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This manual may not be totally or partially reproduced, in any way or
by any means, without prior written authorisation from OSATU
S.Coop.
The information contained in this manual may be modified with no
need for prior notification by the manufacturer. If the information given
in this User Manual does not correspond to the operation of the unit,
please contact an authorised representative of OSATU S.Coop.
REANIBEX Serie 700
Thisisaproductof: OSATU S.Coop
Edificio Zearrekobuelta
Subida de Areitio Nº 5
48260 Ermua (Bizkaia) – SPAIN
Tel: +34 943 17 02 20
Fax: +34 943 17 02 27
e-mail: osatu@bexencardio.com
www.bexencardio.com
USER MANUAL DGH 700 B
USER MANUAL DGH 700 B
DECLARACIÓN DE CONFORMIDAD
DECLARATION OF CONFORMITY
Directiva del Consejo con la que se declara conformidad:
Council Directive to which conformity is declared:
Annex II, section 3 of CD 93/42/EEC concerning medical devices
Aplicación de las Normas / Application of the Standards:
The REANIBEX Serie 700 is a Monitor/Defibrillator system which provides advanced
functions for monitoring and acute cardiac care response using the four available modes of
operation: Monitor with pulse oximetry (SpO2) option, Manual Defibrillator, Semi-automatic
defibrillator (optional) and Transcutaneous External Pacemaker (optional). It is a portable and
lightweight device, designed with the latest groundbreaking technologies in the field of
defibrillation such as the state-of-the-art biphasic waveform.
The unit incorporates a wide screen that allows viewing, not only of the ECG signal, but also
the monitoring parameters for both the patient and the device, warning messages and user guide
messages.
In Monitor mode the REANIBEX Serie 700 can pick up the signal via the 4, 5 or 10 lead patient
cable, or via the adult or paediatric external reusable paddles or via the single-use multifunction
electrodes.
In the Manual Defibrillator mode, if the patient needs a defibrillation shock, this is easily
administered by following the three steps below:
1- Select the energy level
2- Charge
3- Shock
When operating in Semi-Automatic Defibrillator mode (optional) the REANIBEX Serie 700
analyzes the electrocardiogram (ECG) of the patient, and determines if the rhythm analyzed can
be defibrillated, in which case it requires a manoeuvre by the user to deliver the shock. During
the whole process, the device displays on-screen text messages, and provides audible messages
by means of a high-fidelity speaker system located in the front panel, that guides the user in his
manoeuvre, which means the use of the device in this mode requires basic training.
The Pacemaker mode (optional) provides non-invasive transcutaneous stimulation delivering
pulses via single-use multifunction electrodes.
The REANIBEX Serie 700 has a user-configurable high resolution recorder which can print the
waveforms and operation entries.
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USER MANUAL DGH 700 B
In addition to these patient-based operating modes, the REANIBEX Serie 700 has a special
start-up mode that provides direct access to the Configuration mode, where users can configure
and adapt the parameters which control the operation of the device to accommodate their needs.
The REANIBEX Serie 700 can operate with NiMH rechargeable batteries, or it can be
connected to an AC power supply network or car battery. The battery status indicator is
constantly displayed in the top part of the screen. Additionally, when the device is connected to
an external power supply (AC mains or car battery) the battery is automatically charged, by
means of an internal charger, regardless of whether the device is switched on or off.
WARNING: If the power supply is interrupted for more than 30 seconds, when the power is
restored the device settings return to the values set in the configuration. If the power supply
interruption is less than 30 seconds, then the values of the parameters set by the user during
the actuation are maintained.
The REANIBEX Serie 700 performs a number of self-tests at start-up and while in operation
that detects any malfunction or anomalous condition that may occur internally and which could
cause the device to become unsafe for use. A malfunction indicator, located on the front panel of
the device, indicates detected error conditions as well as displaying on-screen error messages.
The device can also perform various self-tests as requested by the user, using the Configuration
mode options.
Finally, the REANIBEX Serie 700 has the option of automatically storing information about the
actions performed with the device in a removable Compact Flash external memory card. This
data includes the patient’s ECG, the events that occurred during the utilization and the audio
(optional) of both of the device and the background noise; provided that the device is operating
in Automatic Defibrillator mode. In addition to this information, the last 100 events /
incidences that occurred during the utilization are stored, grouped according to the utilization to
which they belong. All this information can be downloaded, viewed and stored using the
"VISOR ECG CONTROL" program.
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USER MANUAL DGH 700 B
1.2 Indications for Use
The REANIBEX Serie 700 device is indicated for use in hospital and out-of-hospital settings by
medical personnel who have been specially qualified by training in Basic Life Support (BLS),
Advanced Life Support (ACLS) techniques or in any other type of acute cardiac emergency
response techniques recognised by the competent authority.
The REANIBEX Serie 700 must be used on solely one patient at a time.
1.2.1 Monitoring
The Monitor mode of the REANIBEX Serie 700 allows 4.5 second viewing (9 seconds in
cascaded mode) of the patient’s ECG picked up on the 4, 5 and 10 lead patient cable, on the
reusable external paddles or on the single-use multifunction electrodes.
In addition to those devices in which this option is available, the oxygen saturation (SpO2%) can
be viewed as well as the pleth waveform. Pulse Oximetry is a non-invasive technique used to
measure the percentage of haemoglobin molecules which are saturated with oxygen.
WARNING: Under various conditions such as haemoglobin saturation with compounds
other than oxygen, hypothermia, patient movement, nail polish and excessive light could
cause the pulse oximetry readings to be inaccurate.
1.2.2 Defibrillation
Defibrillation is the only effective treatment for cardiac arrest caused by an abnormal rhythm
that can be defibrillated. In such phenomena, the cardiac muscle is beating in an abnormal
rhythm, producing a polarized and stress effect whose origin can be due to multiple causes.
The REANIBEX Serie 700 delivers a defibrillation shock by means of a biphasic truncated
exponential pulse. The energy from this pulse is delivered to the patient via reusable external
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USER MANUAL DGH 700 B
paddles or single-use multifunction electrodes that are connected to the device and to the bare
chest of the patient.
1.2.2.1 Manual Defibrillation
Manual Defibrillation or Asynchronous Defibrillation is the primary treatment recommended
for patients who suffer episodes of Ventricular Fibrillation (VF) and pulseless Ventricular
Tachycardia (VT). Its use is not recommended for patients who suffer asystole and, generally
speaking, for patients that present one or more of the following symptoms:
-
the patient is conscious
- has a detectable pulse
- breathes spontaneously
1.2.2.2 Semi-Automatic Defibrillation (Optional)
The REANIBEX Serie 700, when operating in Automatic Defibrillator mode, must be used only
in adult patients that present symptoms of suffering sudden cardiac arrest which are:
- the patient is unconscious,
does not have detectable pulse
-
- does not breath spontaneously
WARNING: The REANIBEX Serie 700, when operating in Automatic Defibrillator mode, is
not designed for the treatment of cardia c arre sts in pa ediatric patients and therefore it must n o t
be used in patients under eight years of age or who weigh less than 25 kg.
WARNING: The REANIBEX Serie 700, when in Semi-Automatic Defibrillator mode,
must never be used in patients who are conscious, who have a pulse or who breathe
spontaneously.
WARNING: Do not analyse in moving vehicles when the device is operating in SemiAutomatic mode. Interference caused by motion artifact can affect the device and
may result in erroneous diagnoses. Motion detection may also delay analysis.
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USER MANUAL DGH 700 B
WARNING: Do not move the device during analysis when operating in SemiAutomatic Defibrillator mode. Moving the device can result in erroneous diagnoses.
Do not touch the patient or the device during analysis.
WARNING: The detection sensitivity of the REANIBEX Serie 700 to arrhythmias
that can be defibrillated in patients with implanted cardiac pacemakers can be
diminished.
1.2.3 Synchronized Cardioversion
Synchronized Cardioversion is the recommended treatment for patients who suffer episodes of
Atrial Fibrillation.
The REANIBEX Serie 700, when operating in Synchronized Cardioversion mode, delivers a
biphasic defibrillation shock synchronized with the R wave on the patient’s ECG (immediately
after it).
1.2.4 Non-invasive Pacemaker (Optional)
Non-invasive transcutaneous stimulation is an established and proven technique, which is
performed rapidly and easily. This treatment is recommended for patients who suffer episodes
of symptomatic bradycardia.
This technique can also be useful "in standby" when a case of cardiac arrest or symptomatic
bradycardia is anticipated.
The use of this technique during episodes of Ventricular Fibrillation is not recommended.
WARNING: Do not connect the REANIBEX Serie 700 Pacemaker to the electrodes
of an internal pacemaker.
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USER MANUAL DGH 700 B
1.3 Precautions
WARNING: Dangerous electrical shock hazard. Do not disassemble the defibrillator
as dangerous high voltages can be present. Contact the authorized personnel for any
necessary repairs.
WARNING: Dangerous electrical shock or fire hazard. Do not immerse either the
device or any part of it in water or any other liquid. Avoid spilling liquids on the
device or on its accessories. Do not clean the device with flammable agents such as
acetones. Do not autoclave the device or use any other sterilization method
whatsoever.
WARNING: Dangerous electrical shock hazard. The device must be used only by
qualified medical personnel who have specific basic training in the following areas:
- Cardiac-Pulmonary Resuscitation (CPR)
- Utilization of a Defibrillator/Monitor in accordance with the recommendations of
the American Heart Association (AHA) or of the European Resuscitation Council
(ERC)
- Utilization of
theREANIBEXSerie700
WARNING: Dangerous electrical shock hazard. The defibrillator delivers up to 200
Joules of electrical energy during shock. Do not touch the patient or the defibrillation
electrodes when delivering a shock.
WARNING: During defibrillation, stand clear and avoid contact with any part of the
patient's body (exposed skin on the head, the body and the extremities) and metal
objects such as the bed frame, as these could cause undesirable electrical current
paths during defibrillation.
WARNING: Air pockets formed between the defibrillation electrodes and the skin of
the patient can cause burns during defibrillation. Ensure that the defibrillation
electrodes are perfectly adhered to the skin of the patient. Once good skin contact is
6
USER MANUAL DGH 700 B
established, if the position of the electrodes must be changed, remove the electrodes
and replace them with new ones.
WARNING: Do not allow the defibrillation electrodes to touch each other or to touch
any part of conducting material during defibrillation. This contact could produce an
electric arc and burns to the patient's skin.
WARNING: Possible damage to the device. Before using the defibrillator, disconnect
the patient from all equipment that is defibrillator-protected.
WARNING: Incorrect use of the device can cause injury. Follow the instructions
given in the User Manual for its proper use.
DANGER: Explosion hazard. Do not use the device in the presence of concentrated
oxygen sources or flammable anaesthetic products.
WARNING: The use of cables, electrodes or batteries manufactured by other
manufacturers can result in device malfunction and will make safety certifications
null and void. Use only the accessories specified in this manual.
WARNING: The presence of radio frequency (RF) sources near the device can cause
equipment malfunction. Electromagnetic compatibility with nearby equipment must
be checked before using the REANIBEX Serie 700.
WARNING: Avoid operating the REANIBEX Serie 700 near or on other equipment.
If this cannot be avoided, check that the equipment is in proper operating condition
before its utilization.
WARNING: The REANIBEX Serie 700 must be installed and put into service
according to the information on Electromagnetic Compatibility (EMC) that appears
in the section entitled, “A11 – Manufacturer’s Guide and Declaration of
Electromagnetic Compatibility”.
WARNING: El REANIBEX Serie 700 is designed to be used only by qualified
medical personnel. The device may cause radio interference or may disrupt the
operation of nearby equipment. It may be necessary to take mitigation measures such
7
USER MANUAL DGH 700 B
as changing the position or location of the REANIBEX Serie 700 or even shielding
the area where the device is located.
CAUTION: Care must be exercised when handling patient cables, including the ECG
monitoring equipment when it is used in conjunction with high-frequency surgical
equipment.
FIRE OR SHOCK HAZARD: Make sure that the accessories and all of the
equipment is properly connected. The device or any accessories which are not
properly connected together can be a source of ignition or cause an electrical shock.
CAUTION: The device can become damaged by mechanical or physical misuse, such
as immersion in water or dropping the device from a height of more than 1 m.
CAUTION: The components of the device can become damaged if the device is placed
near vibration sources.
WARNING: The REANIBEX Serie 700 is suitable for use in the presence of highfrequency surgical equipment. Following interference produced by the electrosurgical
unit, the equipment returns to its prior operating mode in 10 seconds without losing
any stored data. The accuracy of the measurements can be temporarily affected
during the use of the electrosurgical unit or defibrillation. This does not affect patient
safety or equipment safety. Consult the Instructions for Use for the electrosurgical
unit to reduce the risk of burns in case of a defect in this equipment.
WARNING: The REANIBEX Serie 700 does not have the capacity to ignore internal
pacemaker pulses. The device could detect the internal pacemaker pulses as QRS
complexes which results in an indication of an incorrect heart rate. Do not rely on the
heart rate indicator displayed by the device with patients who have an internal
pacemaker.
WARNING: The quality of the ECG signal is affected if the electrical installation
connected to the device does not have a ground connection. If this ground connection
is not available, connect the equipotential conductor located in the back panel of the
device to any metal element accessible in the building structure.
8
USER MANUAL DGH 700 B
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USER MANUAL DGH 700 B
2. Description of the Device
2.1 Components of the REANIBEX Serie 700
The following section presents a description of the different REANIBEX Serie 700 components,
controls, indicators and connectors.
2.1.1 Front view
The elements and indicators that make up the front panel of the device are described below:
10
USER MANUAL DGH 700 B
NUMBER DESCRIPTION
1 REUSABLE EXTERNAL PADDLES
2
3
4
5
6
7
8
The PULSE OXIMETER extension cable CONNECTOR allows the
extension cable to be connected to the pulse oximetry sensor.
PATIENT CABLE CONNECTOR. It allows the patient cable to be
connected which can be 4, 5 or 10 leads.
MULTIFUNCTION CONNECTOR. It connects the reusable external
or internal paddles, and the single-use multifunction electrodes.
The high-fidelity SPEAKER system provides the sounds that indicate
an alarm, QRS detection, exceptional conditions that occur during the
utilization and also audible messages that guide the user during his
actions (Only for the devices that have the Semi-Automatic Defibrillator
option).
The FRONT PANEL which includes the activation keys for the
different operating modes.
MALFUNCTION INDICATOR. It is illuminated when the device
detects an error during any of the self-tests.
The BATTERY STATUS INDICATOR is an icon with a light. If this
indicator light is green it means the battery is charging and if it is red it indicates
LOW battery
9
10
11
12
13
14
Protective RECORDER COVER. The device recorder is located under
this protective cover.
DIRECT CURRENT INDICATOR. It indicates that the device is
connected to a DC external power supply source (car battery)
ALTERNATING CURRENT INDICATOR. It indicates that the
device is connected to an AC external power supply source (AC mains)
CARRYING HANDLE. This is a folding handle that allows simple
means of transport for the device.
Device SCREEN. This is a graphic display with 320 x 240 dot
resolution. The device has two types of optional screens: High-resolution
TFT and graphic LCD.
The FRONT PANEL includes the activation keys of the different
operating modes and keys that are common to all operating modes.
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USER MANUAL DGH 700 B
2.1.2 Overhead view
The elements that can be seen in the top part of the REANIBEX Serie 700:
12
NUMBER
DESCRIPTION
1
2
3
4
5
6
HOLDER of the reusable external paddles. To release the paddles, press
the holder and extract the paddles
Protective COVER of the COMPACT FLASH memory card. The
memory card holder is housed under this protective cover, Only the
devices that have the Semi-Automatic Defibrillator option have the
option of data recording in the Compact Flash.
Device SCREEN.
CONNECTOR for the Reusable external Paddles.
Protective RECORDER COVER.
Basic INSTRUCTIONS for use of the REANIBEX Serie 700.
USER MANUAL DGH 700 B
7 CARRYING HANDLE.
2.1.3 Rear view
The rear panel of the REANIBEX Serie 700 presents the following elements:
NUMBER
DESCRIPTION
1
2
3
4
BATTERY HOUSING. The place where the device’s battery is housed.
CAR BATTERY CONNECTOR. It enables the device to be connected
to a D.C. external power supply
AC POWER CONNECTOR. It allows the connection of the device to a
A.C. external power supply
EQUIPOTENTIAL CONDUCTOR. It provides an additional
connection to the ground connection of a building electrical installation.
13
USER MANUAL DGH 700 B
2.2 Front panel
This section describes the functions associated with each of the keys available on the front
panel. The different keys are grouped according to their operating mode.
There are a series of keys which are common to all operating modes:
NUMBER DESCRIPTION
1
2
3
4
5
6
GREEN main on/off (I/O) key of the device. The indicator of this key is
illuminated when the device is switched on.
RECORDER start/stop key. It starts the recording of both the ECG
signal and the events which occurred during the operation.
AUTOMATIC RECORD key for all the leads. It allows all the leads to
be recorded depending upon the available patient cable.
EVENTS Key. It allows an event from a predetermined list to be
included in the actions.
MICROPHONE. It allows the audio recording of the surrounding
setting that unfolds during the utilization (only for devices that have this
option and are operating in Semi-Automatic Defibrillator mode)
FUNCTION KEYS. Their function changes depending upon the
operating mode
14
7
MENU Key. It allows access to the different available configuration
options in the various operating modes.
USER MANUAL DGH 700 B
2.2.1 Monitor Mode
The keys corresponding to the Monitor mode are described below:
NUMBER
DESCRIPTION
1
2
3
MONITOR mode access key. The indicator of this key is illuminated
when the device is operating in Monitor mode.
SUSPENDED SOUND ALARM Key. It allows sound alarm indicators
to be deactivated for a maximum of 2 minutes. If a new alarm occurs
while the sound alarm indicator is suspended, the sound alarm indicator
will be automatically reactivated.
FREEZE Key. It allows the ECG signal to be frozen on-screen. While
the signal is frozen, a small window appears at the top of the screen with
the temporary progression of the ECG signal.
2.2.2 Defibrillator Mode
The keys that correspond to the Defibrillator operating mode that are located on the front panel
of the device are:
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USER MANUAL DGH 700 B
NUMBER
1
2
3
4
5
6
DESCRIPTION
DEFIBRILLATOR mode access key. The indicator of this key is
illuminated when the device is operating in Defibrillator mode.
Indicator to follow audible and visual instructions of the device when it
operates in Semi-Automatic Defibrillator mode.
CHARGE key for the selected energy level. The indicator of this key is
illuminated when the energy has finished charging. It can only be
activated in Manual Defibrillator mode.
ACTIVATION/DEACTIVATION key for SYNCHRONIZED shock.
When this option is active, the indicator of this key is illuminated. This
option is active only in Manual Defibrillator mode.
SELECT ENERGY Keys. They allow the energy level for discharge to
be selected. This key is active only in Manual Defibrillator mode.
SHOCK button. This button illuminates when the device is ready to
deliver a shock, and allows the defibrillation shock to be delivered to the
patient. It is only active when using single-use multifunction electrodes
or internal paddles.
7
ANALYSIS Key. It allows access to the Semi-Automatic Defibrillator
mode or to start an analysis during CPR. This key only appears in those
devices that have the Semi-Automatic Defibrillator option.
2.2.3 Pacemaker Mode (Optional)
The following keys located on the front panel of the REANIBEX Serie 700 allow it to operate
in the Pacemaker mode:
16
NUMBER
DESCRIPTION
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