Safety Manual

Charging Instructions & Safety Manual
MydCombi™ Base Unit
Page 6 of 9
4. EMC COMPLIANCE:
Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15
of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential
installation. This equipment generates, uses, and radiates radio frequency energy and, if not installed and used in
accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee
that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or
television reception, which can be determined by turning the equipment off and on, the user is encouraged to try and correct
the interference by one or more of the following measures:
• Reorient or relocate the receiving antenna
• Increase the separation between the equipment and receiver
• Connect the equipment into an outlet on a circuit different from that to which the receiver is connected
• Consult the dealer or an experience radio/TV technician for help
Note: Changes or modifications not expressly approved by the party responsible for compliance could void the user's
authority to operate the equipment.
Guidance and manufacturer’s declaration – electromagnetic emissions
The device is intended for use in the home healthcare environment in a residential area (CISPR 11 Class B), as
specified below. The customer or the user of the device should assure that it is used in such an environment. The safety
of the device will be ensured, refer to section 2 (notes on safety).
Emissions Test
Compliance
RF emissions CISPR 11
Group 1
RF emissions CISPR 11
Class B
Harmonic Emissions IEC 61000-3-2
Class B
Voltage Fluctuations/Flicker emissions IEC 61000-3-3
Complies
Guidance and manufacturer’s declaration – electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below. The customer or the user of the
device should assure that it is used in such an environment.
Performance Criteria
Phenomena of a continuous nature.
Shall operate as intended.
Shall be no degradation of performance.
Shall be no loss of function.
Phenomena of transient nature.
Functions shall be self-recoverable.
Shall operate as intended after recovering.
Shall be no degradation of performance,
Power interruption exceeding a certain time.
Functions shall be recoverable by the operator.
Shall operate as intended after recovering.
Shall be no degradation of performance.
Immunity Test
IEC 60601 Test Level
Compliance Level
Electrostatic fast transient/burst IEC
61000-4-4
±2 kV for power supply lines
±1 kV for input/output lines
±2 kV for power supply lines
±1 kV for input/output lines
Surge IEC 61000-4-5 EN/IEC 61000-
4-3
±1 kV differential mode
±2 kV common mode
±1 kV differential mode
±2 kV common mode
Surge IEC 61000-4-5 EN/IEC 61000-
4-3
Radiated Immunity
3 V/m, 80 – 2700 MHz
80% AM at 1 kHz & Proximity Fields
from RF
Wireless Communications Equipment
Radiated Immunity
3 V/m, 80 – 2700 MHz
80% AM at 1 kHz & Proximity Fields
from RF
Wireless Communications Equipment
Voltage dips, short interruptions and
voltage variations on power supply
input lines IEC 61000-4-11
Voltage Dips 30% reduction, 25/30
periods
At 0°
Voltage Dips 30% reduction, 25/30
periods
At 0°
Voltage Dips > 95% reduction, 0.5
period
Voltage Dips > 95% reduction, 0.5
period