Tactile Medical Flexitouch Plus, User Manual

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Table 4: Flexitouch Plus System—Classification Information
U.S. FDA Medical Device
Class II per 21 CFR 870.5800 &
21 CFR 890.5650
Canada Medical Device
Class II per Canadian Medical
Devices Regulations SOR/98-282
Protection Against Electric Shock Hazard Class II per UL/EN/IEC 60601-1
Protection Against Fluid Ingress IP21
Applied Part BF
Table 5: Flexitouch Plus System—Conformance Information
Quality Assurance
FDA 21 CFR 820 QSR
ISO 13485
Safety
UL/EN/IEC 60601-1
CAN/CSA C22.2 No. 601.1
Electromagnetic Compatibility (EMC) EN 60601-1-2
Waste Electrical & Electronic Equipment (WEEE) Directive 2002/96/EC
Restriction of Hazardous Substances (RoHS) Directive 2002/95/EC
Wireless Technology
The Flexitouch Plus Bluetooth® controllers use Bluetooth Low Energy
(BLE) 4.0+ which complies to IEEE 802.15.1 and uses a Passkey pairing
method which provides a secure connection between Bluetooth
devices, including data encryption over the wireless link.
Technology Used Bluetooth
Connection Types SPP, iAP2, GATT
Frequency 2400 to 2483.5 MHz
Max RF Power Output +8.2 dBm
Operating Range 33ft (10m)
Emissions and Immunity Compliance
No. Test/Standard
Port (Enclosure, AC,
DC, I/O)
Emissions Class and Group/
Immunity Test Level
1 CISPR 11, Conducted
Emissions
120 VAC/60 Hz,
230 VAC/50 Hz
Class B; Group 1
2 CISPR 11, Radiated
Emissions
Enclosure Class B; Group 1
3 IEC 61000-3-2 AC Port 230 VAC/50 Hz Class A
4 IEC 61000-3-3 AC Port 230 VAC/50 Hz All parameters
5 IEC 61000-4-2 Enclosure ±8kV contact
±2kV, ±4kV, ±8kV, ±15kV air
6 IEC 61000-4-3
Radiated RF
Immunity
Enclosure 10V/m, 80–2700MHz,
80% 1kHz AM
7 IEC 61000-4-3
Proximity Fields
from RF Wireless
equipment
Enclosure Section 8.10 of the
IEC 60601-1-2 standard
8 IEC 61000-4-4 AC 120 VAC/60 Hz 2kV, 100kHz repetition rate
9 IEC 61000-4-4 I/O 1kV, 100kHz repetition rate
10 IEC 61000-4-5 AC 120 VAC/60 Hz ±0.5kV, ±1kV line-to-line
±0.5kV, ±1kV, ±2kV line-to-
ground
11 IEC 61000-4-6 AC 120 VAC/60 Hz 3V, 0.15-80MHz, 80% 1kHz AM
6V in ISM band within
0.15-80MHz, 80% 1kHz AM
6V in amateur radio band within
0.15-80MHz, 80% 1kHz AM
12 IEC 61000-4-6 I/O 3V, 0.15-80MHz, 80% 1kHz AM
6V in ISM band within
0.15-80MHz, 80% 1kHz AM
6V in amateur radio band within
0.15-80MHz, 80% 1kHz AM
13 IEC 61000-4-8 Enclosure 30A/m, 50 or 60Hz
14 IEC 61000-4-11
Voltage Dips 120 VAC/60 Hz,
230 VAC/50 Hz
0% (100% reduction), 0.5 cycle
0% (100% reduction), 1 cycle
70% (30% reduction) UT, 0.5 sec