User's Manual
Table Of Contents
- 1Intended use
- 2Safety information
- 3Overview
- 3.1Introduction
- 3.2Product composition
- 3.2.1Main Box
- 3.2.2Nodes
- 3.2.3Straps
- 3.2.4Computer and Camera
- 3.3Working conditions
- 3.4Transport and storage conditions
- 3.5Symbols used in this product
- 4Specifications and parameters
- 4.1Specification
- 4.2 Indicator light description
- 4.2.1Main Box indicator
- 4.2.2Node indicator
- 5Instructions for use
- 5.1 Preparation for use
- 5.1.1Charging
- 5.1.2Device connection
- 5.1.3Venue set-up
- 5.2 Strap-on wear
- 5.2.1Effect after wearing
- 5.2.2Chest strap
- 5.2.3Waist strap
- 5.2.4Wrist strap
- 5.2.5Thigh strap
- 5.2.6Ankle strap
- 5.2.7Vamp strap
- 5.3Node Wearing
- 5.3.1Node snap-in
- 5.3.2Node pull-out
- 5.4Getting started with the software
- 5.4.1Visit the Wearable Motion and Gait Quantification
- 5.4.2New assessment
- 5.4.3Enter the assessment name and description of the a
- 5.4.4Add a check
- 5.4.5Select an assessment template to carry out the ass
- 5.4.6Enter patient information
- 5.4.7Start assessment
- 5.4.8View the assessment report
- 5.4.9Other functions
- 5.5After use
- 5.5.1End of use
- 6Cleaning and disinfection
- 6.1 Cleaning the main chassis and nodes
- 6.2 Cleaning straps
- 7Maintenance and Care
- 8Exceptions and their handling
- 9Cautions
- 10Contraindications
- 11Electromagnetic compatibility information
- 12Name and content of hazardous substances
- 13REGULATORY INFORMATION
- 14Quality commitment
- 15Disposal
- 16Copyright and Responsibility
- 26 -
GB/T 17626.8
typical of a site in a typical commercial or
hospital environment
Note: UT refers to the AC network voltage before the test voltage is applied.
Table 12 Electromagnetic Immunity Declaration of Conformity A
Guidelines and manufacturer's statements - Electromagnetic Immunity
The Wearable Motion and Gait Quantification Assessment System is intended for use in the electromagnetic environment specified below and the
purchaser or user of the Freeze Gait Assist System shall ensure that it is used in such electromagnetic environment:
Immunity tests
IEC 60601 Test levels
Conformity
level
Electromagnetic Environment - Guide
Radio frequency
conduction GB/T
17626.6
Radiofrequency
radiation GB/T
17626.3
3 V (rms) 150 kHz to
80 MHz
3V/m
80 MHz to 2.5 GHz
Not
applicable
3V/m
Portable and mobile RF communications equipment should not be used closer to any
part of the freeze gait assist system, including cables, than the recommended
isolation distance. This distance is calculated by the formula corresponding to the
frequency of the transmitter.
Recommended isolation distance d = 1.2
P
d = 1.2
P
80MHz to 800MHz
d = 2.3
P
800MHz to 2.5GHz
Where:
P - maximum rated output power of the transmitter in watts (W) according to the
transmitter manufacturer;
d - recommended isolation distance in metres (m)
b
. The field strength of a fixed RF
transmitter is determined by
a
survey of the electromagnetic field house
a, which
should be lower than the compliance level in each frequency range
b.
Interference
may occur in the vicinity of equipment marked with the following symbols :
Note 1: At 80MHz and 800MHz frequencies, the formula for the higher band is used.
Note 2: These guidelines may not be appropriate in all cases, electromagnetic propagation is influenced by absorption and reflection from buildings,
objects and the human body.
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,
amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured
field strength in the location in which the device is used exceeds the applicable RF compliance level above, the device should be
observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as
reorienting or relocating the device.
b. Over the frequency range 150 kHz to 80MHz, field strengths should be less than 3V/m.
a. The ISM (industrial, scientific and medical) bands between 0,15 MHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553 MHz to