Bexen cardio REANIBEX 100 User manual

AED Defibrillator
REANIBEX 100
USER MANUAL
DJH 0100 B –REV: C / 2022.JAN

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REANIBEX 100
USER GUIDE
Review
Date
Approved by
Signature
C
January 2022
Digna González
R&D Manager

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The REANIBEX 100 complies with the requirements of the Medical Device Directive 93/42/EEC
and carries the mark accordingly.
Revision C
January 2022
All rights are reserved for this publication.
This manual may not be totally or partially reproduced, in any way or by any
means, without prior written authorization from of Bexen cardio.
The information contained in this manual may be modified by the manufacturer
without requiring prior notice. If the information in this User Guide does not
correspond to the operation of the device, please contact an authorised
representative of Bexen cardio.
REANIBEX 100
This is a product of:
Bexen cardio
OSATU S.Coop
Edificio Zearrekobuelta
Subida de Areitio Nº 5
48260 Ermua (Bizkaia) –SPAIN
Tel.: [phone]
Fax: [phone]
E-mail: [e-mail]
www.bexencardio.com

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DJH 0100 B –USER GUIDE REANIBEX 100 i
TABLE OF CONTENTS
1INTRODUCTION ................................................................................................................................. 3
1.1 OVERVIEW................................................................................................................................. 3
1.2 INTENDED USE.......................................................................................................................... 3
1.3 SAFETY CONSIDERATIONS..................................................................................................... 4
1.4 ADDITIONAL INFORMATION REQUEST.................................................................................. 8
2DESCRIPTION OF THE EQUIPMENT ............................................................................................... 9
2.1 BASIC ORIENTATION................................................................................................................ 9
2.1.1 INDICATORS AND CONTROLS.......................................................................................... 9
2.1.2 CONNECTORS.................................................................................................................. 10
2.2 BATTERIES .............................................................................................................................. 11
2.2.1 BATTERY DURATION ....................................................................................................... 12
2.3 PADS......................................................................................................................................... 13
3INSTALLATION OF THE EQUIPMENT............................................................................................ 14
3.1 CONNECTING THE PADS....................................................................................................... 14
3.2 INSTALLING THE BATTERY ................................................................................................... 15
4AUTOMATIC EXTERNAL DEFIBRILLATION.................................................................................. 17
4.1 INTENDED USE........................................................................................................................ 17
4.2 WARNINGS AND PRECAUTIONS........................................................................................... 17
4.3 PREPARING FOR AUTOMATIC EXTERNAL DEFIBRILLATION............................................ 18
4.4 AUTOMATIC EXTERNAL DEFIBRILLATION PROCEDURE .................................................. 20
4.5 TROUBLESHOOTING.............................................................................................................. 21
5CONFIGURATION ............................................................................................................................ 22
5.1 ACCESSORIES TO CONFIGURE THE DEVICE..................................................................... 22
5.2 CONFIGURABLE PARAMETERS............................................................................................ 22
5.2.1 AED CONFIGURATION..................................................................................................... 22
5.3 TESTS....................................................................................................................................... 23
5.3.1 TEST MODE....................................................................................................................... 23
5.3.2 SELF- TESTS..................................................................................................................... 24
6DATA MANAGEMENT...................................................................................................................... 26
6.1 DESCRIPTION.......................................................................................................................... 26
6.2 STORED EVENTS.................................................................................................................... 26
7MAINTENANCE ................................................................................................................................ 27
7.1 OVERVIEW............................................................................................................................... 27
7.2 MAINTENANCE ROUTINE....................................................................................................... 27
7.2.1 CHECK LIST....................................................................................................................... 27
7.3 CLEANING INSTRUCTIONS.................................................................................................... 28
7.4 STORAGE................................................................................................................................. 29
7.5 BATTERY MAINTENANCE ...................................................................................................... 29
7.6 SERVICE AND REPAIR ........................................................................................................... 30
7.7 PRODUCT RECYCLING INFORMATION................................................................................ 31
7.8 WARRANTY.............................................................................................................................. 31
7.9 ACCESSORIES, CONSUMABLES AND COMPLEMENTARY TOOLS................................... 31

DJH 0100 B –USER GUIDE REANIBEX 100 ii
TABLE OF CONTENTS
8TROUBLESHOOTING ...................................................................................................................... 32
8.1 GENERAL PROBLEMS............................................................................................................ 32
8.2 AUTOMATIC DEFIBRILLATION PROBLEMS.......................................................................... 33
A.1 SYMBOLS..................................................................................................................................... 35
A.2 MESSAGES .................................................................................................................................. 37
A.3 SPECIFICATIONS AND CHARACTERISTICS........................................................................... 40
A.4 DEFIBRILLATION WAVE............................................................................................................ 43
A.5 RHYTHM DETECTION SYSTEM ................................................................................................ 44
A.6 ELECTROMAGNETIC COMPATIBILITY GUIDE ....................................................................... 45
A.7 CONNECTIVITY GUIDE .............................................................................................................. 48
A.8 CYBERSECURITY....................................................................................................................... 55
A.9 ACCESSORIES, CONSUMABLES AND COMPLEMENTARY TOOLS .................................... 63

DJH 0100 B –USER GUIDE REANIBEX 100 i
TABLE OF FIGURES
Figures
Figure 1: Front View with the cover opened................................................................................................. 9
Figure 2: Front View with the cover closed ................................................................................................ 10
Figure 3: Pads and USB connectors selectable by a sliding lid................................................................. 11
Figure 4: Therapy cable connection........................................................................................................... 15
Figure 5: Battery installation....................................................................................................................... 16
Figure 6: Placing the pads.......................................................................................................................... 19
Figure 7: Defibrillation wave....................................................................................................................... 43

DJH 0100 B –USER GUIDE REANIBEX 100 ii
TABLE OF FIGURES
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DJH 0100 B –USER GUIDE REANIBEX 100 3
1 INTRODUCTION
1 INTRODUCTION
The REANIBEX 100 is a public access defibrillator intended to be used in adult or paediatric cardiac
arrest patients who are unconscious, not breathing and not presenting signs of circulation (for example,
coughing or movement).
This guide contains the instructions necessary for the safe and appropriate use of the equipment, as well
as information on its configuration and maintenance. The guide includes the information and procedures
for all the features of the REANIBEX 100. The device you have purchased may not have all the features
contained in this manual.
WARNING
Accessories of the REANIBEX 100 are not interchangeable with the accessories used in other
REANIBEX equipment.
1.1 OVERVIEW
When connected to a patient, the REANIBEX 100 automatically analyses the patient’s electrocardiogram
(ECG) and decides whether delivering an electrical shock is necessary or not. If an electrical shock is
recommended, the device will automatically charge the required energy. Depending on the version of the
equipment (semi or fully automatic), pressing a button may be required to provide the defibrillation. The
device will guide the user through the episode by providing voice messages.
The REANIBEX 100 operates with disposable LiMnO2batteries.
The REANIBEX 100 has an internal memory that stores the data acquired during the intervention,
including patient ECG signals and relevant events. In addition to these data, the equipment stores the last
50 tests performed at the request of the user or during a Self Test.
In addition to the patient-related operating mode described above, the REANIBEX 100 has a special
switch-on function that accesses the Test mode. This mode can be used to obtain information regarding
the status of the device.
The REANIBEX 100 performs a series of Self Tests to detect any failures or anomalous conditions in the
equipment that may compromise safe operation. Errors are indicated by voice messages.
These tests are performed when the device is switched on and during operation. Additionally, the
REANIBEX 100 performs the following Self Tests:
Daily Self Test; this test is performed every day.
Monthly Self Test; this verification is carried out once a month and includes the daily Self Test.
1.2 INTENDED USE
The REANIBEX 100 is intended for use by laypeople with a minimal knowledge and training in
cardiopulmonary resuscitation (CPR) and basic life support who know how to use the REANIBEX 100
Automatic external defibrillator (AED) or that has been authorized by a competent body . It is also

DJH 0100 B –USER GUIDE REANIBEX 100 4
1 INTRODUCTION
intended to be used by medical personnel that may have training in basic life support or advanced life
support.
The REANIBEX 100 is intended for use in hospital and out-of-hospital environments that meet the
environmental conditions described in this guide.
When considering location, avoid areas that expose the REANIBEX 100 to moisture, dust, or extreme
temperatures. Long-term storage at the high temperatures may reduce the life of the pads.
If the REANIBEX 100 has wireless capability, it should be placed in a location that has adequate signal
strength.
The device is intended to be used in both adult and paediatric patients, as long as the appropriate
operating mode is selected. The device will adjust the energy levels, metronome characteristics and all
the necessary patient parameters according to the type of patient selected: adult or paediatric.
For further information on the intended use of the device, indications for use and contraindications of the
treatment function please refer to the corresponding sections in this guide that explain these functions.
WARNING
The REANIBEX 100 must be used on a single patient at a time.
1.3 SAFETY CONSIDERATIONS
DANGER
EXPLOSION HAZARD. Possible explosion hazard if the REANIBEX 100 is used in the presence of
mixtures with concentrations of oxygen over 25% or flammable anaesthetic products.
WARNING
Incorrect use of the equipment may cause injury. Follow the instructions in the User Guide for correct
use.
WARNING
Avoid touching the pads when these are placed on the patient, as this may affect safety and results.
WARNING
Prevent conductive parts of pads and connectors associated with applied parts, from coming into
contact with other conductive parts, including the earth.
WARNING
SHOCK OR FIRE HAZARD. The defibrillator can deliver up to 200 Joules of energy. If the equipment is
not used correctly, as described in these instructions for use, this energy may cause severe injuries or
death. Ensure that you are familiar with how to use the equipment before using it.
WARNING
SHOCK OR FIRE HAZARD. Do not disassemble the defibrillator. This equipment contains dangerous

DJH 0100 B –USER GUIDE REANIBEX 100 5
1 INTRODUCTION
high voltage. For repairs, please contact authorised technical service staff.
WARNING
SHOCK OR FIRE HAZARD
• Never use the REANIBEX 100 over stagnant water. Do not submerge the equipment or any part of it
in water or any other liquid. Do not spill liquid on the equipment or any of its accessories. If the
equipment gets wet, dry it with a towel.
• Do not clean the equipment with flammable agents such as acetones.
• Do not sterilise the equipment in an autoclave or by any other means.
WARNING
DANGEROUS ELECTRIC SHOCK HAZARD
• The defibrillator may deliver up to 200 Joules of energy during discharge. When the electricity is being
discharged, do not touch the patient or the defibrillation pads.
•During defibrillation, prevent patient body parts (uncovered skin of the head and limbs) from coming
into contact with conductive liquid such as gel, blood or serum and/or metal objects such as the
stretcher, which may give rise to undesirable pathways for the defibrillation current.
•Ensure that no one touches the patient, the bed or any conductive material in contact with the patient
during defibrillation. The defibrillation current may be partially discharged through the person, causing
injury to the user and people near the unit.
WARNING
•The air cavities formed between the defibrillation pads and the skin of the patient can cause burns
during defibrillation. Ensure that the defibrillation pads are perfectly adhered to the patient’s skin. Once
adhered, if the position of the pads needs to be changed, remove the pads and replace them with new
ones.
•Do not allow the defibrillation pads to touch each other or to touch any conducting material during
defibrillation. This contact can generate an electrical arc and cause burns on the patient’s skin, which
could, in turn, divert the current away from the heart.
WARNING
•Carefully follow the instructions indicated on the labels of the defibrillation pads.
•The defibrillation pads must be used before the expiry date indicated on their labels. If the pads are
dried out or damaged, they can generate electrical arcs and burns during their use.
•Do not open the defibrillation pad packaging until just prior to use.
•Do not reuse the defibrillation pads. Dispose of all defibrillation pads after use.
WARNING
A delay in delivering the shock can involve a spontaneous change from a rhythm analysed as
shockable to a rhythm that is not shockable, giving rise to inadequate shock delivery.
WARNING
POSSIBLE ELECTRICAL INTERFERENCE
•The presence of radio frequency (RF) sources near the REANIBEX 100 can cause incorrect operation
of the equipment. The electromagnetic compatibility of adjacent equipment must be verified before

DJH 0100 B –USER GUIDE REANIBEX 100 6
1 INTRODUCTION
using the REANIBEX 100.
•The use of cables, pads or accessories not specified in this manual for use with the REANIBEX 100
can cause an increase in emissions or lower immunity versus electromagnetic or radio interferences.
These interferences can affect operation of the defibrillator or of equipment in the immediate
surroundings.
•The REANIBEX 100 and its accessories may be sensitive to interferences from other sources of
emissions.
•The REANIBEX 100 must be installed and started up according to the information dealing with
Electromagnetic Compatibility (EMC) in Section “A.6 - Electromagnetic Compatibility Guide”.
CAUTION
POSSIBLE EQUIPMENT MALFUNCTION
•The use of pads or batteries from other manufacturers may affect proper operation of the equipment
and invalidate the safety certification. Use only the accessories specified in this User Manual.
•Using the REANIBEX 100 or its accessories in environmental conditions other than those specified
in this manual may affect proper operation of the equipment or the accessories. Before using the
REANIBEX 100, make sure the equipment is stabilised at the operating temperature range.
WARNING
POSSIBLE EQUIPMENT MALFUNCTION. Changing the configuration of the equipment from factory
default values will affect the operation of the equipment. Changes of the default configuration must be
performed only by authorised personnel.
CAUTION
POSSIBLE DAMAGE TO THE EQUIPMENT
•The equipment can be damaged by mechanical or physical maltreatment, such as immersion in water
or by dropping from a height of more than 0.1 m.
•The components of the equipment may be damaged if the unit is located near sources of vibration.
DANGER
FIRE OR ELECTRICAL SHOCK HAZARD: Make sure that the accessories and all the components are
properly connected. Components or accessories that are not properly connected can cause fire or
electrical shock.
WARNING
The REANIBEX 100 does not have the capacity to reject the pulses of internal pacemakers in all cases.
The equipment may detect pulses from internal pacemakers as QRS complexes and therefore the
shock advice algorithm may provide an incorrect shock/no-shock decision.
WARNING
The REANIBEX 100 has been designed for the treatment of cardiac arrest in adult and paediatric
patients. To apply the therapy, the correct patient type should be selected.
DANGER
HAZARD OF EXPLOSION. Do not attempt to open or handle the battery. Do not incinerate the battery.

DJH 0100 B –USER GUIDE REANIBEX 100 7
1 INTRODUCTION
Avoid electrical contact between the battery terminals.
WARNING
• Follow the local, regional or national regulations in your country for the disposal of worn batteries.
• Do not expose batteries to temperatures above 50 ºC for long periods of time as this reduces battery
life.
• Keep batteries away from flames and other heat sources.
•Do not use the batteries in environments with high humidity. Make sure that the batteries do not
get wet.
• Do not crush, strike, dent or deform the batteries.
WARNING
Place the disposable defibrillation pads as indicated in the pads packaging.
WARNING
To guarantee patient safety, do not place the REANIBEX 100 in a position from where it could fall on
the patient.
WARNING
Periodic checks should be performed to ensure that the REANIBEX 100 and its accessories are
operating properly. Follow the recommendations described in the MAINTENANCE section of this
manual.
WARNING
Do not remove the battery from the equipment while working with a patient, as this will switch off the
equipment.
WARNING
Keep the REANIBEX 100 and its accessories out of the reach of children and domestic animals.
WARNING
Keep the REANIBEX 100 away from sources of heat or flames.
WARNING
The temperature of some parts of the equipment, as well as the temperature of the applied parts
exceeded the limits indicated by the standard EN 60601-1 (43ºC). The contact time can exceed 10
minutes. During the tests, working at an ambient temperature of 50ºC, the measured maximum
temperature of the applied parts was 51.9ºC.
This is reasonable considering that the equipment can be used at an ambient temperature of up to
50°C, so the maximum temperature of the applied part must be extrapolated taking this value into
account. The damage caused to the patient due to the temperature of those applied part is not
considered serious.

DJH 0100 B –USER GUIDE REANIBEX 100 8
1 INTRODUCTION
1.4 ADDITIONAL INFORMATION REQUEST
Read this user manual carefully. If needed, contact Bexen cardio or a manufacturer’s authorized
distributor to obtain assistance in setting up, using or maintaining the REANIBEX 100, or to report
adverse events.

DJH 0100 B –USER GUIDE REANIBEX 100 9
2 DESCRIPTION OF THE EQUIPMENT
2 DESCRIPTION OF THE EQUIPMENT
This section provides general information on the use of the REANIBEX 100 and explains controls and
indicators.
Certain functionalities or options that are described in this section may not be included in your REANIBEX
100, depending on the configuration of the equipment.
2.1 BASIC ORIENTATION
This section provides basic guidelines regarding the REANIBEX 100 equipment, its controls, indicators
and connectors.
2.1.1 INDICATORS AND CONTROLS
The following illustrations show the front view of the equipment, showing the operating controls and
indicators:
Figure 1: Front View with the cover opened

DJH 0100 B –USER GUIDE REANIBEX 100 10
2 DESCRIPTION OF THE EQUIPMENT
STATUS
indicator LED
Figure 2: Front View with the cover closed
CONTROL
DESCRIPTION
ON/OFF BUTTON. The equipment is automatically switched on when the lid is
opened. Additionally, this button can be used to switch the equipment on and off.
When the equipment is on, this button is illuminated with a green LED.
PAEDIATRIC MODE BUTTON: This button is used to select the paediatric
mode. When the selected patient type is PAEDIATRIC, the button is illuminated
with a green LED. For patients under 8 years of age or weighing less than 25 kg
(55 lbs) the paediatric mode should be selected
SHOCK BUTTON. In semi-automatic mode, this button should be pressed to
deliver a defibrillation shock. This button flashes when the defibrillator is ready to
deliver the shock.
STATUS INDICATOR LED. In standby mode, this LED, visible through the
REANIBEX 100 cover, indicates the general status of the REANIBEX 100. When
the device is ready to be used with a patient, the LED will flash every 10
seconds. If any problem is detected, the status indicator LED will be off and
depending on the detected condition, a voice message or two beeps will be
issued periodically.
2.1.2 CONNECTORS
On the bottom left corner of the REANIBEX 100 device there are two connectors:
The pads connector, that is used to connect the defibrillation pads when the REANIBEX 100
device is used to treat a patient.

DJH 0100 B –USER GUIDE REANIBEX 100 11
2 DESCRIPTION OF THE EQUIPMENT
A USB-B connector that can be used to connect the REANIBEX 100 device to a PC to
interchange information with the REANIBEX USB SYNC application.
A sliding lid allows selecting which connector is available, depending on the desired operating mode. The
following illustration shows the connectors. Note how the sliding lid changes its position to give access to each
of the connectors. The sliding lid in the top position gives access to the defibrillation pads connector (left), while
the sliding lid in the bottom position gives access to the USB B connector
Figure 3: Pads and USB connectors selectable by a sliding lid.
2.2 BATTERIES
The REANIBEX 100 is battery-powered. When the battery is low, if the device is switched off the status
indicator LED will be off, and if the device is on a periodic voice message will be issued.
The auxiliary mobile application, REANIBEX NFC READER allows checking the battery capacity in
percentage. For that purpose, open the mobile application in a mobile phone, connect the mobile phone to the
REANIBEX 100 device through NFC and check the information regarding battery capacity in the Information
section.
If the battery is not installed in the equipment, the equipment cannot be switched on and the status
indicator LED will be off.
WARNING
Check the status indicator LED periodically and make sure the REANIBEX 100 device is always
connected to a sufficiently charged battery.

DJH 0100 B –USER GUIDE REANIBEX 100 12
2 DESCRIPTION OF THE EQUIPMENT
The REANIBEX 100 uses high-capacity batteries that require minimum maintenance. For further
information, please refer to Section “7.5 BATTERY MAINTENANCE”.
BATTERY CAPACITY
A new, fully charged LiMnO2 battery working at 20ºC delivers more than 300 shocks at 200 Joules and
more than 36 hours of ECG monitoring.
2.2.1 BATTERY DURATION
Battery life depends on how the battery is used and how frequently it is used. When used and maintained
correctly, the useful life of the battery is 5 years.
AUTO POWER-OFF
To optimize the use of the battery, the equipment will automatically power-off after 10 minutes in the
following conditions:
There is no patient connected, and
No button is pressed.
CAUTION
Only use batteries supplied by BEXEN CARDIO or its authorised distributors. Using another type of
battery may mean that the device does not operate correctly.
WARNING
Follow the local, regional or national regulations in your country to recycle the REANIBEX 100 batteries
or send them to BEXEN CARDIO.
WARNING
Storing batteries at temperatures over 30ºC significantly reduces battery life.
WARNING
EXPLOSION HAZARD
• Do not attempt to open or handle the battery.
• Do not incinerate the battery.
• Avoid electrical contact between the battery terminals.
• Do not attempt to recharge the batteries, they could explode.