CVRx BAROSTIMIPG1 Benutzerhandbuch
BAROSTIM NEO LEGACY REFERENCE GUIDE
19-1
1
1
9
9
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R
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D
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E
C
C
L
L
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A
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R
A
A
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T
I
I
O
O
N
N
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O
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F
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Unique identification of this DoC:
Section 19 of 900100-001, Neo Legacy System Reference Guide
We, CVRx, Inc., located at 9201 West Broadway Avenue, Suite 650, Minneapolis, Minnesota
55445, declare under our sole responsibility that the product:
55445, declare under our sole responsibility that the product:
Product Name:
Barostim Neo™ Legacy
Trade Name:
Type or model:
Implantable Pulse Generator (IPG)
2100
CVRx Programmer System
9010
Relevant Supplementary Information:
(e.g. lot, batch or serial number, sources and numbers of items)
Not Applicable
to which this declaration relates is in conformity with the essential requirements and other relevant
requirements of the R&TTE Directive (1999/5/EC). The product is in conformity with the
following standards and/or other normative documents:
requirements of the R&TTE Directive (1999/5/EC). The product is in conformity with the
following standards and/or other normative documents:
Standard Reference
Description
EN 60601-1
2006
Medical Electrical Equipment, Part 1 General Requirements for
Safety
Safety
EN 60601-1-2
2007
Medical Electrical Equipment, Part 1-2 General Requirements
for Safety, Collateral Std: Electromagnetic Compatibility -
Requirements and Tests
for Safety, Collateral Std: Electromagnetic Compatibility -
Requirements and Tests
ETSI EN 301 489-27 V1.1.1:2004-06
Electromagnetic compatibility and Radio spectrum Matters
(ERM); ElectroMagnetic Compatibility (EMC) standard for radio
equipment and services; Part 27: Specific conditions for Ultra
Low Power Active Medical Implants (ULP-AMI) and related
peripheral devices (ULP-AMI-P)
(ERM); ElectroMagnetic Compatibility (EMC) standard for radio
equipment and services; Part 27: Specific conditions for Ultra
Low Power Active Medical Implants (ULP-AMI) and related
peripheral devices (ULP-AMI-P)
ETSI EN 301 489-17
V2.1.1:2009-05
Electromagnetic compatibility and Radio spectrum Matters
(ERM); ElectroMagnetic Compatibility (EMC) standard for radio
equipment; Part 17: Specific conditions for Broadband Data
Transmission Systems
(ERM); ElectroMagnetic Compatibility (EMC) standard for radio
equipment; Part 17: Specific conditions for Broadband Data
Transmission Systems
ETSI EN 301 839-2
V1.3.1:2009-10
Electromagnetic compatibility and Radio spectrum Matters
(ERM); Radio equipment in the frequency range 402 MHz to
405 MHz for Ultra Low Power Active Medical Implants and
Accessories; Part 2: Harmonized EN covering essential
requirements of article 3.2 of the R&TTE Directive
(ERM); Radio equipment in the frequency range 402 MHz to
405 MHz for Ultra Low Power Active Medical Implants and
Accessories; Part 2: Harmonized EN covering essential
requirements of article 3.2 of the R&TTE Directive
ETSI EN 300 328
V1.7.1:2006-05
(Final Draft)
(Final Draft)
Electromagnetic compatibility and Radio spectrum Matters
(ERM); Wideband Transmission systems; Data transmission
equipment operating in the 2,4 GHz ISM band and using wide
band modulation techniques; Harmonized EN covering
essential requirements under article 3.2 of the R&TTE Directive
(ERM); Wideband Transmission systems; Data transmission
equipment operating in the 2,4 GHz ISM band and using wide
band modulation techniques; Harmonized EN covering
essential requirements under article 3.2 of the R&TTE Directive