Edwards ForeSight IQ Gebruiksaanwijzing pagina 2
Grote sensor
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Beschikbare talen
Beschikbare talen
5.0 Warnings
Assess the sensor site at least every 12 hours, or more often as required by the institution's protocol.
•
Remove the sensor if the circulatory condition or skin integrity has deteriorated.
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Do not lay patient on the sensor or cable.
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Do not use in an MR environment due to risk of burn as result of sensor heating.
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Do not attach the sensor to skin with unapproved devices, such as headbands, hats, etc.
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Do not place the sensor or accessories over eyes, nose, or mouth.
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Do not cut the sensor. Cutting the sensor can result in injury to the patient.
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Do not use in an MRI environment.
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When used in settings with LED lighting, sensors should be covered with a light blocker prior to connection to the preamp cable, as some high
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intensity systems can interfere with the sensor's near infrared light detection.
Failure to remove the protective liner may cause erroneous StO2 readings.
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6.0 Cautions
Avoid positioning the sensor over hair, air sinus, hematomas, or broken skin.
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Avoid attaching the sensor to sites with excess adipose, ascites, or edema.
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The materials used in the manufacture of the sensor were NOT designed for reuse. Reuse can cause the sensor not to perform as intended.
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7.0 Instructions
Step
Procedure
1
Remove the sensor from the package. Carefully inspect the sensor for damage. Discard and replace if damage is found.
2
Select sensor location on the monitor.
3
Clean and dry the sensor site (1).
4
Remove protective liner from the sensor (2).
5
Apply the sensor to the patient:
Cerebral Use
a)
(Fig. 3a): Select the site on the forehead well above the eyebrow and just below the hairline. Do not attach sensor over hair.
Somatic Use
b)
(Fig. 3b, 3c, 3d): Select the site that provides ideal access to the desired skeletal muscle tissue, for example:
• Biceps (upper arm), brachioradialis (forearm), or deltoid (shoulder).
• Quadriceps (upper leg), or gastrocnemius and tibialis (calf ). Apply the sensor with the connector towards the feet.
• Latissimus dorsi (flank) or external oblique (abdomen).
Note:
Somatic monitoring only available with ForeSight oximeter cable software version 4.0.1 or above.
Note:
Do not attach sensor over hair.
Note:
You may use Tegaderm under the sensor in patients with delicate skin or edema.
6
Insert the sensor connector straight into the sensor cable connector until it snaps into place (Figure 4). Use the bedsheet clip to secure the cable and prevent pulling on the
sensor.
7
If needed, fold the sensor flat cable to route it in the desired direction.
For use only with ForeSight oximeter cable software version 2.5.7 or above.
8.0 Disposal
Sensors are designed for single-patient use, and are not to be reprocessed. Re-used sensors present a risk of cross-contamination or infection. Use a new sensor for each patient and discard it after
use. Disposal should follow in accordance with local hospital and institution policies.
9.0 Storage
Store in a cool, dry place.
10.0 Shelf Life
The recommended shelf life is as marked on each package. Storage beyond the expiration date may result in product deterioration and malfunction.
11.0 Technical Assistance
For technical assistance, please call Edwards Technical Support at the following telephone numbers:
Inside the U.S. and Canada
(24 hours): . . . . . . . . . . . . . . . . . . . 800.822.9837
Outside the U.S. and Canada
(24 hours): . . . . . . . . . . . . . . . . . . . 949.250.2222
In the UK: . . . . . . . . . . . 0870 606 2040 - Option 4
In Ireland: . . . . . . . . . . . . . . 01 8211012 - Option 4
CAUTION:
Federal (USA) law restricts this device to sale by or on the order of a physician.
Refer to the latest version of the monitoring system operator's manual for more information.
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.
Refer to the symbol legend at the end of this document.
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