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Automatic Defibrillator (AED)Fred Easyport

ManufacturerSCHILLER Medical S.A.S. Tel: + 33 3 88 63 36 004, rue Louis Pasteur Fax: +33 3 88 94 12 82F- 67162 Wissembourg E-mail: tech.support@schiller.frWeb: www.schiller.fr

Address headquartersSCHILLER AG Tel: +41 (0) 41 766 42 42Altgasse 68 Fax: +41 (0) 41 761 08 80CH-6341 Baar, Switzerland E-mail: sales@schiller.chWeb: www.schiller.ch

Sales and Service InformationThe SCHILLER sales and service centre network is world-wide. For the address of yourlocal distributor, contact your nearest SCHILLER subsidiary. In case of difficulty a complete list of all distributors and subsidiaries is provided on ourinternet site: http://www.schiller.chSales information can also be obtained from:sales@schiller.ch

Article no.: 2.510444 Rev.: draft 01Issue date: 07.04.04

Operating Instruction

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Table of Contents1 Safety Information .................................... 31.1 Responsibility of the User ................................................... 31.2 Intended Use ......................................................................... 31.3 Organizational Measures ..................................................... 41.4 Working Safely...................................................................... 41.5 Operation With Other Devices............................................. 41.6 Maintenance.......................................................................... 51.7 General Safety Notes ........................................................... 51.8 Warranty ................................................................................ 51.9 Symbols................................................................................. 61.9.1 Symbols used in this manual ............................................................. 61.9.2 Symbols used on the device .............................................................. 71.9.3 Symbols used on the battery.............................................................. 71.9.4 Symbols used on the electrode packaging ........................................ 7

2 Setup and Function .................................. 82.1 Setup...................................................................................... 82.1.1 Available options ................................................................................ 82.1.2 Overview of configurable parameters ................................................ 82.2 Operating Elements.............................................................. 92.3 LCD display......................................................................... 102.4 Function .............................................................................. 112.4.1 Self-test ............................................................................................ 112.4.2 Defibrillation procedure .................................................................... 112.4.3 Device identifies a shockable rhythm............................................... 112.4.4 Device identifies no shockable rhythm............................................. 122.5 Language Support .............................................................. 132.6 Procedure for Circulatory Arrest ...................................... 14

3 Operation ................................................ 153.1 Initial Operation .................................................................. 153.1.1 Inserting the battery ......................................................................... 153.1.2 Ensuring the Device is Ready for Operation .................................... 163.1.3 Switching the Device On and Off ..................................................... 163.1.4 Internal Safety Discharge................................................................. 16

4 Defibrillating ........................................... 174.1 General Application Guidelines ........................................ 174.2 Additional Safety Information ........................................... 174.3 Applying Defibrillation Electrodes.................................... 184.3.1 Electrodes for adults and children.................................................... 184.3.2 Applying the electrodes.................................................................... 184.3.3 Checking the Electrodes .................................................................. 194.4 Defibrillating the Patient .................................................... 204.4.1 Ending Therapy................................................................................ 22

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5 Intervention Summary (Option) .............235.1 Inserting the Memory Card ................................................ 23

6 Maintenance ............................................246.1 Maintenance interval .......................................................... 246.1.1 Visual Test of the Device ................................................................. 246.1.2 Function test .................................................................................... 246.2 Battery Service Interval...................................................... 256.2.1 Battery disposal ............................................................................... 256.3 Cleaning............................................................................... 266.3.1 Cleaning the Casing......................................................................... 266.3.2 Accessories and Consumables........................................................ 266.4 Troubleshooting ................................................................. 27

7 Technical Specifications ........................287.1 System Data ........................................................................ 287.2 Defibrillation Pulse ............................................................. 297.2.1 Storage of intervention (option)........................................................ 30

8 Appendix .................................................318.1 Accessories......................................................................... 318.2 Bibliography........................................................................ 318.3 Glossary .............................................................................. 31

9 Index ........................................................33

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Safety Information 1Operating Manual Responsibility of the User 1.1

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1 Safety Information1.1 Responsibility of the User

1.2 Intended Use

This device may only be used by qualified doctors or other persons trained inearly defibrillation.The device's numeric and graphic results as well as any other diagnostic findingsmust always be regarded in the context of the patient's overall condition and thequality of the recorded data.Ensure that users have read and understood the Operating Manual andespecially this chapter, "Safety Information."Have damaged or missing parts replaced immediately.The user is responsible for adhering to applicable guidelines pertaining to safetyand accident prevention.Store the device where it is not accessible to children.

FRED Easyport is an automatic external defibrillator (AED) used in the treatmentof ventricular fibrillation (VF) and ventricular tachycardia (VT).The device may be used with the appropriate electrodes on either adults orchildren.The device may only be used on a suspected cardiac arrest victim exhibiting thefollowing symptoms:

– Not responsive– Not breathing– No pulse

The device must not be used if the person:– is responsive.– is breathing.– has a pulse.

FRED Easyport is an emergency device and must be ready for operation at anytime and in all situations. Ensure that the device is always equipped with asufficiently charged battery, and keep a spare battery on hand.Always follow the indicated specifications when operating the device.The device is not intended for use in a sterile environment.The device must not be used in areas where there is a danger of explosion orwhere flammable gases such as anaesthesia are used.

This is a type BF device.

The device is not suitable for use directly on the heart.

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1 Safety Information1.3 Organizational Measures

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1.3 Organizational Measures

1.4 Working Safely

1.5 Operation With Other Devices

The device may not be operated until its features and the necessary safety pre-cautions have been explained and are understood.Always keep the Operating Manual readily available at the location where thedevice is used and ensure that it is both complete and legible.In addition to the operating instructions, be sure also to observe the general pro-visions of law and other obligations pertaining to accident prevention and envi-ronmental protection.

Read the operating instructions¯especially this safety information—and followthese guidelines.Electric shock hazard! The energy supplied to the patient can be conducted through the patient to otherpersons, possibly resulting in a fatal electric shock. For this reason:

– Do not touch the patient, the electrodes or other conductive objects while defi-brillation is in progress.

– Do not defibrillate the patient in a puddle of water or on other conductive sur-faces.

– Switch off the device when it is no longer needed.Any changes that impair the device's safety, including operating performance,should be reported immediately to the appropriate supervisor.Only connect original SCHILLER adhesive electrodes to the device.Prior to switching on the device, perform a visual inspection to ensure that thereis no damage to the device casing or the electrode connector port.

Use only accessories and consumables supplied or recommended by SCHIL-LER. The use of other accessories or consumables may result in injury, inaccu-rate information and/or damage to the device.Magnetic and electric fields from x-ray or tomographic devices, radio equipment,cellular telephones, etc. may affect the device's function. Avoid using such de-vices or maintain a sufficient distance from them.The charging of energy and application of defibrillation pulses by the device mayinterfere with other equipment. Please perform a function control of such equip-ment before further use.Measurement sensors and devices without defibrillation protection must be se-parated from the patient before applying a defibrillation pulse.If the patient has an implanted pacemaker, be sure not to position the electrodedirectly on top of it.Special caution is required when simultaneously using high-frequency surgicalequipment. A distance of at least 15 cm must always be maintained between de-fibrillation electrodes and the high-frequency surgical electrodes. When in doubt,separate the electrode and sensor cables from the device when using high-fre-quency surgical equipment.

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Safety Information 1Operating Manual Maintenance 1.6

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1.6 Maintenance

1.7 General Safety Notes

1.8 WarrantyYour SCHILLER FRED EASYPORT includes a warranty against material and manu-facturing defects for one year from the date of purchase. This warranty excludes da-mages caused by carelessness or improper use. The warranty covers replacementof the defective part at no cost to the buyer. Liability for consequential damages isexcluded. Attempted repairs by unauthorized or unqualified persons nullify the war-ranty.

Defective devices must be sent to the nearest SCHILLER representative or directlyto the manufacturer. The manufacturer can warrant the safety, reliability and properfunctioning of the device only if:

• assembly operations, extensions, readjustments, modifications or repairs are car-ried out by persons authorized to perform such work by the manufacturer; and

• the SCHILLER FRED EASYPORT and the approved accessories are used in ac-cordance with the manufacturer's instructions.

Electric shock hazard! Do not open the device. It contains no user-serviceableparts. Maintenance service should be carried out by qualified service personnelonly.Before cleaning, switch off the device and remove the battery. Do not subject the device to high-temperature sterilization (such as autoclaving).Do not subject the device to electrical or gamma-ray sterilization.Do not use aggressive cleansers or abrasives. The device or the cables must not, under any circumstances, be immersed incleansing fluid.

Operating a device with a damaged casing or faulty cables poses a risk of injuryor death to the patient or operator! For this reason:

– Immediately replace any damaged device, cable connections or connectorports.

No further warranties are assumed. SCHILLER assumes no warranty for theproduct's or product components' commercial viability or suitability for a specificpurpose.

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1 Safety Information1.9 Symbols

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1.9 Symbols

1.9.1 Symbols used in this manualThe danger levels are classified according to ANSI Z535.4. The following overviewpresents the safety symbols and pictograms used in this manual.

Indicates an imminent hazard that can result in death or serious injury.

Indicates a potentially hazardous situation that could result in death or severe injury.

Indicates a potentially hazardous situation that could result in minor injuries. May al-so be used to warn of damage to product or property.

Indicates general safety information as presented in this chapter.

Indicates electrical hazards, warnings or precautionary measures in working withelectricity.

A NOTE indicating a potentially harmful situation in which the device could be dama-ged, or IMPORTANT operational tips and other useful information.

Reference to other documentation.

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Safety Information 1Operating Manual Symbols 1.9

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1.9.2 Symbols used on the device

1.9.3 Symbols used on the battery

1.9.4 Symbols used on the electrode packaging

BF symbol. The device's signal input is defibrillation-proof.

Designated CE certification authority. (G-MED)

Attention: Refer to the document set!

The device/component is recyclable.

Do not dispose of battery with household waste.

Do not incinerate, cut or crush battery.

Do not recharge battery.

Do not short-circuit battery.

Battery storage temperature:unlimited: +15...+25° C (+59...+77° F)

Open electrode packaging.

Remove protective cover.

Designed for single use only. Do not re-use.

Do not bend packaging.

Electrode storage temperature

Expiration date

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2 Setup and Function2.1 Setup

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2 Setup and FunctionFRED EASYPORT is, thanks to its small size and light weight, the ideal companionof physicians, paramedics, public service staff and others trained in early fibrillation.At-risk heart patients carry their own rescue device with them after they and their fa-mily members have received the appropriate instructions from a doctor. This drama-tically reduces the response time for treating ventricular fibrillation (VF) and ventricu-lar cardias (VF), giving the patient a better chance of survival.

2.1 SetupFRED EASYPORT is a battery-powered Automatic External Defibrillator (AED) thatdelivers biphasic defibrillation pulses. The patient is defibrillated via disposable ad-hesive electrodes (pads), which also acquire the ECG signal for analysis. The ope-rator can choose between adhesive electrodes for children and those for adults. Thedevice identifies the connected electrode type and selects the appropriate energy le-vels for defibrillation. The device prompts the operator by text and audio messages(display/loudspeaker). The device is powered by a disposable, replaceable lithiumbattery. The capacity is sufficient for:

• 70 shocks at maximum energy, or• 4 hours of monitoring, or• 5 years of standby operation.Our customer service can configure various device functions via a special PC con-nection (see "Function" section).

2.1.1 Available options• ECG memory card

2.1.2 Overview of configurable parametersThe following parameters can be configured by the SCHILLER customer service:

• Volume of the voice• Energy levels of first, second and third shock separate adjustments for adults and

children• Initiation of ECG analysis with button or automatic

BiocompatibilityThe parts of the product described in this user guide—including all accessories—thatcome in contact with the patient during the intended use fulfill the biocompatibility re-quirements of the applicable standards if used as intended. If you have any questi-ons on this matter, please contact SCHILLER.

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Setup and Function 2Operating Manual Operating Elements 2.2

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2.2 Operating Elements

Fig. 2.1 Operating elements on the front

(1) Green button for switching device on and off(2) Yellow indicator lamp, illuminates as long as no electrodes are connected(3) Connector port for electrodes(4) LCD display(5) Blue button for starting the analysis(6) Button for triggering the defibrillation pulse

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2 Setup and Function2.3 LCD display

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Fig. 2.2 Operating elements on the rear

(7) Battery(8) Rubber seal(9) SD minicard

2.3 LCD displayThe following information is visible on the LCD display:

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(1) Date and time(2) Memory card inserted and memory allocation in %

– blinking = memory card almost full (98% or more)– blinking = error (see page 27 chapter 6.4)

(3) Battery low(4) Defibrillation electrode type

= Adults

= Children

(5) ECG signal(6) Operating status display

Fig. 2.3 LCD display

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Setup and Function 2Operating Manual Function 2.4

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2.4 Function

2.4.1 Self-testTo ensure it is ready for operation, the device runs a self-test of the device and bat-tery. The self-test runs when the device is switched on. If the device identifies an er-ror during the self-test, an error message is displayed.

2.4.2 Defibrillation procedureThe operator is informed of each operating step by voice and simultaneous displayon the screen.

After switching on the device, the operator hears a prompt to attach the electrodesto the patient. FRED easyport then asks the operator to start the ECG analysis andnot to touch the patient any more. The analysis takes about 10 seconds. Dependingon its configuration, the device may automatically start the ECG analysis.

2.4.3 Device identifies a shockable rhythmIf the analysis program identifies a shockable rhythm, the defibrillation energy will becharged and the user will be prompted to deliver the shock. Shockable conditionsare:

• Ventricular fibrillation, or• Ventricular tachycardia with a ratio greater than 180 b/min.If the device detects a shockable rhythm, the shock may still only be released if thepatient was first determined to be without a pulse or to exhibit no signs of circulation.

If the shock is unsuccessful, the device automatically recharges the defibrillation en-ergy for a second or third shock.

SCHILLER customer service can also set other values; seechapter 7 page 28.

The energy levels are set by default at the following values:

Shock Adults Children1 90 joules 15 joules2 90 joules 30 joules3 120 joules 50 joules

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2 Setup and Function2.4 Function

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Shock unsuccessfulIf the 3rd shock is also unsuccessful, FRED Easyport prompts the operator to:

• administer artificial respiration and a cardiac massage in alternation. • start another ECG analysis after one minute. Depending on the configuration, this

second analysis may start automatically.

Shock successfulAfter a successful shock, FRED Easyport prompts the operator to:

• check respiration and signs of circulation, and – if no signs of circulation are evident, administer artificial respiration and a car-

diac massage in alternation.– If signs of circulation can be identified, the patient should be placed on his or her

side.

2.4.4 Device identifies no shockable rhythmIf the analysis program does not identify a shockable rhythm, Fred Easyport informsthe operator of further steps:

• Informs that no shock is required,• Prompts the operator to check for respiration and signs of circulation, and

– if no signs of circulation are evident, administer artificial respiration and a car-diac massage in alternation.

– if signs of circulation can be identified, place the patient on his or her side.– prompts to start another ECG analysis after one minute. Depending on the con-

figuration, this second analysis may start automatically.

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Setup and Function 2Operating Manual Language Support 2.5

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2.5 Language SupportOnce the device is switched on, it runs a self-test and shows the software and hard-ware version. You will hear the following spoken instructions as language support:

Spoken Text Display NoteStick electrodes on bare chest and pluginto machine

Stick on the electrodesPluginto machine.

Technical alarm:Electrodes not yet stuck on. Yellow light goes outas soon as electrodes are properly placed andthe patient resistance is between 30 and 200ohms. See chapter 4.3.2

Poor connectionPress the electrodes Poor connectionPress theelectrodes

Technical alarm: Electrodes do not have sufficient skin contact.The patient resistance is above 200 ohms. Seechapter 4.3.3

Press the blue button Press the blue button Starts analysis of the heart rhythm.Do not touch the patient Analysis in pro-gress

Do not touch the patient, ana-lysis in progress

See page 20 Step 2 Running the Analysis

Movement detected Warning! Stop movement Technical alarm:Patient was moved during analysis and devicecould not run analysis.

Device recommends shock See chapter 2.4.3 and page 21.Shock recommended Warning: Stop movement

Shock recommended Stopmovement

Stand clear of patient, press orange but-ton

Press orange button to shock

Shock not recommended See chapter 2.4.4 Shock not recommended Shock not recommended See chapter 2.6 Check for signs of respiration and circula-tion

Check for signs of respirationand circulation

If no signs of respiration and circulation,give 2 rescue breaths then 15 chest com-pressions in alternation If patient showssigns of life turn onto side

2 rescue breaths then 15chest compressions in alter-nation

See chapter 2.6

If the device is switched off and back on again (e.g. to change the battery), the lan-guage support will resume from the step at which the device was shut off.

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2 Setup and Function2.6 Procedure for Circulatory Arrest

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2.6 Procedure for Circulatory ArrestThis procedure applies to adults and children.

Fig. 2.4 BLS-AED algorithm or CPR (cardiopulmonary resuscitation) with defibrillation

• Collapse• Possible circulatory arrest• Responsive?

Start primary ABCD (BLS algorithm)Activate rescue system (emergency services)Request defibrillator

A Check for respiration (open airways, look, listen, feel)

B 2 breathsC Check pulse, if no pulseC Cardiac massage 15xD Connect defibrillator

Resume artificial respiration and cardiac mas-sage (CPR)

Use defibrillator to determine ECG rhythmDo not touch patient

Defibrillation (up to 3x if defibrilla-tor identifies VF)

No VF/VT identifiedAsystole or PEA

Secondary ABCDmedically trained per-sons only

Not responsive

No respiration

No pulse

VF/VT No VF/VT

2x artificial respira-tion15x cardiac massa-ge for 1 minute

2x artificial respira-tion15x cardiac massa-

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Operation 3Operating Manual Initial Operation 3.1

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3 Operation3.1 Initial Operation

3.1.1 Inserting the battery

Explosion hazard! The device is not designed for use in areas where an explo-sion hazard may occur. In addition, use of the defibrillator is not permitted in anoxygen-enriched environment or in the vicinity of flammable substances (gaso-line) or anaesthetics. Oxygenation in the vicinity of the defibrillation electrodesmust be strictly avoided.Electric shock hazard. FRED Easyport is a high-voltage electric therapy device.Improper use can endanger the life of all involved. Always follow the instructionsin this user guide.Before using the device, the operator is required to ascertain that it is functioningcorrectly and in good operating condition. In particular, the cables, connectorsand electrodes must be inspected. Damaged parts must be replaced immedia-tely.The operator is required to ensure that during ECG analysis and defibrillationthere is no conductive connection between the patient and other persons.Avoid defibrillating in a very moist or wet environment.

The device is powered by a non-rechargeable lithium battery. The battery has a gua-ranteed standby operation of at least 5 years, provided the device was not used.

After 5 years¯provided the device was not used¯the battery must be replaced.

1. Insert the battery into the device as shown in Fig. 3.1. Make sure that the batterylocks into place properly.

2. Switch on the device. A self-test will run. (see chapter 2.4.1)3. Check the battery symbol on the display. If the battery is low, the battery symbol

(1) will appear on the display.

Fig. 3.1 Inserting the battery

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3.1.2 Ensuring the Device is Ready for Operation

To ensure it is ready for operation, the device runs a self-test of the device and bat-tery. The self-test runs when the device is switched on. If the device identifies an er-ror during the self-test, an error message appears.

3.1.3 Switching the Device On and Off

3.1.4 Internal Safety DischargeThe safety discharge ensures that the stored defibrillation energy is discharged in-ternally. This is the case if:

• the battery voltage is insufficient.• the device is defective.• the device is switched off.

• Do not expose the device to direct sunlight or extreme temperatures. The ambienttemperature should be between 0 and 50° C (32-122° F). Temperatures outside ofthis range adversely affect the life of the battery.

• If the device is switched off for less than 5 minutes (e.g. to replace the battery or inerror), all data remains stored and, after the self-test, the device resumes operationas if it had never been shut off.

Switching on the device Switch on the device by pressing the green button (1). The device can be swit-ched off at any time by pressing the same button again.

Switching off the deviceSwitch off the device by pressing and holding the green button (1) for at least 3seconds. The safety discharge ensures that the stored defibrillation energy is di-scharged internally.

Fig. 3.2 Switching the device on and off

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Defibrillating 4Operating Manual General Application Guidelines 4.1

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4 Defibrillating4.1 General Application Guidelines

Observe the following application guidelines to ensure safe and successful defibril-lation. Failure to do so endangers the life of the patient, operator and bystanders.

4.2 Additional Safety InformationIn addition to the application guidelines set forth in section 4.1, the following rulesmust be observed when using an AED. Failure to do so may compromise the suc-cess of the defibrillation or endanger the patient's life.

The patient must:– not have any conductive connection to other persons during defibrillation.– not come into contact with metal parts¯e.g. bed or stretcher frames—or be lying

on wet ground (rain, swimming accidents) to prevent unwanted pathways for thedefibrillation current that may endanger the assistants.

Do not allow the defibrillation electrodes to come into contact with other electro-des or metal parts that are touching the patient. The patient's chest must be dry, as moisture can cause unwanted pathways forthe defibrillation current. For safety, completely wipe off flammable skin clean-sing agents.The high voltages may result in burns where the adhesive electrodes are app-lied.Immediately prior to the shock, heart massage and artificial respiration (CPR)must be interrupted and bystanders warned.Defibrillating a patient with an implanted pacemaker is likely to impair the pace-maker function or destroy the pacemaker. For this reason, do not apply the de-fibrillation pads near the pacemaker, have an external pacemaker at hand, andcheck the implanted pacemaker for proper functioning as soon as possible afterthe shock.

To ensure correct analysis of the heart rhythm, the patient must lie as still as pos-sible and must not be touched. Otherwise, artifacts may lead to incorrect analy-sis results.The operator is obligated to verify the prerequisites for the use of the AED bychecking for lack of responsiveness, lack of breathing and lack of circulatorysigns using the ABCD system (BLS algorithm).If, in the course of treatment, a patient spontaneously regains consciousness, adefibrillation shock that may have been advised just before must not be deliver-ed. If the ECG signal changes such that the shock is not recommended, the shockdelivery is automatically blocked.

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4 Defibrillating4.3 Applying Defibrillation Electrodes

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4.3 Applying Defibrillation Electrodes

4.3.1 Electrodes for adults and children

Large electrodes Use the large electrodes on adults and children weighing 25 kg (55 lbs) or more.

Small electrodes Use the small electrodes on children weighing less than 25 kg (55 lbs).

4.3.2 Applying the electrodes

Use the defibrillation electrodes only up to the indicated expiration date. Pleasenote that the indicated expiration date only applies if the vacuum pack is intact.The electrodes are pre-gelled, so there is no need to use extra contact gel. Do not re-use the electrodes.

Ensure good skin contact of the adhesive electrodes. Suntan lotion, sand andsalt all impair the adhesive properties.The defibrillation electrodes must be applied in a manner that ensures good skincontact and prevents air bubbles from forming under the electrodes. To preventair bubbles, apply the electrodes by pressing on the patient's skin from one endof the electrode across the entire surface to the other end.

1. Prepare the area for the electrodes by cleaning and drying the skin (Fig. 4.1). Cle-an the skin only by rubbing vigorously with a dry cloth.

2. Apply one electrode in the area above the right nipple. Do not apply the electrodeon top of the clavicle, as this surface is uneven.

3. Apply the other electrode diagonally underneath the left breast, as shown in Fig.4.1.

4. Be sure that the connections are on the exterior end so that the cables do not in-terfere with the heart massage (CPR).

Fig. 4.1 Electrode application points

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Defibrillating 4Operating Manual Applying Defibrillation Electrodes 4.3

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4.3.3 Checking the Electrodes

If the transitional resistance is too high, the message CHECK ELECTRODES will ap-pear and the yellow electrode indicator lamp (A) (Figure 4.2) will stay on. Proceed asfollows:

1. Firmly press the defibrillation electrodes in alternation onto the patient's skin andnote which electrode causes the message "Check electrodes" to disappear. Nowpress this electrode once again firmly against the patient's skin. If the "Check electrodes" message does not disappear:

2. Detach both defibrillation electrodes.3. Wipe off the remaining gel with a cloth.4. Shave both application points to remove the uppermost layer of skin.5. Apply new defibrillation electrodes to these points.

Fig. 4.2 Electrode indicator LED

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4.4 Defibrillating the PatientWhen the device is switched on, it will guide you acoustically and visually to the de-fibrillation point. Follow the instructions exactly.

Step 1 Switching On and Preparing Device

Step 2 Running the Analysis

1. Switch on the device by pressing the green button (1). 2. Assess the patient's condition. See the ABCD chapter 2.6.3. Prompt appears to apply electrodes.4. Apply defibrillation electrodes as shown in Fig. 4.1.5. Connect electrode cable to device. (see Fig. 4.3) The yellow electrode indicator

LED will go out as soon as the device is able to identify an acceptable electroderesistance. If the LED does not go out, see chapter 4.3.3

Fig. 4.3 Switching on the device

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Electrode cable port

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6. The prompt to start the analysis appears.7. Press the blue button (2). You will be prompted to no longer touch the patient.

If the device identifies a ventricular fibrillation or ventricular tachycardia with a heart frequency above 180 b/min Step 3, follows; otherwise, continue with Step 4 Perfor-ming Cardiopulmonary Resuscitation.

Fig. 4.4 Running the analysis

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Defibrillating 4Operating Manual Defibrillating the Patient 4.4

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Step 3 Delivering the ShockAs soon as the energy for one shock has been charged, the device prompts the ope-rator to release the shock with button 3.

Electric shock hazard! • Do not, under any circumstances, touch the patient while the shock is delivered.• Make sure that the patient is not touching any conductive objects.

8. Release the shock with button .

After the shock is delivered, the device checks the success of the shock by auto-matically running an analysis. If the shock was not successful, steps 2 to 3 arerepeated once or twice. Here, the energy levels for the 2nd and 3rd shocks arecharged. There follows step 4.

Step 4 Performing Cardiopulmonary ResuscitationThe prompt appears to check the respiration and circulation of the patient.

9. Check patient. – If no signs of circulation are present, perform cardiopulmonary resuscitation. Al-

ternate between 2 breaths and 15 cardiac massages for 1 minute. After one mi-nute, the device begins again with Step 2 Running the Analysis.

– If circulatory signs are present, move the patient onto his or her side.

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4 Defibrillating4.4 Defibrillating the Patient

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4.4.1 Ending Therapy1. Switch off the device as soon as the therapy is finished (press button for about 3

seconds).2. Disconnect the electrode cable plug.3. Carefully pull the electrodes off the patient's skin.4. Discard the disposable electrodes immediately after use to prevent accidental re-

use (hospital waste).

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Intervention Summary (Option) 5Operating Manual Inserting the Memory Card 5.1

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5 Intervention Summary (Option)The following data can be saved to the memory card as a documentation of the in-tervention.

• ½ hour of ECG data,• 500 events with date and time of intervention with the following data:

– Switching on of device– Start of analysis– Results of analysis– Energy charge– Defibrillation shock– Internal discharge– Electrode error alarm– "Battery low" alarm

The memory card can be analyzed on a PC using the"SAED READER" software.

5.1 Inserting the Memory CardDamage to device! The memory card slot must always be sealed with the plasticcap. Otherwise there is a danger that moisture can penetrate the device.

1. Open the rubber seal (1).2. Insert the memory card (2) with the notched side facing up.3. Carefully close the rubber seal.

When the memory card is full, the symbol will blink (3).

Be sure to not insert the card until the device is switched off and only as shown in Fig.5.1 (notched side (2) up). The card will otherwise not be recognized by the deviceand the symbol will not appear.

After inserting the card, close the slot with the plastic seal.

If no symbol appears, even though you have inserted the card, check whether thecard is approved by SCHILLER for this device.

Fig. 5.1 Memory card inserted

PRESS

THE

BLUE

BUTTON

16/03/04

16:54100%

1

2

3

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6 Maintenance6.1 Maintenance interval

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6 Maintenance6.1 Maintenance interval

6.1.1 Visual Test of the Device Check device and electrodes for the following damage:

Device casing deformed?Electrode connector port damaged?Expiration date on electrode packaging elapsed?

Replace defective devices or damaged cables immediately.

6.1.2 Function testSwitch on device and run self-test.

NoteThe device must be serviced at regular intervals. The inspection results should beset forth in writing and compared to the specifications in the document set.

The following table provides information on the maintenace interval and the personresponsible for the servicing.

Interval Maintenance Responsible partyBefore each use • Visual inspection of the device and electrodes Operator

Monthly• Visual inspection of the device and electrodes• Check the expiration date of the electrodes

Operator

Every 4 months • Functional check according to instructions Operator

Every 4 years• All measuring technology tests and calibration according to the ser-

vice manual guidelinesService personnel authorized by SCHILLER AG

Every 5 years • Replace battery Operator

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6.2 Battery Service Interval

6.2.1 Battery disposal

ImportantThe battery generally requires no servicing under normal operating conditions.

It is essential that the battery be replaced after 5 years, regardless of whether thedevice was used or not.

Explosion hazard! The battery must not be incinerated or discarded intohousehold waste.Acid burn hazard! Do not open or apply heat to the battery under any circum-stances.

The battery should be disposed of in accordance with national guidelines or returnedto SCHILLER AG.

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6.3 Cleaning

6.3.1 Cleaning the Casing

Wipe off the device surface with a cloth moisturized with a cleaning or disinfectantsolution (alcohol 70%). No liquid may be allowed to penetrate the device.

6.3.2 Accessories and Consumables

All consumables and accessories for FRED Easyport are available from your SCHIL-LER representative. A complete list of all SCHILLER representatives can be foundon SCHILLER's Web site: www.schiller.ch. Please contact our administrative head-quarters in Switzerland directly if you have any problems. Our staff will be glad to as-sist you and answer your questions.

Before cleaning, switch off the device and remove the battery. Do not, under anycircumstances, immerse the device into a cleaning liquid or sterilize with water,steam, or air.Do not use any phenol-based cleaning agents or peroxide compounds.

Always use replacement parts and consumables from SCHILLER or productsapproved by SCHILLER. Failure to do so can have fatal consequences and/orresult in the nullification of the warranty.

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6.4 TroubleshootingError Possible cause RemedyLCD display does not lightup when the device is swit-ched on

• Battery inserted incorrectly or de-fective

• Device defective

Insert battery correctly or replace

Replace deviceYellow indicator lamp next toelectrode connector lightsup

• Electrode cable not plugged in• Electrode-to-skin contact impe-

dance too high due to– old electrodes (expiration date)– incorrectly applied electrodes

• Device defective

Plug in electrode cable

Replace electrodesApply electrodes according to instructions in chapter 4.3.2 Replace device

"Press the electrodes" dis-play

• Short circuit between electrodes• Device defective

Apply electrodes according to instructions in chapter 4.3.2

Replace deviceUnable to switch off device • Green button pushed down less

than 3 seconds• Device defective

Press down the green button at least 3 seconds

Replace deviceNo analysis • ECG signal too small

• ECG signal interference through electromagnetic waves

• Patient moved or touched during analysis

• Device defective

Perform cardiac massage againTurn off source of signal interference—e.g. radio equip-ment, cell phone—or move patient outside field of inter-ferenceDo not move or touch patient during analysisReplace device

Unable to deliver shock • Battery charge too weak• Electrode error due to resuscitati-

on efforts• Heart rhythm has changed• Device defective

Replace batteryReapply electrodes

Run new analysisReplace device

"Error xxx" display • Device defective Replace deviceBattery capacity display blin-king

• Battery nearly discharged Insert new battery

symbol not displayed • Memory card missing or inserted incorrectly

Insert memory card correctly with device shut off

symbol blinking • Memory card not recognized be-cause inserted while device was still on

Switch device off and back on again

Memory card doesn't storeany data

• Memory card defective• Device defective

Replace memory card Replace device

Date and time shown incor-rectly on memory card

• Internal clock inaccurate

• Device defective

Update internal clock via data transfer from authorized personReplace device

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7 Technical Specifications7.1 System Data

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7 Technical Specifications

7.1 System Data

Unless otherwise indicated, data refers to a temperature of 25° C (77° F).

Manufacturer SCHILLER MEDICAL

Name of device FRED Easyport (First Responder External Defibrillator)

Dimensions 35 x 133 x 126 mm (H x D x W)

Weight 450 g

Casing protection class IPX 4

Power supply Internal power supply

BatteryBattery typeLife

• Lithium• 70 shocks at maximum energy, or• 4 hours of monitoring (alternating 30 minutes on, 30 minutes off), or• 5 years of standby operation.

Environmental conditions:Operating temperature

Storage and transport tempe-rature

• 0 ... 50º C with a relative humidity of 0 to 95% (no condensation)• Atmospheric pressure 500 – 1060 hPa• -20 ... 50º C with a relative humidity of 0 to 95% (no condensation)• Atmospheric pressure 700 – 1060 hPa

DisplayTypeDimensions

• High-resolution back-lit LCD• 60 x 40 mm

Safety standard IEC/EN 60601-2-4The device is designed to provide 2500 shocks

EMC • IEC/EN 60601-1-2• IEC/EN 60601-2-4• CISPR 11 class BThe device can be exposed to the following interferences without impairment:

• Static discharges up to 8 kV• Energy in the radio frequency range of up to 20 V/m (80 – 2500 MHz, 5 Hz modu-

lated)• Magnetic fields of 100 A/m, 50 Hz

Conformity CE according to directives 93/42/EEC class IIb

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Technical Specifications 7Operating Manual Defibrillation Pulse 7.2

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7.2 Defibrillation Pulse

Form • Biphasic pulsed defibrillation pulse with constant physiologically optimum phases • Maintains approximate constancy of energy output as a function of the patient re-

sistance, applying pulse-pause modulation that varies with the measured patientresistance.

Default energy settingAdultsChildren

Deviation at 50Ω: ± 3 J or ± 15 % (the greater value is assumed)• 90/90/120 joules• 15/30/50 joules

(automatic switchover when children electrodes are connected)

Other energy setting

AdultsChildren

Our customer service can change the default energy settings to the following valu-es:• 15/30/50/70/90/120 joules• 15/30/50/70 joules

Charge time for shock• from shock recommendation to

shock standby• max. energy from analysis after

15 shocks• max energy after switching on

(with new batteries and after 15 discharges at max. energy output)• 10 seconds

• 25 seconds

• 29 seconds

Shock-shock cycle time < 25 s

Charge control and monitoring Automatic shock recommendation of analysis

Patient resistance 30 ...200 Ω

Indication when ready to shockIllumination of button

Shock deliveryWith button

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7.2.1 Storage of intervention (option)

Safety discharge if: • the battery voltage is insufficient.• the device is defective.• the device is switched off.

Shock delivery via disposable adhesive electrodes applied in the anterior-anterolateral position

Connector for defibrillation electrodes

BF type

Defibrillation electrodesElectrodes for adultsElectrodes for children

Electrode cable 1.2 m long

• 50 cm2 active area • 15 cm2 active area

VF/VT identification Conditions for ECG analysisMinimal amplitude for analyzable signals > 0.15 mV, signals < 0.15 mV assessedas asystole

Shock recommendationFor VF and VT (VT> 180 b/min)

Sensitivity 96.4%Correct identification of shockable rhythms.

Specificity 99.8%Correct identification of non-shockable rhythms. These values were determined wi-th an AHA database containing VF and VT with or without artifacts.

Storage of ECG 30 minutes

Storage of events 500 events

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Appendix 8Operating Manual Accessories 8.1

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8 Appendix8.1 Accessories

8.2 BibliographyEuropean Resuscitation Council (2000)

Guidelines 2000 for Cardiopulmonary Resuscitation and Emergency CardiovascularCare. Resuscitation 46.

American Heart Association (2000) Guidelines 2000 for Cardiopulmonary Resuscitation and Emergency CardiovascularCare. Suppl. to Circulation Volume 102 – Number 8. ISBN 0-87 493-325-0.

Cansell A. (2000) Safety and Effectiveness of New Pulse Curve Shapes in Transthoracic Defibrillation– Biphasic Pulse Curve Shapes - Emergency and Paramedic Medicine,Springer Verlag 3 : 458 – 474.

8.3 GlossaryABCD The primary ABCD

A = Airways (check breathing)B = Breathing (artificial respiration)C = Circulation (circulatory signs or cardiac massage)D = Defibrillation

ACLS Advanced Cardivascular Life Support. (ACLS Manual AHA 2001)

AED Automatic External Defibrillator

BLS Basic Life Support (artificial respiration and cardiac massage)CPR is frequently used synonymously

CPR Cardiopulmonary resuscitation

PEA Pulseless electrical activity

VT Ventricular tachycardia

VF Ventricular defibrillations

Order no. Article description2.155056 Disposable defibrillation adhesive electrodes for adults2.155057 Disposable defibrillation adhesive electrodes for children3.940002 Battery2.156038 Carrier bag4.150169 Mini SD memory card 16 MB

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Index 9Operating Instruction

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9 IndexAAccessories and consumables ................26Applying defibrillation electrodes .............18

BBattery

Life ...............................................28Battery disposal ....................................25Battery service interval ...........................25Battery type ..........................................28Battery, insert .......................................15Biocompatibility .......................................8BLS-AED algorithm or cardiopulmonary resu-scitation ...............................................14

CCharge control and monitoring ................29Charge time .........................................29Checking electrodes ..............................19Circulatory arrest, procedure ..................14Cleaning ..............................................26

DDefault energy setting ............................29Defibrillating .........................................17Defibrillating the patient .........................20Defibrillation

Additional safety information ...........17general application guidelines ..........17

Defibrillation procedure ..........................11Defibrillation pulse .................................29Device identifies no shockable rhythm .....12Device identifies shockable rhythm ..........11

EElectric shock hazard! ..............................4Electrodes for adults and children ...........18Ending therapy .....................................22Ensuring device is ready for operation .....16Explosion hazard ..................................15

FFunction test .........................................24

IInitial operation .....................................15Inserting the memory card ......................23Internal safety discharge ........................16

LLanguage support .................................13LCD display ..........................................10

MMaintenance interval ............................. 24

NNo pulse .............................................. 14No respiration ...................................... 14Not responsive ..................................... 14

OOperating elements ................................ 9Options ................................................. 8

PParameters, configurable ......................... 8Patient resistance ................................. 29

SSafety discharge .................................. 30Self-test .........................................11, 24Shock delivery ..................................... 30Shock successful .................................. 12Shock unsuccessful .............................. 12Shock-shock cycle time ......................... 29Step 1, switching on and preparing the device........................................................... 20

Step 2, running the analysis ................... 20Step 3, delivering the shock ................... 21Step 4, performing cardiopulmonary resuscita-tion ..................................................... 21Symbols on device ................................. 7Symbols used on battery ......................... 7Symbols used on electrode packaging ...... 7

TTroubleshooting ................................... 27

VVF/VT identification ............................... 30

WWarranty ............................................... 5

YYellow indicator lamp ............................ 27

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