1.2 Product Name and Model
Name: “North-vision”Multi-parameter patient monitor
Model: Elegant-1100
1.3 Description and Indication for use
1.3.1 Device Description
Elegant-1100 is intended to monitor, display and record physiological data to provide cardiac and
vital signs monitoring within a medical facility. It is modular designed patient Monitor, which can
monitor the patient’s Electrocardiograph (ECG) by measuring physical parameters with variety
modules. Also, It can measure non-invasive blood pressure (NIBP) including systolic, diastolic and
mean as well as detect the blood oxygen saturation (SpO2) and pulse rate (PR).
The accessories and the sensors will transfer the physical parameters into electrical signals,
which can be collected and amplified by the circuit in the device. After CPU analyzing and
calculating the parameters are displayed on the screen in a graphical representation and it can
record and/or print if necessary. The device may generate audible and/or visual alarm when a
measured rate falls outside preset limits.
1.3.2 Indication for use
North-vision Elegant-1100 of Multi-parameter Patient Monitor is intended to monitor, display and
record physiological signs of adult, pediatric patients. With the functions of near real-time
recording and displaying parameters ECG, heart rate, non-invasive blood pressure, blood oxygen
saturation and pulse rate, it allows comprehensive analysis of patient’s physiological conditions.
This apparatus is applicable for use in hospitals, clinics, and practitioner’s office. The operation
should be carried out by qualified professionals only.
1.4 Requirement of Operating Environment and Installation
1. This device should be situated in a place protected against direct sunlight, so as to prevent overheating
inside the equipment.
2. Do not use this device in an environment with toxic or inflammable gas.
3. This device should be fixed on a stand or flat platforms, so as to prevent possible shock.
4. Do not use with any equipment other than those expressly permitted in these instructions.
5. When using this device with electrosurgical equipment, the user (doctor or nurse) should pay attention to
the safety of patient.
6. Make sure that the equipotential grounding terminal is grounded correctly.
1.5 Normal Working Environment
1. Ambient temperature range: 10°C ~40°C
2. Relative humidity: ≤80%
3. Atmospheric pressure: 86kPa ~106kPa