PACE 203H User Notes 5I-17-017X-B-18

User Notes PACE 203H

User Notes PACE 203H

Lead Connection Terminals

Powering On/Off, Lock/Unlock

DIFF(-)

INDIFF(+)

VENTRICLE

DIFF(-)

INDIFF(+)

ATRIUM

Connecting Extension Cable/Leads Warning: While the PACE 203H is connected, continuous ECGmonitoring 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.

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

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 P4

User Notes PACE 203H

User Notes PACE 203H

Select the Pacing Mode

Adjustment of Stimulation Parameters

Setting DDD, VVI, AAI, VDD

DDD •

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.)

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 Change of Sensitivity Resulting Mode Mode DDD D00 A- and V- Sensitivity → "–.–" VVI V00 V- Sensitivity → "–.–" AAI A00 A- Sensitivity → "–.–" VDD V00 A- and V- Sensitivity → "–.–" 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 ↑_

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

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 automatic 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 P6

User Notes PACE 203H

User Notes PACE 203H

Determining the Sensitivity Threshold Manually

Determining the Cardiac Capture Threshold

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).

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 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. 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

• 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 P8

User Notes PACE 203H

User Notes PACE 203H

Pause Function

Atrial High Rate Stimulation (Overdrive)

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 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!

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

• • •

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 stimulation rate is to be changed. Press and hold START key to deliver atrial high-rate stimulation impulses (A00 mode). running...

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.

240 ppm (250 ms) Dial RATE to change High-Rate! ↑_

Warning: Because pacing is interrupted, the patient receives no support by the pacemaker as long as the Pause key is pressed.

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 readyto-use state.

These User Notes do not replace the Instruction for Use (IfU). Read the IfU carefully before using the product.

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

Osypka Medical 5I-17-017X-B-18 P10

User Notes PACE 203H

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

↓

•

Beep



Alarms



Atrial Trigger



Language PMC 

BPI

Statistics

more …

more …

↑_

↑_

↑_

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.

• •

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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. Osypka Medical 5I-17-017X-B-18 P11

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.

ARP & VRP

These User Notes do not replace the Instruction for Use (IfU). Read the IfU carefully before using the product.

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.

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 P12

User Notes PACE 203H

User Notes PACE 203H

Changing the Battery

Safety Check-Ups

BUTTON COVER BATTERY COMPARTMENT LID open

BATTERY RELEASE BUTTON

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. 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

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 P14