Information and descriptions contained in this manual are the property of Bistos
Corporation and may not be copied, reproduced, disseminated, or distributed without
express written permission from Bistos Corporation.
Information furnished by Bistos Corporation is believed to be accurate and reliable.
However, no responsibility is assumed by Bistos for its use, or any
infringements of patents or other r igh ts of third parties that may result from its use.
No license is granted by implication or otherwise under any patent or
patent rights of Bistos
WARNING: EXPLOSION HAZARD — Do not use the BT -700 in a
other materials may occur.
WARNING: Be informed that it may cause serious injury or death to the
CAUTION: Be informed that it may cause no harm in life but lead to
Section 1
Safety
1.1 Instructions for the Safe Operation and Use of the
BT-700
Examine the monitor and any accessories periodically to ensure that
the cables, line cords, transducers, and instruments do no t have visible
evidence of damage that may affect patient safety or monitoring
performance. The recommended inspection interval is once per week
or less. Do not use the monitor if there is any visible sign o f damage.
Only the AC line cord supplied with the BT-700, or its eq uivalent, is
approved for use with the Unit.
Do not attempt to service the BT -700 monitor. Only qualified service
personnel should attempt any needed internal servicing.
The BT-700 is not specified or intended for operation during the use of
defibrillators or during defibrillator discharge.
The BT-700 is not specified or intended for operation in the presence
of electrosurgical equipment.
The BT-700 is not specified or intended for operation in conjunction
with any other type of monitoring equipment except the specific
devices that have been identified for use in this Operator’s Manual.
Perform periodic safety testing to insure proper patient safety. This
should include leakage current measurement and insulation testing.
The recommended testing interval is once per year.
1.2 Warnings
patient, property damage, material losses against the “Warning" sign.
injury against the“ Cautio n" sign.
flammable atmosphere where concentrations of flammable anesthetics or
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WARNING: Do not connect to an electrical outlet controlled by a wall
WARNING: SHOCK HAZARD — Do not attempt to connect or
WARNING: Use only patient cables and transducers supplied with the
CAUTION: Keep the operating environment free of dust, vibrations,
CAUTION: The releva nt law restricts this device to sale by or on the orde r
CAUTION: When instal ling the unit into a cabinet, allow for adequate
CAUTION: Do not operate the unit if it is damp or wet because of
CAUTION: Never use sharp or pointed objects to operate the front-panel
WARNING: Do not contact RS-232C port and patient at the same time.
WARNING: AC/DC Adaptor should use appointed product.
WARNING: SHOCK HAZARD — BT-700 doesn't have prot ection
this product along with RF Surgical eq uipment.
WARNING: The power receptacle must be a two wire non-grounded
outlet.
against the burn injury caus ed by RF Surgical equipment. D o NOT use
switch.
disconnect a power cord with wet hands. Make certain that your hands are
clean and dry before touching a power cord.
monitor. Use of any other patient cables may result in out-of-specification
performance and possible safety hazards.
1.3 Cautions
of a physician.
corrosive, or flammable materials, and extremes of temperature and
humidity. The unit should be kept clean and free of transducer gel and
other substances.
ventilation, accessibility for servicing, and room for adequate visualization
and operation.
condensation or spills. Avoid using the equipment immediately after
moving it from a cold environment to a warm, humid location.
switches.
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CAUTION: Accessory equipment such as RS-232 and USB connected to
the technical service department or your local representative.)
CAUTION: Do not autocla ve or gas sterilize the monitor or any
CAUTION: Do not immerse the SpO2 sensor in liquid. When using
CAUTION: If the equipment use in area where the integrity of the
the optional battery is selected.
CAUTION:
the analog and digital interfaces must be certified according to the
respective IEC standards ( e.g. IEC 950 for data processing equipment and
IEC 601-1 for medical equipment ). Furthermore all configuration shall
comply with the system standard EN 60601-1-1:2001 If in doubt, consult
accessories. Follow cleaning and disinfection instructions in Section 7 of
this manual.
solutions, use sterile wipes to avoid pouring fluids directly. Follow
cleaning and disinfection instr uctions in Section 7 of this manual.
external protective conductor in the installation or its arrangement is in
doubt, equipment shall be operated from its internal electrical source when
-The equipment conforms to Class A according to IEC/EN 60601-1(Safety
of Electric Medical Equipmen t)
- This equipment conforms to Level B according to IEC/EN 60601-1-2
(Electromagnetic Compatibility Requirements)
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Power off when
be damaged.
General Precaution on Environment
Do not keep or operate the equipment under the environment listed below.
Avoid placing in an area
exposed to moisture. Do not
touch the equipment with wet
hand.
Avoid placing in an area
where there is a high
variation of temperature.
Operating t emper ature
ranges fr om 10°C to 40°C.
Operating humidity ranges
from 30% to 85%.
Avoid exposure to
direct sunlight
Avoid in the vicinity
of Electric heater
Avoid placing in an area
where there is an
excessive humidity rise or
ventilation problem.
Avoid placing in an area
where chemicals are
stored or where there is in
danger of gas leakage.
Do not disjoint or
disassemble the equipment.
BISTOS Co., Ltd. does not
take responsibility of it.
Avoid placing in
an area where
there is an excessive
shock or vibration.
Avoid dust and
especially metal
material into the
equipment.
the equipment is
not fully installed.
Otherwise, the
equipment could
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Symbol
Description
Requirements
This symbol identifies a safety note . Ensure you
using it. Control function is described in the
operator’s manual.
1.4 Definitions and Symbols
Power On/Off Button IEC TR 60878
understand the function of this control before
External Signal IN/OUT Port IEC TR 60878
Defibrillation-proof type BF applied part IEC60601-1
IPX7
IPX2
IPX7 W ater -proof (Temperature, type rectal) IEC60529
IPX2 Water-proof (SpO2 sensor ) IEC60529
IEC 60601-1
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