Marquette Responder 3000 Defib Ver 2.0 Rev C Operators Manual

Operators Manual

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Operator's Manual

Version 2 227 490 02 GA (e)

Revision C

Contents

Intended Use and Functional Description

Controls and Indicators

Putting the Device into Operation and Performance Check

Manual Defibrillation

4.1 4.2 4.3

18 19 26

Defibrillator Application Guidelines Non-Synchronized Defibrillation Synchronized Defibrillation (Cardioversion)

Semiautomatic Defibrillation

Pacemaker

Displaying and Monitoring the ECG

12-Lead ECG Analysis Program (12SL

Pulse Oximetry (SpO2)

Capnometry (etCO2)

Memories of the Marquette Responder® 3000

Recording

Defibrillator Setup

Battery Power Operation

Test Discharge

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

Error and System Messages

Cleaning, Maintenance

Technical Specifications

Order Information

)

Appendix The Arrhythmia Detection Program EC Declaration of Conformity Index

87 88 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.

227 490 02-C

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

Marquette Responder® 3000

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 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:

The radio-interference emitted by this device is within the limits specified in CISPR11/EN 55011, class A.

Warning indicates a hazard. If not avoided, the hazard can

hazard will result in death or serious injury.

result in death or serious injury.

The device is designed to comply with IEC 60601 requirements. It is a protection class I device and has an internal power source. It is classified as an MDD class IIb device.

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.

Danger indicates an imminent hazard. If not avoided, the

The CE mark covers only the accessories listed in the "Order Information" chapter .

On request Marquette Hellige will provide a service manual.

The product complies with the electromagnetic immunity requirements of standard IEC 60601-1-2/EN 60601-1-2 "Electromagnetic Compatibility - Medical Electrical Equipment".

The symbol means: Consult accompanying documents. It indicates points which are of particular importance in the operation of the device. This manual is in conformity with the device specifications and standards on safety of electromedical equipment valid at the time 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, readjustments, 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

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.

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),

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.

− an alarm is reported (red),

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

− an event memory,

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 interpretation (12SL), − an etCO2 measurement system (capnometry), − an SpO2 measurement system (pulse oximetry), − a transcutaneous pacemaker.

− the system displays a message (yellow). The defibrillator has the following memories for storage and documentation of the relevant procedure data: − 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

1 2

− the optional charging unit, or

− the optional vehicle mounting system. 1 Pacer On Off

10 Dem Fix

20 30

7 5 2 Autoseq

Start Pause

P/min

Biocompatibility The parts of the product described in this operator

2 Sync

manual, including all accessories, that come in

Analyse

50 100 150 200 300 360

contact with the patient during the intended use,

fulfill the biocompatibility requirements of the appliPrint

Event

cable standards. If you have questions in this matter, please contact Marquette Hellige GmbH or its representatives.

Figure 1-1.

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Marquette Responder® 3000

Controls and Indicators

2 Controls and Indicators The Device

31 1

30 29 28 27 26 25 24 23 22 21 20 19 18 17

1 Pacer

20 30

7 On Off

5 2 Autoseq

Dem Fix Start Pause

50 100 150 200 300 360

P/min

Sync

- Analyse

16 Figure 2-1.

Event

5 6 7 8 9 10 11

14 13 12

Controls and indicators of the Marquette Responder® 3000

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!)

18 Button to start and stop the recorder 19 Button to change the pacer output (current) 20 Button to change the pacer rate

APEX paddle

Infrared interface

21 Button to pause the pacer (without changing the settings)

Battery with "Test" button and charge level indication

22 Button to select the pacer mode (fixed rate, demand)

Button to unlock right battery for removal

23 Button to unlock left battery for removal

Energy selector, ON/OFF switch

24 Button to turn the pacemaker on and off

Indicator, yellow, flashes to the QRS rhythm in synchronized mode

25 Indicator, yellow: blinks with each delivered pacing pulse

Button to enable and disable the synchronized mode (cardioversion)

26 Button to open paper compartment

Button to initiate ECG analysis in the semiautomatic mode (only on semiautomatic defibrillator models)

10 Button to initiate defibrillator charging and to trigger the shock (together with button 11) when adhesive pads or internal spoons are used 11 Button to trigger the defibrillation shock (together with button 10) when adhesive pads or internal spoons are used 12 1-Volt ECG output 13 etCO2 signal input (optional) 14 SpO2 signal input (optional) 15 Function keys F1 to F5

27 Battery with "Test" button and charge level indication 28 Indicator, green: is lit when defibrillator is powered from an external source (mains, ambulance) 29 Indicator, yellow blinking: left battery charging on: left battery charged off: left battery missing or partially charged, no external power source connected 30 Indicator, yellow blinking: right battery charging on: right battery charged off: right battery missing or partially charged, no external power source connected 31 STERNUM paddle

16 ECG signal input 17 Event marker button Explanation of symbols used on the device

Battery charging

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

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

Marquette Responder® 3000

Defibrillation Electrodes

Hard Paddles

Hard paddle

c b

CHARGE SHOCK 3 2

APEX

Figure 2-2.

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

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 two spoon electrodes or with one spoon electrode 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

Figure 2-4.

Disposable adhesive electrode (external defibrillation, pacing)

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.

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

Warning

Explosion Hazard – The device is not designed for

Shock Hazard - Observe the following warnings.

use in areas of medically used rooms where an

Otherwise the lives of the patient, the user and

explosion hazard may occur. An explosion hazard

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.

may result from the use of flammable 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

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 particular, all 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 outlet 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 of 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 contact with other grounded conductive parts, as this could bridge the patient's isolation and cancel the protection provided by the isolated input.

electrodes must be strictly avoided. Temporarily interrupt the oxygen supply.

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Marquette Responder® 3000

Putting the Device Into Operation and Performance Check

Electrically conductive contact with parts connected to the heart (pressure transducers, metal tube connections and cocks, 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 stopcocks 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 mandatory. 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 defibrillation.

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 comply 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 devices and verify the defibrillator performance before use.

Equipment Failure - Similarly, the defibrillator may disturb equipment 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 reach.

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 general rule, the distance between the ECG and defibrillation electrodes and the HF surgery 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

Putting the Device Into Operation and Performance Check

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 (mainsindependent). Batteries are recharged by one of the following methods:

Figure 3-1.

Defibrillator with AC power adapter

− 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).

Note The Marquette Responder® 3000 is switched on and off with the energy selector. Once you are familiar with the device operating routines, this

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

control lets you turn on the device and select the required defibrillation energy in one action. No shock can be delivered in the

position of the

energy selector.

Turning the Defibrillator On

1 10 7 5 2 Autoseq

Figure 3-2.

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

20 30

50 100 150 200 300 360

Turning the defibrillator on

• Connect the device to the power supply. • Switch on the device by turning the energy (defibrillation shocks cannot be 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. After the self-test the standard screen appears (Figure 3-3).

Marquette Responder® 3000

227 490 02-C

Putting the Device Into Operation and Performance Check

The Standard Screen Display

a b Electrode

d e

This is the information presented on the standard screen display:

0 Paddle

− windows for heart / pulse rate, SpO2 and etCO2 readings including the limit values a, b

160 / 40

ECG

bpm

SpO2 parameter window

− battery charge level c − ECG lead d

etCO2 parameter window

− window for ECG, SpO2 and etCO2 waveforms

pacemaker window 15.07.1999

09:05:00

semiautom. ECG

SpO2 etCO2

QRSPulse Tone OFF

Next Menu

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

Standard screen display

b selected limit values

− the parameter reading is within the alarm limits (green),

c battery charge level indication

− a technical fault is reported (blue),

d ECG lead (ECG signal acquired via "Paddle")

− an alarm is reported (red),

a measured heart rate/pulse rate

e date, time f selected operating mode, defibrillation energy g menu

227 490 02-C

− date and time e − menu g.

g Figure 3-3.

− window indicating operating mode and defibrillation energy f

− 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 SpO2 and etCO2 parameter windows are also blank and the corresponding waveforms are missing when the required sensors are not connected.

Marquette Responder® 3000

Putting the Device Into Operation and Performance Check

Display Flip

↓ ECG

SpO2 etCO2

Figure 3-4.

QRSPulse Tone OFF

Next Menu

Main menu

↓ Filter ON

Assign Channel Waveform

Figure 3-5.

Display

Previous Menu

• In the main menu, select F5 Next Menu (Figure

Main menu, page 2

↓

Contrast

Figure 3-6.

Memory

3-4).

↓ Select Color

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

Display Flip

Previous Menu

You will see page 2 of the main menu (Figure 35).

• Display the Display menu with F4 Display

Display menu

(Figure 3-6).

• To flip the display, press F4 Display Flip .

Note The main menu will automatically reappear, when

Contrast adjustment

no button is activated for a period of 30 seconds.

• Adjust the contrast from the Display menu with F1 and F2. Adjusting Maximum Contrast (Select Color)

• Adjust the maximum contrast from the Display menu with F3.

• Press F5 Previous Menu for about 2 seconds to

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

System Setup

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

return directly to the main menu.

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.

Marquette Responder® 3000

227 490 02-C

Putting the Device Into Operation and Performance Check

Parameter

Comment

Factory Defaults

Options

User Setup

HR Limit

40/160

OFF, 15 to 300 increments of 5

SpO2 Limit

---/90

OFF, 60 to 99

etCO2 Limit

---/20

OFF, 5 to 76 increments of 1

ALARM LIMITS

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 signal indicating violation of an alarm limit

off

on/off

off

low/middle/high / off

QRS Beep Muscle Filter

suppression of motion artifact

on/off

Gain

for ECG display

1 cm/mV

0.5; 1; 2 cm/mV

Lead Channel 1

standard leads, paddle acquisition

Lead Channel 2

standard leads, SpO2

Lead Channel 3

III

standard leads, SpO2, etCO2 on/off

DEFIB Print on shock

automatic recorder start on shock

Operating Mode**

choice 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

C-LOCK

C-Lock ECG synchronization

off

on/off

SpO2 Integ. Time

SpO2 integration time

4 s, 8 s, 12 s

DATE/TIME**

Change clears all existing settings. day.mon.year

day.mon.year mon/day/year

SpO2

Date Format** Entry of date and time DEVICE Display

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

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/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



OPTIONS

entry of option code to unlock option



 on/off 

** not affected by reactivation of factory defaults

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Marquette Responder® 3000

Putting the Device Into Operation and Performance Test

Performance Check A performance check must be carried out before each use.

Electrode 160 / 40

ECG

Paddle

The check includes:

bpm

− 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. 15.07.1999

09:05:00

semiautom. SpO2 etCO2

ECG

Figure 3-7.

QRSPulse Tone OFF

Next Menu

Standard screen display of a defibrillator ready for operation (no ECG, SpO2 and etCO2 signal available)

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.

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

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

62 160 / 40

ECG

Event

bpm

III

15.07.1998

Text 1

Figure 3-8.

You can use the 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. Furthermore, you can assign a maximum of 8 "event" texts to the function keys F1 to F4 (e.g. names of medications). When you press 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 F5 Next Menu you can display the next line of 4 texts. (Refer to chapter 13 "Device Setup" for instructions on entering event texts.)

Text 2

Event

09:05:00

Text 3

Event texts

semiautom. Next Text 4 Menu

Marquette Responder® 3000

227 490 02-C

Putting the Device Into Operation and Performance Test

How to toggle the defibrillator from semiautomatic to manual operation 2 Sync

Analyse

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)

Figure 3-9. Electrode

Buttons to activate the manual mode Operating Mode "semiautomatic/button"

0 Paddle

• To activate the manual mode, simultaneously

160 / 40

ECG

bpm

press F5 and

15.07.1998

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.

09:05:00

semiautom. 0

ENTER

Operating Mode "semiautomatic/password"

• To activate the manual mode, simultaneously press F5 and Figure 3-10. Buttons for entry of the password

(Figure 3-9).

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

• Enter the password (3-digit number) with F1,

Paddle

160 / 40

ECG

Analyse

bpm

F2, F3. The factory-set password is 111 (also refer to chapter 13, section "Password").

15.07.1998

09:05:00

manual ECG

etCO2 SpO2

QRSPulse Tone OFF

Next Menu

Figure 3-11. Defibrillator set up for manual operation

227 490 02-C

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.

Marquette Responder® 3000

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 heart 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 defibrillation 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 defibrillation 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.

Marquette Responder® 3000

227 490 02-C

Manual Defibrillation / Non-Synchronized Defibrillation

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 Figure 4-1.

Removing the paddles

the paddle surfaces.

• Set the energy selector to "Autoseq" or to the required energy level.

0 Paddle

160 / 40

ECG

bpm

15.07.1999

ECG

09:05:00

QRSPulse Tone OFF

SpO2 etCO2

Figure 4-2.

200 J

manual Next Menu

Power-up screen (paddles connected) 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 M

K OC SH 3

ECG appears on the monitor screen).

• Do not touch the patient any more and warn all those present.

AR 2 GE SH

Figure 4-3.

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O 3 CK

Paddle application points (dashed application points for pacemaker patients)

Marquette Responder® 3000

Manual Defibrillation / Non-synchronized Defibrillation

• Initiate energy storage with the button on the

APEX paddle (a). When the selected energy is stored,

SHOCK 3 STERNUM

CHARGE SHOCK 2 3

− 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).

APEX

• Now trigger the shock within 30 seconds. To do so, simultaneously press the buttons a and b on the paddles. After the 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 pacemaker or defibrillator devices.

Note − If you do not trigger the shock within 30 seconds 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".

− 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.

Marquette Responder® 3000

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Manual Defibrillation / Non-Synchronized Defibrillation

Shock Counter

Defibrillation of Children

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.

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 must be in contact with the skin surface (use the small contact surface of the paddles / pads for children).

Ending Therapy

• Once therapy has ended, set the energy selector to

for continued monitoring of the patient.

• 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".

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.

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Marquette Responder® 3000

Removing the large contact surface from the paddles

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GE Healthcare

Defibrillators

Marquette Responder 3000 Defib Ver 2.0 Rev C Operators Manual