Merit Medical Monarch Inflation Device - Manual

DESCRIPTION:
The Monarch
™
Inflation Device
and Fluid Dispensing
Syringe by Merit Medical
is a 20ml disposable device
with an integral pressure
transducer, microcom-
puter, back-lit LCD,
threaded plunger
assembly with
lock/release bar, a flexible high pressure
extension tube, and a three-way medium pressure stopcock.
The Monarch is designed to generate and monitor pressures
over a range of -1 to +30.0 ATM/BAR (-7 to 441 PSI). The
Monarch syringe dispenses .45ml of fluid ± .07ml for each
360° turn of the syringe plunger handle.
CAUTION: Federal (U.S.A.) law restricts this device to use
by or on the order of a physician.
INSTRUCTIONS FOR USE:
Before use, inspect the device and packaging to verify that no
damage has occurred as a result of shipping.
Press the green button next to the LCD display to activate the mi-
croprocessor. After three seconds, the LCD display and backlight
will come on. The syringe will display 0.0 in the pressure area of
the display and the time will begin incrementing.
The syringe will be set in the ATM/BAR mode when initially turned
on. To change the pressure display to read in PSI, simply press the
blue button. To change back to ATM/BAR, press the blue button
once again.
After an inflation or pressure monitored injection has been
made, pressing the green button will display last inflation
information and an “ “ indicator on the display.
CAUTION:
If “ER” is displayed in the pressure area and a
number appears in the time window, the syringe is defective.
Please return the syringe to Merit Medical for credit.
NOTE: To conserve power the backlight will automatically turn
off after ten minutes of inactivity. Pressing the green button or
inflating the balloon will reactivate the backlight. The syringe’s
microprocessor will turn off after 90 minutes of inactivity.
Pressing the green button will reactivate normal operation.
After ten minutes at a constant pressure the backlight will turn
off, however, the microprocessor will continue to monitor the
pressure. Pressing the green button will reactivate the back
light.
PRIMING WITH PRIMELOK TM
The PrimeLok allows purging of air and
excess fluid without squeezing the
trigger. The Monarch is packaged
with the PrimeLok in the
disengaged position.
1. To engage PrimeLok, squeeze
trigger and slide PrimeLok into slot.
2. To prep syringe, simply aspirate up
to 20ml of contrast solution or fluid to
be dispensed into the inflation syringe by
pulling back on the plunger handle.
CAUTION:
Inspect the syringe
tubing and stopcock (if used) to ensure
that there is no air in the system.
3. Push handle against table
to remove air in syringe.
4. To disengage PrimeLok, squeeze
trigger and slide PrimeLok out of slot. This
will allow the plunger to lock in position
and the device is now ready for use.
NOTE: The PrimeLok must be
disengaged before pressure
can be maintained by the
lock/release mechanism.
INFLATION DEVICE INDICATIONS AND USAGE:
This inflation device is used to inflate and deflate an angioplasty
balloon or other interventional devices, and to measure the
pressure within the balloon.
ATTACHING THE INFLATION DEVICE TO THE BALLOON:
NOTE: Refer to the manufacturer’s directions accompanying the
balloon dilatation catheter or other interventional device for
specific information on use, maximum inflation pressure,
precautions, and warnings for that device.
1. Prepare and test the balloon catheter according to the
catheter manufacturer’s directions for use.
2. Create a fluid-fluid connection between the balloon and the
syringe extension tube, connect the luer connectors securely.
3. Squeeze the trigger and pull back on the plunger handle to
apply a vacuum to the balloon.
BALLOON INFLATION AND DEFLATION:
1. To inflate the balloon, squeeze the trigger allowing the
plunger to return to a resting position (0 ATM/BAR or PSI).
Release grip on the trigger, locking the plunger into position.
To increase pressure, rotate handle clockwise until the desired
pressure is reached. The lock mechanism maintains the pres-
sure. Pressures above the maximum range will be indicated
with flashing numbers and an “ ” indicator on the display.
NOTE: Loss of pressure may indicate a leak in the system.
CAUTION:
To protect the threads of the lock release handle,
the device must be displaying 25 ATM or lower before quick
release mechanism is used to deflate the angioplasty balloon.
2. To deflate balloon, rotate handle counterclockwise to release pres-
sure to 25 ATM or lower. Squeeze the trigger and pull back to gener-
ate a negative pressure. Release grip to lock the plunger in a negative
pressure position. Pressures below the minimum range of the syringe
will be indicated by flashing bars and an “ ” in the pressure area.
Data associated with the last inflation will be displayed when the green
button is depressed and the pressure is zero or less.
CAUTION:
If applied pressure does not indicate on gauge/
digital display, discontinue use immediately and replace it with a
new unit.
FLUID DISPENSING INDICATIONS AND USAGE:
This device is intended for use by healthcare professionals to
dispense fluids to the body from the Monarch syringe and monitor
the pressure of that fluid.
DISPENSING FLUIDS AND MONITORING PRESSURES USING
THE MONARCH SYRINGE
1. To slowly dispense fluids to the body rotate the plunger clock-
wise until the desired fluid is injected. The injection pressure will
be displayed on the LCD and the timer automatically starts once
the device generates a positive pressure. Pressures above the
maximum range of the syringe will be indicated with flashing
numbers and an “ ” indicator on the display.
2. To rapidly dispense fluids to the body squeeze the trigger
while pushing the plunger forward. The injection pressure will be
displayed on the LCD and the timer automatically starts once the
device generates a positive pressure. Pressures above the
maximum range of the syringe will be indicated with flashing
numbers and an “ ” indicator on the display.
3. A negative pressure may be generated by squeezing the trigger
and pulling back the plunger. Release grip on the trigger to lock
the plunger in the negative pressure position.
4. The timer will stop once the pressure returns to zero or less.
Data associated with the last injection will be displayed when
the green button is depressed and held and the pressure is
zero or less.
CAUTION: This syringe is capable of generating high fluid
pressures in a closed fluid system. The volume change of fluid
dispensed may not be accurate due to compliance of the plastic
components as pressure changes.
Inflation Device and
Fluid Dispensing Syringe
U.S. Patent Nos. 5,047,015 5,057,078 5,135,488
Other U.S. and Foreign Patents Pending.
ENGAGED PRIMELOK
DISENGAGED PRIMELOK
ENGAGE PRIMELOK
I N S T R U C T I O N S F O R U S E
S P E C I F I C A T I O N S
________________________________________________
Operating Range: -1 ATM to 30 ATM
(1 ATM = 1BAR = 14.7 PSI)
________________________________________________
Accuracy: ±2.5 % of full scale typical
________________________________________________
Fluid Dispensed: 0.45ml ±.07ml fluid dispensed for each 360°
clockwise turn of the syringe plunger handle.
________________________________________________
Liquid Temp: 10° C to 40° C
________________________________________________
Humidity 20% to 90%
Operation Range: Non-condensing humidity
________________________________________________
Battery Life Fully active device, up to 10 hours
RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RADIO FREQUENCY (RF)
COMMUNICATIONS EQUIPMENT AND THE MONARCH™ INFLATION DEVICE
The Monarch™ Inflation Device is intended for use in an electromagnetic environment in which RF radiated disturbances are
controlled. The user of the Monarch™ Inflation Device can help prevent electromagnetic interference by maintaining a mini-
mum distance between portable and mobile RF communications equipment (transmitters) and the Monarch™ Inflation De-
vice as recommended below, according to the maximum output power of the communications equipment.
Separation distance according to
frequency of transmitter (in meters) m
Rated maximum output power 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
of transmitter (in watts)
W
0.01 0.12 0.23 0.93
0.1 0.37 0.74 2.95
1 1.17 2.33 9.33
10 3.69 7.38 29.51
100 11.67 23.33 93.33
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m)
can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power
rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 – At 80 MHz and 800 MHz, the separation distance for the higher frequency applies.
NOTE 2 – These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY
The EQUIIPMENT is intended for use in the electromagnetic environment specified below.
The customer or the user of the EQUIPMENT should assure that it is used in such an environment.
Immunity Test IEC 60601 Compliance level Electromagnetic
test level environment-
guidance
Electrostatic ±6 kV contact ±6 kV contact Increasing relative
discharge (ESD) ±8 kV air ±8 kV air humidity will reduce
IEC 61000-4-20 the potential for ESD
related difficulties
Users should follow local guidelines and practices regulating the disposal of infected waste products.
PX Only - Caution: Federal (USA) law restricts this device to sale by or on
the order of a physician. / Attention: La loi fédérale américaine limite la vente de cet article à des médecins ou sur ordonnance. / Attenzione:
La legge federale degli Stati Uniti limita la vendita di quest’articolo ai medici o dietro ricetta medica. / Achtung: Das Bundesgesetz der USA
limitiert den Verkauf dieses Artikels an Arzte oder gegen Rezept. / Precaución: La ley Federal de los Estados Unidos de América (EEUU) pro-
hibe la venta de este producto sin prescripción médica. / Atencão: A Lei Federal dos EUA restringe a venda deste dispositivo a, ou sob a pre-
scrição de um medico. / Waarschuwing: de wetgeving van de Verenigde Staten bepaalt dat de verkoop van dit apparaat uitsluitend door of op
recept van een arts kan geschieden. / Försiktighet: l USA förbjuder federala lagar att denna utrustning säljs av läkare eller på ordination av
läkare. / Vigtigt: Foderale myndigheder i USA har bestemt, at denne artikel kun ma saelges til læger eller på recept. / ¶ƒ√™√Г∏: ∞МВЪИО·ÓÈÎfi˜
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Manufacturer Authorized Representative
Merit Medical Systems, Inc. Merit Medical Ireland Ltd
South Jordan, Utah 84095 U.S.A.1-801-253-1600 Parkmore Business Park West, Galway, Ireland
U.S.A. Customer Service 1-800-356-3748
400647002/B ID 070110
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