Intended Use - Tena SmartCare Change Indicator Instrucciones De Uso

Intended Use:

The TENA SmartCare Change Indicator™ is an accessory to absorbent incontinence
products, intended for use on individual(s) suffering from urinary incontinence in a
home or professional environment who are dependent on one or more caregivers to
change the absorbent incontinence products. The TENA SmartCare Change Indicator
estimates the degree of urine saturation in the absorbent incontinence product and
notifies the care giver(s). This facilitates the care giver decision regarding when to
change the absorbent incontinence product.
Standard operation:
• If the Change Indicator is broken, it should be replaced, not repaired.
• The Change Indicator should not be in contact with the user's skin during normal
use. It should always be attached to the outside of the incontinence product.
• The Change Indicator is operated by the caregiver of the incontinent user.
The user wears the Change Indicator in combination with a TENA incontinence
product.
• Attaching the Change Indicator to the incontinence product is considered
a primary operating function.
• Only the caregiver is intended to interact with the Change Indicator.
• To turn the transmitter off, remove the battery.
• The Change Indicator is intended for persons with healthy skin.
Advanced operation:
• Changing the battery and sensor strip are operations that should
be carried out infrequently.
Using the TENA SmartCare Change Indicator according to its intended use
does not add any risk compared to not using it.
The medical device complies with emission and immunity standards
and regulations. It has been tested and fulfils requirements for home
healthcare environments.
Intended use
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