FRED easyport User Guide Rev d June 2008

Sales and Service Information The SCHILLER sales and service centre network is world-wide. For the address of your local distributor, contact your nearest SCHILLER subsidiary. In case of difficulty a complete list of all distributors and subsidiaries is provided on our internet site: http://www.schiller.ch Sales information can also be obtained from: [email protected]

Manufacturer SCHILLER Medical S.A.S. 4, rue Louis Pasteur F- 67162 Wissembourg Web:

Tel: + 33 3 88 63 36 00 Fax: +33 3 88 94 12 82 E-mail: [email protected] www.schiller.fr

Address headquarters SCHILLER AG Altgasse 68 CH-6341 Baar, Switzerland Web:

Article no.: 2.510544 Rev.: d Issue date: 16.06.08

Tel: +41 (0) 41 766 42 42 Fax: +41 (0) 41 761 08 80 E-mail: [email protected] www.schiller.ch

FRED easyport

User Guide

Art. no.: 2.510544 Rev.: d

Table of Contents 1

Safety Notes ... 3

1.1

Responsibility of the User ... 3

1.2

Intended Use ... 3

1.3

Organisational Measures ... 4

1.4

Safety-Conscious Operation ... 4

1.5

Operation with other Devices ... 4

1.6

Maintenance... 5

1.7

General Safety Notes ... 5

1.8

General Notes Regarding the Unit ... 5

1.9

Terms of warranty ... 5

1.10

Display Symbols/Indicators... 6

1.10.1 1.10.2 1.10.3 1.10.4

Symbols Used in this User Guide ... 6 Symbols Used on the Device ... 7 Symbols Used on the Battery... 7 Symbols Used on the Electrode Package... 8

2

Components and Operation ... 9

2.1

Design... 9

2.1.1 2.1.2

Available Options ... 9 Overview of the Configurable Settings... 9

2.2

Operating Elements... 10

2.3

Display... 11

2.4

Function ... 12

2.4.1 2.4.2 2.4.3 2.4.4

Self-Test... 12 Defibrillation Procedure... 12 Device Identifies a Shockable Rhythm... 12 Device Detects no Shockable Rhythm... 13

2.5

Voice Support ... 14

2.6

Procedure in Case of Cardiac Arrest ... 15

3

Operation ... 16

3.1

Start-up and Preparation ... 16

3.1.1 3.1.2 3.1.3 3.1.4

Inserting the Battery ... 16 Ensuring Operational Readiness ... 17 Switching on and off... 17 Internal Safety Discharge... 17

4

Defibrillating ... 18

4.1

General Application Guidelines ... 18

4.2

Additional Safety Notes ... 18

4.3

Applying the Pads ... 19

4.3.1 4.3.2 4.3.3

Adult and Paediatric Electrodes ... 19 Applying the Electrodes ... 19 Checking the Electrodes ... 20

4.4

Defibrillation Procedure ... 21

Page 1

FRED easyport

4.5

Defibrillation in Manual Mode... 23

4.5.1

Finishing the Therapy ... 25

5

Documentation of an Intervention ...26

5.1

Inserting the Memory Card ... 26

6

Maintenance ...27

6.1

Maintenance Intervals ... 27

6.1.1 6.1.2 6.1.3 6.1.4 6.1.5

Visual Unit Check... 27 Functional Test ... 27 Maintenance Interval for the Battery ... 28 Battery Disposal... 28 Disposal at the End of the Device's Useful Life ... 28

6.2

Cleaning... 29

6.2.1 6.2.2

Cleaning the Casing... 29 Accessories and Disposables ... 29

6.3

Error Detection... 30

6.3.1

Measures to Prevent Electromagnetic Interferences ... 31

7

Technical Data ...32

7.1

System Data ... 32

7.2

Defibrillation Impulse ... 33

7.2.1

Storage of an Intervention (Option)... 34

8

Appendix ...35 Accessories... 35

8.2

Literature ... 35

8.3

Glossary ... 35

8.4

Inspection Report ... 36

9

Index ...37

Art. no.: 2.510544 Rev.: d

8.1

Page 2

FRED easyport

User Guide

Safety Notes Responsibility of the User

1 1.1

1 Safety Notes 1.1

Responsibility of the User V The device must only be used by qualified physicians or other persons trained in early defibrillation. V The numerical and graphical results as well as any interpretation suggested by the device must be examined with respect to the patient's overall clinical condition and the quality of the recorded data. V Make sure that the user has read and understood the user guide, and especially these safety notes. V Damaged or missing components must be replaced immediately. V It is the owner's responsibility that the valid regulations for safety and prevention of accidents are observed. V The device must be stored inaccessible to children.

1.2

Intended Use V The FRED easyport is an automated external defibrillator (AED) used for the treatment of ventricular fibrillation (VF) and ventricular tachycardia (VT). V The device may be used with the appropriate electrodes on either adults or children. V The device must only be used if the following symptoms are found: – non-responsive – no respiration – no pulse V The device must not be used if the patient: – is responsive – is breathing – has pulse V The FRED easyport is an emergency device and must be ready for operation at any time and in all situations. Ensure that the device is always equipped with a sufficiently charged battery, and keep a spare battery on hand. V Only operate the device in accordance with the specified technical data. V The device is not designed for sterile use. V Do not use this unit in areas where there is any danger of explosion or in the presence of flammable gases such as anaesthetic agents.

Art. no.: 2.510544 Rev.: d

V

This unit is BF classified.

V This product is not designed for direct cardiac application.

Page 3

1 1.3

Safety Notes Organisational Measures

1.3

FRED easyport

Organisational Measures V V V

1.4

Before using the unit, ensure that an introduction regarding the unit functions and the safety precautions has been provided and understood. Keep these operating instructions in an accessible place for reference when required. Make sure that they are always complete and legible. These operating instructions do not override any statutory or local regulations, or procedures for the prevention of accidents and environmental protection.

Safety-Conscious Operation This user guide, and especially these safety notes, must be read and observed. Danger of electric shock! The energy applied to the patient can be conducted through the patient to other persons, who may suffer a lethal electric shock. Therefore: – Do not touch the patient, the electrodes or other conducting objects during defibrillation – Do not defibrillate the patient in a puddle of water or on other conducting surfaces. – Switch the device off when it is no longer used. V Immediately report any changes that impair safety (including operating behaviour) to the person responsible. V Only connect the original SCHILLER pads to the unit. V Before switching on, check if the unit's casing and electrode connection are undamaged. V V

Operation with other Devices V

V

V V V V

Page 4

Only use accessories and other parts recommended or supplied by SCHILLER AG. Use of other than recommended or supplied parts may result in injury, inaccurate information and/or damage to the unit. Magnetic and electrical fields from X-ray or tomographic devices, portable radio equipment, HF radios and devices labelled with the symbol can affect the operation of this device. (See section 6.3.1.) Avoid using such devices or maintain a sufficient distance from them. The charging of energy and the release of the defibrillation impulse can disturb other devices. Check these devices after a defibrillation. Sensors and devices that are not defibrillation proof must be disconnected from the patient before a shock is triggered. If the patient has an implanted pacemaker, be sure not to position the electrode directly on top of it. Precautions must be observed when using high-frequency electrosurgical devices. A distance of at least 15 cm must be kept between the defibrillation electrodes and the HF surgical electrodes. If in doubt, disconnect the electrodes and sensors from the unit during use of a HF surgical device.

Art. no.: 2.510544 Rev.: d

1.5

FRED easyport

User Guide

1.6

Safety Notes Maintenance

1 1.6

Maintenance V Danger of electric shock! Do not open the device. No serviceable parts inside. Refer servicing to qualified personnel only. V Before cleaning, switch the unit off and remove the battery. V Do not use high temperature sterilisation processes (such as autoclaving). Do not use E-beam or gamma radiation sterilisation. V Do not use solvent or abrasive cleaners on either the unit or cable assemblies. V Do not, under any circumstances, immerse the unit or cable assemblies in liquid.

1.7

General Safety Notes V Operating the device with a defective casing or damaged cables constitutes a danger to life. Therefore: – Immediately replace a damaged unit, or damaged cables and connections.

1.8

General Notes Regarding the Unit A defibrillation can fail with certain clinical pictures.

1.9

Terms of warranty Your SCHILLER FRED easyport is warranted against defects in material and manufacture for the duration of one year (as from date of purchase). Excluded from this guarantee is damage caused by an accident or as a result of improper handling. The warranty entitles free replacement of the defective part. Any liability for subsequent damage is excluded. The warranty is void if unauthorised or unqualified persons attempt to make repairs. In case of a defect, send the apparatus to your dealer or directly to the manufacturer. The manufacturer can only be held responsible for the safety, reliability, and performance of the apparatus if:

Art. no.: 2.510544 Rev.: d

• assembly operations, extensions, readjustments, modifications, or repairs are carried out by persons authorised by him, and • the FRED easyport and approved attached equipment is used in accordance with the manufacturer's instructions. There are no express or implied warranties which extend beyond the warranties hereinabove set forth. SCHILLER makes no warranty of merchantability or fitness for a particular purpose with respect to the product or parts thereof.

Page 5

1 Safety Notes 1.10 Display Symbols/Indicators

FRED easyport

1.10

Display Symbols/Indicators

1.10.1

Symbols Used in this User Guide The safety level is classified according ANSI Z535.4. The following overview shows the safety symbols and pictograms used in this user guide. For a possibly dangerous situation, which could lead to serious bodily injury or to death.

For a possibly dangerous situation which could lead to personal injury. This symbol is also used to indicate possible damage to property.

For a direct danger which could lead to severe personal injury or to death.

For general safety notes as listed in this section.

For electrical hazards, warnings or precautionary measures when dealing with electricity. NOTE for possibly dangerous situations which could lead to damages to property or system failure or IMPORTANT for helpful user information.

Art. no.: 2.510544 Rev.: d

Reference to other user guides.

Page 6

FRED easyport

User Guide

1.10.2

Safety Notes Display Symbols/Indicators

1 1.10

Symbols Used on the Device BF symbol. The device's signal input is defibrillation protected.

Notified body of the CE certification (G-MED).

Note accompanying documents!

Defibrillation electrode connector.

Symbol for the recognition of electrical and electronic equipment. This unit must be disposed of in a municipally approved collection point or recycling centre. Improper disposal harms the environment and human health due to the presence of dangerous substances in electrical and electronic equipment.

This function must only be used by physicians or other authorised persons (see page 23).

1.10.3

Symbols Used on the Battery The unit/component can be recycled. Battery may not be disposed of with domestic refuse.

Do not burn, saw up or crash the battery.

Art. no.: 2.510544 Rev.: d

Do not recharge the battery. Do not short the battery. Storage temperature for the battery: unlimited: +15...+25 °C.

Page 7

1 Safety Notes 1.10 Display Symbols/Indicators

1.10.4

FRED easyport

Symbols Used on the Electrode Package Open the electrode package

Peel off the protective foil

Disposable item; do not reuse

Do not bend packing

Storage temperature for the electrodes

Art. no.: 2.510544 Rev.: d

Expiration date

Page 8

FRED easyport

User Guide

Components and Operation Design

2 2.1

2 Components and Operation Its small size and light weight make the FRED easyport the ideal companion of physicians, paramedics, public service staff and other persons trained in early defibrillation. Risk patients carry their own rescue device after they and their families have been instructed by their doctor. This dramatically reduces the response time to treat ventricular fibrillation and ventricular tachycardia, granting the victims a much better chance of survival.

Biocompatibility The parts of the product described in this user guide, including all accessories, that come in contact with the patient during the intended use, fulfil the biocompatibility requirements of the applicable standards. If you have questions in this matter, please contact SCHILLER.

2.1

Design The FRED easyport is a battery-powered automated external defibrillator (AED) that delivers biphasic defibrillation pulses. The patient is defibrillated via disposable adhesive electrodes (pads), which also acquire the ECG signal for analysis. Adhesive electrodes for children and adults are available. The device recognises the connected electrodes and selects the defibrillation energy levels accordingly. The user will be given visual and audible instructions (display/loudspeaker). The device is powered by a disposable, replaceable lithium battery. The capacity is sufficient for: • 45 shocks at maximum energy, or • 2 hours of monitoring or • 5 years of storage Our customer service can configure various device functions via a special PC connection (see "Function" section).

2.1.1

Available Options • SCHILLER ECG memory card • Manual operational mode (see page 23)

2.1.2

Overview of the Configurable Settings

Art. no.: 2.510544 Rev.: d

The following settings can be configured by the SCHILLER after-sales service: • Voice volume • Energy levels of the first, second and third shocks, individually for adults and children • Initiation of ECG analysis with button or automatic • Activation/deactivation of a 16.7 Hz filter • Silent operational mode (spoken text with reduced repetition rate) • Trace deactivation

Page 9

2 2.2

Components and Operation Operating Elements

2.2

FRED easyport

Operating Elements 4

5

6

3 2

1

8

Fig. 2.1

7

Operating elements

Art. no.: 2.510544 Rev.: d

(1) Green button to switch the device on/off (2) Rubber seal for DS minicard (3) Yellow indicator lamp; lit as long as no electrodes are connected (4) Electrode connector (5) LCD (6) Blue button to start the analysis (7) Key to trigger a defibrillation impulse (8) Battery at back

Page 10

FRED easyport

User Guide

2.3

Components and Operation Display

2 2.3

Display The following information is displayed on the LCD:

1

3

2

4

(1) Time and triggered shocks since switch-on (2) Memory card inserted and memory allocation in % –

PRESS BLUE BUTTON

5

Flashing = memory card almost full (from 98%)

– Flashing = error (see page 30, section 6.3) – No indication = memory card not detected or not inserted (see page 30, section 6.3) (3) Battery low (only 3 more shocks can be released) (4) Defibrillation electrode type = adults

6 = paediatric (5) ECG signal (6) Operational status LCD

Art. no.: 2.510544 Rev.: d

Fig. 2.2

Page 11

2 2.4

Components and Operation Function

FRED easyport

2.4

Function

2.4.1

Self-Test To ensure its readiness for use, the device runs a self-test to check the unit and the battery. The self-test is carried out automatically every time the unit is switched on. If the device detects an error during the self-test, an error message is displayed.

2.4.2

Defibrillation Procedure The user is guided through all operation steps by spoken and displayed instructions. The FRED easyport runs in semi-automatic mode. This means that the shock must be released by the user. When the device is switched on, the user is prompted to apply the electrodes to the patient. Next, he or she is prompted to start the ECG recording and to stay clear of the patient. The analysis takes approximately 10 seconds. Depending on the configuration, the unit automatically starts analysing the ECG.

2.4.3

Device Identifies a Shockable Rhythm If the analysis program detects a shockable rhythm, the defibrillation energy is charged and the user is prompted to deliver the shock. Shockable rhythms are: • Ventricular fibrillation • Ventricular tachycardia with a rate exceeding 180 beats per minute Even if the device detects a shockable rhythm, a shock must only be delivered if lack of breathing and lack of circulatory signs have been established. If the shock is not successful, the device automatically charges the defibrillation energy for another shock after every further analysis. The following standard energy levels are preset:

Shock

Adults

Neonates

1

120 joules

15 joules

2

120 joules

30 joules

3

120 joules

50 joules

Art. no.: 2.510544 Rev.: d

The SCHILLER service centre can define other settings if required (see section 7, page 32).

Page 12

FRED easyport

User Guide

First shock

Components and Operation Function

After the shock, the user is prompted to: 1. 2.

alternately carry out 30 1chest compressions and give 2 breaths for 2 minutes. after 2 minutes, the unit prompts the user again to start a new ECG analysis. Depending on the configuration, this new analysis may start automatically.

Shock unsuccessful:

Second shock release and prompt to restart with step 1.

2

Information that no shock is required and

Shock successful:

2 2.4

• prompt to carry out cardiac compressions and respiration alternately for 2 minutes until the patient breathes or new instructions follow. • after 2 minutes, prompt to start a new ECG analysis

For Qualified Physicians only The analysis can at any time be repeated during CPR by pressing the blue analysis button (2).

2.4.4

Device Detects no Shockable Rhythm If the analysis program does not identify a shockable rhythm, the FRED easyport informs the user:

Art. no.: 2.510544 Rev.: d

• that no shock is required • that he or she should alternately carry out 30 chest compressions and 2 breaths for 2 minutes • after 2 minutes, prompt to start a new ECG analysis

1.

When paediatric electrodes are used, CPR is carried out in the rhythm 15:2 if 2 rescuers are on the spot, otherwise in the 30:2 rhythm. 2. CPR should be continued even after a successful shock to reduce the risk of momentary electrical myocardial stunning after the defibrillation.

Page 13

2 2.5

Components and Operation Voice Support

2.5

FRED easyport

Voice Support When the device is switched on, it carries out a self-test and indicates the software and hardware version. The following instructions will be spoken by the device:

Language

Display

Note

aPlace electrodes on chest and plug into

Technical alarm:

machine.

PLACE ON ELECTRODES PLUG INTO MACHINE

Poor connection; press the electrodes

CHECK THE ELECTRODES

Technical alarm:

Electrodes not connected. The yellow light goes out as soon as the electrodes are properly placed. See section 4.3.2. The contact between the electrodes and the skin is not sufficient. The patient resistance exceeds 200 Ohm. See section 4.3.3.

bPress blue button.

PRESS BLUE BUTTON

Heart rhythm analysis is started.

Do not touch the patient. Analysis in progress.

DO NOT TOUCH THE PATIENT ANALYSING

See page 21, Step 2, Analysis

Stop movement.

MOVEMENT DETECTED STAND CLEAR

Technical alarm: Patient was moved during analysis and device could not run analysis.

Device recommends a shock

See section 2.4.3 and page 22.

Do not touch the patient. Charging.

DO NOT TOUCH THE PATIENT CHARGING

Stand clear of patient. Press orange button.

PRESS ORANGE BUTTON TO SHOCK

Shock not recommended

See section 2.4.4

No shock advised. 30c

Immediately resume CPR – chest compressions, then 2 rescue breaths – continue until patient is breathing normally.

NO SHOCK ADVISED

See section 2.6

30 CHEST COMPRESSIONS THEN 2 RESCUE BREATHS

See section 2.6

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

Page 14

Art. no.: 2.510544 Rev.: d

a.In the "silent" mode, this text is only spoken once. b.In the "silent" mode, this text is only repeated every 2 minutes. c.When paediatric electrodes are used, CPR is carried out in the rhythm 15:2 if 2 rescuers are on the spot, otherwise in the 30:2 rhythm.

FRED easyport

Components and Operation Procedure in Case of Cardiac Arrest

User Guide

2.6

2 2.6

Procedure in Case of Cardiac Arrest This procedure applies to adults and children.

• Breakdown • Possible circulatory arrest • Responsive?

No response Start of primary ABCD (BLS-algorithm) Activate rescue system (emergency medical services) Request a defibrillator

A

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

B

2 rescue breaths No respiration

C

30 chest compressions (with children, 15 compressions)

B

2 rescue breaths

Repeat C and B until the defibrillator is connected.

D

Connect the defibrillator

Determine the ECG rhythm using the defibrillator. Do not touch the patient.

After 2 minutes

No VF/VT

VF/VT Defibrillation if defibrillator detects VF

Art. no.: 2.510544 Rev.: d

After 2 minutes

No VF/VT detected Asystole or PEA

Secondary ABCD

30 chest compressions 2 breaths Continue with 30:2 for 2 minutes

For trained medical personnel only

Fig. 2.3

30 chest compressions 2 breaths Continue with 30:2 for 2 minutes

BLS AED algorithm or cardiopulmonary resuscitation (CPR) with defibrillation

Page 15

3 3.1

Operation Start-up and Preparation

FRED easyport

3 Operation 3.1

Start-up and Preparation V

V

V

V V V

3.1.1

Danger of explosion! The device is not designed for use in areas where an explosion hazard may occur. In addition, use of the defibrillator is not permitted in an oxygen-enriched environment or in the vicinity of flammable substances (gasoline) or anaesthetics. Oxygenation in the vicinity of the defibrillation electrodes must be strictly avoided. Danger of electric shock! The FRED easyport is a high-voltage electric therapy device. Improper use of the device can endanger life. Always follow the instructions given in this user guide. Before using the device, the user is required to ascertain that it is functioning correctly and in good operating condition. In particular, the cables, connectors and electrodes must be inspected. Damaged parts must be replaced immediately. The user must make sure that there are no conductive connections between the patient and other persons during ECG analysis and defibrillation. Avoid defibrillation in very moist or wet surroundings. To ensure the defibrillator's readiness for use, always keep a spare battery on hand.

Inserting the Battery The device is powered by a non-rechargeable lithium battery. The battery has a guaranteed standby operation of at least 5 years if the device is not used. After five years – if the device has not been used – the battery must be replaced.

2. 3.

V

Fig. 3.1

Inserting the battery

1

Page 16

Insert the battery into the device as shown in Fig. 3.1. Make sure it clicks into place. Switch the unit on. A self-test will run. (See section 2.4.1.) Check the battery status on the display. If the battery is low, the battery symbol (1) is displayed.

To enable a quick reaction in the case of any emergency, the high-potential capacitor is charged on switch-on, reducing the battery's capacity (see page 32). The battery capacity is also reduced by the capacitor's trickle charge while the unit is on. For these reasons: – Always keep a new spare battery on hand – Always note the number of switch-ons and the battery's running time in the Inspection Report on page 36, even when you only demonstrate the device to other users.

Art. no.: 2.510544 Rev.: d

1.

FRED easyport

User Guide

3.1.2

Operation Start-up and Preparation

3 3.1

Ensuring Operational Readiness • Do not expose the device to direct sunlight, or extremely high or low temperatures. The ambient temperature should be in the range of 0...40 °C. Lower or higher ambient temperatures will have a negative impact on the battery's life. To ensure its readiness for use, the device runs a self-test to check the unit and the battery. The self-test is carried out when the unit is switched on. If the device detects an error during the self-test, an error message is displayed. V The duration of the self-test and the display check is max. 30 seconds. Immediately switch the device off afterwards! Battery discharge! V Note the test results and the duration of the operation in the Inspection Report on page 36. V If you only carry out the self-tests, the battery will last for approx. 30 switch-ons. V SCHILLER recommends always to keep a spare battery on hand.

3.1.3

Switching on and off • When the device is switched off for less than 5 min. (e.g. for battery replacement or by mistake), the data remains stored and the operation is continued after the self-test as if the device had not been switched off.

Switching on « Switch the device on by pressing the green button (1). It can at any time be switched off using the same button.

Switching off

1

« To switch off the device, keep the green button (1) pressed for at least 3 seconds. A safety discharge ensures that the stored defibrillation energy is discharged internally.

The device is switched off automatically 5 minutes after an electrode error is indicated. Fig. 3.2

Switching the unit on/off

Art. no.: 2.510544 Rev.: d

3.1.4

Internal Safety Discharge A safety discharge ensures that the stored defibrillation energy is discharged internally. It is carried out if: • the battery voltage is insufficient • the device is defective • the device is turned off

Page 17

4 4.1

Defibrillating General Application Guidelines

FRED easyport

4 Defibrillating 4.1

General Application Guidelines Observe the following guidelines to ensure successful and safe defibrillation. Otherwise the lives of the patient, the user and bystanders are in danger. The patient must: – not come into contact with other persons during defibrillation. – not come into contact with metal parts, e.g. bed or litter, or be positioned on wet ground (rain, accident in swimming pool), to prevent unwanted pathways for the defibrillation current, which may endanger the assistants. V Do not allow the defibrillation electrodes to come into contact with other electrodes or metal parts which are in contact with the patient. V The patient's chest must be dry, as moisture causes unwanted pathways for the defibrillation current. For safety, wipe off flammable skin cleansing agents. V Owing to the high currents, there is a risk of skin burns at the site of the electrodes. This is why the electrodes must not be placed on or above: – the sternum, clavicle or mamillas V Immediately prior to the shock, the heart massage (CPR) and artificial respiration must be stopped and bystanders must be warned. V Defibrillating a patient with an implanted pacemaker is likely to impair the pacemaker function or cause damage to the pacemaker. For this reason, do not apply the defibrillation electrodes in the vicinity of the pacemaker, have an external pacemaker at hand, and check the implanted pacemaker for proper functioning as soon as possible after the shock. V

4.2

Additional Safety Notes

V

V V

V

Page 18

To ensure correct analysis of the heart rhythm, the patient must lie as still as possible and must not be touched, as this can lead to incorrect analysis results due to artefacts. The user must apply the ABCD procedure (BLS algorithm) to determine if the AED may be used. If, in the course of treatment, a patient spontaneously regains consciousness, a defibrillation shock that may have been advised just before must not be delivered. If the ECG signal changes such that the shock is not recommended, the shock delivery is automatically blocked in the AED mode.

Art. no.: 2.510544 Rev.: d

In addition to the guidelines set forth in section 4.1, the following rules must be observed when using an AED, as failure to do so may compromise the success of the defibrillation or endanger the patient's life.