Schiller FRED easyport User Manual

FRED® easyport

®

User Guide

Art. no.: 2.510544 Rev.: d

Automated External Defibrillator (AED)

FRED

®

easyport

®

Manufacturer

SCHILLER Medical S.A.S. Tel: + 33 3 88 63 36 00
4, rue Louis Pasteur Fax: [phone]
F- 67162 Wissembourg E-mail: [e-mail]
Web: www.schiller.fr

Address headquarters

SCHILLER AG Tel: [phone]
Altgasse 68 Fax: [phone]
CH-6341 Baar, Switzerland E-mail: [e-mail]
Web: www.schiller.ch

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:

[e-mail]

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

Page 1

User Guide

Art. no.: 2.510544 Rev.: d

FRED easyport

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 Symbols Used in this User Guide ...................................................... 6

1.10.2 Symbols Used on the Device............................................................. 7

1.10.3 Symbols Used on the Battery............................................................. 7

1.10.4 Symbols Used on the Electrode Package.......................................... 8

2 Components and Operation .................... 9

2.1 Design.................................................................................... 9

2.1.1 Available Options ............................................................................... 9

2.1.2 Overview of the Configurable Settings............................................... 9

2.2 Operating Elements............................................................ 10

2.3 Display................................................................................. 11

2.4 Function .............................................................................. 12

2.4.1 Self-Test........................................................................................... 12

2.4.2 Defibrillation Procedure.................................................................... 12

2.4.3 Device Identifies a Shockable Rhythm............................................. 12

2.4.4 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 Inserting the Battery......................................................................... 16

3.1.2 Ensuring Operational Readiness ..................................................... 17

3.1.3 Switching on and off......................................................................... 17

3.1.4 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 Adult and Paediatric Electrodes....................................................... 19

4.3.2 Applying the Electrodes ................................................................... 19

4.3.3 Checking the Electrodes .................................................................. 20

4.4 Defibrillation Procedure..................................................... 21

Page 2

Art. no.: 2.510544 Rev.: d

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 Visual Unit Check............................................................................. 27

6.1.2 Functional Test ................................................................................ 27

6.1.3 Maintenance Interval for the Battery................................................ 28

6.1.4 Battery Disposal............................................................................... 28

6.1.5 Disposal at the End of the Device's Useful Life ............................... 28

6.2 Cleaning............................................................................... 29

6.2.1 Cleaning the Casing......................................................................... 29

6.2.2 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

8.1 Accessories......................................................................... 35

8.2 Literature ............................................................................. 35

8.3 Glossary .............................................................................. 35

8.4 Inspection Report ............................................................... 36

9 Index ........................................................37

Page 3

Safety Notes 1

User Guide Responsibility of the User 1.1

Art. no.: 2.510544 Rev.: d

FRED easyport

1 Safety Notes

1.1 Responsibility of the User

1.2 Intended Use

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.

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 chil-

dren.

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.

V This unit is BF classified.

V This product is not designed for direct cardiac application.

1 Safety Notes

1.3 Organisational Measures

Page 4

Art. no.: 2.510544 Rev.: d

FRED easyport

1.3 Organisational Measures

1.4 Safety-Conscious Operation

1.5 Operation with other Devices

V Before using the unit, ensure that an introduction regarding the unit functions

and the safety precautions has been provided and understood.

V Keep these operating instructions in an accessible place for reference when re-

quired. Make sure that they are always complete and legible.

V These operating instructions do not override any statutory or local regulations,

or procedures for the prevention of accidents and environmental protection.

V This user guide, and especially these safety notes, must be read and observed.
V 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 de-

fibrillation

– Do not defibrillate the patient in a puddle of water or on other conducting surfac-

es.

– Switch the device off when it is no longer used.

V Immediately report any changes that impair safety (including operating behav-

iour) 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 un-

damaged.

V 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.

V 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 main-

tain a sufficient distance from them.

V The charging of energy and the release of the defibrillation impulse can disturb

other devices. Check these devices after a defibrillation.

V Sensors and devices that are not defibrillation proof must be disconnected from

the patient before a shock is triggered.

V If the patient has an implanted pacemaker, be sure not to position the electrode

directly on top of it.

V Precautions must be observed when using high-frequency electrosurgical devic-

es. 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.

Page 5

Safety Notes 1

User Guide Maintenance 1.6

Art. no.: 2.510544 Rev.: d

FRED easyport

1.6 Maintenance

1.7 General Safety Notes

1.8 General Notes Regarding the Unit

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:

• 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.

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.

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.

A defibrillation can fail with certain clinical pictures.

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.

1 Safety Notes

1.10 Display Symbols/Indicators

Page 6

Art. no.: 2.510544 Rev.: d

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.

Reference to other user guides.

Page 7

Safety Notes 1

User Guide Display Symbols/Indicators 1.10

Art. no.: 2.510544 Rev.: d

FRED easyport

1.10.2 Symbols Used on the Device

1.10.3 Symbols Used on the Battery

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).

The unit/component can be recycled.

Battery may not be disposed of with domestic refuse.

Do not burn, saw up or crash the battery.

Do not recharge the battery.

Do not short the battery.

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

1 Safety Notes

1.10 Display Symbols/Indicators

Page 8

Art. no.: 2.510544 Rev.: d

FRED easyport

1.10.4 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

Expiration date

Page 9

Components and Operation 2

User Guide Design 2.1

Art. no.: 2.510544 Rev.: d

FRED easyport

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.

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

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

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 Components and Operation

2.2 Operating Elements

Page 10

Art. no.: 2.510544 Rev.: d

FRED easyport

2.2 Operating Elements

Fig. 2.1 Operating elements

(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

1

2

45

6

3

7

8