Nuvectra 4200 4200 User Manual

Download:
Mirror Download [FCC.gov]
Document ID	2334824
Application ID	7jJat8EFvvYkdewZRV+0cA==
Document Description	User Manual
Short Term Confidential	No
Permanent Confidential	No
Supercede	No
Document Type	User Manual
Display Format	Adobe Acrobat PDF - pdf
Filesize	48.74kB (609311 bits)
Date Submitted	2014-07-24 00:00:00
Date Available	2014-09-07 00:00:00
Creation Date	2014-05-30 13:19:42
Producing Software	Xerox WorkCentre 7535
Document Lastmod	2014-05-30 13:05:38
Document Title	User Manual
Document Creator	Xerox WorkCentre 7535

ALGOSTIM,LLc
Algovita’”
Spinal Cord
Stimulation
System
Programmer Charger
Model 4200
Pocket Programmer
Model 4100
Algorita is a trademark othG Group, 1.1.(1
FCC Information (US Only)
'lltu Ibllmving is communirulmns rrgulunon inlornmtion about the Algovrla Programmer (Zlmrgcr
and Pockct I’rogramnwr.
Programmer (llmlgcr FCC ID: ZARUSAIZOO
PocketProgrammerl-'(f(11D22ABUSHOU
'llwsu dances comply with purl 15 ottlte HIC Rules. Opcratmo 1.» sulvjm‘t lo the following two ronr
(lxlions:(l)'llu'suleiccsmnynotcrltxsrltttl'rt1ltrl1111cr1c1cncc,.m95% dip in UT) (>95% dip in UT) of a typical commercial or hospital
voltage variations for 0.5 cycle for 015 cycle environment. If the user of the
on power supply 40% U 40% U Programmer Charger and Pocket
input lines (60% dTip in U ) (60% dip in Ur) Programmer requires continuous
l IEC 61000 4-11 for 5 cycles T for 5 cycles operation during power mains
70% U 70% UT [ interruptions, it is recommended that
(30% dip in Ur) (30% dip in U1) the Programmer Charger and Pocket
for 25 cycles for 25 cycles Programmeglpe powered frrlJm an
. t t
(5% UT <5% UT Estitléreyn'up l 5 power supp Y 01' 3
(>95% dip in UT) (>95% dip in UT) '
for 5 SW 7 ,7 77 for 5 s 7
Power frequency 3 A/m 3 A/m Power frequency magnetic fields should
Note: U is the A C mains voltage prior to application of the test level.
‘ be at levels characteristic of a typical
l location 1n a typical commercial or
‘ hospital environment.
7 l
107
Patient System Manual
Safety and Compatibility Standards Conformity
Table 11. Guidance and manufacturer’ s declaration- electromagnetic emissions
'[he Programmer Charger and Pocket Programmer are intended for use in the electromagnetic environment ;
specified below The customer or the user of the Programmer Charger and Pocket Programmer should
assure that they are used in such an environment.
test level level
Immunity test [IEC 60601 Compliance
‘ l
‘ 3 Vrms
Conducted RF ‘ 150 kHz to
‘ [EC 610007476 80 MHZ 3 Vrms
l Radiated RF 3 V/m 3 V/m
15c 61000-4-3 so MHz to
‘ 2.5 GHz
1 ,, W ,,
l Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
‘ Note 2: These guidelines may not apply in all situations Electromagnetic propagation is affected by
absorption and reflection from structures. objects, and peopl
‘ 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 Programmer Charger and Pocket Programmer are used exceeds the applicable RF compliance level i
above, the Programmer Charger and Pocket Programmer should be observed to verify normal operation ‘
If abnormal performance is observed, additional measures may be necessary, such as re-orienting or ‘
relocating the Programmer Charger and Pocket Programmer.
l " Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.
Electromagnetic environment- guidance
Portable and mobile RF communications equipment
should be used no closer to any part of the Programmer
Charger and Pocket Programmer, including cables, than ‘
the recommended separation distance calculated from the l
equation applicable to the frequency of the transmitter.
Recommended separation distance
d=1.2JF
d=l.2 «F 80 MHz to 800 MHz
d: 2.3J'P‘ 300 MHz to 2.5 GHz
where P is the maximum output rating of the transmitter in
watts (W) according to the transmitter manufacturer and d
is the recommended separation distance.in meters (n1).
Field strengths from fixed RF transmitters, as determined
by an electromagnetic site survey,i should be less than the
compliance level in each frequency range“
Interference may occur in the vicinity of equipment marked
with the following symbol,
(it’ll
103 SCS System Speclfications
Algovita Spinal Cord Stimulation System
Table 12. Recommended separation distances between portable and mobile RF
communications equipment and the Programmer Charger and Pocket Programmer
The Programmer Charger and Pocket Programmer are intended for use in an electromagnetic environment
in which radiated RF disturbances are controlled. The customer or the user of the Programmer Charger ‘
and Pocket Programmer can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters) and the Programmer
Charger and Pocket Programmer as recommended below, according to the maximum output power of the
communications equipment.
TSeparation distance according to frequency of transmitter
Rated maximum output 7 7 7 7 7 7 7 E7 7 7 7 7 7 7 ‘
POW" 0f transmitter 150 kHz to so MHz 1 so MHz to 800 MHz 800 MHz to 2.5 61-12
W d=1.21/F7 L d 2/1? d=2.3JF
0.01 0.12 0.12 0.23
0.1 0.38 0.33 0.73
1 1.2 112 2.3
10 3.3 3.13 7.3
100 12 12 23
, , , i
1 For transmitters rated at a maximum output power not listed above, the recommended separation distance 1
i d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where 1
P is the maximum output power rating of the transmitter in watts (W) according to the transmitter
manufacturer
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
1 absorption and reflection from structures. objects, and people.
Patient System Manual 109
Safety and Compatibility Standards Conformity
Wireless Information
Table 13. Wireless Specifications and Safety
1 The Programmer Charger and Pocket Programmer interact with the ‘
‘ stimulator using MedRadio Band: 402-405 MHz.
i y The effective radiated power is below the limits as specified in:
Europe: EN ETSI 301 839-2
USA: FCC 47 CFR Part 95; 95601-95673 Subpart E, 951201-
Programmer wireless 95.1219
technolo o eratin ’ ’ ’
g.y . P g The Programmer Charger and Pocket Programmer interact with the
characteristics
i stimulator using
2.45 GHz.
The effective radiated power is below the limits as specified in:
Europe: EN ETSI 300 328
‘ USA. FCC part 15.24
Stimulator wireless
tesltnglosy
'lhe stimulator complies with emissions requirements per
7 % R&TTE Standard EI:I 301339 2 via 171402an to 405MHz);
Wireless integrity The Algovita SCS System employs mechanisms to ensure integrity
of the communication area The stimulator will not respond to any
device to which it is not linked.
Note: This equipment has been tested and found to comply with the limits for a Class B
digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide
reasonable protection against harmful interference in a residential installation. This
equipment generates, uses and can radiate radio frequency energy and, if not installed
and used in accordance with the instructions, may cause harmful interference to radio
communications. However, there is no guarantee that interference will not occur in a
particular installation. If this equipment does cause harmful interference to radio or
television reception, which can be determined by turning the equipment off and on,
the user is encouraged to try to correct the interference by one or more of the following
measures:
. Reorient or relocate the receiving antenna.
. Increase the separation between the equipment and receiver.
110 SCS System Specifications
Algovita Spinal Cord Stimulation System
. Connect the equipment into an outlet on a circuit difl”erent from that to which the
receiver is connected.
. Consult the dealer or an experienced radio/TV technician for help,
This transmitter is authorized by rule under the Medical Device Radiocommunication
Service (in part 95 of the FCC Rules) and must not cause harmful interference to stations
operating in the 400.150-406.000 MHz band in the Meteorological Aids (ie, transmitters
and receivers used to communicate weather data), the Meteorological Satellite, or the
Earth Exploration Satellite Services and must accept interference that may be caused
by such stations, including interference that may cause undesired operation, This
transmitter shall be used only in accordance with the FCC Rules governing the Medical
Device Radiocommunication Service. Analog and digital voice communications are
prohibited. Although this transmitter has been approved by the Federal Communications
Commission, there is no guarantee that it will not receive interference or that any
particular transmission from this transmitter will be free from interference.
This transmitter is authorized by rule under the MedRadio Service (47 CFR part 95).
This transmitter must not cause harmful interference to stations authorized to operate
on a primary basis in the 2360-2400 MHz band, and must accept interference that may
be caused by such stations, including interference that may cause undesired operation,
This transmitter shall be used only in accordance with the FCC Rules governing the
MedRadio Service. Analog and digital voice communications are prohibited. Although
this transmitter has been approved by the Federal Communications Commission, there is
no guarantee that it will not receive interference or that any particular transmission from
this transmitter will be free from interference.
Patient System Manual 111

---

Source Exif Data:

File Type                       : PDF
File Type Extension             : pdf
MIME Type                       : application/pdf
PDF Version                     : 1.4
Linearized                      : Yes
Create Date                     : 2014:05:30 13:19:42-06:00
Creator                         : Xerox WorkCentre 7535
Modify Date                     : 2014:05:30 13:05:38-05:00
XMP Toolkit                     : Adobe XMP Core 5.2-c001 63.139439, 2010/09/27-13:37:26
Creator Tool                    : Xerox WorkCentre 7535
Metadata Date                   : 2014:05:30 13:05:38-05:00
Producer                        : Xerox WorkCentre 7535
Document ID                     : uuid:41a00851-c0d5-4081-8437-1ccd69104480
Instance ID                     : uuid:c15fc959-a341-4060-b740-ce8004ec61be
Format                          : application/pdf
Page Count                      : 9

EXIF Metadata provided by EXIF.tools