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2.0 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.
3.0 Instructions for Use
3.1 Apply the Pressure Controller
Step
Procedure
1
Wrap the pressure controller band around the patient's wrist (Figure 2 on page 82, 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 (Figure 2
on page 82, step 2).
3
Attach the pressure controller cable to the port on compatible Edwards noninvasive monitoring system (Figure 1 on page 82, 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 (Figure 3 on page 82, steps 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 (Figure 3 on page 82, 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.
WARNING: Do not overtighten the pressure controller band.
WARNING: Do not apply pressure controller band on injured skin as this can cause further injury.
3.2 Remove the Pressure Controller Band
To remove the pressure controller from the pressure controller band:
Step
Procedure
1
Pull the sleeve slightly outwards (Figure 4 on page 82, step 1) and tilt the pressure controller to remove it from the sleeve (Figure 4 on page
82, step 2).
If you have a pressure controller cover (PCCVR), follow the instructions below to apply and remove the PCCVR.
3.3 Apply the Pressure Controller Cover
Step
Procedure
1
Ensure the heart reference sensor (HRS) is attached prior to attaching the pressure controller cover to the pressure controller.
2
Place the pressure controller cover's back mounting notch around the pressure controller cable (Figure 5 on page 83).
3
Snap the pressure controller cover over the pressure controller, making sure that the pressure controller cover does not interfere with the
heart reference sensor (HRS) connection.
3.4 Remove the Pressure Controller Cover
Step
Procedure
1
Pull the pressure controller cover upwards from the front tab (Figure 6 on page 83) and tilt the pressure controller cover to remove it from
the pressure controller (Figure 7 on page 83).
2
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