BT-780 Operation manual
6
P/N : 780-ENG-OPM-EXP-R00
Bistos Co., Ltd.
2020.03
•
Do not open the enclosure to avoid an electric shock. Any repair and upgrade of monitor should be done by service
personnel trained and authorized by Bistos. Co., Ltd.
•
When handling packaging materials, abide by local laws and regulations or hospital waste disposal regulations. Keep the
packaging materials away from children.
•
Do not use in the presence of flammable anesthetics to prevent explosion or fire.
•
Install the power lines and cables of accessories carefully to avoid patient entanglement or suffocation, cables tangled or
electrical interference.
•
When the monitor is used together with electrosurgical devices, the user (a doctor or a nurse) should ensure the safety
of the patient and instrument.
•
The physiological wave, physiological parameters and alarm information displayed on the monitor are only for the
doctor’s reference and should not be directly used as the basis for clinical treatment.
•
This is not a therapeutic device.
•
For patients with pacemakers, the cardio tachometer may count the pacemaker pulse in case of a cardiac arrest or
arrhythmias. Never rely solely on the cardio tachometer alarm. Closely monitor the patients with pacemaker. For the
inhibition of the device on pacemaker, refers to this manual.
•
Use of accessories other than those listed and approved for use with this product may result in increased emissions or
decreased immunity.
•
Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service
according to the EMC information provided in this manual. In addition, portable and mobile RF communications
equipment can affect medical electrical equipment.
•
The equipment shall not be used adjacent to other devices unless verification of normal operation in the configuration in
which it is to be used can be achieved.
•
Keep matches, and all other sources of ignition, out of the room in which the patient monitor is located. Textiles, oils,
and other combustibles are easily ignited and burn with great intensity in air enriched with oxygen. Personal injury or
equipment damage could occur.
•
A fire and explosion hazard exists when performing cleaning or maintenance procedures in an oxygen-enriched
environment.
•
The patient monitor has been validated with the accessories and options listed in this manual and found to comply with
all relevant safety and performance requirements applicable to the device. It is therefore the responsibility of the person
or organization who makes an unauthorized modification, or incorporates an unapproved attachment to the device.
•
An operator may only perform maintenance procedures specifically described in this manual.
•
Do not remove the covers of a BT-780 yourself to avoid damage to the equipment and unexpected electrical shock. Only
qualified Bistos service engineer must repair or replace components.
CAUTION
•
Please install or carry the instrument properly to prevent damage due to falling, collision, strong vibration or other
mechanical force.
•
Avoid instrument splashed by water.
•
Avoid high temperatures, the instrument should be used within a temperature range of 5
℃
~ 40
℃
。
•
Avoid using instrument in the environment such as pressure is too high, poor ventilation, dusty, or contain salt, sulfur
gas and chemical.
•
Before using the monitor, check the monitor and accessories if there is damage that may affect patient safety. If there is
obvious damage or aging, replace the parts before use. The replacement should be made with same parts of original
parts.
•
Before powering on the device, make sure that the power used by the device complies with the supply voltage and
frequency requirements on the equipment label or in the Operator’s Manual.
•
Equipment should be tested at least once a year, the test should be done and recorded by trained, have security testing
knowledge and experienced personnel. If there are any problems in the tests, they must be repaired.
•
When the instrument and accessories are about to exceed the useful life (expected service life: 5 years), it must be
treated in accordance with relevant local laws and regulations or the hospital's rules and regulations.
•
Do not connect to other equipment or network which not specified in the instruction for use, in risk of external high
voltage.
•
Do not connect any equipment or accessories that are not approved by the manufacturer or according to IEC 60601-1 to
the monitor. The operation or use of non-approved equipment or accessories with the monitor is not tested or
supported, and monitor operation and safety are not guaranteed in such a case.
•
Any non-medical equipment (such as the external printer) is not allowed to be used within the patient vicinity
(1.5m/6ft.).
•
Parts and accessories used must meet the requirements of the applicable safety standards, and/or the system
configuration must meet the requirements of the medical electrical systems standard.
•
Ensure that the conductive parts of electrodes and associated connectors, including neutral electrodes, do not come in
contact with earth or any other conducting objects.
•
Protection of ME EQUIPMENT against effects of discharge of a cardiac defibrillator depends on use of proper cables.
