Redsense Medical Alarm Unit User manual

Instructions for use / Alarm unit,
Fiber optic cable & Sensor patch
ENGLISH

2IFU | Alarm unit, Fiber optic cable & Sensor patch | ENGLISH | ©
Manufacturer:
Redsense Medical AB
Gyllenhammars väg 26
302 92 HALMSTAD
SWEDEN
www.redsensemedical.com
These instructions are released with the
following date/version: 2017-01-18 Instructions
RM-1RM240
Instructions
Warnings and precautions 3
Mounting Redsense 4
During dialysis 6
After completing dialysis 6
Maintenance 6
Cleaning 6
Charging the battery 6
Replacing the battery 7
Symbols and terms 7
Technical Information 9
EMC Information 9

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IFU | Alarm unit, Fiber optic cable & Sensor patch | ENGLISH | ©
Warnings and precautions
• Please refer to the hemodialysis equipment indication statement to confirm usage is consistent with its labeled
indication.
• The Redsense device model RA-1-RA201 is is designed to detect potential blood loss from the needle access
site during hemodialysis.
• Read and follow all instructions carefully.
• This piece of equipment is only an alarm. It does not replace existing safety procedures.
• Redsense may only be used for its intended purpose and according to these instructions.
• The alarm unit may only be placed on the dialysis machine as shown in the instructions.
• The alarm unit shall only be used with the proper AC adapter.
• The alarm unit may only be used by persons who have received proper training from Redsense Medical or
who have been approved by Redsense Medical. Use by untrained or improperly trained personnel may pose
a danger to the patient.
• All use must be administrated under physician’s prescription. and must be observed by a trained and qualified
person, considered to be competent in the use of this device by the prescribing physician.
• Before use, a test must be performed to make sure the observing person can clearly hear the alarm signal.
The test is further described at page 4 under point 9.
• This device should not be relied upon as the sole monitor for blood loss at the blood access site.
• Redsense requires special precautions in terms of EMC and must be subse quently used in accordance with
the EMC information in these instructions.
• Portable and mobile radio communication equipment may affect Redsense.
• Redsense is not intended to be used in a highly oxygenated environment.
• Modifying the equipment is not permitted. Modification of the equipment will void all guarantees and product
liability on the part of the manufacturer.
• Servicing of the equipment may only be performed by Redsense Medical or by persons authorized by them.
• External equipment intended for connection to signal input, signal output or other connectors shall comply
with the relevant product standard e.g. IEC 60950-1 for IT equipment and the IEC 60601-series for medical
electrical equipment. In addition, all such combinations – systems – shall comply with the safety requirements
stated in the collateral standard IEC 60601-1-1 or the general standard IEC 60601-1, edition 3, clause 16. Any
equipment not complying with the leakage current requirements in IEC 60601-1 shall be kept outside the
patient environment i.e. at least 1.5 m from the patient support. Any person who connects external equipment
to signal input, signal output or other connectors has formed a system and is therefore responsible for the
system to comply with the requirements. If in doubt, contact Redsense Medical or your local representative.
• Redsense is a laser class I product.
About Redsense alarm systems
Redsense is an alarm system for monitoring the blood access during hemodialysis. The Redsense system consists
of the following and can be used in combination with:
• Alarm unit, RA-1-RA201
• AC adapter, RC-1-RC201
• Fiber optic extension, RE-1-RE201
• Sensor patch, RS-1-RS201
When the sensor patch is placed over the blood access, it detects any blood coming in contact with the sensor.
This can occur if the needle is accidentally dislodged or if blood is leaking during dialysis.

4IFU | 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.

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IFU | Alarm unit, Fiber optic cable & Sensor patch | ENGLISH | ©
Warnings and precautions
figure 1 figure 2
1
2
figure 3
figure 4
1
2
YES
YES
NO
figure 5
figure 6