Marquette Hellige Responder 3000 User Manual

Name: Marquette Hellige Responder 3000
Brand: Marquette Hellige
SKU: 4649642
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4.8 (5)

Operator's Manual

Version 2

227 490 02 GA (e) Revision C

Contents

227 490 02-C Marquette Responder® 3000 3

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

)46

9 Pulse Oximetry (SpO

)49

10 Capnometry (etCO

)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

General Information

4 Marquette Responder® 3000 227 490 02-C

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 re-

quirements 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 Equip-

ment".



The radio-interference emitted by this device

is within the limits specified in CISPR11/EN

55011, class A.



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 classi-

fied 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 elec-

tromedical equipment valid at the tim e of

printing. All rights are reserved for devices,

circuits, techniques, software programs, and

names appearing in this manual.



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:

Danger

indicates an imminent hazard. If not avoided, the

hazard will result in death or serious injury.

Warning

indicates a hazard. If not avoided, the hazard can

result in death or serious injury.

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

Intended Use and Functional Description

227 490 02-C Marquette Responder® 3000 5

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 synchro-

nized 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

measurement system (capnometry),

−

an SpO

measurement system (pulse oximetry),

−

a transcutaneous pacemaker.

Analyse

Sync

100

150

200

300

360

Print Event

Autoseq

Off

Start

Pause

+ —

Dem

Fix

P/min

+ —

Pacer

Figure 1-1. Marquette Responder® 3000

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.

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 appli-

cable standards. If you have ques tions in t his matter ,

please contact Marquette Hellige GmbH or its repre-

sentatives.

Controls and Indicators

6 Marquette Responder® 3000 227 490 02-C

2 Controls and Indicators

The Device

Analyse

Sync

100

150

200

300

360

Print Event

Autoseq

Off

Start

Pause

+ —

Dem

Fix

P/min

+ —

Pacer

1316 15 1214

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

Controls and Indicators

227 490 02-C Marquette Responder® 3000 7

Connector for exchange of the defibrillation

electrodes (switch off the device before ex-

changing 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

etCO

signal input (optional)

SpO

signal input (optional)

Function keys F1 to F5

ECG signal input

Event marker button

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

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

Battery charging

Housing without battery (to close the

battery slot)

Standby mode (line power operation)

Audio alarm OFF

Defibrillation Electrodes

8 Marquette Responder® 3000 227 490 02-C

Defibrillation Electrodes

SHOCK

CHARGE

APEX

Figure 2-2. Hard paddle

Figure 2-3. Electrode for internal defibrillation

Figure 2-4. Disposable adhesive electrode

(external defibrillation, pacing)

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 "Defi-

brillation of Children" in section 4.2).

Electrodes for Internal Defibrillation

Electrodes for internal defibrillation consist of a

contact spoon (

, Figure 2-3), a handle

and a

counter nut

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

two

spoon electrodes or with

one

spoon electrode

and a so-called "external counter electrode" (

Figure 2-3) which is placed under the patient and

in the immediate vicinity of the heart.

Defibrillator charging and release of the defibril-

lation 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.

Putting the Device Into Operation and Performance Check

227 490 02-C Marquette Responder® 3000 9

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 anes-

thetics.

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 high-

voltage electrotherapy device and must be

handled by qualified and specially trained per-

sonnel. Improper use of the device can endan-

ger 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 de-

vice. Otherwise there is a risk of coming in

contact with line voltage by inadvertently in-

troducing metal parts in the socket o f the

power cord.

As a general rule, utmost caution is advised

for intracardiac application of medical techni-

cal devices. Great care must be exercised to

prevent that conductive parts (connectors,

electrodes, transducers) connected to the iso-

lated 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.

Putting the Device Into Operation and Performance Check

10 Marquette Responder® 3000 227 490 02-C

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 pa-

tient and secured against inadvertent dis-

connection or they must be isolated and

protected against inadvertent contact (oth-

erwise 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 pace-

maker, both checked for proper functioning,

must be readily available.

Ensure that no conductive connection between

the patient and bystanders exists during defi-

brillation.

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 ambu-

lance 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 manufac-

turers 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 environ-

ment provided the regulations concerning

drip-proof equipment of IEC 60601/EN 60601

are strictly observed. However, do not defi-

brillate patients in a very moist or wet envi-

ronment, unless absolutely necessary. Always

dry the defibrillation electrodes and connec-

tion cables prior to defibrillatio n.

Putting the Device Into Operation and Performance Check

227 490 02-C Marquette Responder® 3000 11

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 op-

erated in the vicinity of the defibrillator com -

ply with the relevant EMC requirements. X-

ray 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 defibril-

lator 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 pack-

aging material, observing the applicable

waste-control regulations. Keep the packaging

material out of children's reac h.

Caution

Equipment Damage, Shock Hazard — De-

vices intended for emergency application must

not be exposed to low temperatures during

storage and transport to avoid moisture con-

densation at the application site. Wait until all

moisture has vaporized before using the de-

vice.

Equipment Damage — Exercise great care

when using HF surgery equipment on the pa-

tient at the same as the defibrillator. As a g en-

eral 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 sur-

gery device.

Equipment Damage — Avoid defibrillating

repeatedly into open air or with the paddles

shorted together, because the device tempera-

ture may increase to an inadmissible level due

to the internal safety discharges.

Literature

Medical Device Directive of August 2, 1994

EN 60601-1: 1990 + A 1: 1993 + A 2: 1995

Medical electrical equipment. General require-

ments 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.

Putting the Device Into Operation and Performance Check

12 Marquette Responder® 3000 227 490 02-C

Figure 3-1. Defibrillator with AC power adapter

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.

100

150

200

300

360

Autoseq

Figure 3-2. Turning the defibrillator on

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

−

by means of the separate charging unit ASU

3000 (P/N 701 279 01).

If you prefer to operate the device mains-

independent, 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

(defibrillation shocks cannot be

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.

After the self-test the standard screen appears

(Figure 3-3).

Putting the Device Into Operation and Performance Check

227 490 02-C Marquette Responder® 3000 13

ECG

Electrode

15.07.1999 09:05:00

160 / 40

bpm

SpO2

etCO2

QRSPulse

Tone

OFF

semiautom.

Paddle

SpO2

parameter

window

etCO2

parameter

window

pacemaker

window

a fedcb

Figure 3-3. Standard screen display

a measured heart rate/pulse rate

b selected limit values

c battery charge level indication

d ECG lead (ECG signal acquired

via "Paddle")

e date, time

f selected operating mode,

defibrillation energy

g menu

The Standard Screen Display

This is the information presented on the standard

screen display:

−

windows for heart / pulse rate, SpO

and etCO

readings including the limit values

−

battery charge level

−

ECG lead

−

window for ECG, SpO

and etCO

waveforms

−

window indicating operating mode and

defibrillation energy

−

date and time

−

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).

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 etCO

parameter windows are also

blank and the corresponding waveforms are

missing when the required sensors are not

connected.

Putting the Device Into Operation and Performance Check

14 Marquette Responder® 3000 227 490 02-C

↓

ECG SpO2

etCO2

QRSPulse

Tone

OFF

Figure 3-4. Main menu

↓

Filter

Assign

Channel

Waveform

DisplayMemory

Figure 3-5. Main menu, page 2

↓ ↓ ↓

Contrast Contrast Display

Flip

Select

Color

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.

Note

Enter your own settings in the column at the far

right (with date and signature).

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-

cally when the defibrillator is inserted in the

vehicle mounting unit (chapter 13 "Defibrillator

Setup").

•

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

Adjusting Maximum Contrast (Select Color)

•

Adjust the maximum contrast from the Display

menu with

•

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

settings for which customer defaults can be

selected, as well as the factory defaults.

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.

Putting the Device Into Operation and Performance Check

227 490 02-C Marquette Responder® 3000 15

Parameter Comment Factory

Defaults

Options User Setup

ALARM LIMITS

HR Limit 40/160 OFF, 15 to 300

increments of 5

SpO

Limit

---/90 OFF, 60 to 99

etCO

Limit

---/20 OFF, 5 to 76

increments of 1

ECG

Print on Alarm autom. recorder start on violation of limit

value

off on/off

Lead Fail Alarm audio signal indicating disconnected

electrode

off 30 s/off

Alarm Tone audio sign al indicating violation of a n

alarm limit

off on/off

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,

paddle acquisition

Lead Channel 2 II standard leads, SpO

Lead Channel 3 III standard leads, SpO

etCO

DEFIB

Print on shock automatic recorder start on shock on on/off

Operating Mode** c hoice of the operating mode semiautomatic/button semiautom./button

semiautom./password

semiautom.

manual

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

SpO

Integ. Time SpO

integration time 8 s 4 s, 8 s, 12 s

DATE/TIME**

Change clears all existing settings.

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

mon/day/year

Entry of date and time

DEVICE

Display

screen display (SmartFlip = disp lay flips

automatically when defibrillator is placed

in vehicle mounting unit)

normal normal, reverse,

SmartFlip

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**

entry of the password 111 000/999

for config** protects access to configuration menu off on/off

EVENT TEXTS** entry of event texts

 

BATTERY battery maintenance program



on/off

OPTIONS entry of option code to unlock option

 

** not affected by reactivation of factory defaults

Putting the Device Into Operation and Performance Test

16 Marquette Responder® 3000 227 490 02-C

ECG

Electrode

15.07.1999 09:05:00

160 / 40

bpm

SpO2

etCO2

QRSPulse

Tone

OFF

semiautom.

Paddle

Figure 3-7. Standard screen display of a

defibrillator ready for operation (no

ECG, SpO

and etCO

signal avail-

able)

Note

A special simulator is required to test the defib ril-

lator performance in the semia uto matic mode.

Text 1

ECG

III

15.07.1998 09:05:00

160 / 40

bpm

Text 2 Text 3 Text 4

semiautom.

Figure 3-8. Event texts

Performance Check

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 self-

tests. 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

Event

button to mark specific

events (e.g. administration of medications). When

you press this key, the corresponding point in time

is earmarked in the full-disclosure ECG. Further-

more, you can assign a maximum of 8 "event"

texts to the function keys

(e.g. names of

medications). When you press

Event

these texts

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

Next Menu

you can display the next line of 4 texts. (Refer to

chapter 13 "Device Setup" for instructions on

entering event texts.)

Putting the Device Into Operation and Performance Test

227 490 02-C Marquette Responder® 3000 17

Analyse

Sync

Figure 3-9. Buttons to activate the manual mode

ECG

Paddle

Electrode

15.07.1998 09:05:00

160 / 40

bpm

0 0 ENTER

semiautom.

Figure 3-10. Buttons for entry of the password

ECG

Paddle

15.07.1998 09:05:00

160 / 40

bpm

etCO2

SpO2

QRSPulse

Tone

OFF

manual

Figure 3-11. Defibrillator set up for manual

operation

How to toggle the defibrillator from

semiautomatic to manual operation

Depending on their setup, semiautomatic defibril-

lators 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 pass-

word)

−

semiautomatic (manual control not possible)

−

manual (only manual control possible)

Operating Mode "semiautomatic/button"

•

To activate the manual mode, simultaneously

press

and

Analyse

(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.

Operating Mode "semiautomatic/password"

•

To activate the manual mode, simultaneously

press

and

Analyse

(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.

Manual Defibrillation / Non-Synchronized Defibrillation

18 Marquette Responder® 3000 227 490 02-C

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 un-

wanted 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 pa-

tient.

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 defi-

brillation.

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 elec-

trodes.

Pacemaker Patients — Defibrillating a patient

with an implanted pacemaker is likely to im-

pair 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 transduc-

ers and devices that are not defibrillation-

proof from the patient before delivering the

shock.

Equipment Damage — Do not defibrillate the

patient with a second defibrillator, while def i-

brillation electrodes (paddles, pads) of the first

device are applied.

If the use of a second defibrillator is inevita-

ble, disconnect the electrodes from the first

device or remove them from the patient.

Manual Defibrillation / Non-Synchronized Defibrillation

227 490 02-C Marquette Responder® 3000 19

Figure 4-1. Removing the paddles

ECG

Paddle

15.07.1999 09:05:00

160 / 40

bpm

manual

200 J

ECG

SpO2

etCO2

QRSPulse

Tone

OFF

b ca

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

nected)

a ECG signal acquired via

"Paddle"

b manual mode

c selected energy

SHOCK

STERNUM

SHOCK

CHARGE

APEX

Figure 4-3. Paddle application points (dashed

application points for pacemaker

patients)

4.2 Non-Synchronized Defibrilla-

tion

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

required energy level.

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 defibrilla-

tions. 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 (

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

ECG appears on the monitor screen).

•

Do not touch the patient any more and warn all

those present.

Manual Defibrillation / Non-synchronized Defibrillation

20 Marquette Responder® 3000 227 490 02-C

SHOCK

STERNUM

SHOCK

CHARGE

APEX

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.

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".

•

Initiate energy storag e with the button on the

APEX paddle (

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

and

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").

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.

Manual Defibrillation / Non-Synchronized Defibrillation

227 490 02-C Marquette Responder® 3000 21

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

for continued monitoring of the patient.

•

If there is no need to monitor the patient, switch

off the defibrillator by setting the energy se-

lector to "Off".

•

Clean the paddles and the device as outlined in

chapter 18 "Cleaning, Maintenance".

Defibrillation of Children

Warning

Damage to Myocardium — Please note that chil-

dren require less energy for successful ventricular

defibrillation than adults. For the first defibrilla-

tion shock delivered to babies and small children,

select an energy of approx. 2 J/kg body weight.

For subsequent shocks, the energy may be in-

creased 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

Manual Defibrillation / Non-synchronized Defibrillation

22 Marquette Responder® 3000 227 490 02-C

Danger

Shock Hazard — For defibrillation with dispos-

able 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 con-

nected to the pads.

Figure 4-6. Connecting the lead

STERNUM

electrode and connector

APEX

electrode and connector

Figure 4-7. Defibrillation pad application points

(anterior - anterior)

Using Disposable Defibrillation Pads

−

Use pads before their expiration date.

−

not

reuse the pads.

−

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).

−

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).

Manual Defibrillation / Non-Synchronized Defibrillation

227 490 02-C Marquette Responder® 3000 23

Warning

Risk of Skin Burns / Equipment Damage — Do not

attach the pads over

sternum or clavicle

nipples

implanted pacema ker or defibrillator devices.

Analyse

Sync

Figure 4-8. Buttons to initiate defibrillator

charging and to trigger the shock

correct

wrong

Figure 4-9. Removing the pads

•

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

and

to deliver the shock by simultaneously pressing

the buttons

and

(Figure 4-8).

•

Carefully remove the electrodes after use

(Figure 4-9) and discard them immediately.

Note

Discard disposable pads immediately after use. Do

not reuse them.

Manual Defibrillation / Non-synchronized Defibrillation

24 Marquette Responder® 3000 227 490 02-C

Note

If you are using internal electrodes with the

Marquette Responder® 3000, defibrillator charg-

ing must be initiated with button and the

shock is delivered by simultaneously pressing

buttons and .

Figure 4-10. External counter electrode

Figure 4-11. Inserting the spoon electrode

Using Internal Defibrillation Elec-

trodes

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").

Inserting the Spoon Electrode

•

Screw the counter nut

(Figure 4-11) onto the

electrode as far as it will go.

•

Screw the contact paddle

into the handle as

far as it will go, then bring it into the appropri-

ate position.

•

Now fix the contact paddle by screwing the

counter nut

tight against the handle

Manual Defibrillation / Non-Synchronized Defibrillation

227 490 02-C Marquette Responder® 3000 25

Analyse

Sync

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).

Manual Defibrillation / Synchronized Defibrillation

26 Marquette Responder® 3000 227 490 02-C

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.

Note

After each synchronized defibrillation, the device

reverts to the non-synchronized mode; the same

applies when the energy selector is set to .

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.

The following electrodes can be used for cardio-

version:

−

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 non-

synchronized mode for defibrillation, because it is

not possible to detect a QRS complex for

triggering in the presence of ventricular fibrilla-

tion.

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 defibril-

late the patient with adhesive pads and pick up the

ECG via the pads.

Manual Defibrillation / Synchronized Defibrillation

227 490 02-C Marquette Responder® 3000 27

R L

N F

red

white

black

yellow

green

Figure 4-13. ECG electrode placement

Figure 4-14. Connecting the electrode leads to

the patient cable

Print Event

Figure 4-15. ECG signal input

Note

The 3-lead patient cable cannot be used with this

defibrillator.

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).

•

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 defibril-

lation 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 elec-

trodes and transducer l eads w hile usi ng the el ectro-

surgery device.

Great care must be exercised to prevent that conduc-

tive parts (connectors, electrodes, transducers) con-

nected 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 par-

ticularly important that the neutral electrode does

not come in contact with ground.

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