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3
Getting Started
3.1
Equipment Preparation Safety Information
WARNING
•
Use only installation accessories specified by Mindray.
•
The equipment software copyright is solely owned by Mindray. No organization or individual shall
resort to modifying, copying, or exchanging it or to any other infringement on it in any form or by
any means without due permission.
•
Connect only approved devices to this equipment. Devices connected to the equipment must meet
the requirements of the applicable IEC standards (e.g. IEC 60950 safety standards for information
technology equipment and IEC 60601-1 safety standards for medical electrical equipment). The
system configuration must meet the requirements of the IEC 60601-1 medical electrical systems
standard. Any personnel who connect devices to the equipment’s signal input/output port are
responsible for providing evidence that the safety certification of the devices has been performed in
accordance to the IEC 60601-1. If you have any questions, please contact Mindray.
•
The monitor and parameter monitoring accessories are suitable for use within the patient
environment. For other equipment and accessories connected to the monitor, consult
corresponding manufacturers for the suitability within the patient environment.
•
If it is not evident from the equipment specifications whether a particular combination with other
devices is hazardous, for example, due to summation of leakage currents, please consult the
manufacturer or an expert in the field. A determination must be made that the proposed
combination will not negatively affect the devices themselves or the patient's safety.
•
If the accuracy of any value displayed on the monitor, central station, or printed on a graph strip or
report is questionable, determine the patient’s vital signs by alternative means. Verify that all
equipment is working correctly.
CAUTION
•
The equipment should be installed by authorized Mindray personnel.
•
When disposing of the packaging material, be sure to observe the applicable waste control
regulations and keep it out of children’s reach.
•
Before use, verify whether the packages are intact, especially the packages of single use accessories.
In case of any damage, do not apply it to patients.
•
Make sure that the equipment operating environment meets the specific requirements. Otherwise
unexpected consequences, e.g. damage to the equipment, could result.
•
Observance of this manual is a prerequisite for proper product performance and correct operation
and ensures patient and operator safety.
NOTE
•
Put the equipment in a location where you can easily view and operate the equipment.
•
Keep this manual in the vicinity of the equipment so that it can be conveniently referenced when
needed.
•
Save the packing case and packaging material as they can be used if the equipment must be
reshipped.
Summary of Contents for ePM 10M
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