Use Instructions

Vital Signs Monitor User Manual Intended Use and Safety Guidance
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Chapter 1 Intended Use and Safety Guidance
1.1 Intended Use/Indications for Use
The device is intended to be used for measuring, storing, and reviewing of, and to generate
prompts for, multiple physiological parameters of adults, pediatrics and neonates. The device is
intended for use by trained healthcare professionals in hospital environments.
Parameters include: NIBP, SpO
2
, PR (pulse rate), TEMP.
The device is not intended for MRI environments.
1.2 Safety Guidance
Federal (U.S.) law restricts this device to sale by or on the order of a physician.
WARNING
1 To ensure that the monitor works properly, please read the user manual and follow
the steps before using the monitor.
2 Before using the device, the equipment, patient cable and sensors etc. should be
checked. Replacement should be taken if there is any evident defect or signs of aging
which may impair the safety or performance.
3 Medical technical equipment such as these monitor/monitoring systems must only be
used by persons who have received adequate training in the use of such equipment
and who are capable of applying it properly.
4 EXPLOSION HAZARD-Do not use the device in a flammable atmosphere where
concentrations of flammable anesthetics or other materials may occur.
5 SHOCK HAZARD-To avoid the RISK of electric shock, this equipment must only be
connected to a SUPPLY MAINS with protective earth. Never adapt the three-prong
plug from the monitor to fit a two-slot outlet.
6 Do not come into contact with the patient, table, or the monitor during defibrillation.
7 The simultaneous use of cardiac pacemaker and other patient-connected equipment
may cause safety hazard.
8 Extreme care must be exercised when applying medical electrical equipment. Many
parts of the human/machine circuit are conductive, such as the patient, connectors,
transducers. It is very important that these conductive parts do not come into contact
with other grounded, conductive parts when connected to the isolated patient input of
the device. Such contact would bridge the patient's isolation and cancel the protection
provided by the isolated input. In particular, there must be no contact of the neutral
electrode and ground.