Intended Use; Standard Operation; Advanced Operation - TENA SmartCare Change Indicator Mode D'emploi

Intended use:

TENA SmartCare Change Indicator
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. TENA SmartCare Change Indicator
estimates the degree of urine saturation in the absorbent incontinence product and
notifies the caregiver(s). This facilitates the caregiver decision regarding when to
change the absorbent incontinence product.

Standard operation:

• 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 operator of this Change Indicator is 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 monitoring off for the Change Indicator for a longer period, change
the status to "Inactive" in the dashboard.
• The Change Indicator is intended for residents 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 fulfills requirements for both home and professional healthcare
environments. The medical equipment is also compliant for professional healthcare
home environment use.
is an accessory to absorbent incontinence
TM/MC
17
TENA SmartCare Change Indicator
INTENDED USE
TM/MC
EN