8161-L
Error Message
User Actions
“Lost connection with the DyeVert.
Attempting to reconnect.”
No action required
“Lost connection with the DyeVert
EZ. Attempting to reconnect.”
No action required
“Lost connection with the Pressure
Module. Attempting to reconnect.”
No action required
“Bluetooth Fault Detected. Turn
system OFF and ON: 1. OFF:
Press & hold blue power button >
5 secs. 2. ON: Press & release blue
power button. “
Perform a hard shutdown of the Display by
holding the power button down for >5
seconds, then restart the Display by
pressing the power button once. If the
problem persists, contact Osprey Medical
“Software Fault Detected. Turn
system OFF and ON: 1. OFF:
Press & hold blue power button >
5 secs. 2. ON: Press & release blue
power button. “
Perform a hard shutdown of the Display by
holding the power button down for >5
seconds, then restart the Display by
pressing the power button once. If the
problem persists, contact Osprey Medical
“Cancelling Connection Attempt”
No action required
“The syringe cannot be connected.
Replace the disposable and
continue the case, or end the
case?”
Replace the Smart Syringe or end case
“The syringe cannot be connected.
Replace the disposable to start the
case, or return to main menu?”
Replace the Smart Syringe and continue
the case or select main menu and cancel
device use
“The DyeVert cannot be connected.
Replace the disposable and
continue the case, or end the
case?”
Replace the DyeVert Plus Module
disposable or end case
“The DyeVert cannot be connected.
Replace the disposable to start the
case, or return to main menu?”
Replace the DyeVert Plus Module and
continue the case or select main menu and
cancel device use
“The DyeVert EZ cannot be
connected. Replace the disposable
and continue the case, or end the
case?”
Replace the DyeVert Plus EZ Module
disposable or end case
“The DyeVert EZ cannot be
connected. Replace the disposable
to start the case, or return to main
menu?”
Replace the DyeVert Plus EZ Module and
continue the case or select main menu and
cancel device use
“The Pressure Module cannot be
connected. Replace the disposable
and continue the case, or end the
case?”
Replace the Pressure Module disposable or
end case
“The Pressure Module cannot be
connected. Replace the disposable
to start the case, or return to main
menu?”
Replace the DyeTect Pressure Module and
continue the case or select main menu and
cancel device use
“There is no remaining battery
power for the syringe.”
Replace the Smart Syringe
“Syringe Battery Level Critical
Replace the Syringe within <timer>“
Replace the Smart Syringe within time
remaining on displayed countdown timer.
“There is no remaining battery
power for the DyeVert.”
Replace the DyeVert Plus Module
disposable.
“There is no remaining battery
power for the DyeVert EZ.”
Replace the DyeVert Plus EZ Module
disposable.
“DyeVert Battery Level Critical
Replace the DyeVert within
<timer>“
Replace the DyeVert Plus or DyeVert Plus
EZ Module disposable within time
remaining on displayed countdown timer.
There is no remaining battery
power for the Pressure Module.”
Replace the DyeTect Pressure Module
disposable.
“Pressure Module Battery Level
Critical. Replace the Pressure
Module within <timer>“
Replace the DyeTect Pressure Module
disposable within time remaining on
displayed countdown timer.
“Would you like to continue the
current case started on <date> at
<time>?”
Select “Yes” to restart the case, “No” to end
the case
“Unable to connect to the Syringe.
Please replace the unit.”
Replace the Smart Syringe
“Unable to connect to the DyeVert.
Please replace the unit.”
Replace the DyeVert Plus or DyeVert Plus
EZ Module disposable
“Unable to connect to the Pressure
Module. Please replace the unit.”
Replace the DyeTect Pressure Module
disposable.
“Please wait as we reconnect to
previously used devices.”
No action required
“Please wait as we dispose of
previously used devices.”
No action required
“Database Error: failed to initialize
database.”
Perform a hard shutdown of the Display by
holding the power button down for >5
seconds, then restart the Display by
pressing the power button once. If the
problem persists, contact Osprey Medical
“Database Error: failed to add
case.”
Contact Osprey Medical
“Database Error: failed to update
case.”
Contact Osprey Medical
Error Message
User Actions
“Database Error: failed to mark all
unfinished cases as abandoned.”
Contact Osprey Medical
DyeVert Plus or DyeVert Plus EZ Contrast Reduction System and Contrast
Monitoring System FCC Information
Display Contains FCC ID: Z64-WL18SBMOD
DyeVert Plus and DyeVert Plus EZ Module FCC ID: 2AHUPDV
Smart Syringe FCC ID: 2AHUPSS
Pressure Module FCC ID: 2AHUPPM
Classifications per IEC 60601-1 / UL 60601-1:
Degree of Protection:
Type CF-Applied Part
Enclosure Degree of Ingress Protection:
IP31
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 or DyeVert
Plus EZ Module, Smart Syringe or Pressure Module not expressly approved by
Osprey Medical 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.
WARNING
: Electromagnetic interference has been observed in testing at 385
MHz and 450 MHz causing display screen distortion or scrambling.
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 Display transmits
a maximum signal strength of 1 mW (0 dBm ERP) using GSFM modulation as
per IEEE 802.15.1 Bluetooth standard and the Bluetooth SIG Working Group
specification Version 4.0+.
Guidance and manufacturer’s declaration – electromagnetic emissions
The system is intended for use in the electromagnetic environment specified below. The
customer or the user of the system should assure that it is used in such an environment.
Emissions Test
Compliance Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
The Display uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely
to cause any interference in nearby electronic equipment.
RF emissions
CISPR 11
Class B
IEC 61000-3-2
Not Applicable
