Intended Use; Important Safety Information - Permobil Smart Check Manual De Instrucciones

Intended Use

Smart Check Cushion Monitoring Device (Smart Check) is a cushion feedback system that is intended to
assist the user by saving an inflation range during cushion setup. During subsequent inflation level checks,
Smart Check is intended to indicate whether adjustments are needed to remain in the saved range.
Smart Check must be connected to a ROHO Single Compartment Cushion with Sensor Ready Technology
(Sensor Ready Cushion) or a ROHO Hybrid Elite SR Cushion (Hybrid Elite SR).
A clinician who is experienced in seating and positioning should determine whether the product is appropriate for the individual's particular seating
needs. The product's intended use statement alone should not be relied upon to make that determination.
The medical products featured in this document are intended to be only one part of an overall care regimen that includes all seating and mobility
equipment and therapeutic interventions. A clinician who is experienced in seating and positioning should identify this care regimen after evaluating
the individual's physical needs and overall medical condition.
A clinician should also evaluate for visual, reading, and cognitive impairment to determine the need for caregiver assistance or the need for other
assistive technology, such as large-print instructions, to ensure proper product use.
Read this instruction manual carefully and completely before using the product, to ensure proper use of this device.

Important Safety Information

Warnings:
- All aspects of Smart Check use described in this manual can be
performed by the individual or by a caregiver. If you are unable to
perform any tasks described in this manual, seek assistance.
- Use of this device does not eliminate routine inspection of the
product and all normal activities associated with skin and soft tissue
protection (weight shifts, skin inspection, overall skin care, etc.)
- DO NOT use a cushion, cover, or hand pump other than those
compatible with Smart Check (see "Product Specifications"). Use of
a non-compatible cushion or cover may interfere with the accuracy
of Smart Check functions and reduce or eliminate the benefits of
the cushion, increasing the risk to skin and other soft tissue. Using
a cushion that is not compatible may also result in damage to Smart
Check and will void the warranty.
- DO NOT use an underinflated or overinflated cushion because 1)
the product benefits will be reduced or eliminated, resulting in an
increased risk to skin and other soft tissue, and 2) the individual
may become unstable and vulnerable to falling. Carefully follow all
instructions, including those provided with the cushion. If the cushion
does not appear to be holding air, or if you are not able to inflate or
deflate the cushion, see "Troubleshooting" in the manual provided
with the cushion. Immediately contact the equipment provider,
distributor or Customer Support if the problem persists.
- Check inflation frequently, at least once a day, using the Smart Check
or a hand check.
- Confirm that Smart Check is not pressing against your body.
- DO NOT modify Smart Check or any component. Doing so may result
in damage to the product and will void the warranty.
- The cushion MUST be properly sized to the user. IF IT IS NOT,
Smart Check may not find the individual's inflation range during
Smart Setup, reducing or eliminating the benefits of the cushion and
increasing the risk to skin and other soft tissue.
- If your cushion feels unstable during Smart Setup, perform a Hard
Reset and then repeat Smart Setup. If you still feel unstable, perform
an Optional Setup and consult with a healthcare provider.
Warning: KEEP BATTERIES OUT OF REACH OF CHILDREN AND ANY INDIVIDUALS WHO HAVE A TENDENCY TO
PLACE INEDIBLE OBJECTS IN THEIR MOUTHS. Swallowing or inhalation may lead to serious injury or death. IMMEDIATELY
seek emergency medical assistance.
Smart Check Operation Manual
Warnings:
- Set up your cushion in the usual environmental conditions. Perform
Check when environmental conditions, including temperature and
altitude, change significantly.
- DO NOT use in the presence of flammable anesthetics and/or in an
oxygen-rich environment. Doing so will increase the risk of fire or
explosion.
- BURN HAZARD: If ambient temperature exceeds 47°C (117°F), DO
NOT maintain contact with product surface for more than ten (10)
minutes. DO NOT expose the product to high heat, open flames, or
hot ashes. Testing or certification claims, including for flammability,
may no longer apply to this device when it is combined with other
products or materials. Check testing and certification claims for all
products used in combination with this device.
- USE CAUTION when in presence of children to avoid a strangulation
hazard. Detach Smart Check when not in use and store in a safe and
accessible location.
Cautions:
- Daily: Inspect Smart Check quick disconnect, tubing, and device
housing for wear or breakage, and to ensure inter-component
attachment. DO NOT continue to use Smart Check if any part is
damaged or cannot be attached securely. Periodically, Smart Check
should be inspected by a qualified technician.
- DO NOT submerge Smart Check in liquid, as it will damage the device.
- Protect Smart Check from blunt force shocks that may cause damage
and/or breakage.
- DO NOT use the inflation valve, quick disconnect, or any Smart
Check component as a handle for carrying or for pulling the cushion.
- Prolonged exposure to ozone may degrade some of the materials
used in the manufacture of this product, affect the performance of this
product, and void the product warranty.
- Prolonged exposure to UV light / sunlight may cause product labels
to fade.
2