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16. 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
Table 8: Emissions
Emissions
Standard
Test
Compliance
Level
Electromagnetic environment - Guidance
IEC 60601-1-2
RF Emissions
CISPR 11
Group 1
RF emissions are very low and are not
likely to cause any interference in nearby
electronic equipment.
IEC 60601-1-2
RF Emissions
CISPR 11
Class A
The orbital atherectomy device is suitable for
use in all locations other than those located
in residential environments and those directly
connected to a low-voltage power supply
network that supplies buildings used for
domestic purposes.
IEC 60601-1-2
Harmonics,
IEC 61000-3-2
Class A
IEC 60601-1-2
Flicker,
IEC 61000-3-3
Complies
Table 9: Immunity
Immunity
Standard
Test
Test Level
Compliance Level
IEC 60601-1-2
Electrostatic
Discharge (ESD),
IEC 61000-4-2
±8 kV contact
±2, ±4, ±8, ±15 kV air
±8 kV contact
±2, ±4, ±8, ±15 kV air
IEC 60601-1-2
Radiated RF,
IEC 61000-4-3
3 V/m
80 MHz to 2.7 GHz
3 V/m
80 MHz to 2.7 GHz
IEC 60601-1-2
Radiated RF,
Proximity Fields,
IEC 61000-4-3
Tested to levels specified in
Table 9 of
IEC 60601-1-2:2014
Complies to levels of Table 9
IEC 60601-1-2
Electrical Fast
Transient / Burst,
IEC 61000-4-4
± 2 kV for power supply lines
± 1 kV for input/output lines
± 2 kV for power supply lines
± 1 kV for input/output lines
IEC 60601-1-2
Surge,
IEC 61000-4-5
± 2 kV line to ground
± 1 kV line to line
± 2 kV line to ground
± 1 kV line to line
IEC 60601-1-2
Conducted
Disturbances RF,
IEC 61000-4-6
3 Vrms 150 kHz to 80 MHz
6 Vrms ISM bands
3 Vrms 150 kHz to 80 MHz
6 Vrms ISM bands
IEC 60601-1-2
Power Frequency
50/60 Hz
Magnetic Field,
IEC 61000-4-8
30 A/m, 50 / 60 Hz
30 A/m, 50 and 60 Hz
IEC 60601-1-2
Voltage Dips and
Interruptions,
IEC 61000-4-11
100 % dip for 0.5 cycle;
0°, 45°, 90°, 135°, 180°, 225°,
270°, 315°
100% dip for 1 cycle
30% dip for 25 cycles
100% dip for 5 seconds
100% dip for 0.5 cycle;
0°, 45°, 90°, 135°, 180°, 225°,
270°, 315°
100% dip for 1 cycle
30% dip for 25 cycles
100% dip for 5 seconds
AIM 7351731
ISO 14223
65 A/m, 134.2 kHz
65 A/m
AIM 7351731
ISO/IEC 14443-3
(Type A)
7.5 A/m, 13.56 MHz
7.5 A/m
AIM 7351731
ISO/IEC 14443-4
(Type B)
7.5 A/m, 13.56 MHz
7.5 A/m
AIM 7351731
ISO/IEC 15693
(ISO 18000-3
Mode 1)
5 A/m, 13.56 MHz
5 A/m
AIM 7351731
ISO 18000-3
Mode 3
12 A/m, 13.56 MHz
12 A/m
AIM 7351731
ISO/IEC 18000-7 3 V/m, 433 MHz
3 V/m
AIM 7351731
ISO/IEC 18000-63
Type C
54 V/m, 860 – 960 MHz
54 V/m
AIM 7351731
ISO/IEC 18000-4
Mode 1
54 V/m, 2.45 GHz
54 V/m
17. Disclaimer of Warranty
Although Cardiovascular Systems, Inc. (CSI)
uses reasonable care in the manufacture of its
devices, they are used in difficult environment
within the human body with many biological
differences between individual patients. CSI has
no control over the conditions under which this
device is used, condition of the patient, methods of
administration or handling after the device leaves
CSI’s possession. THEREFORE, CSI DISCLAIMS
ALL WARRANTIES WHETHER EXPRESSED
OR IMPLIED, WRITTEN OR ORAL, INCLUDING
BUT NOT LIMITED TO ANY WARRANTIES
OF MERCHANTABILITY OF FITNESS FOR
A PARTICULAR PURPOSE. CSI DOES NOT
WARRANT EITHER FOR A GOOD EFFECT
OR AGAINST ALL ILL EFFECT FOLLOWING
ITS USE. CSI (INCLUDING ITS AFFILIATED
ENTITIES, OWNERS, DIRECTORS, OFFICERS,
EMPLOYEES, AGENTS AND VENDORS) SHALL
NOT BE LIABLE FOR ANY DIRECT, INDIRECT,
INCIDENTAL OR CONSEQUENTIAL LOSS,
DAMAGE, OR EXPENSE ARISING FROM OR
RELATED TO THE USE OF THIS DEVICE.
has been tested to Immunity and Emission Test
Levels of a Professional Healthcare Facility
Environment. The OAS is Group 1 (Therapy ME
Equipment and Systems) and therefore must meet
CISPR 11 Class A.
Note:
The Emissions characteristics of this
equipment make it suitable for use in industrial
areas and hospitals (CISPR 11 class A). If it is used
in a residential environment (for which CISPR 11
class B is normally required) this equipment might
not offer adequate protection to radio-frequency
communication services. The user might need to
take mitigation measures, such as relocating or
re-orienting the equipment.
Essential Performance of the OAS:
•
System starts, runs, stops at the operator’s
discretion and recovers in a controlled manner
from external upsets.
No person has authority to bind CSI to any
representation, warranty, or liability except as set
forth in this Disclaimer of Warranty.
CSI may, at its sole discretion, replace any device
that is determined to have been out of specification
at the time of shipment.
The exclusions, disclaimers, and limitations set
forth in this Disclaimer of Warranty are not intended
to, and shall not be construed as to, contravene
mandatory provisions of any applicable law or
regulation. If any part of this Disclaimer of Warranty
is held to be illegal or unenforceable by a court of
competent jurisdiction, the part shall be modified
so as to be enforceable to the maximum extent
possible. If the part cannot be modified, then that
part may be severed and the other parts of this
Disclaimer of Warranty shall remain in full force
and effect.
Appendix A. System Troubleshooting
If issues with the OAS pump or OAD cannot be resolved in each of the situations below, replace the
recommended part and continue with the procedure. Contact CSI Customer Service for returning OAS
components. See the back of these instructions for use for CSI contact information.
Table A1. System Troubleshooting
Issue
Number
Issue
Solution
1
The OAS pump will not
power on and no LEDs are
illuminated on the OAS
pump control panel
1. Ensure that the power cord is properly inserted into the
power module on the back of the OAS pump and that the
power cord is connected to a functioning wall power outlet.
2. Ensure that the Master Power switch, on the back of the
OAS pump, is in the on position.
3. Contact CSI Customer Service at the phone number on the
back of this instructions for use to return to CSI.
2
The OAS pump will not
pump saline
1. Ensure that the OAS pump is properly powered on – see
Issue number 7.
2. Ensure that the saline bag and saline tubing (i.e. bag
spike) are properly connected with no kinks and a sufficient
amount of saline is in the saline bag such that the low
saline level sensor is not active and the red LED on the
OAS pump control panel is not illuminated.
3. Ensure that the saline tubing is routed correctly through the
OAS pump saline tubing guides and that the OAS pump
saline tubing door is closed.
4.
Ensure that the yellow LED is off and the green LED is
illuminated. If the green LED is not illuminated, press the
green Start button and verify that the yellow LED is off and
that the green LED illuminates.
5.
If the green LED is flashing while the yellow LED is
illuminated, press the green Start button twice and
verify that the yellow LED is off and that the green LED
illuminates.
6. If the OAS pump does not restart after completing the
above mentioned steps, press the Master Power switch to
power off the OAS pump. Wait a few seconds and press
the Master Power switch to power on the OAS pump. Verify
that the OAS pump powers on.
3
The OAS pump was
running, but has stopped
pumping and the yellow
LED is illuminated
1. Verify the OAD power cord is connected to the OAS pump.
2. Press the
Master Power
switch, on the back of the OAS
pump, to power off the OAS pump. Wait five (5) seconds
and press the
Master Power
switch to power on the pump.
4
All three LEDs on the front
panel of the OAS pump
remain illuminated
1. Press the
Master Power
switch, on the back of the OAS
pump, to power off the OAS pump. Wait a few seconds and
press the
Master Power
switch to power on the pump.
2. Contact CSI Customer Service at the phone number on the
back of this instructions for use.
5
After OAS pump power up,
all three LEDs on the front
panel of the OAS pump
blink three times and there
is an audible notification
signal three times.
1. Contact CSI Customer Service at the phone number on the
back of this instructions for use.
6
The low saline level
sensor (red LED) is
illuminated
Note: The OAS pump will stop pumping saline and supplying
power to the OAD 30 seconds after the low saline
level sensor activates while the OAD is spinning,
as indicated by an audible information signal every
5 seconds.
1. If there is less than 200 mL of saline left in the bag of saline
and lubricant, replace the bag with a new 1000 mL bag of
normal saline and lubricant solution.
2. Ensure that the bag of saline and lubricant is hanging freely
from the saline bag open hook and that the low saline level
sensor cord is properly inserted into the connector on the
sensor and the connector on the back of the OAS pump.
3. Verify that the red low saline LED on the OAS pump control
panel turns off and either the yellow LED or the green LED
illuminates. If the yellow LED illuminates, press the Start
button on the OAS pump and verify that the green LED
illuminates.
7
All OAD Speed indicator
LEDs blink simultaneously
1. Discontinue treatment.
2.
Press the green start button on the OAS pump to turn off
OAD power. Press the green start button on the OAS pump
to supply power to the OAD.
3. If the OAD LEDs continue to blink simultaneously, replace
the OAD.
8
All speed indicator LEDs
on the OAD handle remain
illuminated
1. Immediately discontinue treatment and replace the OAD.