Marquette Hellige CardioServ User Manual

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CardioServ

Operator’s Manual

Version 4.1

227 446 32 GA(e) Revision D

The product CardioServ bears the marking

-0366

indicating its conformity with the provisions of the Council Directive 93/42/EEC concerning medical devices and fulfills the essential requirements of Annex I 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 device is in radio-interference protection class B in accordance with CISPR11/EN 55011.

The CE marking covers only the accessories listed in section “Order Information and Accessories”.

This manual describes CardioServ with all options included and reflects software version 4.1.

Postfach 600265 D-79032 Freiburg Germany

Telephone +49 7 61 45 43-0

Revision History

This document is subject to the Marquette Hellige change order system. The revision code, a letter that follows the document part number, changes with every update of the manual. The initial version of the manual is without revision code.

Part No./Revision Code Date Comment

227 446 32 29 April 1997 Initial Release 227 446 32-A 14 May 1997 SW version 4.1 227 446 32-B 1 July 1997 ECO 202 998 227 446 32-C 9 July 1998 ECO 060 477 227 446 32-D 6 August 1999 ECO 062 982

2 CardioServ V4.1 227 446 32-D

Contents

1. Introduction to CardioServ

2. Controls and Indicators

3. Setup and Performance Test

4. Non-Synchronized Defibrillation

5 Cardioversion (Synchronized Defibrillation)

6. Displaying and Monitoring the ECG

7. The Memories of CardioServ

8. Recording

9. Oxygen Saturation SpO

10. Pacing

11. Configuring the Defibrillator Settings

12. Error Indications and Messages

13. Cleaning and Maintenance

14. Technical Specifications

15. Order Information and Accessories

Index

227 446 32-D CardioServ V4.1 3

General Information

* This manual is an integral part of the instrument and

describes its normal use. It should always be kept close to the equipment. Observance of the manual is a prerequisite for proper instrument performance and correct operation and ensures patient and operator safety.

* The symbol

It serves as an indicator for important facts to be noted when operating the instrument.

* Information which refers only to certain versions of the

instrument is accompanied by the part number(s) of the instrument(s) concerned. The part number is given on the instrument nameplate.

* Patient safety, specified measuring accuracy, and interfer-

ence-free operation can be guaranteed only if original Marquette Hellige devices are interconnected (e.g. basic units and plug-in modules).

* Only use accessories which are listed in this manual or

which have been tested in combination with the device (e.g. patient cables, electrodes, transducers, sensors, consumables, etc.). If you use accessories or consumables from other manufacturers, Marquette Hellige does not guarantee safe operation or functioning of the device.

denotes: Refer to Operator’s Manual!



* Marquette Hellige considers itself responsible for the

effects on safety, reliability, and performance of the equipment, only if

– assembly operations, extensions, readjustments,

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

– the instrument is used in accordance with the

instructions for use.

* All publications are in conformity with the instrument

specifications and IEC publications on safety of electromedical equipment valid at the time of printing. All rights are reserved for instruments, circuits, techniques, software programs and names appearing in the 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 warranty does not cover damage resulting from the

use of accessories and consumables from other manufacturers.

4 CardioServ V4.1 227 446 32-D

Introduction to CardioServ

1. Introduction to CardioServ

This section describes

– The capabilities and applications of the CardioServ

defibrillator

– points to note when operating CardioServ

– general points to note when handling a defibrillator

227 446 32-D CardioServ V4.1 5

Introduction to CardioServ

1.1 General Information

CardioServ is a high-voltage electrotherapy unit which should be handled only by specially trained

Danger

personnel. Even though the defibrillator is equipped with various safety features, such as internal safety discharging, its operation by unqualified staff could be hazardous to the patient, the operator, and any assisting personnel.

The user instructions given in this manual refer to a

☞

CardioServ unit equipped with pacemaker and SpO2 measuring system.

CardioServ is a light-weight, portable defibrillator with ECG monitor and built-in recorder.

The device is designed for external and internal defibrillation. It can be used both for semi-automatic and for manual defibrillation. Furthermore CardioServ is capable of monitoring the heart rate with adjustable alarm limits.

CardioServ can be expanded with a transcutaneous pacemaker and/or SpO2 measuring system which also monitors the measured SpO2 values.

The device is easy and convenient to operate. Three operating steps are sufficient to deliver the defibrillation shock. The display can be turned 180° to allow the user to view the information when the device is standing upright.

Defibrillation can be performed with standard defibrillation paddles, defibrillation pads and internal electrodes.

In addition to line power operation, the defibrillator operates on battery power from a slot-in rechargeable battery, and on 12-Volt power supplied from an emergency vehicle.

6 CardioServ V4.1 227 446 32-D

Introduction to CardioServ

I/A

120

100

-20 0 2 4 6 8 10 12

Ra = 50 Ohm Ra = 100 Ohm Ra = 25 Ohm

L = 26 mH

C = 32 µF

R = 6,5 Ω

Figure 1-1. CardioServ current-discharge curve (360 J)

t/ms

CardioServ comes with three memories whose contents can be documented individually:

– text memory (code summary documentation) – event memory (16-s ECG) – trend memory (trend plots of HR, SpO2, 45 min,

9 hours)

The built-in recorder is initiated automatically or manually.

Extensive safety precautions have been taken to protect the patient and the user from inadvertent delivery of defibrillation shocks.

The current-discharge curve corresponds to an approximate sinusoidal halfwave with aperiodic decay. Figure 1-1 shows the discharge curve for various external resistances.

227 446 32-D CardioServ V4.1 7

1.2 For your Safety

Warning

Caution

Introduction to CardioServ

The safety information given below is divided into the categories “Danger”, “Warning” and “Caution”.

indicates an imminently hazardous situation which, if not avoided, will result in death or

Danger

serious injury.

indicates a potentially hazardous situation which,

Warnin

if not avoided, could result in death or serious injury.

indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate

Caution

injury and/or damage to the equipment.

provides application tips or other useful information

☞

to assure that you get the most from your equipment.

CardioServ is designed to comply with IEC 60601/

☞

EN60601 requirements. It is Class I equipment and has an internal power source.

CardioServ operates on line voltages between 95 and 240 Volts, 49 to 65 Hz. The mains plug must be connected to an appropriate power supply with a non-fused earthed wire. The use of extension cords is not permitted.

Before putting the device into operation, visually check all connecting cables and electrodes for signs of damage. Damaged cables and electrodes must be replaced immediately, before use.

When disconnecting the device from the power line, first remove the plug from the wall outlet.

Disconnect the device from the power line and operate it on battery power, if the integrity of the protective earth conductor is in doubt.

Set up the device in a location which affords sufficient ventilation. The ventilation openings of the device must not be obstructed. The ambient conditions specified in the “Technical Specifications” section must be ensured at all times.

8 CardioServ V4.1 227 446 32-D

Introduction to CardioServ

Warning

Warnin

Danger

Warnin

Danger

Warnin

Caution

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. Avoid using the defibrillator under conditions where prolonged exposure to or excessive contact with moisture can occur.

Before putting the defibrillator into operation, make sure that the paddles and all connection cables are dry.

CardioServ is an emergency device and must be ready for operation at any time. For this reason, the defibrillator battery must always be charged. This can be achieved by leaving the defibrillator connected to the power line when it is not needed in an environment where only battery operation is possible.

Possible explosion hazard if used in the presence of concentrated oxygen.

CardioServ is suitable for application in a humid environment provided the regulations concerning drip-proof equipment of IEC 60601 are strictly observed. However, avoid defibrillation in a very moist or wet environment, unless absolutely necessary.

Use only the original Marquette Hellige batteries, as these are designed for an extended temperature range.

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 and radio systems are a possible source of interference as they may emit higher levels of electromagnetic radiation.

The defibrillator is designed for intracardiac appli-

☞

cation.

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/ EN 60601-1-1 must be complied with in all cases.

Set up the device so that the operator has a clear,

☞

unobstructed view of the front panel.

Liquids must not be allowed to enter the device. Devices into which liquids have penetrated must be immediately cleaned and checked by a service technician.

227 446 32-D CardioServ V4.1 9

Introduction to CardioServ

Caution

Warning

Danger

Caution

Warnin

Use only the original Marquette Hellige patient cables. Do not connect other signal sources to the cables.

Patient signal inputs labelled with the symbol are protected against damage resulting from defibrillation and electrocautery voltages. Nevertheless extreme care must be taken when devices which are directly connected to the patient remain applied during electrocautery or defibrillation. The distance between ECG electrodes should be at least 15 cm. If in doubt, disconnect the patient cable from the device while applying the defibrillation pulse or performing electrocautery.

For defibrillation of children use only the special clip-on electrodes for children listed in section 15 “Order Information and Accessories”.

CardioServ also operates on line power when the

☞

battery is depleted or missing.

At the end of its service life, CardioServ and its accessories must be disposed of in compliance with the special waste control regulations for electronic parts. If you have any questions in this matter, please contact Marquette Hellige GmbH.

Dispose of the packaging material, observing the applicable waste-control regulations and keeping it out of children’s reach.

Literature

Medical Device Directive

EN 60601-1/1990 + A 1: 1993 + A2: 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

Warnin

The full responsibility for the use of accessories from other manufacturers lies with the user.

systems.

Check the device performance at regular intervals (once a month), strictly following the instructions

Caution

given in section 3.2. Do not select high energy

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

levels for test discharges with defibrillation electrodes shorted together.

ROY, O.Z.: Summary of cardiac fibrillation thresholds for 60-Hz currents and voltages applied directly to the heart.

For each defibrillation, verify that the selected and the displayed/charged energy are identical.

Caution

10 CardioServ V4.1 227 446 32-D

Med. & Biol. Engn. & Computing 18: 657...659 (1980).

Introduction to CardioServ

Caution

Danger

Caution

Danger

Caution

General points to note when handling a defibrillator

Electromedical equipment such as the CardioServ

Warnin

defibrillator 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 equipment, the operator must

Warnin

ascertain that it is in correct working order and operating condition.

The defibrillator paddles must be clean and dry.

Danger

The person carrying out the defibrillation should

☞

have at least one assistant.

The operator must be trained in the use of the

Warnin

defibrillator.

All assistants must be briefed regarding the

Warnin

preparations for and execution of defibrillation.

All tasks must be assigned clearly.

Warnin

Defibrillating a patient with normal heart rhythm may induce ventricular fibrillation.

Danger

Position the patient flat on a hard, dry surface where the patient is electrically insulated. The patient must not be allowed to come into contact with metal parts, e.g., bed or litter, in order to prevent unwanted pathways for the defibrillation current which endanger the assistants. For the same reason, do not place the patient on wet ground (rain, accident in swimming pool).

Have a pacemaker at hand, if possible.

☞

Should cardiac arrest occur or be imminent during

☞

preparations for defibrillation, administer heart massage and artificial respiration (CPR).

Do not allow the defibrillator paddles to come into contact with other electrodes or metal parts which are in contact with the patient.

Transducers and instruments that are not defibrillation-proof must be disconnected from the patient.

Interrupt heart massage and artificial respiration immediately before triggering the shock.

Immediately before triggering the shock disconnect tubes and have assistants step back.

227 446 32-D CardioServ V4.1 11

Introduction to CardioServ

Warning

Caution

Danger

Warnin

Caution

The patient’s chest must be dry, as moisture causes unwanted pathways for the defibrillation current. Therefore, when using flammable skin cleansing agents, wait until they have completely dried.

Possible explosion hazard if used in the presence of concentrated oxygen, flammable substances (gasoline) or anesthetic agents. Oxygenation in the vicinity of the defibrillation paddles must be strictly avoided; if necessary, interrupt oxygen supply while defibrillating the patient.

To prevent sparking

– the electrodes should make full contact with

the body

– the electrodes should be pressed firmly onto

the thorax.

When defibrillating children it is especially important to verify that the paddles make full contact with the body surface. This is to be observed also when using the clip-on electrodes for children (Part No. 303 439 95).

Defibrillating a patient who has an implanted pacemaker is likely to impair the pacemaker function or cause damage to the pacemaker. Therefore, the following should be observed:

– Select the smallest energy level possible for the

application.

– Do not apply the defibrillation paddles in the

vicinity of the pacemaker electrodes.

– The availability of an external pacemaker is

of utmost importance in this case.

– After the defibrillation the working order of

the implanted pacemaker should be checked immediately.

Also be aware that children require less energy for a successful defibrillation than adults. For the first defibrillation pulse delivered to babies and toddlers, select an energy level of 2 joules/kg body weight. For subsequent shocks, increase the energy up to 4 joules/kg.

12 CardioServ V4.1 227 446 32-D

Controls and Indicators

2. Controls and Indicators

This section describes the CardioServ operating controls and indicators and explains their function.

When operating elements in this manual are identified with a reference number in parentheses, this number refers to Figure 2-1 in this section.

You will also find an explanation of all signs and symbols used on the CardioServ defibrillator.

227 446 32-D CardioServ V4.1 13

Controls and Indicators

Charge

102030

100

150

300

J (50 )

200

360

Charge

Shock

Sync

APEX

Apply electrode cream to both paddles

Press charge button on apex paddle (on the device, when using adhesive or internal electrodes)

Press buttons on both paddles simultaneously (on the device, when using adhesive or internal electrodes)

Charge defibrillator

Deliver shock3

1 Select energy

Dem

Fix

P/min

–

Shock

Charge Shock

Autosequence

STERNUM

APEX

1418 17 16 15

13 8 975

Option

SpO

EKG





Figure 2-1. Controls and indicators of CardioServ VF

14 CardioServ V4.1 227 446 32-D

Controls and Indicators

1 Defibrillator paddles

Shock

button to trigger the defibrillation shock – together

with button (8)

3 keys to adjust the LCD contrast. Press both

keys simultaneously to obtain a screen copy.

4 Energy selector, on/off switch

Charge

key to charge the unit (manual mode) and to

Shock

trigger the defibrillation shock – together with key (6). This key assumes the function of button (8) when internal paddles or adhesive electrodes are used.

Shock

key to trigger the defibrillation shock – together

with key (5). This key assumes the function of button (2) when internal paddles or adhesive electrodes are used.

7 Five selection keys F1 to F5 whose functions change

with the menu displayed. The respective key functions are indicated by symbols or labels in the bottom line on the LCD. From the main menu, that appears on power up, you can access submenus which, in turn, allow the selection of further options. The back function returns you to the next higher menu level. The main menu reappears automatically if you do not depress any of the keys for about 30 seconds.

button to charge the unit (manual mode) and

Charge

Shock

trigger the defibrillation shock – together with button (2)

11 key to start and stop the recorder. This key assumes

the function of button (9) when internal paddles or adhesive electrodes are used.

12 Green indicator is lit when the defibrillator operates

on line power.

13 Yellow indicator

is lit when the defibrillator battery

is being charged.

14 Connection for defibrillator paddles

(controls 15 to 18 only on models with pacemaker)

15 Keys

16 Keys

17 Pacing mode selection key

P/min

to adjust the pacer output

P/min

to adjust pacer rate

Dem

(demand/fixed rate)

Fix

18 Key to enable and disable the pacemaker

19 Aperture to open the paper compartment

20 Connector for power cord

21 Unassigned

22 1-Volt ECG output

23 Connector for SpO2 sensor

9 button to start and stop the recorder.

Sync

key to switch to the synchronized operating mode

24 Connector for patient cable (ECG signal input)

(section 5 “Cardioversion”)

227 446 32-D CardioServ V4.1 15

Controls and Indicators

Explanation of the signs and symbols used on the defibrillator

Type CF equipment with highly insulated patient connections, suitable for intracardiac application, connections defibrillation-proof.

Type CF equipment with highly insulated patient connections, suitable for intracardiac application, connections not defibrillation-proof.

Standby mode (for line-power operation)

Power off

Battery charging

Recorder start

ECG signal

Contrast

Standby or preparatory state only for a part of the

equipment

On, only for a part of the equipment



Hardcopy of screen image

Refer to Operator’s Manual

Direction indicator

Signal output

Audible alarm on/off

High voltage

16 CardioServ V4.1 227 446 32-D

Setting Up CardioServ and Testing Its Performance

3. Setting Up CardioServ and Testing Its Performance

In this section you will find information about

– putting CardioServ into operation

– connecting CardioServ to the 12-Volt power supply of

an ambulance vehicle

– customizing the CardioServ settings to suit your per-

sonal requirements

– testing the CardioServ performance before using it on a

patient

227 446 32-D CardioServ V4.1 17

Setting Up CardioServ and Testing Its Performance

3.1 Setting Up CardioServ

The defibrillator is a high-voltage electrotherapy device and must be handled by qualified person-

Danger

nel only. Improper use of this device can endanger life. Do not fail to observe the information given in this manual and only entrust the device to the hands of trained persons.

Check the electrodes and their leads for signs of damage every time before you use the defibrillator. In particular, make a close visual inspection of the insulation. Replace internal electrodes or the contact inserts when you detect signs of mechanical damage.

CardioServ operates on:

– line power (95 to 240 V, 49 to 65 Hz)

– battery power (rechargeable batteries), i.e., independent

of the power line

– 12-Volt power supplied from the emergency vehicle

(with optional defibrillator mounting system)

* Use the power cord to connect the defibrillator to the

power line (Figure 3-1).

Figure 3-1. Power input

18 CardioServ V4.1 227 446 32-D

Setting Up CardioServ and Testing Its Performance

360

Shock

Charge

P/min

Shock

Sync

Figure 3-2. Green indicator (indicating that defibrillator is

supplied from the power line)

Figure 3-3. Inserting the battery

* Check that the green indicator is lit (Figure 3-2).

* Check that the battery is in place (Figure 3-3).

Pull back the catch on the underside of the device to remove the battery. When inserting it, make sure that it clicks properly into place.

When a battery is inserted, the yellow indicator

starts flashing as soon as the defibrillator is connected to the power line (to indicate that the battery is charging). The battery is fully charged after 16 hours and the indicator is continuously lit.

* Check that the supply of chart paper is sufficient (Figure

3-4). A stripe marks the last 3 meters of the roll.

Figure 3-4. Recording strip

227 446 32-D CardioServ V4.1 19

Setting Up CardioServ and Testing Its Performance

Power Supply From Emergency Vehicles

A qualified technician can be called in to connect the CardioServ to the 12-Volt supply of an emergency vehicle. The following points must be noted:

– The negative terminal of the ambulance power supply

system must be connected to the ambulance chassis for grounding.

– The positive lead of the ambulance power supply system

intended to supply the current must be protected with a

10-A fuse.

– Use only the defibrillator mounting system listed in

section 15 “Order Information and Accessories” or the external charging unit, if your CardioServ has been modified accordingly.

Check that the contacts for power supply from the



Figure 3-5. Accu Service Unit

defibrillator mounting system on the underside of CardioServ (next to battery) are clean. Do not damage

We recommend our Accu Service Unit for optimal

☞

them in any way.

care of the batteries. It prolongs the batteries’ service life and guarantees their operational readiness at all

Important Information on Battery-Power Operation

times.

Rechargeable batteries require special maintenance and continued checks to assure they function in emergency situations. It is normal for batteries of this type to selfdischarge when not in use.

Warnin

A NiCd battery should not be charged while located in direct sunlight, over a radiator, in cold storage, or in other temperature extremes (not below 5 °C). When the instrument is charging, ambient temperatures exceeding 40 °C may adversely affect battery capacity and life.

20 CardioServ V4.1 227 446 32-D

The battery charges automatically when CardioServ is connected to the power line (yellow indicator (13) flashes).

Setting Up CardioServ and Testing Its Performance

In order to ensure its functioning as an emergency device, the defibrillator should not be disconnected from the power line for more than 48 hours.

A fully charged battery supplies power for 35 defibrillation shocks of 360 joules or 2 hours of monitoring (or 1.2 hours of monitoring if the CardioServ unit has pacemaker and SpO option). It takes 16 hours to charge a depleted battery.

Proceed as follows to test the battery charge level:

☞

– Disconnect CardioServ from the power line. – Trigger a test discharge of 360 joules (see

section 3.2 “Testing the Defibrillator Performance”).

– If you are not prompted to charge the battery,

the charge level should be sufficient for at least 5 more 360-joule shocks.

Monthly battery maintenance and checks:

☞

1. Disconnect CardioServ from the power line and discharge fully charged battery in the monitoring mode. To do so, set energy selector switch to , (SpO2 sensor not connected) and wait until device switches off.

Inserting CardioServ In Its Softcase

* Open both zips on the CardioServ softcase.

* Undo the two Velcro strips on the front of the softcase.

* Open the Velcro flap located in front of the CardioServ

printer.

* Place the softcase on the small base, so that the softcase is

positioned as though you were carrying it.

* Disconnect the paddles on the CardioServ and remove

them.

* Hold all the opened up parts of the softcase to the side

and put the CardioServ into the softcase.

* Pull the softcase by the two Velcro strips on the black

base into position, ensuring that the feet of the CardioServ are in the cut-out openings provided.

* Close the two front Velcro strips as well as the flap in

front of the printer at the side.

2. Check how long it takes before battery is depleted. If the time is less than 1.8 hours, the battery is too old or improperly maintained and must be replaced.

3. Recharge the battery. This will take 16 hours.

For easy, convenient care and maintenance of the batteries, use our “Accu Service Unit”.

227 446 32-D CardioServ V4.1 21

* Close the zips.

* If the individual cut-out openings for the external con-

nections, paddles or feet are not correctly positioned, pull the material at this point into the right shape.

* Reconnect the paddles and put them back into the

CardioServ recesses.

Customizing the defibrillator settings

Setting Up CardioServ and Testing Its Performance

Further steps that can be taken while setting up the defibrillator include customizing the device functions. This allows you to select defibrillator default settings which suit your personal preferences. CardioServ saves these configured settings and reactivates them automatically every time you switch the

Refer to section 11 “The Defaults Menu” for a detailed explanation of how to customize the CardioServ, including the language selection (available languages are English, French, German, Italian, Portuguese, Russian, Spanish and

Swedish). defibrillator on. The following chart shows the factory settings of all parameters and the optional adjustments.

retemaraP noitpircseD gnitteSyrotcaF egnartnemtsujdA sgnittesdezimotsuC

stimiLRH stimilmralaRH 061/04 ffo003ot51ffo

ytivitisneS ezislangisGCE 1 Vm/mc2,1,5.

daeL 1 selddap+sdaeldradnatslla

.qesotuA slevelygrenegnicneuqesotua J063,J002,J002 ,J063,J003,J002,J051

OpS

stimiL stimilmrala ffo/09 ffo001ot51ffo

kcoL-C OpSdezinorhcnys-GCE

OpS

resU )sretcarahc04(emanrotxeteerf

emiT.tnI OpS

mralAliaFdaeL ffo s03/ffo

peeBSRQ ffo ffo/no

enoTmralA ffo ffo/no

tuotnirPmralA tratsredrocer.motua ffo ffo/no tuotnirPkcohS tratsredrocer.motua no ffo/no

tuotnirP.tnoC tratslaunamnopupotsredrocer ffo ffo/no

rekamecaP etareslup MPB06 nim/P051ot51 yalpsiD lamron desrever/lamron yalpsiD seerged0 seerged081/seerged0

emuloV slangisoiduallafoemulov duol wol/duol

retliFCA zH05 ffo/zH06/zH05

retliFelcsuM tcafitranoitomfonoitanimile no ffo/no

emiT/etaD

tamroFetaD YYYY:MM:DD YYYY:DD:MM/YYYY:MM:DD

egaugnaL namreG ,namreG,hcnerF,hsilgnE

tluafedyrotcaF sgnittesyrotcafhsilbatseer ffo ffo/no

emitnoitargetni s8 )dednemmocerton(s21,s8,s4

tnemerusaem ffo ffo/no

,naissuR,eseugutroP,nailatI

hsidewS,hsinapS

Table 1

22 CardioServ V4.1 227 446 32-D

Setting Up CardioServ and Testing Its Performance

J (50 Ω)

Autosequence

Figure 3-6. Switching on CardioServ

a b

Paddle

160 BPM

140 ECG

HR Alarm

3.2 Testing the Defibrillator

100

150

200

300

360

Charge

Shock

Sync

Performance

On power up CardioServ runs an automatic selftest. Any malfunctions identified during this test result in an error message displayed on the LCD (refer to section 12 “Error Indications and Messages”). As a further performance test a trial defibrillation can be triggered.

The energy selector is used to switch CardioServ on and off. Once you have become familiar with CardioServ you can thus switch on the defibrillator and select the required energy in one single operation.

* Set the energy selector to the position. No energy

will be stored in this position of the switch.

The defibrillator beeps and displays a checkered pattern (LCD performance test). Next the main display appears (Figure 3-7).

The “Paddle” message (b, Figure 3-7) indicates that no patient cable is connected and that the ECG signal is acquired via the defib paddles. Upon connection of the patient cable

FreezeSpO2ECG

the selected ECG lead is displayed here. CardioServ is now ready for operation.

Figure 3-7. CardioServ main display

a heart/pulse-rate reading with alarm limits b ECG signal source c 1-mV calibration pulse d alarm message, QRS blip e signal trace, channel 1 f signal trace, channel 2 g menu

227 446 32-D CardioServ V4.1 23

Setting Up CardioServ and Testing Its Performance

Do not trigger more than 5 consecutive test discharges (or internal safety discharges) within

Caution

15 minutes at max. energy setting.

Paddle

160 BPM

140 ECG

HR Alarm

Figure 3-8. Display of selected energy

360 J

MenuFreezeSpO2ECG

Test Discharge

A test discharge can be triggered to check the defibrillator discharge circuit. For this test the stored energy is discharged into the device via two contacts in the paddle compartments.

* Set the energy selector to 360 joules (50 joules, if inter-

nal electrodes are connected). The display first shows the selected energy (Figure 3-8).

Charge

* Press the

(Press the

Shock

button on the paddle to charge the unit.

Charge

key on the defibrillator, when using

Shock

internal electrodes.)

You may now watch the defibrillator charging.

* When the selected energy level has been reached,

CardioServ beeps and the stored energy is displayed (Figure 3-9).

* Trigger the defibrillation pulse within the next 30 sec-

onds. To do so, simultaneously press the buttons on

Charge

both paddles (or press the two

Shock

keys on the

defibrillator, when using internal electrodes).

If more than 5% of the available energy are lost before the defibrillation pulse is triggered, CardioServ recharges until the required energy level is reached.

24 CardioServ V4.1 227 446 32-D

Setting Up CardioServ and Testing Its Performance

Caution

Paddle

160 BPM

140 ECG

HR Alarm

Energy available

Figure 3-9. Display of available energy

If you do not trigger the defibrillation pulse within

☞

30 seconds, an internal safety discharge is initiated automatically.

360 J

MenuFreezeSpO2ECG

After defibrillation, the beeping sound stops, and the energy actually delivered into a 50-ohm resistance is displayed for 10 seconds in place of the stored energy (Figure 3-9). The delivered energy must not deviate more than ±15% or ±4 joules (whichever is greater) from the selected value. A recording is initiated at the same time (16-second strip).

Should the discharge circuit be interrupted (paddles not properly placed on contacts in the compartments, defective lead), an internal safety discharge is initiated 200 ms after the defibrillation shock has been triggered. In this case the “delivered energy” is “0”.

If the defibrillator cannot store the selected energy so that selected and stored energy values differ, the LCD shows the message “Energy high” or “Energy low”. The defibrillation pulse can be triggeed all the same.

* Switch off CardioServ (set energy selector to ).

The message “Energy high” or “Energy low” indicates that CardioServ needs to be repaired.

Caution

If, in spite of this energy storage problem, the device has to be employed, it will display the message “Self-test failed. Charge Energy Error”

Testing the Pacemaker Performance

The performance of the pacemaker can be tested with a commercially available pacemaker tester (e.g. CS300 Simulator from Marquette Hellige, part no. 417 983-001).

upon power up. In this situation press one of the function keys and proceed as usual.

Performance Test

Test the defibrillator performance once a week: test 1 – defibrillator connected to mains, battery

removed,

test 2 – defibrillator disconnected from mains,

battery inserted

227 446 32-D CardioServ V4.1 25

For your notes

Setting Up CardioServ and Testing Its Performance

26 CardioServ V4.1 227 446 32-D

Non-Synchronized Defibrillation

4. Non-Synchronized Defibrillation

This section describes first how to perform a non-synchronized defibrillation, using the standard defibrillation paddles. The subsequent explanations refer to the use of internal and disposable adhesive electrodes.

At the end of this section you will find a summary of all necessary operating steps (brief operating instructions).

227 446 32-D CardioServ V4.1 27

Non-Synchronized Defibrillation

4.1 Defibrillation with Standard Electrodes

The information given in section 1.2 must be

Warnin

observed without fail to ensure safe and reliable application of the device.

Always switch off CardioServ before exchanging the defibrillation paddles.

Danger

Paddle

160 BPM

140 ECG

HR Alarm

200 J

SpO2ECG

Figure 4-1. Main display, indication of ECG lead, manual

operation and selected energy

MenuFreeze

The energy selector can be set to the autosequence position, where the defibrillator automatically sequences the preset energy levels. The preset factory default setting is the sequence recommended by AHA/ERC (200 J, 200 J, 360 J). The factory default values can be changed from the defaults menu. You can choose among 150 J, 200 J, 300 J and 360 J.

* Set the energy selector (4) to “Autosequence” or to the

required energy value (this turns on CardioServ).

The defibrillator beeps and displays a checkered pattern (LCD performance test). Next the main display appears (Figure 4-1). When a patient cable is connected the selected ECG lead is displayed (selectable).

* Check that the energy selector locks in on the correct

position and that the display shows the selected energy (Figure 4-1).

The energy depends on the defibrillation mode, on the patient’s age and constitution. In external application the thickness of the tissue is also a factor which influences the amount of energy required.

The energy necessary for successful ventricular defibrillation without damaging the myocardium has for many years been a matter of scientific controversy. The manufacturer is therefore not able to give any recommendations.

28 CardioServ V4.1 227 446 32-D

Figure 4-2. Removing the paddles

Do not apply the paddles over

Warnin

– sternum or clavicle – nipples – implanted pacemaker or defibrillator.

Non-Synchronized Defibrillation

In emergency situations AHA recommends for adult patients

1. defibrillation with 200 joules; if unsuccessful, repeat

2. defibrillation with 200 joules; if unsuccessful, repeat

3. defibrillation with max. energy setting (360 joules).

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

In compliance with IEC requirements the energy adjusted on this defibrillator is not the stored energy, but the energy released into an external resistance of 50 ohms (patient resistance + electrode-to-skin contact resistance). The energy selector is labelled accordingly.

* Remove the paddles from their compartments (as shown

in Figure 4-2). Carefully dry the electrodes, if they are wet. The handles, in particular, must be completely dry. Apply an ample amount of electrode cream to each paddle.

STERNUM

C h

a r

g e

APEX

* Apply the electrodes to the patient’s thorax so that the

greatest possible amount of energy flows through the myocardium (the imaginary connecting line between the two electrode centers should be identical with the cardiac median line; Figure 4-3).

* Press paddles firmly down onto the patient’s thorax..

Figure 4-3. Paddle application points

227 446 32-D CardioServ V4.1 29

Non-Synchronized Defibrillation

Charge

Shock

STERNUM

Charge

Shock

APEX

Figure 4-4. Buttons to initiate energy storage and to trigger the

defibrillation shock

Paddle

160 BPM

140 ECG

HR Alarm

The ECG signal trace appears on the monitor.

* Do not touch the patient any more and warn all those

present.

Charge

* Press the

Shock

button (8) on the apex paddle to initiate

charging (Figure 4-4). When using internal electrodes or defibrillation pads, press

Charge

on the device.

Shock

When the selected energy level has been reached (message “Energy available”), CardioServ beeps and the stored energy is displayed (Figure 4-5).

* Trigger the defibrillation shock within the next 30 sec-

onds by simultaneously pressing the buttons on both paddles (Figure 4-4). When using internal electrodes or defibrillation pads, press

Charge

Shock

and

Shock

on the device.

If more than 5% of the available energy are lost before the defibrillation shock is triggered, CardioServ recharges until the required energy level is reached.

Energy available

FreezeSpO2ECG

200 J

Figure 4-5. Display of available energy

☞

When the defibrillator is already charged you can increase the energy level simply by turning the energy selector to the new setting. To decrease the energy level, set the selector to the lower value and initiate charging again.

30 CardioServ V4.1 227 446 32-D

Non-Synchronized Defibrillation

Paddle

160 BPM

140 ECG

HR Alarm

Energy delivered

Figure 4-6. Display of delivered energy

The “Check Electrode” message refers to the defibril-

☞

lation paddles only when no patient cable is connected. It refers to the ECG electrodes when the patient cable is plugged in.

If you do not trigger the defibrillation pulse within

☞

30 seconds, an internal safety discharge is initiated automatically. You will then have to recharge the defibrillator.

The defibrillation energy (high voltage!) remains

Warnin

applied to the defibrillation paddles until fully discharged. Do not touch the paddle surface! The internal safety discharge is completed when the selected energy is displayed again.

198 J

MenuFreezeSpO2ECG

– After defibrillation, the beeping sound stops, and the

energy actually delivered is displayed for 10 seconds in place of the stored energy (Figure 4-6). At the same time the recorder writes a 16-second ECG (including a history of 4 seconds) (adjustable, Figure 4-7). CardioServ saves this recording (4 s history, 5 s blanked, 10 s after release of shock), and it can be printed off again at any time. Also refer to section 7 “The Memories of CardioServ”.

– When the electrodes are not applied at all or they are not

properly applied to the skin, the message “Check Electrode” is displayed. The defibrillation shock can be triggered all the same. Nevertheless it is recommended to reduce skin impedance (risk of skin burns!), for instance, by applying more electrode cream to the paddles or by pressing them down firmly.

– When there is a break in the discharge circuit (paddles

not properly applied, leads or paddles defective), an internal safety discharge is initiated 200 ms after the defibrillation shock has been triggered. In this case the “delivered energy” is “0”.

_ If the defibrillator cannot store the selected energy so

that selected and stored energy values differ, the LCD displays a warning. The defibrillation pulse can be triggered anyway (notify service).

* Once therapy has ended, set the selector switch to

for monitoring of the patient’s ECG.

227 446 32-D CardioServ V4.1 31

Non-Synchronized Defibrillation

DEFIB 09. 07 .1997 09 : 16 : 12 50 Hz 35 Hz 360 JOULES HR : O BPM SHOCK

PADDLE 1 CM/MV 25 MM/S ST. JOHN’S 97

<5s>

Figure 4-7. Example of a recording initiated by a defibrillation pulse

a initiation e delivered energy i paper speed b date f heart rate k name of hospital/practise c time g ECG lead d active filters h sensitivity

PATIENT

DATE OF BIRTH.............

USER........................

COMMENTS.................

SELECTED ENERGY.........

DELIVERED ENERGY........

ALARM LIMIT HR...........

ALARM LIMIT SPO2 .......

PACEMAKER................

DATE/TIME

* After use, switch off CardioServ (set selector switch to

* Clean the paddles and the device as described in section

13.

* After cleaning, return the paddles to their compartments

as shown in Figure 4-8.

Figure 4-8. Returning the paddles to their compartments

32 CardioServ V4.1 227 446 32-D

Non-Synchronized Defibrillation

4.2 Defibrillation with Internal Electrodes or Single-Use Pads

Internal Electrodes

When using CardioServ with internal or adhesive

☞

electrodes, charging is initiated with

Charge

Shock

and defi-

brillation is triggered by simultaneously pressing the

Charge

Shock

and

Shock

(Figure 4-9). Only sterile electrodes

may be used for internal defibrillation!

J (50 Ω)

utosequence

360

300

100

150

200

Charge

Shock

Sync

Figure 4-9. Panel keys to initiate charging and to trigger the

defibrillation shock

When electrodes for internal defibrillation are connected to CardioServ, it is not posssible to store energy above 50 joules. If you set the selector to values higher than 50 joules, release of the defibrillation pulse is blocked for reasons of patient safety (“Energy high” will be displayed!). Simply turn the dial back and initiate charging again, this time selecting not more than 50 joules.

Spoon-shaped electrodes are used for internal defibrillation. Their contact surface must match the dimensions of the heart, as the spoons should make full contact with the tissue.

You can choose from 3 different spoon sizes (section 15 “Order Information, Accessories”). As the spoons are in direct contact with the heart – hence the term “direct defibrillation” – energy levels considerably lower than those for transthoracic (external) defibrillation are sufficient.

Please note that internal electrodes must be sterilized before use (section 13 “Cleaning and Disinfection”).

227 446 32-D CardioServ V4.1 33

Non-Synchronized Defibrillation

STERNUM

electrode + connector

Figure 4-10. Anterior – anterior placement

front back

APEX

Single-Use Defibrillation Pads

* Use pads before their expiration date.

* A pair of defibrillation pads may remain attached to

the patient for up to 24 hours. They withstand up to 50 shocks of 360 joules each.

* Apply the pads (part no. 919 202 94 adult pads, part no.

919 202 95 pediatric pads) as shown in Figure 4-10 for an anterior-anterior placement, and as shown in Figure 4-11 for an anterior-posterior placement:

– Shave any hair from each site. This improves conduc-

tivity and makes removal of the pad easier.

– Place the pads on the patient so that the connectors

point to either side of the patient. In this position the connecting cables will not hinder CPR measures.

– The electrodes are pregelled; therefore do not use

APEX STERNUM

additional contact cream or paste.

Figure 4-11. Anterior – posterior placement

– Do not use pads, if the gel has dried out.

– Peel off the backing from each pad and place the pad

carefully on the appropriate site.

34 CardioServ V4.1 227 446 32-D

223 383 01

Warning

Non-Synchronized Defibrillation

* Then press the connector of cable 223 383 01 on to the

electrode contact pin until you hear it click into place. Observe the connector lables: “A” = apex, “S” = sternum.

Figure 4-12. Connecting the cables

223 346 01

919 202 94 919 202 95 (K)

919 201 89 919 202 75 (K)

The round adhesive electrodes (part no. 919 201 89) can be used with adapter lead 223 346 01. When connecting the electrode to the lead, take care that they engage properly. To disconnect them, simply press on the rear part of the catch (Figure 4-13).

* Before defibrillating the patient, verify the position and

adhesion of the pads.

* Defibrillate the patient as described in section “Defibril-

lation with Standard Electrodes”. Note, however, that energy storage and defibrillation pulse will have to be triggered with the panel keys.

* After use, carefully peel off the electrodes from the

patient’s skin (Figure 4-14) and discard them immediately.

Figure 4-13. Connecting the defib pads to the adapter cable

When monitoring the patient with the adhesive defib pads, make sure that the energy selector is in

incorrect

correct

the monitoring position .

Discard disposable defibrillation pads immediately after use. Do no reuse them!

Figure 4-14. Removing defibrillation pads

227 446 32-D CardioServ V4.1 35

Non-Synchronized Defibrillation

4.3 Brief Operating Instructions (non-synchronized)

External Electrodes/Paddles

* Set energy selector to “Autosequence” or select

the required energy

* Remove paddles from compartments and apply

electrode cream

* Apply electrodes to thorax

Charge

* Initiate defibrillator charging

Shock

* Wait for beep to sound and for stored energy to

be displayed

* Warn bystanders, do not touch the patient any

more and trigger shock; to do this, simultane-

Charge

Shock

ously press

Shock

on both paddles

* Watch ECG, repeat defibrillation if necessary or

set energy selector to , if defibrillation was successful

* Switch off CardioServ after use (set energy

selector to )

* Clean paddles and defibrillator

Internal Electrodes or Pads

* Connect internal electrodes or pads to

CardioServ

* Apply pads

* Set energy selector to “Autosequence” or select

the required energy (50 joules max. for internal

defibrillation)

* Initiate defibrillator charging

* Wait for beep to sound and for stored energy to

be displayed

* Warn bystanders, do not touch the patient any

more and trigger shock; to do this, simultane-

Charge

ously press the

Shock

* Watch ECG, repeat defibrillation if necessary or

set energy selector to , if defibrillation was successful

* Switch off CardioServ after use (set energy

selector to )

* Dispose of single-use electrodes, clean defibrilla-

tor

Charge

Shock

keys on the panel

* Clean/sterilize internal electrodes

36 CardioServ V4.1 227 446 32-D

Cardioversion (Synchronized Defibrillation)

5. Cardioversion

(Synchronized Defibrillation)

This section describes first how to perform a synchronized defibrillation (cardioversion). For this purpose, the ECG is picked up either via the paddles or via separate ECG electrodes.

At the end of this section you will find a summary of all necessary operating steps (brief operating instructions).

227 446 32-D CardioServ V4.1 37

Cardioversion (Synchronized Defibrillation)

5.1 General Information

Warnin

Caution

The information given in section 1.2 must be observed without fail to ensure safe and reliable application of the device. Also read section 6.1 “Displaying the ECG”.

The American Heart Asociation AHA recommends the following energy levels for cardioversion: 50 J, 100 J, 200 J, 300 j, 360 J.

For cardioversion, the defibrillation shock is delivered in synchronization with the heart action (on the R-wave), as the heart is still working. As a prerequisite the patient’s ECG signal must be supplied to the defibrillator. After the defibrillator has received the “defibrillation command” from the operator who pressed the appropriate keys, the defibrillator will wait for the next R-wave to derive the trigger signal.

The ECG signal can be sensed either via a special patient cable or via defibrillation pads. Use the adhesive pads, since the standard paddles may cause major motion artifact during ECG acquisition.

We recommend ECG acquisition by means of the patient cable whenever possible.

38 CardioServ V4.1 227 446 32-D

Cardioversion (Synchronized Defibrillation)

STERNUM

electrode + connector

Figure 5-1. Anterior – anterior placement

front back

APEX STERNUM

APEX

5.2 Performing Cardioversion

ECG Acquisition via Defibrillation Pads

* Apply the pads as shown in Figure 5-1or 5-2 (also refer

to section 4.2 “Defibrillation with Internal Electrodes or Single-Use Pads”).

* Check that no patient cable is connected to ECG signal

input (Figure 5-3).

The ECG will now be acquired via the defibrillation pads. Perform cardioversion as described below.

ECG Acquisition via ECG Electrodes and Patient Cable

Use only siver/silver chloride electrodes if you intend to acquire the ECG signal via the patient cable. This type of electrodes prevents polarization voltages which may be caused by the defibrillation shock, resulting in an ECG trace simulating cardiac arrest.

Figure 5-2. Anterior – posterior placement

* Apply the electrodes (choosing the EINTHOVEN limb lead

system, for instance) and connect them to CardioServ via the patient cable (Figure 5-3).

For further information on ECG signal acquisition, please refer to our application note on electrocardiography and to

Option

SpO



EKG



the relevant literature.

Figure 5-3. ECG signal input

227 446 32-D CardioServ V4.1 39

Cardioversion (Synchronized Defibrillation)

I...III

aV...V

Paddle

cm/mV

100

150

200

300

360

Shock

Charge

Shock

Sync

Figure 5-4. Key to select synchronized defibrillation

APEX

Charge

Shock

Cardioversion

* Set the energy selector to (this turns on

CardioServ) and check the ECG trace.

The defibrillator beeps and displays a checkered pattern (LCD performance test). Next the main display and the label of the selected lead are shown (when patient cable is connected).

CardioServ is now ready for operation.

The defibrillator selects the following settings:

APEX

– EINTHOVEN lead I (selectable) – AC line filter on (selectable) – sensitivity of 1 mV/cm (selectable)

If you wish to select another lead or sensitivity, proceed as follows (these are only temporary changes which will not be saved):

* Press the

* Use the

ECG

softkey to call up the ECG submenu.

softkey to select a suitable ECG lead

(shown at a, Figure 5-5).

* Use the

* Press

Sync

softkey to select the sensitivity.

(Figure 5-4).

The “Sync” mode is indicated on the LCD (c, Figure 5-5).

40 CardioServ V4.1 227 446 32-D

Cardioversion (Synchronized Defibrillation)

160 BPM

140 ECG

Figure 5-5. Screen display

a selected lead b Sync mark c Sync mode on d heart symbol

On the recording strip each sync pulse is identified

☞

with a dash above and below the ECG trace.

Verify that the heart symbol flashes regularly on the LCD and that the sync mark appears at regular intervals along the upper

LCD margin (b, Figure 5-5). Otherwise select another lead

I...III

using softkey

aV...V

of the ECG submenu.

Paddle

When the synchronized defibrillation mode is selected, each QRS complex is identified with a SYNC mark (b, Figure

Sync

5-5). If these SYNC marks are missing, synchronized defibrillation will not be possible, i.e., the defibrillator will not deliver a shock. Reasons for missing SYNC marks include

MenuFreezeSpO2ECG

poor ECG signal quality. Select another ECG lead and/or check electrode contact.

Selecting the non-synchronized mode to defibrillate the patient is only necessary in acute emergencies, such as ventricular fibrillation, because this condition almost certainly precludes detection of a QRS signal to trigger the shock.

* Remove the paddles from their compartments. Carefully

dry the electrodes, if they are wet. The handles, in particular, must be completely dry. Apply an ample amount of electrode cream to each paddle.

Warnin

The defibrillation shock cannot be triggered, when the SYNC marks are missing.

* Set the energy selector to “Autosequence” or to the

required energy level.

227 446 32-D CardioServ V4.1 41

STERNUM

Figure 5-6. Paddle placement

Cardioversion (Synchronized Defibrillation)

When electrodes for internal defibrillation are connected to CardioServ, it is not possible to store energy above 50 joules. If you set the selector to values higher than 50 joules, release of the defibrillation pulse is blocked for reasons of patient safety (“Energy high” will be displayed!). Simply turn the dial back and initiate charging again, this time selecting not more

than 50 joules.

In compliance with IEC requirements the energy adjusted on

Charge

APEX

this defibrillator is not the stored energy, but the energy released into an external resistance of 50 ohms (patient resistance + electrode-to-skin contact resistance). The energy selector is labelled accordingly.

Do not apply the paddles over

Warnin

– sternum or clavicle – nipples – implanted pacemaker or defibrillator.

Charge

Shock

STERNUM

Charge

Shock

APEX

Figure 5-7. Buttons to inititate energy storage and to trigger the

defibrillation shock

* Apply the electrodes to the patient’s thorax so that the

greatest possible amount of energy flows through the myocardium (the imaginary connecting line between the two electrode centers should be identical with the cardiac median line; Figure 5-6).

* Press paddles firmly down onto the patient’s thorax.

* Do not touch the patient any more and warn all those

present.

Charge

* Press the

Shock

button (8) on the apex paddle to initiate

charging (Figure 5-7). When using internal electrodes or defibrillation pads, press the

Charge

key on the CardioServ

Shock

control panel.

When the selected energy level has been reached, CardioServ beeps and the stored energy is displayed (Figure 5-8). It should be identical with the selected value (±15% or ± 4 joules, whichever is greater)

42 CardioServ V4.1 227 446 32-D

Cardioversion (Synchronized Defibrillation)

160 BPM

140 ECG

Energy available

Figure 5-8. Display of the stored energy

The “Check Electrode” message refers to the defibril-

☞

lation paddles only when no patient cable is connected. It refers to ECG electrodes when the patient cable is plugged in.

The defibrillation energy (high voltage!) remains

Warnin

applied to the defibrillation paddles until fully discharged. Do not touch the paddle surface! The internal safety discharge is completed when the selected energy is displayed again.

100 J

MenuFreezeSpO2ECG

Sync

* Simultaneously press the butttons on both paddles

(Figure 5-7) within 30 seconds. The next synchronization pulse will release the defibrillation shock. When using internal electrodes or pads, press the panel keys

Charge

Shock

and

Shock

to deliver the shock.

– After defibrillation, the defibrillator stops beeping, and

the energy actually delivered to the patient is displayed for 10 seconds in place of the stored energy. At the same time the recorder writes a 16-second ECG, including a history of 4 seconds (adjustable, Figure 5-9). CardioServ saves the ECG (4-s history, 5 s blanked, 10 s after release of shock). On the recording the blanked period of time is marked with a spike (Figure 5-9). Refer to section 7

“The Memories of CardioServ”.

– When the electrodes are not applied at all or they are not

properly applied to the skin, the message “Check Electrode” is displayed. The defibrillation pulse can be triggered all the same. Nevertheless it is recommended to reduce skin impedance, for instance, by applying more electrode cream to the paddles or by pressing them down firmly.

– When there is a break in the discharge circuit (paddles

not properly applied, leads or paddles defective), an internal safety discharge is initiated 200 ms after the defibrillation shock has been triggered. In this case the delivered energy is not indicated.

– If the defibrillator cannot store the selected energy so

that selected and stored energy values differ, the LCD shows he message “Energy high” or “Energy low”. The defibrillation pulse can be triggered all the same.

227 446 32-D CardioServ V4.1 43

Cardioversion (Synchronized Defibrillation)

DEFI 09. 04 .1997 09 : 16 : 12 SYNC 100 JOULES HR : 59 BPM SHOCK

I 1 CM/MV 25 MM/S ST. JOHN’S DGH 97

Figure 5-9. Example of a recording initiated by a defibrillation pulse

a initiation b date c time d SYNC mode e delivered energy f heart rate g ECG lead (here: EINTHOVEN I) h sensitivity i paper speed k name of hospital/practice

b d

<5s>

44 CardioServ V4.1 227 446 32-D

Cardioversion (Synchronized Defibrillation)

Always switch off Cardio Serv before exchanging

Warnin

☞

the defibrillation paddles.

Following each synchronized defibrillation, CardioServ reverts to the non-synchronized mode. Please note that the synchronized mode must be deliberately activated with

Sync

every time you want to perform cardioversion. This measure is to ensure that in emergencies the defibrillator is always ready to deliver nonsynchronized shocks.

* Once therapy has ended, set the selector switch to

for monitoring of the patient’s ECG.

* After use, switch off CardioServ (Set selector switch to

* Clean electrodes and the defibrillator as described in

section 13.

* After cleaning, return the paddles to their compartments.

* When using CardioServ with internal electrodes or pads,

please refer to section 4.2 “Defibrillation with Internal Electrodes or Single-Use Pads”.

227 446 32-D CardioServ V4.1 45

Cardioversion (Synchronized Defibrillation)

5.3 Brief Operating Instructions (cardioversion)

ECG Acquisition with ECG Electrodes (this is the preferred method)

* Apply ECG electrodes and connect them to

CardioServ, using the patient cable

* Set energy selector to required energy

* Select synchronized operating mode (

Sync

) and check LCD for regular trigger pulses; if they do not appear, select another lead (F1

ECG

)

* Remove paddles from their compartments and

apply electrode cream

* Apply paddles to patient and initiate defibrillator

Charge

charging

Shock

* Wait for beep to sound and for available energy

to be displayed

* Warn bystanders, do not touch the patient any

more and trigger pulse; to do this, simultaneously

Charge

Shock

press the buttons

Shock

on both paddles; wait

for shock to be delivered

* Watch ECG, repeat defibrillation if necessary or

set energy selector to , if defibrillation was successful

ECG Acquisition with Defib Pads

* Apply pads to patient and connect them to

CardioServ; a patient cable must not be con- nected to the unit (24)!

* Set energy selector to required energy

* Select synchronized operating mode (

Sync

)

* Check LCD for regular trigger pulses; if they do

not appear, apply ECG electrodes for signal acquisition

* Initiate defibrillator charging

Charge

Shock

* Wait for beep to sound and for available energy

to be displayed

* Warn bystanders, do not touch the patient any

press

Charge

Shock

; wait for shock to be delivered

more and trigger pulse; to do this, simultaneously

* Switch off CardioServ after use

* Switch off CardioServ after use (energy selector

at )

* Discard disposable electrodes, clean paddles and

defibrillator

46 CardioServ V4.1 227 446 32-D

Displaying and Monitoring the ECG

6. Displaying and Monitoring the ECG

This section describes how to apply the ECG electrodes in order to display all 12 standard leads, and how to monitor the heart rate (adjusting alarm tone, QRS beep and alarm limits).

At the end of this section you will find a summary of all nesessary operating steps (brief operating instructions).

227 446 32-D CardioServ V4.1 47

Displaying and Monitoring the ECG

red

yellow

white

IEC

red

configuration

black green

white

black

brown

AHA

white

configuration

green red

Figure 6-1. Electrode application points

5-lead cable (left) 3-lead cable (right)

With a 3-lead cable only ECG leads I,II and III can

☞

be displayed.

When monitoring the patient via the adhesive defib pads, make sure that the energy selector is in

Caution

the monitoring position .

yellow

6.1 Displaying the ECG

For a quick diagnosis the ECG signal can be sensed via the defibrillation paddles (see below). For more accurate examinations and heart-rate monitoring, however, ECG electrodes

black

must be applied.

Either 3 or 5 electrodes can be used for ECG acquisition. In emergencies, 3 electrodes are sufficient. Use only silver/silver chloride electrodes. This type of electrodes prevents polarization voltages which may be caused by the defibrillation pulse, resulting in an ECG trace simulating cardiac arrest.

red

For detailed information on ECG signal acquisition, please refer to our application note on electrocardiography and to the relevant literature.

* Apply the electrodes as shown in Figure 6-1.

* Connect the patient cable to the electrodes and to the

ECG signal input (Figure 6-2).

– If you prefer to use 5 ECG electrodes, apply 4 limb-lead

electrodes, for instance, and one precordial electrode.

Option

SpO



EKG



Figure 6-2. ECG signal input

48 CardioServ V4.1 227 446 32-D

Displaying and Monitoring the ECG

– To obtain a recording of all 12 standard leads, attach the

The C-electrodes of the IEC system shown here are

☞

the V-electrodes of the AHA system.

4 limb-lead electrodes and apply suction electrode 217 144 01 to the thorax. This electrode is easy to move from one pick-up point to the next (C1 through C6, Figure 6-3). Use electrode lead 223 404 10 to connect the suction electrode to the patient cable. While record-

I...III

ing the chest leads, leave softkey

aV...V

Paddle

set to V and simply move the chest electrode to application points C1 through C6 (C8).

C2C3

Figure 6-3. Chest electrode application points

C1 in the 4th intercostal space at the right sternal

edge C2 in the 4th intercostal space at the left sternal edge C3 at the level of the 5th rib midway between C2

and C4 C4 in the 5th intercostal space on the left midclavi-

cular line C5 between C4 and C6 on the left anterior axillary

line C6 on the mid-axillary line at the level of C4 C7 in the 5th intercostal space on the left posterior

axillary line C8 in the 5th intercostal space on the left scapular

line

– As an alternative, you can connect the 3-lead monitoring

cable, Part No. 223 287 01 or Part No. 223 288 01 (with HF protection).

In this case only leads I,II and III can be displayed.

☞

* Set the energy selector (4) to : This turns on

CardioServ.

227 446 32-D CardioServ V4.1 49

Displaying and Monitoring the ECG

I...III

aV...V

Paddle

cm/mV

160 BPM

140 ECG

HR Alarm

- % 90 SpO2

Figure 6-4. Main display

a heart/pulse-rate reading with alarm limits b lead c 1-mV calibration pulse d alarm message, QRS blip e channel 1: ECG f channel 2: plethysmogram g menu

The defibrillator beeps and displays a checkered pattern (LCD performance test). Next the software version is displayed, followed by the main display (Figure 6-4).

A field is reserved for technical alarms and messages above the heart and pulse rate reading.

FreezeSpO2ECG

The defibrillator selects the following default settings:

– EINTOVEN lead I (selectable) – AC filter on/ muscle filter on (selectable) – sensitivity of 1 cm/mV (selectable)

If you wish to select another lead or sensitivity, proceed as follows (these are only temporary changes which will not be saved):

* Press the

* Use the

ECG

softkey to call up the ECG submenu.

softkey to select a suitable ECG lead

(shown at b, Figure 6-4).

* Use the

softkey to select the sensitivity.

Filters (AC line filter / muscle filter) enabled during signal acquisition render the ECG display insensitive to signal noise arising from the mains or from muscle tremor or motion. The

Warnin

Filters will falsify the ECG signal. For diagnostic purposes, all filters should be disabled.

filters, however, falsify the ECG signal, making it unsuitable for diagnostic purposes. The heart rate is always calculated from the unfiltered ECG. An artifactual ECG signal may thus lead to a wrong heart rate reading, even though the displayed, filtered ECG is “clean”.

50 CardioServ V4.1 227 446 32-D

Displaying and Monitoring the ECG

Freeze

The Freeze function may mask messages on the

☞

display.

* For a more detailed assessment of the ECG, you can

freeze the trace with the

Freeze

softkey.

The current ECG continues to be displayed in the upper section of the LCD for monitoring, while the frozen segment appears in the bottom section. The monitoring function is still on.

When you press

Freeze

the erase bar moves to the right-hand screen edge, i.e., the entire display shows the period of time immediately prior to depression of

Freeze

The frozen ECG segment can be:

Freeze

– printed out with the

key (incl. a history of

4 seconds)

Store

– stored with the

– released with the

Freeze

Un-

key

key.

Rotating the display (temporary)

The screen display can be rotated 180°.

* Press

to display the submenu.

Display

Flip

to rotate the display.

Pressing the same key again restores the original orientation.

227 446 32-D CardioServ V4.1 51

Displaying and Monitoring the ECG

6.2 Monitoring the Heart Rate

CardioServ can be set up (Section 11 “Configuring

☞

the Defibrillator Settings”) to automatically enable the audible alarm on power-up. The default alarm limits can also be preset.

160 BPM

140 ECG

HR Alarm

- % 90 SpO2

Figure 6-5. Main display

a heart/pulse-rate reading with alarm limits b lead c 1-mV calibration pulse d alarm message, QRS blip e channel 1: ECG f channel 2: plethysmogram g menu

FreezeSpO2ECG

With the factory settings unchanged, there will be no audible alarm upon power up (F4 ). You enable the alarm tone by pressing F4 once.

If the device sounds an alarm, you can press to silence the alarm tone. Should the alarm cause persist, the alarm will recur after 120 s (the remaining time is displayed in the softkey). To permanently disable the audible alarm, press the key longer than 2 seconds. As a result the crossed-out bell symbol will appear.

The alarm limits can be modified either permanently via the defaults menu (section 11 “The Defaults Menu”) or temporarily (see below).

If the heart rate violates one of the set limits for more than 5 seconds CardioServ gives alarm:

– the alarm tone sounds (selectable) – the alarm cause is shown in the display (d, Figure 6-5) – the violated limit value flashes – the alarm recorder is started (selectable) – the ECG is saved (4-s history, 6 seconds after alarm

release). See section 7 “The Memories of CardioServ”.

* Press to silence the alarm.

If the alarm cause has been eliminated, the alarm is cleared; if it persists, the alarm recurs after 120 seconds.

52 CardioServ V4.1 227 446 32-D

Displaying and Monitoring the ECG

When an electrode required for the selected ECG lead drops off, an alarm sounds and the “Check Electrode” message appears on the display.

Modifying Device Settings

Using keys F1 to F5 you can change the settings for ECG monitoring. In this case, however, the settings are only temporary and will not be saved. Permanent adjustments are only possible via the defaults menu (section 11 “Configuring the Defibrillator Settings”).

Adjusting Alarm Limits

I...III

aV...V

Paddle

cm/mV

Alarm

Limits

Alarm

Printout back

Figure 6-6. Next menu

High Alarm

- + ECG

Low Alarm

- + ECG

Figure 6-7. Alarm menu

You can disable the alarm limits by selecting a value

☞

outside the adjustment range.

back

* Press the

ECG

softkey to display the ECG menu

(Figure 6-6).

Alarm

* Press

Limits

to change the alarm limits. The alarm

menu will be displayed (Figure 6-7).

* The + keys increase the values, the - keys decrease them

in steps of 5 BPM. If you hold the key depressed, the digits change at a higher rate.

227 446 32-D CardioServ V4.1 53

Displaying and Monitoring the ECG

QRSPulse

Beep

OFF

Selecting the HR Source

CardioServ automatically returns to the main menu

☞

when no function keys are pressed for more than 30 s.

Source

ECG

QRSPulse

Beep

OFF

Memory

Display

Flip

Figure 6-8. The submenu

With the C-LOCK ECG synchronization function

☞

enabled, the QRS beep is triggered by the ECG signal even when the selected heart rate source is the pulse signal.

back

CardioServ devices with SpO2 measuring system allow the selection of the heart/pulse-rate source (heart rate from ECG or pulse rate from the SpO2 signal). The source is indicated by “ECG” or “Pulse” below the parameter reading.

* Display the submenu with the

key.

Figure 6-8 will appear.

* Select “ECG” or “SpO2” with the

Source

ECG

key.

Enabling/Disabling the QRS Beep

* Display the submenu (Figure 6-8) with the

key.

* Enable or disable the QRS or pulse beep with the

key, as required.

54 CardioServ V4.1 227 446 32-D

Displaying and Monitoring the ECG

6.3 Monitoring Pacemaker Patients

Warnin

If several adverse conditions exist at once, the possibility that pacing pulses are interpreted as QRS complexes should be considered. For safety, always watch pacemaker patients closely.

The device does not recognize pacing pulses with an amplitude below 20 mV.

When monitoring pacemaker patients, it is important that the device counts only the QRS complexes and not the pacing pulses from the pacemaker. For this reason, CardioServ comes with an electronic circuit that filters out pacemaker pulses. However, in exceptional cases, depending on the pacemaker model involved and the electrode placement, the compensation algorithm following every pacing pulse may simulate a QRS complex. Every pacemaker must provide an oppositely charged current (reverse current) after delivering a pacing pulse. Ineffective stimulation (absence of QRS complexes) can lead to misinterpretation, so that alarm is not released in cases of bradycardia (slow heart rate) or cardiac arrest.

For this reason we recommend the plethysmogram (SpO2) for monitoring of pacemaker patients. Also, set the HR source to “Pulse”.

You should disable the C-LOCK synchronization to prevent that frustraneous pacing pulses are counted as QRS complexes.

Whether or not the device interprets the pacemaker compensation algorithm as a QRS complex depends on the pacemaker pulse parameters (See section 14 “Technical Specifications”).

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

227 446 32-D CardioServ V4.1 55

Displaying and Monitoring the ECG

6.4 Brief Operating Instructions

Displaying the ECG

* Apply ECG electrodes and connect them to CardioServ.

* Set energy selector to .

* Display the ECG menu (key F1

ECG

) and select ECG

lead (F1).

* Adjust amplitude (F2).

* Freeze and release the ECG, if desired, with F3 (main

menu).

Monitoring the Heart Rate

* Display the ECG as described above.

* Enable alarm tone with F4.

Modifying the Heart-Rate Alarm Limits

* Press F1

ECG

to display the ECG menu.

* Press F3 to display the alarm limits menu.

* Decrease the values with F1 and F3, increase them with

F2 and F4.

* Silence alarm with F4, if alarm cause persists, the alarm

recurs after 120 seconds (or disable the audible alarm permanently by pressing F4 longer than 2 s).

56 CardioServ V4.1 227 446 32-D

The Memories of CardioServ

7. The Memories of CardioServ

This section of the manual informs you

– about the memories of CardioServ

– how to print out the stored information

– how to clear the memories

227 446 32-D CardioServ V4.1 57

Source

ECG

QRSPulse

Beep

OFF

Figure 7-1. Submenu

Text

Event

Figure 7.2. Memory menu

Memory

Trend

Display

Flip

Memory

Clear

The Memories of CardioServ

CardioServ comes with 3 different memories:

– a text memory – an event memory – a trend memory

All information concerning device operation goes into the text memory where it is saved with the time of day (e.g., device

on, device off, alarms, shocks, etc.). CardioServ can save up to 80 such events. When the memory is full, the device updates the information automatically by saving new events and deleting old ones. Moreover, all three memories can be cleared in one action (see below).

To print out the stored information, proceed as follows:

back

* Press

back

* Press

text memory (Figure 7-3).

to display the submenu (Figure 7-1).

Memory

to display the memory menu (Figure 7-2).

Text

to print out the information stored in the

DEVICE OFF . . . . . . : 17:15:02 28.06.1997

DEVICE ON . . . . . . : 17:15:08 28.06.1997

HR ALARM 335BPM : 17:15:09 28.06.1997 SHOCK 349JOULES: 17:15:25 28.06.1997 HR ALARM 61BPM: 17:16:20 28.06.1997 HR ALARM 60BPM: 17:17:44 28.06.1997 HR ALARM 61BPM: 17:19:31 28.06.1997 SHOCK 205JOULES: 17:20:12 28.06.1997

DEVICE OFF . . . . . . : 17:38:17 28.06.1997

DEVICE ON . . . . . . : 17:52:09 28.06.1997

Figure 7-3. Printout from text memory

58 CardioServ V4.1 227 446 32-D

The Memories of CardioServ

160 BPM 40 ECG

Event SHOCK #6 30.03.1998 11:41

all

Figure 7-4. “Print Event” menu

Select

Event

The event memory contains up to 40 ECG strips of 16 sec- onds duration, each with a history of 4 seconds. The event strips are recorded either automatically (upon violation of a heart-rate limit, delivery of the shock and modification of the pacemaker settings, provided the pacemaker is turned on) or

Store

device updates the information automatically by saving new

manually with the

Freeze

key. When the memory is full, the

events and deleting old ones. Moreover, all three memories can be cleared in one action (see below). Recordings initiated by a defibrillation shock are blanked for 5 seconds after the

200 J

Event

back

4-second strip before the shock. After the blank, the recording continues for another 10 seconds.

To print out the stored events, proceed as follows:

* Press

to display the submenu (Figure 7-1).

Memory

to display the memory menu (Figure 7-2).

Event

to display the print-event menu (Figure

7-4).

Now you can

* select an event with the + and - keys (The event is dis-

played at a in Figure 7-4) and initiate the printout with

Event

* print all stored events with

all

(starting with the

event displayed at a, Figure 7-4) or

* press

227 446 32-D CardioServ V4.1 59

back

to return to the memory menu.

The Memories of CardioServ

Source

ECG

QRSPulse

Beep

OFF

Memory

Figure 7-1. Submenu (repeated)

Text

Event

Trend

Figure 7-2. Memory menu (repeated)

45 min

9 h

45 min

SpO2

Figure 7-5. “Print trend” menu

Display

Flip

Memory

Clear

9 h

SpO2

back

The CardioServ trend memory contains the HR and SpO readings of the past 45 minutes and 9 hours. This memory, too, is updated automatically. The stored trends can be printed out as follows:

* Press

to display the submenu (Figure 7-1).

Memory

to display the memory menu (Figure 7-2).

Trend

to display the print-trend menu (Figure

7-5).

Now you can

45 min

* print the 45-min HR trend with

* print the 9-hour HR trend with

* print the 45-min SpO2 trend with

9 h HR

45 min

SpO2 Print

9 h

* print the 9-hour SpO2 trend with

* press

back

to return to the memory menu.

SpO2

Clearing the Memories

* Press

to display the submenu (Figure 7-1).

Memory

to display the memory menu (Figure 7-2).

Memory

Clear

for 2 seconds to clear all three memories in

one action.

60 CardioServ V4.1 227 446 32-D

Recording

8. Recording

This section describes

– how to initiate a manual recording

– in which situations the recorder operates automatically

– how to load chart paper

227 446 32-D CardioServ V4.1 61

Recording

100

8.1 Manual Recordings

The keys are used to start and stop manual recordings. When “Cont. Printout” in the defaults menu is “off” (Default), CardioServ will record the ECG shown on the display for 16 seconds. The recorder can be stopped before that with . When “Cont. Printout” is “on”, CardioServ will record the ECG until stopped with

360

300

150

200

Charge

Shock

APEX

Shock

Sync

Charge

Shock

recorded first (Figure 8-2). The following information is

annotated in the margin of the recording strip:

a text indicating that this

Figure 8-1. Keys to initiate a recording

b date c time d active filters e delivered energy

MANUAL 09. 04 .1997 09 : 16 : 12 50 Hz 35 Hz 0 JOULES HR:

II 1 CM/MV 25 MM/S ST. JOHN’S DGH 97

. The paper speed is 25 mm/s. A calibration pulse is

f heart rate

is a manual recording

g ECG lead h sensitivity i paper speed k hospital/department name

PATIENT

DATE OF BIRTH.............

USER........................

COMMENTS.................

SELECTED ENERGY.........

DELIVERED ENERGY........

ALARM LIMIT HR...........

ALARM LIMIT SPO2 .......

PACEMAKER................

DATE/TIME..................

Figure 8-2. Manual recording

62 CardioServ V4.1 227 446 32-D

Recording

8.2 Automatic Recordings

It is important that the chart paper exit is unob-

Warnin

structed. If this is not ensured, the paper may be pulled back into the device and wrap around the transport roller. When this happens, remove the paper jam as follows:

– open the paper compartment – carefully pull out the tangled paper and tear

it off the strip

– re-load the chart paper (section 8.3).

You can obtain a copy of the displayed image by

☞

simultaneously pressing the two contrast adjustment keys.

A recording is initiated automatically with each delivered defibrillation shock. Via the defaults menu (section 11) you can select automatic recordings to be triggered by each violation of an alarm limit. An automatic recording covers a period of 16 seconds, including a history of 4 seconds. The following information is annotated in the margin of the recording strip (Figure 8-2):

a Message indicating the reason for the recording b Date c Time d Active filters e Delivered energy f Heart rate g ECG lead h Sensitivity i Paper speed k Hospital/department name

227 446 32-D CardioServ V4.1 63

Figure 8-3. Opening the paper compartment

Recording

8.3 Loading Chart Paper

To prevent damage to the printhead use the original HELLIGE CONTRAST® chart paper only (Part No. 226 130 02).

* Push the cover of the paper compartment upward and

fold it out (Figure 8-3).

* Remove the empty sleeve of the old paper roll by pulling

on the white plastic tab.

* Insert the new roll as shown in Figure 8-4.

Figure 8-4. Inserting the paper roll

64 CardioServ V4.1 227 446 32-D

Figure 8-5. Inserting the leading edge

Recording

* Feed the leading edge of the paper under the paper

transport roller (Figure 8-5) and keep pushing it forward until it appears above the roller.

* Feed the leading edge of the paper through the exit in

the cover as shown in Figure 8-6.

Figure 8-6. Feeding the leading edge through the aperture

227 446 32-D CardioServ V4.1 65

Figure 8-7. Closing the cover

Thermorecordings should only be stored in transpar-

☞

ent envelopes made of polyethylene, since PVC bleaches the text and traces (if in doubt, insert a sheet of tissue paper in between).

Recording

* Close the cover. While doing so, pull firmly on the paper

strip to ensure that it does not get caught behind the cover (Figure 8-7).

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

66 CardioServ V4.1 227 446 32-D

Oxygen Saturation SpO

9. Oxygen Saturation SpO

This section of the manual explains

– the oxygen saturation measuring method

– how to apply the sensors

– points to note during SpO2 measurement

227 446 32-D CardioServ V4.1 67

Oxygen Saturation SpO

9.1 General Information

160 BPM

140 ECG

SpO2 Alarm

100 % 90 SpO2

MenuFreezeSpO2ECG

Figure 9-1. Display of the SpO2 reading and the plethysmogram

Pulse oximetry is not suitable for oxygen monitoring in fetuses before or during birth. Moreover, it

Caution

is not suitable for use on patients with carbonmonoxide poisoning.

SpO2 measurement is employed to determine the oxygen saturation of hemoglobin in the arterial blood. Alarm limits can be adjusted to monitor levels of oxygen saturation. A plethysmographic waveform is displayed in channel 2 (Figure 9-1).

Arterial oxygen saturation is measured by a method called pulse oximetry. It is a continuous, non-invasive method based on the different absorption spectra of reduced hemoglobin and oxyhemoglobin.

Therefore the sensors consist of a light source (two LEDs in most cases) and a photodetector on the opposite side which collects the incident light. The light (red and infrared range between 660 nm and 940 nm) from the LEDs is transmitted through the blood and tissue components of the finger, ear lobe or foot. The photodiode in the sensor measures the light that passes through and converts it into an electrical signal. The pulsatile component of the signal is used to build the plethysmogram.

Elevated levels of CO-Hb and Met-Hb can influence the SpO2 readings. Also dyes in the

Caution

blood (e.g. Cardiogreen) can impair the measuring accuracy of the system.

Literature

WUKITSCH, M.W.; PETTERSON, M.T.; TOBLER, D.R.;POLOGE, J.A.: Pulse Oximetry: Analysis of Theory, Technology, and Practice, J. Clin. Monit. 4: 290– 301 (1988)

CECIL, W.T.; THORPE, K.J.; FIBUCH E.E.; TUOHY, G.F.: A Clinical Evaluation of the Accuracy of the Nellcor N-100 and Ohmeda 3700 Pulse Oximeters, J. Clin. Monit. 4: 31–36 (1988)

68 CardioServ V4.1 227 446 32-D

Oxygen Saturation SpO

C-LOCK ECG Synchronization

The C-LOCK ECG synchronization feature enables the monitor to use an ECG signal as a reference point for identifying the pulse and synchronizing saturation measurements. This enhances the performance of the monitor in the presence of patient movement and when the patient’s perfusion is poor.

When an ECG signal is present during SpO2 measurement, the monitor is receiving two separate signals that reflect cardiac activity: an optical signal from the sensor and an electrical signal from the ECG. The time that elapses between the ECG R-wave and the optical pulse detected at the sensor site depends on the patient’s physiology, the heart rate and the location of the sensor. However, for a given patient the length of the delay is relatively stable. Through C-LOCK ECG synchronization, the monitor uses that time relationship to identify good pulses and reject nonsynchronized artifacts.

Application Hints

– Use only the sensors listed in section 15 “Order Informa-

tion and Accessories”. Apply the sensors as described in their instructions for use. Carefully observe all information and cautions given in these instructions.

– Take care that the sensor does not exert too much pres-

sure on the tissue, as this would result in wrong readings and blistering. The blisters are not caused by overheating but by lack of ventilation.

– Exercise extreme care to assure continued circulation

distal to the sensor site after application.

– Change the application site at least every 24 hours to

allow the skin to breathe.

– Excessive ambient light impairs signal quality. This can

be prevented by covering the sensor site with a cloth.

– Simultaneously determining the cardiac output by means

of dye dilution may prevent SpO2 measurement.

– When circulation of blood is impaired (blood-pressure

cuff or extreme vascular resistance), it may not be possible to determine SpO2 values or the pulse rate.

– Remove nail polish and artificial fingernails before

applying the sensor, as these may affect the reading.

– Do not apply the finger sensor to the same arm as a

blood-pressure cuff.

227 446 32-D CardioServ V4.1 69

Oxygen Saturation SpO

In order to minimize motion artifact:

– take care to provide an ECG of good quality (C-LOCK

ECG synchronization)

– use a new sensor with fresh adhesive backing

– move the sensor to a less active site

– select a slow integration time.

When monitoring SpO2 during electrosurgical intervention, take care that:

– CardioServ is powered from the built-in battery or from

a different power circuit than the electrosurgical unit

– the ground pad is close to the surgical site

– the sensor 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.

70 CardioServ V4.1 227 446 32-D

Oxygen Saturation SpO

The ECG signal (section 6.1 “Displaying the ECG”)

☞

is a prerequisite for the proper functioning of the C-LOCK ECG synchronization feature.

Option

SpO



EKG



Figure 9-2. SpO2 sensor connection

160 BPM

140 ECG

9.2 Measuring and Monitoring Oxygen Saturation

* Turn on CardioServ (switch position ).

* Apply the sensor as described in the instructions for use

enclosed with the sensor.

* Connect the sensor to CardioServ (SpO2 connection,

Figure 9-2).

Within a few seconds the SpO2 reading and the plethysmogram will be displayed (Figure 9-3).

Please note: The following adjustments are temporary and, contrary to the settings of the default menu (Section 11 “Configuring the Defibrillator Settings”), will not be saved.

--- % 90 SpO2

I...III

aV...V

Paddle

cm/mV

Figure 9-3. SpO2 value and plethysmogram

a SpO2 value b plethysmogram c SpO2 alarm limits (upper limit disabled)

227 446 32-D CardioServ V4.1 71

Alarm

Limits

back

Oxygen Saturation SpO

Enabling/Disabling the C-LOCK ECG Synchronization

Disable the C-LOCK ECG synchronization func-

☞

tion for monitoring of pacemaker patients (section

6.3)

C-Lock

Integ.

Time

12 s

Alarm

Limits

Figure 9-4. SpO2 menu

If, in monitoring the patient, several adverse conditions exist at once, a disturbed signal may go

Caution

unnoticed. Artifacts could then be capable of simulating a plausible reading, and no alarm would be released. To assure reliable monitoring, the sensor application and signal quality should be verified from time to time.

When monitoring the pulse rate derived from the SpO2 signal instead of the heart rate, select an

Caution

integration time of 4 s or 8 s. Do not select 12 s.

back

With the factory settings unchanged, the C-LOCK ECG synchronization feature is inactive when the CardioServ is switched on. If an ECG signal is available, enable the synchronization feature as follows:

* Press the

SpO2

softkey to display the SpO2 menu (Figure 9-4) (only available when SpO2 sensor is connected to the unit).

C-Lock

* Press the

OFF

softkey to enable (ON) the C-LOCK feature (or disable the feature by pressing the key again).

Selecting the Integration Time

The integration time is the time over which the SpO2 readings are averaged. Selectable times are 4, 8 (default) and 12 seconds. The integration time of 12 seconds should only be selected in exceptional cases.

* Press the

SpO2

softkey to display the SpO2 menu (Figure 9-4).

Integ.

* Press

Time

to select an integration time.

12 s

72 CardioServ V4.1 227 446 32-D

Oxygen Saturation SpO

Adjusting SpO2 Limits

C-Lock

Integ.

Time

12 s

Alarm

Limits

Figure 9-4. SpO2 menu (repeated)

High

Alarm

SpO2 SpO2

Low

Alarm

Figure 9-5. Alarm limits menu

SpO2 alarms are similar to HR alarms. Please refer

☞

to section 6.2 “Monitoring the ECG”.

MANUAL 29.06.1997 09:16:12 50 Hz 35 H

back

* Press

SpO2

to display the SpO2 menu (Figure 9-4).

Alarm

Limits

to display the alarm limits menu (Figure

9-5).

* The + key increases the limit value, the - key decreases

it.

SpO2 alarms neither initiate an alarm recording nor are they saved to the event memory.

Printing the Plethysmogram

The recordings, no matter whether they are initiated manually or automatically, always display the plethysmorgram in channel 2.

II 1 CM/MV 25 MM/S CARDIOSERV PACEMAKER SPO2

Figure 9-6. ECG and plethysmogram

227 446 32-D CardioServ V4.1 73

For your notes

Oxygen Saturation SpO

74 CardioServ V4.1 227 446 32-D

Pacing

10. Pacing

This section of the manual explains

– the pacemaker uses

– the points to note during pacing

– pacemaker operation

227 446 32-D CardioServ V4.1 75

10.1 General Information

Pacing

Application and Functional Description

The transcutaneous pacemaker of CardioServ is applied in emergencies for external (transcutaneous) cardiac stimulation. It is also used as a temporary aid in cases of acute arrhythmias or Stokes-Adams attacks. Some forms of bradycardia and tachycardia can be treated as well.

The pacemaker offers two modes of operation: demand and fixed-rate pacing.

The pacing pulses are delivered through the defibrillation pads.

Rules for Application of External Pacemakers

These rules are valid for all pacemakers, regardless of model and manufacturer.

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

The safe application of the device lies in the hands of the user; thus, it is very important to observe the following rules:

* Pacemakers may only be used under the supervision of

qualified medical staff.

* The safe application necessitates expert knowledge, good

organization, special care in selecting the technical equipment and regular maintenance.

* Medical-technical devices such as the CardioServ must

only be applied by persons who are adequately trained in the use of such equipment.

* Before application, the user must check the unit for

functional safety.

* The patient’s ECG must be monitored to allow the user

to determine capture. Furthermore, at least one of the persons present must be familiar with the application of the defibrillator.

76 CardioServ V4.1 227 446 32-D

Pacing

Due to their functional requirements pacemakers operate with high voltages and are thus equipped

Caution

with special non-accessible outputs. Nevertheless, it is important not to come into contact with the voltage-conducting contacts via conductive metal objects, such as tweezers, as long as the pacemaker is operating. Currents passing through the heart which exceed 10 µA may induce ventricular fibrillation.

Switch the pacemaker on and off as follows:

Caution

Switching the pacemaker on:

1. Apply the pace pads

2. Connect pads to CardioServ via the adapter lead

3. Switch on CardioServ

4. Switch on the pacemaker

Switching the pacemaker off:

1. Switch off the pacemaker

2. Switch off CardioServ

3. Disconnect adapter lead from CardioServ

4. Remove pace pads

Each of the following rules must be observed:

* Check the performance of the defibrillator at hand.

* When positioning the patient ensure that no electrically

conductive connections are created between the patient and earthed metal parts (also beware of puddles, etc.). Although the pacemaker pulse current output is required to be electrically isolated (floating), this is an additional safety precaution to ensure that the pacemaker current pulse only flows between the pacemaker electrodes.

* Apply electrodes, arrange electrode leads and connect

them to CardioServ. Use only the electrodes and leads listed in section 15 “Order Information and Accessories”.

* Operate the pacemaker as described in this manual.

* The pacemaker is switched off after defibrillation (pacer

rate setting is unchanged, current is reset to 0 mA).

Determine capture by measuring the pulse rate, not the heart rate.

Caution

227 446 32-D CardioServ V4.1 77

Pacing

10.2 Application of Single-Use Defibrillation Pads

STERNUM

electrode + connector

Figure 10-1. Defibrillation pad placement

223 383 01

The single-use defibrillation pads (part no. 919 202 94 adult pads, part no. 919 202 95 pediatric pads) can be used for

– defibrillation/cardioversion (refer to section 4.2 “Defi-

brillation with Internal Electrodes or Defibrillation Pads”)

– ECG monitoring

– transcutaneous pacing.

APEX

Below we will explain the correct pad application for transcutaneous pacing

* Use pads before their expiration date.

* Apply the pads as follows:

– Shave each site. This improves conductivity and makes

removal of the pad easier.

– Place the pads on the patient so that the connectors

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

919 202 94 919 202 95 (K)

Figure 10-2. Connecting the pad to the cable

– The electrodes are pregelled; therefore do not use addi-

tional contact cream or paste.

– Do not use pads, if the gel has dried out.

– Peel off the backing from each pad and place the pad

carefully on the appropriate site.

78 CardioServ V4.1 227 446 32-D

223 346 01

919 201 89 919 202 75 (K)

Figure 10-3. Connecting the defib pads to the adapter cable

Pacing

* Then press the connector of cable 223 383 01 on to the

electrode contact pin until you hear it click into place. Observe the connector labels: “A” =apex, “S” = sternum.

The round adhesive electrodes (part. no. 919 201 89) can be used with adapter lead 223 346 01. When connecting the electrode to the lead, take care that they engage properly. To disconnect them, simply press on the rear part of the catch (Figure 10-3).

* After use, carefully peel off the pads from the patient’s

skin (Figure 10-4) and discard them immediately.

Should a patient require defibrillation during transcutaneous pacing, immediately select the

Caution

required energy with the energy selector, and push

Charge

the

button. The pacemaker automatically

Shock

selects a current of 0 mA in this situation. The shock is delivered by pressing the described in section 4.2). Should the patient require further pacing, resume pacing by following the instructions in sections

10.3 (Demand Mode) or 10.4 (Fixed-Rate Mode).

incorrect

Figure 10.4. Removing defibrillation pads

Shock

buttons (as

correct

Discard disposable defibrillation pads immedi-

Warnin

☞

ately after use. Do not reuse them!

If the ECG signal is extremely noisy and the AC line filter is not sufficient to provide a clean signal, the demand mode operation of the CardioServ may be disturbed. In this situation the message “Check pace pads” will be displayed. To reduce the interference signal, reapply the pads, carefully observing the application instructions.

227 446 32-D CardioServ V4.1 79

Pacing

10.3 Demand Mode

Warnin

Observance of the pacemaker application rules stated in section 10.1 is an absolute must to ensure the safe and successful use of the pacemaker.

During pacing, always set the energy selector to the position. This prevents that a defibrillation pulse is triggered inadvertently.

Caution: The pacing pulses are delivered via the defibrillation pads. These must be applied to the patient as explained in section 10.2.

The pacemaker can be switched on only when the pace pads are connected (otherwise a message will be displayed to inform the user of missing electrodes).

In the demand mode the pacemaker does not deliver a pacing pulse as long as the patient’s intrinsic heart rate exceeds the set pacer rate. When the heart rate drops below the pacer rate, the pacemaker starts delivering pacing pulses. For this reasons the ECG must be continuously monitored. The necessary synchronization pulses are automatically transmitted to the pacemaker.

Demand mode is the method of choice when bradycardia or asystole is expected to develop after critical events. Controlling the pacemaker in this manner precludes the possible competition between intrinsic excitation and external pacing pulses which could result in ventricular fibrillation.

* Acquire the ECG signal as described in section 6.1

“Displaying the ECG”.

* Verify that the pads are properly applied and connected

to CardioServ.

80 CardioServ V4.1 227 446 32-D

Defib

P/min

–

Dem

Fix

STERNUM

18 17 16 15

Figure 10-5. Pacemaker operating controls

15 Buttons for selection of the pacer output 16 Buttons for selection of the pacer rate 17 Pacing mode selection button (Fix/Demand) 18 toggles the pacemaker on and off (press button

longer than 2 seconds to turn the pacemaker off)

The default pacer rate can be preset (Defaults

☞

menu).

Pacing

* Press the button to switch on the pacemaker (Fig-

–

* Using the

ure 10-5). The pacemaker defaults to the demand mode and to a pacer rate of 60 BPM (selectable).

button, select a low pacer output (e.g.

20 mA)

* Increase the pacer rate with the

P/min

button until the

asterisk (a, Figure 10-6) just begins to flash: The pacer rate is now identical with or just above the intrinsic heart rate.

* Press the

button to slowly increase the pacer output to a level which ensures consistent responses from the heart.

* Now select the required pacer rate with buttons

P/min

and

P/min

* Increase the pacer output by another 5 mA to achieve

reliable stimulation.

* To verify the success of the treatment, watch the ECG

on the screen. You can press the

Sync

button to view the

trigger marks on the display.

227 446 32-D CardioServ V4.1 81

160 BPM

140 ECG

Pacing

* At the end of the intervention, first turn off the pace-

maker, then remove the pads carefully.

In order to turn off the pacemaker, button must be held down for at least 2 seconds. This safety precaution has been taken to prevent the pacemaker being turned off inadvertently. For this reason it is not possible to switch off CardioServ while the pacemaker is still on.

Pacemaker Demand 60 BPM 65 mA

Figure 10-6. Screen display with pacemaker switched on

a asterisk, flashing with every delivered pacing

pulse b pacing rate c pacing current d pacing mode

If the defibrillator is put into operation during

☞

pacing, the pacemaker automatically selects an output of 0 mA

MenuFreezeSpO2ECG

82 CardioServ V4.1 227 446 32-D

Pacing

Defib

10.4 Fixed-Rate Mode

Observance of the pacemaker application rules

Warnin

stated in section 10.1 is an absolute must to ensure the safe and successful use of the pacemaker.

P/min

–

Dem

Fix

STERNUM

18 17 16 15

Figure 10-7. Pacemaker operating controls

15 Buttons for selection of the pacer output 16 Buttons for selection of the pacer rate 17 Pacing mode selection button (Fix/Demand) 18 toggles the pacemaker on and off (press button

longer than 2 seconds to turn the pacemaker off)

Caution: The pacing pulses are delivered via the defibrillation pads. These must be applied to the patient as explained in section 10.2.

The pacemaker can be turned on only when the pace pads are connected (otherwise a message will be displayed to warn the

–

user of missing electrodes).

In the fixed-rate mode the pacemaker delivers pacing pulses at a selectable rate and output setting. The selected rate is “fixed”, i.e., it does not take into account intrinsic action of the heart. This mode of operation should be selected in cases of asystole. Some forms of bradycardia and tachycardia can be corrected with fixed-rate pacing, but transcutaneous emergency pacing is not the therapy of choice in these instances.

* Verify that the electrodes are properly applied and

connected to CardioServ.

* Press the button, to switch on the pacemaker

(Figure 10-7). The pacemaker defaults to the demand mode and to a pacing rate of 60 BPM (selectable).

During pacing, always set the energy selector to

Warnin

the , position. This prevents that a defibrillation pulse is triggered inadvertently.

227 446 32-D CardioServ V4.1 83

Pacing

160 BPM

140 ECG

Pacemaker Fix 60 BPM

65 mA

Figure 10-8. Screen display with pacemaker switched on

a asterisk, flashing with every delivered pacing

b pacing rate c pacing current d pacing mode

The default pacer rate can be preset (Defaults

☞

menu).

pulse

MenuFreezeSpO2ECG

* Press the

Dem

button for 3 seconds to select the fixed-

Fix

rate mode (“Demand” is replaced with “Fix” at d in Figure 10-8).

The asterisk (a; Figure 10-8) flashes each time a pacing pulse is delivered.

* Select the pacing rate with the buttons

* Press the

button to slowly increase the pacer output

P/min

and

P/min

to a level which ensures consistent reponses from the heart.

* To verify the success of the treatment, watch the ECG

on the screen.

* Increase the current by another 5 mA to ensure reliable

pacing.

* At the end of the intervention, first turn off the pace-

maker, then remove the pads carefully.

84 CardioServ V4.1 227 446 32-D

Configuring the Defibrillator Settings

11. Configuring the Defibrillator Settings

This section describes the instrument settings that can be modified to suit your personal needs and preferences, and how this is done.

227 446 32-D CardioServ V4.1 85

Configuring the Defibrillator Settings

Defaults

HR Limits Sensitivity Lead

Autosequence SPO2 Limits C-LOCK SPO2-Int. Time Lead Fail Alarm QRS Beep Alarm Tone Alarm Printout Shock Printout Cont. Printout

Defaults

Cont. Printout Pacemaker Display Display Volume AC Filter Muscle Filter Date Format Date/Time Language

User Factory Setting

Figure 11-1. The menu

low : 40 high : 160

0.5 1 2 cm/mV

I II III aVR aVL aVF V

Paddle 200J 200J 360J low : 40 high : OFF

OFF ON

4s 8s 12s

OFF ON OFF ON OFF ON OFF ON

OFF ON

EXIT

OFF ON

60 BPM

normal reverse 0 deg. 180 deg. high low 50Hz 60Hz OFF

OFF ON DD:MM:YYYY MM:DD:YYYY

06.01.1998 11:35:47

deutsch English français

усск espanol italiano Svenska Portugues

OFF ON

Next MenuEXIT

The defaults menu allows you to customize device settings, which means that they are retained in memory and are activated automatically on power up.

* Simultaneously press F1 and F5 to display the defaults

menu.

Page 1 of the menu appears (Figure 11-1 top).

The cursor keys F1, F2 (up/down) and F4 (right) are used to move the cursor to the parameter whose setting is to be modified. Then you can change the setting with function keys F1 through F5. The functions and labels of these keys change with each parameter.

With F5

Confirm each selection with F5

you scroll to the next page of the menu.

EXIT

. This will also take

you back to the main menu.

Defaults

HR Limits

Sensitivity Lead

Autosequence SPO2 Limits C-LOCK SPO2-Int. Time Lead Fail Alarm QRS Beep Alarm Tone Alarm Printout Shock Printout Cont. Printout

low : 40 high : 160

0.5 1 2 cm/mV

I II III aVR aVL aVF V

Paddle 200J 200J 360J low : 40 high : OFF

OFF ON

4s 8s 12s

OFF ON OFF ON OFF ON OFF ON

OFF ON

F1 F2 F3 F4 F5

–

Enter

Figure 11-2. The configuration menu

86 CardioServ V4.1 227 446 32-D

Configuring the Defibrillator Settings

With F3

EXIT

you leave the configuration menu and save

the changes.

The new settings are saved only if you quit the

☞

defaults menu with F3

EXIT

ECG monitoring is suspended during configura-

Warnin

☞

tion.

It is not possible to call up the defaults menu, while the defibrillator is charged, during ECG analysis

Analyse

(

button) or while the pacemaker operates.

When you display the defaults menu, the values preset in this menu will overwrite the temporary

Caution

device settings (alarm limits, leads, etc.).

HR Alarm Limits

The limit values for heart-rate monitoring selected here are automatically activated on power up.

* Using F4, move the cursor to the right.

* Adjust the low limit with F1 and F2 (if you keep the

keys depressed, the digits change at a higher rate) (Figure 11-2). Alarm limits can be disabled by selecting a value outside the adjustment range.

* Using F4, move the cursor to the high limit and adjust it

in the same way as the low limit.

* Confirm the new limit values with F5.

Sensitivity

The setting selected here (.5,1,2 cm/mV) is the CardioServ default sensitivity.

* Using F4, move the cursor to the right.

* Select the desired setting with F3 or F4 and confirm the

selection with F5.

227 446 32-D CardioServ V4.1 87

Configuring the Defibrillator Settings

Lead

The setting selected here is the CardioServ default ECG lead.

* Using F4, move the cursor to the right.

* Select the desired lead with F3 or F4 and confirm the

selection with F5.

Autosequence

This menu item defines the energy levels for the 1st, 2nd and 3rd defibrillation shock in autosequence mode (default: 200 J, 200 J, 360 J).

You can choose a different energy level (150 J, 200 J, 300 J, 360 J) for each shock.

When the cursor highlights a value, this value can be increased with F1 and decreased with F2.

SpO2 Int. Time

Here you select the default integration time for averaging of the SpO2 values. The 12 second integration time should only be selected in exceptional cases.

Lead Fail Alarm

Do you wish the alarm to sound after 30 s when an ECG electrode drops off?

QRS Beep

Do you wish to have the QRS beep enabled or disabled on power up?

Alarm Tone

Do you wish to have the audible alarm enabled or disabled on power up?

SpO2 Limits

Here you adjust the default alarm limits for monitoring of SpO2.

C-LOCK

Do you wish to have the C-LOCK ECG Synchronization feature enabled or disabled on power up?

88 CardioServ V4.1 227 446 32-D

Alarm Printout

Do you want the recorder to start automatically in an alarm situation (violation of HR limits)?

Shock Printout

Do you want the recorder to start automatically when a defibrillation shock is delivered?

Configuring the Defibrillator Settings

Continuous Printout

When the function is disabled, the recorder will stop automatically after 16 seconds. When it is enabled, the recorder must be stopped manually.

Pacemaker

This is to select the default pacing rate.

Display

Normal (black on white) or reverse (white on black) display on the LCD screen.

Normal or flipped display (rotating the display 180° may prove useful for CardioServ units operated in the defibrillator mounting system).

Volume

For selection of the volume of all audio signals emitted by the unit (prompts, alarms).

AC Filter

for elimination of signal noise from the power line. Default setting for 50 Hz (Europe) or 60 Hz (USA) or no filter (OFF).

Muscle Filter

For elimination of motion artifact and muscle action potentials (35 Hz).

Date Format

DD.MM.YYYY (European format) or MM.DD.YYYY (US format).

Date / Time

For adjustment of date and time.

* Using F4, move the cursor to the right (day).

* Using F1 and F2, adjust the day.

* Using F4, move the cursor to the right (month).

* Using F1 and F2, adjust the month.

* Proceed in the same manner to adjust year, hours,

minutes and seconds.

* Confirm the entries with F5.

Depending on the CardioServ model purchased, not

☞

all menu items may be available.

227 446 32-D CardioServ V4.1 89

Configuring the Defibrillator Settings

Language

This menu item is used to select the language for the screen texts and printed documents.

* Using F4, move the cursor to the right.

* Select the desired language with F3 or F4.

* Confirm your selection with F5.

User

Via this menu item you can enter a text or a name which will be printed in the margin of the recording strip.

* Using F4, move the cursor to the right.

You can now use F1 and F2 to select the first numeral, symbol or letter from a character set for the name or text to be entered. With F1 you scroll forward through the set, with F2, backward. F4 moves the cursor to the right, allowing you to enter the second character, etc. The first character is a blank.

Factory Settings

You can restore the factory settings by selecting ON (language and operating mode will not be changed).

Restoring the factory settings will delete the informa-

☞

tion entered with menu item “User”.

* Confirm entries with F5.

90 CardioServ V4.1 227 446 32-D

Error Indications and Messages

12. Error Indications and Messages

In this section of the manual you will find

– the error indications and messages which CardioServ

may display after the power-on self-test

– the error indications and messages which CardioServ

may display while in use

– an explanation of the meaning of each message, and

troubleshooting tips

227 446 32-D CardioServ V4.1 91

Error Indications and Messages

Error Messages during power-on self-test (POST)

egasseMtceffEnoitanalpxEydemeR

rorrEMARehtesutonod,tcefedecived

rorrEMORehtesutonod,tcefedecived

rorrEMARyalpsiD

yekynasserp

yromemdexifnirorrE

yekynasserp

rorrEesaBemiT

yekynasserp

yek”kcohS“kcehC

yekynasserp

eciffoecivresyfitoN

ecived

eciffoecivresyfitoN

ecived

seicnegremerofesudetcirtser

elbissopnoitallirbifed,ylno

llatadaer

seicnegremerofesudetcirtser

elbissopnoitallirbifed,ylno

)devasebtonnac

seicnegremerofesudetcirtser

elbissopnoitallirbifed,ylno

suoenorre

(snottubrehtie 2 (ro/dna) 8)

,purewopnodesserpederew

nehw;evitcefed)s(nottubro

ecived,evitcefednottub

rofdesuebtonnac

roftubsnoitallirbifed

siyalpsideht,tcefedyalpsid

ebtonnacrodaerottluciffid

(syek 7 ecivresyfitondna)

noitcnufehtfoenosserP

eciffo

tcefednoitarugifnocresu

snoitarugifnocmotsuc,.g.e(

(syek 7 ecivresyfitondna)

noitcnufehtfoenosserP

eciffo

sahcus(ataddetaler-emitlla

ebyam)etartraeheht

(syek 7 rorrefi;emittsujda,)

noitcnufehtfoenosserP

eciffoecivresyfiton,stsisrep

noitcnufehtfoenosserP

(syek 7 ,ecivedffohctiws,)

(syeksserptonod 2 (dna) 8)

.niaganoecivedhctiwsdna

,sruceregassemrorrefI

.eciffoecivresyfiton

ylnognirotinom

yekEGRAHCkcehC

)evobayek”kcohS“ees()evobayek”kcohS“ees()evobayek”kcohS“ees(

yekynasserp

)evobayek”kcohS“ees(

rorrEygrenEegrahC

yekynasserp

morfsreffidygrenederots

niecivedesu,ygrenedetceles

!ylnoseicnegreme

devas

ehtemittsalderruccororre

tierofeb(desusawecived

(syek 7 -sidtsetreviled,)

sawdna)ffodenrutsaw

noitcnufehtfoenosserP

dnaffoecivedhctiws,egrahc

egassemrorrefI.niagano

.eciffoecivresyfiton,srucer

92 CardioServ V4.1 227 446 32-D

Messages/problems during operation

egasseMnoitanalpxEydemeR

yrettabwoLdetelpedtsomlayrettabsniamotecivedtcennoc

Error Indications and Messages

mralaRHro,timilRHwolrohgihfonoitaloiv

edortcelekcehCelddaproedortceleGCEhgih

degrahcbifeDs03rofderotsygrenenoitallirbifed

rotceleskcehC;ylreporpgnixednitonsirotcelesygrene

hgihygrenEneve,seluoj05sdeecxeygrenedetceles

wolygrenE;ygrenedetceleswolebygrenederots

edortcelEgnirotinomedortceleroelddapbifed

kcehc,cilotsysatonsitneitapnehw

s4rofdeifitnedievaw-Ron

ehtnehwdaelrehtonatceles;sedortcele

llamsootsiedutilpmalangis

euqinhcetedortcelekcehc

ecnadepmi

;noitisoptcaxeehtotrotcelesygrenetes

elbissoptonnoitallirbifed

ecivresyfiton,sruceregassemnehw

eciffo

,)selddaplanretni(eulavrewolatceles

;detcennoceraselddaplanretnihguoht

detcelesnahtrehgihygrenederots

eciffoecivresyfiton,srucer

egassemnehw;egrahcsidtsetesaeler

elbissopnoitallirbifed;ygrene

egassemnehw;egrahcsidtsetesaeler

elbissopnoitallirbifed

eciffoecivresyfiton,srucer

ecived(niaganodnaffoecivedhctiws

ecivedhtiwselddapfoegnahcxe,tcefed

elbissoptonnoitallirbifed,nodenrut

elddaprofffodehctiwsebtsum

yfiton,sruceregassemnehw;)egnahcxe

eciffoecivres

yltcerrocnoitcnuftonseodeciveDecnabrutsiderawtfosniaganodnaffoecivedhctiws

sdapecapkcehCecnerefretnienilCAevissecxe,retlifenilCAehtelbane

noitacilppaedortcelekcehc

gnirudetanimullitonseodDELneerG

tinuylppusrewopevitcefedecivresyfiton

noitareporewopenil

gnirudetanimullitonseodDELwolleY

tinuylppusrewoproyrettabevitcefedecivresyfiton

noitareporewopenil

227 446 32-D CardioServ V4.1 93

For your notes

Error Indications and Messages

94 CardioServ V4.1 227 446 32-D

Cleaning and Maintenance

13. Cleaning and Maintenance

This section of the manual describes

– how to clean and disinfect the device and the electrodes

– how to sterilize the internal electrodes

– how to clean and disinfect the suction electrodes

– how to perform routine maintenance on the device

227 446 32-D CardioServ V4.1 95

Cleaning and Maintenance

13.1 Cleaning, Disinfection and

Sterilization

Before cleaning the device, disconnect it from the power line. Turn off the device before touching

Danger

the contact susfaces of the paddles, and be careful not to switch it on again while cleaning it. Danger to life! As a safety precaution, remove the battery and disconnect the paddles from the defibrillator.

Do not use hot air to sterilize the internal defibrillation electrodes.

Caution

The defibrillation electrodes and handles must be disconnected from the cable before autoclaving

Caution

(arrow, Figure 13-2).

Device and Paddles

* Discard all disposable electrodes immediately after use to

prevent inadvertent reuse.

* The paddles and their leads can be cleaned and disin-

fected by wiping them down with a gauze pad moistened in a cleaning solution. Before applying the paddles again, check that they have thoroughly dried.

* Clean the instrument surface with a cloth moistened in a

cleaning solution. Take care that the solution does not enter the defibrillator enclosure.

Any hospital-grade cleaning solution and disinfectant containing up to 70% alcohol is suitable.

* The internal defibrillation electrodes are initially cleaned

in the same way as external paddles. For electrodes and connection cables, low-temperature plasma sterilization is the recommended method. Alternative methods are ETO sterilization, water vapor (autoclave at 134 °C) or ionizing radiation. Internal electrodes must be sterilized after each resuscitation code.

96 CardioServ V4.1 227 446 32-D

Cleaning and Maintenance

1 2 3

Figure 13-1. Inserting the contact paddle

Having loosened the counter nut, you can easily alter

☞

the position of the contact paddle.

➙

To insert the contact paddles, proceed as follows:

* Screw the counter nut (2, Figure 13-1) onto the elec-

trode 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 13-2).

* Clean the electrode by rubbing it down with a cloth

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

* Low-temperature plasma sterilization is the recom-

mended sterilization method. Alternative methods are ETO sterilization and ionizing radiation. (Please note:

Figure 13-2. Counter electrode for internal defibrillation

227 446 32-D CardioServ V4.1 97

Frequently sterilizing the electrodes with ethylene oxide reduces the life of the plastic material!) Do not autoclave the electrodes!

Cleaning and Maintenance

Exchanging the Defibrillation Electrode Cable

* Switch off CardioServ.

* Grasp the plug and remove it from the socket (do not

pull on the cable).

* When inserting the plug, observe the orientation

(beveled edges) and click it into place.

Cleaning and Disinfecting Suction Electrodes

Do not use pointed metal objects to remove solid particles of dirt from the electrodes as this would

Caution

destroy the silver/silver-chloride layer. Use a commercially available fiberglass eraser instead.

* Clean the electrodes with water and a detergent. Use a

small brush to remove grime.

* All commercially available cleaning agents used for

surgical instruments are suitable for cleaning of the electrodes. Follow the manufacturer’s instructions to mix the preparation. Do not use metal dishes and take care not to immerse plugs and metal sockets in the solution.

* To disinfect the electrodes, wipe them down with a cloth

moistened in 70% alcohol.

98 CardioServ V4.1 227 446 32-D

13.2 Maintenance

Cleaning and Maintenance

Before each application

* visually check the device and all accessories (leads, elec-

trodes, etc.) for signs of damage

* test the device performance (refer to section 3).

If you detect damages or impaired functions so that the safety of the patient and user are no longer guaranteed, CardioServ must be repaired before it can be applied again.

Checks at regular intervals

CardioServ defibrillators are emergency medical devices

designed to save and preserve life; they must be ready for use at all times. Operational readiness must also be ensured for battery power operation. Therefore, the devices must be subjected to the following checks at regular intervals:

Every month

If batteries are repeatedly partially discharged, the resulting “memory effect” may dramatically reduce the battery capacity. This effect can be efficiently minimized by regular conditioning. If the capacity of a relatively new battery is drastically reduced, the battery may be reconditioned by repeated charging and discharging. Proper maintenance of NiCd batteries is essential and considerably promotes their proper performance. Routine preventive maintenance should be carried out by qualified service technicians on a regular basis (recommended interval: 30 days).

It is the user’s decision whether or not to recondition the battery at regular intervals. Batteries which are not reconditioned have a shorter service life and will have to be replaced more frequently.

We recommend our Accu Service Unit (Figure 3-5)

☞

for optimal care of the batteries. It prolongs the batteries’ service life and guarantees their operational readiness at all times.

* visually inspect the device and accessories

* test the device performance as described in section 3.

Battery Maintenance

Rechargeable batteries require special maintenance and continued checks to assure they function in emergency situations. It is normal for batteries of this type to self-discharge when not in use.

227 446 32-D CardioServ V4.1 99

If you decide not to use the Accu Service Unit, the battery can be checked and reconditioned as described below. With this method, however, the continued operational readiness of CardioServ on battery power is not guaranteed.

1. Disconnect CardioServ from the power line and dis-

charge fully charged battery in the monitoring mode. To do so, set energy selector switch to (SpO2 sensor not connected) and wait until device switches off.

Cleaning and Maintenance

2. Check how long it takes before battery is depleted. If the time is less than 1.8 hours, the battery is too old or improperly maintained and should be replaced.

3. Recharge the battery. This will take 16 hours.

Technical Inspections

For safety, the devices require regular maintenance. To ensure functional and operational safety of the CardioServ Technical Inspections should be carried out annually.

The following checks can be carried out within the framework of a service contract. Otherwise it should be assured that the person inspecting the device is adequately trained and experienced.

* The device and accessories should be visually inspected

for signs of mechanical damage which may impair the device functions.

* The electrode leads of defibrillators and pacemakers

must be carefully checked for signs of mechanical damage, short-circuits and breaks.

* All batteries that are 3 years or older must be replaced.

* The warning system of the defibrillator must be checked.

Testing the Pacemaker Performance

The performance of the pacemaker can be tested with a commercially available pacemaker tester (e.g. CS300 Simulator from Marquette Hellige, part no. 417 983-001).

* Devices which are not in perfect working order or the

use of which is unsafe must be immediately repaired or labelled accordingly to prevent their use.

The device does not require any other maintenace.

* All safety-related labels and instructions printed on the

device must be inspected for legibility.

* A performance test as described in section 3 is to be

performed. The hardware and software functions are to be tested by means of the power-on self-test. All segments of the LCD must be visible.

* On the defibrillator the energy delivered into a 50-ohm

resistance must be measured.

100 CardioServ V4.1 227 446 32-D

Marquette Hellige CardioServ User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual