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

3
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.

5
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

6IFU | Alarm unit, Fiber optic cable & Sensor patch | ENGLISH | ©
Mounting Redsense
A flashing green indicator light indicates that the alarm unit is performing a self-test. During this test, a number of
parameters are checked that may eventually need to be adjusted. These are displayed when the following lights
and symbols appear:
• The yellow indicator light, which is marked with a warning symbol, can indicate any of the following: Moisture
has come in contact with the sensor. The sensor has come loose, is not connected or has been broken. The
optical extension fiber is not connected correctly.
• If all of the indictor lights are flashing, an internal error has been detected. Contact Redsense Medical for
additional support.
Any problems must be corrected before attempting to restart the alarm unit. If blood or moisture has come in
contact with the sensor, it must be replaced with a new sensor. If some other technical problem occurs, do not
use the alarm unit, rather switch to another Redsense alarm unit and contact Redsense Medical for
additional support.
During dialysis
While the unit is running, the green indicator light will light up continuously, and in the event of an error the
following alarm signals may be heard:
• The red indicator lights followed by a continuous alarm signal, indicate that blood has been detected by the
sensor, either because the venous needle has been dislodged or leakage has occurred. First, deal with the leak
and then turn off the alarm by holding in the button for at least 1 second.
• The yellow warning indicator light followed by an intermittent alarm signal indicates one of the following:
Moisture has come in contact with the sensor. The sensor has come loose, is not connected or has been
broken. The optical extension fiber is not connected correctly. Turn off the alarm by keeping the on/off button
pressed, fix the cause of the alarm and then restart the alarm unit.
• The yellow warning indicator together with the battery indicator, followed by an intermittent alarm signal,
means that the alarm unit is no longer receiving power from the AC adapter, which means that monitoring can
no longer be performed correctly. In this case, turn off the alarm unit by keeping the button pressed in, then
fix the cause of the AC power failure for the alarm unit.
• If all the indicator lights are flashing, followed by an intermittent alarm signal, this indicates an internal error.
Turn off the alarm unit by holding in the button and continue running the dialysis without monitoring with
Redsense. Contact Redsense Medical for additional support..
After completing dialysis
1. Press the on/off button for at least 1 second to turn off the alarm.
2. Disconnect the sensor patch from the optical extension fiber.
3. Clean the optical extension fiber.
4. Remove the sensor patch and dispose of it according to the clinic’s procedures for handling dialysis waste.
Note: The alarm can also be turned o using the on/o button at any time during dialysis.
Maintenance
Cleaning
The actual sensor patch is made of disposable material and should not be cleaned or reused. The alarm unit and
the optical extension fiber should be wiped off with disinfectant/alcohol and a moist cloth.
Charging the battery
The alarm unit contains a battery in order to issue an alarm in the event of a power failure from the AC adapter.
When the alarm unit is connected to the AC adapter, the charging status for the built-in battery is displayed as:
• 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.

7
IFU | Alarm unit, Fiber optic cable & Sensor patch | ENGLISH | ©
Maintenance
• A solid battery indicator light indicates that charging is complete and monitoring can begin.
Replacing the battery
In order to replace the battery, the alarm unit must be opened and this can only be done during servicing.
Servicing the equipment and changing the battery should only be done using Redsense Medical or by personnel
authorized by them.
Symbols and terms
The following symbols and terms are used in these instructions and on the product
Connection
for optic fiber
On/off button
Green indicator with
operating symbol
Connector for
AC adapter
Service connector
(Redsense use only)
Yellow indicator with
battery symbol
Yellow indicator with
warning symbol
Red indicator with
alarm symbol
Connection
for optic fiber
On/off button
Green indicator with
operating symbol
Connector for
AC adapter
Service connector
(Redsense use only)
Yellow indicator with
battery symbol
Yellow indicator with
warning symbol
Red indicator with
alarm symbol

8IFU | Alarm unit, Fiber optic cable & Sensor patch | ENGLISH | ©
Symbols and terms
Other symbols displayed on the product and its accessories indicate the following:
REDSENSE MEDICAL AB
Gyllenhammarsväg. 26
302 92 Halmstad
Sweden
RA-1-RA201
SN REF
REDSENSE MEDICAL AB
Gyllenhammarsväg. 26
302 92 Halmstad
Sweden
RA-1-RA201
SN REF
REDSENSE MEDICAL AB
Gyllenhammarsväg. 26
302 92 Halmstad
Sweden
RA-1-RA201
SN
REF
REDSENSE MEDICAL AB
Gyllenhammarsväg 26
302 92 Halmstad
Sweden
EXP.
2018-01
MO130128AA
LOT
RA-1-RA201
REF
REDSENSE MEDICAL AB
Gyllenhammarsväg 26
302 92 Halmstad
Sweden
EXP.
2018-01
MO130128AA
LOT
RA-1-RA201
REF
Manufactured by Redsense
Medical AB – Sweden
Consult warnings and
precautions
Last usage date, year
-month (YYYY-MM)
On/0ff-button
Do not use if package
is damaged
Batchnumber, includes
manufacturing year
Alarm indicator
Item number
On/off indicator
Serial number, includes
manufacturing year
Warning indicator
Consult the instruction
for use
Applied part of type BF –Body Floating
(the surface between the equipment and
the patient does not conduct electricity)
The alarm unit covered by the WEEE
directive and must therefore be recycled
Class I laser product
Class II – double insolation
The sensor has been sterilized using
Ethylene Oxide (Sensorpatch)
For single use only
Battery indicator
1
2
1
2
1
2
1
2
1
2
REDSENSE MEDICAL AB
Gyllenhammarsväg 26
302 92 Halmstad
Sweden
EXP.
2018-01
MO130128AA
LOT
RA-1-RA201
REF
REDSENSE MEDICAL AB
Gyllenhammarsväg. 26
302 92 Halmstad
Sweden
RA-1-RA201
SN REF
REDSENSE MEDICAL AB
Gyllenhammarsväg 26
302 92 Halmstad
Sweden
EXP.
2018-01
MO130128AA
LOT
RA-1-RA201
REF

9
IFU | Alarm unit, Fiber optic cable & Sensor patch | ENGLISH | ©
Technical Information
The Redsense power adapter is approved according to EN60601-1 01/2006 and EN 60601-1-2 10/2006.10
EMC Information
Redsense has been tested and approved according to the IEC 60601-1-2 standard for electromagnetic
compatibility (EMC).
Guidance and manufacturer’s declaration – electromagnetic emissions
Redsense is intended for use in the electromagnetic environment specified below. The customer or the user of Redsense
should ensure that it is used in such an environment.
Parameter
Size
Weight
Usage Temperature
Temperature Transportation
Temperature Storage
Usage humidity
Transportation Humidity
Storage Humidity Air pressure
Shelf life
EMC precautions
Alarm unit
128 x100 x 35 mm
150 g
+15 to +40 °C
-20 to +60 °C
-10 to +40 °C
<75%
<75%
<75%
5 years
See EMC Information
Extension ber
Ø10mm x diffent lenghts
ca 10-30 g
+15 to +40 °C
-20 to +60 °C
-10 to +40 °C
<75%
<75%
<75%
5 years
Sensor patch
140 x 60 x 1 mm
150 g
+15 to +40 °C
-20 to +60 °C
-10 to +40 °C
<75%
<75%
<75%
See expiry date
RF-emissions CISPR 11
RF-emissions CISPR 11
Harmonic emission IEC 61000-3-2
Voltage fluctuations/ flicker
emissions IEC 61000-3-3
Group 1
Class B
Class A
Complies
Emissions test Compliance
Redsense uses RF energy only for its internal function. Therefore, its RF
emissions are very low and are not likely to cause any interference in
nearby electronic equipment.
Redsense is suitable for use in all establish- ments including domestic
establishments and those directly connected to the public low-voltage
power supply network that supplies buildings used for domestic
purposes.
Electromagnetic environment - guidance

10 IFU | Alarm unit, Fiber optic cable & Sensor patch | ENGLISH | ©
Guidance and manufacturer’s declaration – electromagnetic immunity
Redsense is intended for use in the electromagnetic environment specified below. The customer or the user of
Redsense should ensure that it is used in such an environment.
Redsense is intended for use in the electromagnetic environment specified below. The customer or the user of
Redsense should ensure that it is used in such an environment.
Immunity test
Immunity test
Electrostatic discharge
(ESD) IEC 61000-4-2
Electrical fast transient
/Burst IEC 61000-4-4
Surge IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines IEC 61000-4-11
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
Conducted RF IEC
61000-4-6
Radiated RF IEC
61000-4-3
IEC 60601
test level
IEC 60601
test level
+/- 6 kV contact
+/-8kVair
+/- 2 kV for power
supply lines
+/- 1 kV for input
/output lines
+/- 1 kV differential
mode
+/- 2 kV common
mode
<5%UT (>95%dipinUT)
for 0,5 cycle 40%UT
(60%dipinUT) for
5 cycles 70%UT(30%
dipinUT) for 25 cycles
<5%UT(>95% dipinUT)
for 5 sec
3A/m
3 Vrms
1
50 kHz to 80 MHz
3 V/m
80MHz to 2,5GHz
Compliance
level
Compliance
level
+/- 6 kV contact
+/-8kVair
+/- 2 kV for power
supply lines n/a. for
input/ output
ines
+/- 1 kV differential
mode n/a. for
common mode
<5%UT (>95%dipinUT)
for 0,5 cycle 40%UT
(60%dipinUT) for
5 cycles 70%UT(30%
dipinUT) for 25 cycles
<5%UT(>95% dipinUT)
for 5 sec
3A/m
3 Vrms
3 V/m
Electromagnetic
environment
Electromagnetic environment –
guidance
Floors should be wood, concrete or ceramic tile.
If floors are covered with synthetic material, the
relative humidity should be at least 30 %.
Mains power quality should be that of a typical
commercial or hospital environment.
Mains power quality should be that of a typical
commercial or hospital environment.
Mains power quality should be that of a typical
commercial or hospital environment. If the user
of the [Equipment or System] requires continu-
ed operation during power mains interruptions,
it is re- commended that the [Equipment or
System] be powered from an uninterruptible
power supply or battery.
Power frequency magnetic fields should be
at levels characteristic of a typical location in a
typical commercial or hospital environment
Portable and mobile RF communications
equip- ment should be used no closer to any
part of Red- sense, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency
of the transmitter.
Recommended separation distance
80 MHz to 800 MHz
800 MHz to 2,5 GHz
Where P is the maximum output power rating
of the transmitter in watts (W) according to
the trans- mitter manufacturer and d is the re-
commended separation distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,
ashould be less than the compliance level in
each frequency range. bInterference may occur
in the vicinity of equipment marked with the
following symbol.

11
IFU | Alarm unit, Fiber optic cable & Sensor patch | ENGLISH | ©
Guidance and manufacturer’s declaration – electromagnetic immunity
NOTE 1 At 80MHz and 800MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflected from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio
broadcast and TV broadcast cannot be predicted with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site
survey should be considered. If the measured field strength in the location in which Redsense is used exceeds the applicable RF compliance level above, Redsense
should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating
Redsense. bOver the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.
Recommended separation distances between portable an mobile RF communications equipment and Redsense
Redsense is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
The customer or the user of Redsense can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters) and Redsense as recom-
mended below, according to the maximum output power of the communications equipment.
For transmitters rated at a maximum output power not listed above, the recommended separation distance in meters (m) can be estimated using the equation
applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manu-
facturer.
Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
Rated maximum output
power of
transmitter W
0.01
0.1
1 1
0
100
Separation distance according to frequency of transmitter m
150 kHz to 80 MHz
0.12
0.38
1.2
3.8
12
80 MHz to 800 MHz
0.12
0.38
1.2
3.8
12
800 MHz to 2.5 GHz
0.24
0.73
2.3
7.3
23

Connection
for optic fiber
On/off button
Green indicator with
operating symbol
Connector for
AC adapter
Service connector
(Redsense use only)
Yellow indicator with
battery symbol
Yellow indicator with
warning symbol
Red indicator with
alarm symbol
Connection
for optic fiber
On/off button
Green indicator with
operating symbol
Connector for
AC adapter
Service connector
(Redsense use only)
Yellow indicator with
battery symbol
Yellow indicator with
warning symbol
Red indicator with
alarm symbol
Redsense Medical AB | Gyllenhammars väg 26
302 92 HALMSTAD | SWEDEN | www.redsensemedical.com