Oas Pump Declaration Of Conformity; Emc Declaration - Cardiovascular Systems, Inc. DIAMONDBACK 360 Peripheral Orbital Atherectomy System Exchangeable Series Instructions For Use Manual

13.2. VIPERWIRE ADVANCE Guide Wire Specifications
VPR-GW 14
Guide Wire
335 cm
Length
Guide Wire
Silicone
Coating
Core wire
.014"
diameter
Core wire
Stainless Steel
material
Spring Tip
3 cm
Length
Spring Tip
.014"
Diameter
Platinum/
Spring Tip
Material
Tungsten
Spring Tip
Straight
Shape

14. OAS Pump Declaration of Conformity

CSI declares that the peripheral system is in conformity with the requirements of: IEC 60601-
1. The OAS pump is compatible for use in a standard catheter laboratory environment.

15. EMC Declaration

Medical electrical equipment needs special precautions regarding electromagnetic
compatibility (EMC). Install and use medical electrical equipment according to the EMC
information below:
•
Do not have portable and/or mobile radio-frequency (RF) communications equipment
within close proximity of medical electrical equipment as portable and mobile RF
communications equipment can affect medical electrical equipment.
•
Ensure that power frequency magnetic fields are at levels characteristic of a typical
commercial or hospital environment.
•
Under an EMC phenomena the OAS may stop operation, and may require user
intervention to recycle the power to resume operation.
The Orbital Atherectomy System has been tested to IEC 60601-1-2. The Orbital Atherectomy
System has been tested to Immunity and Emission Test Levels of a Professional Healthcare
VPR-GW-FT14
VPR-GW-17
VPR-FLEX14
335 cm 335 cm
Silicone Silicone
.014" .014"
Stainless Steel Stainless Steel
3 cm 3 cm
.017" .014"
Platinum/ Platinum/
Tungsten Tungsten
Straight Straight
VPR-GW-FT18
VPR-FLEX18
335 cm
Silicone
.014"
Stainless Steel
3 cm
.018"
Platinum/
Tungsten
Straight
35
VPR-GW-EL-14 VPR-GW-EL18
VPR-ELFLEX14 VPR-ELFLEX18
475 cm
Silicone Silicone
.014"
Stainless Steel Stainless Steel
3 cm
.014"
Platinum/ Tungsten Platinum/ Tungsten
Straight Straight
475 cm
.014"
3 cm
.018"