Merit Medical BlueFIRE User manual
EN-USERMANUAL
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WARNINGS:
The BlueFIRE Monitor and BlueFIRE Syringe instruc-
tions for use must be completely read and under-
stood prior to use. If performing PTA, the angio-
plasty balloon manufacturer’s instructions for use
should be read and followed.
CAUTION: The BlueFIRE Monitor should not be sub-
merged or wet with liquids during use. The BlueFIRE
Monitor may be cleaned with a damp cloth and mild
detergent between uses.
CAUTION: The BlueFIRE Syringe must be open to at-
mospheric pressure during zeroing. If the syringe is
not open to atmosphere during zeroing, inaccuracy
in pressure readings may result.
CAUTION: To ensure Monitor stability, use BlueFIRE
mounting accessories only.
CAUTION: The use of accessories, sensors and
cables other than those specied may result in in-
creased emission and/or decreased immunity and
inaccurate readings of the BlueFIRE Monitor.
CAUTION: Portable and mobile RF communication
equipment can aect the BlueFIRE Monitor.
Refer to the provided iPad user manual for instruc-
tions on how to connect the BlueFIRE Monitor to Wi-
Fi to enable email capability.
INDICATIONS
The Merit Medical BlueFIRE Monitor is for use only
with the disposable BlueFIRE Syringe. It may be used
to measure the pressure and time of ination within
balloon angioplasty catheters or other intervention-
al devices.
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DESCRIPTION
The BlueFIRE Monitor displays pressures created by
the BlueFIRE Ination Syringe. The BlueFIRE Syringe
is connected to the Monitor via Bluetooth wireless
technology. In addition to displaying pressure pa-
rameters in ATM (atmospheres), psi (pounds per
square inch), mmHg (millimeters of mercury), or Bar,
the BlueFIRE Monitor displays duration of pressur-
ization in minutes and seconds, time elapsed since
last pressurization, and indicates when a negative
pressure has been reached. The Monitor also stores
an activity log of the ination pressures reached
during the procedure, and has the capability to
email or print the activity logs.
The BlueFIRE Ination Syringe is a 30mL disposable
device with an integral pressure transducer, thread-
ed plunger assembly with lock/release bar, a exible
high-pressure extension tube, and a three-way stop-
cock. The BlueFIRE Syringe generates positive and
negative pressure over a range of -1 to +40ATM/BAR
(-1 to 588 PSI), and sends pressure information to the
BlueFIRE Monitor via Bluetooth wireless technology.
COMPONENETS
PRINTER
ENGLISH
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MOUNTINGTHEBLUEFIREMONITOR
The BlueFIRE Monitor has two mounting options:
1. Pole Mounting: The BlueFIRE pole mount (part
number IN10POLE) may be clamped to any
round or square tube from 0.5” to 2”. To connect
the Monitor to the clamp, loosen the Monitor
thumb screw until the socket ts onto the ball
on the clamp, position the Monitor, then tighten
the thumb screw.
2. Table Mounting: The BlueFIRE table mount
(part number IN10TABLE) may be inserted into
the edge of a surgical table. To connect the
Monitor to the table mount, loosen the Monitor
thumb screw until the socket ts onto the ball
on the clamp, position the Monitor, then tighten
the thumb screw.
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ENGLISH
CONNECTINGASYRINGE
NOTE: Refer to the BlueFIRE Syringe“Instructions for
Use” for the correct preparation of the syringe be-
fore connecting it to the Monitor.
1. Pull the orange tab from the BlueFIRE Syringe.
2. To connect the Syringe, you can either scan
the QR code on the Syringe or press “Connect
Manually” and select the Syringe from the list.
Note: To scan, hold the Syringe QR code steady
and aligned within the red box on the screen. If
it does not immediately scan, try slowly rotating
the Syringe QR code within the red box.
CAUTION: The syringe must be open to at-
mospheric pressure during connection or
accurate zeroing of the pressure transducer
is not assured and inaccuracy may result.
SCANCONNECT MANUALCONNECT
QR CODE
ALIGN
HERE
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OPERATINGTHEBLUEFIRE
MONITORWITHABLUEFIRE
SYRINGE:
After connecting the BlueFIRE Syringe, the display
will show the current pressure 1and a time 2.
As the pressure exceeds 0.7 ATM (10 psi), the timer
will reset and begin timing the ination. Upon com-
pletion of an ination, the timer will reset to zero
and the duration since the last pressurization will
be displayed. The last pressurization maximum val-
ue and pressurization duration are displayed in the
lower right corner 3. Values are also stored to the
activity log within the BlueFIRE app (see above).
When monitoring is complete, disconnect the Blue-
FIRE Syringe by pressing the“Disconnect” button.
CLEANING:
The BlueFIRE Monitor is not required to be sterile.
It should be cleaned regularly to prevent the build-
up of contrast, saline and other contaminants with
a cloth dampened with water, isopropyl alcohol or
mild detergent. Do not spray the Monitor directly
with the cleaning solution.
MENUFUNCTIONS
Note: Menu Functions are not available while ina-
tion is in progress (while there is positive pressure
displayed).
Activity Log:
Access the activity log by pressing the clipboard
icon . This allows the user to review data associ-
ated with all syringes in the log memory. Syringe IDs
in the activity log are displayed on the left side of
the screen. Select the desired syringe for review by
pressing the syringe ID. The BlueFIRE app will display
all events associated with that syringe on the right
side of the log. Swipe up/down to review all data.
• Press the trash can icon to delete the
selected syringe from the log memory.
• Press the email icon to email the data.
• Press the print icon to print the data.
• Press the Xin the upper right corner to return to
the previous screen.
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ENGLISH
Set Units allows the user to change the
current pressure display units. To set units,
press the desired unit of pressure measure-
ment (ATM, PSI, BAR, mmHg).
Press this icon to set up a Bluetooth printer.
Refer to the Star Micronics website to ac-
cess the printer manual.
Swipe this slider to toggle auto-printing
after the procedure. With this function
activated, the ination data will automati-
cally print to a Bluetooth printer after the
procedure.
Note: The Bluetooth printer must be set up.
SETTINGS:
Access settings by pressing this icon
Press the +symbol to add email addresses
to the address list. These email addresses
will be added to the “To” eld of the email.
Swipe to the left to delete entries from the
address list.
Swipe this slider to toggle auto-emailing
after the procedure. With this function
activated, the ination data will automat-
ically be sent to the address list after the
procedure.
Press this icon to view information on the
BlueFIRE app and syringe.
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SPECIFICATIONS:
Calibration Preset
Transducer Zero Automatic at connection of syringe
Operating
Temperature Range
10°C – 35°C (50°F – 95°F)
Storage
Temperature Range
-25°C – 60°C (-11°F – 140°F)
packaged
Relative Humidity 30%-70% Non-condensing
Power 100-240V
50-60Hz
0.45A
System Accuracy ±3.0% of full scale range
FCC15.21STATEMENT:
This device complies with Part 15 of the FCC rules. Its opera-
tion is subject to the following two conditions:
• This device may not cause harmful interference,
and
• This device must accept any interference received, in-
cluding interference that may cause undesired operation.
Changes or modications not expressly approved by Merit
Medical Systems, Inc. would void the user’s authority to op-
erate this produce.
FCC15.105STATEMENT:
This equipment has been tested and found to comply with
the limits for a Class A digital device, pursuant to part 15
of the FCC Rules. These limits are designed to provide rea-
sonable protection against harmful interference when the
equipment is operated in a commercial environment. This
equipment generates, uses, and can radiate radio frequency
energy and, if not installed and used in accordance with the
instruction manual, may cause harmful interference to radio
communications. Operation of this equipment in a residen-
tial area is likely to cause harmful interference in which case
the user will be required to correct the interference at his own
expense.
BLUEFIREPARTNUMBERS
Part Number Description
IN10START BlueFIRE Starter Kit, includes Monitor,
Syringe, printer, pole mount, table
mount, and cables.
IN10140 BlueFIRE Syringe
IN10XXX BlueFIRE Syringe with MAP kit XXX
IN10XXX BlueFIRE Syringe with MAP kit XXX
IN10XXX BlueFIRE Syringe with MAP kit XXX
IN10XXX BlueFIRE Syringe with MAP kit XXX
IN10PAD BlueFIRE Monitor (includes cables)
IN10CABLE BlueFIRE Cables
IN10POLE BlueFIRE Pole Mount
IN10TABLE BlueFIRE Table Mount
IN10PRINT BlueFIRE Printer
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ENGLISH
End of English Manual
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