Device labels and symbols
Vscan Air
–
User Manual
2-29
Direction GP092020-1EN
Rev 18
Manufacturer name and address
- Vscan Air CL probe
- Vscan Air app
ISO 7000-3082
Manufacturing date (year-month)
- Vscan Air CL probe
- Vscan Air app
ISO 7000-2497
Brand and model identifier.
- Vscan Air CL probe
- Vscan Air app
ISO 7000-2493
Serial number
Vscan Air CL probe
ISO 7000-2498
Unique Device Identification (UDI).
Every system has a unique marking
for identification. Scan or enter the
UDI information into the patient health
record according to governing laws.
- Vscan Air CL probe
- Vscan Air app
21 CFR 830
Unique Device
Identification
MDR Regulation
(EU) 2017/745
Assembled in
Austria (Austria is
a country name)
Identify the customs country of origin
of the materials.
Vscan Air CL probe
N/A- by GEHC
IP67
Vscan Air can be completely
submerged upto 1m in water.
Vscan Air CL probe
IEC 60529
LOT
Batch or lot code
Vscan Air app
ISO 7000-2492
CAUTION: For
use with Vscan
Air CL only.
Guidance to user to use the AC
adapter and wireless charger pad only
with Vscan Air CL.
Accessories and
Service probe
shipment box.
N/A- by GEHC
This symbol indicates the item is a
medical device
Vscan Air probe
ISO15223-1
Indicates that the device poses
unacceptable risks to the patient,
medical staff or other persons within
the MR environment
Vscan Air probe
FDA guidance:
Testing and
Labeling Medical
Devices for
Safety in the
Magnetic
Resonance (MR)
Environment.
Assembled in
Mexico (Mexico is
a country name)
Identify the customs country of origin
of the materials.
Vscan Air CL probe
N/A- by GEHC
UK Conformity Assessed (UKCA)
mark
- Vscan Air CL probe
battery
N/A - by
certification body
Table 2-8: Label Icons
Label
Purpose
Location
Standard
Summary of Contents for Vscan Air
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Page 324: ...Using Vscan Air CL 5 112 Vscan Air User Manual Direction GP092020 1EN Rev 18...
Page 370: ...Vscan Air Maintenance 6 46 Vscan Air User Manual Direction GP092020 1EN Rev 18...
Page 382: ...Privacy and Security 7 12 Vscan Air User Manual Direction GP092020 1EN Rev 18...
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