Use Instructions

SAIT‐IFU‐GEMS‐HRev.1.1(2019‐11) Page73of79
EMCTable–Guidanceandmanufacturer’sdeclaration
Electromagneticemissions
TheGEMS‐Hisintendedforuseinelectromagneticenvironments,asspecifiedbelow.
ThecustomerortheuseroftheGEMS‐Hshouldensurethatitisusedinsuchanenvironment.
Emissiontest Compliance Electromagneticenvironment
guidance
RFemissions
CISPR11
Group1 TheGEMS‐H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.
RFemissions
CISPR11
ClassA The GEMS‐H is suitable for use in all establishments other than
domestic, and may be used in domestic establishments and those
directly connected to the public low‐voltage power supply network
that supplies buildings used for domestic purposes, provided the
followingwarningisheeded:
Warning!TheGEMS‐Hisintendedforusebyphysicaltherapistsonly.
Thisequipment/systemmaycauseradiointerferenceormaydisrupt
the operation of nearby equipment. It may be necessary to take
mitigation measures,such as re‐orienting orrelocatingthe GEMS‐H
orshieldingthelocation.
Guidanceandmanufacturer'sdeclaration‐electromagneticimmunity
TheGEMSHisintendedforusein the electromagnetic environment specified below. The customer or the user of the GEMS‐H should
assurethatitisusedinsuchanenvironment.
Immunitytest
IEC60601
testlevel
Compliance
level
Electromagneticenvironment‐guidance
Electrostaticdischarge(ESD)
IEC61000‐4‐4
±8kVcontact
±2,4,8,15kVair
±8 kVcontact
±2,4,8,15kVair
Floorsshouldbewood,concreteorceramictile.
Iffloorsarecoveredwithsyntheticmaterial,the
relative humidity of at least 30% is
recommended.
Electricalfast
Transient/burst
IEC61000‐4‐4
±2kVforpower
supplylines
±2kVforpower
supplylines
The main power quality should be that of a
typicalcommercialorhospitalenvironment.
Surge
IEC61000‐4‐5
±0.5kV,±1kV
differentialmode
±0.5kV,±1kV,±2kV
commonmode
±0.5kV,±1kV
differentialmode
±0.5kV,±1kV,±2kV
commonmode
The main power quality should be that of a
typicalcommercialorhospitalenvironment.
Voltagedips,
Short
Interruptionsandvoltage
variationsonpowersupplyinputlines
IEC61000‐4‐11
0%U
T
(100%dipinU
T)
for0.5/1cycles
70%U
T
(30%dipinU
T
)
for25/30cycles
0%U
T
(100%dipinU
T
)
for250/300cycles
0% U
T
(100%dipinU
T)
for0.5/1cycles
70%U
T
(30%dipinU
T
)
for25/30cycles
0%U
T
(100%dipinU
T
)
for250/300cycles
The main power quality should be that of a
typical commercial or hospital environment. If
the user of the GEMS‐H requires continued
operation during power mains interruptions. It
is recommended that the GEMS‐Hbe powered
from an uninterruptible power supply or a
battery
Powerfrequency(50/60Hz)magnetic
field
IEC61000‐4‐8
30A/m 30A/m Power frequency magnetic fields should be at
levels characteristic of a typical commercial or
hospitalenvironment
NOTE:U
T
isthea.c.mainsvoltagepriortoapplicationofthetestlevel.
aForexample,10/12means10cyclesat50Hzor12cyclesat60Hz.
