ZOLL PD™ 1200 Pacemaker/Defibrillator

Operator's Guide

TABLE OF CONTENTS

SECTION DESCRIPTION PAGE
I. GENERAL INFORMATION 1
II. OPERATING CONTROLS AND INDICATORS 11
III. EMERGENCY DEFIBRILLATION PROCEDURE 15
IV. SYNCHRONIZED CARDIOVERSION 19
V. NONINVASIVE TEMPORARY PACING (NTP) 23
VI. ECG MONITORING 29
VII. OPERATION WITH MULTI-FUNCTION ELECTRODES 33
VIII. OPERATIONAL CHECKS AND PROCEDURES 39
IX. EXTENDED DIAGNOSTICS 47
X. TROUBLESHOOTING GUIDES 51

SECTION I

GENERAL INFORMATION

This operating guide provides instructions for the safe use and proper care of the ZOLL PD 1200 Pacemaker/Defibrillator (PD). Before using the instrument, CAREFULLY read this entire manual.

SAFETY CONSIDERATIONS

The ZOLL PD is a high energy device and is capable of delivering up to 360 joules. Disconnecting the line cord of an operating PD from an AC power outlet will not remove power since the instrument is battery-powered. To completely deactivate the PD, you must turn the SELECTOR SWITCH to the OFF position.

In order to disarm a charged defibrillator:

• Turn the SELECTOR SWITCH at least one position in either direction.

or

If using paddles, place them in their holders and depress both DISCHARGE buttons.

As a safety feature, the ZOLL PD will automatically discharge internally if it has been left charged for more than 60 seconds.

WARNINGS

• This instrument is for use by authorized personnel only.

Do not use the ZOLL PD in the presence of flammable agents (such as gasoline) or anesthetics. Using the instrument near the site of a gasoline spill may cause an explosion.

Do not discharge with paddles shorted together or in open air. Stand clear of patient when defibrillating.

Do not discharge into multi-function electrodes that are not properly placed on a patient.

Using the device near or within puddles of water is a shock hazard to the operator, patient, and nearby personnel.

Internal pacemakers may cause the heart rate meter to count the pacemaker rate during incidences of cardiac arrest or other arrhythmias. Pacemaker patients should be carefully observed. Do not rely solely on heart rate meters.

PRODUCT DESCRIPTION

The ZOLL PD 1200 Pacemaker/Defibrillator combines a patented noninvasive temporary pacemaker, a DC defibrillator, a non-fade monitor, and an annotating strip chart recorder in an integral, self-contained instrument. The PD 1200 is lightweight, compact, and can be transported with a patient. It can be operated by either an AC line or batteries. Built-in batteries are kept at full charge when the unit is connected to line power. The batteries are rechargeable and can be easily replaced by the user.

PACEMAKER FUNCTION

Noninvasive temporary pacing (NTP) $ ^{*} $ is an established and proven technique. This therapy is safe and is easily and rapidly applied in both emergency and non-emergency situations when temporary cardiac stimulation is indicated.

The ZOLL Pacemaker/Defibrillator (PD) contains a demand pacemaker consisting of a pulse generator and ECG sensing circuitry. The output current of the pacemaker is continuously variable up to 140 mA and the rate is continuously variable from 30 to 180 pulses per minute (ppm).

The pacing output pulse is delivered to the heart by specially designed ZOLL NTP pacing electrodes or ZOLL PD multi-function electrodes placed on the back and the precordium. Only ZOLL NTP or ZOLL PD electrodes should be connected to this instrument.

The characteristics of the output pulse, together with the design and placement of the electrodes, minimize cutaneous nerve stimulation, lower cardiac stimulation thresholds, and reduce discomfort due to skeletal muscle contraction.

The unique design of the ZOLL PD allows clear viewing and interpretation of the electrocardiogram (ECG) on the monitor during external pacing, without offset or distortion.

Intended Use -- Pacemaker

This product may be used for cardiac pacing for any purpose in conscious or unconscious patients for up to a few hours duration as an alternative to endocardial stimulation. The purposes of pacing include:

1. Resuscitation from standstill or bradycardia of any etiology

Noninvasive pacing has been used for resuscitation from standstill or temporary acceleration of bradycardia in Stokes-Adams disease, sick-sinus syndrome, reflex vagal standstill and drug-induced standstill (due to procainamide, quinidine, digitalis, b-blockers, verapamil, etc.), and unexpected circulatory arrest (due to anesthesia, surgery, angiography, and other therapeutic or diagnostic procedures). It is safer, more reliable, and more rapidly applied in an emergency than endocardial or other temporary electrodes.

2. As a standby when standstill or bradycardia might be expected

As a stand-by when arrest or symptomatic bradycardia might be expected, the external pacer is used especially in pacemaker procedures (e.g., acute myocardial infarction, drug toxicity, anesthesia, or surgery, especially when disturbances of rhythmicity or

conduction are present). Prophylactic placement of endocardial electrode, which carries risks of displacement, infection, hemorrhage, embolization, perforation, phlebitis, and mechanical or electrical stimulation of ventricular tachycardia and fibrillation, can be avoided.

3. Suppression of tachycardia

An increase in heart rate from external pacing often suppresses ventricular ectopic activity and may prevent tachycardia.

Pacemaker Complications

Ventricular fibrillation will not respond to pacing and requires immediate