97715 Medical Implant Transmitter Cover Letter Medtronic, Inc.
Medtronic, Inc. Medical Implant Transmitter
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7435 Oakland Mills Rd
Columbia, MD 21045
Re: Questions related to Rule Sections 2.1046, 2.1047, 2.1049, 2.1051, 2.1053, 2.1055, and 2.1057 and
the requirements therein. A question has been raised that compliance with the above rule sections as
well as Part 95 rule sections for implants. Following is an excerpt from the correspondence regarding
Dear Mr. Harrington
Issue 6 of your review correspondence stated the following:
“6) EMC/radio report includes the following ambiguities and/or inapplicable indications.
a) pdf pg 7/47
To meet the essential EMC and radio spectrum requirements according to Industry Canada
b) pdf pg 1/47
"Report No. ... DRAFT"
c) pdf pg 2/47
"Certificate of Test
Further to 2.1033(c)(14), please amend to explicitly show compliance for 2.1046 through 2.1057,
AND 2.911(b) i.e. part 95 test data and information requirements.
[Incl: 2013 e-CFR 95.627(d), 95.627(e)(1), 95.627(g)(3), 95.633(e),
95.635(d)(1)(i), 95.635(d)(2), 95.635(d)(3), 95.635(d)(4),
95.639(f)(1) report EIRP data [95.627(g)(3)], 95.1209(b), 95.1209(c)..”
The following is provided to fulfill the request as written by the reviewing officer. Below is a cross
reference from the above rule parts in 47CFR Part 2 to those portions of the FCC Test Report from
Northwest EMC that show compliance with the requirements of each of the referenced Part 2 rule
Part 2 rule section
Part 95 Test Report Item and
page no. that addresses
applicable Part 2 requirements
RF Power Output
Field Strength of Fundamental,
p.14-15. A calculation of the
radiated power was made using
the maximum measured field
strength. This produced a power
level of 82.2 nWatts after
accounting for the reflected
Part 2 references info covered by
Part 95.633(e)(3), p.30-33
Part 95 has no requirement for
measuring occupied bandwidth.
However, this information is
presented on p. 30-33
Spurious emissions at ant.
The EUT has a built in antenna
that is not accessible. Also the
Part 95 rules only have limits in
terms of radiated field strength.
See the following sections.
Field strength of spurious
Spurious transmitter emissions
according to Section 95.635,
Part 95.628(e) specifies the
frequency stability requirements
of MedRadio transmitters.
Pages 16-29 of the test report
contain the specific info.
Frequency spectrum to
investigate—requires up to the
10th harmonic. Emissions more
than 20 dB below the limit need
not be reported.
The files on p.34-36 show
spectral plots from 10 MHz to 5
GHZ covering all emissions
emanating from the device from
the lowest RF frequency
generated to the 10th harmonic.
Noting that emissions more than
40 dB below the limit were
measured and reported the
requirement has been met.
Phillip Inglis (signed)
Authorized agent for Medtronic