Zoll m series дефибриллятор инструкция

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OPERATOR’S GUIDE

October 2010 9650-0200-01 Rev YH

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An issue or revision date for this manual is shown on the front cover.
If more than three years have elapsed since this date, contact ZOLL Medical Corporation to determine if additional

product information updates are available.
ZOLL, M Series, CPR-D•padz, and stat•padz are registered trademarks of ZOLL Medical Corporation. ZOLL Data

Control Software, and Real CPR Help are trademarks of ZOLL Medical Corporation. 12SL and Catalyst MUSE are
trademarks of GE Medical Systems.

Copyright © 2010 by ZOLL Medical Corporation. All rights reserved.

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Table of Contents

Section 1 General Information

Product Description ………………………………………………………………………………………………1-1

How to Use This Manual………………………………………………………………………………………..1-2

Manual Updates……………………………………………………………………………………………………1-2

Unpacking…………………………………………………………………………………………………………… 1-2

Accessories …………………………………………………………………………………………………………1-2

Symbols Used on the Equipment ……………………………………………………………………………1-3

Defibrillator Function……………………………………………………………………………………………..1-4

Intended Use — Manual Operation ………………………………………………………………….1-4

Intended Use — Semiautomatic Operation (AED) ……………………………………………..1-4

Intended Use — CPR Monitoring …………………………………………………………………….1-4

Semiautomatic Operation Contraindications for Use …………………………………………..1-4

Defibrillator Complications ………………………………………………………………………………1-4

Defibrillator Output Energy ……………………………………………………………………………..1-4

External Pacemaker (Pacer Version Only)……………………………………………………………….1-5

Intended Use — Pacemaker ……………………………………………………………………………1-5

Pacemaker Complications ………………………………………………………………………………1-5

Pediatric Pacing …………………………………………………………………………………………….1-6

Monitor……………………………………………………………………………………………………………….. 1-6

Recorder Function………………………………………………………………………………………………..1-6

Paddle — Electrode Options ………………………………………………………………………………….1-6

Batteries………………………………………………………………………………………………………………1-6

Internal Battery Charger ………………………………………………………………………………………..1-6

External Battery Charger……………………………………………………………………………………….1-7

Diagnostics………………………………………………………………………………………………………….1-7

Safety Considerations……………………………………………………………………………………………1-8

WARNINGS …………………………………………………………………………………………………. 1-8

CAUTIONS …………………………………………………………………………………………………1-10

Restarting the Device…………………………………………………………………………………………..1-10

FDA Regulations………………………………………………………………………………………………… 1-11

Tracking Requirements …………………………………………………………………………………1-11

Notification of Adverse Events ……………………………………………………………………….1-11

Warranty (U.S. Only)…………………………………………………………………………………………… 1-11

Software License………………………………………………………………………………………………..1-12

Service……………………………………………………………………………………………………………… 1-12

U.S.A. Customers ………………………………………………………………………………………..1-12

International Customers ………………………………………………………………………………..1-12

Defibrillator Waveform Information………………………………………………………………………..1-13

ECG Analysis Algorithm Accuracy…………………………………………………………………………1-14

Clinical Performance Results …………………………………………………………………………1-14

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Section 2 Operating Controls and Indicators

Code Markers………………………………………………………………………………………………………2-3

Summary Report…………………………………………………………………………………………………..2-4

Summary Report Formats ………………………………………………………………………………2-4

Defibrillation Format ……………………………………………………………………………………….2-4

Pacer Format (Pacer version only) …………………………………………………………………..2-5

Heart Rate Alarm Activated Format ………………………………………………………………….2-5

VF Alarm Activated (Refer to Section ……………………………………………………………2-5

Recorder On Format ………………………………………………………………………………………2-5

Analyze Format ……………………………………………………………………………………………..2-6

Manual Mode Activated ………………………………………………………………………………….2-6

Printing a Report…………………………………………………………………………………………………..2-7

Printing Part of a Report………………………………………………………………………………………..2-7

Adding Patient Name and ID# to a Report ……………………………………………………………….2-7

Printing an Incident Log…………………………………………………………………………………………2-7

Erasing Summary Report Memory ………………………………………………………………………….2-8

Section 3 Manual Defibrillation

Emergency Defibrillation Procedure with Paddles……………………………………………………..3-1

Emergency Defibrillation Procedure with MFE Pads………………………………………………….3-4

Open Chest Defibrillation with Internal Handles and Electrodes………………………………….3-6

Troubleshooting……………………………………………………………………………………………………3-6

Section 4 Advisory Defibrillation

Advisory Defibrillation ……………………………………………………………………………………………4-1

Advisory Function Messages………………………………………………………………………………….4-3

Warning Messages……………………………………………………………………………………………….4-3

Troubleshooting……………………………………………………………………………………………………4-4

Section 5 Automated External Defibrillator (AED) Operation

Introduction………………………………………………………………………………………………………….5-1

AED Semi-Automatic Operation……………………………………………………………………………..5-1

Operating Messages ………………………………………………………………………………………5-3

AED Manual Mode Operation…………………………………………………………………………………5-5

AED Voice Prompts ……………………………………………………………………………………….5-5

Troubleshooting……………………………………………………………………………………………………5-5

Section 6 Synchronized Cardioversion

General Information………………………………………………………………………………………………6-1

Synchronized Cardioversion…………………………………………………………………………………..6-1

Troubleshooting……………………………………………………………………………………………………6-3

Section 7 CPR Assistance

Prepare the Patient and Attach the CPRD-to-MFC Connector…………………………………….7-1

CPR Assist Display……………………………………………………………………………………………….7-1

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CPR Compressions Indicator …………………………………………………………………………………7-2

CPR Idle Time Display…………………………………………………………………………………………..7-2

CPR Metronome…………………………………………………………………………………………………..7-2

Section 8 Non-Invasive Temporary Pacing (Pacer Version Only)

Non-invasive Temporary Pacing……………………………………………………………………………..8-1

Special Pacing Applications……………………………………………………………………………………8-3

Standby Pacing ……………………………………………………………………………………………..8-3

Asynchronous Pacing …………………………………………………………………………………….8-4

Pediatric Pacing …………………………………………………………………………………………….8-4

Troubleshooting……………………………………………………………………………………………………8-4

Section 9 ECG Monitoring

Introduction………………………………………………………………………………………………………….9-1

Preparations…………………………………………………………………………………………………………9-1

Electrode Placement ………………………………………………………………………………………9-1

Attach Monitoring Electrodes …………………………………………………………………………..9-2

Troubleshooting……………………………………………………………………………………………………9-2

Set the Controls……………………………………………………………………………………………………9-2

Spikes from Implant able Pacemakers………………………………………………………………………9-2

Alarms…………………………………………………………………………………………………………………9-3

Setting Alarm Limits ……………………………………………………………………………………….9-3

Alarm Function ………………………………………………………………………………………………9-3

Alarm Limits ………………………………………………………………………………………………….9-3

Suspending and Silencing Alarms ……………………………………………………………………9-3

Smart Alarms ………………………………………………………………………………………………..9-4

Recorder Operation………………………………………………………………………………………………9-4

Diagnostic Bandwidth …………………………………………………………………………………….9-4

5 Lead Monitoring…………………………………………………………………………………………………9-4

Simultaneous 3 Lead Printing (If Configured) …………………………………………………….9-5

Changing from 5 Lead to 3 Lead ECG Monitoring ………………………………………………9-5

Vital Signs Trending………………………………………………………………………………………………9-5

Viewing Vital Signs Trending Data on the Display ………………………………………………9-5

Printing a Vital Signs Trend Report ………………………………………………………………….9-6

NIBP Trend Operation ……………………………………………………………………………………9-6

Clearing Vital Signs Trend Records ………………………………………………………………….9-6

Section 10 General Maintenance

Periodic Testing ………………………………………………………………………………………………….10-1

Inspection …………………………………………………………………………………………………..10-1

Cleaning ……………………………………………………………………………………………………..10-1

Cleaning the Recorder Printhead …………………………………………………………………..10-1

Semi-Automatic Defibrillator Testing………………………………………………………………………10-2

1. Power-Up Sequence Check ……………………………………………………………………..10-2

2. Defibrillator Test ………………………………………………………………………………………10-2

3. Recorder Check (if applicable) ………………………………………………………………….10-2

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Manual Defibrillator Testing ………………………………………………………………………………….10-2

1. Power-Up Sequence Check ………………………………………………………………………10-2

2. Delivered Energy and Shock Buttons ………………………………………………………….10-2

3. Energy Delivery Test (Paddles/MFE Pads) ………………………………………………….10-3

4. Pacer Operation (Pacer Version Only) ………………………………………………………..10-3

5. Recorder Check ……………………………………………………………………………………….10-3

Changing Paper………………………………………………………………………………………………….10-4

Setting Time and Date…………………………………………………………………………………………10-4

Manual Method ……………………………………………………………………………………………10-4

Automated Method ………………………………………………………………………………………10-4

Operator’s Shift Checklist for MSeries Products (Manual)……………………………………….10-6

Operator’s Shift Checklist for MSeries Products (Semi-Automatic) …………………………..10-7

Section 11 Battery Management

Battery Care……………………………………………………………………………………………………….11-1

Battery Life Expectancy ………………………………………………………………………………..11-1

Low Battery Message …………………………………………………………………………………..11-1

Changing the Battery Pack ……………………………………………………………………………11-1

Charging and Testing Battery Packs ………………………………………………………………11-2

Achieving Optimal Battery Pack Performance………………………………………………………… 11-2

Appendix A Specifications

General……………………………………………………………………………………………………………….A-1

Pacemaker (Pacer Version Only) ……………………………………………………………………………A-2

ECG Monitoring……………………………………………………………………………………………………A-3

CPR Monitoring ……………………………………………………………………………………………………A-3

Display………………………………………………………………………………………………………………..A-3

Recorder……………………………………………………………………………………………………………..A-4

PCMCIA Card………………………………………………………………………………………………………A-4

Battery Packs……………………………………………………………………………………………………….A-4

Guidance and Manufacturer’s Declaration — Electromagnetic Emissions…………………….A-5

Electromagnetic Immunity Declaration (EID)…………………………………………………………….A-6

EID for Life-Support Functions ……………………………………………………………………………….A-7

Recommended Separation Distances from RF Equipment for the MSeries Life

Functions…………………………………………………………………………………………………………..A-8

EID for Non–Life-Support Functions………………………………………………………………………..A-9

Recommended Separation Distances from RF Equipment for the MSeries

Non–Life

—Support Functions……………………………………………………………………………….A-10

—Support

Appendix B Troubleshooting Guides

General……………………………………………………………………………………………………………….B-1

Monitor …………………………………………………………………………………………………………B-1

Recorder ………………………………………………………………………………………………………B-3

Pacer (Pacer Version Only) ……………………………………………………………………………. B-4

Defibrillator ……………………………………………………………………………………………………B-5

AC Charger …………………………………………………………………………………………………..B-6

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Appendix C Medical Report Capability

PCMCIA Data Card……………………………………………………………………………………………….C-1

Installing the PCMCIA Data Card……………………………………………………………………………C-1

Erasing A Memory Card ………………………………………………………………………………………..C-1

Warning Messages……………………………………………………………………………………………….C-2

Transferring Data to a PC with a PCMCIA Data Card Reader……………………………………..C-2

Uploading Data to a PC via Serial Link…………………………………………………………………….C-2

Troubleshooting……………………………………………………………………………………………………C-3

Display Messages…………………………………………………………………………………………………C-4

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SECTION 1
GENERAL INFORMATION

NOTE: Y our M Series may or may not contain all the features listed in this manual,

depending on your particular configuration.

Product Description

The ZOLL® MSeries® products combine a defibrillator, ECG display, advanced monitoring capabilities, and
Noninvasive Transcutaneous Pacing (NTP) with communication, data printing and recording capabilities in a single
lightweight portable instrument. The unit has been designed for all resuscitation situations and its small, compact,
lightweight design makes it ideal for accompanying patients during transport. The product is powered by AC or DC
mains and an easily replaced battery pack that is quickly recharged in the device when it is connected to AC or DC
mains. In addition, the unit’s batteries may be recharged and tested using ZOLL PowerCharger systems designed for
standard interchangeable ZOLL battery packs.

The product is designed for use in both the hospital and the rugged EMS environment. All of its ruggedized features
add to its durability in hospital applications. The device is a versatile automated external defibrillator with or without
manual capabilities and may be configured to operate in manual, advisory or semi-automated modes. Semi-automated
versions of the device have a distinctive front panel with a single “ON” position. Conventional hospital style devices,
which can be configured for manual, advisory or semi-automated operation, have a standardized ZOLL operator
interface.
device’s charging and discharging is fully controlled by the operator. In advisory and semi-automatic modes, some
features of the device are automate d and a sophisticated detection algorithm is used to identify ventricular fibrillation
and determine the appropriateness of defibrillator shock delivery. Units may be configured to automatically charge,
analyze, recharge, and prompt the operator to “PRESS SHOCK,” depending on local protocols. The unit is switched
from the semi-automated mode to manual mode for ACLS use by pressing the appropriate soft key on the front panel.

The M Series assists caregivers during cardiopulminary resuscitation (CPR) by evaluating the rate and depth of chest
compressions, and providing feedback to the rescuer. Real CPR Help™ requires the use of CPR-D•padz and the
CPRD-to-MFC connector. Real CPR Help is available in the M Series unit with software ve rsion 38.90 or higher.

Information regarding the unit’s operation, patient ECG, and other physiological waveforms are displayed on a large

5.66 inch diagonal display which provides high contrast and visibility under virtually all lighting conditions. Operating
and warning messages are displayed on the monitor and the unit can also be configured with voice prompts to alert the
user to unit status. Self-diagnostic tests are performed when the instrument is turned on and the unit is periodically
tested during operation.

A sophisticated data collection system, an optional internal summary report feature with printer, and PCMCIA cards are
available for this unit. A PCMCIA card can be installed in the unit to record ECG and virtually all device data when the
device is turned on. In addition, voice data from any incident around this device can also be recorded. The data stored
on the PCMCIA card can be reviewed and archived on a properly equipped personal computer using ZOLL Data
Control™ software.

An annotating stripchart recorder can be included to provide immediate documentation as well as summary report
functions about patient care and treatment during use.

Some MSeries products are intended for use in the semiautomatic mode by first responders and emergency medical
technicians certified by an appropriate federal, state or local government authority. Some MSeries products are
intended for use in manual mode by personnel certified by appropriate federal, state or local authority to provide
advanced life support care.

When operating in the manual configuration the device operates as a conventional defibrillator where the

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M SERIES OPERATOR’S GUIDE

Some MSeries products are intended for use in the pre-hospital emergency medical care setting, indoors and
outdoors, including first response vehicles, fire vehicles, basic and advanced level ambulances as well as by both
Basic Life Support (BLS) and Advanced Cardiac Life Support (ACLS) staff in hospitals under protocol control.

How to Use This Manual

The MSeries Operator’s Guide provides information operators need for the safe and effective use and care of the
M Series products. It is important that all persons using this device read and understand all the informati on contained

within.
This manual is organized for manual mode operators, advisory mode operators and semiautomatic mode operators. If

you will only use the device in manual mode or advisory mode you do not need to read Section 5. If you will only use
the device in semi-automatic mode you do not need to read Sections 3, 4, or 6.

Please read thoroughly the safety considerations and warnings section.
Procedures for daily checkout and unit care are found in the Maintenance Section.
This manual is supplemented by manual inserts for options available on the MSeries. These inserts contain additional

warnings, precautions, and safety-related information.

Manual Updates

ZOLL Medical Corporation provides Manual Updates to inform customers of changes in device information and use.
The updates are mailed to each registered MSeries purchaser automatically. All users should carefully review each
manual update to understand its significance and then file it in its appropriate section within this manual for subsequent
reference.

Unpacking

Carefully inspect each container for damage. If the shipping container or cushion material is damaged, it should be
kept until the contents have been checked for completeness and the instrument has been checked for mechanical and
electrical integrity. If the contents are incomplete, if there is mechanical damage, or if the instrument does not pass its
electrical self-test, U.S.A. customers should call ZOLL Medical Corporation (1-800-348-9011). International customers
should contact the nearest ZOLL authorized representative. If the shipping container is damaged, also notify the
carrier.

Accessories

Note: The terms “ZOLL Multi-Function Electrode (MFE) Pads” and “MFE Pads” are used interchangeably throughout

this manual.

• Service Manual

• Internal Defibrillator Handles and Cable Assembly *

• Internal Defibrillator Electrodes: 3.0″ (7.6 cm), 2.7″ (6.8 cm), 2.0″ (5.1 cm), 1.6″ (4.0 cm), & 1.0″ (2.5 cm) diameter.*

• Adult, Multi-Function pacing/defibrillation electrode pads (12 pair/box)

• Pediatric, Multi-Function pacing/ defibrillation electrode pads (6 pair/box)

• Adult Multi-Function pacing/defibrillation stat•padz

• Multi-Function Cable assembly for use with Multi-Function pacing/defibrillation Electrode Pads*

• CPR-D•padz

•CPR stat•padz

• CPRD-to-MFC connector

• Base PowerCharger

• Base PowerCharger

• ECG Simulator

• Battery Management Program Manual

• Replacement battery packs*

• Smart Batteries

• AAMI Standard 3-lead ECG patient cable & 5-lead ECG patient cable

• IEC Standard 3-lead ECG patient cable & 5-lead ECG patient cable

• Carry Case

®

4×4
1×1

®

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* These accessories are considered safety-relevant components

Symbols Used on the Equipment

Any or all of the following symbols may be used in this manual or on this equipment:

Type B patient connection

Type BF patient connection

Type CF patient connection

Defibrillation protected Type BF patient connection

General Information

Defibrillation protected Type CF patient connection

Attention Refer to manual for more information

Fusible Link

Protective (earth) ground terminal

DANGER High Voltage present

Alternating current

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M SERIES OPERATOR’S GUIDE

Defibrillator Function

The MSeries products contain a DC defibrillator capable
of delivering up to 360 joules of energy. It may be used in
synchronized mode to perform synchronized
cardioversion by using the R-wave of the patient’s ECG
as a timing reference. The unit uses paddles or
disposable, pre-gelled, MFE Pads for defibrillation.

Intended Use — Manual Operation

Use of the MSeries products in the manual mode for
defibrillation is indicated on victims of cardiac arrest
where there is apparent la ck of circulation as indicated
by:

• Unconsciousness

• Absence of breathing

• Absence of pulse.

This product should be used only by qualified medical
personnel for converting ventricular fibrillation and rapid
ventricular tachycardia to sinus rhythm or other cardiac
rhythms capable of producing hemodynamically
significant heart beats.

Intended Use — Semiautomatic Operation (AED)

The MSeries products are designed for use by
emergency care personnel who have completed training
and certification requirements applicable to the use of a
defibrillator where the device operator controls delivery
of shocks to the patient.

They are specifically designed for use in early
defibrillation programs where the delivery of a
defibrillator shock during resuscitation involving CPR,
transportation, and definitive care are incorporated into a
medically-approved patient care protocol.

The MSeries products must be prescribed for use by a
physician or medical advisor of an emergency response
team.

Use of the device in the Semiautomatic mode for
defibrillation is indicated on victims of cardiac arrest
where there is apparent la ck of circulation as indicated
by:

• Unconsciousness

• Absence of breathing

• Absence of pulse.

Specifications for the ECG rhythm analysis function are
provided at the end of this section.

The CPR monitoring function is not intended for use on
patients under 8 years of age.

Semiautomatic Operation Contraindications for Use

The rhythm analysis function may not reliably identify
ventricular fibrillation in the presence of an implantable
pacemaker. Inspection of the electrocardiogram and
clinical evidence of cardiopulmonary arrest should be the
basis for any treatment of patients with implantable
pacemakers.

Do not use the rhythm analysis function during patient
movement on a stretcher or in an ambulance or other
conveyance. A patient must be motionless during ECG
analysis. Do not touch the patient during analysis. Cease
all movement via stretcher or vehicle prior to analyzing
the ECG. If using the device in an emergency vehicle,
bring the vehicle to a halt before activating the analysis
function.

Note: Do not use the unit’s AED function on patients

under 8 years of age.

Defibrillator Complications

Inappropriate defibrillation or cardioversion of a patient
(e.g., with no malignant arrhythmia) may precipitate
ventricular fibrillation, asystole, or other dangerous
arrhythmias.

Defibrillation without proper application of electrode pads
or paddle electrolyte gel may be ineffective and cause
burns, particularly when repeated shocks are necessary.
Erythema or hyperemia of the skin under the paddles or
MFE Pads often occurs; this effect is usually enhanced
along the perimeter of the paddle or electrode. This
reddening should substantially lessen within 72 hours.

Defibrillator Output Energy

The MSeries products may deliver up to 360 joules into
a 50 ohm impedance. The energy delivered through the
chest wall, however, is determined by the patient’s
transthoracic impedance. An adequate amount of
electrolyte gel must be applied to the paddles and a
force of 10-12 kilograms must be applied to each paddle
in order to minimize this impedance. If MFE Pads are
used, make sure that they are properly applied. (Refer to
the instructions on the Multi-Function Electrode
package).

Intended Use — CPR Monitoring

The CPR monitoring function provides visual and audio
feedback designed to encourage rescuers to perform
chest compressions at the AHA/ERC recommended rate
of 100 compressions per minute. Visual prompts
encourage a compression depth of 1.5 to 2 inches (3.8 to

5.0 cm) for adult patients.

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General Information

External Pacemaker (Pacer Version
Only)

Non-invasive Transcutaneous Pacing (NTP) is an
established and proven technique. This therapy is easily
and rapidly applied in both emergency and non­emergency situations when temporary cardiac
stimulation is indicated.

Some MSeries products may contain an optional
demand pacemaker consisting of a pulse generator and
ECG sensing circuitry. The output current of the
pacemaker is continuously variable from 0 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 MFE Pads placed on the back
and the precordium.

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

The unique design of the MSeries products allow clear
viewing and interpretation of the electrocardiogram
(ECG) on the display without offset or distortion during
external pacing.

Proper operation of the device, together with correct
electrode placement, is critical to obtaining optimal
results. Every operator must be thoroughly familiar with
these operating instructions.

Intended Use — Pacemaker

This product may be used for temporary external cardiac
pacing in conscious or unconscious patients as an
alternative to endocardial stimulation.

Note: This device must not be connected to internal

pacemaker electrodes.

The purposes of pacing include:

Resuscitation from standstill or bradycardia of any
etiology:

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

As a standby when standstill or bradycardia might be
expected:

Noninvasive pacing may be useful as a standby when
cardiac arrest or symptomatic bradycardia might be
expected due to acute myocardial infarction, drug
toxicity, anesthesia or surgery. It is also useful as a
temporary treatment in patients awaiting pacemaker
implants or the introduction of transvenous therapy. In
standby pacing applications, noninvasive pacing may
provide an alternative to transvenous therapy that avoids
the risks of displacement, infection, hemorrhage,
embolization, perforation, phlebitis and mechanical or
electrical stimulation of ventricular tachycardia or
fibrillation associated with endocardial pacing.

Suppression of tachycardia:

Increased heart rates in response to external pacing
often suppress ventricular ectopic activity and may
prevent tachycardia.

Pacemaker Complications

Ventricular fibrillation will not respond to pacing and
requires immediate defibrillation. The patient’s
dysrhythmia must therefore be determined immediately,
so that appropriate therapy can be employed. If the
patient is in ventricular fibrillation and defibrillation is
successful, but cardiac standstill (asystole) ensues, the
pacemaker should be used.

Ventricular or supraventricular tachycardias may be
interrupted with pacing but in an emergency or during
circulatory collapse, synchronized cardioversion is faster
and more certain. (See Synchronized Cardioversion
Section.)

Electromechanical dissociation may occur following
prolonged cardiac arrest or in other disease states with
myocardial depression. Pacing may then produce ECG
responses without effective mechanical contractions,
and other treatment is required.

Pacing may evoke undesirable repetitive responses,
tachycardia, or fibrillation in the presence of generalized
hypoxia, myocardial ischemia, cardiac drug toxicity,
electrolyte imbalance, or other cardiac diseases.

Pacing by any method tends to inhibit intrinsic
rhythmicity. Abrupt cessation of pacing, particularly at
rapid rates, can cause ventricular standstill and should
be avoided.

Noninvasive Temporary Pacing may cause discomfort of
varying intensity, which occasionally can be severe and
preclude its continued use in conscious patients.

Similarly, unavoidable skeletal muscle contr action may
be troublesome in very sick patients and may limit
continuous use to a few hours. Erythema or hyperemia
of the skin under the MFE Pads often occurs; this effect
is usually enhanced along the perimeter of the electrode.

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M SERIES OPERATOR’S GUIDE

This reddening should substantially lessen within 72
hours.

There have been reports of burns under the anterior
electrode when pacing adult patients with severely
restricted blood flow to the skin. Prolonged pacing
should be avoided in these cases and periodic
inspection of the skin is advised.

There are reports of transient inhibition of spontaneous
respiration in unconscious patients with previously
available units when the anterior electrode was placed
too low on the abdomen.

This device must not be connected to internal
pacemaker electrodes.

Pediatric Pacing

Pacing can be performed on pediatric patients weighing
33lbs / 15kg or less using special ZOLL pediatric MFE
Pads. Prolonged pacing (in excess of 30 minutes),
particularly in neonates, could cause burns. Periodic
inspection of the underlying skin is recommended.

Monitor

The patient’s ECG is monitored by connecting the patient
to the unit via the 3 or 5 lead patient ca ble, MFE Pads, or
through the paddles. Four seconds of ECG is presented
on the display along with the following information:

• averaged heart rate, derived from measuring R to R
intervals

• lead selections — I, II, III, aVR, aVL, aVF, V (with ECG
cable), PADDLES, or PADS

• ECG size — 0.5, 1, 1.5, 2, 3 cm/mV

• pacemaker output in millia mps (Pacer version only)

• pacemaker stimulus rate in pulses per minute (Pacer
versions only)

• defibrillator output in joules

• other operational prompts, messages, and diagnostic codes

Monitoring or diagnostic ECG bandwidth is selectable.

Recorder Function

A strip recorder is provided to document events. The
strip recorder normally operates in the delay mode (6
seconds) to insure capture of critical ECG information.
The recorder may be activated manually by pressing the
RECORDER button. It will be activated automatically
whenever a defibrillation SHOCK is delivered, a heart
rate alarm occurs, or the rhythm analysis function is
activated. The strip recorder may also be configured not
to print during these events.

Paddle — Electrode Options

The MSeries products will defibrillate, cardiovert and
monitor ECG using either defibrillation paddles or ZOLL
Multi-Function Electrode (MFE) Pads.

The pacer version of the MSeries will also pace using
ZOLL MFE Pads.

Energy Select, Charge, and Shock controls are located
on the paddles and front panel. When using MFE Pads,
the controls on the front panel of the unit must be used.
To switch between paddles and MFE Pads, remove
Multi-Function cable from the apex paddle and connect
the MFE pads to the Multi-Function cable.

The Advisory function cannot be activated unless MFE
Pads are attached to the Multi-Function Cable and used
as the ECG monitoring lead.

Note: The MFE Pads, Pediatric MFE Pads, stat•padz,

and ECG electrodes (not the ECG cable) are
disposable, single-use items.

Batteries

The MSeries products use easily replaced sealed, lead-
acid battery packs that, when new and fully charged, will
provide at least 2.5 hours of monitoring. Use of the
defibrillator, stripchart recorder, and pacemaker will
reduce this time.

When a “LOW BATTERY” message appears on the
display and the unit emits two beeps in conjunction with
the displayed message, the battery must be replaced
and recharged.

Internal Battery Charger

Battery charging can be performed within the devi ce via
AC mains, an optional DC input, or by using an external
battery charger.

When the MSeries products are plugged into AC mains
or to a DC power supply, the CHARGER ON indicators
will operate in the following manner:

The orange-yellow CHARGER ON indicator will
illuminate continuously whenever; the device is turned
OFF and charging the battery or turned ON with a
battery installed.

The green CHARGER ON indicator will illuminate
continuously whenever the unit is turned OFF and the
installed battery has been fully charged to present
capacity.

The green and orange-yellow Charger On indicators will
illuminate alternately when no
unit or a battery charging fault has been detected.

When the device is not connected to AC mains, the
CHARGER ON indicators will remain extinguished.

If your MSeries unit does not function as expected, see
the AC Charger Troubleshooting section on page B-7.

battery is installed in the

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External Battery Charger

External battery charging and capacity evaluation is
performed with the ZOLL Base PowerCharger

four battery packs can be charged simultaneously and
testing is automatic. See the appropriate ZOLL battery
charger Operator’s Guide and Battery Management
Program for more detailed information on the
specifications, use and management of ZOLL battery
packs.

4×4

. Up to

Diagnostics

A computer contained within the unit performs self­diagnostic tests whenever the product is initially turned
on and periodically during operation. During operation, a
“Function* FAULT XX” message will be displayed if a
fault is detected. If this occurs, turn the unit off and then
on and recheck operation. Contact authorized service
personnel if the message continues to be displayed.

* Function: may include Recorder, Pace, Defib, etc.

General Information

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M SERIES OPERATOR’S GUIDE

Safety Considerations

The MSeries products are high energy devices capable
of delivering up to 360 joules. To completely deactivate
the device, you must turn the SELECTOR SWITCH to
the OFF position.

In order to disarm a charged defibrillator:

• T urn the SELECTOR SWITCH to MONITOR, OFF or
PACER (pacer equipped versions only)

or

WARNINGS

General

• Federal (U.S.A.) law restricts this device to use by or on
the order of a physician.

• The use of external pacing/defibrillation electrodes or
adapter devices from sources other than ZOLL is not
recommended. ZOLL makes no representations or
warranties regarding the performance or effectiveness of
its products when used in conjunction with pacing/
defibrillation electrodes or adapter devices from other
sources. Device failures attributable to the use of pacing/
defibrillation electrodes or adapters not manufactured by
ZOLL may void ZOLL’s warranty.

• Proper operation of the unit, together with correct
electrode placement is critical to obtaining optimal
results. Operators must be thoroughly familiar with
proper device operation.

• Do not use the unit in semiautomatic mode during patient
movement. A patient must be motionless during ECG
analysis. Do not touch the patient during analysis. Cease
all movement via stretcher or vehicle before analyzing
the ECG. If using the device in an emergency vehicle,
bring the vehicle to a halt before using in semiautomatic
mode.

• Place the patient on a firm surface before performing
CPR.

• The device is protected against interference from radio
frequency emissions typical of two-way radios and
cellular phones (digital and analog) used in emergency
service/public safety activities. Users should assess the
device’s performance in their typical environment of use
for the possibility of radio frequency interference from
high-power sources. Radio Frequency Interference (RFI)
may be observed as shifts in monitor baseline, trace
compression, display brightness changes or transient
spikes on the display.

• MSeries units equipped with the Bluetooth® option
include an RF transmitter which transmits with 0dBm
power in the 2.4 GHz ISM band.

• Do not operate the unit without a battery. Keep a fully
charged spare battery pack with the device at all times.

• Change the selected defibrillator energy

As a safety feature, the device will automatically disarm if
left charged for more than 60 seconds (15 seconds for
AED versions).

Note: The terms “ZOLL Multi-Function Electrode (MFE)

Pads” and “MFE Pads” will be used
interchangeably throughout this manual.

• Regular use of partially charged battery packs without
fully recharging between uses will result in permanently
reduced capacity and early battery pack failure.

• Test batteries regularly. Batteries that do not pass ZOLL’s
capacity test could unexpectedly shutdown without
warning.

• Replace the battery with a fully charged battery
immediately after the “LOW BATTERY” or “REPLACE
BATTERY” message.

• Emergency defibrillation should be attempted only by
appropriately trained, skilled personnel who are familiar
with equipment operation. Training appropriateness, such
as Advanced Cardiac Life Support (ACLS) or Basic Life
Support (BLS) certification, should be determined by the
prescribing physician.

• Synchronized cardioversion should only be attempted by
skilled personnel trained in Advanced Cardiac Life
Support (ACLS) and familiar with equipment operation.
The precise cardiac arrhythmia must be determined
before attempting defibrillation.

• Prior to attempting synchronized cardioversion, ensure
that the ECG signal quality is good and that sync marks
are displayed above each QRS complex.

• These operating instructions describe the functions and
proper operation of the MSeries products. They are not
intended as a substitute for a formal training course.
Operators should obtain formal training from an
appropriate authority prior to using the device for patient
care.

• Do not disassemble the unit. A shock hazard exists. Refer
all problems to authorized service personnel.

• Follow all recommended maintenance instructions. If a
problem occurs, obtain service immediately. Do not use
the device until it has been inspected by the appropriate
personnel.

• Do not use the unit’s ECG out signal as a sync pulse for
another defibrillator or cardioverter.

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WARNINGS (Continued)

• The ECG out signal is delayed by up to 25 ms. This delay
must be considered when the ECG out signal is used as an
input to other devices requiring R-wave synchronization.

• The MSeries device may not perform to specifications
when stored at the upper or lower extreme limits of
storage temperature and immediately put into use.

• Avoid using the MSeries adjacent to, or stacked on other
equipment. If unavoidable, verify that the MSeries
operates normally in this configuration before clinical
use.

• The MSeries should be installed and put into service
according to the Electromagnetic Compatibility (EMC)
information in Appendix A of this manual.

• The use of accessories, transducers, and cables other than
those specified in this manual and related MSeries
option manual inserts may result in increased emissions
or decreased immunity of the MSeries.

Operator Safety

• Do not use MSeries products in the presence of oxygen-
rich atmospheres, flammable anesthetics or other
flammable agents (such as gasoline). Using the
instrument near the site of a gasoline spill may cause an
explosion.

• Do not use the instrument near or within puddles of
water. Electrical safety of the device may be
compromised when wet.

• Do not discharge with paddles or MFE Pads shorted
together or in open air.

• Warn all persons in attendance of the patient to STAND
CLEAR prior to defibrillator discharge.

• Do not touch the bed, patient, or any equipment
connected to the patient during defibrillation. A severe
shock can result. Do not allow exposed portions of the
patient’s body to come in contact with metal objects, such
as a bed frame, as unwanted pathways for defibrillation
current may result.

• For defibrillation using paddles, utilize only high
conductivity electrolyte gel specified by the manufacturer
for such use.

• To avoid risk of electrical shock, do not allow electrolyte
gel to accumulate on hands or paddle handles.

• To avoid risk of electrical shock, do not touch the gelled
area of the MFE Pads while pacing.

• When defibrillating with paddles use your thumbs to
operate the SHOCK buttons in order to avoid inadvertent
operator shock. No portion of the hand should be near the
paddle plates.

• Only use thumbs to depress the paddle SHOCK buttons.
Failure to do so could result in the inadvertent depression
of the energy select buttons, causing the defibrillator to
disarm itself.

• Do not discharge the defibrillator except as indicated in
the instructions. Do not discharge the defibrillator if the
MFE Pads are not properly attached to the patient.

General Information

• Always check that the equipment functions properly and
is in proper condition before use.

• Disconnect all electro-medical equipment that is not
defibrillation protected from the patient prior to
defibrillation.

• The use of ACCESSORY equipment not complying with
the equivalent safety requirements of this equipment may
lead to a reduced level of safety of the resulting system.
Consideration relating to the choice shall include:

•

Use of the accessory in the PATIENT VICINITY

• Evidence that the safety certification of the

ACCESSORY has been performed in accordance with
the appropriate IEC (EN) 60601-1 and/or
IEC (EN) 60601-1-1 harmonized national standards.

Patient Safety

• Neonatal and pediatric defibrillation energy levels should
be set based on site-specific clinical protocols.

• Do not use the unit’s AED function on patients under
8 years of age. *

• The device detects ECG electrical signals only. It will not
detect a pulse (i.e. effective circulatory perfusion).
Always verify pulse and heart rate by physical
assessment of the patient. Never assume that a non-zero
heart rate display means that the patient has a pulse.

• Implanted pacemakers may cause the heart rate meter to
count the pacemaker rate during incidents of cardiac
arrest or other arrhythmias. Pacemaker patients should be
carefully observed. Check the patient’s pulse; do not rely
solely on heart rate meters. Dedicated pacemaker
detection circuitry may not detect all implanted
pacemaker spikes. Patient history and physical exam are
important in determining the presence of an implanted
pacemaker.

• Use only high quality ECG electrodes. ECG electrodes
are for rhythm acquisition only. Do not attempt to
defibrillate or pace through ECG electrodes.

• The ECG rhythm analysis function does not warn the
operator of patient asystole, as it is not a shockable
rhythm.

• Do not use ECG electrodes or MFE Pads if the gel is
dried, separated, torn, or split from the foil; patient burns
may result from using such electrodes. Poor adherence
and/or air under the MFE Pads can lead to the possibility
of arcing and skin burns.

• Excessive body hair or wet, sweaty skin can inhibit good
coupling (contact), which can lead to the possibility of
arcing and skin burns. Clip excess hair and dry
surrounding moisture from the area where the electrode is
to be attached.

• MFE Pads should be replaced after 8 hours of continuous
pacing (2 hours for Radiolucent stat•padz) to ensure
maximum patient benefit).

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M SERIES OPERATOR’S GUIDE

WARNINGS (Continued)

• To avoid electrosurgery burns at monitoring sites, ensure
proper connection of the electrosurgery return circuit so
that the return paths cannot be made through monitoring
electrodes or probes.

• Prolonged pacing (in excess of 30 minutes), particularly
in neonates or adults with severely restricted blood flow,
may cause burns. Periodic inspection of the underlying
skin is recommended.

* AHA Guidelines 2000 for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care, I-64, 2000.

CAUTIONS

• Do not install the battery into the de vice when storage may exceed 90 days. Battery damage may occur.

• The “LOW BATTERY” message display-to-shutdown interval may be less than one minute when older
batteries become depleted.

• The M Series ships standard with a PD 4410 battery, but can optionally use the XL battery if properly
configured. Incorrectly configuring the unit for XL battery operation when the PD 4410 is installed will
substantially reduce the number of defibrillation shocks that can be delivered between the onset of the
“LOW BATTERY” warning message and M Series shutdown. (See the MSeries Configuration Guide,
P/N 9650-0201-01, for complete details on properly configuring the selected battery type.)

• Do not sterilize the device.

• Do not sterilize the CPRD-to-MFC connector.

• Do not immerse any part of the device in water.

• Do not use alcohol or ketones (MEK, acetone, etc.) on the device.

• Avoid using abrasives (e.g. paper towels) on the display window.

• Grounding reliability can only be achieved when the equipment is connected to an equivalent receptacle
marked “HOSPIT AL ONLY” or “HOSPITAL GRADE”. If the grounding integrity of the lin e cord or AC
receptacle is in doubt, operate on battery only.

• Use only ECG cables (namely, ones with internal current-limiting resistors) specified or supplied by
ZOLL Medical Corporation to protect the M Series from damage during defibrillation, for accurate ECG
information, and for protection against noise and other interference.

• Check leakage levels prio r to use . Le aka g e current may
be excessive if more than one monitor or other piece of
equipment is connected to the patient.

Restarting the Device

Certain events require the MSeries products to be restarted after they shut off or become inoperative.
One example is when the battery runs down and the unit shuts off. The selector switch should always be turned to the

OFF position before removing the battery. The selector switch may then be turned to the desired operating mode to
resume operation after insertion of a new battery. This sequence is needed to restart the device, and can also be used
to clear some “X FAULT XX” messages, if immediate use of the device is required.

Note that some settings (for example, alarm settings, lead selection, ECG size) may need to be restored from their
default values when operation is resumed.

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General Information

FDA Regulations

Tracking Requirements

U.S. Federal Law (21 CFR 821) requires the tracking of
defibrillators. As an owner of this device, you have the
responsibility under this law to notify ZOLL Medical
Corporation if this product has been received; lost, stolen
or destroyed; or has been donated, resold, or otherwise
distributed to a different organization.

If any of the events described above occur, please
contact ZOLL Medical Corporation in writing with the
following information:

1. Originator’s organization — Company Name,
Address, Contact Name, and Contact Phone Number

2. Part Number/Model Number and Serial Number

3. Disposition of Device (e.g., received, lost, stolen,
destroyed, distributed to another organization), New
Location and/or Organization (if different from #1
above) — Company Name, Address, Contact Name,
and Contact Phone Number

4. Date change took effect

5. Other information or comments
Please address your information to:

ZOLL Medical Corporation
Attn: Tracking Coordinator
269 Mill Road
Chelmsford, MA 01824-4105

Fax: (978) 421-0010
Tel: (978) 421-9655

Notification of Adverse Events

As a health care provider, you may have responsibilities
under the SMDA, for reporting to ZOLL and possibly to
the FDA the occurrence of certain events.

These events, described in 21 CFR Part 803, include
device-related death and serious injury or illness. In any
event, as part of our Quality Assurance Program, ZOLL
should be notified of any device failures or malfunctions.
This information is required to assure th at ZOLL provides
only the highest quality products.

Warranty (U.S. Only)

(a) ZOLL Medical Corporation warrants to the original
equipment purchaser that beginning on the date of
installation, or thirty (30) days after the date of shipment
from ZOLL Medical Corporation’s facility, whichever first
occurs, the equipment (other than accessories and
electrodes) will be free from defects in material and
workmanship under normal use and service for the
period of one (1) year. During such period ZOLL Medical
Corporation will, at no charge to the customer, either
repair or replace (at ZOLL Medical Corporation’s sole
option) any part of the equipment found by ZOLL Medical
Corporation to be defective in material or workmanship.
If ZOLL Medical Corporation’s inspection detects no
defects in material or workmanship, ZOLL Medical
Corporation’s regular service charges shall apply. (b)
ZOLL Medical Corporation shall not be responsible for
any equipment defect, the failure of the equipment to
perform any function, or any other nonconformance of
the equipment, caused by or attributable to: (i) any
modification of the equipment by the customer, unless
such modification is made with the prior written approval
of ZOLL Medical Corporation; (ii) the use of the
equipment with any associated or complementary
equipment, (iii) installation or wiring of the equipment
other than in accordance with ZOLL Medical
Corporation’s instructions. (c) This warranty does not
cover items subject to normal wear and burnout during
use, including but not limited to lamps, fuses, batteries,
patient cables and accessories. (d) The foregoing
warranty constitutes the exclusive remedy of the
customer and the exclusive liability of ZOLL Medical
Corporation for any breach of any warranty related to the
equipment supplied hereunder. (e) Limitation of Liability:
ZOLL shall not in any event be liable to Purchaser, nor
shall Purchaser recover, for special, incidental or
consequential damages resulting from any breach of
warranty, failure of essential purpose, or under any other
legal theory including but not limited to lost profits, lost
savings, downtime, goodwill, damage to or replacement
of equipment and property, even if ZOLL has been
advised of the possibility of such damages.

THE WARRANTY SET FORTH HEREIN IS EXCLUSIVE
AND ZOLL MEDICAL CORPORATION EXPRESSLY
DISCLAIMS ALL OTHER WARRANTIES WHETHER
WRITTEN, ORAL, IMPLIED, OR STATUTORY,
INCLUDING BUT NOT LIMITED TO ANY
WARRANTIES OF MERCHANTABILITY OR FITNESS
FOR A PARTICULAR PURPOSE.

For additional information, please call ZOLL Medical
Corporation at 1-800-348-9011. International customers
should call the nearest authorized ZOLL Medical
Corporation service center.

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M SERIES OPERATOR’S GUIDE

Software License

Note: Read this Operator’s Manual and License

agreement carefully before operating any of the
MSeries products.

Software incorporated into the system is protected by
copyright laws and international copyright treaties as
well as other intellectual property laws and treaties. This
software is licensed, not sold. By taking delivery of and
using this system, the Purchaser signifies agreement to
and acceptance of the following terms and conditions:

1. Grant of License: In consideration of payment of the
software license fee which is part of the price paid for
this product ZOLL Medical Corporation grants the
Purchaser a non-exclusive license, without right to
sublicense, to use the system software in object-code
form only.

2. Ownership of Software/Firmware: Title to,
ownership of and all rights and interests in the
system software and all copies thereof remain at all
times vested in the manufacturer, and Licensors to
ZOLL Medical Corporation and they do not pass to
Purchaser.

3. Assignment: Purchaser agrees not to assign, sub­license or otherwise transfer or share its rights under
the license without the express written permission of
ZOLL Medical Corporation.

4. Use Restrictions: As the Purchaser, you may
physically transfer the products from one location to
another provided that the software/firmware is not
copied. You may not disclose, publish, translate,
release or distribute copies of the software/firmware
to others. You may not modify, adapt, translate,
reverse engineer, decompile, crosscompile,
disassemble or create derivative works based on the
software/firmware.

Service

The device does not require periodic recalibration or
adjustment. Appropriately trained and qualified
personnel should, however, perform periodic tests of the
device to verify proper operation. (See General
Maintenance Section).

U.S.A. Customers

Should the unit require service, it should be returned, in
its original container, to:

ZOLL Medical Corporation
269 Mill Road
Chelmsford, Massachusetts 01824-4105,
Attn: Technical Service Department

Loaner instruments are available for use while repairs
are being completed. T o request loan equipment, contact
the ZOLL Technical Service Department at
1-800-348-9011. Have the following information
available to expedite service:

• The device’s serial number

• A description of the problem

• Department where equipm ent is in use

• Sample ECG strips documenting problem (if available)

• A Purchase Order to allow tracking of loan equipment

International Customers

Should the unit require service, return it, in its original
container, to the nearest authorized ZOLL Medical
Corporation service center.

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General Information

Defibrillator Waveform Information

General

The following defibrillation waveforms are produced when the device is discharged into 25, 50 and 100 ohm loads at
maximum energy. Each major vertical division equals 1000 volts; each major horizontal division equals 2 milliseconds.

Discharge into a 25 ohm load

Discharge into a 50 ohm load

Discharge into a 100 ohm load

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M SERIES OPERATOR’S GUIDE

ECG Analysis Algorithm Accuracy

Sensitivity, specificity, false positive rate and positive predictivity are expressions of the accuracy of an ECG analysis
system when compared with clinicians or experts. The specifics of computations are detailed below. The
accompanying data details the accuracy of the algorithm as tested by independent investigators.

The Algorithm:

• Divides the ECG rhythm into three 3-second segments.

• Filters and measures noise, artifact, and baseline wander.

• Measures baseline content (‘waviness’ at the correct frequencies- frequency domain analysis) of signal.

• Measures QRS rate, width, and variability.

• Measures amplitude and temporal regularity (‘auto-correlation’) of peaks and troughs.

• Determines if two-out of-three, 3 second segments are shockable then displays “SHOCK ADVISED” message.

The Algorithm sequence takes approximately 9 seconds.

Clinical Performance Results

Applications: # of analyses # of patients

316 194

Shockable Rhythm

Overall Sensitivity 95.7%
Positive Predictability100.0%

Non-shockable Rhythm

Overall Sensitivity 100%
False Positive Rate 0%

Sensitivity = # of “correct shock” decisions by algorithm

Total # of rhythms for which a shock is clinically advised

Specificity = # of “correct no shock” decisions by algorithm

Total # of rhythms for which no shock is clinically advised

False Positive Rate = # of “incorrect shock” decisions by algorithm

Total # of rhythms for which no shock is clinically advised

Positive Predictivity = # of “correct shock” decisions by algorithm

Total # of rhythms for which shock is advised by unit

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SECTION 2

OPERATING CONTROLS AND INDICATORS

10

789

m

CO2 Hg

ECG

CO2

Param Wave 2 Alarms

Sp02 % ECG

31 x1.5 72

m

RR

17 PADS100

CHARGER ON

LEAD SIZE HR

SUMMARYSUMMARY

RELEASE

CODE

MARKER

SIZE

ALARM

SUSPEND

RECORDER

PACER
OUTPUT
mA

MONITOR

OFF

PACER

CHARGE

ENERGY
SELECT

4:1

1

DEFIB

ANALYZELEAD

2

SHOCK

3

PACER

RATE

ppm

23

3

5

4

2

1

22

21

20

19

11

16151413 612

1. SELECTOR SWITCH

The selector switch allows selection of the following
modes: OFF, MONITOR, DEFIB, and PACER, (Pacer
version only)

2. DEFIB ENERGY SELECT BUTTONS

Two sets of up-down arrow buttons control the
defibrillator energy level, one set located on the front
panel and the other located on the sternum paddle.

Press and hold the appropriate up (▲)or down (▼) arrow
button until the desired energy level is indicated on the
display.

3. DEFIB CHARGE

Pressing the CHARGE button on the front panel or, if
using paddles, on the apex paddle handle, charges the
defibrillator to the selected energy level.

17 18

4. SHOCK

The SHOCK button illuminates when the defibrillator is
charged and ready. Press and hold the button to
discharge the defibrillator.

The SHOCK button is only active when using
Multi-Function Electrodes (MFE) Pads, external
autoclavable paddles, or internal defibrillation paddles
without a discharge button. The SHOCK button is not
functional when external paddles are connected to the
unit.

Each external paddle has a SHOCK button located near
the forward end of the handle. Press and hold both
buttons simultaneously to discharge the defibrillator.

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M SERIES OPERATOR’S GUIDE

5. ANALYZE

The ANALYZE button initiates ECG analysis to identify
shockable rhythms.

6. SOFTKEYS

Five unlabeled buttons located directly beneath the
display control different functions depending on the
operating mode of the unit. Labels for the softkeys
appear at the bottom of the display directly above each
softkey to indicate its function.

7. LEAD

The LEAD button determines selection of the ECG
source. Pressing this button sequentially selects ECG
signals derived from each of the following lead
configurations — «I», «II», «III», “aVR, aVF, aVL, PADDLES»
(defibrillator paddles), or «PADS» (Multi-Function
Electrode (MFE) Pads) for display. The “PADS” or
“PADDLES” Lead setting is automatically selected when
the instrument powers up in DEFIB or MONITOR mode
and MFE Pads or Paddles are connected to the
Multi-Function cable.

Lead II is automatically selected when the MSeries unit
powers up in PACER mode (Pacer version only). Pads
or Paddles monitoring is not available in PACER mode.

8. SIZE

The SIZE button allows you to change the display size of
the ECG signal. Size options are 0.5, 1, 1.5, 2, 3 cm/mV
and are indicated in the upper right center of the display.

9. ALARM SUSPEND

The ALARM SUSPEND button is used to activate,
deactivate and audibly suspend all alarm functions. A

bell symbol (
when the alarms are enabled. When the alarms are

either audibly or permanently disabled, an “X” crosses
through the bell ( ) symbol.

When the alarms are enabled, and an alarm condition
occurs, an audible tone sounds and the bell symbol
flashes. To avoid possible confusion with the defibrillator
charged tone, the heart rate alarm tone sounds at a
different frequency when the Selector Switch is set to
DEFIB.

) appears in the top-center of the display

10. RECORDER

This control starts and stops the strip recorder. There is a
RECORDER button located on the unit’s front panel and
another located on the sternum paddle.

The unit can be switched to diagnostic ECG bandwidth
(0.05-150 Hz) by pressing and holding the RECORDER
button.

Diagnostic bandwidth is maintained as long as the
RECORDER button is held down. The unit reverts to

standard monitoring bandwidth when the RECORDER
button is released.

11. BEEPER VOLUME (ECG)

This button allows for manual adjustment of the QRS
beeper tone from maximum volume to inaudible. (The
heart rate alarm and charge ready volumes are not
adjustable.) Press this button to display a menu for
adjusting the volume using softkeys.

12. BRIGHTNESS/CONTRAST ADJUSTMENT

This button causes a menu to appear on the display for
adjusting the display brightness using softkeys (contrast
on LCD).

13. CHARGER ON

When the MSeries products are plugged into AC mains,
the CHARGER ON indicators will operate in the
following manner:

The orange-yellow CHARGER ON indicator will
illuminate continuously whenever; the device is turned
OFF and charging the battery or turned ON with a
battery installed.

The green CHARGER ON indicator will illuminate
continuously whenever; the unit is turned OFF and the
installed battery has been fully charged to present
capacity.

The green and orange-yellow CHARGER ON indicators
will illuminate alternately when; no
the unit or a battery charging fault has been detected.

When the device is not connected to AC mains, the
CHARGER ON indicators will remain extinguished.

battery is installed in

14. Paper Tray

Holds the paper supply for the recorder. Press down and
pull to open the drawer and replace the paper.

15. SUMMARY

The SUMMARY button retrieves stored patient
information and prints it on the unit recorder as a
Summary Report. The Summary Report function
automatically collects critical patient ECG data, control
settings, date, time and therapies administered during
certain events.

See the “Summary Report” section for more information.

16. CODE MARKER

The CODE MARKER button activates a menu and
softkeys that allow the unit to record in its internal
memory the delivery of specific drugs or treatments.

See the “Code Markers” section for more information.

17. PCMCIA Data Card Slot

Holds the PCMCIA flash memory card for data storage
and retrieval.

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18. PC Card Modem Slot (12-Lead Option Only)

Holds the modem card for transmitting 12-Lead ECG
information to remote locations via landline or cellular
phone. See the 12-Lead ECG Monitoring insert (part
number 9650-0215-01) for more information.

Note: The modem slot is covered by a plastic bezel.

19. PACER OUTPUT mA (Pacer Version Only)

When pacing is selected, this control sets the amount of
current delivered to the MFE Pads. For conscious
patients, it should be gradually increased until capture is
recognized. The selected current setting is indicated on
the display.

Operating Controls and Indicators

20. 4:1 BUTTON (Pacer Version Only)

This control is used to test for threshold or to determine
the patient’s underlying rhythm. When depressed this
button causes pacing stimuli to be delivered at ¼ the
indicated ppm setting. Releasing the control causes the
instrument to resume normal pacing operation.

21. PACER RATE ppm (Pacer Version Only)

When pacing is selected, this control sets the rate at
which the pacemaker will operate. It must be set above
the patient’s intrinsic rate in order for the pacemaker to
provide stimulation. The selected pace rate setting is
indicated on the display.

22. Systole and Alarm Speaker

Emits audible heart rate tone during ECG monitoring,
and audible alarm indications when an alarmed condition
occurs.

23. Microphone (Optional)

Records audio activity in the vicinity of the MSeries unit
for storage in non-volatile memory and on the PCMCIA
data card.

CHARGE INDICATOR LIGHT (Not Shown)

Located on the apex paddle, this light turns on when the
defibrillator is charged and ready.

DEFIBRILLATOR TEST PORT (Not Shown)

Located on the Multi-Function Cable, the test connector
is used to test the defibrillator output using the Multi­Function Cable only.

PEDIATRIC PADDLES (Not Shown)

Pediatric-size electrodes are built into the paddle
assembly. They lie directly under the adult electrode
surface and are accessed by pushing the black PEDI
button at the front of each paddle and sliding the adult
surface forward. When replacing the adult electrodes, it
is important that the electrode is locked correctly in
position on the paddle handle.

VOLT ECG OUT (Not Shown)

A 1 volt/cm of displayed ECG signal output is available
from a subminiature phone jack located on the back of
the device. This output may be used for interconnections
to patient monitors and radio-telemetry equipment. The
tip carries the ECG signal and the sleeve is ground.

Code Markers

Pressing the CODE MARKER button causes the unit to
display a preconfigured list of clinical actions. Pressing
the softkey associated with a particular action causes
that action to be recorded along with a date and time
stamp in the Summary Report Memory.

CPR EPI DOPA MORE

Up to five Code Markers can be displayed on the screen
at one

time. The right-most softkey is labeled “MORE”

when there are more than five items on the Code Marker
list. Pressing the MORE softkey will cause the next set of
Code Markers to be displayed above the softkeys.
Separate Code Marker lists are maintained for PACER,
MONITOR, and DEFIB modes thereby enabling the
appropriate Code Markers to be displayed for the
particular protocol (e.g. PACE: EPI, Atrop MONITOR:
Valium, LIDO DEFIB: BRET, AMIO).

The Code Markers are removed from the display after 10
seconds. If no Code Marker softkey has been pressed in
that time, a generic event MARK is stored in Summary
Report memory.

Atrop

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M SERIES OPERATOR’S GUIDE

Summary Report

Summary Report allows you to store and later retrieve important ECG and device event information. The unit’s internal
memory automatically records defibrillation and cardioversion segments, PACER mode (Pacer version only), heart
rate alarm and ECG segments upon activation of the stripchart recorder. Associated event information including device
control settings, patient ECG, time and date are recorded as well.

Note: Dia gnostic bandwidth recordings are not included in Summary Report.
Six events will trigger Summary Report to automatically record information:

• VF Alarm triggered

• Defibrillator Shock

• Selecting PACER mode (Pacer version only)

• Heart Rate Alarm triggered

• Turning Strip Recorder on (or on and then off in rapid sequence)

• Initiating analysis of the ECG

Summary Report records each event in chronological order and will store up to 65 defibrillation or 140 recorder­activated ECG events. All event data will remain in memory and be accessible until data is manually erased. A new
patient record is automatically created if the unit has been turned off for a user configurable time period of 5 minutes to
36 hours. If all memory has been used for a particular patient, a “REPORT FULL” message will appear on the display
and no further data is recorded.

Summary Report Formats

Summary Report prints an overview of all the events currently stored in memory including total number of defibrillation
shocks delivered, total pacing time (cumulative), time and date the device was turned on (or if you have just manually
erased summary reports, then start time and date of the next report), time of last event, as well as space for patient
name, date and comments. All segments have vertical dashed cut lines every 8.5 inches to facilitate easy mounting on

8.5″ x 11″ p aper. On the last event recorded “SUMMARY COMPLETE” will be printed at the bottom left of the recorder

strip.

NAME

SUMMARY REPORT

DATE I I
REPORT START

LAST EVENT TIME

TO TAL S HOC KS 1

PAC ER T OTA L TIM E 00:01 :21

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COMMENTS

Defibrillation Format

Summary Report records 6 seconds of pre-shock and 8 seconds of post-shock patient ECG data. Also recorded are
joules selected, joules delivered, sync if active, (includes sync markers), ECG lead, ECG size, patient impedance, time
and date. AED units will additionally include shock count and AED mode annotations.

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Operating Controls and Indicators

Pacer Format (Pacer version only)

Summary Report records 6 seconds of pre-pacer patient ECG data. Also recorded are the ECG lead, ECG size,
patient’s heart rate, time and date.

After establishing a paced rhythm, turning the recorder on briefly will record the paced rhythm for later reports. If async
pace is active, the annotation “ASYNC PACE” is also recorded.

Heart Rate Alarm Activated Format

Summary Report records 6 seconds of pre-alarm patient ECG. Also recorded are the ECG lead, ECG size, patient’s
heart rate, time, and date. If the pacer is on during this event the pacing rate and pacing current are also recorded.

VF Alarm Activated (Refer to Section

The summary report records 15 seconds of patient ECG data associated with each “VF” alarm. Also recorded are the
shock count, ECG lead, ECG size, patient’s heart rate, and noise events.

Recorder On Format

Summary Report records 6 seconds of patient ECG prior to turning on the recorder. Also recorded are the ECG lead,
ECG size, patient’s heart rate, time, and date. If the Pacer is on during this event the pacing rate and pacing current
are also recorded. If async pace is active, the annotation “ASYNC PACE” is recorded. AED units will additionally
include shock count and AED mode annotations.

NAME

SUMMARY COMPLETE

DEFIB ADVISORY

15:19:50 10 FEB 98

CHECK PATIENT

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M SERIES OPERATOR’S GUIDE

Analyze Format

The summary report records 6 seconds of pre analysis ECG and 9 seconds of ECG recorded during the ECG analysis
interval with the annotation “SHOCK ADVISED” or “NO SHOCK ADVISED”. AED units will additionally include shock
count and AED mode annotations.

Manual Mode Activated

AED versions of the MSeries that are equipped with manual mode capabilities will record a “MANUAL MODE
ST ARTED” event within Summary Report whenever the device is switched from the AED (Default) mode to the Manual
operating mode.

The following annotations may also be printed at the top of the Analyze Format printout:

Annotation Description

1. POOR PAD CONTACT: The MFE Pads are detected as having poor connection.

2. ANALYSIS HALTED: The ECG analysis is halted due to either the ANALYZE button being pushed or a fault

condition.

3. NOISY ECG: Excessive noise is detected.

4. SHOCK ADVISED: Shockable rhythm has been detected at the end of user-initiated ECG analysis.

5. NO SHOCK ADVISED No shockable rhythm has been detected at the end of user-initiated ECG analysis.

6. ECG TOO LARGE The amplitude of the ECG signal is too large for proper rhythm analysis.

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Operating Controls and Indicators

Printing a Report

To print the stored information, press the SUMMARY
button below the screen display. Then press the
corresponding softkey to print configuration settings,
print chart, or print log.

The recorder will print all events currently in memory in
chronological order. If the stripchart recorder is on or the
defibrillator is charged, summary report printing is
disabled. To stop printing a report, press the
RECORDER button or turn the unit off. An unlimited
number of copies of the report may be printed by simply
pressing the SUMMARY button and corresponding print
softkey again.

Pressing the RECORDER button while printing a
Summary Report will cause the unit to stop printing the
report. Press the RECORDER button again to begin
printing an ECG trace. The stripchart recorder will run
continuously until the button is pressed again.

Pressing the SUMMARY button and a corresponding
print softkey while printing a report will cause the current
report to stop printing and a new report to begin printing.

Printing is interrupted if a vital sign alarm occurs (i.e. HR,
SpO

, etc.), the ANAL YZE button is pressed, or the

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defibrillator is charged.

If the recorder is out of paper when the SUMMARY
button and a corresponding print softkey are pressed, a
“CHECK RECORDER” message will appear on the
display. Load paper and press SUMMARY again to
select the report to print.

Printing Part of a Report

If you want to print out only a portion of the Summary
Report:

1. Press the SUMMARY button.

2. Press the Print Chart softkey.

3. Press the Print Range softkey.

4. Press Prev. Event or Next Event softkey to scroll
through the events.

5. Press Print softkey.

The MSeries unit prints the displayed event and all
following events.

Adding Patient Name and ID# to a
Report

To add patient name and identification number to the
summary report:

1. Press ID # softkey.

2. Press Prev . Digit or Next Digit softkey to select letter
for patient name.

3. Press Inc Digit or Dec. Digit softkey to change value
of letter.

Repeat steps 2 and 3 until you have entered the patient’s
entire name.

4. Press Enter Name softkey.

5. Press Prev. Digit or Next Digit softkey to select digit
or letter for identification number.

6. Press Inc Digit or Dec. Digit softkey to change value
of digit.

Repeat steps 5 and 6 until you have entered the patient’s
entire identification number.

7. Press Enter ID and Return softkey.

Note: Patient name cann ot be retrosp ectively added to

summary report events already stored in memory .
The patient name is only stored with summary
events saved after the patient name has been
entered.

Printing an Incident Log

An incident log is an abbreviated list of all major events
recorded in the summary report. You can print out an
incident log that includes the time of occurrence of the
following events:

• MSeries unit powered on.

• Defibrillation advisory messages (for example, CHECK

PATIENT and SHOCK ADVISED).

• Defibrillation shocks (including energy level).

• Pacer mode activated.

• Manual mode started (AED only).

• Alarms triggered.

• Code markers.

• 12 Lead analysis initiated.

• 12 Lead data transmission.

• Recorder turned on.

• NIBP measurements activated.

In addition, the incident log lists the following:

• Report start time (time when summary report memory wa s

erased).

• Last event time (time of last event in memory).

• Total number of shocks.

• Total pacer time.

• System serial number .

• Device identification number.

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