AED-3100 User Manual and Guidelines
AED-3100 User Manual and Guidelines
Cardiolife
AED-3100
Index
MANUAL OF Precautions
general handling
OPERATOR
Introduction
Installation
DEA verification
-5°C
50°C Voice instructions
Use of DEA
References
Indicate the number of a precaution in the section 'General Handling Precautions'. It is assigned.
a number for each of the precautions, as indicated in the left column.
12
When I see a symbol similar to in this manual, consult the precaution number
indicated 12 .
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The rest of the models and trademarks are the property of their respective owners.
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About this DEA About the sequence
The AED-3100 device is an external defibrillator. of rescue
compact automated. When placing the electrodes of the
The rescue sequence employed by the DEA is adjusted to the
automated external defibrillator AED-3100 on
following guidelines based on the 2010 CoSTR* recommended
1
International
2 Liaison Committee on Resuscitation
European
4 Resuscitation Council Guidelines
The automated external defibrillator AED-3100 does not apply. for Resuscitation 2010. Resuscitation, 81 (2010) 1219 to 1452
the download when it is unable to detect the heart rate
(heart rate) of the patient (when this is present
asystole). In this case, the automated external defibrillator
AED-3100 indicates to the user to continue with CPR.
1
What is a DEA? Note for the medical staff
An automated external defibrillator (AED) determines This manual has been written for the general public to
the heart diseases suffered by patients. If necessary, understand how the DEA works. Therefore, it is possible
the AED delivers a defibrillation shock to the heart that certain expressions in this manual may deviate
to return cardiac activity to its normal state, of the medical terminology used by healthcare personnel.
as far as possible.
The heart sends blood throughout the body. If a Transfer of the DEA to others
heart attack, the heart cannot pump blood and the brain
it could suffer damage after a few minutes in which it does not people
blood flow has occurred. If this time is prolonged, Please contact your Nihon Kohden representative
the patient could end up dying. when the DEA is ceded to other users.
However, the person who has suffered a heart attack does not die
at the moment it occurs. Death can be
preventing the return of cardiac activity to a normal state
as quickly as possible, so that it is possible
the pumping of blood throughout the body.
2
Index
Introduction..................................................... 17
Explanation of the componentss....................................... 17 Index
Elementos que deben comprobarse ................................. 19
Installation........................................................ 21 Precautions
Preparation.......................................................................... 21
generals of
Location ................................................................................ 25
management
Installation and usage precautionso .................................... 26
Introduction
DEA verification .................................. 27
Daily check .......................................................... 27
Monthly check ..................................................... 28
Installation
Voice instructionsz ....................................... 31
3
General handling precautions
Make sure to read and fully understand the content before using the AED in order to be able to employ it.
el dispositivo con seguridad.
CAUTION
Aprecautionwarnstheuseraboutthepossible
damages or problems that could arise with it
I use or the erroneous application of the DEA, such as,
example,thattheDEAorotherpropertiessuffered
damages,willshowerrorsorwillfunctionpoorly.
4
General
WARNING 01 WARNING 06
Never use the DEA in the presence of gas. Do not disassemble or modify the AED, as this
inflammable anesthetic or in an atmosphere with it could have consequences such as burns
a high concentration of oxygen. If not skin, fires, electric shocks
respect this warning, it could provoke or injuries. It is not possible to provide guarantees.
WARNING 02 CAUTION 07
Never use the DEAin an oxygen chamber. The DEA could consider that defibrillation
hyperbaric. If this warning is not observed, it is not necessary even though it actually is.
an explosion or a fire could occur. Likewise, in very few situations, the DEA
one could consider that defibrillation is
necessary although it may not actually be.
WARNING 03
DEA considers that defibrillation is not
Do not introduce the AED in a testing room necessary, will provide instructions to carry
of the IRM. This DEA has not been designed for The cardiopulmonary resuscitation was completed.
to be used during MRI tests.
CAUTION 08
WARNING 04
Use the specific accessories and components.
To use the DEA in an appropriate manner Otherwise, theAED may not work.
It is effective to undertake a course. correctly and, therefore, cannot guarantee
in first aid training, in which to achieve the maximum performance of the device.
include CPR and the use of this AED.
CAUTION 09
WARNING 05
Install the AED in a place that presents the
The effectiveness of defibrillation depends on the
following conditions. Otherwise, it could
estado del paciente: altura, peso, historia,
not work properly.
current medication, combination of symptoms and
•Temperatura: De -5 a +50 °C (de 23 a 122 °F)
the time that has passed until it has From 5 to 95% (without condensation)
Humidity:
CPR has been performed and defibrillation has been applied
Atmospheric pressure: From 540 to 1060 hPa
fibrillation after syncope.
5
General handling precautions
General During resuscitation
CAUTION 10 WARNING 11
When it comes to getting rid of the DEA, Before carrying out defibrillation, remove
Remove the DEA battery. any element (electrodes, patches, and gel)
Respect local laws. from the place where the electrodes are going to be placed.
If the disposable electrodes come into contact
with any type of gel or object arranged
over the patient's chest, it is possible that the
the discharged energy is not sufficient and it is reached
to burn the skin.
WARNING 12
WARNING 13
6
WARNING 14 WARNING 18
When performing defibrillation, do not touch the Do not use the AED when the patient's body
disposable electrodes. Keep them away from is wet. If the patient's body has
other electrodes or instruments connected to the wet with water, sweat, or oil, clean it before
patient and other metal objects that are to carry out defibrillation. If the body
get in touch with him, like the framework the patient's is wet, the discharge energy
from the bed or stretcher. In another case, the energy it may not be enough and the user could suffer
downloaded may not be enough and cause an electric shock. It could also happen
burns on the skin. that the disposable electrodes cannot
adhere to the patient.
WARNING 15
patient all the electrodes, probes and trans- If the patient is 8 years or older, use the mode
drivers of the connectors that do not have the adult. If child mode is selected, it can
symbol o Otherwise, the user that the energy discharged is not sufficient.
I could suffer an electric shock and the equipment
connected could be damaged.
WARNING 20
7
General handling precautions
During resuscitation
22 CAUTION 23
WARNING
While the DEA is analyzing the ECG of Defibrillation cannot be performed if
patient, stop the CPR and do not move or shake asystole occurs. Follow the instructions of
the patient's body. If the patient is voice and carry out CPR.
in a car, stop it. Otherwise, the DEA
will not be able to properly analyze the ECG of the
CAUTION 24
patient.
Before using the AED, check the following:
The patient is unconscious.
The patient is not breathing.
No pulse (only medical staff).
CAUTION 25
When activating the AED, ensure that you have selected...
CAUTION 26
CAUTION 27
CAUTION 30
The defibrillation could cause the patient
If the patient has a pacemaker or ICD*
skin burns at the insertion site
implanted
of the electrodes.
Do not connect the disposable electrodes
less than 8 cm from a pacemaker or ICD.
CAUTION 28 Don't wait to decide where to connect the
If the disposable electrodes are not placed disposable electrodes, since it reanimates
correctly on the patient's skin due to The action should start without delay.
in the presence of hair, it is not possible to guarantee If defibrillation has been performed
the maximum performance of the DEA. In this case, in a patient with a pacemaker or ICD
Press the electrodes firmly against the skin. implanted, check the system of
If the placement indicators of the electrodes cardiac electrostimulation of the ICD
they remain illuminated and there are electrodes of the pacemaker in a medical center.
spare part, press the electrodes that have already been If the patient has a defibrillator that supplies
placed on the skin of the chest, peel them off downloads, please wait between 30 and 60 seconds
quickly to remove the hair and then, until this device completes the cycle of
put the replacements to carry out the treatment before placing the electrodes
rescue sequence. Shave the hair if available disposables. The analysis and the cycles of discard-
from a tool to do it. give an automatic DAI and the DEA can
enter into conflict.
While the pulse amplitude of the mark-
CAUTION 29 steps are big, the results of the analysis
Before performing defibrillation, make sure they can be incorrect.
that the patient is not in contact with a
fluid, such as gel, blood or saline, Implantable automatic defibrillator
or any metallic object, like the frame of the
bed or the stretcher. The contact between the patient
and a metallic object could generate a circuit, right?
desired for the DEA current and the operator
You could receive an electric shock.
9
General handling precautions
Battery
WARNING 31 WARNING 35
Never carry out any of the following Do not use the battery if it is wet. It is possible.
actions, as they could cause leaks, that too much electricity is discharged and that
overheating, explosions or fires. the battery suffers damage.
Do not pull or allow the package to fall off
the battery and hit myself.
WARNING 36
The device should not be charged, short-circuited,
desmontar, sobrecalentarse, introducir en Do not use a broken or deformed battery pack.
fire or immerse in water. It can explode or cause a fire.
32 CAUTION 37
WARNING
Install it correctly. If the DEA is unavailable. Only use the indicated battery.
of the battery, the self-check will not be carried out On the contrary, performance cannot be guaranteed.
from the DEA.
And the DEA will not stay the same.
state.
CAUTION 38
10
CAUTION 41 WARNING 44
In the following situations, the lifespan of You should only open the packaging of the electrodes.
the battery package can be reduced to less disposable when I go to use them in a way
of 4 years. immediate. If not, these could deteriorate
Turn the DEA off and on very often. and cause skin [Link] electrodes
sequence for an end different from rescue they are disposable and for single use. If you use
or the inspection. the disposable electrodes more than once,
• Turn on the AED for a long time, like, they could cause skin burns.
for example, in a training process
or inspection.
WARNING 45
• Download the energy too many times to
carry out checks. Do not use disposable electrodes if the gel
it has a dark brown color or if there is gel of
this color on the protection sheet. If not
respect this warning, the patient's skin
Disposable electrodes it could be burned or it could also be supplied
an insufficient energy discharge.
WARNING 42
Do not use the electrodes if the package has
expired. If this warning is not heeded, WARNING 46
the patient's skin could be burned or also Do not use disposable electrodes if the gel
an energy discharge could be supplied has dried out or shows an abnormal appearance
insufficient. (has turned to liquid or spills over the edges
of the electrode, etc.). If this is not respected
43
warning, the patient's skin could burn
WARNING
or it could also be provided as a download
Do not use disposable electrodes if your
of insufficient energy.
packaging is perforated. It is possible that the
discharged energy is not sufficient, which
it could cause skin burns when 47
WARNING
patient.
Do not use disposable pads if the gel
it peels off while removing the protective sheet
or if the foam detaches. If this is not respected
Warning, the patient's skin may burn.
orsupplyaninsufficientenergydischarge.
11
General handling precautions
WARNING 48 CAUTION 52
When placing the disposable electrodes, The DEA will not be able to carry out the analysis or the de-
remove the clothes and apply them directly on the fibrillation if the disposable electrodes are placed
patient's skin so that there is no about the patient's body without removing them from their
space between these and the skin. If they are not placed packaging. Follow the instructions in this manual
correctly, the AED will not be able to analyze the ECG to place the disposable electrodes and take
and the energy discharged will not be sufficient, with the defibrillation is completed.
Disposable electrodes
WARNING 50
CAUTION 54
Do not use demonstration electrodes for the
Before placing the disposable electrodes
defibrillation. The AED cannot analyze the ECG
on the patient's skin, peel them off
it can carry out defibrillation if it
posterior sheet.
uses this type of electrodes.
CAUTION 55
CAUTION 51
Replace the disposable electrodes with others.
When connecting the disposable electrodes to the AED,
new every 24 hours in case the DEA
introducetheelectrodeconnectorwaste
it is used continuously for more than
pluginthefemaleconnectoroftheAEDandmakesure
that time. Otherwise, it is possible that the
that it is well coupled. If the electrodes
discharged energy may not be enough and could
disposables do not connect properly,
to cause burns on the patient's skin.
the DEA will not be able to analyze the ECG or carry out
defibrillation.
12
CAUTION 56 CAUTION 60
Keep the disposable electrodes in the Do not install the AED near equipment that emits
conditions described on its packaging. Of the intense electromagnetic waves, such as the
on the contrary, they will deteriorate and cannot be guaranteed therapeutic instruments by [Link]
at its maximum performance. I might not be able to perform the resuscitation.
CAUTION 57
Do not place heavy objects on the electrodes Communication
disposable or double. The metal sheet
WARNING 61
the disposable electrodes can break,
the discharged energy may be insufficient Do not use the wireless communication function
and could cause skin burns within a radius of 15 cm of a pacemaker
to the patient. DAI implanted. The radiofrequency energy
from the DEA could affect the pacemaker or ICD.
CAUTION 58
WARNING 62
The used disposable electrodes are waste
doctors. Dispose of the disposable electrodes Do not use the wireless communication function.
bles in accordance with local legislation. on a plane. The radiofrequency energy of the
DEA could impact vital instruments
for the plane.
Installation, replacement
and operation The changes or modifications that do not exist
expressly authorized the responsible party
CAUTION 59 the compliance could invalidate the authority
The DEA is a medical device. Assign a from the user to set the equipment in
person responsible for the installation functioning.
and the use of this AED.
13
General handling precautions
GENERAL HANDLING PRECAUTIONS
Only use Nihon Kohden authorized products with this device. If you use unauthorized products
if done improperly, the device's performance specifications could be affected. This includes
the batteries, although not exclusively.
1. When installing or storing the DEA, make sure to observe the following precautions:
Avoid humidity or contact with water, extreme atmospheric pressures, humidity and excessive temperatures, poorly ventilated areas.
ventilated and saline, sulfuric or dusty air.
(2) Place the DEA on a flat and level surface. Avoid vibrations and mechanical shocks, even during transportation.
Avoid placing it in an area where chemical products are stored or where there is a risk of gas leaks.
3. During operation
When using the AED, do not exceed the specified diagnostic or treatment value or the specified time.
Both the DEA and the patient must be perfectly assisted at all times.
(3) To ensure patient safety, turn off the device or remove the disposable electrodes if you notice any type of
of anomaly in the DEA.
Avoid contact between the DEA and the patient.
4. After use
Place the AED in its original position with all controls and accessories in the situation described in this manual.
Remove the cables carefully and without using force.
Clean the AED along with the other accessories so that they are ready for the next use.
5. The DEA must be used in an expert and professional manner when carrying out maintenance and repair tasks.
If the DEA is not working properly, it should be clearly indicated to prevent it from being used if it is out of service.
7. The DEA and its components must undergo a general maintenance inspection, as indicated in this manual.
14
WARRANTY POLICY
Nihon Kohden Corporation (NKC) guarantees its products against all kinds of defects in materials and workmanship.
for eight years from the date of shipment. However, this warranty excludes consumables, such as the battery and the electrodes
disposables.
NKC or its authorized agents will repair or replace any product that shows the presence of deficiencies during the period
under warranty, provided that these products have been used as indicated in the instructions of this user manual.
No other party is authorized to grant any type of warranty or to assume responsibilities regarding NKC products.
NKC will not recognize any other type of guarantee, either implicit or written. In addition, maintenance, technical modifications
or any other change that the product may undergo that has not been made by NKC or its authorized agents and that
without the prior consent of NKC, it could result in the annulment of said guarantee.
Defective products or components must be returned to NKC or its authorized agents along with an explanation of the error.
that has been produced. Shipping costs must be paid in advance.
This warranty does not apply to products that have been modified, disassembled, reinstalled, or repaired without consent.
Nihon Kohden for what may have been the subject of negligence or accident, damage caused by an accident, fire, lightning, vandalism,
agua u otro tipo de siniestro, instalación o aplicación inadecuada, o si se han eliminado las marcas de identificación originales.
The following are some common sources of interference and their corrective measures:
Strong electromagnetic interference from a nearby emitting source, such as a mobile phone:
Turn off the phone.
15
General handling precautions
3. Electromagnetic interference with a radio wave receiver, such as a radio or a television:
If the equipment or system interferes with a radio wave receiver, place it as far away as possible from it.
receptor.
If the problem is not resolved with the actions suggested above, please contact us.
with the representative of Nihon Kohden to provide more suggestions.
The CE mark is a protected conformity mark of the European Union. Products with the mark
They comply with the requirements of the Medical Devices Directive 93/42/EEC and the Directive on equipment.
of radio and telecommunications terminals 1999/5/EC.
This device complies with Section 15 of the FCC rules. Operation is subject to the following two conditions:
This device may not cause harmful interference.
This device must accept any interference received, including interference that may cause
an undesired operation.
16
Introduction
Explanation of the components
Cover
Power switch
Activated
Status indicator
OK
Deactivated
Needs verification
Battery support
VER.
0 0 -0 0
A E D -3 1 0 0 K
00000 00
A E D -3 1 0 0 K
Buzzard
17
Introduction
Placement indicator
of electrodes
Adult/Child mode switch
Battery
Closure
Battery connector
18
Elements that must be checked
Make sure that all the necessary elements are ready.
To request additional consumables, please contact your Nihon Kohden representative.
DEA
When you turn on the AED and open the lid, the device starts the guided process.
voice. When the AED determines that a defibrillation shock is needed, the device
It starts to load. Once the loading is complete, the download button begins to light up.
If the button is pressed, the AED delivers a shock. The data collected during
Resuscitation, such as heart rate, is recorded in internal memory.
Note: The battery is sold separately. Please also read the document that comes with the battery.
Note: Disposable electrodes are sold separately. Please also read the accompanying document.
to the disposable electrodes.
19
Introduction
Caution labels and symbols
Conexión de
the disposable electrodes
AED -3100K
VER. 00-00
the DEA.
p. 4: “Pprecautions
general handling
20
Installation
Preparation
This section describes how to operate the AED for use at any time.
p. 5 08 , p. 19: "Elementthe ones that must be checked," p. 13 59
21
Installation
Connection of the disposable electrodes
Note 1: Check the expiration date indicated on the packaging of the disposable electrodes.
Note 2: Connect the disposable electrodes in a place where it is not possible for either them or the AED to get wet.
Slide the power switch Insert the tab into the connector
and open the lid inside the slot.
1 2
Push the connector until it clicks Store the electrodes in the part
and a click is heard back of the DEA cover
p. 12 51 Make sure that the face with illustrations of each
disposable electrode look towards you. Insert
the package on the supports.
3 4
Pull the cable through the cable guides How to extract the connector
Squeeze the ends of the connector and pull it out
moving it upwards.
22
2. Activation of the adult/child mode switch and closing of the lid
Check the mode switch Close and lock the lid
adult/child Close the lid and slide the power switch.
Set the switch to '8+', the adult mode. until a click is emitted.
C°
5-
50
If you think that the DEA could be used with children of ages
between 0 and 7 years, set the switch to '0-7',
the childish mode.
23
Installation
3. Installation of the battery package
Check that the current date is not later than the date indicated on the label.
When you start using the battery pack, write the date (year, month, and day) on the label.
When you are about to install the package, make sure to turn off the power switch and set it to the OFF position.
Place the battery in a location where neither it nor the DEA can get wet.
Click!
1 2
AED AED
00000 -3100K 0 0000-3100K
00
00 AED
AE
VERD -3 VER -3100 K
. 00-00
. 0100K
-
0
Check that the status indicator How to remove the battery pack
it is lit in green Push the tab and carefully extract the package.
VERD -3
00
. 00100
-00K
0K
p. 31 "Voice Instructions"z
Before removing the battery pack, make sure that the cover
the DEA is closed, the supply has been interrupted
and that more than 5 seconds have passed since
the DEA turned off.
Otherwise, they may not be saved correctly.
the data in the DEA.
24
Location
Install the AED in an easily accessible location in case of emergency. We also recommend placing
a signal for the DEA to identify itself easily.
If you would like to obtain information about the DEA installation, please contact the person in charge.
from the installation.
Example
25
Installation
Installation and usage precautions
Designate a person in charge of the DEA before installing and putting it into operation.
p. 13 59
Install the AED so that you can see the expiration date on the disposable electrodes and the status indicator.
• Keep the AED with the disposable electrodes connected and the child/adult mode switch set to the type of
most common patient.
The AED is a medical device. The location of the facility may be restricted by local legislation or directives.
Make sure that the AED is always ready for use and that it is easily accessible.
Install the AED in a suitable place where it can be kept in good condition and will not cause harm to children.
Avoid places where the DEA might come into contact with liquids.
Avoid places with humidity and excessive temperatures, as well as exposing it to direct sunlight, dust, or air with components.
sulfuric or saline.
Place the DEA on a flat surface. Avoid vibrations and mechanical shocks, even during transport.
• Avoid places where chemical substances are stored or where there is a possibility of gas leaks.
Do not install the DEA near equipment that emits intense electromagnetic waves, such as microwave therapeutic instruments.
The AED may not be able to perform the resuscitation. p. 13 60
• Keep the AED under the following conditions. The AED may not be able to carry out the resuscitation.
p. 5 09
- Temperatura: From -5 to +50 °C (from 23 to 122 °F)
- Humedad: From 5 to 95% (without condensation)
Atmospheric pressure: From 540 to 1060 hPa
The DEA may not work properly in a cold environment, for example when the temperature is below
-5 °C (23 °F), because the battery performance reaches low levels or the disposable electrodes freeze. Install the DEA
in an environment with an appropriately controlled temperature, so that the AED functions correctly for resuscitation.
If you have problems with the AED or are going to transfer it to another user, please contact your Nihon Kohden representative.
When disposing of the AED, remove the battery. Comply with local legislation.p. 6 10
Installation options
To learn about the various options for sale, please contact your representative.
from Nihon Kohden.
Optional elements
26
DEA verification
Daily check
The DEA conducts a daily automatic test and displays the results on the status indicator.
To carry out the daily inspection, it is enough to check the status indicator once a day.
Note 1:Use the checklist on page 69 [Link] that it is necessary.
Note 2: The person in charge must carry out a daily inspection to ensure that the AED is in perfect condition.
p. 13 59 Appoint a person in charge of the DEA before installing it and putting it into operation.
5 0°C
-5°C
27
Verification of the AED
Monthly check
To ensure that the AED works properly, it is recommended to conduct monthly inspections.
Note 1:Use the checklist on page 69 [Link] that it is necessary.
Note 2: The person in charge must carry out a daily inspection to ensure that the AED is in perfect condition.
p. 13 59 Designate a person in charge for the DEA before installing it and putting it into operation.
Installation
Service indicator
This indicator lights up if the DEA has errors. Please contact the representative.
from Nihon Kohden.
28
Monthly inspection procedure
Inspection of the status indicator, LED, speaker, switch, and button
Check that all functions are working correctly.
Check that a sound has been emitted and that all the LEDs are lit.
Check that the status indicator is red and, two seconds later, turns green.
1 Connect the switch
• Check that it issues the voice instruction 'Adult mode. If the patient does not respond
of energy and open the lid.
and does not breathe...
Check that at least two green battery status indicators are lit.
Set the adult/child mode switch to the '0-7' position and check that it is emitting.
the voice message "Child mode". If the patient is an adult, set the switch to "8+".
Set the adult/child mode switch to the '8+' position and check that it is emitting.
"Adult mode" voice message.
3 Move the switch of the
adult/child mode.
Make sure that the adult/child mode switch is set back to '8+' afterwards
from the inspection. If it is assumed that the DEA will be used primarily for children
from 0 to 7 years old, set the adult/child mode switch to position '0-7' afterwards
of the inspection.
The alarm will not sound even if the status indicator remains red after the monthly inspection.
What to do if you hear the voice message 'Check the AED after use' when opening the lid
Although you hear the voice instruction 'Continue using theAED. Check theAED after use. Refer to the operator's manual' when turning on.
el DEA, ello no significa que el DEA presente problemas de funcionamiento. Para utilizar el DEA, proceda de la siguiente manera:
Close the lid of the AED and turn it off.
After 5 seconds, remove the battery and put it back in.
3. After 10 seconds, turn on the AED and reopen the lid.
4. Check that the status indicator is illuminated in green. If the status indicator remains red, please contact.
with its representative from Nihon Kohden.
This message indicates when the internal clock of the AED exhibits anomalies, if the AED has been used outside the temperature range.
of operation and installation or if unspecified electrodes have been connected.
29
DEA verification
Other checks
Aspect
Periodically check that the AED is not cracked, chipped, or has loose parts, and is not dirty.
Consumables
Note: If you would like information about purchasing consumables, please contact your Nihon Kohden representative.
Battery [SB-310V]
The duration is four years after its first use.
The battery life may be shorter, depending on the installation conditions and frequency of use.
p. 11 41
Write the date (year, month, and day) on the label when you start using it.
Do not use the battery if the date on the label has passed.
Prepare the spare battery in case the current one fails.
Note 1: Depending on the purchase date, the storage period may be reduced.
Note 2: Certain parts of the DEA can be repaired even after the storage period has expired.
30
Voice instructions
The DEA instructs the user on what to do through various instructions.
This section lists the voice instructions you will hear and the action you must take.
Please note that certain voice instructions differ for adult mode and for the
childish mode.
31
Voice instructions
Voice instructions
Voice instruction/Description and action Consult
Mode check
Adult mode. P35
Child mode. If the patient is an adult, switch to '8+'. P. 36
Placement of the electrodes
If the patient does not respond and is not breathing, remove all clothing from the patient's chest. Take out the package.
of the electrodes of the AED.
32
Voice instruction/Description and action Consult
Performing CPR
It is safe to touch the patient. Begin CPR.
Continue CPR. P42
5 times more. Do not touch the patient.
33
Voice instructions
Voice instruction/Description and action Consult
34
Use of the DEA
Patient status check and placement of the
electrodes
Voice instructions are issued when turning on the power switch and lifting the lid.
Do everything indicated to place the disposable electrodes on the patient and wait to hear the next one.
voice instruction.
Adult mode. If the patient is unresponsive and not breathing, remove all clothing.
from the patient's chest.
Check if the selected mode is suitable for the patient. Select the pediatric mode for children of ages
aged between 0 and 7 years.
You will hear a message when opening the lid or switching between adult/child mode.
35
Use of the DEA
Check if the patient is a child or an adult
If the patient's age is 8 years or older, make sure the adult/child mode switch is set to '8+'.
If the patient's age is between 0 and 7 years, set the adult/child mode switch to '0-7'.
The voice instruction will change and the child mode will light up.
Select the child mode for children aged between 0 and 7 years.
You will hear this message when opening the lid or switching between adult and child mode.
36
Placement of disposable electrodes on the patient's chest
p. 11 42 a p. 13 57 For children, please refer to the p. 43 'Placement of the electrall in a child.
p. 11 44 , p. 12 49
p. 11 45 46 47
37
Use of the DEA
Place the electrode on the top right of the chest
Remove the electrodes from the blue protector.
Apply them to the top right side of the
chestandontheleftsideasillustrated.
4 You will continuously hear this voice instruction until you place.
correctly to the patient the electrodes.
As shown in the illustration of the electrode, place the electrode.
in the upper right part of the chest (below the collarbone, to the right
from the sternum). Do not place the electrode in the center of the chest.
p. 6 11 , p. 9 28 30
p. 11 45 46 47
38
Check if the electrode placement indicators
they do not blink
If two electrodes are placed on the patient, the placement indicators
The electrodes will stop flashing. The indicators will continue to blink.
7 if the electrodes have not been placed correctly or have come off.
Checkthattheelectrodeshavebeenfirmlyplacedonthepatient.
39
Use of the DEA
Supply of a defibrillation shock
Once the disposable electrodes are placed, the AED starts to analyze the heart rhythm.
Voice instructions vary depending on the patient's condition.
Do not approach the patient and wait for the next voice instruction to be issued.
You will hear this message when the AED analyzes the heart rate.
p. 8 22 26
p. 6 12 13 , p. 7 14 15 , p. 9 29
40
Do not touch the patient. Press the blinking button.
When you hear this instruction, make sure no one is touching the patient and press
the flashing download button.
The download button flashes when the AED determines that a shock is needed.
Press this button to deliver a shock.
Note: If you press the download button when it is not lit, the download will not take place.
Download completed.
Do not approach the patient and wait for the next voice instruction to be issued.
You will hear this message after delivering the defibrillation shock to the patient.
41
Use of the DEA
Performing CPR
Once the defibrillation shock has been delivered or theAED has decided that a shock is no longer necessary,
start cardiopulmonary resuscitation (CPR) and respiratory resuscitation.
Leave the disposable electrodes placed on the patient and start CPR.
You will hear that voice instruction when the DEA has decided that no shock is needed after the device
Analyze the patient's ECG or when the AED delivers a defibrillation shock. Immediately initiate CPR.
Continue CPR.
Compress the chest five times and then step away from the patient.
You will hear this voice instruction for about two minutes after starting CPR.
Do not approach the patient and wait for the next voice instruction to be given.
You will hear this instruction while the AED analyzes the patient's heart rate variation after CPR.
p. 8 23 , p. 9 27
Until the emergency medical team arrives, leave the disposable electrodes connected to the patient and follow the instructions.
from the voice of the DEA.
42
Placement of electrodes on a child
If the patient's age is between 0 and 7 years, switch to child mode and perform resuscitation.
It is necessary to place the electrodes in various locations on the patient depending on the size of their body.
p. 7 19 a 21
p. 6 11 , p. 7 18
p. 6 11 , p. 7 18 21
back chest
Remove the electrodes from the blue protector and apply them to the patient as
is illustrated.
You will continuously hear this voice instruction until you correctly place the electrodes on the patient.
43
Use of the DEA
Until an emergency medical team arrives.
Until the emergency medical team arrives, leave the disposable electrodes connected to the patient.
Do not turn off the AED and follow the instructions.
Until the emergency medical team arrives, follow the voice instructions of the AED and continue.
CPR and the patient's ECG analysis. Even if the patient becomes conscious and starts
Move, the patient's situation can change at any moment. Leave the AED on.
and do not remove the electrodes from the patient.
As long as the disposable electrodes are connected to the patient, the AED will not turn off and will continue.
issuing voice instructions, even if you close the DEA lid and turn off the power switch
in the off position.
44
Preparation for the next use
After using the AED to carry out the rescue, prepare the AED for the next use.
Save the file Visualization and storage of files
of rescue. rescue with the help of a PC
Connect the AED to a PC Consult the manual As soon as I placed the disposable electrodes on the patient, the internal memory
software user the DEAwill begin to record data, such as heart rate and discharges
via Bluetooth and saved
1 the resuscitation file from the report viewer
of defibrillation applied.
The DEA has a Bluetooth wireless communication function. Use it.
on the PC via the software of the defibrillator Bluetooth to connect the DEA to a PC with Bluetooth module using
optional accessory of the viewer QP-551VK. from the Bluetooth adapter. Use the optional report viewer software.
defibrillator reports from the QP-551VK defibrillator to copy the resuscitation files to the PC.
You will be able to view and print the rescue file when it is transferred to the PC.
QP-551VK.
Note: It is not possible to copy the DEA recovery files to
Note: when starting the following resuscitation, if there are PC while the disposable electrodes are connected to the
three files in the internal memory of the DEA, patient.
the older data will be overwritten.
Three rescue files can be saved.
in the internal memory of the DEA. Each file
resuscitation lasts up to
30 minutes.
p. 22 "How
extract the connector
Defibrillator report viewer software
2 Remove the electrodes To dispose of electrodes QP-551VK
used disposables. used disposables, With the help of the report viewer software of the defibrillator QP-551VK,
consult the You will be able to view and save the data stored in theAED during resuscitation.
p. 13 58 You can also use this software to configure the internal clock on the
DEA and receive the results of the self-checks. To use this
Connect the connector of software, you must install it on a PC.
the new electrodes To know how to use it, consult the software user manual.
disposables to the DEA from the report screen of the defibrillator QP-551VK.
p. 22 'Connection'
and I kept the packaging of
3 of the electrodes
Adjustment of the internal clock of the DEA
the disposable electrodes The accuracy of the DEA's internal clock is as follows:
disposable
bles in the support sit Ambient temperature from 0 to +50 °C (from 32 to 122 °F): +/- 6 s/month
of the back The ambient temperature of -20 to +70 °C (from -4 to +158 °F): ±10 s/month
fromtheDEAcover. When you transfer the resuscitation files to the PC with the software
optional report viewer of the defibrillator QP-551VK, also
p. 28 "About You will be able to check and adjust the internal clock of the AED if necessary.
4 Check the load
of the indicators in ARM-1000AEDremotemonitoringsystem
remaining battery.
the diagnostic panel The remote supervision system for connection with the DEA ARM-1000
AED allows you to monitor the status and manage consumable items
Activation and remote DEA.
Check the position
5 ofthemodeswitch
of the mode switch A wireless modem next to the DEA sends data to the system server.
from remote DEA supervision.
adult/child and closure
adult/child. You can check the status of the DEA online. If an anomaly is detected in a
from the lid
DEAis about to expire or has expired the expiration date of elements.
Close the DEA lid consumables such as disposable electrodes and batteries, an email is sent
Activation electronic to the registered DEA officials.
and turn it off.
The DEA inspection officer can also enter results.
6 Check that the indicator
of the mode switch
of daily inspections in a record and see the inspection record of
adult/child and closure all the DEA.
the state is illuminated
from the lid Please contact your Nihon Kohden representative for
in green. more details about the connection with the DEA.
45
References
Notes on the use of Bluetooth wireless communication
The DEA has Bluetooth wireless communication, so it can receive the rescue files from the DEA, change its
parameters and automatically send the test results to the PC. For more information, see the user manual
of the optional software of the QP-551VK defibrillator report viewer.
1. Before using the DEA's wireless communication function, ensure that there are no other radio stations in operation.
naming in the vicinity.
If radio interference occurs between the DEA and other radio stations, immediately move the DEA to another location or stop.
individual communication to avoid interference.
3. In the case of other radio interferences from the DEA, please contact your Nihon Kohden representative.
Bluetooth devices use the same frequency band (2.4 GHz) as wireless LAN (IEEE 802.11b/g). Therefore, if a
If a Bluetooth device is used near a wireless LAN device, interferences could cause slowdowns or disappearance.
of communication, or the emergence of noise.
This DEA has a wireless communication equipment "EYXFDCA" certified by the Conformity Certification of the
technical regulations of the Japan Telecommunications Engineering Center.
FCC WARNING
The changes or modifications that have not been expressly authorized by the responsible party for compliance could
invalidate the user's authority to operate the equipment.
The wireless communication module in this AED complies with Section 15 of the FCC regulations. The operation is subject to
to the following two conditions:
The wireless communication module in the AED can cause harmful interference.
2) The wireless communication module in the AED must accommodate the received interference, which includes the interference
that cause undesired functioning.
46
Frequently Asked Questions
During resuscitation
P If I do not know if the child is over 8 years old, R Select adult mode, connect the electrodes immediately.
What mode should I select, adult dispose of patient items and follow the voice instructions.
the children's?
P What should I do when it is issued? R Even if a defibrillation discharge is not recommended, it is needed.
the voice message 'Not recommended' perform CPR. Follow the voice instructions and start CPR
descarga.”? immediately.
The voice message indicates that the DEA has analyzed the patient's ECG and has
it was decided that no defibrillation discharge or state is needed
the patient's condition will not change with the defibrillation shock. For example,
the DEA has detected spontaneous pulse from the patient or asystole.
P When is it heard 'It's safe' R When the DEA analyzes the heart rate and determines that it is not needed
Touch the patient. Start CPR. a defibrillation shock.
After delivering a defibrillation shock.
p. 42 "Performing CPR" in the section "Voice Instructions"z
P Is CPR necessary? R Yes. CPR should be performed to save the patient's life.
Cuando el DEA emite “Es seguro tocar al paciente. Inicie RCP.”,lleve
perform CPR.
P Can I perform CPR? R No, it is not possible.
while the DEA is analyzing If you touch the patient while the AED is analyzing the heart rhythm of
the heart rate? Patient, it is possible that the AED misanalyzes the heart rhythm.
Do not touch the patient while the AED analyzes the heart rhythm so that
the device can make the right decisions.
P Can I transport the patient by car? R No, it cannot be done. If you need to start using the AED while transferring
while the DEA analyzes its rhythm to the patient in the car, stop the vehicle.
cardiac? If the car is in motion, noise is produced and the AED could
make wrong decisions.
p. 8 22
P Why do I hear the instruction to R If the disposable electrodes are placed and removed three times or more, the
voice to carry out CPR while DEA stops analyzing the heart rate and urges you to perform CPR to
the DEA is analyzing the rhythm minimize the interruption of CPR.
patient's cardiac?
P Before placing the electrodes on the R No, in general it is not necessary to clean the chest.
patient, do I need to clean the chest? If the patient's chest shows sweat or oil: p. 7 18
P Can I touch the electrodes that are R No. Do not touch the electrodes that have been placed on the patient while
have they placed on the patient? the DEA is in operation.
If the user touches the electrodes while a shock is being delivered,
the user will receive an electric shock.
p. 6 13 , p. 7 14
P I heard the instruction "Do not touch the " R For one of the following reasons:
patient. Press the button that blinks 30 seconds passed without pressing the DOWNLOAD button afterwards.
"DEA." coming from the DEA and I saw how to listen to the voice instruction.
the DOWNLOAD button was blinking and The disposable electrodes have come off the patient.
The connector of the disposable electrodes got disconnected from the AED.
it stopped blinking next. The DEA considered that a discharge was not necessary.
Why did it stop blinking?
47
References
P What should I do if the battery is R The first time you hear 'Low battery', you will still be able to supply.
about to download and I am up to nine defibrillation shocks.
using the DEA? Prepare a new battery pack before the existing pack.
download completely and replace the package with a new one.
P The DEA does not turn on afterwards. R Perform CPR immediately. Use another AED.
to open the lid. What should I do?
P The DEA unexpectedly shut down. R Perform CPR immediately. Use another AED.
during resuscitation. What should I
to do?
P Can I open the lid when I am not there? R Yes. You can open the lid for the monthly inspection.
using DEA? p. 29 “Pmonthly inspection procedure
P How can I find out if there is any left? R The battery will be about to run out when the status indicator of
low battery? the battery located at the far left is illuminated in red or the
the second indicator on the left is green. After seeing the first
red indicator, it will still be able to provide approximately nine charges
of defibrillation.
p. 28 “About the indicators on the diagnostic panel
P Can I turn the volume up or down? R Yes. You can adjust the volume of the voice instructions with the visualizer.
from the voice instructions? optional defibrillation reports. Please refer to the user manual of
defibrillator report viewer software.
48
Terminology
DEA Cardiopulmonary resuscitation (CPR)
Automated external defibrillator The chest compressions and the artificial breathing performed
to the patient with cardiac arrest to ensure circulation
RCP from the blood and breathing. If the patient does not respond or breathe,
Cardiopulmonary resuscitation. Automatically start CPR. It is important to continue CPR.
Consult 'Cardiopulmonary Resuscitation'. without stopping all the time that is possible.
49
References
Symbols
The following are the names and meanings of the symbols of the AED, the battery, and the disposable electrodes.
Service indicator
50
Battery Disposable electrodes
Symbol Description Symbol Description
Batch number
Avoid strong impacts or falls.
circular band The CE mark is a protected conformity mark.
crossed out: red
from the European Union. Products with this symbol
they meet the requirements of Directive 93/42/EEC
Do not dismantle or alter in any case. relating to medical devices.
Circular band
tachada: roja Non-sterile
Do not recharge.
Circular band
deleted: red
Manufacturer
Batch number
51
References
Specifications
Defibrillator
Operation: Semiautomatic (download is recommended)
Audible alerts: Voice alert, charge alert, maintenance alert
Indicadores visibles: Status indicator, battery status indicator, service indicator, check indicator
electrodos, indicador de sustitución de electrodos, indicador del botón de descarga, indicador del modo infantil
Internal memory: Up to 3 records, ECG of up to 30 minutes with annotations for one record
Dimensions and weight: 97 × 206 × 252 mm (height × width × length), 2.3 kg (with disposable electrodes and battery included)
Environment Operating and installation conditions
Temperatura: From -5 to +50 °C (from 23 to 122 °F)
Humedad: From 5 to 95% (without condensation)
Atmospheric pressure: From 540 to 1060 hPa
Shipping, transport, and storage conditions
Temperatura: From −20 to +70 °C (from −4 to +158 °F)
Humedad: From 5 to 95%.
Presión atmosférica: De 540 a 1060 hPa
If the DEA is stored at the maximum limit temperature (70 °C [158 °F] or at the minimum (−20 °C [−4 °F])
of the storage conditions and is moved to an environment at about 20 °C (68 °F), it may be necessary
It will take up to an hour and a half to function at the specified performance.
Clock precision The ambient temperature from 0 to +50 °C (from 32 to 122 °F): ±6 s/month
The ambient temperature of −20 to +70 °C (from −4 to +158 °F): ±10 s/month
Disposable electrodes: IEC 60601-2-4: 2010
Adhesive disposable electrodes
Battery Battery type: Lithium and manganese dioxide battery
Nominal voltage: 15.0 V
Nominal capacity: 3300 mAh
Non-rechargeable
Lithium content: 6.40 g (max.) (When transporting the battery by air or sea, it must be treated as
Class 9 dangerous material.
Battery life of the AED in standby mode:
4 years (with the battery and disposable electrodes connected to the AED and its lid closed).
Deadline for its installation:
2 years from the date of manufacture
Expiration date: 6 years from the date of manufacture
52
Loading times: Up to 8 seconds (With the battery fully charged, at a temperature of 20 °C)
[68 °F]) from the beginning of the analysis to the moment it is ready to download 200 J
of energy)
Up to 10 seconds (with a battery that has undergone 15 discharges at a)
temperature of 20 °C [68 °F]. From the beginning of the analysis until the moment when it
you can download 200 J).
Up to 20 seconds (with a battery that has undergone 15 discharges at a)
temperature of 20 °C [68 °F]. From the connection of the AED until the moment when
it is possible to download 200 J).
Self-check Diaria: Battery, disposable electrodes, internal electronic components, discharge button, software
Monthly: Charged battery, disposable electrodes, internal electronic components, charging cycle
full energy, download button and software
Communication Communication method: Bluetooth standard, version 2.1+EDR
Carrier frequency: 2,400 to 2,4835 GHz
Potencia de salida de RF máxima:
4 dBm (class 2 power)
Communication distance: 10 m maximum without any kind of obstacle
Regulation: Japan's Radiation Law: Low Data Communication System
energy and 2.4 GHz bandwidth
EN 60950-1: 2006
EN 60950-1: 2006/AC: 2011: 2011.11
EN 60950-1/A11: 2009.3
EN 60950-1/A1: 2010.3
EN 60950-1/A12: 2011.2
EN 50371: 2002.3
EN 301 489-1 V1.9.2: 2011.9
EN 301 489-17 V2.2.1: 2012.9
EN 300 328 V1.8.1: 2012.6
EN 62479: 2010.9
FCC, Section 15
Useful life 8 years, with Nihon Kohden authentication based on internal data
Security
Type of protection against electric shocks
INTERNALLY POWERED EQUIPMENT (battery)
Level of protection against electric shocks
BF type defibrillation proof applied part: Disposable electrodes
Protection against harmful access of water or solid particles
IP55
IPx5: When the DEA is placed level on the ground with the lid open and the electrodes connected.
IP5x: When the DEA is positioned level on the ground with the cover open and the electrodes connected, thus
like when it is placed upright on the ground with the lid closed and the electrodes connected.
Resistance (classification under standard IEC 60601-2-4: 2010)
FREQUENT USE
53
References
Disinfection or sterilization method
Equipment not suitable for sterilization.
Suitability for use in a HIGH OXYGEN CONCENTRATION ENVIRONMENT
Equipment not suitable for use in a HIGH OXYGEN CONCENTRATION ENVIRONMENT
Application security level in the presence of a flammable anesthetic mixture with air, or with oxygen
Nitrous Oxide
The EQUIPMENT cannot be used in the presence of an INFLAMMABLE ANESTHETIC MIXTURE WITH AIR.
OR WELL WITH OXYGEN OR NITROUS OXIDE
Mode of operation CONTINUOUS OPERATION
Type of ELECTROMEDICAL EQUIPMENT
PORTABLE EQUIPMENT
Safety regulations IEC 60601-1: 2005 + Amendment 1: 2012
IEC 60601-2-4: 2010
IEC 60601-1-6: 2010 + Amendment 1: 2013
IEC 60601-1-9: 2007 + Amendment 1: 2013
IEC 60601-1-11: 2010
IEC 60601-1-12: 2014
IEC 62304: 2006
ISO 14971: 2007
EN ISO 14971: 2012
EN 1789: 2007 + Amendment 1: 2010
Electromagnetic compatibility (EMC)
IEC 60601-1-2: 2007
IEC 60601-2-4: 2010
Emissions CISPR 11, group 1, class B
Immunity IEC 61000-4-3: 2006 + Amendment 1: 2007 + Amendment 2: 2010
IEC 60601-2-4: 2010 [Link]
Magnetic IEC 61000-4-8: 2009
IEC 60601-2-4: 2010 [Link]
3 A/m (50 Hz, 60 Hz)
ESD IEC 61000-4-2: 2008
IEC 60601-2-4: 2010 [Link]
Contact discharge: 2 kV, 4 kV, 6 kV
Interturn voltage: 2 kV, 4 kV, 8 kV
Conductive RF IEC 61000-4-6: 2008
IEC 60601-2-4: 2010 [Link]
54
Immunity/electromagnetic emissions
The essential yields of the AED-3100 in the CEM standard meet the following criteria.
El desfibrilador AED-3100 está diseñado para utilizarse en los siguientes entornos electromagnéticos.
The client or user of the AED-3100 must ensure that its use is carried out in such environments.
Electromagnetic emissions
The AED-3100 is designed to be used in the following electromagnetic environments. The customer or user of the AED-3100 must
to ensure that its use is carried out in such environments.
Test
Compliance Electromagnetic environment: Guide
of emissions
The AED-3100 uses RF energy only for its internal operation. Therefore, its
RF emissions
Group 1 RF emissions are very low and are unlikely to cause interference with equipment.
CISPR 11
nearby electronics.
RF emissions
Class B
CISPR 11
Harmonic emissions
Not applicable The AED-3100 can be used in all establishments, including those
IEC 61000-3-2
domestic and those that connect directly to the low public power supply network
Fluctuations tension that supplies energy to buildings for domestic purposes.
of voltage/emissions
Not applicable
from flicker
IEC 61000-3-3
55
References
Electromagnetic immunity
The AED-3100 is designed for use in the following electromagnetic environments. The customer or user of the AED-3100 must
ensure that its use is carried out in such environments.
Level of
Immunity test IEC 60601 test level Electromagnetic environment: Guide
compliance
Electrostatic discharge ±6 kV by contact ±6 kV by contact The floors must be made of wood, concrete or tiles-
(ESD) ±8 kV through air ±8 kV through air ceramic pots. If the floors are covered with
IEC 61000-4-2 synthetic material, the relative humidity should be
at least 30%.
Fast electric pulses ±2 kV for lines of Not applicable
IEC 61000-4-4 power supply
–
±1 kV for circuits of Not applicable*
input/output
Source +1 kV differential mode Not applicable
–
IEC 61000-4-5 ±2 kV common mode
Tension gaps, < 5 %Ut Not applicable
brief interruptions (gap of > 95% in Ut)
and variations in tension during 0.5 cycles
in input lines
40 %Ut
power supply
(60% gap in Ut)
IEC 61000-4-11
for 5 cycles
–
70 %Ut
(30% gap in Ut)
for 25 cycles
< 5 %Ut
(gap of > 95% in Ut)
for 5 seconds
Power frequency 3 A/m 3 A/m The magnetic fields of power frequency
(50/60 Hz) field they must be at certain characteristic levels
magnetic from a usual location in a commercial environment
IEC 61000-4-8 a typical hospital.
NOTE: Remove the AC mains supply tension before applying the test level.
The instrument does not have a cable longer than 3 m.
56
Electromagnetic immunity (1/2)
The AED-3100 is designed to be used in the following electromagnetic environments. The customer or user of the AED-3100 must
ensure that its use takes place in such environments.
Test of IEC 60601 Level of
Electromagnetic environment: Guide
immunity test level compliance
The mobile and portable RF communication equipment should not be used.
near nowhere of the AED-3100, including the cables, with a
recommended separation distance calculated from the equation
Requirement applicable to the frequency of the transmitter.
Conducted RF additional of
IEC 61000-4-6 IEC-60601-2-4: Recommended separation distance
3 Vrms 3 Vrms d = 1.2 P
150 kHz to 80 MHz
out of the bands
ISMa
NOTE 1: At 80 MHz and 800 MHz, the upper frequency range will be applied.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
the absorption and reflection of structures, objects, and people.
The ISM bands (industrial, scientific, and medical) between 150 kHz and 80 MHz are from 6.765 MHz to 6.795 MHz; from 13.553 MHz
from 13.567 MHz; from 26.957 MHz to 27.283 MHz; and from 40.66 MHz to 40.70 MHz.
The levels of compliance in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range of 80 MHz
The 2.5 GHz are designed to reduce the possibility that mobile/portable communication devices cause interference.
if they are accidentally placed in the patient's areas. For this reason, an additional factor of 10/3 is used for the calculation of
the recommended separation distance for transmitters in these frequency ranges.
The field intensities of fixed transmitters, such as base stations for radiotelephones (mobile/wireless) and mobile radios
From the ground, amateur radio, AM and FM broadcast transmission, and TV broadcasting cannot be predicted theoretically with precision.
To assess the electromagnetic environment produced by fixed radio frequency transmitters, the realization should be considered.
from an electromagnetic study of the site. If the field intensity measured at the location where the AED-3100 is used
to exceed the applicable RF compliance level, it is necessary to check the AED-3100 to verify its proper functioning.
If abnormal functioning is observed, it will be necessary to take additional measures, such as, for example, reorientation or relocation.
of the AED-3100.
d: Over the frequency range of 150 kHz to 80 MHz, the field strengths must be below 3 V/m.
57
References
Electromagnetic immunity (2/2)
The AED-3100 is designed for use in the following electromagnetic environments. The customer or user of the AED-3100 must ensure
that its use takes place in these environments.
Test of IEC 60601 Level of Electromagnetic Environment: Guide
immunity nivel de prueba cumplimiento
The mobile and portable RF communication equipment should not be used near any
part of the AED-3100, including the cables, with a recommended separation distance
data calculated from the equation applicable to the transmitter's frequency.
Correct works
RRD lie: Correct operation of RRD:
10 V/m 10 V/m d = 1.2 P from 80 to 800 MHz
80 MHz to 2.5 GHz d = 2.3 P from 800 MHz to 2.5 GHz
No one is allowed.
in energy emission
involuntary No involuntary energy emission is allowed.
20 V/m 20 V/m d = 0.6 P from 80 to 800 MHz
80 MHz to 2.5 GHz d = 1.2 P from 800 MHz to 2.5 GHz
where P is the maximum output power classification of the transmitter in watts (W)
according to the manufacturer of the transmitter and d is the separation distance
recommended in meters (m). b
Intensity of fixed RF transmitter fields, determined according to an examination
Electromagnetic placement must be below c
the compliance level.
in each frequency interval. d
NOTE 1: At 80 MHz and 800 MHz, the upper frequency range will be applied.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection.
of structures, objects, and people.
The ISM (industrial, scientific, and medical) bands between 150 kHz and 80 MHz are from 6.765 MHz to 6.795 MHz; from 13.553 MHz to 13.567 MHz;
from 26.957 MHz to 27.283 MHz; and from 40.66 MHz to 40.70 MHz.
The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range from 80 MHz to 2.5 GHz are designed for
decrease the likelihood that mobile/portable communication devices cause interference if placed in patient areas in a way
accidental. For this reason, an additional factor of 10/3 is used for calculating the recommended separation distance for transmitters in these
frequency intervals.
c: The field intensities of fixed transmitters, such as base stations for radiophones (mobile/wireless) and ground mobile radios, amateur radio,
AMandFMbroadcasting,[Link]
fixed radio frequency transmitters, an electromagnetic study of the location should be considered. If the field intensity measured at the site...
the moment in which theAED-3100 is used exceeds the applicable RF compliance level, it is necessary to check theAED-3100 to verify its proper functioning
[Link],itwillbenecessarytotakeadditionalmeasures,suchas,forexample,thereorientationorrelocationoftheAED-3100.
On the frequency range from 150 kHz to 80 MHz, the field intensities must be below 3 V/m.
• RRD is the abbreviation for rhythm recognition detector.
58
Recommended separation distances between radio frequency communication equipment
laptops and mobiles and the AED-3100 device
The AED-3100 is designed for use in an electromagnetic environment where radiated RF disturbances are controlled.
The client or user of the AED-3100 can help prevent electromagnetic interference by maintaining distance.
minimum between the portable and mobile RF communications equipment (transmitters) and the AED-3100, as recommended below
and according to the maximum output power of the communications equipment.
Separation distance according to the transmitter frequency (m)
Output power
From 150 kHz to 80 MHz Between 150 kHz and 80 MHz
calculated maximum From 80 MHz to 800 MHz From 800 MHz to 2.5 GHz
of the transmitter
outside ISM bands in the ISM bands
d = 1,2 P d = 2.3 P
(W) d = 1.2 P d = 1.2 P
NOTE 1: At 80 MHz and 800 MHz, the separation distance of the upper frequency range applies.
NOTE 2: The ISM bands (industrial, scientific, and medical) between 150 kHz and 80 MHz are between 6.765 MHz and 6.795 MHz;
between 13.553 MHz and 13.567 MHz; between 26.957 MHz and 27.283 MHz; and between 40.66 MHz and 40.70 MHz.
NOTE 3: An additional factor of 10/3 is used to calculate the recommended separation distance for transmitters in the bands
of ISM frequency between 150 kHz and 80 MHz and in the frequency range between 80 MHz and 2.5 GHz in order to reduce
the possibility that the mobile/portable communications device may cause interference if placed inadvertently in the areas
of the patient.
NOTE 4: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
the absorption and reflection of structures, objects, and people.
59
References
Mechanical force
Vibration MIL-STD-810G 514.6 (VIBRATION), category 4 (Safe Load)
Duración de exposición X: 20 hY:20 h Z: 20 h
MIL-STD-810G 514.6 (VIBRATION), category 9 (helicopter)
Duración de exposición X: 10 hY:10 h Z: 10 h
IEC 60601-1-11: 2010
IEC 60601-1-12: 2014
EN 1789: 2007 + Amendment 1: 2010
Download IEC 60068-2-27: 2008, peak shock value: 50 G
IEC 60601-1-11: 2010
IEC 60601-1-12: 2014
EN 1789: 2007 + Amendment 1: 2010
Fall MIL-STD-810G 516.6 (DROP), procedure 4, transit drop: 1.22 m
IEC 60601-1-11: 2010
IEC 60601-1-12: 2014
EN 1789: 2007 + Amendment 1: 2010
Wave
60
Energy released: 150 J
Energy released: 70 J
61
References
Energy released: 50 J
62
Ondas de salida: 200 J/25, 50, 75, 100, 125, 150, 175 Ω
60 60
25 50
40 40
20 20
0 0
-20 -20
0 2 4 6 8 10 12 14 16 18 20 22 24 0 2 4 6 8 10 12 14 16 18 20 22 24
Time (ms) Time (ms)
60 30
75 100
40 20
20 10
0 0
-20 -10
0 2 4 6 8 10 12 14 16 18 20 22 24 0 2 4 6 8 10 12 14 16 18 20 22 24
Tiempo (ms) Time (ms)
30 30
125 150
20 20
10 10
0 0
-10 -10
0 2 4 6 8 10 12 14 16 18 20 22 24 0 2 4 6 8 10 12 14 16 18 20 22 24
Time (ms) Time (ms)
30
175
20
10
-10
0 2 4 6 8 10 12 14 16 18 20 22 24
Time (ms)
Discharged energy (this setting can be modified with the optional software of the defibrillator report viewer)
Modo adulto: primera vez, 150 J; segunda vez, 200 J; tercera vez: 200 J
Modo infantil: primera vez, 50 J; segunda vez, 70 J; tercera vez: 70 J
Energy accuracy: ±10% (at 50 Ω impedance)
63
References
Declaration of CE compliance
Hereby, Nihon Kohden, declares that this AED-3100 automated external defibrillator is in compliance with the essential requirements
and other relevant provisions of Directive 1999/5/EC.
Nihon Kohden hereby certifies that the AED-3100 automated external defibrillator type device is in compliance with the essential requirements of Directive 1999/5/EC.
in accordance with the requirements and other conditions of the directive.
Hereby, Nihon Kohden declares that the device AED-3100 automated external defibrillator complies with the essential
iron and the other relevant provisions of Directive 1999/5/EC
Hereby Nihon Kohden declares that this AED-3100 automated external defibrillator meets the essential requirements and other
relevant provisions of Directive 1999/5/EC.
Hereby, Nihon Kohden declares that the AED-3100 automated external defibrillator complies with the essential requirements and
other relevant provisions of Directive 1999/5/EC
Hereby, Nihon Kohden declares that this AED-3100 automated external defibrillator complies with the essential requirements.
and to the other provisions of Directive 1999/5/EC that are applicable to it
Hereby, Nihon Kohden certifies that this AED-3100 automated external defibrillator complies with the essential
requirements and other relevant provisions as set out in Directive 1999/5/EC.
The undersigned Nihon Kohden hereby declares that the following equipment AED-3100 automated external defibrillator complies with the essential
requirements and other relevant requirements in Directive 1999/5/EC
Nihon Kohden hereby declares that this AED-3100 automated external defibrillator is in accordance with
meets the basic requirements and other relevant provisions of Directive 1999/5/EC. (BMWi)
Hereby, Nihon Kohden declares the conformity of the device AED-3100 automated external defibrillator with the fundamental
Requirements and other relevant provisions of Directive 1999/5/EC. (Vienna)
WITH THIS Nihon Kohden DECLARES THAT AED-3100 automated external defibrillator COMPLIES WITH
ESSENTIAL REQUIREMENTS AND OTHER RELEVANT PROVISIONS OF DIRECTIVE 1999/5/EC
With this, Nihon Kohden declares that this AED-3100 automated external defibrillator complies with the essential requirements and
all other relevant provisions established by directive 1999/5/EC.
Hereby, Nihon Kohden declares that the automated external defibrillator AED-3100 meets the essential requirements and
any other applicable or enforceable provisions of Directive 1999/5/EC
Nihon Kohden declares that this AED-3100 automated external defibrillator complies with the essential requirements and others.
provisions of Directive 1999/5/EC.
Nihon Kohden hereby declares that the AED-3100 automated external defibrillator meets the basic requirements and other relevant
provisions of Directive 1999/5/EC.
With this, Nihon Kohden confirms that the AED-3100 automated external defibrillator meets the essential requirements of Directive 1999/5/EC.
and other relevant regulations.
With this, Nihon Kohden confirms that the AED-3100 automated external defibrillator complies with the essential requirements of Directive 1999/5/EC.
one with its conditions.
Hereby, Nihon Kohden states that this AED-3100 automated external defibrillator complies with the essential requirements of Directive 1999/5/EC.
requirements and other important provisions.
64
The undersigned, Nihon Kohden, declares that the current AED-3100 automated external defibrillator complies with Directive 1999/5/EC.
specific fundamental requirements and other relevant regulations.
Here, Nihon Kohden declares that the AED-3100 automated external defibrillator meets essential needs and provisions
other relevant aspects of Directive 1995/5/EC.
Nihon Kohden hereby declares that the AED-3100 automated external defibrillator meets the fundamental requirements and other significant
provisions of Directive 1999/5/EC.
With this, Nihon Kohden declares that this AED-3100 automated external defibrillator complies with the basic requirements and other relevant
Directive 1999/5/EC.
Nihon Kohden hereby declares that the AED-3100 automated external defibrillator meets the basic requirements and other relevant
provisions of Directive 1999/5/EC.
With this document, Nihon Kohden declares that the AED-3100 automated external defibrillator complies with the essential requirements.
and the corresponding regulations of Directive 1999/5/EC.
Hereby, Nihon Kohden declares that this AED-3100 automated external defibrillator complies with the main requirements and with
the other relevant provisions of Directive 1999/5/EC.
By this document, Nihon Kohden certifies that this AED-3100 automated external defibrillator meets the essential requirements of Directive 1999/5/EC and other
that it complies with the conditions
65
References
Specifications (continuation from the previous page)
Analysis accuracy
The validation has been carried out using data from the official AHA (American Heart Association) database.
official data from MIT (Massachusetts Institute of Technology) and medical facilities in Japan.
The following analysis accuracy is guaranteed when the ECG contains pacemaker pulses with lower amplitudes.
at 2 mV and a width of less than 1.3 ms.
66
Timely defibrillation download and survival rate
As shown in the graph, the probability of a successful rescue decreases by 7 to 10 % every minute. If defibrillation
it occurs during the first minute after the heart attack, 90% of patients survive. The probability of
survival decreases to 50% after 5 minutes; to 30%, 7 minutes later; to 10%, after 9-10 minutes; and to 2-5%,
after 12 minutes or more.
(Guideline of the American Heart Association: 2000) Tasa de éxito* (%)
67
References
Consumables and optional components
Please contact your Nihon Kohden representative if you would like to obtain more accessories.
Model
Consumables
Battery Disposable electrodes
[SB-310V] [P-740K]
Optional elements
DEA Box Visualization software Transport bag Assembly kit
[YZ-042H8] of defibrillation reports [YC-310V] on the DEA wall
[QP-551VK] [KG-202V]
DEA/Resuscitation Kit
of CPR
[YZ-043H3]
68
List of inspections AED-3100
Daily inspection Note: Make several copies of this sheet for use.
Contact details confirmed as of January 2015. Visit [Link] for more recent information.
The model and serial number of your device are indicated on the back or bottom of the unit.
Please write the model and serial number in the spaces provided for this purpose.
Remember to mention this information whenever you contact your representative regarding this equipment.
with the aim of providing a more agile and better service.
Your representative
AED-3100_0616-904160
Cardiolife
AED-3100
Manufacturer
NIHON KOHDEN CORPORATION
1-31-4 Nishiochiai, Shinjuku-ku Tokyo 161-8560, Japan
Phone+813-5996-8036
Fax+813-5996-8100