User's Manual

Page 4
Introduction
This manual (direction for use) is designed to help you understand the capabilities and
operation of the Fukuda DS-101 series of monitors. The information in this manual, including
the illustrations, is based on a monitor configured with electro-cardiogram (ECG), heart rate,
noninvasive blood pressure (NIBP), body temperature, pulse oximetry (SpO2), and pulse
rate. If your monitor configuration lacks any of these options, some information in this manual
may not apply.
Before using the monitor, read the sections of the manual that pertain to your use of the
monitor.
Intended Use
The DS-101 Patient Monitoring System is intended for monitoring single adult patient
conditions by measuring/displaying/recording/alarming the patients parameters which
include Electrocardiograms (ECG), Heart Rate (HR), Pulse Rate (PR), Respiration (RESP),
Oxygen Saturation of Arterial Blood (SpO2), non-Invasive Blood Pressure (NIBP).
The device is intended to be operated by trained healthcare professionals in hospital
environment, private practices, and during patient transport using battery power.
The device is also used as a data collection terminal with its equipped NFC Reader to read
data, such as patient temperature data, from a passive NFC Tag. The NFC Reader
interface does not provide any measurement functions.
The device is not intended to be used in Home, Ambulance, Airplanes, MRI environment,
hyperbaric oxygen chambers, or near flammable anesthetic gasses.
Contraindications
This system is not intended to be used.
l On patients connected to heart/lung machines
l On patients being transported outside a healthcare facility
l Near an MRI machine
l In a hyperbaric chamber
l Near flammable anesthetics
l Near electro-cauterization devices