Cautions
9
CAUTIONS:
1. Do not operate the ReDS System without proper training. For additional
information, and in case additional training is needed, contact support.
2. In case of user discomfort, abort the operation of this system by using the
console or by unfastening and removing the sensor vest.
3. Federal law (USA) restricts this device to sale by or on the order of a physician.
4.
The sensor vest should be individually adjusted for the measured patient as
described in Chapter 2, Setting Up on page 21.
5. To ensure high quality measurements, the patient should wear light clothing,
such as a t-shirt or an undershirt. Metal elements under the sensors should be
avoided, such as jewelry. Avoid using the device over a bra.
6. Pay attention to the sensor vest cable in order to avoid entanglement,
strangulation or pulling the Bedside Console.
7. When using the table stand mount, place the Bedside Console on a flat and
stable surface to prevent tipping and falling.
8. The basket on the cart is designed to carry weight of up to 3 Kg (6.5 pounds).
Do not overload it, as this may make the device unstable.
9. Avoid exposing the system to liquids, as this may cause damage to the device.
10. This system should only be serviced by qualified personnel.
11. Remove the vest before performing defibrillation to avoid system damage or
ineffective defibrillation therapy.
12. The ReDS System fluid reading is intended to be used as an adjunct parameter
to standard clinical assessment methods.
13. When considering using the ReDS System, take the following patient-related
considerations into account:
Physical deformities in the thorax area that may prevent application or
correct adjustment of the sensor vest.
Recent surgery in the torso area.
Surgical wounds, healing tissue or recent skin grafts or flaps on the thorax.
Burns, open wounds or skin infections on the thorax.
Osteoporosis or osteomyelitis of the ribs.
Complaints of chest-wall pain.
