Redsense Medical Alarm Unit Instructions For Use Manual Download Page 10

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,

a

 should be less than the compliance level in 

each frequency range. 

b

 Interference may occur 

in the vicinity of equipment marked with the 
following symbol.

Summary of Contents for Alarm Unit

Page 1: ...Instructions for use Alarm unit Fiber optic cable Sensor patch ENGLISH ...

Page 2: ...edical 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 ...

Page 3: ...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...

Page 4: ... 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 t...

Page 5: ...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 ...

Page 6: ...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 t...

Page 7: ...pment 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 Yellow indicator with battery symbol Yellow indicator with warning symbol Red indicator with alarm symbol ith Co...

Page 8: ... 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...

Page 9: ...recautions 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 fiber 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 fluctua...

Page 10: ...5 cycles 5 UT 95 dipinUT for 5 sec 3A m 3Vrms 3V 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 ho...

Page 11: ... 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 m...

Page 12: ...ellow indicator with warning symbol Red indicator with alarm symbol on ator with ymbol Connector for AC adapter Service connector Redsense use only ellow indicator with attery symbol Yellow indicator with warning symbol or with ol Redsense Medical AB Gyllenhammars väg 26 302 92 HALMSTAD SWEDEN www redsensemedical com ...

Reviews: