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Mobius AIRO Mobile CT System - Labels; Labels Used

Mobius AIRO Mobile CT System
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224 MI-42-0001 Rev. 19
TECHNICAL DESCRIPTION: Labels
9.15 Labels
9.15.1 Labels Used
Labels and
Explanations
Label Explanation
System Name Plate/Ratin
g Plate Label:
Indicates manufacturer and input power
requirements.
This equipment is certified to be in compliance
with the applicable standards of CFR, Title 21,
subchapter J as of the date of manufacture.
Location: On the base to the right of the sockets
for power and network cables.
NOTE: Values and information marked by label
components listed below may be different on
your system than on the sample label shown.
ETL Field Evaluated Mark:
This equipment is
certified as compliant with relevant US and
Canadian product safety standards.
WEEE label:
Electrical and electronic equipment
must be sent to separate collection facilities for
recovery and recycling.
CE mark
: This system complies with the
requirements of all relevant standards and
directives in effect within the European
Community.
REF:
System catalog/model number
SN:
System serial number
Date of system manufacture
Manufacturer name and address
Type B Applied Part according to IEC 60601-1
Read product documentation and follow
instruction for use.
Mobius Imaging LLC system Unique Device
Identification (UDI) label
Maximum Total Mass
Maximum total mass of system, accessories,
compatible equipment, and patient with specified
subtotals.

&21)250672
$$0,67'(6
,(&67'
,(&67'
,(&67'
,(&67'
&(57,),('72
&6$67'&12
0123

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