Use Instructions
SAIT‐IFU‐GEMS‐HRev.1.1(2019‐11) Page73of79
EMCTable–Guidanceandmanufacturer’sdeclaration
Electromagneticemissions
TheGEMS‐Hisintendedforuseinelectromagneticenvironments,asspecifiedbelow.
ThecustomerortheuseroftheGEMS‐Hshouldensurethatitisusedinsuchanenvironment.
Emissiontest Compliance Electromagneticenvironment
–
guidance
RFemissions
CISPR11
Group1 TheGEMS‐HusesRFenergyonlyforitsinternalfunction.Therefore,its
RFemissionsareverylowandarenotlikelytocauseanyinterference
innearbyelectronicequipment.
RFemissions
CISPR11
ClassA 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
followingwarningisheeded:
Warning!TheGEMS‐Hisintendedforusebyphysicaltherapistsonly.
Thisequipment/systemmaycauseradiointerferenceormaydisrupt
the operation of nearby equipment. It may be necessary to take
mitigation measures,such as re‐orienting orrelocatingthe GEMS‐H
orshieldingthelocation.
Guidanceandmanufacturer'sdeclaration‐electromagneticimmunity
TheGEMS‐Hisintendedforusein the electromagnetic environment specified below. The customer or the user of the GEMS‐H should
assurethatitisusedinsuchanenvironment.
Immunitytest
IEC60601
testlevel
Compliance
level
Electromagneticenvironment‐guidance
Electrostaticdischarge(ESD)
IEC61000‐4‐4
±8kVcontact
±2,4,8,15kVair
±8 kVcontact
±2,4,8,15kVair
Floorsshouldbewood,concreteorceramictile.
Iffloorsarecoveredwithsyntheticmaterial,the
relative humidity of at least 30% is
recommended.
Electricalfast
Transient/burst
IEC61000‐4‐4
±2kVforpower
supplylines
±2kVforpower
supplylines
The main power quality should be that of a
typicalcommercialorhospitalenvironment.
Surge
IEC61000‐4‐5
±0.5kV,±1kV
differentialmode
±0.5kV,±1kV,±2kV
commonmode
±0.5kV,±1kV
differentialmode
±0.5kV,±1kV,±2kV
commonmode
The main power quality should be that of a
typicalcommercialorhospitalenvironment.
Voltagedips,
Short
Interruptionsandvoltage
variationsonpowersupplyinputlines
IEC61000‐4‐11
0%U
T
(100%dipinU
T)
for0.5/1cycles
70%U
T
(30%dipinU
T
)
for25/30cycles
0%U
T
(100%dipinU
T
)
for250/300cycles
0% U
T
(100%dipinU
T)
for0.5/1cycles
70%U
T
(30%dipinU
T
)
for25/30cycles
0%U
T
(100%dipinU
T
)
for250/300cycles
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‐Hbe powered
from an uninterruptible power supply or a
battery
Powerfrequency(50/60Hz)magnetic
field
IEC61000‐4‐8
30A/m 30A/m Power frequency magnetic fields should be at
levels characteristic of a typical commercial or
hospitalenvironment
NOTE:U
T
isthea.c.mainsvoltagepriortoapplicationofthetestlevel.
aForexample,10/12means10cyclesat50Hzor12cyclesat60Hz.