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 previous notification by the manufacturer. If the
information given in this User Manual does not correspond to the
functioning of the unit, please contact an authorised
representative of OSATU S.Coop.
A.1 Manufacturer’s guide and declaration of Electromagnetic Compatibility ____ 147
A.3 Procedures for Changing Components _______________________________ 155
A.4 Assembly Diagrams _______________________________________________ 157
iii
TECHNICAL MANUAL DGG 700 B
Blank page
iv
TECHNICAL MANUAL DGG 700 B
1. Warnings
1.1 Safety
This symbol indicates the need to read the user’s manual since pertinent
information relating to the operation of the equipment is to be found in said
manual.
Read the user manual carefully before using the unit
Keep the user manual next to the unit, in order to refer to it whenever necessary.
1.2 General
• The equipment must be used only by suitably qualified personnel.
• Remove clothing from the patient’s chest, and, if necessary, dry the patient’s chest and
shave off excess hair in the areas where the paddles or electrodes, both for defibrillation and
monitoring are to be placed.
Avoid cutting the skin. Do not apply alcohol or any other
substance to the patient’s skin.
• Before defibrillating, remove any equipment connected to the patient that is not protected
against defibrillation.
• Make sure that no one is in contact with the patient when defibrillating.
• The defibrillation electrodes must never be in open circuit or short circuit during the shock.
They should be kept away from other electrodes or metallic parts that may be in contact
with the patient.
• Avoid any contact between any part of the patient’s body, such as the exposed skin of the
head and limbs, and metal objects such as the bed or stretcher frame, that could cause
undesirable deviation of the defibrillation current.
• Install the unit in a position not exposed to contact with water.
1
TECHNICAL MANUAL DGG 700 B
• Install the unit in a position where it is not negatively affected by atmospheric pressure,
temperature, damp, ventilation, sunlight and air that contains particles dust, salt, sulphur
components or other particles.
• The unit should be kept in a stable position, and any sudden movements, vibrations, blows
or any other destabilising factor should be avoided.
• Do not touch, press or scratch the screen of the device with hard objects as they may
damage it.
• Keep the apparatus clean. Clean with a damp cloth and a neutral detergent. Take account of
the directions in this manual for cleaning of the different parts of the unit.
DANGER OF FIRE OR SHOCK: Do not submerge the unit or any part of the unit in water
or other liquids. If the unit is accidentally submerged in water or other liquids, remove the
battery until it is operative again.
DANGER OF FIRE OR SHOCK: Make sure accessories and all the equipment are correc tly
connected. Equipment or accessories not correctly interconnected can be a source of ignition,
or cause shock.
CAUTION: The unit can be damaged by mechanical or physical misuse, such as immersion
in water, or drops of more than 1 metre.
CAUTION: The components of the unit can be damaged if they are placed near sources of
vibration.
WARNING: Risk of dangerous electrical shock or fire. Do not immerse either the unit or any
part of it in water or any other liquid. Avoid spilling liquids on the unit or on its accessories.
Do not clean the unit with inflammable agents such as acetones. Do not sterilize the
equipment in autoclave nor in any other way.
WARNING: Dangerous electrical discharge. The equipment must be used only by authorized
personnel, by a doctor or medical director, and that has minimal training in the following
areas:
2
- Cardio-pulmonary resuscitation (CPR)
- Use of a Monitor/Defibrillator in accordance with the recommendations of the
American Heart Association - AHA or of the European Resuscitation Council ERC
- Use of the REANIBEX 700 Series
TECHNICAL MANUAL DGG 700 B
WARNING: Risk of dangerous electrical shock. The defibrillator can provide up to 200
Joules of energy during a discharge. When the discharge is taking place do not touch either
the patient or the defibrillation electrodes.
ATTENTION: During defibrillation avoid contact between parts of the patient’s body
(exposed skin of the head and limbs), and metallic objects such as the frame of the bed, which
can produce undesirable paths for the defibrillation current.
WARNING: Air cavities formed between the defibrillation electrodes and the patient’s skin
can cause burns during defibrillation. Make sure that the defibrillation electrodes are
perfectly adhered to the patient’s skin. Once adhered, 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 or the paddles to touch each other, nor
that they touch any part of a conductive material during defibrillation. Such contact can
produce an electrical arch and burns to the patient’s skin.
WARNING: Incorrect use of the equipment can result in injury. Follow the instructions of
the User's Manual for its correct use.
DANGER: Possible danger of explosion if the equipment is used in the presence of
concentrated oxygen or inflammable anaesthetic products.
ATTENTION: The use of cables, electrodes or batteries of other manufacturers can cause
the unit to work incorrectly, and they invalidate the safety certifications. Use only the
accessories specified in this manual and that have been supplied by OSATU S. Coop.
WARNING: The presence of radio frequency (RF) emitter sources near the equipment can
cause its incorrect operation.
1.3 Design and Fabrication
The REANIBEX 200 unit meets the safety requirements laid down by the International
ElectroTechnical Commission, and is classified as Class I, internally powered equipoment, type
CF and continuous operating mode.
3
TECHNICAL MANUAL DGG 700 B
1.4 Preventive Maintenance
The aim of Preventative Maintenance is to ensure that the unit operates under safe working
conditions, and prevent potential problems. Suitably qualified personnel should carry preventive
Maintenance out at least once a year, only.
Make sure the unit is damage-free before using it. An immediate check should be carried out in
the following cases:
• The unit has suffered serious mechanical stress, for example after being dropped.
• The unit has suffered serious mechanical stress, for example after a fall.
• Liquid has fallen onto the unit.
• Anomalous operation of the unit has been detected.
• Any connector or cables showing signs of deterioration.
• The reusable paddles show any sign of deterioration or are broken.
• The unit’s malfunction indicator is blinking with a red color and on screen an error
code appears.
• The unit’s status indicator is red and on screen, when some of the operating modes are
accessed, an error message appears.
• In the upper part of the screen one of the icons that indicates that an error has been
detected in the unit’s modules appears.
• The battery shows signs of deterioration.
1.5 Check list
The checks and tests that it is recommended to perform to ensure the correct operation of the
device is listed below.
4
TECHNICAL MANUAL DGG 700 B
Serial number:
Operative:
Procedure/Incident Recommended action Result
1. Visual inspection of the device
• The device is dirty
• There are cracks or damage
2. Visual inspection of accessories
•Connectors, cables or paddles
damaged or broken
• Battery damaged or leaking
• Battery discharged
• Inspection of the recorder paper
3. Expiry dates
•Monitoring or defibrillation electrodes
expired
•Monitoring or defibrillation electrodes
opened
Date:
Signature:
• Clean the device
• Contact Technical service
• Contact Technical service
• Replace the battery
• Charge the battery
• If there is no paper, replace the
recorder paper
• Replace the expired electrodes
• Replace the opened electrodes
4. Supply
•Connect the device to an external
VAC source and check the indicator
•Connect the device to an external
VDC source and check the indicator
5. Integrity of the device
• Run the test Hardware
• Run the Accessories Test
• Run the Front Panel Test
• Run the Paddles Interface Test
• If the indicator does not light up,
contact Technical service
•If the indicator does not light up,
contact Technical service
•If any error exists contact
Technical service
•If any error exists contact
Technical service
•If any error exists contact
Technical service
•If any error exists contact
Technical service
5
TECHNICAL MANUAL DGG 700 B
1.6 Cleaning
To clean the REANIBEX Serie 700 device, the cables and the reusable external paddles the
following considerations must be taken into account:
• Use a slightly damp soft cloth. Do not use abrasive or inflammable cleaning products.
• Do not immerse the device in liquids.
• Clean the device with the batteries installed to prevent the fluids from penetrating into
the battery contacts.
• Use only the following products:
- Isopropyl alcohol
- Ammonia-based cleaning products
- Common cleaning products
- Hydrogen peroxide
- Soapy water
WARNING: Do not immerse the device or any part of it in water or in any other fluid. Do not
use abrasive or inflammable cleaning agents.
WARNING: Do not sterilize the REANIBEX Serie 700, or its accessories, in autoclave or
with gas, unless it is specified to the contrary in the instructions for use of the accessory.
WARNING: Clean and dry well the reusable external paddles after every use. The
defibrillation gel (damp or dry) accumulated both in the handles and in its containers can
interfere in monitoring with the paddles and cause shock to the user.
If the quality of printing of the recorder is not adequate the recording head must be cleaned. For
cleaning, perform the following steps:
1. Open the cover of the device under which the recorder is located
2. Open the door of the recorder pressing its safety catch
3. Extract the roll of paper.
4. Clean the printing head, above the brush, with cotton moistened in isopropyl
alcohol.
5. Position the roll of paper again and close the door of the recorder and the cover
of the device.
6
TECHNICAL MANUAL DGG 700 B
1.6.1 Sterilization of the internal paddles
In this section the steam sterilization process of the internal paddles is described. Continue the
instructions provided when carrying out this process.
1. Clean the surface of the electrodes and the handles with a standard hospitable
solution, such as, for example, isopropyl alcohol, using a soft cloth. Do not use
acetone or ammonia-based cleaners.
2. Do not put the connector into the cleaning solution.
3. Before sterilization remove any excessive residue accumulated on the surface of
the electrodes or on the handles.
4. Carry out the sterilization in a gravity sterilizer using the following parameters:
- Sterilization temperature: 121 ºC
- Duration of sterilization: 30 minutes
5. Protect the paddles before and after cleaning to avoid damaging their surface.
The shelf life of the internal paddles is affected by the number of sterilization cycles. The
internal paddles supplied by OSATU have been proven to last almost for 50 steam sterilization
cycles carried out with the previous parameters.
1.7 Storage
When the REANIBEX Serie 700 is not being used, follow the recommendations herein below
for storage of the device:
- Store the REANIBEX Serie 700 with the NiMH battery pack installed at
temperatures between 0 ºC and 40 ºC.
- Store the REANIBEX Serie 700 without the NiMH
battery pack installed at
temperatures between -20 ºC and 60 ºC.
If the device is operating outside of the recommended operating or storage temperature, the
malfunction indicator located in the device front panel will remain switched on until the
ambient temperature is within the stated range.
7
TECHNICAL MANUAL DGG 700 B
1.8 Explosions
This unit has not been designed to be explosion-proof, and therefore it must not be used in
rooms or environments where there is a risk of explosion, nor in the presence of inflammable
anaesthetic products nor concentrated oxygen.
FIRE OR EXPLOSION HAZARD: Do not use the unit when inflammable or anaesthetic
gases are present.
1.9 Batteries
In this section the considerations to be taken into account for correct battery maintenance are
explained, as well as the process for changing it. Good battery maintenance optimizes its
duration, and guarantees that the that the device provides accurate indication about battery
charge.
The REANIBEX Serie 700 uses high capacity rechargeable NiMH batteries that require
minimal maintenance. The duration of a rechargeable NiMH battery depends on its frequency
and use. When used and maintained correctly the useful life of the battery is 5 years or 500
charge/shock cycles.
Adequate maintenance of the battery implies taking the following considerations into account:
• Store the battery at temperatures less than 30 ºC and never expose the battery to high
temperatures, greater than 40 ºC.
• Periodically carry out complete discharges of the battery (it is recommended once a
month), for this purpose switching the device on without connecting it to any external
power supply, until the battery condition indicator lights up with a red color.
• If the battery of the device is left out of it for a long period of time, and is stored at a
temperature less than 30 ºC, recharge the battery every 6 months.
ATTENTION: Use only batteries supplied by OSATU or by its authorized distributors. The
use of another battery type can cause the device not to operate correctly.
8
TECHNICAL MANUAL DGG 700 B
WARNING: Storage of the batteries at temperatures greater than 30 ºC significantly reduces
their lifespan.
When it performs self-tests at start-up and during operation, the device checks the battery
charge giving the appropriate instructions in case its charge is low.
If on switching the device on, the battery indicator located on the front panel of the device is red
in colour at start-up, it indicates that it is necessary to charge the battery, for this purpose
connecting the device to an external power supply (car battery or AC mains).
WARNING: Danger of explosion. Do not recharge the REANIBEX Serie 700 batteries
outside of the device, since they could explode.
Store the new battery packs at temperatures between 0 ºC and 35 ºC. The optimum temperature
for storage of the batteries is 25 ºC.
When the battery is stored under ideal conditions, its capacity is equivalent to more than 130
discharges of 200 J, or more than 150 minutes of monitoring, or more than 120 minutes of
monitoring plus pacemaker stimulation at 60 mA and 60 bpm.
Changing of the device external battery is shown in the following drawing:
When the batteries are installed in the equipment, and this in turn is connected to an external
power supply (AC mains or car battery), the device continuously charges the battery, using an
internal charger.
9
TECHNICAL MANUAL DGG 700 B
To extract the battery, pull upwards the battery retaining device (coloured black) and supporting
it in this position extract the battery from its compartment.
If there is visible damage or if they become damaged, the NiMH batteries must be recycled.
Follow the local, regional or national instructions of your country when recycling.
WARNING: Follow the local, regional or national instructions of your country when
recycling the REANIBEX Serie 700 batteries, or send them to OSATU S. Coop.
WARNING: Danger of explosion. Do not try to open or to handle the battery. Do not
incinerate the battery. Avoid electrical contact between the battery terminals.
1.10 Repairs and Inspection
OSATU S.Coop. can only accept liability for the safety aspects of the REANIBEX 700 when
the maintenance, repairs and subsequent modifications have been carried out by our technical
personnel or by companies authorised by us, and when components affecting the safety of the
unit have been replaced with original spare parts.
The company reserves the right to carry out possible modifications without prior notice.
On request, OSATU S.Coop will provide circuit diagrams, component lists, descriptions,
calibration instructions and other information that assist the suitably qualified technical
personnel to repair those parts of the unit designated by the manufacturer as repairable.
1.11 Recycling
• The REANIBEX Serie 700 must be cleaned and disinfected before being recycled. The
device must be recycled in accordance with the recommendations of local, regional or
national authorities of each country.
• The NiMH batteries once their useful life has finished, must be recycled in accordance with
local, regional or national procedures of each country.
10
TECHNICAL MANUAL DGG 700 B
The disposable defibrillation electrodes must be recycled in accordance with local, regional
•
or national clinical procedures of each country.
• The device packaging must be been recycled in agreement with local, regional or national
regulations of each country.
WARNING: Follow the local, regional or national instructions of your country when
recycling the different parts of the REANIBEX Serie 700, or send them to OSATU S. Coop.
1.12 REANIBEX 700 Series Symbols
SYMBOL MEANING
General ON/OFF button of the device.
I/O
BATTERY STATUS indicator
MALFUNCTION Indicator
Indicates that the device is connected to an external
ALTERNATING SUPPLY source (Vac)
Indicates that the device is connected to an external
DIRECT SUPPLY source (Vdc)
RECORDER Activate/deactivate key
Automatic RECORD key of all the LEADS
EVENTS Key.
MENU key
11
TECHNICAL MANUAL DGG 700 B
FUNCTION Keys
Alarms sound PAUSED key
On-screen signal FREEZE-HOLD key
Selected energy CHARGE key
Synchronism ACTIVATION/DEACTIVATION key
ENERGY SELECTION keys
ECG signal ANALYSIS start key
DISCHARGE Button
Icon for following the audible and visual instructions
of the device when it is operating in Semi-Automatic
Defibrillator mode.
Pacemaker stimulation CURRENT SELECTION
keys
Pacemaker stimulation FREQUENCY SELECTION
keys
Key for reducing the stimulation frequency by 4
(while it is being pressed)
Microphone (Only for device with this option)
12
Equipotencial connection
TECHNICAL MANUAL DGG 700 B
Connection of the direct external supply (car
battery)
Connection of the alternating external supply (AC
mains)
Non-protected against defibrillation.
CF type device
Protected against defibrillation.
CF type device
1.13 On-screen symbols
SYMBOL MEANING
XX:XX:XX
140
ATTENTION: See accompanying documents
Symbol of certification in accordance with the
Directive for medical devices 93/42/CEE
TIME PASSED since the device was switched on or
real time (depends on configuration)
HEART RATE
LOW CONFIDENCE in the PULSE RATE
obtained from the pulsioximeter
HEART RATE cannot be obtained
- - -
13
TECHNICAL MANUAL DGG 700 B
Loose PATIENT CABLE LEAD
ERROR in the RECORDER (includes the lack of
paper and the door being open)
QRS BEEP DEACTIVATED
ALARMS SOUND IN PAUSE
COMPACT FLASH FULL
1
ERROR in the COMPACT FLASH or no card
installed
VT/VF ALARM ACTIVATED and analyzing ECG
signal
NUMBER of SHOCKS supplied in Semi-Automatic
Defibrillator mode
STATUS OF BATTERY CHARGE
There is NO BATTERY INSTALLED in the device
SpO2%, signal intensity and perfusion index
LOW CONFIDENCE in shown SpO2 % value
14
SpO2% and PI can not be obtained
The SpO2 SENSOR is not CONNECTED to the
patient
TECHNICAL MANUAL DGG 700 B
There is an error in the PULSE OXIMETRY
module
TIME REMAINING for CPR
TIEMPO RCP (SEG)
30
CHARGING the CAPACITOR to the selected
CARGANDO
energy
15
TECHNICAL MANUAL DGG 700 B
1.14 Battery symbols
SYMBOL MEANING
ATTENTION: See accompanying documents
Recyclable material. Heavy metal substances. Do not
dispose them inappropriately
Do not try to open the battery casing.
Do not expose the battery to excessive heat or to
flames. Do not incinerate the battery.
LOT
Batch of manufacture of the battery
Date of manufacture of the battery
Electrical and electronic equipment in accordance
with Article 11(2) of Directive 2002/96/CE (WEEE)
Rechargeable battery
Battery operating temperature range
1.15 Unit labels
In the upper part of the device there is a label that contains a Serie 700 of warnings and
precautions that it is necessary to follow when using the device, and the basic instructions for
use of the device:
16
TECHNICAL MANUAL DGG 700 B
In the lower part of the device there is the following label, where the serial number of the device
is shown.
In the upper part of the device, just under the protection cover of the Compact Flash, but only
for those equipments which have Automated Defibrillation option, there is the following label
that contains the indication of switching off the equipment before inserting and extracting the
Compact Flash memory card:
17
TECHNICAL MANUAL DGG 700 B
1.16 Battery labels
The label included in the battery holds information relating to the battery characteristics (type,
capacity, voltage, batch and date of manufacture), as well as recommendations for its handling
and storage.
18
TECHNICAL MANUAL DGG 700 B
2. General description
The REANIBEX Serie 700 is a Monitor/Defibrillator which allows advanced monitoring and
resuscitation functions to be performed, for this purpose having four modes of operation:
Monitor with pulse oximetry (SpO2) option, Manual Defibrillator, Semi-Automatic (optional)
Defibrillator and External transcutaneous (optional) Pacemaker. It is a portable and light piece
of device, designed with the latest technologies in the field of the defibrillation such as the
biphasic wave.
The device incorporates a wide screen that allows the viewing, not only of the ECG signal, but
also of the monitoring parameters, both of the patient and of the device, information messages
and user guide messages.
In Monitor mode the REANIBEX Serie 700 can pick up the signal via 3, 5 or 10 lead patient
cable, from adult or paediatric external reusable paddles or from multifunction disposable
electrodes.
In the Manual Defibrillator mode, if the patient needs a defibrillation shock this is simply
applied by following three steps:
1- Select the energy
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 action on behalf of the user to provide the shock.
During the whole process, the device displays on-screen text messages, and provides audible
messages by means of a loudspeaker situated in its front part, that guides the user in his action,
which makes the use of the device in this mode require minimal training.
The Pacemaker mode (optional) provides a non-invasive transcutaneous stimulation treatment
providing the pulses via multifunction disposable electrodes.
The REANIBEX Serie 700 has a user-configurable high resolution recorder, which allows the
printing of waveforms and of notes relating to the utilization.
In addition to this manner of operating with a patient, the REANIBEX Serie 700 has a special
way of starting that provides access to the Configuration mode, from where setting and adapting
19
TECHNICAL MANUAL DGG 700 B
the parameters which control the operation of the device to the needs of the different users is
permitted.
The REANIBEX Serie 700 can operate with NiMH rechargeable batteries, connected to a
supply AC mains or connected to a car battery. The remaining battery capacity is constantly
seen in the top part of the device screen. Likewise when the device is connected to an external
power supply (AC mains or car battery) the battery is charged, by means of an internal charger,
independently of whether the device is switched on or off.
At start-up and during the utilization, the REANIBEX Serie 700 carries out a number of self-
tests that allow the detection of any malfunction or anomalous condition that may occur in it,
and whose effect is that the device may not be safely used. Indication of error conditions that are
detected is provided by means of an malfunction indicator located in the front part of the device
and by means of on-screen error messages.
The device can also carry out various self-tests as requested by the user, using the Configuration
mode options.
Finally, the REANIBEX Serie 700 has the option of automatically storing, in a Compact Flash
type extractable external memory, information about the utilizations carried out with the device.
This information includes the patient’s ECG, the events that occurred during the utilization, and
optionally, audio, both of the device and the ambient sound; provided always that the device is
operating in Automatic Defibrillator mode. In addition to this information, they 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, visualized and stored using the
"VISOR ECG CONTROL " program.
ATTENTION: Dangerous electrical shock. The device must be used only by qualified
personnel,by a medical doctor or manager, and that has minimal training in the following
areas:
20
- Cardiac-Pulmonary Resuscitation (CPR)
- Use of a Monitor/Defibrillator in accordance with the recommendations of the
American Heart Association (AHA) or of the European Resuscitation Council
(ERC)
- Using the REANIBEX Serie 700
TECHNICAL MANUAL DGG 700 B
2.1 Front view
The elements and indicators that make up the front part of the device are described below:
NUMBER DESCRIPTION
1 REUSABLE EXTERNAL PADDLES
2
PULSE OXIMETER extension cable CONNECTOR; it allows the
connection of the extension cable to which the pulse oximetry sensor is
connected
3
PATIENT CABLE CONNECTOR, it allows the connection of the
patient's cable, that can be 4, 5 or 10 lead
4
MULTIFUNCTION CONNECTOR. It allows the connection of the
reusable external or internal paddles, and of the multifunction disposable
electrodes.
21
TECHNICAL MANUAL DGG 700 B
5
6
7
8
9
10
11
12
The LOUDSPEAKER provides the sounds indicative of alarm, QRS
detected, exceptional conditions produced during the utilization and also
audible messages that guide the user during his utilization (Only for device
that has the Semi-Automatic Defibrillator option).
The FRONT PANEL, that includes the activation keys of 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, while if it is red it
indicates LOW BATTERY
RECORDER protection COVER. Under it the device recorder is located
DIRECT CURRENT INDICATOR. It indicates that the device is
connected to a D.C. external supply source (car battery)
ALTERNATING CURRENT INDICATOR. It indicates that the device is
connected to an A.C. external supply source (AC mains)
CARRYING HANDLE. This is a folding handle that allows simple means
of transport of the device.
13
Device SCREEN. This is a graphic display of 320x240 points of resolution.
The device has two types of optional screens: A high resolution TFT and a
graphical LCD.
14
The FRONT PANEL, that includes the activation keys of the different
operating modes, and keys common to all the operating modes.
2.2 Upper view
The items that can be seen in the top part of the REANIBEX Serie 700:
22
TECHNICAL MANUAL DGG 700 B
NUMBER DESCRIPTION
1
HOLDER of the reusable external paddles. To release the paddles, press the holder and extract the paddles
2
PROTECTION cover of the COMPACT FLASH memory card. Under
this cover the memory card holder is located. Only device that has the SemiAutomatic Defibrillator option has the possibility of data recording in the
Compact Flash.
3 DEVICE SCREEN
4
5
6
7
CONNECTOR of the Reusable external Paddles.
RECORDER protection COVER..
BASIC INSTRUCTIONS of use of the REANIBEX Serie 700.
CARRYING HANDLE. This is a folding handle that allows simple means
of transport of the device.
23
TECHNICAL MANUAL DGG 700 B
2.3 Rear view
The rear part of the REANIBEX Serie 700 presents the following items:
NUMBER DESCRIPTION
1
2
BATTERY HOUSING. The place where the device battery is housed.
CAR BATTERY CONNECTOR. It allows the connection of the
device to a D.C. external power supply
3
AC MAINS CONNECTOR. It allows the connection of the device to a
A.C. external power supply
4
EQUIPOTENCIAL CONDUCTOR. It gives an additional conection
for the earth conection of the building electric installation.
24
TECHNICAL MANUAL DGG 700 B
2.4 Front panel
In this section the functions associated with each of the keys available in the front panel are
described. The different keys are grouped according to the mode to which they belong.
A series of keys common to all the ways of operation exists:
NUMBER DESCRIPTION
1
GREEN general on/off (I/O) key of the device. The indicator of this key
is illuminated when the device is switched on.
2
RECORDER start/stop key. For starting, and a record of both the ECG
signal and the events occured during the utilization.
3
AUTOMATIC RECORD key of all the leads. It allows all the leads to
be recorded depending on the available patient cable.
4
EVENTS Key. It allows an event from a predetermined list to be
included in the utilization.
5
MICROPHONE. It allows the audio recording of the scene produced
during the utilization (only for device that has this option and operating
in Semi-Automatic Defibrillator mode)
6
FUNCTION KEYS. Their meaning change depending on mode of
operation
7
MENU Key. It allows access to the different available configuration
options in the different operating modes.
25
TECHNICAL MANUAL DGG 700 B
2.4.1 Monitor Mode
The keys corresponding to the Monitor mode are described below:
NUMBER DESCRIPTION
1
MONITOR mode access key. The indicator of this key is illuminated
when the device is operating in Monitor mode.
2
ALARMS SOUND PAUSED key. It allows sound alarms indication to
be deactivated during a maximum time of 2 minutes. If a new alarm is
generated while the sound of the alarms is in pause, a new sound
indication will be generated.
3
FREEZE-HOLD Key. It allows the ECG signal on the screen to be
frozen. While the signal is frozen, in the top part of the screen a small
window appears with the evolution of the ECG signal with time.
2.4.2 Defibrillator Mode
The keys that correspond with the Defibrillator mode of operation and that are located in the
front panel of the device are:
26
TECHNICAL MANUAL DGG 700 B
NUMBER DESCRIPTION
1
2
3
4
5
6
Access key for the DEFIBRILLATOR mode. The indicator of this key
is illuminated when the device is operating in Defibrillator mode.
Indication for following the audible and visual instructions of the device
when it operates in Semi-Automatic Defibrillator mode.
Charge the selected energy key. The indicator of this key illuminates
when the energy has finished charging. It is only active in Manual
Defibrillator mode.
ACTIVATION/DEACTIVATION of the SYNCHRONIZED shock
key. When this option is active the indicator of this key is illuminated.
This option is active only in Manual Defibrillator mode.
ENERGY SELECTION keys. They allow the selection of the level of
energy to be discharged. This key is active only in Manual Defibrillator
mode.
SHOCK button. This button illuminates when the device is ready to
provide a shock, and allows the defibrillation shock to be given to the
patient. It is only active when operating with multifunction disposable
electrodes or internal paddles.
7
ANALYSIS Key. Allows access to the Semi-Automatic Defibrillator
mode or to initiate an analysis during the CPR time. This key only
appears in that device that has the Semi-Automatic Defibrillator option.
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TECHNICAL MANUAL DGG 700 B
2.4.3 Pacemaker Mode (Optional)
The following keys located in the front panel of REANIBEX Serie 700 allow operation in the
Pacemaker mode:
NUMBER DESCRIPTION
1
PACEMAKER mode access key. The indicator of this key illuminates
when the device is operating in Pacemaker mode.
2
3
4
AMPLITUDE SELECTION of the pacemaker stimulation pulses key
FREQUENCY SELECTION of the pacemaker stimulation pulses key
Key 4:1. While this key is pressed the stimulation frequency of the
pacemaker is divided by 4 to be able to observe the intrinsic rhythm of
the patient.
2.5 Screen
The REANIBEX Serie 700 has a high resolution LCD type graphic display of 320x240 pixels
(1/4 VGA) where both ECG signal and optionally the plethysmographic curve (SpO2), and the
information relating to the patient monitoring parameters and to the state of the device are
displayed. Optionally the device can have a wide vision angle EL type screen.
The device screen subdivides into three well differentiated parts:
1. Top part - Displays the operating parameters of the device (real time clock, information
using icons of the state of the battery, state of the device, unhooked electrodes, cancellation
of the alarms sound...),the numerical values of the monitoring parameters (Heart Rate and
%SpO2), and the icons that indicate exceptional operating conditions (errors in the recorder,
errors in the Compact Flash memory card).
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TECHNICAL MANUAL DGG 700 B
2. Middle part – Displays the biological signals. It will be possible to display a single ECG
channel or cascaded, or an ECG channel along with the plethysmographic curve, for device
with this option.
In the lower part of this area guide messages for the user, when in Semi-Automatic
Defibrillator mode, and informative messages for the rest of the modes, are displayed.
3. Lower part - Displays the meaning that is acquired by each of the function keys, that are
located under the screen.
SpO2
00:00:30
PADDLES x1
SpO2(%)
PI: 12.7
SpO2
PADDLES
CH2 : SpO2
SEN : 1FILT : NO
2.6 Paddles, electrodes and patient cable
For monitoring, the REANIBEX Serie 700 can use patient's cable, external or internal reusable
paddles and multifunction disposable electrodes. For defibrillation, external or internal reusable
paddles and multifunction disposable electrodes.
The patient cable that the device uses can be 3, 5 or 10 lead. The device automatically detects
the type of cable connected allowing the viewing of the different leads.
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TECHNICAL MANUAL DGG 700 B
The external reusable paddles have keys for the selection and charging with energy, for printing,
and two shock push buttons:
NUMBER DESCRIPTION
30
1
SHOCK Push button of the Sternum pad. Operating in Manual
Defibrillator mode allows the shock to be supplied to the patient when
simultaneously pushed with that of the Apex pad.
2
ENERGY SELECTION Keys. They allow the level of the energy to be
supplied, when operating in Manual Defibrillator mode, to be fixed.
3
CHARGE Key. Operating in Manual Defibrillator mode allows the
charging of energy to be supplied
TECHNICAL MANUAL DGG 700 B
4
SHOCK Push button of the Apex pad. Operating in Manual Defibrillator
mode allows the shock to be supplied to the patient when simultaneously
pushed with that of the Sternum pad.
5
PRINT Key. It allows the recording both of the biological signals and of
the events that occur with the device during the utilization.
The device can use two types of different multifunction disposable electrodes:
Permanent connector-cable with disposable
electrodes
Disposable electrode-cables
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TECHNICAL MANUAL DGG 700 B
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TECHNICAL MANUAL DGG 700 B
3. Technical specifications
3.1 General
TECHNICAL SPECIFICATIONS
Electrical protection
Safety Classification
MONITOR
ECG
Outputs
Loose lead indication
Input protected against high voltage defibrillation
pulses (IEC 60601)
IEC 60601, type CF, class I, internally powered
equipoment. Continuous operating mode.
Monitoring is performed using 4, 5 and 10 lead
cable, internal or external reusable paddles and
disposable multifunction electrodes
- 4 Lead cable: PADDLE, I, II, III , aVR, aVL y
aVF.
- 5 Lead cable: PADDLE, I, II, III aVR, aVL, aVF
and V
- 10 Lead cable: PADDLE, I, II, III aVR, aVL, aVF
and V1 to V6
An icon appears on-screen when any lead is loose or
badly connected.
The amplitude of the current applied to the patient to
detect a lead-off is less than 0.5 uA.
Size of the ECG
On-screen speed of the ECG
Frequency response
Cardiac frequency
Heart rate meter accuracy and
response to irregular rhythm
Averaged heart rate
0.5, 1, 2 and 4 cm/mV selectionable from the front
panel
25 mm/sec
- MAINS Filter: (50/60 Hz).
- Diagnostic: 0.05-150 Hz (only on the recorder)
- Muscle filter: 0.67-40 Hz (only on the recorder)
- On-screen response: 00.5-25 Hz
30-300 ppm ± 10 % shown on the unit screen
Meets the IEC 60601-2-27:2005 standard for
ventricular bigeminy (HR=40 bpm).
- For heart rates greater than or equal to 50 bpm, the
8 most recent R-R intervals are used for
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TECHNICAL MANUAL DGG 700 B
averagingthe heart rate
- For heart rates lower than 50 bpm, the 4 most
recent R-R intervals are used for averaging the
heart rate.
Heart rate response time
Alarm response time for tachycardia
Capacity to reject T-waves
Alarms
Common mode rejection
- From 80 to 40 bpm: 3 secods
- From 80 to 120 bpm: 2 secondss
- 206 bpm (1 mV): 2 seconds
- 206 bpm (half amplitude): 3 seconds
- 206 bpm (double amplitude): 3 seconds
- 195 bpm (2 mV): 2 seconds
- 195 bpm (half amplitude): 2 seconds
- 195 bpm (double amplitude): 2 seconds
Rejects T-waves with a maximum amplitude of 0.7
mV
- Maximum and Minimum Cardiac frequency
- Maximum and Minimum% SpO2 (only with the
pulse oximetry option)
- VT/VF Alarm (only with the Semiautomatic
Defibrillator option)
> 100 dBs
Simultaneous use of the REANIBEX
Serie 700 with other equipment
connected to the patient
SpO2 Pulse oximetry (Optional)
- The REANIBEX Serie 700 can be utilized
simultaneously with an electrosurgical unit. A
defect in the neutral electrode of the
electrosurgical unit does not represent any safety
risk for the patient since the device provides
protection against high-frequency burns. This
protection resides in the fact that the patient cable
is electrically isolated through a ground
connection.
Consult the Instructions for Use for the
electrosurgical unit to reduce the risk of burns in
case of a defect in this device
The simultaneous use of the REANIBEX Serie
700 with an external pacemaker and other
electrical pacers connected to the patient do not
represent any safety risk. The device could detect
the internal pacemaker pulses as QRS complexes
which results in an indication of an incorrect eart
rate.
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TECHNICAL MANUAL DGG 700 B
Saturation (% SpO2) range
Saturation (%SpO2) accuracy
during no motion conditions
Saturation (%SpO2) accuracy
during motion conditions
Saturación (% SpO2) resolution
Pulse Rate Range (bpm)
Pulse rate (ppm) accuracy during no
motion conditions
Pulse rate (ppm) accuracy during
motion conditions
1-100%
Adults/Peditrics 70% - 100 % : ± 2 digits
0% - 69 % : Not especified
Neonates 70% - 100 % : ± 3 digits
0% - 69 % : Not especified
Adults/Peditrics /
Neonates
70% - 100 % : ± 3 digits
0% - 69 % : Not especified
1%
25-240 bpm
± 2 bpm
± 5 bpm
Pulse rate (ppm) resolution
DEFIBRILLATOR
Waveform
Output Energy accuracy (over 50 Ω)
Manual Defibrillator
Output energy
External paddles
Internal paddles
1 bpm
Truncated exponential biphasic, with compensation of
energy depending on the impedance of the patient
± 15 % or ± 3 j, whichever is greatest in the entire