3
IFU |
Alarm unit, Fiber optic cable & Sensor patch |
ENGLISH |
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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.
