NORTHSTAR ECHO USER’S MANUAL
© 2018 JTECH Medical MN065_N
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EMC Notice
The Northstar Echo wireless system includes a variety of devices containing a built-in radio frequency transceiver that transmits to,
and receives data from, the Northstar Echo receiver. For more information on EMC see appendix “EMC Guidance” on page 37.
WARNING: Medical Electrical Equipment needs special precautions regarding EMC and needs to be
installed and put into service according to the EMC information provided in this manual. Carefully read
the information contained in this section.
WARNING:
The use of portable and mobile RF equipment can affect the normal operation of medical
electrical equipment.
WARNING:
Making any modifications or using any accessories not specifically approved by JTECH
Medical may reduce immunity to electromagnetic interference or increase electromagnetic emissions.
WARNING:
The Northstar Echo devices and receiver 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 operation.
Wireless information
The Northstar Echo devices and receiver transmit in a 2.4GHz 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. Operation is subject to the following two conditions:
(i) this device may not cause harmful interference and (ii) this device must accept any interference
received, including interference that may cause undesired operation.
Declaration of Conformity
These devices are:
Class I measuring medical devices per Annex IX of Council Directive 93/42/EEC
Class I medical devices per CFR Title 21 Part 888 Subpart B
Class II medical devices per Schedule 1, Part 1 of SOR/98-282 of the Canadian Medical Devices Regulations
These devices also meet the following Technical Standards, to which Conformity is declared:
IEC 60601-1
IEC 60601-1-2
These devices are designed and manufactured in a facility certified to the following international standards:
ISO 13485 with Canadian Medical Devices Conformity Assessment System (CMDCAS)
Intended Use
The intended use of the Northstar Echo product line is to assist the clinician with establishing an objective
assessment of a person’s physical strength, range of movement, and (with the Algometer) establishing pain
tolerance levels. The devices are intended to be used as non-invasive, non-surgical and transient devices. The
devices are indicated for use when objective assessment of strength, range of motion, or pain tolerance is required.
