Edwards C1113 Manual De Instrucciones página 2

English
Pressure Controller Kit
PC2K
For Figures 1 through 4, please refer to page 56.
Description
The pressure controller kit consists of a pressure controller
(PC2) and accompanying band (PC2B). The pressure controller
can be used with the EV1000 clinical platform NI and
HemoSphere advanced monitoring platform to noninvasively
measure blood pressure and key hemodynamic parameters
using a compatible Edwards finger cuff wrapped around the
finger. The pressure controller is worn on the patient's wrist
and connects to the compatible Edwards noninvasive
monitoring system, heart reference sensor and compatible
Edwards finger cuff(s) (Fig 1).
Intended Use
The pressure controller is intended for use with an Edwards
compatible noninvasive monitoring system - composed of
compatible monitor, pressure source (pump), heart reference
sensor, compatible Edwards finger cuff(s) and pressure
controller - for noninvasive measurement of blood pressure
and associated hemodynamic parameters. Refer to the
operator's manual of the compatible Edwards monitor being
used for specific information on the intended use
environment and patient population.
Instructions for Use
Apply the Pressure Controller
1. Wrap the pressure controller band around the patient's
wrist (Fig 2, step 1).
2. Snap the pressure controller into the plastic sleeve of the
band, making sure that the cuff connectors are facing
towards the fingers (Fig 2, step 2).
3. Attach the pressure controller cable to the port on
compatible Edwards noninvasive monitoring system
(Fig 1A).
4. Remove the plastic connector caps in order to connect
the finger cuff and heart reference sensor to the pressure
controller according to the Instructions for Use supplied
with the particular units (Fig 3, step 1-2), or consult the
operator's manual of the EV1000 clinical platform NI and
HemoSphere advanced monitoring platform.
Note: It is recommended that the cuff connector caps be
kept and used to protect the pressure controller against
the ingress of water and dirt when only a single cuff is
used (Fig 3, step 3).
5. Once the heart reference sensor (HRS) is connected to the
pressure controller, then place the pressure controller
cover (PCCVR) on the pressure controller.
Edwards, Edwards Lifesciences, the stylized E logo, EV1000,
and HemoSphere are trademarks of Edwards Lifesciences
Corporation. All other trademarks are property of their
respective owners.
WARNING: Do not overtighten the pressure controller band.
WARNING: Do not apply pressure controller band on injured
skin as this can cause further injury.
Remove the Pressure Controller Band
To remove the pressure controller from the pressure controller
band:
1. Pull the sleeve slightly outwards (Fig 4, step 1) and tilt
the pressure controller to remove it from the sleeve
(Fig 4, step 2).
Cleaning Instructions
The pressure controller can be cleaned using the following
disinfectants:
• 70% isopropyl alcohol solution
• 10% sodium hypochlorite water solution
1. Moisten a clean cloth with disinfectant and wipe the
surfaces.
2. Dry the surface with a clean dry cloth.
CAUTION: Do not immerse the pressure controller.
CAUTION: Do not disinfect the pressure controller by
autoclave or gas sterilization.
CAUTION: Do not immerse any cable connectors in fluid.
The pressure controller band is intended for limited reuse.
The operator shall assess whether reuse is appropriate. When
reused, the same cleaning instructions can be followed as
specified for the pressure controller.
Accessories
Model Number Accessory Description
PC2K Pressure Controller Kit
PC2B Pressure Controller Band
(Multi Pack of 5)
PC2CCC Pressure Controller Cuff Connector
Caps (Multi Pack of 25)
PCCVR Pressure Controller Cover
Warranty
The pressure controller is warranted for a period of
one (1) year from the date of purchase when used in
accordance with the directions for use. This warranty does not
include the pressure controller band. For a full description of
the warranty conditions refer to the operator's manual of the
EV1000 clinical platform NI and HemoSphere advanced
monitoring platform. Both the pressure controller and the
pressure controller band are non-serviceable parts.
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