User Manual
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| Document ID | 2334941 |
| Application ID | mZEKsGQToV9e+TD9dfUaUQ== |
| Document Description | User Manual |
| Short Term Confidential | No |
| Permanent Confidential | No |
| Supercede | No |
| Document Type | User Manual |
| Display Format | Adobe Acrobat PDF - pdf |
| Filesize | 42.75kB (534338 bits) |
| Date Submitted | 2014-07-24 00:00:00 |
| Date Available | 2014-09-07 00:00:00 |
| Creation Date | 2014-05-30 13:19:04 |
| Producing Software | Xerox WorkCentre 7535 |
| Document Lastmod | 2014-05-30 13:04:28 |
| Document Title | User Manual |
| Document Creator | Xerox WorkCentre 7535 |
algzg-Vitam
A LGOSTIM,LLC
Clinician Programming Manual
Algovita'"
Spinal Cord
Stimulation
System
riiu' .m :"‘"-‘IV;lllll\l~l'
-J'l‘l,
pining [.mi
Algovitn ‘ is A lmdumut‘k of OK} Gmup, LLC
Ctiit-Gitnrii‘ is u trath-innik of Gruathatch, Inc.
CASE" 5 d lt'iitlcmuik m‘QIG Group, I.I,C
Rulcr [ii [in- Information [or Pr crilwrs Manual for indrcntinns. conu.nniiirntmin. warningo, prcrauliuns. in!“ ~ miinicalstudy
results, and rclnit-ii information.
‘ ‘c information (us Onlv)
The following is mmmunimiiuns regulation information about the Algovim Cliniuan I’rtigrummcr and Patient FL‘L‘ddek 'i‘nni;
Clinician ngmmnmrFCC ID: EABUMSUU contains FCCID: Liaiuv- . won}
l’am'nll mllumk'l'tmlFC in:tnnninsxxxii'i'iwma
These devices conipiy with part 15 oftiie FCC rules. Operation is aulmct to [11c milmving two conditions: (1) “use devices mm, iml
cause harmful \merft'rence, and (2)1hcsn dsvices must accept any interference receivcd including intarfurcncn that may must undo
sired operation.
Important- Ciinngas and nioiiiticntions m the products not autlmriztvd by Algnslim. LI C, multl void tht- FCC m niimtion and negate
your authority in DIM‘I’ML‘ (husu pmdncls
Algovlta Spinal Cord Sflmulalion System
Clinician Programmer Specifications
Table 18. Clinician Programmer Specifications
Operating temperature l 32° F to 122° F (0°C to 50°C)
"1; Emcee(ammo
‘ Cflnrating/storflg humidity £6 to 975% 7 7 7 j
l Operating/storage atmospheric pressure #20 3717.3 in. 55179019190,qu kPa)
ezemeximge) ,, ,, , ,mow-204gnxayx123239195 ,
Weight including battery (approximate) l 450 grams (15.8 ounces) 7 7 7 ,
I Battery— —_ > - chargeable lithium—ion battery
l Mode of operation [ Continuous
Safety and Compatibility Standards Conformity
Algovita Model 4500 Clinician Programmer and Model 4250 Patient Feedback Tool comply with the following standards:
. IEC60601- 1, Medical Electrical Equipment Safety
. IEC60601-l-2, Electromagnetic Compatibility
- EN45502-l, Safety, Marking and Information of Medical Devices
Electromagnet Compatibility Declaration Tables
This section lists the EMC Declaration tables. The Clinician Programmer and Patient Feedback Tool are intended for use
in the electromagnetic environment specified below The customer or the user of the Clinician Programmer and Patient
Feedback Tool should assure that they are used in such an environment. The Clinician Programmer and Patient Feedback
Tool contain RF transmission and receiving capabilities; consequently, it is possible that other portable and mobile RF
communications equipment may interfere with the Clinician Programmer and Patient Feedback Tool
The power supply cable (maximum length 188 cm) was included in the system testing to demonstrate compliance with
the requirements ofIEC 60601-1-2 2007. Use of accessories and cables other than those specifically listed may result in
increased emissions or decreased immunity of the Clinician Programmer and Patient Feedback Tool.
The Clinician Programmer and Patient Feedback Tool should not be used adjacent to or stacked with other equipment If
adjacent or stacked use is necessary, the Clinician Programmer and Patient Feedback Tool should be observed to verify
normal operation in the configuration in which it will be used
Cllnlclan Progummlng Manual 71
Electromagnet Compallblllty Dedarallon Tables
Table 19. Guidance and manufacturer's declaration - electromagnetic emissions
‘ The Clinician Programmer and Patient Feedback Tool are intended for use in the electromagnetic environment specified below.
The customer or the user of the Clinician Programmer and Patient Feedback Tool should assure that they are used in such an
environment.
. 7Emlsslons test
RP emissions CISPR ll
‘ RF emissions CISPR 11
liarmonic emissions lEC SIOOOVE-Z Cl;ss A
Voltage fluctuations/flicker
emissions IEC 61000- 3-3
J 90mpliance ‘
Group 1
Electromagnetic environment - guldance
The Clinician Programmer and Patient Feedback Tool use RF energy primarily ‘
for its internal function. Therefore' its RF emissions are very low and are not
9132A
'1
likely to cause interference in nearby electronic equipment.
The Clinician Programmer and Patient Feedback Tool are suitable for use in
all establishments, other than domestic and those directly connected to the
public low-voltage power supply network that supplies buildings used for
Table 20. Guidance and manufacturer’s declaration » electro
magnetic immunity
The Clinician Programmer and Patient Feedback Tool are intended for use in the electromagnetic environment specified below.
The customer or the user of the Clinician Programmer and Patient Feedback Tool should assure that they are used in such an
environment.
Immunity test
l Electrostatic discharge
1 (ESD)
[EC 510007472
Electrical fast
transient/burst
legumes:
‘ Surge
l IEC 61000-4-5
‘ Voltage dips. short
interruptions and
voltage variations on
power supply input
lines
IEC 61000-4711
Po7we7r frequency
(50/50 Hz) magnetic
field
>1§c 751000-315
[EC 6060! test level Compliance level
7 1- 6 kV contact
1 8 kV air
1 6 kV contact
:t 8 kV air
7 i 2 kV for power supply lines
i 1 kV for input/output lines
.1, .
1 i 1 leine(s) to |ine(s)
1 t 1 kV line(s) to earth
: 2 kV for power supply lines
1 1 kV for input/output lines
: 1 kV differential mode
<5% UI <5% UT
(>95% dip in U1) for 0.5 cycle ‘ (>95% Clip in (1|) for 0.5
‘ cycle
40% U‘ l
(60% dip in U‘) {or 5 cycles 40% U,
l (60% dip in U‘) for 5 cycles
70% U1 ‘
(30% dip in UT) for 25 cycles ‘ 70% U1.
. (30% dip in UI) for 25 cycles
<5% U.‘
(>95% dip in Ur) for 5 5 <5% UI
‘ (>95% dip in UT) for 5 s
737A/7m77 7 7 7 73A/m 7
Note: U‘ is the A:C;n17a7inis [0113: 7pm: to application of the test level.
72 Ollnlclan Programming Manual
Electromagnetic environment - guidance 1
Floors should be wood, concrete or ceramic
tile. If floors are covered with synthetic
material, the relative humidity should be at \
least 30%.
Mains power quality should be that of a
typical commercial or hospital environment. 1
, , 4
Mains power quality should be that of a ‘
typical commercial or hospital environment. J
7 7 7 l
Mains power quality should be that ofa
S typical commercial or hospital environment. ‘
‘y lithe user of the Clinician Programmer
and Patient Feedback Tool requires
continuous operation during power mains
interruptions, it is recommended that the
Clinician Programmer and Patient Feedback ‘
Tool be powered from an uninterruptible
power supply or a battery.
Power frequency magnetic fields should
be at levels characteristic of a typical
. location in a typical commercial or hospital
environment.
Algovila Spinal Cord Stimulation System
‘ customer or the user of the Clinician Programmer and Patient Feedback Tool should assure that it is used in such an environment.
lImmunitytest lECGOGOltestlevel Compliancelevel ‘Eleetmmegnetieenvtromnent.gntdanee
l , , r , , ,
Portable and mobile RF communications equipment
should be used no closer to any part of the Clinician
l Programmer and Patient Feedback Tool, including cables,
than the recommended separation distance calculated l
from the equation applicable to the frequency of the
transmitter.
Recommended separation distance
d=1r2 r/F
Conducted RP IEC 3 Vrms c ,2 JP so MHz to 300 MHz
3 V
61000-4-6 150 kHz to so MHz ""5 d: 2 3 r/F 300 MHZ to 2 5 GHZ
. where P is the maximum output rating ofthe transmitter
Radiated RF 3 Wm 3 V (m in watts (W) according to the transmitter manufacturer
IEC 61000743 80 MHz to 2.5 GHz and d is the recommended separation distance in meters
(mi
Field strengths from fixed RF transmitters, as determined
by an electromagnetic site survey: should be less than the
compliance level in each frequency range. t i
Interference may occur in the vicinity of equipment
l marked with the following symbol.
1 l , , (“30),
l NOTE 1 At 80 MHz and 800 MHZ, the higher frequency range applies. 7 7
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from ‘
structures, objects, and people ‘
i 7 7777
field strengths from fixed transmitters, such as base stations for radio (cellular/cor ess) 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
l field strength in the location in which the Clinician Programmer and Patient Feedback Tool are used exceeds the applicable RF
compliance level above, the Clinician Programmer and Patient Feedback Tool should be observed to verify normal operation.
If abnormal performance is observed, additional measures may be necessary, such as re»orienting or relocating the Clinician
Programmer and Patient Feedback Tool.
‘ t Over the frequency range 150 kHz to so MHz, field strengths should be less than 3V/m.
ollnlclan Programming Manual 73
Vlfireless Information Table
Table 22. Recommended separation distances between portable and mobile RF communications equipment and the Clinician
Programmer and Patient Feedback Tool
The Clinician Programmer and Patient Feedback Tool are intended for use in an electromagnetic environment in which radiated
RF disturbances are controlled. The customer or the user of the Clinician Programmer and Patient Feedback Tool can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the Clinician Programmer and Patient Feedback Tool as recommended below, according to the maximum output
power of the communications equipment.
l‘ Rated maximum output Separation distance according to frequency of transmitter
‘ power of transmitter 1 In
W V 150 kHz to at) 1141-127 so MHz to 306 MHz 300 MHz to 2.5 01-1:
1 . l d=1.2 .115 . d=1.2 JP _‘ d=2.3 t/P
‘ 0.01 0.12 . 0.12 _ 0.23 7‘
0.1 . 0.38 0.33 . 0.73
1 1.2 1.2 2.3
10 3.8 3.3 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above. the recommended separation distance d in meters (in) can be
estimated using the equation applicable to the frequency of the transmitter, where 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 separation distance for 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 people.
Wireless Information Table
Table 23. Wireless Specifications and Safety
l The Clinician Programmer interacts with the stimulator using MedRadio Band: 402405 MHz. The
effective radiated power is below the limits as specified in:
Europe: EN ETSI 301 83972
Pmsfamm" Wireless USA: FCC 47 CFR Part 95; 95.601-95.673 Subpart E, 9112013512 19
technology operating t _ _ 4 ~ _ ' ~ . . .
characteristics . The C11 clan Programmer Interacts With the stimulator usmg 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 The stimulator complies with emissions requirements per RSKTTE Standard EN 301 83972 v13.1
1 ‘Ed‘n‘llf’fil’ . @E&Z ”LEAH” - ,7 . . . - 7. ,. - W,
Wireless integrity The Algovita 505 System employs mechanisms to ensure integrity of the communication area. The
‘ stimulator will not respond to any device to which it is not linked.
Compliances and Authorizations
The Clinician Programmer has been tested and found to comply with the limits for a Class A digital device, pursuant to
part 15 of the FCC Rules .These limits are designed to provide reasonable protection against harmful interference when
the equipment is operated in a commercial environment. This equipment generates. uses, and can radiate radio frequency
energy, and if not installed and used in accordance with the instruction manual. may cause harmful interference to radio
communications. Operation of this equipment in a residential area may cause harmful interference in which case the user
will be required to correct the interference at his own expense.
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 400.150-406000 MHz band in the Meteorological
Aids (i.e., transmitters and receivers used to communicate weather data), the Meteorological Satellite, or the Earth
74 clinician Programming Manual
Algovna Splnal Cord Sllmulation System
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 bases 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 transmissions from this
transmitter will be free from interference
Cllnlclnn Programming Manual 75
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