Merit Medical Meritrans DTXPlus Gebrauchsanleitung

Monitoring Life™
Instructions for use
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Istruzioni per l'uso
Meritrans DTXPlus
™
Disposable Pressure Transducer Sets
Safedraw™ Blood Sampling System
Description
Meritrans
This set contains
transducer(s) and may contain Safedraw™ blood sampling
system. As customer designated set configurations vary from
institution to institution, it is the responsibility of institutions to
establish their specific policies and procedures governing the
use of the set including safety measures
those described in this instruction sheet. Section A
describes Meritrans DTXPlus™ transducers with or without
Safedraw™. Section B describes EasyVent™ deadender
cap usage. Section C describes standardise Safedraw™
sets. Section D describes blood sampling using Safedraw™.
Intended Use
The Merit Disposable Blood Pressure Transducer (DTX)
is intended for invasive
monitoring. The Disposable Blood Pressure Monitoring Kit
(DTX Kit) packaged with the Safedraw blood sampling model
is intended to allow blood to be drawn from the patient
without the patient being exposed
environment (closed loop blood sampling).
Section A
The Meritrans DTXPlus™ family of transducers consists of
three flush models (DT-XX, DT-NN and DT-XO) and one no-
flush model (TNF-R).
The DT-XX model has a blue clip fast-flush actuator and a
zeroing stopcock as shown in Figure 1. To maintain catheter
patency, the integral flush device delivers a continuous
(nominal) flow rate of 3 mL/hr with a differential pressure of 200
mmHg (infusion bag pressure minus mean physiological
pressure monitored). The flush device also incorporates an
overpressure safety valve to prevent the pressure on the
transducer from exceeding approximately 7000 mmHg. The
valve will vent excess fluid safely back into the infusion bag
while maintaining a sealed, sterile pathway. Merit fast-flush
actuators (clip or pull tab) offer convenience in fluid filling,
debubbling and fast-flushing.
The DT-XO model is similar to the DT-XX model with a nominal
flow-rate of 3 mL/hr but does not have a zeroing stopcock.
The DT-NN model (up to 30 mL/hr nominal flow rate) for
neonatal applications. It has an integral zeroing stopcock like
the DT-XX model but its clip actuator is yellow in colour. USE
ONLY IN CONJUNCTION WITH A MECHANICAL FLUID
INFUSION PUMP. The actual continuous infusion rate for
neonatal monitoring is determined by the clinician and
controlled by a mechanical infusion pump. Fast flushing with
the flush-device in neonatal applications should only be done
as part of initial fluid filling and debubbling procedure. Flushing
after drawing blood or administering medications should be
done manually with a syringe to control fluid infusion precisely.
Fast flush rate varies with the type of administration set, the
length and lumen diameter of pressure tubing which couples
the transducer to the patient.
The TNF-R model does not have a flush device, clip/pull tab
actuator or a zeroing stopcock and may be supplied in a set
along with a separate in-line flow/flush device.
CAUTION: D-cap (transparent deadender) may be
supplied with TNF-R. Do not overtighten the D-cap as this
may deform the male luer fitting of TNF-R and prevent
connection of other components.
Set Up Procedures
Use aseptic technique. Verify that all connections are secure
and stopcock handles in the desired directions.
CAUTION: Tighten all connections before use. Do not
overtighten connections as this may crack the connection
leading to leaks, air embolism, bleed backs or loss of
pressure waveforms.
All side ports of stopcocks are protected by vented caps which
should remain in place until system is primed. Vented caps
should always be replaced with non-vented caps unless it has
EasyVent™ deadender caps. See Section B for more
instructions.
CAUTION: Disposable transducers offer a single mode of
electrical isolation through a diaphragm, air gap, insulation
gel or some combination of the above and are not
recommended for use with non-isolated patient monitors. If
in doubt about the isolation characteristics of your monitor,
refer to monitor service manual or call the monitor
manufacturer.
Instruções de Uso
Transducer, Interface Cable Connection
Connect transducer to reusable interface cable by aligning
Инструкции по
connector arrows and pushing them together (see Figure 2).
применению
CAUTION: Failure to use a Merit interface cable may
Instrucciones de
result in signal disruption. Always test reusable cable
uso
before use.
Bruksanvisning till
Filling IV Set (See Figure 3, 4 & 5 )
användning
Following instructions apply to IV sets with either micro or
macro-drip chambers in single line configurations.
使用說明
1. Prepare sterile flush solution in a non-vented solution bag
per physician's prescription.
使用方法
2. Evacuate air from solution bag by pushing IV spike into
solution bag and rotate bag down to facilitate trapped air to
사용 지침
escape through spike. Open roller clamp and gently squeeze
IV bag until air is forced into drip chamber.
NOTE: Eliminating air from solution bag will prevent air from
entering monitoring system when solution is exhausted or
when bag is inverted.
3. Close roller clamp and squeeze bag slightly to force
solution into drip chamber (about 1/3 filled since level will
increase when bag is pressurized). Place bag in pressure cuff
and hang on IV pole.
CAUTION: If drip chamber is filled completely, drip
cannula would be submerged in solution and drop-count
(flow-rate determination) would not be possible. With a
DTXPlus™ pressure
differential pressure of 200 mmHg (bag pressure minus
mean physiological pressure monitored), 2-4 drops per
minute from a micro-drip IV Administration Set or 2-4
drops per three minutes from a macro-drip IV set equates
to 2-4mL/hr flow-rate.
to supplement
NOTE: To minimize air bubble-formation, fill monitoring system
by gravity without pressurizing bag.
4. Open roller clamp and fill IV Set by gravity. Tap IV Set to
free trapped bubbles. Close roller clamp.
5. Connect filled IV set to monitoring system. There are two
methods of filling the transducer set - Manual Filling and
Automatic Filling. Proceed to the selected method for further
instructions.
blood pressure
For DT-NN model apply the following steps.
6. Connect the IV set to the appropriate mechanical infusion
pump. If the pump utilizes a cassette, connect the tubing to the
cassette system. An in-line burette may be used between the
to the outside
IV and infusion pump, in accordance with your hospital
standards, policies or procedures. If other components such as
particulate or air eliminating filters are used, complete the
necessary connections. This IV tubing system should remain
disconnected from the transducer/flush-device tubing at this
point.
7. Connect the transducer (see Figure 4) to the IV tubing
system. Release the roller clamp. Set the pump on "purge" or
at an infusion rate setting to allow the fluid to completely fill the
IV set, burrette tubing and cassette system. After filling is
completed, close the roller clamp.
NOTE: Fluid filling and debubbling the IV tubing system before
attachment to the transducer/flush-device will allow for faster,
more bubble-free filling of the transducer, stopcocks, and
pressure tubing.
Manual Transducer Set Filling Method
CAUTION: Transducer should not be tapped with metal
objects, such as hemostats, to purge air bubbles. Doing so
may damage the transducer.
1. With pressure cuff still deflated, hold transducer vertical
with zeroing stopcock facing up. Open roller clamp on IV set
and squeeze clip actuator to allow solution to completely fill the
monitoring system. For Safedraw™ sets, make sure that the
barrel of the volume restricted syringe is completely depressed
when filling the system. The side port of the stopcock should
be filled and debubbled.
NOTE: Since transducer is gravity-filled, ensure bag is higher
than transducer and monitoring system.
2. Tap transducer on open palm of hand and at the same time
squeeze clip actuator to purge air from transducer chamber
(see Figure 6).
NOTE: Transducer should not be tapped with metal objects
such as hemostats to purge air bubbles as this may damage
the transducer.
3. (For Safedraw™ sets only) After pressure tubing is filled
with solution, the volume-restricted syringe and side port of
attached stopcock is debubbled by turning the handle of
attached stopcock "OFF" to the transducer. Slowly pull back
and fill the volume restricted syringe with solution from
pressure tubing until contact is made with the built-in syringe
stop. Rotate the set so that syringe tip points up. Tap the
syringe so that trapped air rises toward the Luer tip, then press
the plunger fully back into syringe thereby forcing trapped air
and solution into patient line. Turn the handle of attached
stopcock "OFF" to the volume-restricted syringe.
CAUTION: DO NOT perform purging with the patient line
connected to the catheter or cannula. Doing so may infuse
air into the patient. For either the Manual or Auto
Transducer Filling Methods.
4. Activate the fast flush device to purge any air from the
patient line.
5. Inspect all fluid-filled portions of the monitoring system to
verify that bubbles have been eliminated. Pressurize the
1 / 32
infusion bag to 300 mmHg. If bubbles remain in transducer
chamber, flush again using technique shown in Figure 6.
Automatic Transducer Set Filling Method
The Meritrans DTXPlus™ Transducer allows transducer
filling (usually bubble-free) in about five minutes.
1. Place transducer in a transducer holder (TBG) or other
holders which will hold the transducer in a vertical position (see
Figure 7b).
2. Pressurize cuff to 300 mmHg and verify that drip chamber
of IV set is not filled completely during pressurization as this
prevents reading of flow-rate. Open roller clamp. Transducer
will fill automatically.
3. Return in five minutes to inspect transducer for bubbles and
flush to fill rest of monitoring set. Tap gently while squeezing
clip actuator to remove any remaining air bubbles (see Figure
6).
Securing the Transducer set (See Figure 7 )
1. Replace all vented caps on side ports of stopcocks with
non-vented caps (deadenders). If the side port has an
EasyVent™ deadender cap, do not replace but tighten cap to
achieve non-vented position. (See Section B.)
2. Mount transducer on a holder (see Figure 7b) or directly on
patient's arm (see Figure 7a) with transducer zeroing port at
mid-heart level.
CAUTION
Safedraw™ blood sampling system is not intended to be
patient-mounted.
Several models of transducer sets are designed to
accommodate both IV pole- and patient-mounting. These
sets may have model numbers ending with "M" or "SM".
When mounted on patients, precautions should be taken
to ensure that a change in body position of the patient
does not accidentally actuate the flush device.
Merit fast-flush clip actuator is uniquely designed to
minimize this risk as it can only be activated by
squeezing the clip actuator with two fingers. However,
precautions are still recommended.
3. Connect monitoring system to patient's cannula or catheter.
Flush system to clear blood from cannula or catheter.
CAUTION: Avoid flushing air bubbles or blood clots in
catheter or cannula into the patient by making sure that
monitoring system is filled completely with solution and by
allowing a small amount of blood to flow back through the
cannula before making the pressure line connection. For
left atrial pressure monitoring, an air eliminator filter must
be installed between the cannula and the transducer prior
to flushing.
4. In multiple transducer installations, a colour coding system
is used to identify the appropriate monitor inputs. Color coded
labels are available. Affix appropriate labels to TBG or the
monitoring line closest to each transducer.
Red ('ARTERIAL') = Arterial Pressure
Blue ('CVP') = Central Venous Pressure
Yellow ('PA') = Pulmonary Artery Pressure
White ('LAP') = Left Atrial Pressure
White (Blank) = Miscellaneous Pressure
Zeroing and Calibration
1. Zero-balance the monitoring system to atmospheric
pressure and calibrate transducer according to monitor
manufacturer's instructions.
NOTE: It is recommended that the three-way stopcock closest
to the transducer be located at mid-heart level and used
exclusively for zeroing purposes. The transducer can be
quickly and easily vented to atmospheric pressure by turning
the stopcock handle counter clockwise (i.e. "OFF" to patient
line) and removing the non-vented cap from the zeroing port . If
an EasyVent™ deadender cap is present, do not remove but
loosen cap to achieve vented position (Section B).
2. Turn zeroing stopcock handle clockwise (i.e. "OFF" to
zeroing side port) and admit patient's pressure to transducer.
Check quality of waveform.
3. Allow approximately one minute for the system to
equilibrate to ensure that flush device is operating properly.
Then make a drop count to verify that the flow-rate is about
3mL/hr. A visual inspection for leaks should also be made.
Thirty minutes after installation and periodically afterwards,
check the system for correct bag pressure, flow rate, zero level
and ensure no leaks. Leaks, however small, may lead to
inaccurate flow-rate readings. If zero-drift is suspected e.g.
abnormal reading, re-position transducer and re-zero. If
problem persists, change the transducer. After each fast-flush,
it is recommended to reconfirm flow rate.
4. Replace the deadender cap and turn stopcock closed to the
side port. If the side port has an EasyVent™ deadender cap,
do not replace but tighten cap to achieve non-vented position
(Section B).
5. (For DT-NN only) Set mechanical infusion pump to desired
flow rate as prescribed by the physician.
CAUTION
If a damped waveform is observed, it may be the result of
several factors including but not exclusive to:
• Mis-positioned stopcocks
• Air in monitoring line, catheter or cannula
• Loose connections
• Improperly calibrated monitor
• Blood clots in catheter, cannula or monitoring line
• Catheter or Cannula positioned against a blood vessel
wall
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