4
IFU |
Alarm unit, Fiber optic cable & Sensor patch |
ENGLISH |
©
Indications For Use
The Redsense device is intended to monitor for
potential blood loss from the hemodialysis access
site in hemodialysis patients undergoing hemo-
dialysis treatment. The device includes a blood
sensor incorporated into a sensor patch. The sensor
monitors potential blood leakage from the venous
needle blood access via a light signal and will alarm
if blood leakage is detected by the device’s sensor.
Mounting Redsense
The Redsense sensor should be placed on the patient
after the needles have been inserted and before
dialysis begins. Redsense must be turned on the entire
time that dialysis is running.
1.
Attach the alarm unit to the dialysis machine’s IV pole / drip stand
(see figure 1)
. If this isn’t possible please contact
Redsense Medical for consultation. Connect the AC adapter to a wall outlet and to the black-colored
connector on the alarm unit.
(Figure 2 shows the connector.)
2.
The alarm unit indicates as follows whether the built-in battery is charged:
• A flashing battery indicator light means that the battery is being charged. The unit cannot be started in this
case. Wait until the charging is complete.
• A solid battery indicator light indicates that charging is complete and monitoring can begin.
3.
Connect the optical extension fiber to the alarm unit. Turn the coupling roughly a 1/3 turn to lock it. Check
that the coupling is locked
(see figure 3).
4.
Check the date on the packaging for the sensor patch and be sure that the packaging has a Redsense label on
it. Open and check that the sensor patch does not have any mechanical damage.
5.
In order to start Redsense, push the on/off button and check that all the indicator lights are on and the
speaker is functional. A short beep should be heard. If it is the first set-up or it is a new environment for the
Redsense, please check that the patient’s supervising staff or observing person can clearly hear the alarm
sound at the correct distance. The alarm signal should be a continuous signal with three different levels/tones
and can be initiated by starting Redsense and then provoking an alarm. The observing person must be sure
that the alarm signal can be heard from other rooms or while there is noise. The observing person must be
situated at places where the alarm signal can be heard during the entire dialysis treatment. If this isn’t possible
please consult Redsense Medical.
6.
To stop testing the indicator lights and the alarm signal, push the on/off button again. The green indicator light
starts to flash together with a intermittent signal.
7.
Connect the fiber from the sensor patch to the optical extension fiber. Open the connector on the end of the
optical extension fiber by holding in the locking button, inserting the sensor patch fiber from the sensor patch
until it stops/resists, then releasing the lock button
(see figure 4).
When the green indicator light is solid, and the
intermittent signal is turned off the monitoring function is working correctly.
8.
Make sure the area around the needle is dry.
9.
Apply the sensor patch to the skin over the needle with the absorbent part of the sticker centered directly
over the insertion point. Be sure that the self-adhesive part of the patch does not cover the wings
(see figure 5).
10.
Secure the needles in place as usual using tape or similar material. Secure the needles in place according to
the existing policy and procedure. Dressing material and or tape may be applied directly over the surface of
the sensor patch according to the facility policy and procedure.
Figure 6
shows an example of how the sensor patch and the optical extension fiber can be attached to the
patient’s arm. Check that the sensor patch is clean and dry.
