for use for details.
These User Notes do not replace the Instruction for Use (IfU).
Read the IfU carefully before using the product.
Osypka Medical
5I-17-017X-B-18 P11
These User Notes do not replace the Instruction for Use (IfU).
Read the IfU carefully before using the product.
Osypka Medical
5I-17-017X-B-18 P12

User Notes PACE 203H
Changing the Battery
The battery symbol in the upper display continuously indicates the
battery voltage. The change level is reached when only one
segment (the rightmost triangular one) is blinking and the text
message "Change battery!" appears in the lower display. During a
battery change continuous stimulation is maintained for minimum
of 30 seconds.
•Have a new 9V-battery (6LR61)
•Turn the button cover away
and push the battery release button located below.
•Remove the battery from the battery compartment.
•Place a new battery in the compartment.
The polarity is irrelevant.
•Close the battery compartment until it is audible latched in
place. Rotate the protective cover over the battery release
button.
•Please dispose of the battery properly.
Warning: If the critical battery depletion level is reached, the
battery symbol becomes empty and blinks as a whole, and the text
message "Hurry up! Change battery!" requests an immediate
replacement of the battery.
In order to provide continuous operation of the PACE 203H during
a battery replacement, the battery must be replaced before the
critical depletion level is reached.
User Notes PACE 203H
Safety Check-Ups
Before each use: Visual inspection and function test
•Inspect the PACE 203H and accessories for visible damage.
•Inspect the connections for visible damage.
•Inspect all connections to ascertain if they hold tightly and
function to specification.
•Inspect all operating elements and displays for specified
function.
After each use:
•Care and cleaning of the PACE 203H and of the accessories
shall be done according to instruction of use.
Care and Cleaning:
To clean the device, use a towel or sponge moistened (but not
soaked) with water or alcohol.
To disinfect the PACE 203H, the casing can be cleaned with
alhydex or cydex or with detergicide.
Warning: The PACE 203H must not be submerged in either water
or in any other cleaning solution. Do not use any scrubbing
powder / liquid on the PACE 203H.
The PACE 203H must not be sterilized in an autoclave.
Sterilization with ultrasound or gamma rays is also not permitted.
The PACE 203H can be damaged by such procedures.
Re-usable cables must be cleaned, disinfected and sterilized after
each use. Single use cables must not be re-used.
These User Notes do not replace the Instruction for Use (IfU).
Read the IfU carefully before using the product.
Osypka Medical
5I-17-017X-B-18 P13
These User Notes do not replace the Instruction for Use (IfU).
Read the IfU carefully before using the product.
Osypka Medical
5I-17-017X-B-18 P14
BUTTON COVER
BATTERY
COMPARTMENT
LID
BATTERY RELEASE BUTTONopen