Osprey Medical DyeVert Power XT Instrucciones De Uso página 3

B. System Operation
4F
1) DyeVert Valve Selection
&
a. Based on the catheter size being used for the procedure and
5F
consistent with the fluid flow shown in Figure 1, orient the Valve
Selection Stopcock to the corresponding "4F & 5F" or "6F & 7F"
position. (See Figure 6)
6F & 7F
Figure 6 – DyeVert Valve Selection Stopcock
Note: If catheter size changes during the case – reorient Valve Selection
Stopcock as appropriate.
2) Contrast Injections
a. To save contrast during a contrast injection, orient the DyeVert Power
XT Stopcock such that it is ON to both the Valve Selection Stopcock and
the catheter. (See Figure 7)
Figure 7 – Contrast Injection (Savings ON)
b. Inject contrast per normal operating procedure.
3) Saline Flushing
a. If flushing with saline, turn DyeVert Power XT Stopcock OFF to the
Valve Selection Stopcock. (See Figure 8)
Figure 8 – Saline Flush (Savings OFF)
b. To allow contrast saving to resume, orient the DyeVert Power XT
Stopcock such that it is ON to both the Valve Selection Stopcock and
the catheter. (See Figure 9)
Figure 9 – Resume Savings
4) System Bypass
a. To bypass the DyeVert Power XT System (i.e. no diversion) orient the
DyeVert Power XT Stopcock to OFF to the Valve Selection Stopcock
(see Figure 10). The Power XT System should be bypassed for the
following instances: saline flush of catheters or drug delivery.
6F 4F 6F
& &
&
5F 7F
7F
4F & 5F
F
F
O
O
F
F
Figure 10 – System Bypass (Savings OFF)
b. To allow contrast saving to resume, orient the DyeVert Power XT
Stopcock such that it is ON to both the Valve Selection Stopcock and
the catheter. (See Figure 9)
5) Contrast Accounting Estimation
a. At the end of the case, to estimate the total volume of contrast
that was delivered to the patient (i.e. Estimated Patient Contrast
Volume), subtract the Estimated Diverted Contrast Volume
(collected in the Smart Bag) from the power injector Contrast
Volume stated on the power injector display screen.
Estimated Patient Contrast Volume = [Contrast Volume injected
by power injector as shown in injector display minus estimated
Diverted Contrast Volume contained in the Smart Bag]
Note: contrast accounting estimation may be inaccurate due to other
fluids, such as saline being in the Smart Bag.
Classifications per IEC 60601-1:
Degree of Protection:
Smart Bag Enclosure Degree of
Ingress Protection (when hung vertical):
Mode of Operation:
This device complies with part 15 of the FCC Rules. Operation is subject to the
following two conditions: (1) This device may not cause harmful interference, and
(2) this device must accept any interference received, including interference that
may cause undesired operation.
WARNING: Changes or modifications to the Smart Bag not expressly approved
by Osprey Medical, Inc. could void the user's authority to operate the equipment.
ELECTROMAGNETIC INTERFERENCE PRECAUTIONS
This equipment has been tested and found to comply with the class B limits,
pursuant to IEC/EN 60601-1-2, 4 th edition. These limits are designed to provide
reasonable protection against harmful interference. This equipment, if not
installed and used in accordance with the instructions, may cause harmful
interference to other equipment. However, there is no guarantee that interference
will not occur in a particular installation. If this equipment does cause harmful
interference to other devices, which can be determined by turning the equipment
off and on, the user is encouraged to try to correct the interference by one or
more of the following measures:
• Reorient or relocate the other equipment.
• Increase the separation between the Smart Bag and the other equipment.
• Consult Osprey Medical for help.
WARNING: Portable and mobile RF communications equipment may affect the
devices. The device should not be used adjacent to, or stacked with, other
equipment. If adjacent or stacked use is necessary, the Smart Bag should be
observed to verify normal operation.
WARNING: Portable RF communications equipment (including peripherals such
as antenna cables and external antennas) should be used no closer than 30 cm
(12 inches) to any part of the device or disposables, including cables specified by
the manufacturer. Otherwise, degradation of the performance of this equipment
could result.
If performance of the system is lost or degraded due to electromagnetic
interference, the procedure may continue without diverted contrast monitoring.
O
F
F
Type CF-Applied Part
IP32
Continuous
8300-E Jan 2021