Technical Manual
Technical Manual
Technical Manual
Technical Manual
Revision C 02/2008
e-mail: [email protected]
www.osatu.com
TECHNICAL MANUAL DGG 700 B
TECHNICAL MANUAL DGG 700 B
CONTENTS
1. Warnings _________________________________________________________ 1
1.1 Safety_______________________________________________________________ 1
1.2 General _____________________________________________________________ 1
1.3 Design and Fabrication ________________________________________________ 3
1.4 Preventive Maintenance _______________________________________________ 4
1.5 Check list ___________________________________________________________ 4
1.6 Cleaning ____________________________________________________________ 6
1.6.1 Sterilization of the internal paddles ___________________________________________7
1.7 Storage _____________________________________________________________ 7
1.8 Explosions___________________________________________________________ 8
1.9 Batteries ____________________________________________________________ 8
1.10 Repairs and Inspection _______________________________________________ 10
1.11 Recycling___________________________________________________________ 10
1.12 REANIBEX 700 Series Symbols________________________________________ 11
1.13 On-screen symbols ___________________________________________________ 13
1.14 Battery symbols _____________________________________________________ 16
1.15 Unit labels __________________________________________________________ 16
1.16 Battery labels _______________________________________________________ 18
2. General description________________________________________________ 20
2.1 Front view__________________________________________________________ 22
2.2 Upper view _________________________________________________________ 23
2.3 Rear view __________________________________________________________ 25
2.4 Front panel _________________________________________________________ 26
2.4.1 Monitor Mode __________________________________________________________27
2.4.2 Defibrillator Mode_______________________________________________________27
2.4.3 Pacemaker Mode (Optional)_______________________________________________29
2.5 Screen _____________________________________________________________ 29
2.6 Paddles, electrodes and patient cable____________________________________ 30
3. Technical specifications ____________________________________________ 34
3.1 General ____________________________________________________________ 34
3.2 Defibrillation waveform ______________________________________________ 40
4. General Block Diagram ____________________________________________ 44
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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.
Keep the user manual next to the unit, in order to refer to it whenever necessary.
1.2 General
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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 correctly
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:
- 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
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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.
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.
The REANIBEX 200 unit meets the safety requirements laid down by the International
ElectroTechnical Commission, and is classified as Class IIb, type CF.
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TECHNICAL MANUAL DGG 700 B
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.
The checks and tests that it is recommended to perform to ensure the correct operation of the
device is listed below.
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TECHNICAL MANUAL DGG 700 B
Operative: Signature:
3. Expiry dates
• Monitoring or defibrillation electrodes • Replace the expired electrodes
expired
• Monitoring or defibrillation electrodes • Replace the opened electrodes
opened
4. Supply
• Connect the device to an external • If the indicator does not light up,
VAC source and check the indicator contact Technical service
• Connect the device to an external • If the indicator does not light up,
VDC source and check the indicator contact Technical service
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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.
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TECHNICAL MANUAL DGG 700 B
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:
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 0 ºC and 50 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.
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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 2 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.
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TECHNICAL MANUAL DGG 700 B
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.
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.
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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.
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.
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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.
SYMBOL MEANING
General ON/OFF button of the device.
I/O
MALFUNCTION Indicator
EVENTS Key.
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MENU key
FUNCTION Keys
DISCHARGE Button
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SYMBOL MEANING
TIME PASSED since the device was switched on or
XX:XX:XX real time (depends on configuration)
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SpO2
SpO2
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SYMBOL MEANING
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:
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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:
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TECHNICAL MANUAL DGG 700 B
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.
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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 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
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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:
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TECHNICAL MANUAL DGG 700 B
The elements and indicators that make up the front part of the device are described below:
NUMBER DESCRIPTION
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TECHNICAL MANUAL DGG 700 B
6 The FRONT PANEL, that includes the activation keys of the different
operating modes.
14 The FRONT PANEL, that includes the activation keys of the different
operating modes, and keys common to all the operating modes.
The items that can be seen in the top part of the REANIBEX Serie 700:
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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
3 DEVICE SCREEN
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The rear part of the REANIBEX Serie 700 presents the following items:
NUMBER DESCRIPTION
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TECHNICAL MANUAL DGG 700 B
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.
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.
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TECHNICAL MANUAL DGG 700 B
NUMBER DESCRIPTION
The keys that correspond with the Defibrillator mode of operation and that are located in the
front panel of the device are:
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TECHNICAL MANUAL DGG 700 B
NUMBER DESCRIPTION
1 Access key for the DEFIBRILLATOR mode. The indicator of this key
is illuminated when the device is operating in Defibrillator mode.
2 Indication for following the audible and visual instructions of the device
when it operates in Semi-Automatic Defibrillator mode.
3 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.
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TECHNICAL MANUAL DGG 700 B
The following keys located in the front panel of REANIBEX Serie 700 allow operation in the
Pacemaker mode:
NUMBER DESCRIPTION
4 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.
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.
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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The external reusable paddles have keys for the selection and charging with energy, for printing,
and two shock push buttons:
NUMBER DESCRIPTION
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TECHNICAL MANUAL DGG 700 B
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:
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TECHNICAL MANUAL DGG 700 B
3. Technical specifications
3.1 General
TECHNICAL SPECIFICATIONS
MONITOR
Loose lead indication An icon appears on-screen when any lead is loose or
badly connected
Size of the ECG 0.5, 1.2 and 4 cm/mV selectionable from the front
panel
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TECHNICAL MANUAL DGG 700 B
DEFIBRILLATOR
Manual defibrillator
Output energy
Charge Indication Charging tone, end of charging tone, LED in the front
panel charging button and discharge button blinking
for multifunction disposable electrodes and internal
paddles
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Maximum time from the start of the With the set delivery voltage, and a defibrillator with
rhythm analysis until ready status an internal supply, having a completely charged new
for shock battery: 21seconds.
Maximum time from the initial For a delivery voltage of 90 % of the set value and
supply connection until ready status for a defibrillator with an internal supply, after 15
for shock shocks at maximum energy: 26 seconds.
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TECHNICAL MANUAL DGG 700 B
PACEMAKER (Optional)
- Fixed
Operating modes
- On Demand
SCREEN
RECORDER(Optional)
Continuous ECG strip Prints a continuous strip with an ECG channel along
with annotations and events.
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TECHNICAL MANUAL DGG 700 B
Width of Paper 50 mm
GENERAL
Self-checks - At start-up
- During operation
- Manuals on user demand
SUPPLY
Battery
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TECHNICAL MANUAL DGG 700 B
ENVIRONMENTAL CONDITIONS
PHYSICAL CHARACTERISTICS
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TECHNICAL MANUAL DGG 700 B
For defibrillation the REANIBEX Serie 700 has incorporated a BIPHASIC TRUNCATED
EXPONENTIAL WAVEFORM:
Phase 1
V1
Phase 2
V2
Commutation time between phase 1 and phase 2 of the wave is 600 µsec. Furthermore, it is
devised so that the negative tension (V2) coincides with the positive (V1) in the change of
polarity.
The energy supplied during both phases depends on the impedance of the patient, maximizing in
this way the effectiveness of defibrillation.
The device provides shocks with impedances that vary between 20 and 300 Ω. If the impedance
is less than 20 Ω it is assumed that a short circuit exists between the defibrillation electrodes.
For impedance greater than 300 Ω it will be assumed that the electrodes are badly connected to
the patient, or that there is no patient connected, emitting the corresponding messages.
The energy supplied in each phase of the wave is dynamically adjusted based on the impedance
of the patient:
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TECHNICAL MANUAL DGG 700 B
Discharged energy waveforms at differente patient impredance, for a selected energy of 200 J:
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TECHNICAL MANUAL DGG 700 B
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TECHNICAL MANUAL DGG 700 B
At the present time greater efficiency has been demonstrated for biphasic wave defibrillation
than for traditional single-phase waves, since they require less energy for this purpose; it also
being noted that the displacements that the aforementioned wave gives rise to on the ST
segment of the ECG are less, likewise presenting lower incidence of cardiac dysfunction after
defibrillation.
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TECHNICAL MANUAL DGG 700 B
PRINTER
Power Supply
NiMH Filter
Battery
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TECHNICAL MANUAL DGG 700 B
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5.
DIBUJADO:
Graphic LCD
(Hitachi)
REVISADO:
ANULA A / FECHA:
Microphone J3
TFT Planar
CANT.
TECHNICAL MANUAL
J6
ESCALA /
Screen J5 DGS 04_ A
Keyboard (Display Block Board)
J2 JP1 J8
Functions
J1
Keyboard
Connections Diagram
DGS 03_ A
DENOMINACION:
J2 J2
(Printer J10 +-
J1 J3 Capacitor
Support
J3 Board)
J4 J11
J10 J11 J3 J5
J27 J7
(CPU + J26 J1
Power J6
J1(High Voltage
J4 J2 J1 J2
(Power Supply Filter)
Patient + Supply J7
J12 Board) J3 J8
TES 106 A Comprocessor
SpO2 (SpO2 J16 Board) J20 J13
Connector
J1 Board) J2
J21 J6 J5
CONNECTIONS DIAGRAM
Patient Cable J18
Connector J2
J3 J3
DGS 07_ A
APEX J19 J1 (Pacemaker
J13 J24 EXT
Speaker Board)
CODIGO:
Multifunction
Connector
DGG 700 B
TECHNICAL MANUAL DGG 700 B
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TECHNICAL MANUAL DGG 700 B
6. CPU Board
SH2
Basic
Patient Signal Audio
Cable Adaptation ADuC
Coprocessor
Audio Memory
(messages)
CPU Board
SH2
Power
Supply
Audio
Compact Recording
Flash
6.2 Description
The main function of the CPU Board is to control all the functions that the REANIBEX 700
Series must perform, as well as to carry out the monitoring of the patient, and in case of units
that have the Semiautomatic Defibrillator option, to carry out an analysis of the ECG signal, to
emit the user guide messages both on-screen and audibly, and to control the interface with the
Compact Flash card in which the recording of all of the procedure information is carried out.
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TECHNICAL MANUAL DGG 700 B
In the CPU Board three well-differentiated parts can be distinguished, each of which
implements one of the previous functions:
- CONTROL – In charge of the control of the different modules of the unit as well
as of the control of the user interface elements (on-screen information, indicating
LEDs, keyboard and basic audio). Within this area the principal microprocessor is
to be found.
- PATIENT MONITOR - In charge of the patient interface (both signal capture and
provision of treatment) of input signal adjustment, of impedance measurement and
of the detection of the QRS complexes for the measurement of the Cardiac
Frequency (CF), operation in On-Demand mode of the Pacemaker (optional) and
synchronized shock.
In the following sections, each of these parts is described one in greater detail.
6.2.1 Control
Within this area the principal microprocessor (SH-2 de Hitachi), entrusted with execution of the
main software of the REANIBEX 700 Series and of the control of the rest of the modules and
cards of the unit, is to be found. Within this processor the main program, which is entrusted
with the control of the different elements of the unit, is executed:
- HV Card
- SpO2 Card
- Pacemaker Card
- Patient monitor
- Coprocessor
- Recorder
- Screen
- Keyboards
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TECHNICAL MANUAL DGG 700 B
- Basic audio
- Series line Controller (for recording of the unit software)
Control
Serial Line
Memory Keyboard
Controler
Register Screen
SH2
Basic
Audio
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TECHNICAL MANUAL DGG 700 B
Patient Monitor
Paddles /
electrodes Power
I2C Supply
Bus
Relays
Patient Signal
Cable Adaptation ADuC
ECG signal capture can carry out by means of them following elements:
Furthermore it adapts the patient signal, where three parts can be differentiated:
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TECHNICAL MANUAL DGG 700 B
Signal Adaptation
QRS Detector ADuC
APEX EXTER
27 Hz Zp Zp
Generator Adaptation Meter
ADuC
Vref
Measurement of the impedance of the patient (Zp) is carried out by injecting an electrical
signal to the patient through the defibrillation electrodes. This is a 27 KHz sine wave signal,
of 1 mA, in a way that does not affect the patient. It is isolated.
The impedance meter is capable of distinguishing four situations depending on the patient's
impedance:
B) QRS Detection – The purpose of this module is the detection of onset of rise of QR in order
to allow the calculation of the cardiac frequency.
QRS detection is also necessary in order to synchronise the discharge of the defibrillation
pulse with the ECG, in the case that the Synchronisms option in <Manual >Defibrillator
mode is activated, or in the case of Ventricular Tachycardia (VT) in Semiautomatic
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TECHNICAL MANUAL DGG 700 B
Defibrillator mode. The QRS ONSET must be detected in a time less than that given in the
following sections: ANSI/AAMI DF2-1996 section 4.3.17, IEC 60601-2-4 section 104. It is
recommended that the time be less than 60 msec.
The shock is synchronized in both cases with the QR ONSET, at 30msec ± 5 msec from the
start of the ONSET.
This meter allows frequency cardiac of up to 300 pulses per minute to be detected.
Sample Negative
ECG Signal Peaks
& Filtering Peak
Detector
Hold sInverter
Comparator Monoestable
QRS_Signal
Finally the QRS signal, that is a rectangular pulse of 200 msec of duration, is obtained. A
QRS_signal will be generated whenever a QRS is detected in the ECG signal.
C) Detection of the Type of cable connected and of a loose lead - This part is entrusted with
determining what type of cable is connected to the REANIBEX 700Series and with
detecting if any of the leads of the above-mentioned cable are disconnected. Depending on
the type of patient cable and of the leads that are disconnected different outputs will be
obtained and visualized.
D) Adaptation and filtering of the ECG signal - It is necessary to adapt the ECG signal to
the characteristics of the equipment, whether it be captured by the electrodes or by the
paddles or by the patient cable. For this purpose adjustment is made in gain and the signal
is filtered. All of this processing allows to the ECG signal to be correctly visualized on-
screen.
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TECHNICAL MANUAL DGG 700 B
This module is only present in those units that have the Semiautomatic Defibrillator option. The
functions of this module are the following:
- Analysis of the ECG signal samples and issue of a diagnosis
- Issuing of audio messages that guide to the user in his procedure
- Audio recording both of the unit and of the scene
- Management of the interface with the Compact Flash memory card for recording
both the ECG signal samples, and the events, and optionally the audio when
working in Semiautomatic Defibrillator Mode.
Coprocessor
Audio Memory
(messages)
SH2
Power
Supply
Audio
Compact Recording
Flash
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TECHNICAL MANUAL DGG 700 B
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TECHNICAL MANUAL DGG 700 B
C128,C133-
C139,C141,
C152,C154-
C156,C172,
C181,C199,
C227,C243,
C245,C258
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TECHNICAL MANUAL DGG 700 B
C210-C214,
C218-C219,
C221-C222,
C224,C228-
C229,C231-
C233,C235-
C236,C238-
C239,C242,
C244,C248-
C250,C252-
C254,C256-
C257,C259,
C263,C270-
C271
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TECHNICAL MANUAL DGG 700 B
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TECHNICAL MANUAL DGG 700 B
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TECHNICAL MANUAL DGG 700 B
118 6 NFW31SP506X1E4 EMI Filter for high speed lines (muRata) L70-L75
122 1 OUPIIN 3213-40C00SB2A Straight flat cable connector of 2x20 pins J15
raster 1.27mm (JAE).
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TECHNICAL MANUAL DGG 700 B
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186 1 R_2512_0R18_5% 0.18 ohm resistor power 1W, format 2512 R75
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TECHNICAL MANUAL DGG 700 B
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TECHNICAL MANUAL DGG 700 B
HV Board
NiMH 10-16 Vdc
Battery (external supply)
Power Supply
47-63 Hz,
Tarjeta CPU Distribution + 90-264 Vac
battery charger
CAPACITOR
Charge
Alarms Alarms
pulses train
H Circuit Coontrol
(CPU Board)
7.2 Description
The High Voltage Board (HV) mainly carries out the following functions:
• Charge and discharge of the defibrillation capacitor
• Control of the supply to the unit
• Battery charger
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TECHNICAL MANUAL DGG 700 B
In order to ascertain the necessary charge voltage, the energy selected by the user and the
patient impedance must be known, so that depending on these according the capacitor can be
charged as required.
The capacitor is charged via a sequence of pulses that allows the capacitor to reach the energy
required. The frequency of this sequence is controlled by the capacitor voltage (signal between
0 and 5 volts).
When an overrun is detected in the level of energy required, charging is stopped and the
capacitor discharges internally, giving an error indication. As the charge is dependant on this
signal, in the event of a breakdown in the microprocessor for whatever reason, a warning might
not be given, but there would be no discharge.
The energy of the positive and negative phases of the biphasic waveform are dependent on
patient impedance.
Once the capacitor has been been charged, if after 15 seconds in Semiautomatic Defibrillator
mode, or 60 seconds in Manual Defibrillator mode, the SHOCK has not been carried out on the
patient, the above mentioned energy is internally discharged. The equipment maintains the
capacitor charge during all this time interval, recharging if necessary the energy lost due to the
self-discharge of the main capacitor. In this way it ensures that the energy given the patient is
always within the established limits (±15% or ± 3 Joules).
Before beginning charging and once this is completed, the impedance of the patient is
monitored.
If the unit is operating with multifunction disposable electrodes and the impedance measured,
before starting to charge, is greater than 2800 Ω (open circuit) or less than 15 Ω (short circuit),
it will not be allowed charge the energy giving an on-screen message that the electrodes should
be checked. If, once the energy has been charged and before proceeding to shock the patient, the
value of the measured impedance is greater than 2800 Ω or less than of 15 Ω, the energy
internally discharges, providing notification of what has occurred.
In the case of working with reusable paddles the unit will allow charging of the energy without
the patient being connected, nevertheless if a short circuit is detected in these paddles charging
of the energy will not be permitted.
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TECHNICAL MANUAL DGG 700 B
Once the energy has been charged, and before proceeding to shock the patient, the value of the
impedance of the patient will also be verified, in order to determine if the shock can continue or
not.
Capacitor
Charge Discharge
Circuit C Rd Rtr Zp
Circuit
VC
Adaptador
T1 T3 T2 T2 T4 T4
(+) (+) (-) 2(- (-) 4(-
) )
This part of the unit is in charge of controlling supply to the unit, and of carrying out charging
of the NiMH battery when this is installed in the unit, which is in turn connected to an external
alternating power supply (47-63Hz, 90-264 Vac) or direct (10-16 Vdc). Charging of the NiMH
battery is carried out independently of whether the REANIBEX 700 Series is switched on or
switched off.
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TECHNICAL MANUAL DGG 700 B
CPU Board
Power Supply NiMH
Battery
Distribution
Battery
CPU Board
Charger
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TECHNICAL MANUAL DGG 700 B
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TECHNICAL MANUAL DGG 700 B
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TECHNICAL MANUAL DGG 700 B
Pacemaker Board
Power Supply
Constant Disposable
12 V Filter 125 V Current Electrodes
(Patient)
Generator
Pulse control
CPU Board and
monitoring
8.2 Description
This board is entrustd with generating the stimulation pulses when operating in Pacemaker
mode. The pulses emitted have a width of 40 msec, their amplitude can be varied from 5 to 150
mA in steps of 5 mA and the frequency of emission of the pulses can vary from 30 to 180 ppm
in steps of 5 ppm.
Basically this board includes a constant current source that provides energy for the pulses a
control section in charge of the supervision of the pulses emitted in order to ensure that they are
correct.
In this board the various protections that ensure that the pacemaker works correctly, avoiding
risk for the patient, are implemented
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TECHNICAL MANUAL DGG 700 B
- The amplitude of the pulses given to the patient is monitored in order to verify that
it is appropriate. This information is sent to the CPU for its processing
- It implements a redundant control of the width of the pulses emitted, in order to
ensure that in no case does this exceed 60 msec., even supposing that the main
microprocessor of the CPU board becomes damaged.
Control both of the stimulation frequency and of the amplitude of the pulses, is effected by the
CPU Board. This board and specifically the main microprocessor, is that which indicates to the
pacemaker board when it must emit a pulse, and what must be its amplitude.
Furthermore the pulses emitted are controlled in the CPU board by means of monitoring signals
that come from the pacemaker board.
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TECHNICAL MANUAL DGG 700 B
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TECHNICAL MANUAL DGG 700 B
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TECHNICAL MANUAL DGG 700 B
1 6 M3 Washer M3 ARAN1,
ARAN2,
ARAN3,
ARAN4,
ARAN5,
ARAN6
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TECHNICAL MANUAL DGG 700 B
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TECHNICAL MANUAL DGG 700 B
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TECHNICAL MANUAL DGG 700 B
9. Display Board
Display Board
Only for
Automatic equipments with
CPU
Microphone Gain Board
Semi-Automatic
Defibrillator
Control option
Only for
CPU Board
Contrast Display equpment with
Planar PLANAR
Control display
9.2 Description
This board is located in the display block that contains the unit screen and a part of the keyboard
(keyboard display). This card carries out the following functions:
- It holds the inverter necessary for the LCD type screen lamps
- It controls the contrast for the screens, depending on temperature
- It carries out the recording of external audio of the scene by means of a microphone
positioned in this scene.
- It measures the ambient temperature by means of a temperature sensor
- It serves as interface between the keyboard display and the CPU board
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TECHNICAL MANUAL DGG 700 B
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TECHNICAL MANUAL DGG 700 B
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TECHNICAL MANUAL DGG 700 B
Functions
Keyboard Interface CPU Board
10.2 Description
This board basically serves to physically support the unit recorder and to act as interface
between the functions keyboard positioned in the front part of the unit and the CPU board
entrusted with control of the unit.
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TECHNICAL MANUAL DGG 700 B
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TECHNICAL MANUAL DGG 700 B
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TECHNICAL MANUAL DGG 700 B
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TECHNICAL MANUAL DGG 700 B
VAC Signal
EMC Power
(mains) Filter Supply
EMC
VDC Signal HV Board
Filter
11.2 Description
This board has two EMC filters for the input supply signals. There is one filter for the electrical
mains signal (VAC) and another for the signal that comes from a constant external power
supply (VDC).
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TECHNICAL MANUAL DGG 700 B
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TECHNICAL MANUAL DGG 700 B
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TECHNICAL MANUAL DGG 700 B
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TECHNICAL MANUAL DGG 700 B
The different self-tests that the unit runs, and their frequency, are given below:
TYPE OF TEST
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TECHNICAL MANUAL DGG 700 B
COPROCESSOR
Each of the self-checks and/or checks that the REANIBEX Series 700 performs in different tests
that it carries out is described below (at start-up, while operating, at start up of the module and
Test Hardware manuals):
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TECHNICAL MANUAL DGG 700 B
1- FLASH MEMORY - Perform the standard CRC test, in order to verify the
integrity of the memory. With this test the resources (Font and Texts) and the
parameters of the unit are tested.
2- RAM MEMORY - The state of the RAM memory of the unit is checked
5- SUPPLY - It tests the general supply of the unit. The value has to be kept pre-
defined limits (10-16V). This supply refers to the DC_SENSE generated in the
supplies commutator.
- Discharge Process - During this test, the discharge circuit is checked. Two
possible situations can occur:
If the capacitor does not discharge it means that one of the branch
components is in open circuit or that the lead circuitry does not work
correctly.
If on the contrary the capacitor discharges rapidly, it means that part of the
other branch is in short circuit, which would produce an alarm due to over-
current.
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TECHNICAL MANUAL DGG 700 B
- Discharged energy and biphasic pulse phases time - It verifies during the
discharge, that the phase times of both the biphasic pulse and the discharged
energy are within the established limits.
- Communication with the paddles - The purpose of this test is to check the
correct operation of the I2C bus that communicates with the paddles
11- PACEMAKER - During this test apart from comunication with the Pacemaker, the
following points are tested:
- 125 V Source - The control signal will be viewed to see if the source works or
not.
- Pulse time - Checks that the duration of the pulse provided by the pacemaker is
correct and does not exceed the established limits.
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TECHNICAL MANUAL DGG 700 B
14- PATIENT CABLE and PADDLES -At start-up the presence of patient cable and
paddles connected to the unit, and the type, will be detected and identified
15- NiMH BATTERY: Presence and condition - The V_BATT signal is viewed, to
check the carge of the battery and to provide the corresponding indications.
16- COMPACT FLASH: Presence and status - If there is no coprocessor there will
be no CF. In the case that there is, to check its status and the memory capacity that it
still has for recording. Also it will check the capacity of the memory card.
This is a manual Test that is carried out on request of the user that enters Configuration mode.
By means of this test all the hardware elements of the system will be checked. If in a period of
30 days there has been no discharge, the equipment will indicate the need of carrying out a
Hardware Test in order to check the condition of the equipment.
To execute this Test, it is necessary to enter the Configuration mode. For this it is necessary to
switch the equipment on keeping pressed the MENU key positioned in the lower part
of the front panel of the unit. Once in Configuration mode, the option " 5. Test " is entered and
within it, the option " 5.1 Test Hardware ".
Once this option has been entered, by pressing the key this test starts. As this is
executed, on the screen of the unit the result of the different checks that comprise this test
appear.
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TECHNICAL MANUAL DGG 700 B
PRINT PAGE
If an error is detected, it will be shown associated with the element in which it has detected the
error code. If on the contrary the results of the checks performed are correct, an "OK",
associated with each one of the elements, will be shown on-screen.
In addition, beside the CPU test, the value of the temperature measured by the sensor placed in
the unit appears. In the case of the battery and supply there the value of voltage read appears.
The value of the battery voltage will depend on its capacity.
Once all the self-checks included in this section have been completed, the results of these can be
PRINT
printed on the unit recorder by means of the key located below the screen. The
appearance of the printed results appears in the following figure:
It is recommended not to carry out this Test Hardware more than 5 consecutive times to avoid
excessive temperatures in the test resistance located the interior of the unit. If it is required to
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TECHNICAL MANUAL DGG 700 B
carry out this test more often, it is recommended to switch the equipment off for an interval of at
least one hour.
If the " PAG " key is pressed and the recorder is operative, there a test sheet will be printed on it
whose purpose is to ensure that it prints correctly. The appearance of the test sheet must be as
follows:
=========================
=========================
---- -----
TEST PAGE
SN 12345678
This option allows the operation of the accessories connected to the equipment, understanding
as such, the patient cables and the paddles, to be checked.
In the case of the paddles the type is shown and beside a symbol that indicates if the paddles are
in short circuit (__) or in open circuit (_ - _).
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TECHNICAL MANUAL DGG 700 B
RA LA LL RL V1 V2 V3 V4 V5 V6
?
1- PATIENT CABLE – Indicates the type of patient cable that is connected the unit (3,
5 or 10 lead) in the moment of carrying out the test. In the case that there is no
patient cable connected to the unit itself the word NONE will be shown.
2- PADDLES – Indicates the type of paddles that are connected to the unit at the
moment of carrying out the test: External paddles (EXTERNAL), Internal paddles
(INTERNAL) or Disposable paddles (DISPOSABLE). In the case that there is no
paddle connected the word DISPOSABLE will also be shown.
By means of this Test the operation of the patient cable loose lead detection circuit can be
checked. In the lower part of the screen a representation of the patient cable leads appears. If a
cable of less than 10 leads is connected, under the name of the lead that does not exist the
symbol "-" appears. If the lead is not connected under the indication appears the symbol "X" and
if the lead is connected the symbol "O" appears.
In the RL lead the symbol "?" always appears, since this is the one that is taken as reference. If
this lead is not connected, in all the remaining leads the symbol "x" appears, since the
connections cannot be checked.
NOTE: In case of working with 3 lead patient cable, only the cable type will be indicated, but it
will not be possible to check the connection of the different leads, since with this type of cable
indication of loose lead is not given.
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TECHNICAL MANUAL DGG 700 B
This option allows the correct operating of all the keys and indicators of front panel to be
checked. When this option is accessed, a screen appears with a graphical representation of the
front panel that includes all the keys of the REANIBEX 700Series. The function keys located
below the screen appear illuminated. The correct operation of the above-mentioned keys is
checked on exiting this option, since it is necessary to touch one of the function keys to exit.
While in this option, the battery and malfunction indicators will blink a red colour, their correct
operation being checked in this way.
It is an interactive test. On pressing the different keys of the front panel of the unit, its graphical
representation is illuminated on the screen and a beep is emitted. If the above-mentioned key
has an associated luminous indicator, this is illuminated during the time that the key is pressed.
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TECHNICAL MANUAL DGG 700 B
This test, like that of the previous section, is an interactive test that allows the operation of the
interface with the reusable external paddles to be checked. On accessing this option, a graphical
representation of the paddles with all its keys appears.
If this option is accessed without having reusable external paddles connected to the unit, the
message " NOT CONNECTED " will appear. To be able to carry out the test, it is necessary to
exit from the option, to connect the reusable external paddles to the unit and to re-enter.
On pressing the different paddles keys their position is illuminated on the screen.
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TECHNICAL MANUAL DGG 700 B
13. Troubleshooting
The REANIBEX Series 700 carries out self-checks at start-up and during its operation in the
different modes, in order to detect possible problems that may cause incorrect operation of the
unit.
If an anomalous condition is detected during any of these self-checks, the equipment will act in
two different ways, depending on the type of error detected:
- SERVICE RECOMMENDED– A fault that affects some part of the unit, not
considered critical for its operation or for the operation of any of the accessories, is
detected. Depending on the type of fault detected the unit will work in a some ways
and not in others.
1. The LED service indicator placed in the front screen of the unit remains lit and
steady.
1. The LED service indicator will blink until the malfunction is corrected.
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TECHNICAL MANUAL DGG 700 B
The following list shows the different error codes that the unit may display, together with an
explanation of the system that they affect:
CODE ERROR
GENERAL errors
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TECHNICAL MANUAL DGG 700 B
13.2 Tests
In this section, the different test carried out by the equipment are described, and the error code
which is shown on screen if the verification is not fullfilled
CPU TEST
It is the basic test of the CPU. Durign this test, the following devices are tested:
- RTC - It performs a test of the format of the data readed in the real time clock (in fact, it
checks the data). If data do not have the right format, it returns the error 221.
- DUART - It performs a reading of the DUART predefining register. If the reading is not
according to the expected result, it returns the error 15.
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TECHNICAL MANUAL DGG 700 B
- Temperature sensor - It performs a reading of the temperatura and checks that the
temperature is within the established limits. If the temperature is greater than the upper limit
it returns the error 11. If the temperature is below the minimum limit, it returns the error
12.
Battery Test
It is tested if the battery is connected or not. In the case that there is a battery connected, the
readed voltage value is shown on the screen.
If the ADuC answers, several data are requested and after that, the calibration of the circuits is
performed connecting then to the calibration resistor (STG_CAL a 1).
If there have been any error the CPU goes on testing the rest of the patient monitor circuits:
1. ADuC Overall Test - The ECG is reseted setting the signal RST_BPF to 1. If the ECG
value is no within a range the equipment returns the error 32, which indicates that the
reference Vref is not 2.5V.
2. Impedance circuit Test - It is connected to the calibration resistor and the ADuC performs
the impedance circuit test. It is checked the impedance value in both the high and the low
range.
The high range is selected (signal ZP_GAIN to 1) and the impedance value is readed, if it is
higher than 250 mV, the low range is selected (signal ZP_GAIN to 0) and it returns the
error 35 and finishes the test.
If in the high range the measurement has been good, the low rango is (signal ZP_GAIN to
0). The calibration value is readed and it is saved in the ADuC Flash memory and then, it is
checked if there is deviatioon between the measure valuey and the stored value of previous
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TECHNICAL MANUAL DGG 700 B
calibrations. If the deviation is outside the established range, the equipment returns the
error 36 and finishes the test.
The calibration resistor is disconnected, and the ADuC performs the ECG circuit test.
3. ECG circuit Test. The ECG buffer is reseted (signal RST_BPF to 1) in order to dischar the
capacitor and the ECG reference signal is selected setting the signal TEST_mV to 1.
The ECG buffer is inicialized (signal RST_BPF to 0). The signal DAC1 is setted to 5V
(Corresponding to 10 mV after the divider resistor) and the ECG value is readed. If this
value is outside the established range it is returned the error 37 and the test is finished.
The ECG chanel is reades, because the ECG signal should be lessening. If this does not
happen, the ECG meter is reseted (signal TEST_mV to 0), error 37 is returned and the test
is finished.
ECG buffer is activated reseting it (positive pulse of RST_BPF), and the ECG value is
readed. If the value is less than a range, the ECG meter is reseted (signal TEST_mV to 0),
only the DAC0 is activated, error 37 is returned and the test is finished.
4. OCD Test (open circuit detection circuit for patient cable leadwire) and DAC0
converter
- DAC0 Test - Test voltages for the OCD and GND are selected (signal
TEST_LEAD_OFF to 1) as an input (signal TEST_S3 to 1). The value obtained in the
DAC0 is readed and if it is no within the limits (arround 1.25 V) error 38 it is returned
and the equipment finishes the test.
If there have been any error, test voltages for the OCD and GND are selected again, and
2.5V (signal TEST_LEAD_OFF to 1) as an imput (signal TEST_S3 to 0). If the readed
value is no within the lismit (arround 1.875V) error 38 is returned and the test is
fihished.
WARNING. If the patient cable is connected, only the first part of the test is going to
be performed.
- OCD Test - The test signal for the test voltages of the OCD is putted off (signal
TEST_LEAD_OFF to 0) and there is no patient cable connected is verified. If there is
no patient cable the equipment goes on with the test. It is check is any of the leadwires
seem to be disconnected, and if it is true error 38 is returned and the equipment
finished the test.
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TECHNICAL MANUAL DGG 700 B
Coprocessor Test
If the option is not included, the equipment advised the user and finishes the test. If the option
is included, the SH2 U3 is reseted (negative pulse in COP_RST_NOT), and the microprocessor
performs severals tests and return the result. The error codes that can return are the following:
- 100: the coprocessor does not communicate.
- 101: the coprocessor does not have recorded the audio messages
- 102: the coprocessor does not undertand command codes, misundestanding between
SW versions.
- 103: error in the 3.3 V power supply. The voltage reading performed by the
microprocessor is no within the limits.
- 104: error in the audio recorder. There is an error in the communication with the
compressor.
If there have been any error, the equipment returns the code, and if it no returns OK.
After this, the wellcome message is emitted to check the audio reproduction. It the wellcome
message is no heared, check the following elements:
- The speaker must be connected.
- Check the reproduction path (U18, U68 y U15).
- Check that U7 is recorded
Defibrillator Test
This test is made up by several verifications that perform consecutively. If there is an error in
any of then, the equipment does not perform the following test and at the end of this
verification, an OK is shown on screen if there have been any error or the error code.
1. Presence Test - Alarms are configurated, so that it could be possible to distinguish is the
40 pin flat cable is connected or not. If there is no cable, the error 40 is reported and the
test is finished.
2. Low voltage Test 15V power supply is activated (PWRON_15 to 1), the main capacitor is
disconnected from the discharge resistor (HV_STG0 to 1) and a charge at a low voltage is
programmed (200 V in this case). During this process the following errors can occur:
- error 47: charged voltage do not coincide with the programmed one
- error 44: fast charge. The possible cause of this error is that the main capacitor is
not connected.
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TECHNICAL MANUAL DGG 700 B
If there have been an error, the discharge resistor is connected to assure the protection and
the test is finished. Otherwise, the capacitor charge is mantained for the following phase.
4. High voltage Test - This test is similar to the low voltage one, but a higher voltage (800V).
The errors that can occur are the same as in the low voltage test.
- error 47: the charge voltage does not fit in with the programmed one.
- error 44: fast charge
- error 45: slow charge
If there has been any error, the discharged resistor is connected for protection reasons, and
the test is finished. On the contrary if the test has been correct, the main capacitor is left
charged for the next step.
5. Discharge circuit Test - It is assumed that the main capacitor is charged to a voltage of 800
V. The Test resistor is connected (STG_1 y STG_2 to 1) and several elements are tested:
• Relays Test - Alarms are activated and the discharge through the first branch is forced
(HV_SCR1, HV_IGBT3 and HV_IGBT33 to 1 // HV_SCR2, HV_IGBT4 and
HV_IGBT44 to 0). The oscilator is switched on and it is tested is a discharged has been
produced. Then, the discharge is forced through the second branch (HV_SCR1,
HV_IGBT3 and HV_IGBT33 to 0 // HV_SCR2, HV_IGBT4 and HV_IGBT44 to 1) and it
is tested if the discharged has been produced. The error codes that this test can generate are
the following ones (if there has been any error the test is finished):
- error 50: Error in the two discharge branchs
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TECHNICAL MANUAL DGG 700 B
Then, the Relay 1 is disconnected (STG_1 to 0) and it is tested that there has not been a
lost in the voltage. On the contrary, the error 51 is returned and the test is finished.
After thar, the Relay 1 is again connected (STG_1 to 1), Relay 2 is disconnected (STG_2
to 0) and it is tested that there has not been a lost in the voltage. On the contrary, the
error 52 is returned and the test is finished.
Finally the discharge circuit is tested through the discharge resistor. The Relay 2 is
connected (STG_2 to 1) and the discharge resistor is (HV_STG0 to 0 and STG_2 to 0). It
is tested that the discharge has performed. If there has been any discharga, the capacitor is
discharged through the test resistor, the error 53 is returned and the test is finished.
If there has been any error, se the discharge resistor is disconnected (HV_STG0 to 1) and
the Relay 2 is connected.
• SCR-s Test - All the semiconductors are opened, and another high voltage test is
performed to charge the main capacitor to 800 V. If there has been any error, it is started
with the SCR-s Test.
First, the SCR_1 is tested. Only the iGBT-s are connected (HV_IGBT3 and HV_IGBT33
to 1) and the SCR_1 is remained open. If it is discharged the error 62 is returned and the
test is finished. If there has been any error, both the iGBT-s (HV_IGBT3 and HV_IGBT33
to 1) and the SCR (HV_SCR1 to 1) are connected and it is tested is there is a discharge. If
there is no dicharge, it is returned the error 62 and the equipment finishes the test.
Next, the SCR_2 is tested. Only the iGBT-s are connected (HV_IGBT4 and HV_IGBT44
to 1) and the SCR_2 is kept open. If it is discharged the error 63 is returned and the test
is finished. If there has been any error, both the iGBT-s (HV_IGBT4 and HV_IGBT44 to
1) and the SCR (HV_SCR2 to 1) are connected and it is tested is there is a discharge. If
there is no discharge, the error 63 is returned and the test is finished.
• iGBT-s Test - The first branch is closed (HV_IGBT3, HV_IGBT33 and HV_SCR1 to 1)
and the second one is opened (HV_IGBT4, HV_IGBT44 and HV_SCR2 to 0). The
oscilator is switched on, and the discharge is being carring out is checked. Then the iGBT3
is opened (HV_IGBT3 to 0) and that there is no discharge is checked. If there has been any
error, the error 64 is returned and the test is finished. The same process is repited for the
iGBT33. If there is an error, the error 65 is performed and the test is finished.
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All the semiconductors are opened and the branch is changed (HV_IGBT3, HV_IGBT33
and HV_SCR1 to 0 // HV_IGBT4, HV_IGBT44 and HV_SCR2 to 0). The iGBT4 and the
iGBT44 are tested. The corresponding errors are error 66 and error 67.
All the semiconductors and the test resistor are disconnected (STG_1 y STG_2 to 0).
• Time protection Test - Alarms are restarted (positive pulse in HV_REARM), a virtual
discharge of 50 msecs is performed (HV_SHOCK to 1 and the oscilator is switched on)
and the time alarm is checked. If the alarm does not produce between 20 and 30
miliseconds, the error 42 is returned because it should trip after 24 msec. Alarms are
restarted, the discharge resistor is disconnected and the test result is returned.
Finally, the main capacitor is discharged, all the semiconductors are opened, the test
resistor is disconnected, the discharge resistor is connected and the15V source is switched
off.
Pacemaker Test
If this option is not included the equipment advises the user and finishes the test.
If the option is included, the pacemaker is connected to the internal resistor, and the relays
control signal as configured as follow: (STG_1 to 0, STG_2 to 1, STG_3 to 0). The Flyback
source is activated using the control signals (PMK_ION and PMK_FLYBACK to 1).
1. 125V source Test - SENSE_DC_A chanel is selected in the multiplexer U8 and the
collected value in the CPU is readed through an AD converter (AN4). If this value is no
within a range (arround 125V), the error 70 is returned and the test is finished.
2. DAC(U3) Test - A serie of values are programmed in the converter DAC(U3), the VDAC
chanel in the multiplexer U8 is selected and the collected value in the CPU is readed
through an AD converte(AN4). If this value is not within a limits ( 90% of the programmed
value), the error 71 is returned and the test is finished.
3. Pulse current Test - The pulses are programmed with an amplitude from 20 mA to 100
mA. For each current pulse the following verification is performed:
- The corresponding current is programmed
- It is verified that there is no current to the patient through the upper chanel of
SENSE because the pulse is not active. If it is not true, the error 74 is reported and
the test is finished.
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TECHNICAL MANUAL DGG 700 B
- The pulse is activated and the two SENSE signal are readed. If there is deviation
outside the range between the two measurements the error 72 is returned and the
test is finished. If the two measurements are equal, one of then is comparated with
the programmed value. If there is a deviation outside the ranga the CPU reports the
error 73 and finishes the test.
4. Pulse protection Test - A low current is programmed (20mA) and the pulse is activated
(PMK_PULSE to 1), the equipment watis for 80 ms and read the current in high SENSE. If
there is more than 5 mA the protection has fault, because there should have tigger at 65 ms.
The pulse is desactivated (PMK_PULSE to 0) and a null current is programmed. If there is
an error, the error 75 is returned and the test is finished.
When the pacemaker test is finished, the supply is disconnected (PMK_ION and
PMK_FLYBACK to 0) and the pacemaker internal resistor is disconnected (STG_2 to 0). To
finish the test result is returned: OK if all the tests have fullfilled or the code of the first error.
Pulsioximeter Test
In the case that the option is not included, the equipmente avised the user.
If the option is included, the equipment resets the pulsioximeter through the DUART and waits
the pulsioximeter inicial message. If the message is the corret one, the equipment shows the
type of pulsioximeter and if not, it returns the error 80.
Recorder Test
In the case that there is no recorder, the equipmente avised the user.
If the option is included, the equipment checks the recorded status reading one of its pins. If this
pin is no correct, it returns the error 90 and finishes the test.
After the inicial verification, it is tested if the recorder door is open or if it is out of paper and
the equipment finishes the test showing the result of the test.
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TECHNICAL MANUAL DGG 700 B
When the REANIBEX 700 Series detects some anomaly on performing the different self-checks
(at start-up, while operating, at start up of the module and during manual tests), this fact will be
reflected by means of the malfunction indicator located in the equipment screen (blinking or it
will remain steady depending on the type of error detected) and by means of on-screen
messages. This indication will be given whenever the equipment is switched on until the
malfunction is resolved. Furthermore if the error detected is critical and prevents initiation of
procedure with the unit, at start-up a screen will appear along with an error code.
In the case that the error affects only some modules of the unit, whenever it is attempted to
access this module an error detected indication will be given by means of an on-screen message,
and access to this operating mode will be prevented.
If the unit shows an error screen with a code, it will be possible to start it only in
“CONFIGURATION MODE”, and its start-up to provide treatment to a patient will never be
allowed. The purpose of allowing start-up of the unit only in this mode of operation is to allow
the user to carry out different Manual Tests to determine in which elements or modules the error
has been detected.
To access the Configuration Mode, it is necessary to switch the unit on keeping pressed the
MENU key located in the front panel, until the configuration screen appears.
As soon as the configuration mode main screen appears, the option “5. TESTS”, should be
accessed, and within this “5.1 TEST HARDWARE”, since this is the test entrustd with
checking the main elements of the unit.
If after carrying out the test, the error continues, the equipment needs to be repaired. By means
of the error code or codes indicated during the carrying out of the Hardware Test the elements
or equipment modules whose operation is considered to be faulty can be determined.
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TECHNICAL MANUAL DGG 700 B
ACTIONS TO BE
PROBLEM OBSERVED
PERFORMED
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STARTUP The unit does not start If working from battery, use a fully
charged battery or connect the unit to the
mains or to an external battery
Check the connections to the HV Board
of the internal battery, the mains supply
and the external battery
Check the battery terminals and the
polarity of the battery connectors, of the
external mains and of the external
battery
Check the internal fuse and confirm that
it has not blown
Check that the start-up key works
correctly, and check the connection
between the keyboard and the Display
board
Check the connections between the HV
Board and the CPU board and between
the CPU board and the Display board
Check or replace the CPU board
Check or replace the HV board
Check or replace the Display board
KEYBOARD The equipment does not Make sure that the equipment has supply
DISPLAY KEYS respond to pressing of (internal battery, mains connection or
the keys located in the external battery)
display area of the
Check the display keyboard by means of
keyboard or the LEDs
the Interface Test
associated with this area
do illuminate Check the connections between the
keyboard and the Display board
Check the connections between the
Display board and the CPU board.
Check or replace the CPU board
Check or replace the Display board
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TECHNICAL MANUAL DGG 700 B
KEYBOARD The equipment does Make sure that the equipment has
FUNCTION KEYS not respond to pressing supply (internal battery, mains
of the keys located in connection or external battery)
the functions area of
Check the functions keyboard by
the keyboard, or the
means of the Interface Test
LEDs associated with
this area do not Check the connections between the
illuminate keyboard and the printer support board
Check the connections between the
printer support board and the CPU
board
Check or replace the CPU board
Check or replace the printer support
board
BATTERY AND The supply indicators Check the connections of the internal
do not illuminate battery, the mains supply and the
MAINS
external battery, to the HV board
INDICATION
Check the functions keyboard and the
indicators by means of the User
Interface Test
Check the connections between the
keyboard and the printer support board
Check the connections between the
HV board and the CPU board.
Check the connections between the
printer support board and the CPU
board
Check or replace the CPU board
Check or replace the HV board
Check or replace the printer support
board
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This icon appears on Make sure that all the patient cable
screen leads are correctly positioned
Check and if necessary replace the
patient cable
Check and if necessary replace the
patient cable connector
Check the connection of the patient
cable connector to the CPU board
Check or replace the CPU board
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TECHNICAL MANUAL DGG 700 B
RECORDER This icon appears on Make sure that the recorder has paper
screen and that the door is closed
Check the connections between the
recorder and the CPU board
Check or replace the recorder
Check or replace the CPU board
COMPACT FLASH This icon appears on Make sure that the card inserted in the
CARD screen unit is the correct one
Check the Compact Flash card
connector
Check or replace the CPU board
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TECHNICAL MANUAL DGG 700 B
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TECHNICAL MANUAL DGG 700 B
Electrical Medical Device requires special precautions with respect to EMC and needs to be
installed and put into service in accordance with the EMC information provided in this document.
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TECHNICAL MANUAL DGG 700 B
ELECTROMAGNETIC IMMUNITY
The REANIBEX Serie 700 is designed for use in electromagnetic environments such as those
specified below. The client or user of the REANIBEX Serie 700 must ensure that is used in this
environment.
Surges ± 1 kV Complies
IEC 61000-4-5 differential mode
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TECHNICAL MANUAL DGG 700 B
ELECTROMAGNETIC IMMUNITY
The REANIBEX Serie 700 is designed for use in electromagnetic environments such as those
specified below. The client or user of the REANIBEX Serie 700 must ensure that is used in this
environment.
Recommended distances of
separation
d =1.15 √P of 800MHz at
2.5GHz
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TECHNICAL MANUAL DGG 700 B
a
The ISM bands (Industry, scientific and medical) between 150 KHz and 80 MHz are from 6.75
MHz to 6.795 MHz; from 13.553 MHz to 13.567 MHz; from 26.975 MHz to 27.283 MHz; and
from 40.66 MHz to 40.70 MHz.
b
The degree of compliance in the ISM frequency bands between 150 KHz and 80 MHz and in the
range of frequencies from 80 MHz to 2.5 GHz, is designed to reduce the probability that the
mobile/portable communications device may cause interference if it is inadvertently brought into
patient areas. For this reason, an additional factor of 10/3 is used in the calculation of the separation
distances recommended in these frequency ranges.
c
The field intensity of fixed transmitters, such as base stations for radio (cellular and wireless),
mobile, land and amatuers telephones and radios, AM and FM radio broadcast, TV broadcast,
cannot be theoretically predicted with accuracy. To evaluate the electromagnetic environment
due to RF fixed transmitters, an on-site measurement must be considered. If the field intensity
measured in the location using REANIBEX SERIE 700 exceeds the applicable RF level of
compliance, the REANIBEX SERIE 700 must be examined to verify normal operation. If
abnormal operation is observed, additional measurements will be necessary as well as
reorientation or repositioning of the REANIBEX SERIE 700.
d
Around the range of frequencies from 150 kHz to 80 MHz, the field intensities must be less than
(V1) V/m
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TECHNICAL MANUAL DGG 700 B
The REANIBEX Serie 700 is designed for use in environments in which radiated RF
interferences are controlled. The client or the user of the REANIBEX Serie 700 can help to
prevent electromagnetic interferences, maintaining minimal distance between RF mobile and
portable communications device (transmitters) and the REANIBEX Serie 700 as is
recommended below, in accordance with the maximum outlet power of the communication
device.
Maximum output 150 KHz to 80 150 KHz to 80 80 MHz to 800 800 MHz to 2.5 GHz
power of the MHz outside of MHz within the MHz
transmitter the ISM bands ISM bands d=1.15 √P
d =0.6 √P
W
d =1.16 √P d =1.2 √P
For transmitters with maximum output power not specified above, the recommended distance of
separation d in meters (m) can be determined using the equation applicable to the transmitter
frequency, where P is the maximum output power in watts (W) in accordance with the transmitter
manufacturer
NOTE 1: At 80 MHz and 800 MHz the separation distance is applied for the highest frequency
NOTE 2: The ISM bands (scientific and medical) between 150 kHz and 80 MHz are from 6.75 MHz
to 6.795 MHz; from 13.553 MHz to 13.567 MHz; from 26.975 MHz to 27.283 MHz; and from
40.66 MHz to 40.70 MHz.
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TECHNICAL MANUAL DGG 700 B
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(*) This function will only be considered in the case that the Reanibex 700 Series has this
option.
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TECHNICAL MANUAL DGG 700 B
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TECHNICAL MANUAL DGG 700 B
When disconnecting cables, label these cables and the connections in a way that facilitates later
assembly. For additional information, consult the “Connections Diagram”.
Before handling the components of the equipment, make sure that the energy storage element is
discharged.
DANGER OF SHOCK: Maintenance of this unit must be carried out by properly qualified
personnel. Potentially mortal electrical discharges can occur at any time in his unit.
Some electronic components can become damaged by static electricity discharges. These static
discharges habitually occur when the operator is wearing synthetic clothes. To prevent static
shocks keep in mind the following recommendations:
• Always carry out repairs or maintenance on a surface that dissipates static electricity,
connected to earth.
• Always use a conductive wristband connected to the dissipative surface and to earth,
except when the high voltage capacitor has energy stored; in this case first discharge this
energy.
DANGER OF SHOCK: Remove the wristband when the high voltage capacitor has
energy stored; in this case first discharge this energy.
• Transport and store the PCBs in antistatic presses or in conductive bags. Label the
packaging that contains PCBs “Sensitive to static electricity”
• Keep the working area free from static electricity. For this purpose connect all electrical
equipment to earth using a 3 pin plug.
Before opening the unit, disconnect all the cables connected to it (patient cable, of SpO2 sensor
cable, paddles or disposable electrodes). When opening and closing the unit keep in mind the
assembly diagrams described in this manual.
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TECHNICAL MANUAL DGG 700 B
Once the equipment has been reassembled, enter Configuration mode and perform a Hardware
Test in order to check the correct operation of the equipment. Also carry out a series of
discharges at different energy levels, checking the energy discharged by means of a discharge
checker or QED.
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TECHNICAL MANUAL DGG 700 B
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TECHNICAL MANUAL DGG 700 B
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TECHNICAL MANUAL DGG 700 B
OSATU S.Coop., will provide on request assembly diagrams, circuit diagrams, descriptions and
any information that will help to appropriately qualified technical personnel to repair those parts
of the unit that are designated by the manufacturer as repairable.
152