Idmed ToFscan - VI Technical Specifications and Warranty; Safety Compliance and Certifications; EMC Performance Data

User Manual ToFscan 23
Unsorted electronic waste products are potentially hazardous to the environment.
Packaging materials must be disposed of or recycled in accordance with the regulations in force.
VI Technical specications and warranty
The ToFscan comes with a microcontroller and a colour LCD screen for optimal legibility and ease
of use.
Safety
• Biocompatible material sensors (part in contact with the patient). Latex free
• Compliant with European directive CEE 93/42. Class 2a device (CE 0459 LNE/G-MED)
• Compliant with standards IEC 60601-1. Class II equipment.
• Compliant with standards IEC 60601-2-10.
• EMC: IEC 60601-1-2
EMC Emission
Emission test Compliance EMC Instructions/cautions
RF Emissions CISPR 11
Group 1
The ToFscan uses RF energy only for internal func-
tions. Therefore RF emissions are very low and
should not disturb other nearby devices.
RF Emissions CISPR 11
Harmonics IEC 61000-3-2 Class B
The ToFscan must be use in professional healthcare
facility environment
Voltage uctuations Class A
and icker IEC 61000-3-3 Compliant
The ToFscan can be connected to the public mains
network
EMC Immunity
Phenomenon
Basic EMC
standard
Professional
healthcare
facility
environment
Immunity Test
Levels
Compliance
levels
EMC
Instructions/precautions
ELECTROSTATIC
DISCHARGE
(ESD)
IEC
61000-4-2
± 8 kV contact ± 8 kV contact
In order to reduce ESD, the device
must be used in a 35% humidity envi-
ronment or more
± 2 kV, ± 4 kV,
± 8 kV,
± 15 kV air
± 2 kV, ± 4 kV,
± 8 kV air
Radiated RF EM
Fields
IEC
61000-4-3
3 V/m
80 MHz – 2,7
GHz
80 % AM at
1 kHz
3 V/m
80 MHz – 2,7
GHz
80 % AM at
1 kHz
Use of this equipment adjacent to or
stacked with other equipment should
be avoided because it could result in
improper operation. If such use is ne-
cessary, this equipment and the other
equipment should be observed to ve-
rify that they are operating normally
Proximity elds
from RF
wireless com-
munications
equipment
IEC
61000-4-3
Complies to
table 9 of IEC
60601-1-2
(2014)
Complies to
table 9 of IEC
60601-1-2
(2014)
In order to prevent electromagnetic
disturbance, keep minimum separa-
tion from RF communication equip-
ment of 30cm