Merit Medical BlueFIRE Bedienungsanleitung

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 specied 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 aect 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 ination within

balloon angioplasty catheters or other intervention-

al devices.

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DESCRIPTION

The BlueFIRE Monitor displays pressures created by

the BlueFIRE Ination 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 ination pressures reached

during the procedure, and has the capability to

email or print the activity logs.

The BlueFIRE Ination 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 ination. Upon com-

pletion of an ination, 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 ina-

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 ination 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 ination 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 modications 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

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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BlueFIRE_UserManual2.indd 10 10/20/2017 2:51:29 PM

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