BODYGUARDIAN CONTROL UNIT – BASE KIT Operator Manual
CHAPTER 1
INFORMATION ABOUT SAFETY
1.1 INFORMATION ABOUT THE MANUAL
This document contains proprietary information. No part of this publication may
be photocopied or reproduced without the prior written permission of the
manufacturer PREVENTICE.
Information in this document is subject to change and revision without notice.
Issues:
First edition:SPMHBGW1-MAN - Rev. A - November 2011
This manual is to be considered as a component of the equipment. When installing
the equipment for the first time, the user should accurately check the content of
the Manual in order to verify its integrity and completeness.
In the event the Operator Manual should be ruined, incomplete or inadequate,
please contact PREVENTICE in order to immediately restore or replace the
uncompliant Manual.
The official version of the Operator Manual, of which PREVENTICE is directly
responsible, is the English versions. For countries in which languages other than
English are spoken, the official Manual is the one in the English version.
PREVENTICE does not undertake any responsibility for any translations in other
languages made by distributors or users.
The observance of the operating procedures and of the warnings described in this
Manual is a basic requirement for the correct working of the equipment and to
guarantee the patient’s and the user’s safety.
The Manual must be read in every part in front of the equipment before using it,
in order to become familiar with the operating procedures, the commands, the
connections to the peripheral instruments, and the precautions for a correct and
safe usage.
The Operator Manual should be kept, complete and readable in every part, in a
safe place, and, at the same time, it should be rapidly accessible to the user when
using the equipment.
This Operator Manual is intended for System Builder and not for the end-user of
the device.
The equipment Service Manual is available on request. This Manual contains all
information directed to the qualified staff in charge for servicing.
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BODYGUARDIAN CONTROL UNIT – BASE KIT Operator Manual
1.1.1 CONVENTIONS
In this Operator Manual the following conventions are used:
NOTE
The NOTE messages contain important information, which must be noticeable with
respect to the regular text. Usually they have useful information for the operator:
detailed data on the correct operating procedures of the instrument.
WARNING
The WARNING messages show in the manual before operations and procedures,
which must be strictly observed in order to avoid possible loss of data or damage
to the equipment.
ATTENTION
The ATTENTION messages show in the manual in correlation with the description
of procedures and operations, which could cause injury to the operator or to the
patient, if not correctly performed.
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BODYGUARDIAN CONTROL UNIT – BASE KIT Operator Manual
1.2 DECLARATION OF RESPONSIBILITY BY THE MANUFACTURER
PREVENTICE is responsible for safety, reliability and performances of the
equipment only when the equipment is used in compliance with the following
conditions:
Calibrations, modifications or servicing must be performed by qualified staff
expressly authorized by PREVENTICE.
The equipment must be opened and its internal parts must be accessed to by
maintenance qualified staff only expressly authorized by PREVENTICE.
The environment where the equipment is used must be in compliance with the
safety prescriptions.
The electric wiring of the building must be designed according to the standards
and perfectly working.
Parts of the equipment that can be replaced by the user and accessories must be
replaced with items of the same kind and with the same characteristics.
The connection of the equipment with peripherals or other instruments supplied
by the mains must be performed according to the IEC 60601-1-1 standards
(standards for electrical safety of medical electric systems) and to the IEC
60601-1-2 standards (standards for electromagnetic compatibility).
Usage and maintenance of the equipment and of its accessories must be
performed in compliance with the instructions described in this Manual.
This Manual must be kept complete and readable in every part. The equipment is used and serviced until its “End of Life”.
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BODYGUARDIAN CONTROL UNIT – BASE KIT Operator Manual
1.3 USAGE RESTRICTIONS AND SAFETY PRECAUTIONS
In order to guarantee the patient’s and the user’s safety as well as a correct
working of the equipment, it is necessary to operate within the consented
restrictions and adopt all the precautions listed below:
ATTENTION
Prior to usage, verify that all the safety requirements are satisfied.
The equipment must not be supplied by or connected to other instruments until
such safety conditions are restored.
1.3.1 ELECTRIC SAFETY
Leakage current
The maximum patient leakage current from the equipment, measured according to
the IEC 60601-1 standard (for Type BF) is less than 100 A.
However take care when using the equipment at the same time with other
instruments. In the event the patient is connected to several instruments at the
same time, it is necessary to remember that the sum of the leakage currents
determined by each instrument may exceed this value.
Patient Connection
All patient connections to the equipment are through the device using the proper
adhesive electrode patch provided. Any patient electrodes connected to the device
by any other means may constitute an unsafe condition that could result in injury
or death to the patient.
ATTENTION
All patient connections on the device are isolated from AC power ground.
Do NOT join these connections to earth ground or AC power ground since such an
action constitute an unsafe condition that could result in serious injury or
accidental death to the patient.
ATTENTION
The electrode through which the signal is captured from the body of the patient are
not part of the amplifier system, in any case it is MANDATORY to use only
electrode or sensor approved for commercial use by FDA (USA) or/and CE marked
(93/42 EEC directive and following amendment 2007/47/EC).
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BODYGUARDIAN CONTROL UNIT – BASE KIT Operator Manual
To ensure the safety of the patient and the operator, please follow all the warnings
and caution listed in this manual.
Connect to the equipment the proper specified power supply only. In order
to guarantee the electrical safety requirements, the recharge of internal battery
pack of equipment, must be performed by means the proper medical AC/DC
adapter only. The power supply is supplied by PREVENTICE with the
equipment. The allowed models are:
Trademark FRIWO, Model FW7662M/06
To recharge the equipment place it on the Charging Cradle according to the
appropriate orientation (only one is possible due to the mechanical constraints)
and only after this operation connect the Charging Cradle to the AC/DC Power
supply and this last to the mains.
After the recharging operation is complete disconnect the AC/DC Power
supply from the mains and only after this operation remove the equipment from
the Charging Cradle.
Take care when using the equipment at the same time with other
instruments. In the event the patient is connected to several instruments at the
same time, it is necessary to remember that the sum of the leakage currents
determined by each instrument may endanger his life.
Take care when using the equipment at the same time with other radio-
frequency instruments. In the event the equipment is used in a surgery room
at the same time with a radio knife (Radio-Frequency instrument = RF), it is
necessary to hold the radio knife point as far as possible from the electrodes, in
order to reduce as much as possible the risk of RF currents making on such
electrodes and the consequent burns. Therefore it is necessary to use electrodes
with a larger surface contacting the patient body, in order to limit the RF
current density to acceptable values. In case it is not possible to use the proper
electrodes, it is recommended to disconnect the patient from the equipment
before using radio-frequency instruments.
The equipment is not protected against the defibrillator discharges. Please
remember that the equipment is not protected against the defibrillator
discharges; for this reason, in the event it should be necessary to use the
defibrillator, it is necessary to disconnect the patient from the equipment in
order to avoid the patient being burned in the electrode contact areas and the
equipment undergoing sever and irreversible damages.
Avoid contact of patient and electrodes with conductive metal items. When
the equipment is connected to other instruments supplied by the mains, the
whole input circuit to which the patient is connected is electrically isolated
(floating isolation). It is necessary to avoid the patient and any conductive part
connected to the patient (electrodes, connectors, and transducers) coming into
contact with conductive parts (ground included). Please observe this precaution
to avoid compromising the equipment isolation level. This precaution must be
observed in order to avoid that accessible metal parts of the device get in touch
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BODYGUARDIAN CONTROL UNIT – BASE KIT Operator Manual
with external conductive parts thus damaging the isolation level of the
equipment.
Do not connect additional Multiple Portable Socket-Outlet or extension
cord. Multiple portable socket-outlet or extension cord shall not be connected
to the system.
Observe the IEC 60601-1-1 and the IEC 60601-1-2 standards in case of
connection with other instruments. The connection of the equipment with
other devices is allowed only when the safety requirements for the patient, the
user and the environment are not compromised. If the Manual does not contain
enough information about the possibility of interconnection with other devices,
the user should contact the manufacturer or the nearest authorized servicing
center to have information about the effects that coupling devices may have on
the patient, the user and the environment.
Replace damaged parts immediately. Cables, connectors, accessories, or
other parts of the equipment must be replaced immediately when damaged or
not working correctly. In these cases, contact the nearest authorized servicing
center.
Do not connect items (accessories and peripherals) which are not specified
as part of the system expressley indicated by PREVENTICE. In order to
guarantee all the safety requirements, it is necessary to use only the accessories
and peripherals specified in this Manual as part of the system, which have been
tested with the equipment. The usage of accessories and consumer goods
supplied by other manufacturers or not specifically indicated by
PREVENTICE does not guarantee the safety and the correct working of the
equipment. Use only peripherals in compliance with the standards of the class
they belong to.
Check the functionality of the system before starting any recording. It is
strongly recommended to check the overall functionality of the system before
starting any recording. In case any anomalies or malfunctioning should be
noticed, immediately disconnect the patient from the system (if a patient is
already connected), switch off the system and ask for service to qualified
personnel. In particular (for example) if, with a patient connected to the
system, some anomalous tracing, like isoelectric or greatly artefacted signal,
should be noticed on the monitor during recording: in this case if the problem
should not be solved with the assembly standard technique (poor electrode
connection, broken lead etc) immediately acts as above, disconnect the patient,
do not use the system and ask for servicing.
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Periodically check that all the system works regularly during “long term
recording”. During “long term recording” (more than one hour) it is strongly
recommended to periodically check that all the system works regularly without
any sign of malfunctioning. If any anomalies or flat traces should be noted act
as in the previous warning. In particular any electrode site used for long term
must be checked for irritation and redness. Check each electrode periodically to
BODYGUARDIAN CONTROL UNIT – BASE KIT Operator Manual
evaluate the skin condition under the electrode. Redness, blistering and
permanent skin scarring can occur if electrodes are not regularly monitored.
Using the equipment on patients with a heart pace-maker is not allowed. It
is not allowed using the equipment in the case of patients with implanted
electric devices (or bed partners with implantable devices), especially heart
pace-makers, because the equipment may cause the cardiac stimulator
malfunctions. Patients with cardiac pacemakers should not undergo any
examination with this equipment without authorization and under the severe
control of a specialized physician. For the same reason it is also necessary to be
careful when using the equipment in proximity of operators or persons with
implanted electric devices
Rechargeable Battery Pack. The rechargeable battery pack installed in the
equipment contains one cell that is not accessible to the user and its
replacement should be performed only by qualified personnel, authorized by
PREVENTICE. Anyway, you should consider the following general warnings
(e.g. in case of disposal of replaced parts with technical assistance).
Do not let the ends of the battery pack to come in contact with metal
objects.
Keep away the battery pack from heat or flames. Do not immerse the battery pack and avoid exposing it to rain or
moisture.
Avoid direct mechanical trauma to the battery pack. Do not attempt to disassemble, puncture, incinerate or short-circuit the
battery. These operations may cause a fire or the emission of toxic
chemicals.
Charge the battery pack. In order to ensure the safety requirements, the
battery pack must be recharged only by using the proper Charging Cradle and
its medical AC/DC adapter, specifically provided by PREVENTICE together
with the equipment. The model of adapter to be used is:
Trademark FRIWO, Model FW7662M/06
1.3.2 SAFETY OF THE OPERATING ENVIRONMENT
The equipment is not designed to be used in locations with inflammable
vapors or gases that may cause explosions. The equipment must not be used
in atmospheres with a high concentration of oxygen or in buildings where
inflammable substances or anesthetic agents are present. The atmosphere is
considered as oxygen-saturated when the oxygen or nitrous oxide (NO2)
concentration contained in the environment is over 24%.
The equipment is not designed to be used in MRI area. The equipment
should be removed before Magnetic Resonance Imaging (MRI).
The equipment and its internal parts are protected against the inflow of
liquids according to IPX4 degree of protection. The equipment is protected
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BODYGUARDIAN CONTROL UNIT – BASE KIT Operator Manual
against the dripping, spraying and splashing of water and relevant harmful
effects. Avoid submitting the equipment to the risk of water jetting or
temporary and continue immersion because its protection degree do not
guarantees protection of internal parts against ingress of liquids. Do not use the
equipment where such risks are present. Devices in which liquids have
accidentally penetrated must be immediately cleaned and checked by
authorized qualified staff.
Use of the equipment in humid Environment is allowed if conditions are
compliant to the environmental limits defined in the following bullet, which are
in accordance with the requirements of the applicable general and particular
IEC 60601 standards.
Use the equipment within the environmental limits of specified
temperature, humidity and pressure. The equipment is designed to work in
environmental conditions that, in compliance with the IEC 60601-1 directions
and the 60601-2-47, are defined as standard:
- temperature +10°C / +45°C
- relative humidity 10% / 95% RH
- atmospheric pressure 700 / 1060 hPa
The equipment could heat up during its normal use or battery recharge. This
aspect should be considered as a normal characteristic of the equipment due to
the high integration of the electronic circuitry inside. Never the equipment
heating up should be considered as a potential fault or as a defect of the
equipment itself.
Make sure the electric wiring of the building is efficient before connecting
the power supply to the mains. When the equipment (power supply of
Charging Cradle) is connected the environmental mains, make sure that the
building wiring is correctly functioning and efficient and compliant to the local
regulations and standards.
Be careful using the equipment in locations disturbed by strong magnetic
fields. The equipment is compliant with the EMC requirements
(Electromagnetic Compatibility) according to what specified by the IEC
60601-1-2 standard and 93/42/EEC European Directive. In every case it is
recommended to keep the equipment away from disturbance sources and
induced electromagnetic fields surpassing the values prescribed by the standard
in order to avoid any possible instabilities and malfunctioning of the
equipment. For more detail about device classification and minimum distances,
please refer to paragraph 1.11 “Electromagnetic compatibility” of the present
manual.
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Be careful using the equipment near short-wave or micro-wave devices. If
the equipment is used in an area where there are also short-waves or microwave devices, it is necessary to remember that these may cause instability and
interfere with the correct working of the equipment. Do not use the equipment
near X-ray or diathermy devices.
BODYGUARDIAN CONTROL UNIT – BASE KIT Operator Manual
1.3.3 OTHER PRECAUTIONS
Take care when using the equipment on patients who are pregnant. It is
necessary to be careful when using the equipment in the case of patients who
are pregnant. These patients should not undergo any examination with this
equipment without authorization and under the severe control of a specialized
physician.
The equipment is intended for adult use only with a weight greater than 10
Kgs.
Take care when using the equipment on patients with potentially life-
threatening arrhythmias requiring hospitalization. These patients should
not undergo any examination with this equipment without authorization and
under the severe control of a specialized physician.
Take care when using the equipment on patients with known skin allergies
or sensitivities to acrylic, hydrogel or silicone adhesives.
Take care when using the equipment on patients with friable skin. It is
necessary to be careful when using the equipment in the case of patients with
sensitive skin or skin disease, because the adhesive electrode may cause skin
irritation. Patients with sensitive skin should not undergo any examination with
this equipment without authorization and under the severe control of a
specialized physician.
Do not apply creams or lotion to the skin prior to use equipment. The
application of creams or lotion could cause a bad contacts of the electrodes and
a bas adhesion of the patch and consequently a bed signal acquisition
Bodyguardian is not waterproof. The device should be removed by patient
before bathing, showering or swimming.
Bodyguardian has a usage limited to one patient at a time.
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BODYGUARDIAN CONTROL UNIT – BASE KIT Operator Manual
IEC 60601-1
SYMBOL
DESCRIPTION
POSITION
Alternating current
Symbol placed on the connection
points between the equipment and the
mains (alternating current source).
Direct current
Symbol placed on the connection
points to direct current source.
Equipotential terminal
Symbol placed on the outlet
connecting the equipment to the
equipotential node of the building, if
any.
Protective earth (ground)
Symbol placed on the connection
points between the equipment and the
protective grounding.
High voltage
Symbol placed on circuits or
equipment parts with high voltage.
Attention! Refer to the
attached instructions.
Symbol placed on items for which it is
important to read the Operator
Manual for relevant information (see
ATTENTION paragraph).
Device with CF-type applied
parts
Symbol placed on applied parts to
the patient with a CF-protection level.
parts
the patient with a BF-protection level.
parts
patient with a B-protection level.
1.4 GRAPHIC SYMBOLS IN COMPLIANCE WITH THE IEC 60601-1
STANDARD
The following table shows description and localization of all graphic symbols in
compliance with the IEC 60601-1 safety standards present on the equipment
panels and/or on any other instruments or external devices to which the equipment
may be used in cojunction to or present in the same environment.
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BODYGUARDIAN CONTROL UNIT – BASE KIT Operator Manual
IEC 60601-1
SYMBOL
DESCRIPTION
POSITION
Off (disconnected from the
mains)
Symbol placed on the off/on positions
of the whole equipment general power
switch.
On (connected to the
mains)
Symbol placed on the off/on positions
of the whole equipment general power
switch.
Off (for a single part of
equipment)
Symbol placed on the off/on switch of
a single part of the equipment.
On (for a single part of the
equipment)
Symbol placed on the off/on switch of
a single part of the equipment.
Device with Class II
protection type against
electric shock
Symbol placed in the identification
label of the equipment.
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BODYGUARDIAN CONTROL UNIT – BASE KIT Operator Manual
SYMBOL
DESCRIPTION
POSITION
Input
Symbol placed on the signal input or
mains voltage input connectors of
the equipment.
Output
Symbol placed on the signal output
or the mains voltage output
connectors of the equipment.
Rx Only
Prescription Only
Symbol placed on the identification
label of the medical device indicating
that Federal (USA) law restricts this
product to sale by or on the order of
a physician.
IPX4
Degree of protection
against ingress of water
(spashing)
Symbol placed on the identification
label of the medical device indicating
that the device is protected against
the splahing of water.
Functional Mode and
Communications status
Symbol placed close the central led
of device to indicate the functioning
and communication status of the
device
Radio Frequency emitting
device (non-ionizing
electromagnetic radiation)
Symbol placed on the identification
label of the medical device to
indicate that the device emittes
Radio-Frequency for its normal
functioning.
Lot number
Symbol placed on the identification
label of the medical device together
with the device lot number.
Battery charge status
Symbol placed close the led of
device to indicate the battery charge
status and re-charge condition.
REF
Reference number
Symbol placed on the identification
label of the medical device together
with the device reference number.
SN
Serial number
Symbol placed on the identification
label of the medical device together
with the device serial number.
1.5 OTHER GRAPHIC SYMBOLS
The following table shows description and localization of all symbols placed on
the equipment panels and/or on any other instruments or external devices to which
the equipment may be used in cojunction to or present in the same environment.
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BODYGUARDIAN CONTROL UNIT – BASE KIT Operator Manual
Date of manufacture
Symbol placed on the identification
label of the medical device together
with the device manufacture date.
Manufacturer
Symbol placed on the identification
label of the medical device together
with the name and address of the
device Manufacturer
Authorized Representative
in the European Community
Symbol placed on the identification
label of the medical device together
with the name and address of the
device Authorized Representative in
the European Community.
Crossed-out wheeled bin
Symbol placed on the identification
label of the medical device. This
symbol indicates the prohibition of
throw the medical device in the
household wheeled bin device when
at its “end of life”.
Recyclable
Symbol placed on Battery Pack. The
symbol indicates the components of
the object are recyclable at the end
of life.
Use by
Symbol placed on the identification
label of the medical device together
with the device expiration date.
Do not reuse
Symbol placed on the identification
label of the medical device. This
symbol indicates that the device is a
disposable one and cannot be used
more than once.
Sterile
Symbol placed on the identification
label of the medical device indicating
a sterile device.
Sterilization with steam or
dry heat
Symbol placed on the identification
label of the medical device indicating
a sterile device and the sterilization
method used (steam or dry heat).
Sterilization with ethylene
oxide
Symbol placed on the identification
label of the medical device indicating
a sterile device and the sterilization
method used (ethylene oxide).
Sterilization by irradiation
Symbol placed on the identification
label of the medical device indicating
a sterile device and the sterilization
method used (irradiation).
Refer to the instructions for
Use/functioning.
Symbol placed on the identification
label of the medical device
recommending to refer to the
instruction for use/functioning for
more information about the usage of
the device.
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BODYGUARDIAN CONTROL UNIT – BASE KIT Operator Manual
Temperature Limit
label of the medical device together
with the indication of temperature
limits (high and low limits) for the
usage/storage of device.
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BODYGUARDIAN CONTROL UNIT – BASE KIT Operator Manual
1.6 ATTENTION SYMBOL
The ATTENTION symbol shown below, placed on the equipment casing, refers
the user to the Operator Manual for information, warnings and suggestions which
are particularly important for a correct and safe use of the equipment.
In particular, when it is placed on connecting points or commands or led
indicators, this symbol refers the user to carefully read the Operator Manual for
instructions concerning the nature and safety of such connection and/or detailed
description of the commands and meaning of indicated events/situations for the
operator.
For location of the ATTENTION symbols placed on the equipment, please refer
to chapter 2 “Description of the Device” of this Operator Manual. This chapter
shows the pictures of the equipment panels with the corresponding commands,
connections, symbols, and labels. Each attention symbol comes with a detailed
explanation of its meaning.
1.7 PRODUCT TRACEABILITY
In order to guarantee the traceability of the product, according to what stated in
the ISO 13485 quality standard, QSR 21 CFR Parte 820 FDA, and the 93/42/EEC
European Directive on Medical Devices (and its revised version 2007/47/EC
directive), PREVENTICE kindly requests the original owner of the equipment to
give communication to our main offices of any conveyance of the product to third
parts, by sending a photocopy of the proper duly filled-in Product traceability form (see enclosure 1.7), or by communicating in writing the data indicated in the
form. The data concerning the device can be found on its identification label.
The form shall be sent either directly or through any subsidiary or the nearest
authorized distributor to the any PREVENTICE operating office. The list of the
main PREVENTICE head and branch offices is contained in chapter “Request for
assistance” of this manual.
1.8 VIGILANCE SYSTEM
The device is subject to a vigilance system (post-marketing vigilance) that
PREVENTICE and their distributors and retailers apply to the products they put
on the market to safeguard the patient and the physician from serious or
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