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8287-E Jan 2020
STOPCOCK
OFF
TO SAVINGS COULD RESULT IN A LOWER DOSE
OF THE DRUG BEING ADMINISTERED.
E. End Case
1)
Select
End Case
and confirm “Yes”
Caution:
Ending case will permanently disable communication between the
Display and disposables.
After End Case is selected, a Case Summary screen appears showing
cumulative volume of contrast administered to patient, contrast saved
(mL and %) and % of physician specified threshold, if used.
The Smart Syringe and DyeVert Plus EZ Module contain batteries. Discard the
Smart Syringe and DyeVert Plus EZ Module and single-use contrast source
according to hospital procedures.
Follow local governing ordinances regarding disposal. Do not incinerate as the
enclosed batteries may explode at excessive temperatures
Note: To view summaries for previous cases, from
Main Menu
select
Settings,
User Settings, Case History.
Select Main Menu
to return to the main menu and start a new case.
System Discontinuation
Smart Monitor: Select Power Down
by pressing and holding the power button
on the end of the Monitor, then swiping the screen as indicated.
Contrast Monitoring Display: Select Power Down
from the main menu.
DyeVert Plus EZ Contrast Reduction System FCC Information
DyeVert Plus EZ Module FCC ID: 2AHUPDV
Smart Syringe FCC ID: 2AHUPSS
Classifications per IEC 60601-1 / UL 60601-1:
Degree of Protection:
Type CF-Applied Part
Mode of Operation:
Noncontinuous
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 Display, DyeVert Plus EZ Module or
Smart Syringe 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 limits for a Group
1 Class B device, 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 Display and the other equipment.
•
Connect the other equipment into an outlet on a circuit different from that to
which Display is connected.
•
Consult Osprey Medical for help.
WARNING:
Portable and mobile RF communications equipment may affect the
devices. The Display should not be used adjacent to or stacked with other
equipment. If adjacent or stacked use is necessary, the Display should be
observed to verify normal operation.
WARNING
: Use of accessories, transducers and cables other than those
specified or provided by Osprey Medical could result in increased
electromagnetic emissions or decreased electromagnetic immunity of this
equipment and result in improper 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 Display 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 contrast monitoring.
The Display and disposables have Bluetooth transceivers using short-wavelength
UHF radio waves in the ISM band from 2.4 to 2.485 GHz. The DyeVert Plus EZ
Module and Smart Syringe transmit a maximum signal strength of 0.063 mW
(-12 dBm ERP) using GSFM modulation as per IEEE 802.15.1 Bluetooth
standard and the Bluetooth SIG Working Group specification Version 4.0+.
WARNING:
Refer to the Smart Monitor or Contrast Monitoring Display IFU for
the electromagnetic compliance information of this system.
DISCLAIMER OF WARRANTY AND LIMITATION OF REMEDY
THERE IS NO WARRANTY EXPRESSED OR IMPLIED, INCLUDING
WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY
OR OF FITNESS FOR A PARTICULAR PURPOSE, ON THE OSPREY
MEDICAL PRODUCT(S) DESCRIBED IN THIS PUBLICATION. IN THE
EVENT OF ANY DEFECT OR NONCONFORMITY OF OR TO THIS
PRODUCT(S), OSPREY MEDICAL’S LIABILITY SHALL NOT BE IN EXCESS
OF THE PURCHASE PRICE OF THE PRODUCT(S) TO BUYER. UNDER NO
CIRCUMSTANCES SHALL OSPREY MEDICAL BE LIABLE FOR ANY
DIRECT, INDIRECT OR CONSEQUENTIAL DAMAGES BASED UPON
BREACH OF WARRANTY, BREACH OF CONTRACT, NEGLIGENCE,
STRICT TORT OR ANY OTHER THEORY ARISING OUT OF THE
PURCHASE, USE OR REUSE OF THIS PRODUCT(S). OSPREY MEDICAL
NEITHER ASSUMES NOR AUTHORIZES ANY PERSON TO ASSUME FOR
IT ANY OTHER OR ADDITIONAL LIABILITY OR RESPONSIBILITY IN
CONNECTION WITH OSPREY MEDICAL PRODUCT(S). Descriptions or
specifications in Osprey Medical printed matter, including this publication, are
meant solely to generally describe the product at the time of manufacture and
do not constitute any express warranties.
Stopcock
“OFF”