JTECH Medical COMMANDER ECHO - Waste Disposal; Wireless Information; Declaration of Conformity; Intended Use and Intentions for Use

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© 2017 JTECH Medical MN022_M
Waste Disposal
Warning: Echo devices contain Lithium Polymer baeries. Do not dispose of any Echo device in
re.
Disposal Instrucons: Echo Devices are not known to contain any hazardous materials. Consult
your local waste management facility on proper disposal of solid waste. Recycling should be used
where available.
EMC Noce
The Commander Echo wireless system includes a variety of instruments containing a built-in radio frequency
transceiver that transmits to, and receives data from, the Commander Echo Console. For more informaon on
EMC see appendix “EMC Guidance” on page 62.
WARNING: Medical Electrical Equipment needs special precauons regarding EMC and needs to be
installed and put into service according to the EMC informaon provided in this manual. Carefully
read the informaon contained in this secon.
WARNING: The use of portable and mobile RF equipment can aect the normal operaon of
medical electrical equipment.
WARNING: Making any modicaons or using any accessories not specically approved by JTECH
Medical may reduce immunity to electromagnec interference or increase electromagnec
emissions.
WARNING: The Commander Echo Console and Echo devices should not be used while stacked on, or
adjacent to, other electrical or medical electrical equipment. If stacked or adjacent use is necessary,
all electrical equipment should be observed to verify normal operaon.
Wireless informaon
The Commander Echo Console and Echo devices transmit in a 2.4 GHz wireless frequency.
Contains FCC ID: OUR-XBEE
Contains Model XBee-Radio, Canada IC: 4214A-XBEE
Japan ID: 005NYCA0378
This device complies with Part 15 of the FCC Rules. Operaon is subject to the following two
condions: (i) this device may not cause harmful interference and (ii) this device must accept any
interference received, including interference that may cause undesired operaon.
Declaraon of Conformity
Echo instruments are:
Class I measuring medical devices per Annex IX of Council Direcve 93/42/EEC
Class I medical devices per CFR Title 21 Part 888 Subpart B
Class II medical devices per Rule 10 of the Canadian Medical Devices Regulaons
Echo devices also meet the following Technical Standards, to which Conformity is declared:
IEC 60601-1
IEC 60601-1-2
Echo devices are designed and manufactured in a facility cered to the following internaonal standards:
ISO 9001:2008
ISO 13485:2003 with Canadian Medical Devices Conformity Assessment System (CMDCAS)
Intended Use and Intenons for Use
The intended use of the Commander Echo Console and Echo devices is to assist the clinician with establishing
objecve assessment of a person’s physical strength, exibility, and (with the Algometer) establishing pain
tolerance levels. The devices are intended to be used as non-invasive, non-surgical and transient devices.