FRED easy User Guide Ver 0-48-0013 Aug 2007

General Information

General Information •

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The product complies with the electromagnetic immunity requirements of standard IEC 60601-1-2/EN 60601-1-2 "Electromagnetic Compatibility - Medical Electrical Equipment".

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The radio interference emitted by this device is within the limits specified in the CISPR 11 standard.

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The user guide is an integral part of the device and should always be kept near the device. Close observance of the information given in the user guide is a prerequisite for using the device as intended for and correct operation and ensures patient and operator safety. Therefore, be sure to read the complete user guide.

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FRED easy bears the CE mark CE-0459 indicating its compliance with the provisions of the Council Directive 93/42/EEC about medical devices and fulfills the essential requirements of Annex I of this directive. FRED easy® is a class IIb device.

To ensure patient safety, the specified measuring accuracy, and interference-free operation, we recommend to use only original SCHILLER accessories. The user is responsible if accessories from other manufacturers are used. The warranty does not cover damage resulting from the use of unsuitable accessories and consumables from other manufacturers.

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The user guide informs the device operator about the intended use, exact function, operation and required preventive maintenance. It is not a substitute for product training.

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The safety information given in this manual is classified as follows: Danger indicates an imminent hazard. If not avoided, the hazard will result in death or serious injury.

Warning indicates a hazard. If not avoided, the hazard can result in death or serious injury.

Caution indicates a potential hazard. If not avoided, this hazard may result in minor personal injury or product/property damage. •

This manual conforms with the device specifications and safety standards valid at the time of printing. All rights are reserved for devices, circuits, techniques, software programs, and names appearing in this manual.

SCHILLER is responsible for the effects on safety, reliability, and performance of the device, only if

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The SCHILLER quality management system complies with the international standards ISO 9001 and ISO 13458.

− assembly operations, extensions, readjustments, modifications, or repairs are carried out by SCHILLER or by persons authorized by SCHILLER − the device is used in accordance with the instructions given in this manual. The customer is responsible, if the device is employed in a manner different from the method described in this manual.

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No part of this manual may be reproduced without written permission from SCHILLER.

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On request SCHILLER will provide a detailed field service manual.

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The manufacturer is only liable for SCHILLER-supplied accessories.

Manufacturer SCHILLER MEDICAL SAS 4, Rue Louis Pasteur F-67162 Wissembourg – Cedex, France Telephone **33 (0) 3 88 63 36 00 FAX **33 (0) 3 88 94 12 82 E-mail [email protected]

FRED easy®

Intended Use

1

Intended Use

FRED easy® is an automated external defibrillator (AED). AEDs are devices for semiautomatic defibrillation by non-medical staff. They are particularly easy to operate and their use is relatively harmless for both the patient and the operator. FRED easy® is also available as an automatic external defibrillator.

Note The laws and regulations for the use of AEDs differ 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 a special training. For teaching purposes, we offer the FRED easy® TRAINER version.

Note Typical sites for the installation of FRED easy® units would be much-frequented buildings such as − airports

This document describes the semiautomatic version of FRED easy®. Refer to section 6.4 for information on operating the device in the automatic mode.

− railway stations − shopping malls − public swimming pools

The regulations governing the use and training requirements for AEDs such as FRED easy® differ from country to country. The local laws and regulations must be observed in each case.

− sports centers − municipal/public offices 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, fulfill the biocompatibility requirements of the applicable standards if applied as intended. If you have questions in this matter, please contact SCHILLER.

FRED easy®

5

Product Description and Function

2

Product Description and Function − automatic version (automatic defibrillator, see

Product Description FRED easy® is a battery-powered, automated, external defibrillator that delivers biphasic defibrillation pulses. The patient is defibrillated via disposable adhesive electrodes (pads) which also acquire the ECG signal for analysis. The operator can choose between adhesive electrodes for children and for adults. The device identifies the connected electrode type and automatically preselects the corresponding energy levels for defibrillation.

Options − ECG display (see section "ECG Display", page 22) − conversion to manual defibrillation (see section "Manual Defibrillation", page 22) − Metronome (see section 6.3) Functional Description Ensure Operational Readiness

The device prompts the operator by text and audio messages (display/speaker).

As soon as a battery is inserted, FRED easy® runs a self-test of the device and the battery. If this test does not reveal any problems, the green indicator starts blinking to indicate that the device is ready for operation, and the displayed information disappears. The device also runs a self-test each time it is turned on.

The intervention is documented on a memory card that records the ECG, speech and events (see section "Intervention Summary" on page 21). The device is powered by a plug-in, disposable lithium battery. The battery capacity is sufficient for

If the device identifies a problem during these self-tests − it emits an alarm tone

− 180 shocks at maximum energy or − 6.5 hours of monitoring (alternately 30 min-

− the green indicator does not blink.

utes ON and 30 minutes OFF) or − 5 years standby operation. As an alternative, we can supply a rechargeable NiCd battery. When new or fully charged, its capacity is sufficient for − 45 shocks at maximum energy or − 80 minutes of monitoring Our customer service can configure various device functions via a special PC connection (see section “Functional Description”). Variants and Options

The alarm tone continues until the battery is depleted. With the button (arrow, Figure 2-1) the self-test can be repeated and the corresponding error message will appear. In addition, the device runs a self-test every 7 days; this self-test is announced by a beep. If the device identifies a problem during this self-test − it emits an alarm tone − the green indicator does not blink. When equipped with the optional NiCd battery, the device runs a daily self-test. By pressing the key (arrow, Figure 2-1) you can view the corresponding error message.

Semiautomatic Defibrillator Equipment Models − standard version − Ethernet version (data transmission via Ethernet, see section "6.4)

section 6.6)

In this situation a new self-test must be initiated by insertion of a battery. Depending on the result of the self-test, the error message will disappear or a new one appears.

− Online version (Online communication via SNMP protocol, see section 6.5)

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FRED easy®

Product Description and Function

Device identifies a shockable rhythm SCHILLER

If the analysis algorithm identifies a shockable rhythm, the device will automatically charge the required defibrillation energy and, when charged, prompts the user to deliver the shock.

1

2

Shockable conditions are

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− ventricular fibrillation or − ventricular tachycardia with a rate greater than 180 B/min.

FRED easy

If the algorithm detects a shockable rhythm, the shock may still only be released if the patient does not show any signs of circulation.

Figure 2-1. FRED easy®, button to turn the device on and off and to initiate the analysis

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After an unsuccessful shock FRED easy prompts the user to perform CPR for two minutes (in Norway: three minutes): 30 chest compressions to every two breaths.

Defibrillation (semiautomatic defibrillator) The operator is informed of each operating step by voice and text which is displayed on the screen. After activation of the button, an introductory text tells the operator what to do, if the patient is unconscious or does not breathe. FRED easy® will continue repeating this introductory text until defibrillation pads are attached to the patient. The device can also be configured to skip the introductory text and to prompt the operator immediately to attach the pads. After that FRED easy® will ask the operator to start ECG analysis and warns not to touch the patient any more. The analysis takes approx. 10 seconds. Depending on its configuration, the device may automatically start the ECG analysis. Note − With signals from the AHA (American ® Heart Association) database, FRED easy achieved a detection accuracy of 98.43 % (sensitivity) and 99.80 % (specificity). − The device may be configured to automatically start the ECG analysis.

Warning Patient Hazard  In the treatment of children only 15 chest compressions must be performed to every two breaths.

After these two (three) minutes, the device again prompts the user to start ECG analysis. The device may be configured to automatically restart analysis. If the device again detects a shockable rhythm, it will automatically charge the defibrillation energy necessary for the second or third shock. For all subsequent shocks the energy remains fixed at the level of the third shock. Note The energy levels can be set to the default values or the SCHILLER customer service can adjust customer-specific energy settings (see 9 „Technical Specifications“).

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After a successful shock FRED easy prompts the user to perform CPR (30 chest compressions to every two breaths) until the patient starts breathing or until new instructions are given.

FRED easy®

7

Product Description and Function

Device identifies no shockable rhythm If the algorithm does not identify a shockable ® rhythm, FRED easy informs the user that a shock is not necessary and prompts to perform CPR (30 chest compressions to every two breaths) until the patient starts breathing or until new instructions are given.

Configurable device parameters The SCHILLER customer service can configure the following device parameters: − upon power up: introductory text or immediate prompt to apply the defib pads − volume of the voice prompts − energy levels for the 1st, 2nd and 3rd shock, separate adjustments for adults and children − initiation of ECG analysis with button or automatic − activation/deactivation of a 16.7-Hz filter

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FRED easy®

Controls and Indicators

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Controls and Indicators

a

b

c

e

d

g

f SCHILLER

1

2

3 FRED easy

Figure 3-1. Controls and indicators a Green indicator blinks when device is ready for operation b Yellow indicator is illuminated while no pads are connected c Connection for defib pads d Green button to turn the device on and off and to initiate the analysis (press the button only briefly, if you wish to initiate an analysis; otherwise you would turn the device off) e Button to trigger the defibrillation shock f Memory card g Battery

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Figure 3-2. FRED easy for semiautomatic and manual defibrillation

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Figure 3-3. FRED easy for automatic defibrillation

FRED easy®

9

Controls and Indicators

Explanation of Symbols Symbols on the device and accessories

Symbols used on the display

Type BF signal input, defibrillation-

Number of shocks delivered since

proof

device was turned on

Caution! High Voltage!

Battery capacity

Defibrillation pad expiration date Memory card Consult accompanying documents

Memory card not identified

Open defib pad package GB

I

D

E

A

Adult pad identified

C

Pediatric pad identified

NL

F

N

SF

S

Peel off protective foil

Time elapsed since device was turned Disposable item, do not reuse

on (minutes, seconds)

Do not bend packing

Storage temperature range for the electrodes Product is recyclable

Do not dispose of with household waste, separate disposal required Do not recharge

Do not short-circuit Do not incinerate

Do not destroy with a saw

Do not destroy

Unlimited storage between +15 °C and +25 °C, storage for 48 hours max. between

+60 ˚C +25 ˚C 48h

+20 ˚C +15 ˚C 0 ˚C

10

+25 °C and +60 °C and between +15 °C and 0 °C

FRED easy®

Putting the Device into Operation and Functional Test

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Putting the Device into Operation and Functional Test

4.1 Safety Information Danger Explosion Hazard  FRED easy® is not designed for use in areas where an explosion hazard may occur. Also, it is not permitted to operate the defibrillator in an oxygen-enriched environment or in the presence of flammable substances (gas) or flammable anesthetics. Oxygenation in the vicinity of the defibrillation electrodes must be strictly avoided. Oxygen concentrations below 25% of the ambient air are not considered dangerous. Dangerous, high oxygen concentrations can only occur in oxygen masks or in enclosed areas, such as hyperbaric chambers.

− Devices may be connected to other devices or to parts of systems only when it has been made certain that there is no danger to the patient, the operators, or the environment as a result. In those instances where there is any element of doubt concerning the safety of connected devices, the manufacturers concerned or other informed experts must be contacted as to whether there is any possible danger to the patient, the operator, or the environment as a result of the proposed combination of devices. Standard IEC 60601-1-1 must be complied with in all cases. − The device is suitable for application in a humid environment provided the regulations concerning splash-proof equipment of IEC 60601-2-4 are strictly observed.

Warning Shock Hazard  Observe the following warnings. Failure to do so endangers the lives of the patient, the user and other persons present. − FRED easy® is a high-voltage electrotherapy device. Only authorized personnel is permitted to use these devices. Improper use of the device can endanger life. Always follow the instructions given in this user guide. − Before using the device, the operator 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, before use. − The operator is required to ensure that during ECG analysis and defibrillation there is no conductive connection between the patient and other persons.

Warning Equipment Failure  − Magnetic and electrical fields are capable of interfering with the proper performance of the device. For this reason make sure that all external devices operated in the vicinity of the defibrillator comply with the relevant EMC requirements. X-ray equipment, MRI devices, radio systems, and cellular telephones are possible sources of interference as they may emit higher levels of electromagnetic radiation. Keep the equipment away from these devices and verify its performance before use. − If the devices are used in the vicinity of power networks operating at a frequency of 16.7 Hz (railway systems in some countries), the 16.7-Hz filter should be activated via the configuration menu. The filter should be turned off, when the device is not used in the vicinity of these networks.

FRED easy®

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Putting the Device into Operation and Functional Test

Warning − Equipment Failure  The defibrillator may disturb equipment operating in its vicinity when charging or delivering the shock. Verify the performance of these devices before use. − Operational Readiness  FRED easy® 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 charged battery and always have a spare battery at hand. − Suffocation Hazard  Dispose of the packaging material, observing the applicable waste-control regulations. Keep the packing material out of children's reach.

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Caution Equipment Damage  − Exercise great care when using HF surgery equipment on the patient at the same as the defibrillator. As a general rule, the distance between the defib pads and the HF surgery electrodes should not be less than 15 cm. If this is not ensured, disconnect the electrodes and transducer leads while using the HF surgery device. − Disconnect all transducers and devices that are not defibrillation-proof from the patient before defibrillation.

FRED easy®

Putting the Device into Operation and Functional Test

4.2 Inserting the Battery The device is normally powered by a disposable lithium battery. As an alternative, a rechargeable NiCd battery can be used (see section 4.3 "NiCd Batteries"). With the lithium battery, the device is ready for operation for a minimum of 5 years (including the weekly functional test), provided it is not used on a patient. Each time the device is turned on it checks the battery and indicates the remaining capacity on the display. After five years – if the device has not been used on a patient – the battery must be replaced with a new one.

Figure 4-1. Inserting the battery

Warning Shock Hazard  When the green indicator blinks, the device is ready for operation. In addition, the cables, connectors and electrodes must be visually inspected on a regular basis. If problems are identified which may impair the patient's or operator's safety, the device must be repaired before it can be used again.

Warning Erroneous capacity indication  − Replace the battery when the device indicates a battery problem. In some cases the device may continue to operate with the old battery but the indicated capacity may be incorrect. − Turn off the device before removing an intact battery. Otherwise the device is unable to determine the exact capacity when the battery is reinserted and will report "ERROR BATTERY", which makes the battery useless.

Caution Equipment Damage  Use the connector in the battery compartment for service purposes only.

Insert the battery as shown in Figure 4-1. Verify that − the battery label faces up − the battery clicks audibly into place. As soon as a battery is inserted, FRED easy® runs a self-test of the device and the battery. If there are no problems with the device and the battery, the green indicator starts blinking to indicate that the device is ready for operation, and the displayed information disappears. Note − Do not expose FRED easy® to direct sunlight or temperature extremes. The ambient temperature should be between 0 and 50 °C. Higher or lower temperatures adversely affect the life of the battery. − FRED easy® automatically monitors the battery capacity. When the capacity drops below the minimum level - an alarm tone sounds - the green indicator stops blinking.

Warning Erroneous capacity indication  Do NOT use the Lithium battery to power the FRED easy® TRAINER device, because this device does not monitor the battery capacity.

FRED easy®

13

Putting the Device into Operation and Functional Test

Note If the device is turned off for less than 5 minutes (e.g. to replace the battery), all data remains stored and, after the self-test, the device continues to operate as if it had never been turned off.

4.3 NiCd Batteries (Option) As an alternative a rechargeable NiCd battery (12 V, 650 mAh) is available for the defibrillator. The capacity of a new, fully charged battery is sufficient for − 45 shocks at maximum energy or − 80 minutes of monitoring With this type of battery, however, the remaining capacity is not indicated. The symbol appears when a battery is inserted; it starts blinking when the capacity reaches a given minimum value. Replace the battery in this case and recharge. Figure 4-2. Charging unit Note The battery symbol appears only when the device is equipped with a new version of the CPU board (these boards have a 12-digit serial number).

To recharge these batteries, use the charging unit with part no. 3-55-0030. The charging time is 1 hour maximum. When equipped with the NiCd battery, the device runs a daily self-test.

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FRED easy®

Defibrillation

5

Defibrillation

5.1 Defibrillator 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. Non-medical staff is permitted to use an AED such as FRED easy® only if local jurisdiction approves of this practice. Make sure that FRED easy® is only accessible to persons who are legally authorized to use an AED. Warning Risk for patients, users and assistants  − Position the patient flat on a surface which is not too soft and where he is electrically insulated. The patient must not be allowed to come into contact with metal parts, e.g., bed or litter, to prevent unwanted pathways for the defibrillation current which may endanger the assistants. For the same reason, do not position the patient on wet ground (rain, accident in swimming pool). Do not allow the defibrillation electrodes to come into contact with other electrodes or metal parts which are in contact with the patient. The patient's chest must be dry, because moisture can cause unwanted pathways for the defibrillation current. For safety, wipe off flammable skin cleansing agents.

Warning − Pacemaker Patients  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 defib pads near the pacemaker, - have an external pacemaker at hand, - check the implanted pacemaker for proper functioning as soon as possible after the shock. − Risk of Skin Burns  Owing to the high currents, there is a risk of skin burns.

Note Depending on the clinical aspects, defibrillation may not be successful.

− The operator and all assistants must be briefed regarding the preparations for and execution of defibrillation. All tasks must be clearly assigned. Immediately prior to the shock - heart massage and artificial respiration must be interrupted and - bystanders must be warned. − Ensure that there are no conductive connections between the patient and other persons during defibrillation.

FRED easy®

15

Defibrillation

5.2 Safety Information for the Use of an AED In addition to the guidelines set forth in section 5.1, the following rules must be observed when using an AED. Failure to do so may compromise the success of the defibrillation or endanger the patient's life. Warning − Patient Hazard  Only patients without response, respiration and signs of circulation may be defibrillated with an AED.

Special notes for devices with automatic ECG analysis Caution Risk for patients, users and assistants 

− During ECG analysis – suspend CPR – ensure that the patient lies as motionless as possible – do not touch the patient. Otherwise, artifacts may lead to incorrect analysis results.

With these devices it is not necessary to initiate the ECG analysis with the green button. The "analysing" status is indicated in written and audible form. To achieve a correct analysis, do not touch or move the patient during the analysis.

− In unfavorable situations the analysis of the ECG may occasionally be incorrect. Therefore the user is obliged to make certain that the conditions for use of an AED are met: - no response, - no respiration, - no signs of circulation.

Danger Patient Hazard 

Warning Patient Hazard  If, in the course of treatment, the patient spontaneously regains consciousness, a defibrillation shock that may have been advised just before must not be delivered.

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− Touching or transporting the patient during analysis may impair the analysis. A valid analysis result can only be obtained when the patient does not move and is not touched while the analysis is in progress. − An ECG signal disturbed by CPR measures may cause an incorrect analysis. For this reason, heart massage and artificial respiration must be suspended during the analysis. The patient must not be touched during analysis and shock delivery.

FRED easy®

Defibrillation

5.3 Defibrillating the Patient b

d

1

Figure 5-1. Operating controls d Button to turn the device on b Indicator is illuminated when the defibrillation pads are not connected and/or not attached to the patient

Turn on the device by briefly (1 second maximum) pressing the button (d, Figure 5-1). The device emits a beep upon power on. Then the defibrillator addresses the operator with an introductory text and prompts the operator to determine the patient status. When no signs of circulation can be identified, the device prompts the operator to apply the defib pads. The introductory text will be repeated until the device detects the applied defib pads. The device may also be configured to skip the introductory text. In that case, the operator will be asked to apply the defib pads immediately after turning the device on. Furthermore, the electrode indicator (b, Figure 5-1) is illuminated to signal that defib pads must be attached to the patient and connected to the device. Applying the Defib Pads For use with an AED, the defibrillation electrodes (pads) should be applied on the apex and sternum as usual. However, you may choose the anterior-posterior positions to avoid shorting the pads together, e.g., when defibrillating small children. •

Before applying the pads, check the application points on the patient’s chest (Figure 5-2); they must be clean and dry. Then clean the skin by rubbing the application points vigorously with a dry cloth. Do not use alcohol or alcohol wipes. This could increase the contact impedance. Shave, if the patient’s chest is hairy.

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Apply the STERNUM pad (+) above the right nipple. Do not apply the pad on the clavicle (uneven surface).

•

The applied pads must have good contact with the patient’s skin. Air bubbles under the pad must be avoided. To do so, stick on one end of the pad, then smooth it out to the other end.

Figure 5-2. Pad application points nd (+): right sternal edge at the level of the 2 intercostal space, th (-): left axillary line at the level of the 5 intercostal space) Warning Risk of Skin Burns / Equipment Damage  Do not apply the defibrillation pads over − sternum or clavicle − nipples − implanted pacemaker or defibrillator devices. Poor Electrode Contact - Sea water, sand and sunscreen products may impair electrode contact or the electrodes may become disconnected.

FRED easy®

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Defibrillation

•

− The large adult electrodes with a surface 2 area of 78 cm should be used on adults and on children weighing 25 kg or more. − The small pediatric electrodes with a sur2 face area of 28 cm should be used on children weighing less than 25 kg (younger than 8 years of age).

1

Figure 5-3. Yellow defib pad indicator

Adhesive electrodes for adults / children (AHA "Guidelines 2000 for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care”, page I-64)

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Use the pads before their expiration date. Please note that the indicated expiration date only applies when the vacuum pack is intact. The pads are pregelled. Do not use extra contact agent (gel). Do not reuse the pads.

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Place the pads on the patient such that the connectors point to either side of the patient and that the cables are not hindering CPR measures.

If the contact impedance is high, the message “Check the electrodes” will appear and the yellow indicator (Figure 5-3) remains illuminated. Follow these steps to check the pads: •

Alternately press down firmly on the defibrillation pads and check when the message “Check the electrodes” disappears.

•

Press that pad for which the message disappeared again onto the skin.

If the message “Check the electrodes” does not disappear,

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•

Remove the two defib pads.

•

Wipe rests of contact agent off with a cloth.

•

Shave the two application points to remove the epidermal skin layer.

•

Apply new defib pads to these points.

FRED easy®

Defibrillation

h

i

j

k

l

The rest of the workflow is described in steps: step 1:

00:13 00 100% A

The device requests initiation of the ECG analysis with the button or automatically initiates ECG analysis (as configured). Note

PRESS THE GREEN BUTTON Figure 5-4. On-screen display h Time since device was turned on i Number of delivered shocks j Residual battery capacity k Memory card inserted l Adult pads (A) or pediatric pads (C) connected

1

2

3

Press the

to initiate an analysis. Otherwise you would turn the device off. During the analysis, the message „Do not touch the patient – analysing” is displayed. The analysis takes approx. 10 seconds. From now on contact with the patient must be avoided and the bystanders must be warned. The following operation depends on whether the device identifies a shockable rhythm (continue with steps 2 and 3 in that case) or whether no shockable rhythm is identified (continue with step 4). step 2:

The device detects ventricular fibrillation or ventricular tachycardia with a rate above 180 B/min and automatically starts charging the defib for the first shock.

step 3:

As soon as the defib is charged, it prompts the user to trigger the shock

Figure 5-5. Button to trigger the defibrillation shock Note − If the patient’s rhythm changes to a nonshockable rhythm after the message “Shock advised”, the defibrillation energy will be discharged internally. − If an electrode becomes disconnected during ECG analysis, the message "Connect the electrodes" will be displayed and the device suspends the analysis. − If, during ECG analysis, the impedance at one of the defib pads reaches an inadmissible value, the message "Check the electrodes" will appear and the device suspends the analysis. The analysis continues as soon as the high impedance is eliminated.

button only briefly (1 second max.)

with the

button.

After delivery of shock the device checks the outcome of the defibrillation by running an automatic analysis. If the shock was not successful, the device prompts the user to perform CPR (30 chest compressions to every two breaths) for two minutes (in Norway: for three minutes). After these two (three) minutes, the device again prompts the user to start ECG analysis. Steps 2 and 3 will be repeated until a delivered shock is successful. For the second and third shock, the device will charge to the configured energy levels. For all subsequent shocks it will charge to the energy level of the third shock.

FRED easy®

19

Defibrillation

After a successful shock, step 4 will follow.

Internal Safety Discharge

step 4:

A safety circuit ensures that the stored defibrillation energy is discharged internally if the shock cannot be delivered correctly. This situation exists when

The device prompts the user to perform CPR (30 chest compressions to every two breaths) until the patient starts breathing or until new instructions are given.

− a non-shockable rhythm is identified − the shock is not delivered within 20 seconds of defibrillator charging

Warning Patient Hazard  In the treatment of children only 15 chest compressions must be performed to every two breaths.

− an electrode problem is identified − the battery voltage is insufficient − the device is defective − the device is turned off.

Warning Patient Hazard  If the device behavior differs from the description given in this user guide, the device is defective and must be repaired.

Ending Therapy •

Turn off the device after therapy (push button for approx. 3 seconds).

•

Disconnect the electrode lead.

•

Carefully peel the pads off the patient’s skin (Figure 5-6).

•

Discard the disposable pads immediately after use to prevent that they are reused (hospital waste).

Figure 5-6. Removing the defibrillation pads

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FRED easy®

Defibrillation

Intervention Summary The following can be saved to the memory card as a documentation of the intervention

Overview of events documented with date and time:

− 45 minutes of ECG data − 45 minutes of sound

•

power on

•

start of analysis

•

analysis result

Inserting the memory card automatically activates

•

defibrillator charging

the memory function and the

•

defibrillation shock

on the display (Figure 5-7).

•

internal discharge

The memory card is analyzed on a PC with the

•

electrode alarm

SAED READER software program.

•

"battery low" alarm

The

− 500 events concerning the intervention (see list at left).

symbol appears

symbol starts blinking when the memory

card is full. Be sure to turn off the device before inserting the memory card and insert the card as shown in Figure 5-8 (text facing up, observe direction

00:13 00 100% A

indicated by arrow). Otherwise the device will not identify the card and the symbol appears. Having inserted the card, close the card slot with

PRESS THE GREEN BUTTON

the plastic cover.

Figure 5-7. Memory card inserted

If the

3

have inserted the card, check whether this is a

rd

device.

SanDisk

MultiMediaCa

MB

special SCHILLER card intended for use with this

16 FRED easy

symbol does not appear although you

Figure 5-8. Inserting the memory card (text facing up, insert in direction indicated by arrow)

Caution Equipment Damage  − Always close the card slot with the plastic cover. Otherwise, moisture may penetrate into the device. − Always turn off the device before inserting or removing the memory card. − Do not plug the Ethernet adapter into the slot.

FRED easy®

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Options and Equipment Versions

6

Options and Equipment Versions

6.1 ECG Display (Option) With the ECG display option installed, the ECG will be displayed on the screen (Figure 6-1).

6.2 Manual Defibrillation (Option)

00:13 00 100% A PRESS THE GREEN BUTTON Figure 6-1. Screen display with ECG waveform

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Figure 6-2. FRED easy for semiautomatic and manual defibrillation Switching to the manual mode Warning Patient Hazard  Only a physician is allowed to enable the manual mode. Observe the information given in sections 5.1 and 5.2.

Non-medical staff is not permitted to use the manual mode, if local laws authorize non-medical staff to employ semiautomatic defibrillators only. In some countries, however, EMT's and the supervising physicians demand that defibrillators be pushbutton-convertible from semiautomatic to manual operation. In these cases, individual protocols must be determined in cooperation with the EMT's. These will be based on the AHA or ERC protocols or on the respective local regulations. Furthermore, the emergency service is required to ensure that − the agreed algorithms are observed − the staff is trained accordingly You select the manual mode by simultaneously pushing the green and the orange buttons (1 + 3,

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FRED easy®