Marquette Hellige Responder 3000 User Manual

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Operator's Manual

Version 2

227 490 02 GA (e) Revision C

Contents

1 Intended Use and Functional Description 5 2 Controls and Indicators 6 3 Putting the Device into Operation and Perf ormance Check 9 4 Manual Defibrillation 18

4.1 Defibrillator Application Guidelines 18

4.2 Non-Synchronized Defibrillation 19

4.3 Synchronized Defibrillation (Cardioversion) 26

5 Semiautomatic Defibrillation 30 6 Pacemaker 36 7 Displaying and Monitoring the ECG 41 8 12-Lead ECG Analy sis Program (12SL TM)46 9 Pulse Oximetry (SpO2)49 10 Capnometry (etCO2)54 11 Memories of the Marquette Responder® 3000 58 12 Recording 61 13 Defibrillator Setup 63 14 Battery Power Operation 67 15 Test Discharge 70 16 Operation in the Vehicle Mounting Unit,

Mounting the AC Power Adapter 73 17 Error and System Messages 74 18 Cleaning, Maintenance 75 19 Technical Specifications 78 20 Order Information 84 Appendix

The Arrhythmia Detection Program 87

EC Declaration of Conformity 88

Index 89

Revision History

This manual is subject to the Marquette Hellige change order service. The revision code, a letter that follows the document part number, changes with every update of the manual.

P/N / Index Date Comment

227 490 02-A January 1999 Initial Release 227 490 02-B October 1999 Version 2 227 490 02-C January 2000 ECO 064 064

227 490 02-C Marquette Responder® 3000 3

General Information

The product Marquette Responder® 3000 bears



the CE marking

CE-366

indicating its compliance with the provisions of the Council Directive 93/42/EEC about medical devices and fulfills the essential requirements of Annex 1 of this directive.

The product complies with the electromagnetic



immunity requirements of standard IEC 60601-1-2/EN 60601-1-2 "Electromagnetic Compatibility - Medical Electrical Equipment".

The radio-interference emitted by this device



is within the limits specified in CISPR11/EN 55011, class A.

General Information

On request Marquette Hellige will provide a



service manual. The Marquette Hellige quality management



system complies with the standards DIN EN ISO 9001 and EN 46001.

The safety information given in this manual is



classified as follows:

indicates an imminent hazard. If not avoided, the hazard will result in death or serious injury.

indicates a hazard. If not avoided, the hazard can result in death or serious injury.

Danger

Warning

The device is designed to comply with I EC 60601



requirements. It is a protection class I device and has an internal power source. It is classified as an MDD class IIb device.

The CE mark covers only the accessories



listed in the "Order Information" chapter . This manual reflects software version 2.



This manual is an integral part of the device. It



should always be kept near the device. Close observance of the information given in the manual is a prerequisite for proper device performance and correct operation and ensures patient and operator safety. Please note that

information pertinent to several chapters is given only once. Therefore, carefully read the manual once in its entirety.

The symbol means: Consult accompany-



ing documents. It indicates points which are of particular importance in the operation of the device.

This manual is in conformity with the dev ice



specifications and standards on safety of electromedical equipment valid at the tim e of printing. All rights are reserved for devices, circuits, techniques, software programs, and names appearing in this manual.

Caution

indicates a potential hazard. If not avoided, this hazard may result in minor personal injury and/or product/property damage.

To ensure patient safety, the specified



measuring accuracy, and interference-free operation, we recommend to use only original Marquette Hellige components. The user is responsible for application of accessories from other manufacturers.

The warranty does not cover damage resulting



from the use of unsuitable accessories and consumables from other manufacturers.

Marquette Hellige is responsible for the effects



on safety, reliability, and performance of the device, only if

assembly operations, extensions, readjust-

−

ments, modifications, or repairs are carried out by Marquette Hellige or by persons authorized by Marquette Hellige,

the device is used in accordance with the

−

instructions given in this operator's manual.

 Marquette Hellige GmbH 2000 Postfach 600265 79032 Freiburg, Germany Telephone +49 761 45 43-0

4 Marquette Responder® 3000 227 490 02-C

Intended Use and Functional Description

1 Intended Use and Functional Description

The Marquette Responder® 3000 is a lightweight, portable defibrillator with ECG monitor and integrated recorder.

It is perfectly geared both to hospital and to prehospital use; in conjunction with the vehicle mounting unit, it can also be used in an ambulance.

There are two versions of the Marquette Responder® 3000:

a version for manual defibrillation,

−

a version for semiautomatic defibrillation

−

which can be switched to manual operation.

Both versions are capable of delivering synchronized and non-synchronized defibrillation shocks.

The following paddle types can be used with the defibrillator: hard paddles (with integrated contact surfaces for children), adhesive electrodes and internal spoons.

The device features can be upgraded with the following options:

a program for ECG measurement and interpre-

−

tation (12SL), an etCO

−

an SpO

−

a transcutaneous pacemaker.

−

measurement system (capnometry),

measurement system (pulse oximetry),

The color concept for the displayed information lets you see at a glance whether

the parameter reading is within the alarm limits

−

(green), a technical fault is reported (blue),

−

an alarm is reported (red),

−

the system displays a message (yellow).

−

The defibrillator has the following memories for storage and documentation of the relevant procedure data:

an event memory,

−

an ECG memory,

−

a trend memory, and

−

a memory for the 12SL analysis results.

−

The integrated 3-channel recorder can be started manually and automatically.

The defibrillator is powered from

an optional AC power adapter which is

−

permanently attached to the defibrillator, or 1 or 2 plug-in batteries, or

−

the vehicle mounting unit / wall mount unit.

−

Autoseq

Analyse

100

150

200

300

360

Sync

Pacer

On Off

Start Pause

P/min

+ —

Print Event

Dem

Fix

Figure 1-1. Marquette Responder® 3000

Batteries are recharged via:

the optional AC power adapter

−

the optional charging unit, or

−

the optional vehicle mounting system.

−

Biocompatibility

The parts of the product desc ribed in this operator manual, including all accessories, that come in contact with the patient during the intended use, fulfill the biocompatibility requirements of the applicable standards. If you have ques tions in t his matter , please contact Marquette Hellige GmbH or its representatives.

227 490 02-C Marquette Responder® 3000 5

2 Controls and Indicators

The Device

Controls and Indicators

30 29 28 27

26 25

24 23 22 21 20

18 17

Pacer

Dem

Off

Start

Pause

P/min

+ —

Print Event

3 4

360

Sync

100

150 200

300

5 6

7 8

Fix

Autoseq

Analyse

10 11

1316 15 1214

Figure 2-1. Controls and indicators of the Marquette Responder® 3000

6 Marquette Responder® 3000 227 490 02-C

Controls and Indicators

Connector for exchange of the defibrillation

electrodes (switch off the device before exchanging the electrodes!)

APEX paddle

Infrared interface

Battery with "Test" button and charge level

indication Button to unlock right battery for removal

Energy selector, ON/OFF switch

Indicator, yellow, flashes to the QRS rhythm

in synchronized mode Button to enable and disable the synchronized

mode (cardioversion) Button to initiate ECG analysis in the

semiautomatic mode (only on semiautomatic defibrillator models)

Button to initiate defibrillator charging and to

trigger the shock (together with button 11) when adhesive pads or internal spoons are used

Button to trigger the defibrillation shock

(together with button 10) when adhesive pads or internal spoons are used

1-Volt ECG output

etCO2 signal input (optional)

SpO2 signal input (optional)

Function keys F1 to F5

ECG signal input

Button to start and stop the recorder

Button to change the pacer output (current)

Button to change the pacer rate

Button to pause the pacer (without changing

the settings) Button to select the pacer mode (fixed rate,

demand) Button to unlock left battery for removal

Button to turn the pacemaker on and off

Indicator, yellow: blinks with each delivered

pacing pulse Button to open paper compartment

Battery with "Test" button and charge level

indication Indicator, green: is lit when defibrillator is

powered from an external source (mains, ambulance)

Indicator, yellow

blinking: left battery charging on: left battery charged off: left battery missing or partially charged, no external power source connected

Indicator, yellow

blinking: right battery charging on: right battery charged off: right battery missing or partially charged, no external power source connected

STERNUM paddle

Event marker button

Explanation of symbols used on the device

Consult accompanying documents

Caution, High Voltage

Type CF signal input: highly insulated, suitable for intracardiac application, defibrillation-proof Type CF signal input: highly insulated, suitable for intracardiac application

227 490 02-C Marquette Responder® 3000 7

Battery charging

Housing without battery (to close the battery slot) Standby mode (line power operation)

Audio alarm OFF

Defibrillation Electrodes

Figure 2-2. Hard paddle

APEX

CHARGE

SHOCK

Hard Paddles

Hard paddles are the electrodes commonly used for external, transchest defibrillation. There is a special Apex paddle and a Sternum paddle. For delivery of the defibrillation shock, the paddles are placed directly on the body surface. Before use, however, an ample amount of electrode gel must be spread onto the paddles. Both paddles have a shock button: The shock button on the Apex paddle is used to initiate defibrillator charging; afterwards the defibrillation shock is triggered by pushing both shock buttons. The paddles can also be used to acquire the ECG signal. A smaller contact surface for defibrillation of children is integrated in the paddles (see "Defibrillation of Children" in section 4.2).

Electrodes for Internal Defibrillation

Figure 2-3. Electrode for internal defibrillation

Figure 2-4. Disposable adhesive electrode

(external defibrillation, pacing)

Electrodes for internal defibrillation consist of a contact spoon (a, Figure 2-3), a handle b, and a counter nut c. The spoon must match the size of the heart and have full contact with the myocardium. There is a choice of 3 different spoon sizes. The electrodes as well as their connection cable must be sterilized before each use. An internal defibrillation is either performed with

spoon electrodes or with

two

spoon electrode

one

and a so-called "external counter electrode" (d, Figure 2-3) which is placed under the patient and in the immediate vicinity of the heart. Defibrillator charging and release of the defibrillation shock are initiated with buttons on the device.

Disposable Adhesive Electrodes

Disposable adhesive electrodes are used both for defibrillation and for pacing. These electrodes are self-adhesive and pregelled. They are connected by means of a special cable and may remain attached to the patient for a maximum of 24 hours.

8 Marquette Responder® 3000 227 490 02-C

Putting the Device Into Operation and Performance Check

3 Putting the Device into Operation and Performance Check

Safety information

Danger

Explosion Hazard – The device is not designed for use in areas of medically used rooms where an explosion hazard may occur. An explosion hazard may result from the use of flamm able anesthetics, skin cleansing agents and disinfectants. Also, it is not permitted to operate the defibrillator in an oxygen-enriched environment or in the presence of flammable substances (gas) or anesthetics. Oxygenation in the vicinity of the defibrillation electrodes must be strictly avoided. Temporarily interrupt the oxygen supply.

Warning

Shock Hazard — Observe the follo wing warnings. Otherwise the lives of the patient, the user and bystanders are in danger.

The Marquette Responder® 3000 is a highvoltage electrotherapy device and must be handled by qualified and specially trained personnel. Improper use of the device can endanger life. Always follow the instructions given in the operator's manual.

When equipped with the AC power adapter, do not use the defibrillator outdoors because the power adapter is not splash-proof.

Before using the device, the operator must ascertain that it is in correct working order and operating condition. In particula r, a ll connectors, electrodes as well as sensors and probes must be checked for signs of damage. Damaged parts must be replaced immediately, before use.

When disconnecting the device from the power line, remove the plug from the wall o utlet first, before disconnecting the cable from the device. Otherwise there is a risk of coming in contact with line voltage by inadvertently introducing metal parts in the socket o f the power cord.

As a general rule, utmost caution is advised for intracardiac application of medical technical devices. Great care must be exercised to prevent that conductive parts (connectors, electrodes, transducers) connected to the isolated patient signal input come in co ntact with other grounded conductive parts, as this could bridge the patient's isolation and cancel the protection provided by the isolated input.

227 490 02-C Marquette Responder® 3000 9

Putting the Device Into Operation and Performance Check

Electrically conductive contact with parts connected to the heart (pressure transducers, metal tube connections and cock s, guide wires, electrode catheters and the metal parts of syringes) must be avoided at all cost. When using devices intracardially, observe these guidelines:

always wear isolating rubber gloves;

parts with a conductive connection to the heart must be isolated from ground;

do not use tube fittings and stopcock s made of metal, if possible;

when connecting the heart catheter, observe these guidelines:

- the connection must be isolated

- all electrodes must be attached to the patient and secured against inadvertent disconnection or they must be isolated and protected against inadvertent contact (otherwise electrodes that become disconnected could bring the patient in contact with ground).

When devices are used intracardially, the annual Technical Inspections are manda tory. During intracardiac application of medical electrical devices, a defibrillator and pacemaker, both checked for proper functioning, must be readily available.

Ensure that no conductive connection between the patient and bystanders exists during defibrillation.

The mains plug must be connected to an appropriate power supply with a non-fused earthed wire. If these requirements cannot be guaranteed, connect the device to the ambulance power supply or operate it on battery power.

Do not use multiple portable socket outlets (MPSO) to connect the device to the power line.

Devices may be connected to other devices or to parts of systems only when it has been made certain that there is no danger to the patient, the operators, or the environment as a result. In those instances where there is any element of doubt concerning the safety of connected devices, the user must contact the manufacturers concerned or other informed experts as to whether there is any possible danger to the patient, the operator, or the environment as a result of the proposed combination of devices. Standards IEC 60601-1-1/EN60601-1-1 must be complied with in all cases.

The device (without AC power adapter) is suitable for application in a humid environment provided the regulations concerning drip-proof equipment of IEC 60601/EN 60601 are strictly observed. However, do not defibrillate patients in a very moist or wet environment, unless absolutely necessary. Always dry the defibrillation electrodes and connection cables prior to defibrillatio n.

10 Marquette Responder® 3000 227 490 02-C

Putting the Device Into Operation and Performance Check

Warning

Equipment Failure — Magnetic and electrical fields are capable of interfering with the proper performance of the device. For this reason make sure that all external devices operated in the vicinity of the defibrillator com ply with the relevant EMC requirements. Xray equipment, MRI devices, radio systems, and cellular telephones are a possible source of interference as they may emit higher levels of electromagnetic radiation. Keep the defibrillator away from these d evices and verify the defibrillator performa nce before use.

Equipment Failure — Similarly, the defibrillator may disturb equip ment operating in its vicinity when charging or delivering the shock. Verify the performance of these devices before use.

Suffocation Hazard — Dispose of the packaging material, observing the applicable waste-control regulations. Keep the packaging material out of children's reac h.

Literature

Medical Device Directive of August 2, 1994 EN 60601-1: 1990 + A 1: 1993 + A 2: 1995

Medical electrical equipment. General requirements for safety.

EN 60601-1-1: 9/1994 + A1: 12/1995 General requirements for safety. Requirements for the safety of medical electrical systems.

IEC-Publication 513/1994: Fundamental aspects of safety standards for medical equipment.

Caution

Equipment Damage, Shock Hazard — Devices intended for emergency application must not be exposed to low temperatures during storage and transport to avoid moisture condensation at the application site. Wait until all moisture has vaporized before using the device.

Equipment Damage — Exercise great care when using HF surgery equipment on the patient at the same as the defibrillator. As a g eneral rule, the distance between the ECG and defibrillation electrodes and the HF surg ery electrodes should not be less than 15 cm. If this is not ensured, disconnect the electrodes and transducer leads while using the HF surgery device.

Equipment Damage — Avoid defibrillating repeatedly into open air or with the paddles shorted together, because the device temperature may increase to an inadmissible level due to the internal safety discharges.

227 490 02-C Marquette Responder® 3000 11

Putting the Device Into Operation and Performance Check

Figure 3-1. Defibrillator with AC power adapter

Power Supply

The defibrillator can be powered

from the power line (requires AC power

−

adapter, P/N 205 108 01, Figure 3-1), from the ambulance power supply system

−

(requires vehicle mounting unit, P/N 202 317 01),

from the wall mount unit (P/N 202 317 03)

−

from 1 or 2 rechargeable batteries (mains-

−

independent).

Batteries are recharged by one of the following methods:

in the defibrillator, when the defibrillator is

−

connected to the power line or to the ambulance power supply system, or

Note

The Marquette Responder® 3000 is switched on and off with the energy selector. Once you are familiar with the device operating ro utines, this control lets you turn on the device and select the required defibrillation energy in one action. No shock can be delivered in the po sitio n of the energy selector.

Autoseq

Figure 3-2. Turning the defibrillator on

100

300

360

150 200

by means of the separate charging unit ASU

−

3000 (P/N 701 279 01).

If you prefer to operate the device mainsindependent, ensure that the batteries are charged (chapter 14 "Battery Power Operation").

Please refer to chapter 16 for information on operating the device in the vehicle mounting unit and on installing the AC power adapter.

Turning the Defibrillator On

•

Connect the device to the power supply.

•

Switch on the device by turning the energy selector to delivered in this position).

The test screen appears and the device emits a short audio signal.

On the test screen you can see the software version and a message referring to the self-test. The three color blocks in red, green and blue are displayed to verify the correct representation of the colors.

(defibrillation shocks cannot be

After the self-test the standard screen appears (Figure 3-3).

12 Marquette Responder® 3000 227 490 02-C

Putting the Device Into Operation and Performance Check

The Standard Screen Display

a fedcb

Electrode

Paddle

160 / 40

SpO2

window

etCO2

window

ECG

bpm

15.07.1999 09:05:00

SpO2

etCO2

QRSPulse

Tone

OFF

semiautom.

ECG

parameter

pacemaker

Figure 3-3. Standard screen display

a measured heart rate/pulse rate b selected limit values c battery charge level indication

This is the information presented on the standard screen display:

windows for heart / pulse rate, SpO

−

readings including the limit values a, battery charge level

−

ECG lead

−

window for ECG, SpO

−

window indicating operating mode and

−

defibrillation energy date and time

−

menu g.

−

and etCO2 waveforms

and etCO

The color concept for the displayed information lets you see at a glance whether

the parameter reading is within the alarm limits

−

(green), a technical fault is reported (blue),

−

d ECG lead (ECG signal acquired

via "Paddle")

e date, time f selected operating mode,

defibrillation energy

g menu

an alarm is reported (red),

−

the system displays a message (yellow).

−

If the device does not receive an ECG signal, the HR window is blue (technical fault) and a sawtooth signal is displayed instead of an ECG. The SpO

and etCO2 parameter windows are also

blank and the corresponding waveforms are missing when the required sensors are not connected.

227 490 02-C Marquette Responder® 3000 13

ECG SpO2

etCO2

QRSPulse

Tone

OFF

Figure 3-4. Main menu

Filter

Assign

Channel

Waveform

Putting the Device Into Operation and Performance Check

Display Flip

The screen display can be rotated 180° to adapt it

↓

to the operating position of the defibrillator. The display can be flipped permanently from the setup menu or temporarily as outlined below. You can also set up the system to flip the display automati-

↓

DisplayMemory

cally when the defibrillator is inserted in the vehicle mounting unit (chapter 13 "Defibrillator Setup").

Figure 3-5. Main menu, page 2

↓ ↓ ↓

Contrast Contrast Display

Select

Color

Flip

Figure 3-6. Display menu

Note

The main menu will automatically reappear, when no button is activated for a period of 30 seconds.

Note

Press F5 for about 2 seconds to return directly to the main menu.

In the main menu, select

•

Next Menu

(Figure

3-4).

You will see page 2 of the main menu (Figure 3-

5). Display the Display menu with

•

Display

(Figure 3-6). To flip the display, press

•

Display Flip

Contrast adjustment

Adjust the contrast from the Display menu with

•

and F2.

Adjusting Maximum Contrast (Select Color)

Adjust the maximum contrast from the Display

•

menu with F3. Press

Previous Menu

for about 2 seconds to

•

return directly to the main menu.

System Setup

The device has a configuration menu which allows you to customize some of the functions to suit your personal requirements. These settings will be retained. The table at right shows all device

Note

settings for which customer defaults can be selected, as well as the factory defaults.

Enter your own settings in the column at the far right (with date and signature).

The information given in this manual is based on a defibrillator with the factory defaults.

In chapter 13 "Defibrillator Setup" you will find instructions on setting up the defibrillator. The same chapter explains how to change the language and how to restore the factory defaults.

14 Marquette Responder® 3000 227 490 02-C

Putting the Device Into Operation and Performance Check

Parameter Comment Factory

Options User Setup

Defaults

ALARM LIMITS

HR Limit 40/160 OFF, 15 to 300

SpO2 Limit etCO2 Limit

ECG

Print on Alarm autom. recorder start on violation of limit

Lead Fail Alarm audio signal indicating disconnected

Alarm Tone audio sign al indicating violation of a n

QRS Beep off low/middle/high / off Muscle Filter suppression of motion artifact on on/off Gain for ECG display 1 cm/mV 0.5; 1; 2 cm/mV Lead Channel 1 I standard leads,

Lead Channel 2 II standard leads, SpO Lead Channel 3 III standard leads, SpO2,

DEFIB

Print on shock automatic recorder start on shock on on/off Operating Mode** c hoice of the operating mode semiautomatic/button semiautom./button

Autosequence energy selection 200 J, 200 J, 360 J 150 to 360 J per shock Pacemaker default pacer rate 60 P/min 30 to 200 P/min

SpO

C-LOCK C-Lock ECG synchronization off on/off SpO2 Integ. Time SpO2 integration time 8 s 4 s, 8 s, 12 s

DATE/TIME**

Date Format** day.mon.year day.mon.year

Entry of date and time

DEVICE

Display

Volume valid for all audio signals high high/low/middle Cont. Printout continuous recording or 14-second strip off on/off Analysis continuous ECG analysis on on/off AC Line Filter** elimination of AC line interference 50 Hz off/50 Hz/60 Hz Language** selection of the language Factory Default restores factory defaults User** text or name (20 characters)

PASSWORD**

for config** protects access to configuration menu off on/off EVENT TEXTS** entry of event texts

BATTERY battery maintenance program OPTIONS entry of option code to unlock option

** not affected by reactivation of factory defaults

value

electrode

alarm limit

Change clears all existing settings.

screen display (SmartFlip = disp lay flips automatically when defibrillator is placed in vehicle mounting unit)

entry of the password 111 000/999

---/90 OFF, 60 to 99

---/20 OFF, 5 to 76

off on/off

off 30 s/off

off on/off

normal normal, reverse,

     

    

increments of 5

increments of 1

paddle acquisition

etCO

semiautom./password semiautom. manual

mon/day/year

SmartFlip

on/off

227 490 02-C Marquette Responder® 3000 15

Putting the Device Into Operation and Performance Test

Event

Performance Check

Electrode

Paddle

160 / 40

ECG

bpm

15.07.1999 09:05:00

SpO2

etCO2

QRSPulse

Tone

OFF

semiautom.

ECG

Figure 3-7. Standard screen display of a

defibrillator ready for operation (no ECG, SpO

and etCO2 signal avail-

able)

Note

A special simulator is required to test the defib rillator performance in the semia uto matic mode.

A performance check must be carried out before each use.

The check includes:

a visual inspection of the device, the cables and

−

the electrodes for signs of mechanical damage, verification of the functional readiness of the

−

device, delivery of a test discharge.

−

After power-up and during operation, the Marquette Responder® 3000 runs automatic selftests. If malfunctions are identified, an error message will be displayed (see chapter 17 "Error and System Messages"). In this situation do not put the device into service.

In all other cases you will see the standard screen display (Figure 3-7) and the device is ready for use.

Now verify that the defibrillation shock is correctly delivered by triggering a test discharge (chapter 15 "Test Discharge"). If the energy of the test discharge is not within the specified limits, a defibrillation is possible all the same (it is the user's decision whether or not to employ the defibrillator). However, the device must be immediately checked and repaired by a service technician.

Event Button

You can use the

ECG

160 / 40

bpm

events (e.g. administration of medications). When you press this key, the corresponding point in time

is earmarked in the full-disclosure ECG. Furthermore, you can assign a maximum of 8 "event" texts to the function keys F1 to F4 (e.g. names of

Text 1

III

15.07.1998 09:05:00

semiautom.

Text 2 Text 3 Text 4

medications). When you press appear in the menu line (Figure 3-8). You can press one of the function keys to assign the corresponding text to the event. With you can display the next line of 4 texts. (Refer to

Figure 3-8. Event texts

chapter 13 "Device Setup" for instructions on entering event texts.)

16 Marquette Responder® 3000 227 490 02-C

button to mark specific

these texts

Next Menu

Putting the Device Into Operation and Performance Test

How to toggle the defibrillator from semiautomatic to manual operation

Sync

Analyse

Figure 3-9. Buttons to activate the manual mode

Electrode

Paddle

160 / 40

ECG

bpm

15.07.1998 09:05:00

semiautom.

Depending on their setup, semiautomatic defibrillators can be switched to manual control. The defibrillator can be set up for four different modes of operation:

semiautom./button (switching to manual mode

−

by activating button) semiautom./password (switching to manual

−

mode by activating button and entering password)

semiautomatic (manual control not possible)

−

manual (only manual control possible)

−

Operating Mode "semiautomatic/button"

•

To activate the manual mode, simultaneously

Analyse

press F5 and

(Figure 3-9).

When switched on again, the defibrillator will reactivate the operating mode selected in the setup menu. Date and time of the change of operating modes is stored in the event memory.

0 0 ENTER

Figure 3-10. Buttons for entry of the password

Paddle

160 / 40

ECG

bpm

15.07.1998 09:05:00

etCO2

SpO2

QRSPulse

Tone

OFF

manual

ECG

Figure 3-11. Defibrillator set up for manual

operation

Operating Mode "semiautomatic/password"

•

To activate the manual mode, simultaneously

Analyse

press F5 and

(Figure 3-9).

The screen for entry of the password appears (Figure 3-10).

•

Enter the password (3-digit number) with F1, F2, F3. The factory-set password is 111 (also

refer to chapter 13, section "Password").

When switched on again, the defibrillator will reactivate the operating mode selected in the setup menu. Date and time of the change of operating modes is stored in the event memory (chapter 11 "Memories of the Marquette Responder® 3000"). If you wish to return to the semiautomatic mode, you will have to turn the device off and on again.

227 490 02-C Marquette Responder® 3000 17

Manual Defibrillation / Non-Synchronized Defibrillation

4 Manual Defibrillation

4.1 Defibrillator Application Guidelines

Observe the following guidelines to ensure successful and safe defibrillation. Otherwise the lives of the patient, the user and bystanders are in danger.

Warning

Defibrillating a patient with normal hea rt rhythm may induce ventricular fibrillation.

Position the patient flat on a hard surface where he is electrically insulated. The patient must not be allowed to come into contact with metal parts, e.g., bed or litter, to prevent unwanted pathways for the defibrilla tion current which may endanger the assistants. For the same reason, do not position the patient on wet ground (rain, accident in swimming pool). Do not allow the defibrillation electrodes to come into contact with other electrodes or metal parts which are in contact with the patient. The patient's chest must be dry, because moisture can cause unwanted pathways for the defibrillation current. After use of flammable skin cleansing agents, wait until they have completely dried.

The operator and all assistants must be briefed regarding the preparations for and execution of defibrillation. All tasks must be clearly assigned . Immediately prior to the shock

- interrupt heart massage and artificial respiration,

- disconnect tube connections, and

- warn bystanders.

Ensure that no conductive connection between the patient and bystanders exists during defibrillation.

Before delivering the shock, verify that the charged and selected energies are the same.

Shock Hazard — Always switch off the device before exchanging the defibrillation electrodes.

Pacemaker Patients — Defibrillating a patient with an implanted pacemaker is likely to impair the pacemaker function or cause damage to the pacemaker. For this reason

- select the smallest energy level possible for the application,

- do not apply the defibrillation paddles in the vicinity of the pacemaker electrodes,

- have an external pacemaker at hand,

- check the implanted pacemaker for proper functioning as soon as possible after the shock.

Caution

Equipment Damage — Disconnect transducers and devices that are not defibrillationproof from the patient before delivering the shock.

Equipment Damage — Do not defibrillate the patient with a second defibrillator, while def ibrillation electrodes (paddles, pads) of the first device are applied. If the use of a second defibrillator is inevitable, disconnect the electrodes from the first device or remove them from the patient.

18 Marquette Responder® 3000 227 490 02-C

Manual Defibrillation / Non-Synchronized Defibrillation

Figure 4-1. Removing the paddles

4.2 Non-Synchronized Defibrillation

Using Paddles

Remove the paddles from their compartments

•

as shown in Figure 4-1. Carefully dry the paddles and the handles in

•

particular, if they are wet. Apply an ample amount of electrode cream to

•

the paddle surfaces. Set the energy selector to "Autoseq" or to the

b ca

•

required energy level.

Paddle

160 / 40

ECG

bpm

15.07.1999 09:05:00

SpO2

etCO2

QRSPulse

Tone

OFF

manual

200 J

ECG

Figure 4-2. Power-up screen (paddles con-

nected) a ECG signal acquired via

"Paddle"

b manual mode c selected energy

In the "Autoseq" position of the energy selector, the defibrillator automatically sequences the preset defibrillation energy levels. The level for the 3rd shock is maintained for all subsequent defibrillations. When you set the energy selector again to "Autoseq", the automatic charge sequence starts over. The factory set Autosequence energy levels are the values recommended by AHA/ERC for ventricular fibrillation and pulseless tachycardia. 1st shock with 200 J 2nd shock with 200 J 3rd and all subsequent shocks with 360 J.

Check that the selected energy is displayed (c,

•

Figure 4-2). Apply the paddles on the patient's thorax such

•

that the greatest possible amount of energy flows through the myocardium. The imaginary line connecting the paddle centers should be identical with the cardiac median line (Figure 4-3).

Press the paddles firmly onto the thorax (the

SHOCK

STERNUM

CHARGE

SHOCK

APEX

•

ECG appears on the monitor screen). Do not touch the patient any more and warn all

•

those present.

Figure 4-3. Paddle application points (dashed

application points for pacemaker patients)

227 490 02-C Marquette Responder® 3000 19

Manual Defibrillation / Non-synchronized Defibrillation

•

Initiate energy storag e with the button on the

APEX paddle (a).

STERNUM

SHOCK

CHARGE

APEX

SHOCK

Figure 4-4. Buttons to initiate defibrillator

charging (a) and to trigger the shock (a+b)

Warning

Risk of Skin Burns / Equipment Damage — Do not apply the paddles over

sternum or clavicle,

nipples

implanted pacema ker or defibrillator devices.

When the selected energy is stored,

−

the device emits an audio signal

−

the message "Energy available" appears,

−

the available energy is displayed (if the available energy drops below a given level, the defibrillator recharges automatically).

•

Now trigger the shock within 30 seconds. To do so, simultaneously press the buttons a and b on the paddles.

After the shock

−

the audio signal stops and the delivered energy is displayed for approx. 6 seconds (in place of the available energy),

−

the recorder prints a 14-second ECG strip (4 seconds before the shock, 5 seconds blanked, 10 seconds after the shock) (configurable); the blanked period of time is indicated by a vertical line on the recording;

−

the shock delivery is annotated on the stored ECG (also refer to chapter 11 "Memories of the Marquette Responder® 3000").

Note

If you do not trigger the shock within 30 sec-

−

onds of charging, the energy will automatically be discharged internally. You will then have to recharge the defibrillator. When the defibrillator is charged, you can

−

increase and decrease the energy level to any value with the energy selector (without pressing the "Charge" button again). For an internal discharge of the stored energy, set the energy selector to or to "Off".

If the defibrillator cannot store the selected energy so that selected and stored energy values differ, a warning will be displayed. The defibrillation pulse can be triggered all the same.

In this situation we recommend to check the batteries first. If the batteries are intact, have the defibrillator immediately repaired.

20 Marquette Responder® 3000 227 490 02-C

Manual Defibrillation / Non-Synchronized Defibrillation

Shock Counter

The number of delivered shocks is indicated below the energy value.

This counter is reset to 0 when you set the energy selector to

The number of delivered shocks is also shown on the recording strip (Figure 5-5, intervention report d). This counter, however, counts all shocks since the device was turned on and is reset to 0 only when the device is turned OFF.

Ending Therapy

Once therapy has ended, set the energy selector

•

to If there is no need to monitor the patient, switch

•

off the defibrillator by setting the energy selector to "Off".

Clean the paddles and the device as outlined in

•

chapter 18 "Cleaning, Maintenance".

for continued monitoring of the patient.

Defibrillation of Children

Warning

Damage to Myocardium — Please note that children require less energy for successful ventricular defibrillation than adults. For the first defibrillation shock delivered to babies and small children, select an energy of approx. 2 J/kg body weight. For subsequent shocks, the energy may be increased to 4 J/kg body weight.

Risk of Skin Burns — The full electrode m ust be in contact with the skin surface (use the small contact surface of the paddles / pads for children).

The paddles have two different contact surfaces; a large one (can be removed) for the defibrillation of adults and a smaller one for the defibrillation of children.

Remove the large contact surface for pediatric use:

Press on the lock button 1 (Figure 4-5).

•

Slide the contact surface 2 towards the front

•

and take it off the paddle. When re-installing it, the large contact surface

•

must audibly click into place.

Figure 4-5. Removing the large contact surface

from the paddles

227 490 02-C Marquette Responder® 3000 21

Manual Defibrillation / Non-synchronized Defibrillation

Danger Shock Hazard — For defibrillation with disposable adhesive electrodes, the paddles including their leads must be replaced with the adapter cable 223 383 01. Switch off the defibrillator before exchanging the lead. Also, the defibrillator must be switched off when the adapter cable is connected to the pads.

Using Disposable Defibrillation Pads

Use pads before their expiration date.

−

A pair of pads may remain attached to the

−

patient for up to 24 hours and withstands up to 50 shocks of 360 J each.

Use electrodes 919 202 94 for adults and

−

electrodes 919 202 95 for children. Shave the application points; this improves

−

conductivity and makes removal of the pads easier. STERNUM: right sternal edge at the level of the 2nd intercostal space, APEX: left axillary line at the level of the 5th intercostal space (Figure 4-7).

reuse the pads.

not

Figure 4-6. Connecting the lead

STERNUM electrode and connector

Place the pads on the patient such that the

−

connectors point to either side of the patient and that the cables are not hindering patient treatment.

The electrodes are pregelled; therefore, do not

−

use additional contact cream or gel. Do not use pads, if the gel is dry.

−

•

Rub the patient's chest dry.

•

Press the connector of the lead on to the electrode contact pin until you hear it click into place (Figure 4-6).

•

Peel off the backing from each pad.

•

Press the pads carefully on the appropriate sites, observing the APEX and STERNUM labels (Figure 4-7).

APEX

electrode and connector

Figure 4-7. Defibrillation pad application points

(anterior - anterior)

22 Marquette Responder® 3000 227 490 02-C

Manual Defibrillation / Non-Synchronized Defibrillation

Warning

Risk of Skin Burns / Equipment Damage — Do not attach the pads over

sternum or clavicle

nipples

implanted pacema ker or defibrillator devices.

Sync

•

Before delivering the shock, check that the pads are firmly seated.

•

Defibrillate the patient as described for defibrillation with paddles (page 19). Be sure to charge the defibrillator with to deliver the shock by simultaneously pressing

and

the buttons

•

Carefully remove the electrodes after use

(Figure 4-8).

(Figure 4-9) and discard them immediately.

and

Analyse

Figure 4-8. Buttons to initiate defibrillator

charging and to trigger the shock

wrong

Figure 4-9. Removing the pads

correct

Note

Discard disposable pads immediately after use. Do not reuse them.

227 490 02-C Marquette Responder® 3000 23

Manual Defibrillation / Non-synchronized Defibrillation

Using Internal Defibrillation Electrodes

Note

If you are using internal electrodes with the Marquette Responder® 3000, defibrillator charging must be initiated with button and the shock is delivered by simultaneously pressing buttons and .

Warning

Shock Hazard – Always switch off the device before exchanging the defibrillation electrodes and internal spoons.

Spoon-shaped electrodes are used for internal defibrillation. Their contact surface must match the dimensions of the heart. The spoons must make full contact with the heart. There is a choice of 3 different spoon sizes. You can use either two spoon electrodes or one spoon electrode and one external counter electrode for defibrillation (Figure 4-10, chapter 20 "Order Information"). Sterilize internal electrodes before each use (chapter 18 "Cleaning, Maintenance").

Figure 4-10. External counter electrode

Figure 4-11. Inserting the spoon electrode

Inserting the Spoon Electrode

•

Screw the counter nut 2 (Figure 4-11) onto the electrode as far as it will go.

•

Screw the contact paddle 1 into the handle as far as it will go, then bring it into the appropriate position.

•

Now fix the contact paddle by screwing the counter nut 2 tight against the handle 3.

24 Marquette Responder® 3000 227 490 02-C

Manual Defibrillation / Non-Synchronized Defibrillation

Sync

Analyse

Figure 4-12. Buttons to initiate defibrillator

charging and to trigger the shock

Defibrillating the Patient

With internal electrodes, it is not possible to select a value above 50 Joules, because higher energies may damage the myocardium. When you set the energy selector to a value above 50 Joules, you will be alerted by a message and defibrillator charging will not proceed.

Defibrillate the patient as described for

•

defibrillation with paddles (page 19). Be sure to charge the defibrillator with

and to deliver the shock by simultaneously pressing buttons

and (Figure 4-12).

227 490 02-C Marquette Responder® 3000 25

Manual Defibrillation / Synchronized Defibrillation

Warning

False Triggering — Do not use a pacemaker ECG for triggering, because the trigger pulses derived from pacemaker ECGs may be incorrect and synchronized delivery of the defibrillation shock may not be possible.

4.3 Synchronized Defibrillation (Cardioversion)

Some Basic Facts

For synchronized defibrillation (cardioversion) the defibrillation shock is delivered in synchronization with the heart action, as the heart is still working. As a prerequisite, the patient's ECG signal must be supplied to the defibrillator. After the attending physician has given the "defibrillation command" by pressing the appropriate buttons, the device will wait for the next QRS complex to derive the trigger signal for actual delivery of the shock.

Note

After each synchronized defibrillation, the device reverts to the non-synchronized mode; the same applies when the energy selector is set to .

The following electrodes can be used for cardioversion:

−

paddles (+ separate ECG electrodes),

−

adhesive electrodes (pads), or

−

internal electrodes (+ separate ECG electrodes).

Indications

Examples

−

mitral stenosis

−

left ventricular hypertrophy (aortic stenosis, hypertension)

−

impaired myocardiac function (ischemia, right heart failure)

−

patients with atrial or ventricular arrhythmias, hypotension and/or pulmonary edema.

If ventricular fibrillation develops, select the nonsynchronized mode for defibrillation, because it is not possible to detect a QRS complex for triggering in the presence of ventricular fibrillation.

Cardioversion with the Marquette Responder® 3000 is only possible in the manual mode.

We recommend acquiring the ECG with separate ECG electrodes. However, you can also defibrillate the patient with adhesive pads and pick up the ECG via the pads.

26 Marquette Responder® 3000 227 490 02-C

Manual Defibrillation / Synchronized Defibrillation

Print Event

red

R L

white

black

N F

Figure 4-13. ECG electrode placement

yellow

green

ECG Acquisition via Separate ECG Electrodes and Patient Cable

Use only silver/silver-chloride electrodes to acquire the ECG signal. These electrodes prevent polarization voltages which may be caused by the defibrillation shock, resulting in an ECG trace on the monitor screen or recording that simulates cardiac arrest. The ECG can be picked up with 5 or with 10 electrodes (for ECG measurement, however, 10 ECG electrodes are required (chapter

8)). Apply the electrodes as shown in Figure 4-13.

•

Plug the block of leadwires (N, R, L, F, C1)

•

into the patient cable (Figure 4-14). Connect the patient cable to the device (Figure

•

4-15).

Figure 4-14. Connecting the electrode leads to

the patient cable

Figure 4-15. ECG signal input

Note

The 3-lead patient cable cannot be used with this defibrillator.

Turn on the device (energy selector to ).

•

On the monitor screen you will now see the 3 ECG leads selected in the setup menu (factory defaults: leads I, II, III).

Warning

Sho c k H a zard / Equipment Da m ag e — All patient signal inputs labeled with the symbol are protected against damage resulting from defibrillation and electrocautery voltages. For th i s re a son, patient safety and device protecti on are en sur ed during defibrillation and HF surgery. Nevertheless, extreme care should be exercised when electrosurgery devices are used on a patient who is connected to other devices. As a general rule, a minimum distance of 15 cm between the ECG and electrosurgery electrodes should be maintained. If this is not ensured, temporarily disconnect the electrodes and transducer l eads w hile usi ng the el ectrosurgery device. Great care must be exercised to prevent that conductive parts (connectors, electrodes, transducers) connected to the isolated patient signal input come in contact with other grounded conductive parts, as this could bridge the patient 's i solat ion an d cancel th e protection provided by the isol ated inpu t. It is particularly important that the neutral electrode does not come in contact with ground.

227 490 02-C Marquette Responder® 3000 27

STERNUM electrode and connector

Manual Defibrillation / Synchronized Defibrillation

ECG Acquisition via Defibrillation Pads

Apply the defibrillation pads as shown in

•

Figure 4-16. Turn on the device (energy selector to ).

•

The ECG signal is now acquired via the pads and will automatically be displayed in channel 1 (unless a patient cable is connected).

APEX

electrode and connector

Figure 4-16. Defibrillation pad application points

28 Marquette Responder® 3000 227 490 02-C

Manual Defibrillation / Synchronized Defibrillation

Performing Cardioversion

Check the ECG.

•

ECG

Channel1 Channel2 Channel3

ECG

160 / 40

bpm

III

15.07.1998 09:05:00

ECG

Vit. Sign

ECG

Vit. Sign

manual

Figure 4-17. Menu for selection of the displayed

ECG leads

Sync

Analyse

The ECG signal must be interference-free and have an adequate amplitude. Follow these steps to select another lead (only possible when the ECG is acquired via separate ECG electrodes) or to change the signal size:

Press F1

−

Press

−

ECG

I...III, aV...V, Paddle

again. The menu for selection of the ECG lead appears (Figure 4-17).

Using F1, select the lead to be displayed in

−

channel 1, with F2 select the lead for channel 2, and with F3 select the lead for channel 3 (with each key press the device advances to the next lead).

Press F5

−

size with F2 Press

−

Previous Menu

Next Menu

1 cm/mV

and change the signal

for about 2 seconds to

return to the main menu.

Figure 4-18. Sync button, activates the synchro-

nized defibrillation mode

ECG

Channel1 Channel2 Channel3

ECG

Figure 4-19. SYNC marker above QRS complex

160 / 40

bpm

III

15.07.1998 09:05:00

ECG

Vit. sign

ECG

Vit. sign

manual

Activate the synchronized mode with

•

Sync

(Figure 4-18). Verify that

•

the heart symbol blinks regularly,

−

a SYNC marker appears above each QRS

−

complex (Figure 4-19), and the yellow indicator above the

−

Sync

button

briefly goes off with each trigger pulse.

Set the energy selector to the required energy

•

level ("Autoseq" is not suitable for cardioversion).

Note

For cardioversion, AHA and ERC recommend the following energy levels: 50 J, 100 J, 200 J, 300 J, 360 J.

Defibrillate the patient as described on page 19.

•

When using adhesive pads, please note that defibrillator charging is initiated with

and the shock is triggered by simultaneously pressing

227 490 02-C Marquette Responder® 3000 29

and

Semiautomatic Defibrillation

5 Semiautomatic Defibrillation

Safety Information

In addition to the defibrillation guidelines set forth in chapter 4, please observe the following information: Failure to do so may compromise the success of the defibrillation or endanger the patient's life.

Warning

Semiautomatic defibrillation is only permitted for patients with a body weight of at least 35 kg, who are unconscious, have no respiration and no pulse.

Although the arrhythmia detection a lgorithm yields good results, we cannot entirely exclude false analysis in specific situations. Therefore the user is obliged to make certa in that the conditions for use of a semiautomatic defibrillator are met: unconsciousness, no respiration, no pulse. For the same reason, the user is entirely responsible for delivery of the defibrillation shock.

Do not use the anterior-posterior electrode placement.

In the semiautomatic mode, the defibrillator cannot deliver synchronized shocks.

For semiautomatic defibrillation, do not analyze the ECG during HF surgical interventions.

Caution

When used on pacemaker patients, the device may fail to make correct recommendations for delivery of a shock. Defibrillate pacema ker patients following the guidelines applicable in your institution.

During ECG analysis interrupt CPR me asures, do not touch the patient and ensure that the patient does not move. Otherwise artifacts may adversely influence the analysis.

In the semiautomatic mode, defibrillator charging cannot be initiated manually.

30 Marquette Responder® 3000 227 490 02-C

Some Basic Facts

Analyse

Semiautomatic Defibrillation

On the control panel of the semiautomatic

Analyse

defibrillator there is one additional button:

In the semiautomatic mode, an arrhythmia detection program scans the patient's ECG to check whether or not a shockable rhythm exists. If a shockable rhythm is found, the unit recommends defibrillation and automatically starts charging. In this operating mode, conventional control of the defibrillator is not possible (charging cannot be initiated manually).

The semiautomatic mode is thus suitable for persons who are not legally permitted to utilize a manual defibrillator (e.g. persons with insufficient knowledge of ECG analysis).

Observe the recommendations published by the AHA (American Heart Association) and the ERC (European Resuscitation Council).

In the semiautomatic mode, the defibrillator will start analyzing the ECG when the

button is pressed. If the analysis algorithm detects ventricular flutter (> 120 bpm), ventricular fibrillation or ventricular tachycardia with a deviating QRS morphology, the defibrillator

If you do not set the energy selector to "Autoseq", an error message will be displayed. The message is cleared when

you select "Autoseq" or

−

switch to the manual operating mode.

−

It is recommended to acquire the ECG signal for analysis via the disposable defibrillation pads. ECG electrodes can be used as well. Paddles should not be used because they are likely to induce artifact.

Note

The analysis algorithm only responds to shockable arrhythmias.

Literature (at the time of printing)

Guidelines for Resuscitation, European Resuscitation Council (1998), ISBN 0-444-82957-1

displays a message,

−

starts charging, and

−

informs the user when it is ready to deliver the

−

shock.

The energy selector must be set to the "Autoseq" position, where the defibrillator automatically sequences the energy levels preset for the first three shocks. The factory default setting is the sequence recommended by AHA/ERC: 200 J, 200 J, 360 J. You are free, however, to select the energy levels for the Autosequence shocks from the following values: 150 J, 200 J, 300 J, 360 J.

Handbook of Emergency Cardiac Care, American Heart Association (1996), ISBN 0-8151-0885-0

"The Arrhythmia Detection Program" in the appendix of this manual.

227 490 02-C Marquette Responder® 3000 31

a c db

161

ECG

160 / 40

Pads

bpm

15.07.1999 09:05:00

SpO2

etCO2

QRSPulse

Tone

OFF

Semiautomatic Defibrillation

semiautom.

200 J

Defibrillating the Patient in the Semiautomatic Mode

We recommend to defibrillate the patient with disposable adhesive pads in this mode. Thus, you only have to apply two electrodes, because the ECG signal can also be acquired via the pads.

If you are using separate ECG electrodes, please refer to the end of this chapter.

Apply the defibrillation pads as described on

•

page 22. Before delivering the shock, check that the pads

•

are firmly seated. Set the energy selector to "Autoseq".

•

Check that the semiautomatic mode is enabled

•

(c, Figure 5-1) and that the selected energy is displayed (d, Figure 5-1).

Figure 5-1. Standard display

a Heart rate

green = HR detection OK blue = lead failure red = medical alarm

b QRS blip c semiautomatic mode selected d selected energy e menu

32 Marquette Responder® 3000 227 490 02-C

Semiautomatic Defibrillation

Analyse

161

ECG

Do not touch patient

ECG

Pads

160 / 40

bpm

15.07.1999 09:05:00

ANALYZING

SpO2

etCO2

QRSPulse

Tone OFF

semiautom.

200 J

Figure 5-2. Message indicating that the ECG is

being analyzed

Do not touch the patient any more and warn all

•

those present. Press

Analyse

to initiate ECG analysis.

•

You will see the message "ANALYZING Do not touch patient" (Figure 5-2).

If the analysis algorithm detects ventricular flutter (> 120 bpm), ventricular fibrillation or ventricular tachycardia with a deviating QRS morphology, the defibrillator

displays the message "Shock advised - Do not

−

touch patient" (Figure 5-3) and automatically begins charging.

−

You can watch the defibrillator charging. When the charge level has been reached,

161

ECG

Do not touch patient

ECG

Pads

160 / 40

bpm

15.07.1998 09:05:00

Shock Advised

SpO2

etCO2

QRSPulse

Tone

OFF

Energy available

200 J

Figure 5-3. "Energy available" message and

indication of charged energy

Sync

Analyse

the device emits an audio signal

−

the message "Energy available" appears,

−

the charged energy will be displayed (Figure 5-

−

3).

Do not touch the patient any more and warn all

•

those present. Now trigger the shock within 30 seconds. To do

•

so, simultaneously press

and (Figure

5-4).

If the analysis algorithm does not detect a shockable rhythm, the message "No Shock Advised" is displayed and an audio signal sounds.

Note

Activating the energy selector during ECG analysis will abort the analysis and you have to restart it.

ECG analysis takes 8 to 12 seconds. If you press the

button immediately after delivery of a shock, this period may be extended to 20 seconds.

Figure 5-4. Buttons to deliver the shock

227 490 02-C Marquette Responder® 3000 33

Semiautomatic Defibrillation

Analyse

Note

Immediately after selecting "Auto seq ", the charge sequence restarts with the lowest energy level. There is no time limit for the Autosequence shocks. The Autosequence can only be interrupted by activation of the energy selector. The energy level selected for the 3rd shock is

If the analysis algorithm does not recommend a defibrillation, even though the patient is suspected to suffer from a shockable arrhythmia, press again. If possible, apply ECG electrodes to acquire the ECG. Also the device can be switched to manual defibrillation by authorized personnel.

Note

maintained for all subsequent shocks.

If the shock is not delivered within 30 seconds of charging, an automatic internal safety discharge will be initiated. In this case you must press the

Analyse

button again.

a b c d

Shock

(198 J)

Pads

25 mm/s 1 cm/mV 50Hz 35Hz

17.07.1999 09:30:26 HR:161 bpm

Patient………………..….: Date of birth…...…….…. :

User.......……………..….:

Comments....……….….. :

Defib Mode……………...:

Selected Energy…..…....:

Delivered Energy............:

No of Shocks………..…. : HR Alarm Limits... ……...: ETC Alarm Limits…...….:

HELLIGE

semiautom./button 200 J 198 J 1

40 :160 bpm 20 : --- mmHg

Figure 5-5. Example of a recording initiated by a defibrillation shock

reason for recording, delivered energy

date, time

heart rate

intervention report

user text

speed, gain, filter(s)

shock delivery, 5 seconds blanked

34 Marquette Responder® 3000 227 490 02-C

red

white

R L

Semiautomatic Defibrillation

ECG Acquisition via Separate ECG Electrodes

Use only silver/silver-chloride electrodes to acquire the ECG signal. These electrodes prevent polarization voltages which may be caused by the

yellow

defibrillation shock, resulting in an ECG trace on the monitor screen or recording that simulates cardiac arrest. The ECG can be picked up with 5 or with 10 electrodes (for ECG measurement, however, 10 ECG electrodes are required (chapter

8)). Apply the electrodes as shown in Figure 5-6.

•

Ensure that only those leadwires are connected

•

to the patient cable that are actually required.

black

N F

Figure 5-6. ECG electrode placement

161

ECG

160 / 40

bpm

III

15.07.1999 09:05:00

Check patient

SpO2

etCO2

QRSPulse

Tone

OFF

Energy available

Figure 5-7. ECG display (acquisition via

separate ECG electrodes)

green

200 J

Via the patient cable, connect the electrodes to

•

the defibrillator. Turn on the device (energy selector to ).

•

On the monitor screen you will now see the 3 ECG leads selected in the setup menu (factory defaults: leads I, II, III, Figure 5-7). The analysis algorithm always uses ECG lead II. If lead II is not available, the first suitable ECG lead shown will be selected.

Follow these steps to change the displayed leads or the signal size:

Press F1

−

Press

−

ECG

I...III, aV...V, Paddle

again. A menu for selection of the ECG lead appears.

Using F1, select the lead to be displayed in

−

channel 1, with F2 select the lead for channel 2, and with F3 select the lead for channel 3 (with each key press the device advances to the next lead).

Press F5

−

Note

The main menu will automatically reappear, when no button is activated for a period of 30 seconds.

227 490 02-C Marquette Responder® 3000 35

size with F2 Press

−

return to the main menu.

Defibrillate the patient as described on page 32.

•

Previous Menu

Next Menu

1 cm/mV

and change the signal

for about 2 seconds to

6 Pacemaker

)

On Off

)

Analyse

Start

Pause

Some Basic Facts

Application and Functional Description

Pacemaker

The transcutaneous pacemaker of the Marquette Responder® 3000 is used for external (transchest) cardiac stimulation in emergencies. It is applied temporarily in cases of acute arrhythmia, such as cardiac arrest or Stokes-Adams attacks. Specific forms of bradycardia and tachycardia can also be treated with the pacemaker.

The pacemaker offers two modes of operation: demand and fixed-rate pacing ("Fix").

The pacer pulses are delivered via the adhesive defibrillation electrodes (pace pads). Electrodes 919 202 94 (for adults) and 919 202 09 (for children) can be used.

Separate ECG electrodes must be applied for acquisition of the ECG signal.

Turning the pacemaker ON:

1. Apply ECG electrodes to patient.

2. Connect ECG electrodes to the device.

3. Turn on the Marquette Responder® 3000 (energy selector to

4. Check ECG and vital signs.

5. Attach pace pads to patient.

6. Connect pace pads to the Marquette Responder® 3000.

7. Turn the pacemaker ON (button

Off

Turning the pacemaker OFF:

1. Turn the pacemaker OFF (button

2. Disconnect pace pads from the Marquette Responder® 3000.

3. Remove pace pads from patient.

4. If monitoring of the patient is no longer required, turn off the Marquette Respond e r® 3000 (energy selector to OFF).

5. Remove ECG electrodes from patient.

Warning

Shock Hazard — Due to their functional requirements, pacemakers operate with high voltages and are therefore equipped with specially protected outputs. Nevertheless, it is important not to touch live contacts with conductive metal objects, such as tweezers, as long as the pacemaker is operating. Currents exceeding 10 µA may induce ventricular fibrillation, if they flow through the heart. Observe the following sequence of operating steps when turning the pacemaker on and off:

Caution

Success of the Intervention — Verify the success of pacemaker stimulation by measuring the pulse rate, not the heart rate.

Warning

Pausing the Pacemaker — Pushing the button automatically pauses the pacer output and suspends delivery of pacer pulses. Pressing the

button will terminate the pacer pause and

resumes pacing with the previous settings.

36 Marquette Responder® 3000 227 490 02-C

Pacemaker

Guidelines for the Application of External Pacemakers

All electrical devices that deliver energy to patients in any form or have an electrically conductive connection to the patient present a potential hazard.

The user is responsible for the safe application of the devices. Observance of the instructions given in the user manual and of the guidelines below is therefore of utmost importance:

Pacemakers must only be used under the

•

supervision of qualified and authorized staff. The prerequisite for safe application is the use

•

of intact devices in rooms that meet the applicable requirements. Expert knowledge, good organization and special care in selecting the technical installation as well as regular maintenance are required to ensure such operating conditions.

•

Check the defibrillator performance before using the pacemaker on a patient.

The pulse current output of the pacemaker is ungrounded. This ensures that the pacer current only flows between the pacemaker electrodes.

If the patient needs to be defibrillated while the pacemaker is on, the pacemaker pauses when the defibrillator begins charging, and the delivery of pacer pulses is suspended. After delivery of the defibrillation shock, you can resume the pacemaker operation with the previous settings

Start

by pressing Use only the electrodes and cables listed in

chapter 20 "Order Information".

Pause

Medical electrical devices such as the

•

Marquette Responder® 3000 must only be handled by persons who are trained in the use of such equipment and are capable of applying it properly.

Before using the device, the operator is obliged

•

to verify that it is in correct working order and operating condition.

It is assumed that the patient's ECG is being

•

monitored to be able to assess the effect of pacing. Furthermore, at least one of the persons present must be trained in the use of the defibrillator.

227 490 02-C Marquette Responder® 3000 37

Pacemaker

Demand Pacing

Warning

Shock Hazard — During pacing set the energy selector to to prevent that a defibrillation pulse is triggered inadvertently.

25 24

22 21

20 19

Pacer

On Off

Start

Pause

P/min

+ —

Dem

Fix

Figure 6-1. Pacemaker operating controls

Button to change the pacer cur-

rent output

Button to change the pacer rate

Button to pause the pacer func-

tion (settings remain stored)

Button to toggle between demand

and fixed-rate pacing

Button to enable and disable the

pacemaker

Indicator is illuminated when the

pacemaker is on and goes off briefly with each delivered pacer pulse

Caution

The pacemaker can be enabled only when adhesive electrodes are connected.

In demand mode, the pacemaker does not deliver pacing pulses as long as the patient's intrinsic heart rate exceeds the set pacing rate. When the heart rate drops below the pacing rate, the pacemaker starts emitting stimulation pulses. This can only be ensured by continued electronic monitoring of the ECG. The necessary synchronization pulses are automatically sent to the pacemaker.

The demand mode is the recommended pacing mode when the patient is at risk of developing bradycardia or even cardiac arrest as a result of a critical event. As the pacemaker function is controlled by the patient's ECG, the harmful competition between intrinsic and external stimulation which could induce ventricular fibrillation is excluded.

Check that the ECG electrodes and the pace

•

pads are correctly applied and connected to the device.

•

Press

Off

(24, Figure 6-1) to turn on the

pacemaker.

The device defaults to the Demand mode and selects a pacer rate of 60 P/min (configurable) (Figure 6-2).

Caution

Interrupted Arrhythmia Monitoring — Arrhythmia monitoring is disabled while the pacemaker is operating.

38 Marquette Responder® 3000 227 490 02-C

Pacemaker

•

Select a low pacer current output with

+ —

ECG

Pacer

Dem.

ECG

160 / 40

P/min

bpm

III

15.07.1998 09:05:00

SpO2

etCO2

QRSPulse

Tone

OFF

Figure 6-2. Pacer window

manual

e.g. 20 mA (19, Figure 6-1).

P/min

Select the required pacer rate with

•

Now increase the pacer current output slowly

•

with

+ —

until the heart reliably responds to

+ —

the stimulation. Increase the pacer current output another 5 mA

•

to ensure continued stimulation. Verify the stimulation by watching the ECG on

•

the display.

Start

You can press

•

Pause

press

Start

Pause

to pause the stimulation and

again to resume pacing with the same

settings. After therapy, turn off the pacemaker before

•

removing the pace pads carefully.

(To turn off the pacemaker press the

Off

for at least 2 seconds (this is to prevent that the

button

pacemaker is turned off inadvertently.) For this reason the Marquette Responder® 3000 cannot be turned off while the pacemaker is on.

227 490 02-C Marquette Responder® 3000 39

Pacemaker

+ —

Fixed-Rate Pacing

Note

The default pacer rate can be configured.

If a defibrillation shock is trigg e red during pacing, the pacemaker pauses automatically.

End the therapy as described under "Demand Pacing" above.

Caution

Interrupted Arrhythmia Monitoring — Arrhythmia monitoring is disabled while the pacemaker is operating.

Caution

: The pacer pulses are delivered via the adhesive defibrillation electrodes which must be applied as described in chapter 4. Separate electrodes must be applied for acquisition of the ECG signal (chapter 7). The pacemaker can be enabled only when adhesive electrodes are connected. In fixed-rate m ode, the dev ice deliv ers pacing pulses at the selected rate and current. The selected rate remains constant and is not affected by intrinsic actions of the patient's heart. This is the preferred mode for cases of cardiac arrest.

•

Check that the ECG electrodes and the pace pads are correctly applied and connected to the device.

•

Press

Off

(24, Figure 6-1) to turn on the pacemaker. The device defaults to the Demand mode and selects a pacer rate of 60 P/min (configurable).

Dem

•

Press the

Fix

button for 3 seconds to activate the fixed-rate pacing mode (in the pacemaker window on the screen, you will see "Fix" instead of "Dem" (Figure 6-2).

•

Indicator 25 (Figure 6-1) goes off briefly with

delivered

each

•

Select the required pacer rate with

•

Now increase the pacer current output slowly with

pacing pulse.

P/min

+ —

until the heart reliably responds to

the stimulation.

•

Verify the stimulation by watching the ECG on the display.

•

Increase the pacer current output another 5 mA to ensure continued stimulation.

40 Marquette Responder® 3000 227 490 02-C

Displaying and Monitoring the ECG

L F

C C1

C4 C5 C6

7 Displaying and Monitoring the

ECG

red

white

black

R L

N F

yellow

green

Figure 7-1. Signal acquisition with 5 electrodes

red

black

R L

C4 C5 C6

N F

C1 C3C4

yellow

green

Figure 7-2. Chest electrode placement

Displaying the ECG

For a quick diagnosis of the ECG, you can use the defibrillation electrodes (paddles) to acquire the ECG. For in-depth examinations and heart rate monitoring, the ECG signal should be acquired via separate ECG electrodes. Five or 10 ECG electrodes can be applied to the patient. Ten electrodes are required for the 12SL measurement and interpretation program. Use silver/silver chloride electrodes, if possible. Otherwise the polarization voltages caused by the defibrillation shock could simulate cardiac arrest.

If you are using only 5 electrodes, apply them

•

as shown in Figure 7-1. When working with 10 electrodes, additionally apply all chest electrodes as shown in Figure 7-2.

Connect one (5 electrodes) or both leadwire

•

blocks to the patient cable (Figure 7-3).

Ensure that all leadwires are always connected. Otherwise the connector of the leadwire may come in contact with conductive parts and cancel the protection provided by the isolated patient input.

Set the energy selector to .

•

After the test screen, the standard screen display will appear (Figure 7-4), showing leads I, II and III (factory defaults).

Note

ECG lead II is used for analysis and for cal-

−

culation of the heart rate. If lead II is not available, the first suitable ECG lead displayed will be selected.

The 3-lead patient cable cannot be used with

−

this defibrillator.

Figure 7-3. Connecting the leadwires to the

patient cable

227 490 02-C Marquette Responder® 3000 41

Displaying and Monitoring the ECG

ECG

160 / 40

bpm

III

15.07.1999 09:05:00

SpO2

etCO2

QRSPulse

Tone

OFF

semiautom.

Figure 7-4. Standard screen display with ECG

Note

The main menu will automatically reappear, when no button is activated for a period of 30 seconds.

The HR window is green, indicating that no electrode problem was detected and the heart rate is within the alarm limits. I f an electrode problem exists, the color changes from green to blue (in addition, an audio signal sounds after 30 seconds configurable). If the HR violates one of the alarm limits, the color changes from g reen to red.

The default defibrillator settings are:

leads I, II, III (configurable)

−

AC line filter enabled, muscle filter enabled

−

(configurable) gain 1 cm/mV (configurable)

−

the audio alarm for heart rate and CO

−

monitoring is disabled arrhythmia monitoring is enabled (do not rely

−

on this alarm alone because it will only be activated in the event of shockable arrhythmias; also monitor the patient by means of the HR alarm limits).

These settings can be changed permanently from the setup menu (chapter 13 "Defibrillator Setup") or temporarily.

For monitoring of the heart rate, please observe the information in the following section "Heart Rate Monitoring".

Assigning Channel Waveforms

•

Press F1

•

Press Using F1, select the lead to be displayed in

ECG

I...III, aV...V, Paddle

again.

channel 1, with F2 select the lead for channel 2, and with F3 select the lead for channel 3 (with each key press the device advances to the next lead).

Gain Selection

•

Press F1

•

Change the signal size with F2

42 Marquette Responder® 3000 227 490 02-C

ECG

1 cm/mV

Displaying and Monitoring the ECG

Activating and Deactivating Filters

Activating muscle and AC line filters makes the displayed ECG insensitive to AC interference and muscle tremor. However, the filters alter the ECG signal, and a filtered signal is not suitable for diagnosis (displayed or printed ECG). The heart rate is always derived from the raw ECG signal.

Press F5

•

Using F1

•

Next Menu

Filter

, enable or disable the muscle

filter, as appropriate. The AC line filter is enabled and disabled from

•

the setup menu.

Note

Active filters will alter the ECG signal. Switch off the filters to obtain a diagnostic ECG.

Enabling/Disabling the QRS Beep

The QRS beep can be enabled (high, middle, low volume) and disabled with F3

QRSPulse Beep .

227 490 02-C Marquette Responder® 3000 43

Warning

No Asystole Alarm — The defibrillator gives asystole alarm only when the heart rate falls below the low HR limit. Therefore, do not disable the low HR limit.

Incorrect HR / No HR Alarm — In the presence of arrhythmias and morphological changes of the ECG, the device may not be able to calculate the correct heart rate. Beats may be counted twice or may be ignored.

Note

The defibrillator can be set up to automatically activate the alarm tone on power up. The default alarm limits can also be adjusted in the setup menu.

Furthermore the defibrillator can be set up fo r continuous ECG analysis. If the algorithm identifies shockable arrhythmias, the defibrillator will display the message "Check Patient" (manual defibrillator) or "Press Analyse" (semiautomatic defibrilla tor). When the audio alarms are active, the device will also em it an audible signal. During patient transport the device may fail to identify these arrhythmias due to mo tion artifact.

ECG

160 / 40

bpm

Displaying and Monitoring the ECG

Monitoring Heart Rate

The default heart limits are 40 and 160 bpm and the audio alarm is disabled (factory default settings, bell symbol in button F4 is crossed out

). The audio alarm can be enabled permanently from the setup menu or temporarily with (symbol

The defibrillator reports an alarm condition if the HR exceeds one of the alarm limits for more than 10 seconds:

−

the HR window and the QRS indicator change from green to red,

−

the audio alarm sounds (configurable),

−

the recorder starts (configurable),

−

the alarm is annotated in the full disclosure ECG.

When the parameter reading returns to the normal range, the window and the QRS indicator change back to green and the audio alarm stops.

You can also silence the alarm tone with the alarm cause persists, the alarm condition is reported again after 120 s (a count-down timer in the button indicates the remaining time in seconds). To permanently disable the audio alarm, press the button longer than 2 seconds. Then the symbol reappears.

The alarm limits can be modified permanently from the setup menu or temporarily as described below:

appears).

. If

•

High ECG

III

15.07.1998 09:05:00

Alarm AlarmLow

ECG

semiautom.

Press F1

•

Press F3

The display shown in Figure 7-5 will appear.

•

Change the high limit with limit with

ECG

Alarm Limits

F3/F4.

F1/F2

and the low

Figure 7-5. Buttons for modification of the HR

alarm limits

44 Marquette Responder® 3000 227 490 02-C

Displaying and Monitoring the ECG

Monitoring Arrhythmia

The device allows you to continuously monitor the ECG for arrhythmias (see Appendix "The Arrhythmia Detection Program").

The program is enabled and disabled from the setup menu (see chapter 13, section "Device – Analysis").

When the program is active, you will see the message "VF/VT" in the ECG parameter window (Figure 7-6).

When the analysis algorithm detects a shockable arrhythmia, the message "Check Patient" (manual defibrillator) or "Press Analyse" (semiautomatic defibrillator) is displayed, and the device will also give VF alarm. When the audible alarm is active you will also hear an alarm tone.

Enabling the pacemaker will automatically interrupt the arrhythmia monitoring program.

Due to motion artifact the device may not be able to detect these arrhythmias during patient transport.

Note

Do not rely on this alarm alone because it will only be activated in the event of shockable arrhythmias; also monitor the patient by means of the HR alarm limits.

Monitoring Pacemaker Patients

When monitoring the heart rate of pacemaker patients, only the patient's QRS complexes must be counted and pacer pulses must be rejected. For this purpose, the Marquette Responder® 3000 has an electronic pacer pulse suppression algorithm which rejects the pacer pulses so they are not counted as QRS complexes. Depending on the pacemaker model used and on the position of the electrodes, the compensation pulse following every pacer pulse may be considered as a QRS complex. Every pacemaker must provide an oppositely charged current (reverse current) after delivering a pacing pulse. In this situation and when the pacer pulse is ineffective, the displayed heart rate may be misinterpreted, and the device will not give alarm in the presence of bradycardia or asystole.

Always monitor pacemaker patients by means of separate ECG electrodes and not via the defibrillation electrodes.

As an additional precaution, monitor pacemaker patients by means of pulse oximetry.

It depends on the pacer pulse parameters, whether or not the compensation pulse is counted as a QRS complex (see chapter 19 "Technical Specifications").

For pacemaker patients, the ECG signal size should be greater than 1 mV.

VF / VT

ECG

160 40

bpm

III

15.07.1999 09:05:00

SpO2

etCO2

QRSPulse

Tone

OFF

semiautom.

Warning

No HR Alarm — If several adverse conditions exist at once during monitoring of pacemaker patients, the possibility that pacer pulses are interpreted (and counted) as QRS complexes should be considered. Therefore, pacemaker patients should always be watched closely.

Figure 7-6. Arrhythmia monitoring enabled

227 490 02-C Marquette Responder® 3000 45

12-Lead ECG Analysis Program (12SLTM)

8 12-Lead ECG Analysis Program (12SL TM)

Introduction

Overview

The first human electrocardiogram was taken over a hundred years ago, and computerized electrocardiography has been in existence since the late 1950s.

The pioneers of this technology had motivations which could mimic human activity to the basic requirement of efficiently recording artifact free tracings.

Computerization has resulted in two practical advantages for the overreading physician. First, the computer can serve as an additional expert opinion. Second, cardiologists have found that it is possible for them to overread computer analyzed tracings in half the time required for conventional, non-analyzed ECGs.

The computer, therefore, is not only used to efficiently record, store, transmit, and present the ECG; but it is also used to assist the physician in overreading an ECG.

A program's accuracy is directly dependent upon the quality of the signal it acquires. In 1979, Marquette Hellige introduced an electrocardiograph that simultaneously acquired all of the leads from the 12-lead electrocardiogram. Prior to this time, all commercially available electrocardiographs could only acquire 3 leads at a time.

Simultaneous recording was adopted so that the computer could use all signals from all 12 leads to properly detect and classify each QRS complex.

It should be made clear that a computerized analysis is not a substitute for human interpretation. There are two reasons for this. First,

statements of accuracy need to be viewed from a statistical perspective. Although accuracy levels may be high, outliers can and will exist. Second, a computer does not have the ability to include the entire clinical picture of the patient. A person with

organic heart disease can exhibit an ECG within normal limits. Conversely, a normal individual can have an abnormal appearing ECG. The ECG, therefore, must always be reviewed in light of the surrounding clinical circumstances.

46 Marquette Responder® 3000 227 490 02-C

12-Lead ECG Analysis Program (12SLTM )

Median Beat, Signal Averaging

Computer measurement for features within the QRS complex are very susceptible to artifact. To remove artifact, filtering may be used. Beyond filtering, there is another method able to eliminate noise from the QRS complex: signal averaging. Instead of analyzing a single QRS complex, the 12 SL program generates a median complex. In other words, all QRS complexes of the same shape are aligned in time. Next, the algorithm generates a representative QRS complex from the median voltages that are found at each successive sample time. This is more complicated than creating an average. The method results in a cleaner signal since it is able to disregard outliers.

Comparisons of all averaging against all nonaveraging programs yields a 70% higher detection instability for the non-averaging programs and worse performance in most tested measurements.

Measurements, Onsets and Offsets

All ECG computer programs are composed of two parts: one which measures the waveforms and one which does the analysis based upon those measurements. The main task of computerized measurement determines the location of major reference points (onsets and offsets for P, QRS, and T waves). Consistent with the signal processing portion of the program, the major wave onsets and offsets are delineated by an analysis of the slopes in all 12 simultaneous leads. That is, QRS duration is measured from the earliest onset in any lead to the latest deflection in any lead. Similarly, the QT interval is measured from the earliest detection of depolarization in any lead to the latest detection of repolarization in any lead. After the onsets and offsets for P, QRS, and T complexes have been demarcated, the waves within each complex are then measured according to published standards. These amplitudes and durations result in a measurement matrix containing more than 1600 values. Measurements are then passed onto the criteria portion of the program so that it can generate an interpretation.

Literature "Marquette Hellige 12SL

Program", PN MO 1417 DE 0, English

ECG Analysis

227 490 02-C Marquette Responder® 3000 47

ECG

Start

160 / 40

bpm

15.07.1998 09:05:00

Print Recall

Figure 8-1. 12SL analysis menu

12-Lead ECG Analysis Program (12SLTM )

12SL Measurement

For measurement and interpretation 12 seconds of ECG data are saved. After the analysis, the interpretation is presented on the monitor screen. You can also print the ECG including the measurement results and the interpretation. The printed segment, however, is only 3,2 seconds. If 12SL analysis was already performed with the defibrillator when you activate the program, the previous interpretation will appear on the display. In addition, the full-disclosure ECG of channel 1 is

semiautom.

stored in the ECG memory.

Press F1

•

Display the 12SL menu with

•

ECG

8-1).

12SL

(Figure

ECG

Recall

160 / 40

bpm

20.07.1998 14:35:37 NORMAL SINUS RHYTHM NORMAL ECG

20.07.1998 14:35:37

Recall

Figure 8-2. 12SL interpretation

semiautom.

Press F1

•

to start the program.

Start

After acquisition, the ECG data is analyzed and stored. Afterwards, the interpretation is displayed on the screen (Figure 8-2).

Press F2

to print the ECG, including

measurement results and interpretation. Press F4

Recall

to recall the 3 most recent 12SL records. The corresponding acquisition time is shown in the softkey.

48 Marquette Responder® 3000 227 490 02-C

ECG

SpO2

160 / 40

Pulse Oximetry

9 Pulse Oximetry (SpO2)

Some Basic Facts

SpO2 measurement is used to determine the

bpm

---

SpO2

percentage of functional hemoglobin saturated with oxygen in the patient's arterial blood. Alarm limits can be set for monitoring of the SpO

value.

The plethysmogram waveform can be displayed on the screen (Figure 9-1).

III

15.07.1999 09:05:00

semiautom.

ECG

SpO2

etCO2

QRSPulse

Tone

OFF

Figure 9-1. SpO2 value and plethysmogram

Warning

False Parameter Readings — Pulse oximetry is not suitable for oxygen monitoring of fetuses (ante-partum or sub-partu). Also this method is not suitable for patients with carbon monoxide poisoning. Elevated levels of carboxyhemoglobin (CO-Hb) and methemoglobin (Met-Hb) may affect the measured values. Also dyes injected in the blood stream (such as Cardiogreen) may impair measurement accuracy.

The device measures arterial oxygen saturation by a method called pulse oximetry. This method is based on the measurement of the different absorption spectra of reduced hemoglobin and oxyhemoglobin.

Therefore the probes consist of a light source (two LEDs in most cases) and a photodetector on the opposite side which collects the incident light. After interaction with the blood and tissue, the red and infrared light (range between 660 nm and 940 nm) from the LEDs hits the photodetector which converts it into an electrical signal. The pulsatile component of the signal is used to build the plethysmogram.

Literature

UKITSCH

D.R.;P

, M.W.; P

OLOGE

ETTERSON

, J.A.: Pulse Oximetry: Analysis of Theory, Technology, and Practice, J. Clin. Monit. 4: 290–301 (1988)

, M.T.; T

OBLER

Warning

No Alarm — Under certain conditions the device may not be able to identify a signal disturbance when monitoring the patient. In this situatio n artifacts are capable of simulating a plausible

, W.T.; T

ECIL

A Clinical Evaluation of the Accuracy of the Nellcor N100 and Ohmeda 3700 Pulse Oximeters, J. Clin. Monit.

: 31–36 (1988)

HORPE

, K.J.; F

IBUCH

E.E.; T

UOHY

, G.F.:

parameter reading, so that the monitor fails to sound an alarm. In order to ensure reliable patient monitoring the proper application of the probe and the signal quality must be checked at regular intervals.

227 490 02-C Marquette Responder® 3000 49

Pulse Oximetry

C-Lock ECG Synchronization

The C-Lock ECG synchronization feature enables the device to use an ECG signal as a reference point for identifying the pulse and synchronizing saturation measurements. This enhances the measurement accuracy when the patient's perfusion is poor and in the presence of patient movement. When an ECG signal is present during SpO

measurement, the device receives two separate signals that reflect cardiac activity; an optical/electrical signal from the SpO

probe and the

ECG signal. The time that elapses between the ECG R-wave and the optical pulse detected at the probe site depends on the heart rate and on the location of the probe. However, for a given patient the length of the delay is relatively stable, and the device uses that time relationship to identify good pulses and reject non-synchronized artifacts.

Application Tips

General Tips

Use only the probes listed in chapter 20 "Order

−

Information". Apply the probes as described in their instructions for use. Carefully observe all information and cautions given in these instructions.

Take care that the probe does not exert too

−

much pressure when applied to avoid erroneous readings and blistering. Inadequate oxygen supply to the skin, not heat, causes blisters.

Change the probe site at least every 24 hours to

−

allow the skin to breathe. Be careful to ensure continued circulation at

−

the probe site. Incident light may cause inaccurate readings.

−

Cover the measuring site with a cloth, if necessary.

It may not be possible to measure SpO

−

values,

if cardiac output is determined at the same time by means of the dye dilution technique.

It may not be possible to measure SpO

−

values

or the pulse rate, if the circulation is impaired (e.g. by a blood-pressure cuff or by an extremely high vascular resistance).

Remove nail varnish and artificial finger nails

−

before applying the probe. Both may lead to inaccurate readings.

Do not apply the finger probe to the same arm

−

as the blood-pressure cuff.

50 Marquette Responder® 3000 227 490 02-C

Pulse Oximetry

To minimize motion artifact

take care to provide an ECG of good quality

−

(C-Lock ECG synchronization), use a new probe with fresh adhesive backing,

−

move the probe to a less active site,

−

select a slow integration time.

−

When monitoring SpO

during electrosurgical

intervention, take care that

the device is powered from the internal battery

−

or from a different power circuit than the electrosurgical unit,

the ground pad is close to the surgical site,

−

the probe is applied as far from the surgical

−

site, the ground pad and the electrosurgical unit as possible.

In the presence of AC line interference

When interference signals from the power line

−

are present, square waves may be displayed instead of the plethysmogram. In this situation we recommend to disconnect the device from the power line and operate it on battery power.

227 490 02-C Marquette Responder® 3000 51

ECG

SpO2

ECG

160 / 40

bpm

---

III

15.07.1999 09:05:00

SpO2

etCO2

QRSPulse

Tone

OFF

semiautom.

Figure 9-2. SpO2 parameter window

Pulse Oximetry

Measuring and Monitoring Oxygen Saturation

Apply the probe as described in the user

•

instructions supplied with the probe and connect it to the defibrillator (blue connector).

The SpO sensor is connected. During the short self-test, the parameter window is blue. As soon as the probe supplies a valid signal, the color changes to green (Figure 9-2).

At the factory, only a low limit of 90% is adjusted, no high limit. When the parameter reading drops below this value, the defibrillator sounds an alarm and the window changes from green to red.

measurement begins as soon as the

C-LOCK

OFF

Integ.

Time

8 s

QRSPulse

Tone

OFF

Source

ECG

Figure 9-3. SpO2 menu

Note

Disable the C-Lock ECG synchronization feature when monitoring pacemaker patients.

Warning

Delayed Alarm — When monitoring the pulse rate derived from the SpO2 signal instead of the heart rate, select an integration time of 4 or 8 seconds; do not select 12 seconds because of the slower display update.

Enabling/Disabling C-Lock ECG Synchronization

With the factory default settings unchanged, the CLock ECG synchronization is disabled when the device is first turned on. If the ECG signal is acquired, enable the feature.

Press F2

•

Press F3

•

SpO2 etCO2

SpO2

(Figure 9-3) (displays only when SpO

to display the SpO2 menu

probe is

connected). Press F1

•

C-LOCK

to enable the C-Lock feature

(or press the key again to disable it).

Selecting the Integration Time

The integration time is the time over which the measured values are averaged. You can select an integration time of 4, 8 or 12 seconds. The default setting is 8 seconds. The integration time of 12 seconds should only be selected in exceptional cases.

Display the SpO2 menu as described above

•

(Figure 9-3). Select the integration time with F2

•

52 Marquette Responder® 3000 227 490 02-C

Integ. Time

Pulse Oximetry

Selecting the HR Source

The device can be set up to derive the heart rate from the SpO selected with F4 in the SpO

Adjusting Alarm Limits

signal. The heart rate source is

menu (Figure 9-3).

High

SpO2

Alarm

SpO2

AlarmLow

Figure 9-4. Alarm limits menu

Note

SpO2 alarms are similar to HR alarms. Please refer to chapter 7 "Displaying and Monitoring the ECG".

ECG SpO2

etCO2

QRSPulse

Tone

OFF

Figure 9-5. Main menu

↓

Filter

Assign

Channel

Waveform

DisplayMemory

Figure 9-6. Main menu, page 2

↓

Channel 1

ECG

Channel 2

ECG

Vit. Sign

Channel 3

ECG

Vit. Sign

Figure 9-7. Menu to assign waveforms to

channels

↓

The alarm limits can be modified permanently from the setup menu or temporarily as described below:

Press F2

•

Press F2

•

SpO2 etCO2

SpO2 Alarm Limits

to display the alarm

limits menu (Figure 9-4). Change the high limit with F1, F2 and the low

•

limit with F3, F4. To deactivate the SpO2 measurement, remove

•

the probe connector and press

SpO2 etCO2

Displaying the Plethysmogram

The plethysmogram can be displayed in channel 2 or 3 with a sweep speed of 25 mm/s.

•

Press Press Press

Next Menu

Assign Channel Waveform

(Figure 9-7) repeatedly until "SpO2" is

(Figure 9-5).

(Figure 9-6).

displayed (Figure 9-8). When the SpO2 measurement is disabled, a

sawtooth signal is displayed which can be replaced with an ECG lead.

ECG

SpO2

ECG

160 / 40

bpm

---

SpO2

III

15.07.1999 09:05:00

SpO2

etCO2

QRSPulse

Tone

OFF

semiautom.

Figure 9-8. Plethysmogram in channel 2

227 490 02-C Marquette Responder® 3000 53

CO2 ADAPTER

OPER/ALARM

Figure 10-1. CO2 sensor and airway adapter

a airway adapter b sensor c adapter cable

Infrared light source

Airway

adapter

No-fog membrane

Filter (4.3 µm)

Detector

Figure 10-2. Principle of operation

Capnometry (etCO2)

10 Capnometry (etCO2)

Some Basic Facts

The etCO2 sensor uses the infrared spectroscopy

method. The sensor consists of the sensor itself (including the IR source and the photodetector) and the airway adapter a which is attached to the sensor. The entire sensor is placed in the patient's airway (expired air) between the respirator and the tube. The airway adapter is for single use only. It must not be reused (Figure 10-1). The etCO mmHg and can be m onitored. A capnog ram waveform can be displayed on the screen.

Principle of Operation

The method of infrared spectroscopy is based on the fact that the CO absorbs infrared light at specific wavelengths. The absorbed amount of light is in proportion with the amount of CO membrane" ensures that no condensation collects on the sensor (Figure 10-2). The method used is a semi-quantitative measuring method and it is assumed that the inspired air is free of CO

etCO

Falk J L, Rackow E C, Weil M H (1988) End-tidal carbon dioxide concentration during cardiopu lmonary resus citation. New Eng l J Med 318: 607- 611 MacLeod B A, Heller M B, Gerard J et al. (1991) Verification of endotracheal tube placement w ith colorim etric end-tidal CO detection. Ann Em erg Med 20: 267-270 Sanders A B, Kern K B, Otto C W (1998) En d- tidal carbon dioxide monitorin g du ring CPR: A prog nos tic in dicator f or survival. JA MA 262: 1347-1351 White R D, Asplin B R (1994) Out- of-h ospital qu antitative monitoring of end- tidal carbon diox ide press ure du ring CPR. Ann Em erg Med 23: 25- 29 Bhavani-Shankar K; Mosley H; Kumar Y Y (1992) Capnometry and anaesthesia (Review Article). Can. J. Anaesth. 39: 617-632

gas in the patient's expired air

in the respired air. A "No-fog-

Monitoring Literature

value is given in

54 Marquette Responder® 3000 227 490 02-C

Safety Information

Capnometry (etCO2)

Warning

Observe the following information to prevent erroneous CO2 measurements. Inappropriate therapeutic measures based on erroneous readings may cause severe damage or the patient's death.

etCO2 measurement is not suitable for p atients under 3 years of age or patients weighing less than 10 kg.

The sensor may give inaccurate readings when used on patients with a respiration rate greater than or equal to 60 breaths per minute.

etCO2 measurement is not suitable for q uantitative measurement during intraoperative anesthesia or in the ICU environment.

etCO2 readings should be considered as additional parameters in the assessment of a patient's condition. They should always be seen in the context of other clinical signs and symptoms.

Do not use the sensor on patients with small tidal volumes because the dead space volume of the airway adapter is about 5 cc. This could affect the ventilation. If the tidal volume is too low, the sensor may not be able to d e tect the patient's inspiration and expira tion.

Do not touch or wipe the window of the airway adapter to avoid damage. If the window is damaged, water droplets may adhere to the surface which could affect the performance and accuracy of the sensor.

The airway adapter can be continuously used for about 24 hours under normal operating conditions. If blood, sputum or phlegm has entered the airway adapter, discard the airway adapter and use a new one.

Do not measure the etCO2 concentration on a patient undergoing an MRI examination. This could cause the sensor to give inaccurate readings.

The sensor may give lower readings when used in a low pressure environment (do not use in airplane).

Do not allow condensation to develop in the sensor, condensation can attenuate the signal, resulting in degraded performance.

The sensor may give erroneous read ings when exposed to rapid temperature changes.

The readings may be inaccurate when CO2 is present in the airway adapter during inspiration. The displayed etCO2 values are based on the assumption that the inspired a ir is free of CO2. The readings obtained during mouth-tomouth resuscitation may therefore b e inaccurate. The same is true if Jackson-Rees and Mapleson-D ventilators are used.

The readings may be inaccurate in patients with high or irregular respiration rate (indicator in sensor goes briefly off).

The measurement accuracy depends on the altitude of the measurement site. It decreases with increasing altitude (Figure 10-6) .

Note

In most cases the endtidal CO2 value (etCO2) is below the arterial CO2 partial pressure (paCO2) determined by blood-gas analysis (see Literature). Possible clinical causes are:

- dead-space ventilation, ventilation/pe rfusion mismatch

- decreased cardiac output

- alveolar shunts

- incomplete emptying of the alveoli.

High concentrations of nitrous oxide (N2O) or halogenated anesthetic agents can cause the sensor to give inaccurate readings.

227 490 02-C Marquette Responder® 3000 55

Capnometry (etCO2)

Figure 10-3. Attaching the airway adapter

ECG

etCO2

ECG

Figure 10-4. etCO2 reading

160 / 40

mmHg

bpm

---

III

15.07.1998 09:05:00

etCO2

SpO2

QRSPulse

Tone

OFF

semiautom.

Measuring and Monitoring etCO

Obtain a new airway adapter and check that the

•

windows are intact and clean. Attach the airway adapter to the sensor (the

•

triangles on the airway adapter and on the sensor must be in alignment - Figure 10-3).

Connect the airway adapter to the respirator

•

system (connector c towards the patient, connector d towards the respirator - Figure 10-3).

Ensure that the sensor is on top and that the

•

windows of the airway adapter are in a vertical position. Although the "No-fog-membrane" prevents moisture condensation on the window, liquid secretions could soil the window.

Connect the sensor to the defibrillator (yellow

•

connector, right).

The CO

measurement begins as soon as the sensor

is connected. During the short self-test, the parameter window is blue. As soon as the sensor supplies a valid reading, the color changes to green. Check that the indicator on the CO

adapter

cable lights green; if a problem is detected, the indicator flashes red (apnea or system failure).

At the factory, only a low etCO

limit of 20 mmHg

is adjusted, no high limit. When the parameter reading drops below this value, the defibrillator sounds an alarm and the window changes from green to red.

Adjusting Alarm Limits

High

etCO2

Alarm

etCO2

AlarmLow

The alarm limits can be modified permanently from the setup menu or temporarily as described

Figure 10-5. Alarm limits menu

Note

etCO2 alarms are similar to HR alarms. Please refer to chapter 7 "Displaying and Monitoring the ECG".

56 Marquette Responder® 3000 227 490 02-C

below:

Press F2

•

Press F1

•

SpO2 etCO2

etCO2 Alarm Limits

to display the alarm

limits menu (Figure 10-5). Change the high limit with F1, F2 and the low

•

limit with F3, F4. To deactivate the etCO2 measurement, remove

•

the sensor connector and press

SpO2 etCO2

Capnometry (etCO2)

altitude error

-5.0%

-10.0%

-15.0%

-20.0%

error

-25.0%

-30.0%

-35.0%

-40.0%

0.0%

500 1000 1500 2000

altitude (m)

2500 3000 3500 4000 50004500

Figure 10-6. Measurement accuracy as a function

of the altitude of the measuring site

↓

ECG SpO2

etCO2

Figure 10-7. Main menu

QRSPulse

Tone

OFF

↓

Filter

Assign

Channel

Waveform

DisplayMemory

Displaying the Capnogram

The capnogram can be displayed in channel 3 with a sweep speed of 6.25 mm/s (but it is printed with a speed of 25 mm/s).

Press

•

Press Press

Next Menu

Assign Channel Waveform

(Figure 10-9) repeatedly until "etCO2"

is displayed (Figure 10-10). When the etCO2 measurement is disabled, a

•

sawtooth signal is displayed which can be replaced with an ECG lead.

During the automatic sensor calibration

•

process, a calibration pulse is superimposed on the capnogram (a, Figure 10-10).

(Figure 10-7).

(Figure 10-8).

Figure 10-8. Main menu, page 2

↓

Channel 1

ECG

Channel 2

ECG

Vit. Sign

Figure 10-9. Menu to assign waveforms to

ECG

etCO2

ECG

160 / 40

mmHg

bpm

---

etCO2

15.07.1999 09:05:00

etCO2

SpO2

Figure 10-10.Capnogram in channel 3

Channel 3

ECG

Vit. Sign

channels

QRSPulse

Tone

OFF

a automatic sensor calibration

semiautom.

Cleaning the Sensor

Use a soft cloth moistened with an alcoholic, nonabrasive cleaning agent to wipe the sensor surface including the IR light source, the photodetector and the connecting lead carefully clean. Use an alcoholic, non-abrasive cleaning agent.

Caution

Damage to Sensor — Do not use caustic or abrasive cleaners or hard cleaning utensils.

Do not touch the surface of the IR light source or of the photodetector with fingers or any hard object. This could affect the performance of these fine optical devices.

Do not autoclave the sensor or sterilize it with ethylene oxide.

Do not immerse the sensor in liquid.

Warning

Infection Hazard — The airway adapter is for single use only and must not be reused.

227 490 02-C Marquette Responder® 3000 57

Memories of the Marquette Responder® 3000

Event

11 Memories of the Marquette

Responder® 3000

Note

Switching off the defibrillator does no t automatically clear the memories. Therefore, the memories could contain data from different patients. We recommend to clear the memories before using the defibrillator on a new patient, or to program an event text "New patient" (see section "Event Button" in chapter 3 and "Event Texts" in chapter 13). Changing the date and/or time will clear the memories.

The Marquette Responder® 3000 has 4 different memories:

an event memory

−

an ECG memory

−

a trend memory

−

a 12SL memory (optional).

−

Event Memory

The event memory stores up to 250 events, annotated with date, time and parameter readings (e.g. HR), which document the operating procedures (e.g. device on, off, alarms, defibrillation shocks, events -

-). When the event memory is full, the device updates the information automatically by saving new events and deleting old ones. It is also possible to clear the memories (see below).

ECG SpO2

etCO2

QRSPulse

Tone

OFF

Figure 11-1. Main menu

↓

Filter

Figure 11-2. Main menu, page 2

Assign

Channel

Waveform

↓

Event

Text

Trend Playback

Figure 11-3. Memory menu

Primary

Events

All

Events

Figure 11-4. Memory menu

Clear

Memory

When printing the contents of the memories you can choose between a list of the major events ("Primary Events") and of all events ("All Events"). The primary events include device on, device off, shock advised, no shock advised, pacer pause,

↓

configuration change, alarm silence and all alarms.

In the main menu, select

•

Next Menu

(Figure 11-

1).

DisplayMemory

You will see page 2 of the main menu (Figure 11-

2).

Press

Memory

(Figure 11-2).

•

You will see the memory menu (Figure 11-3).

Press F1

•

Event Text

You will see the menu shown in Figure 11-4.

Press F1

•

Print Primary Events

events, or press F2

to print the major

Print All Events

to print all

events.

58 Marquette Responder® 3000 227 490 02-C

Memories of the Marquette Responder® 3000

ECG Memory

The defibrillator saves the most recent 180 minutes of full disclosure ECG data displayed in channel 1 and acquired while the defibrillator was on. When the memory is full, the information is automatically updated, so that the most recent 180 minutes are always available. It takes about 1 minute before the stored ECG can be played back.

You can either print the full disclosure ECG in 5second segments, or you can search the data for events that occurred in the last 180 minutes and then print the corresponding ECG strip.

Events whose ECG strips are older than 180 minutes are still listed in the event memory (if they are among the most recent 250 events), but the ECG strip is no longer available. When you attempt to print this event, the message "No ECG Data" will be displayed.

ECG

160 / 40

bpm

III

21.07.1999 12:05:15

21.07.1998 12:05:15

Figure 11-5. Playback function

semiautom.

Select

ECG

Printing the ECG

Press F5

•

Next Menu

in the main menu to display

page 2 (Figure 11-2). Display the memory menu with F3

•

Memory

(Figure 11-3). Display the playback menu with F4

•

Playback

(Figure 11-5).

Now you can scroll through the stored ECG in steps of 5 seconds with F1 and F3. The corresponding time is annotated below the waveform window (Figure 11-5).

•

Press

to print the displayed segment (press

again to stop the printout).

If you want to find events in the full disclosure ECG, activate the search function with F4 "Select Event". You can now move between events with F1 and F3. Date and time of the event are displayed below the waveform window.

Press

•

227 490 02-C Marquette Responder® 3000 59

to obtain a printout of the event.

Memories of the Marquette Responder® 3000

Note

Power on and off are marked with a vertical line in the graphic trends.

ECG SpO2

etCO2

QRSPulse

Tone

OFF

Figure 11-6. Main menu

↓

Filter

Assign

Channel

Waveform

Figure 11-7. Main menu, page 2

DisplayMemory

↓

Event

Text

Trend Playback

Figure 11-8. Memory menu

Clear

Memory

↓

Trend Memory

In the trend memory the device collects the HR,

and etCO2 values of the past 4 hours. The

SpO

trend data, too, are automatically updated. The stored data can be printed out in the form of graphic trends. You can choose between a 1-hour and a 4-hour trend window.

Press F5

•

Next Menu

in the main menu to display

page 2 (Figure 11-7). Display the memory menu with F3

•

Memory

(Figure 11-8). Display the trend menu with

•

Trend

(Figure

11-9). In the trend menu (Figure 11-9), select the time

•

window The following graphic trends are now available

•

Trend 4 h

Trend 1 h

with F4.

for printing:

heart rate with F1

−

SpO etCO

with F2

with F3

Print HR

Print SpO2

Print etCO2

↓ ↓ ↓

SpO2

Figure 11-9. Trend menu

etCO2

TREND 01.10.99

Patient..........................:

Date of birth.................:

User..............................:

Comments....................:

HR BPM

60min 45min 30min 15min 0min

↓

Trend

4 h

120

Clearing the Memories

The memories cannot be cleared individually, all of them are cleared in one pass .

Press F5

•

Next Menu

in the main menu to display

page 2 (Figure 11-7). Display the memory menu with F3

•

Clear the memories with F3

•

Memory

Clear Memory

. Keep

the button depressed until the text disappears.

Figure 11-10.Graphic trend

device OFF

60 Marquette Responder® 3000 227 490 02-C

Recording

12 Recording

Initiating a Recording

Contin.

Printout

Hardcopy

14 s

Figure 12-1. Print menu

Auto.

Printout

The recorder can be started and stopped with

. With the factory settings unchanged, the recorder will print a 14-second strip of the displayed ECG and a status report when you press

. Then the recorder

stops. The recording can be stopped at any time with

. You can also set up the recorder to continue printing the ECG until stopped with

(Cont. printout - ON). Simultaneously press

and

Event

.to obtain a

hardcopy of the screen display.

Print Menu

•

Press

for approx. 2 seconds to display the

print menu.

The display shown in Figure 12-1 will appear.

With F1

•

Contin. Printout

you can start and stop a

continuous recording. With F2

•

Hardcopy

you can print a hardcopy of

the screen display. With F3

•

you can print a 14-second ECG

14 s

strip. With F4

•

Auto. Printout

you initiate an automatic (synchronized) recording of all leads (12 standard leads with 10-lead patient cable or 7 leads with 5-lead patient cable) (only in conjunction with the optional "12 SL" program).

In the setup menu, you can choose the condition for an automatic 14-second ECG strip (incl. a history of 4 seconds):

upon delivery of a defibrillation shock ("Print

−

on shock - ON") upon violation of a HR limit ("Print on alarm -

−

ON").

On the recording, a dashed line marks the time the alarm/event occurred.

227 490 02-C Marquette Responder® 3000 61

Figure 12-2. Opening the paper compartment

door

Recording

Loading Chart Paper

To prevent damage to the printhead, use the original HELLIGE CONTRAST paper only (P/N 226 168 02).

•

Open the paper compartment door all the way (Figure 12-2).

Remove the spindle with the sleeve of the previous paper roll.

Insert the spindle in the new roll and place the roll into the device as shown in Figure 12-3.

Pull a length of paper (approx. 15 cm) from the compartment and close the door (Figure 12-4). The paper compartment door must click into place audibly on both sides.

Figure 12-3. Inserting the new roll

The last 3 meters of the roll paper are marked. Insert a new paper roll in time to ensure that all alarm recordings are documented.

Caution

Risk of Skin Burns — When inserting a new paper roll, be careful not to touch the thermal printhead. Particularly after long recording s it may be very hot.

Paper Jam — When operating the defibrillator in the carrying bag, the flap covering the recorder must be open and secured with the Velcro fastener against dropping to prevent that it obstructs the paper exit.

Figure 12-4. Closing the paper compartment door

Note

If you store the recordings in plastic folders these should be made of polyethylene, because the traces fade in PVC covers (if in doubt, insert a sheet of paper between recording and folder).

62 Marquette Responder® 3000 227 490 02-C

ECG

160 / 40

bpm

Setup

ALARM LIMITS

ECG DEFIB DATE/TIME DEVICE PASSWORD EVENT TEXTS BATTERY OPTIONS

20.07.1998 14:35:37

ENTER

Figure 13-1. Setup menu

semiautom.

EXIT

Defibrillator Setup

13 Defibrillator Setup

The defibrillator has a setup menu which allows you to adjust many of the device functions to your preferred settings and to save these as defaults which are activated each time the defibrillator is switched on.

Simultaneously press F1 and F5 to display the configuration menu (if the password function is enabled, you will be prompted to enter the password – see "Password" below).

You will see the setup menu as shown in Figure 13-1.

For a complete list of the parameters of each menu item, please refer to table 1 on page 15.

ECG

Print on Alarm

Lead Fail Alarm Alarm Tone QRS Beep Muscle Filter Gain Lead Channel1

160 / 40

bpm

Channel2 Channel3

off off off off on 2 I II III

20.07.1998 14:35:37

Figure 13-2. Setup, ECG menu

semiautom.

The operating steps are always the same:

Use the arrow keys F1, F2 to position the bar

•

cursor on one of the topics and press

ENTER

This will open the corresponding submenu, e.g. the ECG menu (Figure 13-2).

Use the arrow keys to position the bar cursor on

•

the parameter to change. Change the setting with F3

•

Select

•

Select

Previous Menu

Save & EXIT

to quit the menu and save the

to close the submenu.

or F4

new settings.

•

Select

if you wish to quit the menu

EXIT

without saving the changes.

227 490 02-C Marquette Responder® 3000 63

Defibrillator Setup

Alarm Limits

selection of the HR, SpO

and etCO2 alarm limits

ECG

Print on Alarm

recorder starts upon violation of an alarm limit

Lead Fail Alarm

audio signal when electrode is off the patient

Alarm Tone

audio signal upon violation of alarm limit

QRS Beep

audio signal to the rhythm of the heart beat

Muscle Filter

elimination of motion artifact (35 Hz ECG, 20 Hz Paddles)

Gain

for the displayed ECG (0.5, 1, 2 cm/mV)

Lead Channel 1/2/3/Vital Signs

ECG leads and vital signs waveforms to display in the 3 channels, from top to bottom

Note

Autosequence

entry of the energy levels for the 1st, 2nd and 3rd defibrillation shock

Pacemaker

default pacer rate

Date/Time

Date format

either DD.MM.YYYY (day, month, year) or MM/DD/YYYY (month, day, year).

Note

Date and time are saved immediately, without pressing

Save & EXIT

. All memories will be cleared.

Device

Display

screen display normal, reverse, SmartFlip (automatic display flip after insertion in vehicle mounting unit)

Volume

for alarms, QRS beep, and alerts

ECG lead II is used for analysis and for calculation of the heart rate. If lead II is not availab le, the first suitable ECG lead displayed will be selected.

Defib Print on shock

recorder starts upon shock release

Operating Mode

semiautomatic, manual, semiautomatic/button, semiautomatic/password

When choosing "semiautomatic/password", the defibrillator requests a 3-digit password which can be entered with F1, F2 and F3 (factory-set password: "111").

Cont. Printout

Continuous printout enabled: When initiated with

the recorder continues printing until stopped

with

Continuous printout disabled: When initiated with

the recorder prints a 14-s ECG strip and then

stops automatically.

Analysis

Enables/disables the arrhythmia monitoring program. When the analysis algorithm detects a shockable arrhythmia, the message "Check Patient" or "Press Analyse" will be displayed.

64 Marquette Responder® 3000 227 490 02-C

Defibrillator Setup

AC Line Filter

eliminates AC interference (50 Hz = filter enabled, 50 Hz AC line frequency in Europe; 60 Hz = filter enabled, 60 Hz AC line frequency in the USA)

Language

language selection for the display and recorder.

Factory Default

to restore the factory defaults Restoring the factory defaults will not affect the device settings marked with the asterisks ** in table 1 on page 15.

User

entry of a text or of the institution name (will be printed in the lower margin of the recording strip) Using

←

character; with

, choose the position for the

→

↑

, choose the letter or

↓

number.

Changing the Password

•

Using F1

↓

or F2

, position the bar

↑

cursor on PASSWORD and confirm the selection with F3

ENTER

The password menu will be displayed. The bar cursor highlights the menu item "Password".

•

Confirm the command with F4

The menu for entry of the password will be displayed.

0000 ENTER

Figure 13-3

•

First, enter the old password with F1, F2 and F3 (factory-set password: 111) and confirm it with F5

ENTER

. If you do not remember your own password, you can use the master password (see footnote).

The menu for entry of the password appears only if you enter the current password at this point.

Password

The password function allows you to protect conversion of the defibrillator to the manual mode (for defib set up for "semiautomatic / password). With the same password you can also lock the setup menu, so that only persons knowing the password have access to this menu.

The factory-set password is 111, and access to the setup menu is not locked ("For setup - OFF").

To protect the defibrillator setup, choose "For setup - ON". In this case, you will have to enter the code combination before you can display the setup menu.

•

Press F2

twice to display the current

→

password (***).

Figure 13-4

•

Using the 4 cursor keys F1, F2, F3 and F4, overwrite the current password with your new password and confirm it with F5

ENTER

The submenu appears.

–+

Figure 13-5

•

Select F5

•

Exit the setup menu with F5 F4

Previous Menu

, if you do not want to use the new

EXIT

to close the submenu.

Save & EXIT

password).

ENTER

(or with

✂-------------------------------------------------------------------------------------------------------------------------------------

The master password which overrides all other passwords is 360 (can be used if you forget your own password).

227 490 02-C Marquette Responder® 3000 65

Defibrillator Setup

Event Texts

Entry of up to 8 event texts (max. 8 characters each); these texts are assigned to the softkeys F1 to F4 (chapter 3, section "Event Button") Using character; with

←

, choose the position for the

→

↑

, choose the letter or

↓

number.

Battery

For details on the battery maintenance program, please refer to chapter 14, section "Battery Maintenance Program".

Options

For activation of optional program modules (Figure 13-6). The defibrillator serial number has already been entered. We need to know this number when you order optional program modules. Then you will be given the option code number. When you enter this number and exit the configuration menu with

Save & EXIT

, the defibrillator will automatically

restart and activate the new program module(s).

ECG

OPTIONS

SER. NO

12SL VFVT

160 / 40

bpm

100.00.309

604.705.273.662

221.763.542.440

20.01.1999 14:35:37

–+

Figure 13-6. Activating optional program

modules 12SL: ECG analysis program VFVT: semiautomatic defibrillator

66 Marquette Responder® 3000 227 490 02-C

Battery Power Operation

14 Battery Power Operation

Battery Charging (ambulance power supply, power line)

The batteries recharge when you

−

place the defibrillator in the vehicle mounting unit / wall mount unit or

−

connect the defibrillator to the power line (units with AC power adapter).

Figure 14-1. Battery charging indicators

Warning

Operational Readiness — Defibrillators a re emergency medical devices designed to save and preserve lives. They must be ready for use at all times. This applies also to mainsindependent operation. Ensure that the device battery is always fully charged.

Do not recharge NiCd batteries in direct sunlight, on sources of heat or at extremely low ambient temperatures (minimum temperature 5 °C/41 °F). The ambient temperature should not exceed 40 °C/104 °F, as this could have adverse effects on the battery's service life.

The two indicators (Figure 14-1) light up when the batteries are charging. Charging will take approx. 4 hours per battery (the batteries are recharged one after the other). The defibrillator can be operated in the vehicle mounting system or on mains power, even when the batteries are discharged. Also observe the information given in chapter 16 "Operation in the Vehicle Mounting Unit".

Charging the Batteries with the Separate Charging Unit ASU 3000

In addition to charging the batteries, the charging unit also maintains them (see section "Information on Battery Power Operation" below). Please note the instructions given in the charging unit operator's manual.

227 490 02-C Marquette Responder® 3000 67

Battery Power Operation

Electrode

ECG

160 / 40

bpm

III

15.07.1999 09:05:00

SpO2

etCO2

QRSPulse

Tone

OFF

semiautom.

Figure 14-2. Battery charge level indicators

Note

The battery on the left is the working battery, the one on the right the spare battery. Exchange the batteries on a monthly basis.

Information on Battery Power Operation

Rechargeable batteries require special maintenance and continued checks to assure they function in emergency situations. I t is norm al for batteries of this type to self-discharge, even w hen the dev ice is switched off. Furthermore, the capacity decreases with age. By regular maintenance (charging and discharging at regular intervals) the battery service life can be considerably extended. The defibrillator as well as the separate charging unit ASU 3000 have a special battery maintenance program (see next section).

To ensur e th at th e Marquette Responder® 3000 will always function in an emergency, it must not be disconnected from an external power source for more than 48 hours (mains or ambulance power supply). Reconnect the defibrillator to the external power source immediately after use or recharg e the batteries with the separate charging unit. The batteries cannot be overcharged.

Test

The two horizontal bars in the upper margin of the screen (Figure 14-2) continuously indicate the battery charge level:

green: battery full (40 to 100%) yellow: medium charge level (20 to 40%) red: battery depleted (0 to 20%) If two batteries are inserted, they will be dis-

charged one after the other, not at the same time. The battery charge level can be checked by

pressing the

Test

button (Figure 14-3) on the battery (for this test, the battery does not have to be inserted in the defibrillator).

5 LEDs: charge level between 80 and 100% 4 LEDs: charge level between 60 and 80% 3 LEDs: charge level between 40 and 60% 2 LEDs: charge level between 20 and 40% 1 LED: charge level between 0 and 20% no LED: battery depleted

Figure 14-3. Battery test button and charge

indicators

68 Marquette Responder® 3000 227 490 02-C

Battery Power Operation

abcd

Figure 14-4. Battery maintenance indicators

a = yellow, battery charging b = red, battery discharging c = yellow, battery charging d = green, battery charged

Note

The waveform and trend memories are overwritten during the battery maintenance program.

At the end of the maintenance program, you can check the event memory for details of the battery maintenance routine.

Battery Maintenance Program

The batteries should be reconditioned once a month with the battery maintenance program. As the battery will be discharged in the course of the maintenance program, a second battery is required to ensure that the defibrillator is ready for use. The maintenance program can be activated with the defibrillator connected to the power line or to the ambulance power system.

•

Connect the device to the power supply system.

•

Turn on the defibrillator with the energy selector (position

•

Simultaneously press F1 and F5 to display the

setup menu.

•

Press F1 to position the bar cursor on BATTERY and confirm the selection with

ENTER

•

Press F4

to select the "Battery Mainte-

nance ON" option and confirm the selection with F5

•

Set the energy selector to "Off".

Previous Menu

Warning

Operational Readiness — Recondition the batteries at least once every month. using either the separate charging unit ASU 3000 or the battery maintenance program.

This is what happens during the automatic maintenance program:

1. Battery 1 charges

2. Battery 2 charges

3. Battery 1 is discharged and then recharged

4. Battery 2 is discharged and then recharged

5. defibrillator prints maintenance report, then switches off (screen blanks)

The progress bar on the monitor indicates the battery status (Figure 14-4): green battery charged yellow Battery charging red Battery discharging

You can abort the maintenance program at any time by switching the defibrillator on with the energy selector. In this case, however, the battery charge level is unknown. For discharged batteries, the maintenance program may take up to 20 hours to complete. At the end of the maintenance program, you can check the event memory for details of the battery maintenance routine.

227 490 02-C Marquette Responder® 3000 69

Test Discharge

Analyse

15 Test Discharge

Sync

Analyse

Figure 15-1. Buttons to activate the manual mode

Electrode

Paddle

160 / 40

ECG

bpm

On defibrillators set up for semiautomatic defibrillation, a test discharge can be delivered only

when you activate the manual mode (next

−

section) or use a simulator.

−

How to toggle the defibrillator from semiautomatic to manual operation

•

Simultaneously press F5 and

(Figure 15-

1).

When the defibrillator is set up for "Semiautom./Button", it will immediately activate the manual mode. When the defibrillator is set up for "Semiautom./Password", the screen for entry of the password appears (Figure 15-2).

15.07.1998 09:05:00

semiautom.

0 0 ENTER

Figure 15-2. Buttons for entry of the password

Paddle

160 / 40

ECG

bpm

15.07.1998 09:05:00

etCO2

SpO2

QRSPulse

Tone

OFF

manual

ECG

•

Enter the password (3-digit number) with F1, F2, F3. The factory-set password is 111 (also

refer to chapter 13, section "Password").

When switched on again, the defibrillator will reactivate the operating mode selected in the setup menu. Date and time of the change of operating modes is stored in the event memory.

When the defibrillator is set to "Semiautomatic", it cannot be switched to the manual mode. You will have to select another operating mode first from the setup menu (chapter 13 "Defibrillator Setup").

Figure 15-3. Defibrillator set up for manual

operation

70 Marquette Responder® 3000 227 490 02-C

Test Discharge

Electrode

160 / 40

ECG

bpm

III

15.07.1998 09:05:00

etCO2

SpO2

QRSPulse

Tone

OFF

manual

ECG

Figure 15-4. Indication of selected energy

STERNUM

SHOCK

CHARGE

APEX

SHOCK

360 J

Test Discharge (manual mode)

The correct release of the defibrillation shock can be checked by means of a test discharge. For this test, the stored energy is discharged into the device via two contacts in the paddle compartments. When adhesive pads are connected to the defibrillator, the test discharge is only possible with a suitable simulator; a test discharge with internal spoons is not possible.

Set the energy selector to 360 J.

•

The selected energy will be displayed (Figure 15-

4). Initiate defibrillator charging by pressing the

•

Charge/Shock button on the right paddle (Figure 15-5), or by pressing

on the control panel (Figure 15-6) when using adhesive pads.

Figure 15-5. Buttons to initiate defibrillator

charging and to trigger the shock

Sync

Analyse

When the selected energy is charged,

the device emits an audio signal

−

the color of the energy field changes to yellow

−

the message "Energy available" appears.

−

Warning

Shock Hazard — When delivering the test discharge, hold on to the paddle handles and be careful not to touch the contact surfaces.

Do not touch the simulator while the shock is delivered. Do not place the simulator on a metal surface.

Test Discharge (semiautomatic defibrillator)

A special simulator is required to test the defibrillator performance in the semiautomatic mode.

Figure 15-6. Button to initiate defibrillator

charging when adhesive or internal electrodes are connected

227 490 02-C Marquette Responder® 3000 71

Test Discharge

•

Now trigger the shock within 30 seconds. To do

Sync

Analyse

Figure 15-7. Buttons to deliver the shock

Caution

Equipment Damage — Do not trigger more than 3 consecutive test discharges (or internal safety discharges) with the maximum energy of 360 J with 15 minutes. Otherwise the device may reach inadmissible high temperatures.

Note

If the shock is not delivered within 30 seconds of charging, an internal safety discharge will be initiated.

so, simultaneously press the two buttons on the paddles (or

and on the control panel,

when using adhesive pads) (Figure 15-7).

After the shock release, the audio signal stops and the delivered energy is displayed for about 6 seconds. According to the requirements of the IEC / AAMI standards, this value must be between 306 and 414 Joules. At the same time, the defibrillator prints a 14-second ECG strip (incl. history of 4 seconds), if this function is enabled.

If the discharge circuit is interrupted (electrodes not properly inserted in their compartments, cable defect), a safety discharge will be initiated 200 ms after release of the test discharge.

Switch off the Marquette Responder® 3000

•

(energy selector to "Off").

Incorrect Shock Delivery, Error Messages

If the energy of the test discharge is not within the specified limits, a defibrillation is possible all the same (it is the user's decision whether or not to employ the defibrillator). However, the device must be immediately checked and repaired by a service technician.

72 Marquette Responder® 3000 227 490 02-C

Operation in the Vehicle Mounting Unit, Mounting the AC Power Adapter

16 Operation in the Vehicle M ounti ng Unit,

Mounting the AC Power Adapter

Operating the Defibrillator in the Vehicle Mounting Unit

When you place the defibrillator in the mounting unit, it will be powered from the ambulance power system. Check that the power supply contacts on the defibrillator and on the mounting unit (Figure 16-1) are clean. Always secure the defibrillator with both locking devices (Figure 16-1, arrows at top).

In the vehicle mounting unit, the defibrillator display is upside down. Therefore you can flip the display (see chapter 3, section "Display Flip").

Mounting the AC Power Adapter

The AC power adapter is screwed to the rear of the



Marquette Responder

Remove the two legs (a, Figure 16-2) and the

•

screws (b) on the underside. Attach the AC power adapter and secure it with

•

the new screws supplied. Connect the device to the power line.

•

Check that the batteries are charging.

•

Remove the batteries and check the device

•

performance (chapter 3 "Putting the Defibrillator Into Operation").

On line power, the defibrillator charges to 360 Joules in approx. 9 seconds.

3000.

Note

Figure 16-1. Vehicle mounting unit

Figure 16-2. Mounting the AC power adapter

227 490 02-C Marquette Responder® 3000 73

Error and System Message

17 Error and System Messages

Message Effect Explanation Remedy

D-RAM Error device defect, device

cannot be used

S-RAM Error device defect, device

cannot be used

FLASH Error device defect, device

cannot be used

EEPROM Error restricted use for

emergencies only, defibrillation possible

Charge Energy Error charged energy differs

from selected energy, use device only in emergencies

Time Base Error restricted use for

emergencies only,

defibrillation possible Battery battery almost depleted charge battery HR, etC alarm, violation of alarm

Electrode high ECG or defibrillation

defective user setup (e.g. user setup cannot be saved)

error occurred last time the device was used (before switched off) and was saved

all time-related data (e.g heart rate) may be erroneous

limit

electrode impedance

notify service

press one of the function keys, notify service

press one of the function keys, trigger test discharge, switch device off and on again; if error message recurs, notify service

press one of the function keys, adjust time; if error message recurs, notify service

reapply electrode

Check selector energy selector is not

indexing properly; defibrillation possible

Energy high internal spoons are

connected and selected energy is above 50 J; charged energy higher than selected energy; defibrillation possible

Energy low charged energy below

selected energy; defibrillation possible (e.g. battery depleted)

Device Behavior Explanation Remedy

Device not functioning properly

software problem switch device off and on again;

set energy selector to the exact position; if error message recurs, notify service

select a lower value (internal spoons) or trigger test discharge; if message recurs, notify service

trigger test discharge; if message recurs, notify service check battery

notify service

74 Marquette Responder® 3000 227 490 02-C

Danger

Shock Hazard — Before cleaning the device, disconnect it from the power line. Ensure that it is switched off and that it is not switched on while being cleaned. Danger to life! As a safety precaution, remove the batteries and disconnect the defibrillation electrodes from the defibrillator.

Shock Hazard, Equipment Damage — Liquids must not be allowed to penetra te the d evice. Devices into which liquids have entered must be immediately cleaned and checked by a service technician, before they can be reused.

Caution

Electrode Damage — Do not sterilize the electrodes for internal defibrillation (spoons) with hot air.

Cable Damage — Disconnect the cable from the electrodes before sterilization (arrow, Figure 18-2).

Cleaning, Maintenance

18 Cleaning, Maintenance

Cleaning, Disinfection and Sterilization

Electrodes, Device

•

Discard all disposable items immediately after use to prevent that they are reused.

•

The paddles and their leads can be cleaned and disinfected by wiping them down with a gaze pad moistened with a cleaning solution or disinfectant. Before using the paddles again, however, make sure that they are completely dry.

•

The device surface too can be wiped down with a cloth moistened with a cleaning solution or disinfectant. Liquids must not be allowed to enter the device.

Any cleaning agents and disinfectants commonly used in hospitals are suitable for cleaning of the device.

•

The internal electrodes are cleaned in the same way. The electrodes and connecting cables should be sterilized by the low-temperature plasma sterilization method. Alternative methods are ETO sterilization, water vapor (134 °C) or ionizing radiation. Ensure that internal defibrillation electrodes are sterilized before each use.

227 490 02-C Marquette Responder® 3000 75

Figure 18-1. Inserting the spoon electrodes

Note

Having loosened the counter nut 2, you can easily alter the position of the contact paddle.

Cleaning, Maintenance

Inserting the Spoon Electrode

Screw the counter nut 2 (Figure 18-1) onto the

•

electrode as far as it will go. Screw the contact paddle 1 into the handle as

•

far as it will go, then bring it into the appropriate position.

Now fix the contact paddle by screwing the

•

counter nut 2 tight against the handle 3.

External Counter Electrode for Internal Defibrillation

Disconnect the electrode from its lead before

•

cleaning or sterilizing it (Figure 18-2).

Figure 18-2. Counter electrode for internal

defibrillation

Clean the electrode by rubbing it down with a

•

cloth moistened with soap water. Use a disinfectant for disinfection. Do not immerse the electrode in the liquid.

Low-temperature plasma sterilization is the

•

recommended sterilization method. Alternative methods are ETO sterilization or ionizing radiation. (Please note: Frequent ETO sterilization reduces the life expectancy of the plastic material!) Do

not

autoclave the electrodes.

76 Marquette Responder® 3000 227 490 02-C

Maintenance

Cleaning, Maintenance

Checks before each use

Before each use, visually inspect the device, the

•

leads and electrodes for signs of mechanical damage.

Also check the device performance as outlined

•

in chapter 3 "Putting the Device Into Operation", and trigger a test discharge (chapter 15).

If you detect damages or impaired functions which may result in a hazard to the patient or the operator, the device must be repaired before it can be used again.

Checks at regular intervals

The Marquette Responder® 3000 is an emergency device and must always be ready for use. These checks must be carried out once a month:

visual inspection of the device and the

•

accessories performance check as outlined in chapter 3

•

"Putting the Device Into Operation"

Technical Inspections

For safety, the devices require regular maintenance. To ensure functional and operational safety of the Marquette Responder® 3000, Technical Inspections should be carried out on an annual basis.

These checks should be performed by persons with adequate training and experience.

The checks can be carried out by Marquette Hellige within the framework of a service contract.

The nature and scope of these checks are explained in the corresponding sections of the Service Manual.

Battery Replacement

NiCd batteries have a limited service life as their storage capacity deteriorates with age. For this reason, the batteries must be replaced every 3 years.

The device does not require any other maintenance.

Disposal at the End of Its Service Life

Note

At the end of their service life, the device described in this manual and its accessories must be disposed of in compliance with the applicable local waste control regulations. If you have questions regarding the dispos al of th e pr odu ct or of t h e accessories, please contact Marquette Hellige GmbH or its representatives.

227 490 02-C Marquette Responder® 3000 77

19 Technical Specifications

Technical Specifications

Operating Modes

non-synchronized (defibrillation on demand)

−

synchronized (cardioversion)

−

semiautomatic (in the presence of shockable

−

arrhythmias)

Energy Selection

by means of energy selector, energy to be delivered into 50 Ohms is indicated as a numerical value:

•

energy adjustable in steps, energy values as energy delivered into 50 Ohms (internal defibrillation: energy limited to 50 Joules)

AutoSeq 2 5 7 10 20 30 50 100 150 200 300 360 Joules

•

capacitor charging time for energy setting of 360 J:

on line power and when inserted in vehicle

−

mounting unit typically 9 s with fully charged battery typically 6 s,

−

with partially discharged battery typically

−

7 s (max. 10

Defibrillation Shock

capacitor discharge via induction coil (Lown / Edmark); exponential pulse shape, monophase, damped sinusoidal halfwave:

•

pulse duration for an external resistance of 50 ohms approx. 4 ms, measured from the beginning of the pulse to the intersection of the zero line and the inflection point of the trailing pulse edge, according to AAMI DF-2

•

in synchronized mode, the defibrillation shock is released within 40 ms of the R-wave trigger

Discharge Circuit

serial oscillating circuit in series with external resistance (patient):

•

capacitance 34 µF

•

inductance 26 mH

•

equivalent resistance 6 ohms

•

possible deviation from selected energy less than permitted by IEC

Defibrillator Charging

with capacitor; capacitor is charged from built-in battery, from 12-V DC power via vehicle power system or from the power line with optional AC power adapter buzzer indicating "charge done"

78 Marquette Responder® 3000 227 490 02-C

l/A

100

80 60 40 20

-20 4 6 8 10 12 t/ms2

Ra=50 Ω Ra=100 Ω Ra=25 Ω

Figure 19-1. Current discharge curve (360 J)

L=26 mH Rt=6 Ω

C=34 µF

Technical Specifications

Pulse Output

isolated, no conductive connection with enclosure, open-circuit and short-circuit-proof as required by AAMI DF-2:

insulation test voltage 8 kV DC, type CF

•

according to IEC 60601-2-4

Safety Discharge

capacitor discharge via internal load resistance:

when the defibrillation shock is not triggered

•

within 30 s of charging when the defibrillation shock is triggered, but

•

the discharge circuit is interrupted, after 0.2 s when the selected energy is not reached, after

•

32 s in the presence of technical malfunctions

•

when the energy selector is set to or "Off"

•

after charging was initiated when a shock is delivered into open air,

•

when the battery voltage is insufficient,

•

Synchronization

with ECG signal of either polarity:

minimum ECG amplitude for reliable triggering

•

approx. 0.50 mV and QRS width of 80 ms indicated by yellow LED

•

SYNC marker on display

•

ECG Signal Input Via Defibrillation Electrodes

automatic switching to defibrillation electrodes when there is no patient cable or lead is open; differential input, isolated, IEC class CF, with overvoltage protection:

input voltage range ± 10 mV

•

input impedance > 1 MOhms

•

differential DC voltage tolerance ± 1 V

•

frequency response 1.2 Hz to 35 Hz (-3 dB)

•

common-mode rejection > 80 dB

•

patient leakage current: in normal condition <

•

10 µA, in single-fault condition < 100 µA

Test Features

indicator for battery charging

•

defibrillator test by discharging the stored

•

energy into the integrated 50-ohm load resistance (max. twice within 15 minutes)

3-digit display of the delivered energy

•

warning on LCD when discharge circuit is

•

interrupted (e.g. defibrillation electrode not applied)

automatic power-on self-test with error

•

message

detection of pacing pulses

•

pulse duration d

−

pace marker independent of polarity

−

pulse amplitude a

−

reverse current pulse a

−

time constant t

−

> approx. 0.1 ms < 2.0 ms

± 10 to ± 700 mV

= 25 to 100 ms

± 1 mV

227 490 02-C Marquette Responder® 3000 79

Technical Specifications

ECG Signal Input Via Patient Cable

automatic switching to ECG electrodes, if they are applied; differential input, symmetrically referred to N, isolated, IEC class CF; 7 standard leads via lead selector; input overvoltage protected (defibrillation-proof):

input voltage range ±10 mV for recorder and

•

display input impedance > 10 MOhms for 10 Hz

•

common-mode dynamic range ±1 V

•

differential DC voltage tolerance ± 0.6 V

•

common-mode rejection (CMRR) RL referred

•

to N > 65 dB, N referred to chassis > 110 dB band width 0.15 to 100 Hz,

•

with 12 SL 0.08 to 100 Hz

Signal Transmission

signal input --> amplification --> signal sampling -

-> AD conversion --> digital processing --> display and recorder

adjustable gain: 0.5 – 1 – 2 cm/mV (with max.

•

gain a 1-mV input signal results in 2 cm/mV) amplitude limited to the area of the waveform

•

window on the display and to the recorder writing width

signal sampling rate of 1000 Hz (reduction to

•

400 Hz)

ECG Signal Output ("Option" port)

ECG lead shown in channel 1 on the display

•

1 V output signal for 1 mV input signal

•

max

±2 V

•

patient leakage current: in normal condition <

•

10 µA, in single-fault condition < 50 µA ground leakage currents: in normal condition <

•

0.5 µA, in single-fault condition < 1 µA voltage resistance referred to ground reference

•

3 kV (static) detection of pacing pulses

•

pulse duration d

−

pace marker independent of polarity

−

pulse amplitude a

−

reverse current pulse a

−

time constant t

−

overall error < 20 % (typical)

−

> approx. 0.1 ms < 2.0 ms

± 10 to ± 700 mV

± 1 mV

= 25 to 100 ms

overall error < 3% (typical)

•

500 Ω min.

•

delay < 150 ms (not suitable for triggering of

•

external devices) no electric isolation

•

9 = ECG 10 = chassis

Only connect devices that meet the requirements of EN 606011 and EN 60601-1-1, respectively.

80 Marquette Responder® 3000 227 490 02-C

Technical Specifications

Signal Display

active backlit VGA color LCD, 3-channel erase bar display, alphanumeric indication of alarms, gain, lead, QRS indicator, alarm limits, heart rate, energy and function key labels At a gain of 1 cm/mV a 1-mV signal is 1 cm in size on the display.

erase bar sweep speed 25 mm/s

•

trace length in real-time mode 4.08 s

•

SYNC marker

•

display size: width 130 mm, height 97 mm

•

VGA resolution 640 x 480 pixels (pitch 0.204 x

•

0.202 mm) displayed image can be reversed (180°)

•

AC line filter 50/60 Hz

•

muscle filter ECG 35 Hz, paddles 20 Hz

•

Alarm System

electronic release of alarm

when the heart rate violates one of the set alarm

•

limits (after condition exists for 10 seconds): audio signal sounds (can be disabled), message "HR Alarm", alarm recording is initiated (configurable)

when at least one of the selected electrodes is

•

off the patient: audio signal sounds (only when patient cable is connected), message "Alarm, Electrode" on display

adjustment range for ECG alarm limits: off, 15

•

to 300 bpm (not overlapping) adjustment range for etCO2 alarm limits: off, 5

•

to 76 mmHg digit height of the displayed alarm limits

•

2.0 mm

Systole Check

heart symbol on display

•

QRS beep (can be switched off)

•

Heart-Rate Measurement

derivation of trigger pulses from the ECG of either polarity, adaptive trigger threshold, calculation of the average rate, storage of the result, 3-digit display on LCD, alarm limits to the left of the HR

measuring range 15 to 300 bpm

•

digit height of HR reading 7.5 mm

•

digit height of alarm limits approx. 2.0 mm

•

minimum amplitude for reliable triggering

•

>0,3 mV for an ECG signal with a QRS duration of 80 ms

QRS trigger according to AAMI EC 13

•

T-wave suppression up to 1 mV

•

Recording

manually initiated continuous ECG recording, or recording of the delayed ECG signal from memory (14 seconds, incl. history of 4 seconds) upon alarm and

alphanumeric annotation of the following parameters in the paper margin:

Heart rate

−

ECG lead

−

filter(s)

−

date, time

−

paper speed

−

reason for recorder start (shock, alarm,

−

manual, event, auto, 12SL, test, recall, trend, text) selected energy [J into 50 Ohms]

−

delivered energy

−

SYNC marker

−

user/hospital/practice name

−

response time to HR changes approx. 5 s

•

227 490 02-C Marquette Responder® 3000 81

Technical Specifications

After recording the ECG, the recorder will print an intervention report (name, date of birth, user, comments – entered by the user - defibrillation mode, selected and delivered energy, number of shocks and alarm limits).

Direct writing with rectangular coordinates using thermorecording technology (printhead with electronically controlled thermal elements records on thermosensitive paper), roll paper, paper transport by stepper motor:

number of recorder channels: 3

•

paper width: 90 mm

•

max. roll diameter 55 mm (roll with 40 m of

•

HELLIGE CONTRAST® paper) printhead resolution: vertically 8 dots/mm,

•

horizontally 40 dots/mm at 25 mm/s recorder speed 25 mm/s ±5 %

•

end-of-paper detection and message on display

•

SpO

saturation: 0 to 100% in increments of 1 %

•

rate: 0 to 250 P/min in increments of 1 P/min

•

limit value: OFF, 60 to 100%

•

display of the plethysmogram

•

C-Lock ECG synchronization

•

Integration time: 4, 8, and 12 seconds

•

measurement error: 70 to 100% ±2 digits

•

50 to 69% ±3 digits

pulse readout 1.2% or ±1 P/min

•

etCO

semi-quantitative measuring method, using IR technology

This method is based on the condition that the inspired air is free of CO

To prevent damage to the printhead use only the original HELLIGE CONTRAST paper.

Memory

storage of 180 minutes of ECG data with full

•

intervention report storage of three 12SL ECG analysis reports

•

including the ECG 1 and 4-hour trends for ECG and etCO

•

storage of the most recent 250 actions (e.g.

•

device on/off, alarms, defibrillation energy) including date and time

Pacemaker

Operating Modes: Demand, Fix

•

pacer rate: 30 to 200 P/min +-5%

•

measuring range: 0 to 76 mmHg

•

error (at ambient pressure of 1 atmosphere and

•

no CO mmHg);

response time: approx. 200 milliseconds

•

rise time: approx. 100 ms (10 to 90%)

•

warm-up time : approx. 10 seconds

•

dimensions: 58H × 39W × 17D mm (w/o.

•

airway adapter, cable and CO weight: 100 g (incl. CO2 sensor)

•

safety standard IEC 60601-1, type BF

•

capnogram display

•

in the inspired air: ± 4 mmHg (≤40

10% (>40 mmHg)

sensor)

pacer current: 0 to 200 mA +- 10% (for 500 Ω)

•

pulse width: 20 ms

•

pulse shape: monophase square wave pulse

•

82 Marquette Responder® 3000 227 490 02-C

Technical Specifications

Power supply

Battery

power supply from 1 or 2 exchangeable NiCd batteries

rated voltage 12 V

•

rated capacity 2.0 Ah

•

battery charging in device

•

max. charge time of a depleted battery 4 hours

•

operating time with one fully charged battery

•

approx. 60 shocks of 360 Joules each (into 50 Ohms) or 1.4 hours of monitoring (1 h if pacemaker, etCO used)

Line Power (optional)

100 V to 240 V ± 10 % (47 Hz to 63 Hz)

•

power consumption at 230 V:

•

during defibrillator charging 240 VA

−

during monitor operation 40 VA

−

during battery charging 25 VA

−

max. charge time of a depleted battery 4 hours

•

intrahospital use (IPX 1)

•

and SpO

measuring system are

Type of Protection

protected against splashing water; Marquette Responder: IPX 4 (batteries inserted, cables connected)

AC power adapter: IPX 1

Environment

Operation

operation under the following conditions considered to be normal:

temperature between 0 and +45 °C

•

relative humidity between 5 % and 95 %, no

•

condensation atmospheric pressure between 700 and

•

1060 hPa vibration acc. to MIL 810E Cat.10 and

•

prEN 1789

Transport and storage

temperature between -25 and +70 °C

•

relative humidity between 10 % and 95 %, no

•

condensation atmospheric pressure between 500 and

•

1060 hPa (with etCO 1060 hPa)

adapter cable: 700 and

Operation in Vehicle Mounting Unit, Power from 12 V DC Ambulance Supply System:

11.5 to 18 V

•

power consumption

•

during defibrillator charging 130 W

−

during monitor operation 27 W

−

during battery charging 14 W

−

Operational readiness

4 seconds, incl. automatic self-test

•

Operating position

any, horizontal with AC power adapter

Dimensions

width 307 mm

•

height 202 mm

•

depth 412 mm (without AC power

•

adapter) 476 mm (with AC power adapter)

Weight

with one battery approx. 8 kg (w/o. AC power

•

adapter)

227 490 02-C Marquette Responder® 3000 83

20 Order Information

Order Information

Subject to change. Always refer to latest list of accessories.

101 164 01 Marquette Responder® 3000,

basic system, manual operation, recorder

101 264 02 Marquette Responder® 3000,

basic system, manual operation, pacemaker, recorder

101 264 03 Marquette Responder® 3000,

basic system, manual operation, pacemaker, SpO

, recorder

101 164 13 Marquette Responder® 3000,

basic system, manual operation, SpO

, recorder

101 164 14 Marquette Responder® 3000,

basic system, semiautomatic operation (convertible to manual operation), SpO

, recorder

101 164 04 Marquette Responder® 3000,

basic system, semiautomatic operation (convertible to manual operation), recorder

101 264 05 Marquette Responder® 3000,

basic system, semiautomatic operation (convertible to manual operation), pacemaker, recorder

101 264 06 Marquette Responder® 3000,

basic system, semiautomatic operation (convertible to manual operation), pacemaker, SpO recorder

Options

205 108 01 AC power adapter 384 018 86 Upgrade kit, semiautomatic 384 018 90 Upgrade kit, 12SL

Accessories ECG

412931-002 Patient trunk cable, 5-lead cable,

3.6 m, IEC, MultiLink

412931-001 Patient trunk cable, 5-lead cable,

3.6 m, AHA, MultiLink

416035-002 Patient trunk cable, 10-lead

cable, 3.6 m, IEC, MultiLink

416035-001 Patient trunk cable, 10-lead

cable, 3.6 m, AHA, MultiLink

384 018 10 Set of 5 leadwires, 70 cm, clip

connector, IEC, MultiLink

384 018 11 Set of 5 leadwires, 70 cm, clip

connector, AHA, MultiLink

414556-003 Set of 5 leadwires, 74 cm, clip

connector, for limb leads and C1, IEC, MultiLink

414556-001 Set of 5 leadwires, 74 cm, clip

connector, for limb leads and V1, AHA, MultiLink

416467-004 Set of 5 leadwires, 74 cm, clip

connector, for C2 to C6, IEC, MultiLink

416467-003 Set of 5 leadwires, 74 cm, clip

connector, for V2 to V6, AHA, MultiLink

919 200 31 Disposable adhesive electrode

for adults, press stud, silversilver chloride, pregelled, diam. of contact surface 20 mm,

200/cs.

217 320 01 Adhes ive elect ro d e f o r ch i ld r e n ,

silver-silver chloride, press stud, reusable

217 321 01 Adhes ive elect ro d e f o r ad u l ts ,

silver-silver chloride, press stud, reusable

84 Marquette Responder® 3000 227 490 02-C

Order Information

Consumables

226 168 02 Chart paper, 90 mm, 10 rolls 217 123 01 Adhesive rings for electrode

217 320 01, 500/cs.

927 223 00 Adhesive rings for electrode

217 321 01, 500/cs.

217 083 05 Electrode cream, pkg. of 10

tubes, 100 ml per tube

217 083 18 Electrode cream, 250-ml bottle,

refillable 217 083 14 Electrode cream, 5-l container 930 115 82 Dispenser, 30 ml

External defibrillation

217 333 01 Two paddles for external

defibrillation with shock buttons

(d)

Internal defibrillation

217 308 01 Pair of defib electrodes for

internal defibrillation (w/o. contact insert)

384 013 19 Contact inserts (2), internal, for

adults

384 013 20 Contact inserts (2), internal, for

children

384 013 21 Contact inserts (2), internal, for

babies

919 202 36 External counter electrode for

internal defibrillation

etCO

220 106 01 etCO2 sensor 711 053 01 etCO

airway adapter (25/cs.)

217 333 02 Two paddles for external

defibrillation with shock buttons

(e) 217 329 01 Defibrillation electrode anterior -

posterior 919 202 94 Disposable defibrillation pad,

rectangular, for adults (1 pair) 919 202 95 Disposable defibrillation pad,

rectangular, for children (1 pair) 223 383 01 Connecting cable for defibrilla-

tion electrodes 919 202 94/95

SpO

223 394 01 Connection cable for the

following probes (length: 4 m)

701 240 21 Standa rd f i n ger prob e f o r a d u l ts >

40 kg, reusable, type DS-100-A

407705-005 Disposable nose probe for adults

> 50 kg, flexible, type R-15, 12/cs.

701 240 22 Disposable probe for children

and adults (10 to 50 kg), flexible, type D-20, 24/cs.

701 240 26 Disposable probe for children (1

to 20 kg), flexible, type I-20, 24/cs.

701 240 27 Disposable probe for adults

, flexible, type D-25, 24/cs.

> 30

701 240 32 Disposable probe for neonates <

3 kg and for adults > 50 kg, 24/cs.

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Order Information

Pacemaker

919 202 94 Disposable defibrillation pad,

rectangular, for adults (1 pair)

919 202 95 Disposable defibrillation pad,

rectangular, for children (1 pair)

223 383 01 Connecting cable for defibrilla-

tion electrodes 919 202 94/95

Miscellaneous

227 490 02 Operator's Manual 931 099 56 Carrying bag, no labeling 919 062 00 Power cord, EURO 919 201 81 Power cord, US 919 203 37 Power cord, UK 401855-107 Power cord, CH 303 446 31 Rechargeable battery, 2 Ah 701 279 01 Battery Station ASU 3000 202 317 01 Vehicle mounting unit with 12 V

DC power supply

202 317 02 Vehicle mounting unit with 12 V

DC power supply, US version 223 425 01 Adapter cable, 12 V 919 200 37 Potential equalization cable, 3 m 200 172-001 Field Service Manual 202 317 03 Wall-mount system with AC

power adapter

86 Marquette Responder® 3000 227 490 02-C

The Arrhythmia Detection Program

Appendix The Arrhythmia Detection Program

Overview

The arrhythmia detection program used in the Marquette Responder® Series defibrillators was developed by Marquette Medical Systems, Inc. After initial performance evaluation in the laboratory,(against recognised databases .i.e. MIT* and AHA**), independent clinical evaluation was performed in hospital and field settings. The hospital tests were performed in over 500 witnessed cardiac arrests and the program performance was very successful. Pre-hospital evaluation followed and the arrhythmia detection program was found to perform equally well. Moreover, the algorithm was tested against the Marquette Hellige database with over 150 true prehospital ECG rhythms.

Arrhythmia Detection

The “accuracy” of any arrhythmia program is quantified in terms of;

Sensitivity: in this case, the ability to identify

−

correctly a shockable rhythm Specificity: the ability to correctly identify

−

non-shockable rhythms

An ideal system would have a sensitivity and specificity of both 100%, but in practice there is always a trade-off between the two.

The consensus opinion published by AAMI***(TIR #2-1987), is that specificity should be as high as possible, even at the sacrifice of some sensitivity. This approach minimizes the likelihood of shocking a non-shockable rhythm. However, this does mean that a system may not be able to identify

shockable rhythm.

every

The arrhythmia detection program of the Marquette Responder® 3000 achieves a sensitivity of 86 % and a specificity of 99.8 %. These values refer to ventricular fibrillation and ventricular tachycardia rhythms.

VT is shockable in the presence of a nonperfusing, high rate VT. There is no consensus as to what constitutes a “high rate”. Therefore, in order to achieve a high specificity a rate of 120 bpm is used to identify shockable VT.

The algorithm uses a ‘Majority Decision’ approach to advising a shock, whereby two-ofthree ECG analysis segments must be in agreement(each segment is 4 s).

The overall performance of the algorithm was tested in ambulance trials. It is important to bear in mind the many factors that can affect the performance of such a system. These include skin preparation, electrode quality and placement, as well as patient or vehicular motion.

* Massachusetts Institute of Technology ** American Heart Association *** Association for the Advancement of Medical Instrumentation

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EC Declaration of Conformity

88 Marquette Responder® 3000 227 490 02-C

Index

12SL ECG analysis program 46

AC line filter 43 AC power adapter, mounting 73 Accessories 84 Adhesive electrode, defibrillation, pacing 8 Airway adapter 54 Alarm limits, etCO2 56 Alarm limits, SpO2 53 Application Tips, SpO2 50 Arrhythmia detection program 31, 87 Arrhythmia monitoring 45, 64 Autosequencing 19

Battery charging 67 Battery maintenance program 69 Battery power operation 68 Battery power operation, charge level 68 Battery replacement 77 Biocompatibility 5

Capnogram 57 Cardioversion 26 Caution, definition 4 CE marking 4 Channel waveforms, assign 42 Charge level 68 Charging the batteries 67 Charging unit 67 Chart paper, load 62 Checks at regular intervals 77 Checks before each use 77 Cleaning recommendations 75 C-Lock ECG synchronization 50, 52 Color concept 5, 13 Contrast adjustment 14 Controls and indicators 6 Counter electrode for internal defibrillation 76 Current discharge curve 78

ECG acquisition via separate ECG electrodes 35 ECG display 41 ECG memory 59 ECG signal size 42 Electrode for internal defibrillation 8 EMC requirements 11 Error messages 74 Event memory 58 Event texts 66 Events, primary 58 Expiration date, defib pads 22 Explosion hazard 9

Fixed-rate mode (pacemaker) 40 Functional description 5

Gain selection 42 General information 4

Hardcopy 61 Heart rate monitoring 41, 44 Hemoglobin saturated with oxygen 49

Indicators 6 Infrared spectroscopy 54 Integration time 52 Intended use 5 Interpretation program 48 Intracardiac application 9

Language selection 65 Literature 11, 31, 49 Low-temperature plasma sterilization 75

Danger, definition 4 Date format 64 Date, enter 64 Dead space volume 55 Defibrillating the patient in the semiautomatic mode 32 Defibrillation of children 21 Defibrillation pads, application 22 Demand mode 38 Disinfection 75 Display flip 14 Disposable defibrillation pads 22 Disposal of the device 77

227 490 02-C Marquette Responder® 3000 89

Maintenance 77 Manual defibrillation, switchover from semiautomatic17, 70 Measurement and interpretation program 41 Measurement program 48 Memories of the defibrillator 58 Memories, clear 60 Monitoring the heart rate 44 Multiple portable socket outlets 10 Muscle filter 43

Non-synchronized defibrillation 19

Index

Options 66 Order information 84

Pacemaker 36 Pacemaker patients 45 Pacemaker, guidelines for application 37 Pacemaker, turn off 39 Packaging material, disp osal 11 Paddle application 19 Paddles 8 Part numbers 84 Password, change 65 Password, enter 65 Performance check 16 Plethysmogram 53 Power supply 5 Primary events 58 Probes (SpO2) 49 Pulse oximetry 49

Recording 61 Revision code 3 Revision history 3 Rotate display 14

Safety information, etCO2 55 Sawtooth signal 13 Selecting the HR source 53

Semiautomatic defibrillation 30, 31 Setup 14 Setup menu 63 Shock counter 21 Specifications 78 SpO2 measurement 49 SpO

measurement, begin 52

Spoon electrode, insertion 24, 76 Sterilization 75 Switching from semiautomatic to manual defibrillation

17, 70 Symbols used on the device, explanation 7 Synchronization pulses 38 Synchronized defibrillation 26

Technical inspections 77 Technical Specifications 78 Test discharge 7 1 Therapy, end 21 Tidal volume 55 Time, enter 64 Transcutaneous pacemaker 36 Transport conditions 11 Trend memory 60 Trigger signal for cardioversion 26

Vehicle mounting unit 67, 73

Warning, definition 4 Warranty 4

90 Marquette Responder® 3000 227 490 02-C

Marquette Hellige Responder 3000 User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual