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English
TruClip Pressure Monitoring
Accessory
Model: TCLIP05
Carefully read these instructions for
use, which address the warnings,
precautions, and residual risks for this
medical device.
1.0 Indications for Use
The TruClip holder is intended to be
mounted to an IV pole to hold Edwards
Lifesciences pressure monitoring, arterial
pressure cardiac output (APCO) and
blood sampling devices.
2.0 Contraindications
There are no known contraindications.
3.0 Description
The TruClip holder provides a platform
that can hold up to seven devices.
Dimensions: 8" L x 2.75" W x 2.5" H
Weight Limit: 2.5 lbs
Compatible pole diameters: 0.5"-1.5"
4.0 Warnings
• The TruClip holder must be mounted
securely to ensure clinical stability, to
prevent injury to the patient or the
user, and to avoid damage to the
TruClip holder.
• The TruClip holder is indicated for
non-sterile use only.
• Do Not mount to bed railing for
monitoring. Risk of rotating the
TruClip holder and displacing
calibrated transducers may result in
inaccurate values.
• Do not soak the TruClip holder in any
cleaning agent as it may cause
material degradation.
• Do not use product if grip pads are
detached. Missing grip pads may
cause device to slide when under load,
displacing calibrated transducers.
• Do not exceed weight limit. Excess
weight may cause device to slip,
displacing calibrated transducers
resulting in inaccurate values.
• Do not slide the TruClip holder up or
down the IV pole without unclamping
to extend useable life.
• Users and/or patients should report
any serious incidents to the
manufacturer and the Competent
Authority of the Member State in
which the user and/or patient is
established.
5.0 Cautions
• Use only with Edwards Lifesciences
TruWave transducer, VAMP system
(with the exception of VAMP Jr.),
FloTrac sensor and VolumeView
devices to avoid damage to the
TruClip holder and to ensure accuracy
of patient information.
• Do not sterilize the TruClip holder.
6.0 Instructions
Ensure the TruClip holder is securely
mounted to a pole (0.5"-1.5" diameter)
prior to sliding Edwards Lifesciences
devices in place. Slide
Edwards Lifesciences device until they
snap into place. For proper height
positioning of the TruClip holder, refer to
the TruWave transducer, FloTrac sensor or
VolumeView kit instructions for use.
Refer to the TruWave transducer, FloTrac
sensor, VolumeView kit or VAMP system
instructions for proper use of those
devices.
Adjust the colored tabs to the
appropriate configuration for use.
To reposition the TruClip holder on the
pole: unclamp, adjust position, reclamp,
and ensure transducers are properly
leveled.
7.0 Maintenance and Cleaning
Clean the surface of the TruClip holder
before and after each use by wiping with
only 70% isopropyl alcohol or 5% bleach.
Check the TruClip holder for grip pad
detachment, cracking, and warping after
cleaning and before each use. Do not use
if present.
8.0 Storage
Store in a cool, dry place.
Temperature Limitation: 0 °-40 °C
Humidity Limitation: 5%-90% RH
Edwards, Edwards Lifesciences, the
stylized E logo, FloTrac, TruClip, TruWave,
VAMP, VAMP Jr., and VolumeView are
trademarks of
Edwards Lifesciences Corporation. All
other trademarks are the property of
their respective owners.
TruClip Pressure Monitoring Accessory
Model: TCLIP05
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