GE Vscan Air Manual page 65

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