FRED easyport User Guide Rev k Dec 2015

Sales and Service Information The SCHILLER sales and service centre network is world-wide. For the address of your local distributer, 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 AG Altgasse 68 CH-6341 Baar, Switzerland Web:

0123

Article-No.: 2.510544 Rev.: k Issue date: 15.12.15

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

The FRED easyport bears the CE-0123 mark (Notified Body TÜV-SÜD Produkte Service GmbH, Ridlerstr. 65, 80339 Munich, Germany), indicating its compliance with the essential requirements of the Annex I of the Medical Device Directive 93/42/EE regarding safety, functionality and labelling. The requirements apply to patients, users and third persons who come into contact with this device within the scope of its intended use. First declaration 01.01.2004.

FRED easyport

User Guide

Art. no.: 2.510544 Rev.: k

Table of Content 1

Safety Notes ... 5

1.1

User profiles... 5

1.2

Responsibility of the User ... 5

1.3

Intended Use ... 5

1.4

Contra-indication ... 6

1.5

Organisational Measures ... 6

1.6

Safety-Conscious Operation ... 6

1.7

Maintenance... 7

1.8

General Safety Notes ... 7

1.9

General Notes Regarding the Unit ... 7

1.10

Terms of Warranty... 8

1.11

Symbols... 9

1.11.1 1.11.2 1.11.3 1.11.4 1.11.5

Symbols used in this user guide ... 9 Symbols used in different locations... 10 Symbols used on the device ... 11 Symbols used on the battery... 11 Symbols used on the electrode package ... 12

2

Components and Operation ... 13

2.1

General Information ... 13

2.2

Design... 14

2.2.1 2.2.2

Available options ... 14 Overview of the configurable settings ... 14

2.3

Operating Elements... 15

2.4

Display... 16

2.5

Function ... 17

2.5.1 2.5.2 2.5.3 2.5.4 2.5.5

Self-test ... 17 Function test... 17 Defibrillation procedure ... 17 Device identifies a shockable rhythm... 18 Device detects no shockable rhythm ... 19

2.6

Voice support... 20

2.7

Procedure in case of a cardiac arrest... 21

3

Operation ... 22

3.1

Initial operation... 22

3.1.1 3.1.2 3.1.3 3.1.4

Inserting the Battery ... 22 Ensuring operational readiness... 23 Switching On and Off ... 23 Internal safety discharge ... 23

Page 3

Page 4

4

Defibrillation ...24

4.1

Application guidelines ... 24

4.2

Additional Safety Notes ... 24

4.3

Applying the defibrillation electrodes ... 25

4.3.1 4.3.2 4.3.3 4.3.4

Electrodes for adults and children... 25 Applying the electrodes... 25 Checking the electrodes ... 26 Device is not working, error message... 26

4.4

Defibrillation procedure ... 27

4.5

Defibrillation in manual mode ... 29

4.5.1

Finishing the therapy... 31

5

Documentation of an Intervention ...32

5.1

Inserting the memory card... 32

6

Maintenance ...33

6.1

Maintenance intervals ... 33

6.1.1 6.1.2 6.1.3 6.1.4 6.1.5 6.1.6

Visual inspection of the device... 33 Performing a manual self-test ... 34 Function test ... 35 Maintenance interval for the battery... 36 Battery disposal ... 36 Disposal at the end of its useful life ... 36

6.2

Cleaning... 37

6.2.1 6.2.2

Cleaning the casing ... 37 Accessories and disposables... 37

6.3

Error detection ... 38

6.3.1

Preventing electromagnetic interferences ... 40

7

Technical Specifications ...41

7.1

System Specifications... 41

7.2

Safety standard... 42

7.3

Defibrillation impulse ... 43

7.3.1

Storage of an intervention (option)... 44

7.4

Electromagnetic interferences ... 45

7.4.1 7.4.2 7.4.3

Electromagnetic emissions ... 45 Electromagnetic immunity... 45 Recommended minimum distances... 47

8

Appendix ...48

8.1

Accessories ... 48

8.2

Literature ... 48

8.3

Glossary ... 49

8.4

Inspection Report ... 50

9

Index ...51

Art. no.: 2.510544 Rev.: k

FRED easyport

FRED easyport

User Guide

Safety Notes User profiles

1 1.1

1 Safety Notes 1.1

User profiles The following people may use the FRED easyport: • Physicians or other trained medical personnel • other people (non-professionals) trained in early defibrillation • other people not trained in early defibrillation, as long as they can understand and follow the spoken and displayed instructions. Even though untrained people may use the device, training and instructions are recommended to guarantee an optimal resuscitation procedure.

1.2

Responsibility of the User  The regulations governing the use and training requirements for devices such as the FRED easyport vary from country to country. In any case, legal regulations have to be observed.  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.  Make sure that the user has read and understood the user guide, and especially these safety notes.  Damaged or missing components must be replaced immediately.  It is the owner's responsibility that the valid regulations for safety and prevention of accidents are observed.  The device must be stored inaccessible to children.

Art. no.: 2.510544 Rev.: k

1.3

Intended Use  The FRED easyport is an automated external defibrillator (AED) used for the treatment of ventricular fibrillation (VF) and ventricular tachycardia (VT).  The device may be used with the appropriate electrodes on either adults or children.  The device must only be used if the following symptoms are found: – not responsive – no respiration – no pulse

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1 1.4

Safety Notes Contra-indication

FRED easyport

1.4

Contra-indication 

The device must not be used if the patient: – is responsive – is breathing – has a pulse  The device is not designed for sterile use.  Do not use this device in areas where there is any danger of explosion or in the presence of flammable liquids, flammable anaesthetic agents or in places where the ambient air's oxygen concentration is higher than 25 %.  The device is not designed for direct cardiac application.  The device must be used according to the technical data.

1.5

Organisational Measures 

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, procedures for the prevention of accidents or environmental protection.  FRED easyport is an emergency device and must be ready for operation at any time and in all situations. Make sure that – the device is always equipped with a sufficiently charged battery and that a spare battery is at hand – the maintenance steps, in particular the 4-monthly maintenance step indicated by the symbol

1.6

, are performed.

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 – Wear rubber gloves – 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.  Immediately report any changes that impair safety (including operating behaviour) to the person responsible for servicing the monitor.  Only connect the original SCHILLER pads to the unit.  Before switching on, check if the unit's casing and electrode connection are undamaged.

Page 6

Art. no.: 2.510544 Rev.: k

 

FRED easyport

User Guide

1.7

Safety Notes Maintenance

1 1.7

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

1.8

General Safety Notes  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.

1.9

General Notes Regarding the Unit

Art. no.: 2.510544 Rev.: k

A defibrillation can fail with certain clinical pictures.

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1 Safety Notes 1.10 Terms of Warranty

FRED easyport

1.10

Terms of Warranty Your SCHILLER FRED easyport is warranted against defects in material and manufacture, as stated in the Terms and Conditions. Excluded from this warranty is damage caused by an accident or as a result of improper handling. The warranty entitles to 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 the device is defective, send it to your local SCHILLER representative or directly to the manufacturer. The manufacturer can only be held responsible for the safety, reliability, and performance of the apparatus if: • 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.

Art. no.: 2.510544 Rev.: k

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.

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FRED easyport

User Guide

1.11

Symbols

1.11.1

Symbols used in this user guide

Safety Notes Symbols

1 1.11

The safety level is classified according to ISO 3864-2. The following overview contains the safety symbols and pictograms used in this user guide. For a possibly dangerous situation which could lead to severe personal 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 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.: k

Reference to other instructions.

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1 Safety Notes 1.11 Symbols

FRED easyport

1.11.2

Symbols used in different locations Manufacturer symbol

0xxx

Notified body of the CE certification • CE 0123TÜV-SÜD Produkte Service GmbH • CE 408 TÜV AUSTRIA Service Note accompanying documents!

Consult user guide!

Symbol for the recognition of batteries as well as 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.

Art. no.: 2.510544 Rev.: k

Expiry date

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FRED easyport

User Guide

1.11.3

Safety Notes Symbols

1 1.11

Symbols used on the device BF symbol. The device's signal input is defibrillation-protected.

IPX4

The device is protected against splashing water. Defibrillation electrode connector.

This function must only be used by physicians or other authorised persons (see page 30).

1.11.4

Symbols used on the battery The unit/component can be recycled.

Do not burn, saw up or crash the battery.

Do not recharge the battery.

Do not short-circuit the battery.

Art. no.: 2.510544 Rev.: k

Storage temperature for the battery: unlimited: +15...+25 °C

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1 Safety Notes 1.11 Symbols

FRED easyport

1.11.5

Symbols used on the electrode package • Remove the patient's clothes • Open the electrode packaging • Peel off the protective foil

Disposable item; do not reuse Do not bend packing

Storage temperature for the electrodes

Latex-free Use within one day after opening. Do not use if the packaging is damaged

Store in a dry location

Art. no.: 2.510544 Rev.: k

Protect from direct sunlight

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FRED easyport

User Guide

Components and Operation General Information

2 2.1

2 Components and Operation 2.1

General Information FRED easyport® is an automated external defibrillator (AED). The FRED easyport® is available as a semi-automatic or manual defibrillator. The regulations governing the use and training requirements for AEDs such as FRED easyport® differ from country to country. The laws and regulations for the use of AEDs need to be strictly observed. Local laws and regulations regarding the use of an AED differs from country to country. While some countries allow laypersons to use AEDs without any special training, other countries restrict the use of AEDs to EMTs or First Responders after they have undergone special training. For training purposes, SCHILLER offers the FRED easyport® TRAINER. 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

Art. no.: 2.510544 Rev.: k

The product parts and accessories described in this user guide that come into contact with the patient when the device is used as intended fulfil the biocompatibility requirements of the applicable standards. If you have any questions in this matter, please contact SCHILLER.

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2 2.2

Components and Operation Design

2.2

FRED easyport

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 battery capacity is sufficient for: • 45 shocks at maximum energy, or • 2 hours of monitoring Our customer service can configure various device functions via a special PC connection (see "Function" section).

2.2.1

Available options • SCHILLER ECG memory card • Manual operation mode (see page 30)

2.2.2

Overview of the configurable settings

Art. no.: 2.510544 Rev.: k

The following settings can be configured by the SCHILLER after-sales service: • Voice volume • Energy level for 1st, 2nd and 3rd shock (separate settings for adults and children) • Start of the ECG analysis by pressing a button or automatic • Enable/disable the 16.7 Hz filter • Silent operational mode (spoken text with reduced repetition rate) • Trace deactivation

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FRED easyport

Components and Operation Operating Elements

User Guide

2.3

2 2.3

Operating Elements 4

5

6

3 2

1

8

Fig. 2.1

7

Operating Elements

Art. no.: 2.510544 Rev.: k

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

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2 2.4

Components and Operation Display

2.4

FRED easyport

Display The following information is displayed on the LCD:

1

3

2

00:13 05

100%

PRESS BLUE BUTTON

7

6

4

5

(1) Time passed and shocks delivered since the device has been switched on (2) Perform the function test at the next opportunity (see page 36 section 6.1.3) (3) Memory card inserted and occupied memory in % –

Flashing = memory card almost full (from 98%)

– Flashing = error (see page 40, section 6.3) – No indication = memory card not detected or not inserted (see page 40, section 6.3) (4) Battery low (only 3 more shocks can be released) (5) Defibrillation electrode type = adults = children (6) Display of defibrillation steps / error messages (7) ECG signal

LCD screen

Art. no.: 2.510544 Rev.: k

Fig. 2.2

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FRED easyport

User Guide

2.5

Function

2.5.1

Self-test

Components and Operation Function

2 2.5

Automatic self-test at switch-on To ensure its readiness for use, the device runs a self-test to check the unit and the battery.

Manual self-test A manual self-test can be performed at any time. During manual self-tests, the capacitor is charged with a reduced energy of 15 joule and the safety discharge is tested (see page 35).

2.5.2

Function test The device reminds the user every 4 months to perform a function test; during function tests, the capacitor is charged to the max. energy value.

2.5.3

Defibrillation procedure

Art. no.: 2.510544 Rev.: k

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 analysis and to stay clear of the patient. The analysis takes approximately 10 seconds. Depending on the configuration, the unit automatically starts analysing the ECG.

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2 2.5

Components and Operation Function

2.5.4

FRED easyport

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

150 Joules

50 joules

2

150 Joules

50 joules

3

150 Joules

50 joules

The SCHILLER service centre can define other settings if required (see section 7, page 42). First shock

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 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.

2Shock successful:

Information that no shock is required and • 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

Art. no.: 2.510544 Rev.: k

The analysis can be repeated at any time during CPR by pressing the blue analysis button (2). CPR needs to be interrupted while the analysis is performed.

1.

When children electrodes are used, the 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.

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FRED easyport

User Guide

2.5.5

Components and Operation Function

2 2.5

Device detects no shockable rhythm

Art. no.: 2.510544 Rev.: k

If the analysis program does not identify a shockable rhythm, the FRED easyport informs the user: • 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

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2 2.6

Components and Operation Voice support

2.6

FRED easyport

Voice support Once the device is switched on, it runs a self-test and shows the software and hardware version. The following instructions will be spoken by the device:

Voice

Display

a

Place electrodes on chest and plug into machine.

Poor connection; press the electrodes

b Press the blue button.

Note

PLACE ON ELECTRODES PLUG INTO MACHINE

Technical alarm: Electrodes not connected. The yellow light goes out as soon as the electrodes are properly placed. See section 4.3.1.

CHECK THE ELECTRODES

Technical alarm: The contact between the electrodes and the skin is not sufficient. The patient resistance exceeds 200 Ohm. See section 4.3.2.

PRESS BLUE BUTTON

Heart rhythm analysis is started.

Do not touch the patient; analysing.

DO NOT TOUCH THE PATIENT ANALYSING

(See page 28, Step 2, Analysis)

Movement detected; stand clear.

MOVEMENT DETECTED STAND CLEAR

Device recommends a shock

Technical alarm: Patient was moved during analysis and device could not run analysis. See section 2.5.4 and page 29.

DO NOT TOUCH THE PATIENT CHARGING Stand clear of patient. Press orange button.

When this message is displayed, the required energy is charged.

PRESS ORANGE BUTTON TO SHOCK

Shock not recommended

See section 2.5.5.

No shock advised. 30c

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

NO SHOCK ADVISED

See section 2.7.

30 CHEST COMPRESSIONS THEN 2 RESCUE BREATHS

See section 2.7

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 children electrodes are used, the CPR is carried out in the rhythm 15:2 if 2 rescuers are on the spot, otherwise in the 30:2 rhythm.

Art. no.: 2.510544 Rev.: k

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. If the device detects a serious error that makes shock delivery impossible, you are prompted to continue cardiopulmonary resuscitation.

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