European Radio Equipment Directive (2014/53/EU)
Declarations of Conformity
"All Documents" (-)
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ALTRUA™ 2 | ESSENTIO™ | ESSENTIO™ MRI | PROPONENT™ | PROPONENT™ MRI | ACCOLADE™ | ACCOLADE™ MRI | VALITUDE™ | VISIONIST™ Declaration of Conformity
PDF( 439.0 KB )
Models:
ALTRUA 2 (S701, S702, S722)
ESSENTIO (L100, L101, L121)
ESSENTIO MRI (L110, L111, L131)
PROPONENT (L200, L201, L221, L209)
PROPONENT MRI (L210, L211, L231)
ACCOLADE (L300, L301, L321)
ACCOLADE MRI (L310, L311, L331)
VALITUDE (U125, U128)
VISIONIST (U225, U226, U228) -
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AUTOGEN™ | DYNAGEN™ | INOGEN™ | ORIGEN™ | RESONATE™ | RESONATE™ HF | CHARISMA™ | VIGILANT™ | PERCIVA™ | PERCIVA™ HF | MOMENTUM™ Declaration of Conformity
PDF( 259.0 KB )
Models:
AUTOGEN (D046, D044, D047, D045, D176, D174, D177, D175, G179, G172, G177, G173, G175)
DYNAGEN (D022, D020, D023, D021, D152, D150, D153, D151, G158, G150, G156, G151)
INOGEN (D012, D010, D013, D011, D142, D140, D143, D141, G148, G140, G146, G141)
ORIGEN (D002, D000, D003, D001, D052, D050, D053, D051, G058, G050, G056, G051)
RESONATE (D420, D421, D432, D433, G424, G425, G426, G428, G437, G447, G448)
RESONATE HF (D520, D521, D532, D533, G524, G525, G526, G528, G537, G547, G548)
CHARISMA (D320, D321, D332, D333, G324, G325, G328, G337, G347, G348)
VIGILANT (D220, D221, D232, D233, G224, G225, G228, G237, G247, G248)
PERCIVA (D400, D401, D412, D413)
PERCIVA HF (D500, D501, D512, D513)
MOMENTUM (D120, D121, G124, G125, G126, G128, G138) -
AVVIGO Guidance System Declaration of Conformity
PDF( 2.0 MB )
Model: AVVIGO Guidance System Tablet
FFR Link -
Clinician Programmer (Microsoft Surface Pro 6) Declaration of Conformity
PDF( 1.0 MB )
Model: Microsoft Surface Pro 6
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Clinician Programmer (Microsoft Surface Pro 6) Power Supply RED Declaration of Conformity
PDF( 450.0 KB )
Model: Microsoft Surface Pro 6
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FFR Link and Bluetooth Communication Module
PDF( 751.0 KB )
Models:
FFR Link
Bluetooth Communication Module
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PRECISION™ SPINAL CORD STIMULATOR SYSTEM | PRECISION SPECTRA™ SPINAL CORD STIMULATOR SYSTEM | PRECISION NOVI™ SPINAL CORD STIMULATOR SYSTEM | PRECISION™ MONTAGE™ MRI SPINAL CORD STIMULATOR SYSTEM| PRECISION™ MONTAGE™ SPINAL CORD STIMULATOR SYSTEM | SPECTRA WAVEWRITER™ SPINAL CORD STIMULATOR SYSTEM Declaration of Conformity
PDF( 7.0 MB )
Models: PRECISION SYSTEM (SC-1110-02, SC-1112, SC-5110, SC-5112, SC-5212, SC-5213, SC-5500-4, SC-5312, SC-6412-3) PRECISION SPECTRA SYSTEM (SC-1132, SC-5132, NM-7190, SC-5232, SC-5532-1, SC-5532-1A, SC-5312, SC-6412-3) PRECISION NOVI SYSTEM (SC-1140, SC-5132, NM-7190, SC-5240, SC-5542-1A, SC-1042-A) PRECISION MONTAGE AND PRECISION MONTAGE MRI SYSTEMS (SC-1120, SC-1200, SC-5132, NM-7190, SC-5250, SC-5552-1A, SC-5312, SC-6412-3, SC-1210B) SPECTRA WAVEWRITER SYSTEM (SC-1160, SC-5160, SC-5160R, SC-5260, SC-5562-1A, NM-7190, SC-5312, SC-6412-3)
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Rhythmia HDx™ Mapping System Declaration of Conformity
PDF( 407.0 KB )
Model: Rhythmia HDx™ Mapping System
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Vercise Genus™ DBS System and WaveWriter Alpha™ System Declaration of Conformity
PDF( 2.0 MB )
Models: DB-1408, DB-1416, DB-1432, DB-1216, DB-1232, DB-5170, DB-5270, DB-5572-1A, SC-1216, SC-1232, SC-1416, SC-1432, SC-5170, SC-5170R, SC-12010, SC-12030, SC-14016, SC-14032, SC-5270, SC-5270R, SC-5572-1A
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VERCISE™ DEEP BRAIN STIMULATION SYSTEM | VERCISE™ PC DEEP BRAIN STIMULATION SYSTEM | VERCISE GEVIA™ DEEP BRAIN STIMULATION SYSTEM Declaration of Conformity
PDF( 9.0 MB )
Models:
VERCISE SYSTEM (DB-1110-C, DB-5110-C, DB-5212-C, DB-5500-C, NM-5312, DB-6412-EU-C, SC-6412-3)
VERCISE PC SYSTEM (DB-1140, DB-5132, NM-7190, DB-5240, DB-5542-1A)
VERCISE GEVIA SYSTEM (DB-1200, DB-5132, DB-7190, NM-7190, DB-5250, DB-5552-1A, NM-5312, DB-6412-5, DB-6412-EU-C, SC-5312, SC-6412-3)