Otivio FLOWOX 2.0 Manual De Uso página 8

Environmental and handling conditions: Operation Temperature range: +15 to +40°C. Note: if device is taken from storage
that is outside of operating temperature (15 – 40°C), at least 2 hours need to be waited before using the device.
● Operation Air Humidity: 15 – 95 % ● Operation Ambient pressure: 70 – 106 kPa (525 – 795 mmHg) ● Storage and transport
Temperature range: - 25 to +70 °C ● Storage and transport Air Humidity: Up to 93 % relative humidity at +70 °C ● Storage and
transport Ambient pressure: 50 – 106 kPa ● Degree of enclosure protection: IP21 (Protected against solid objects over
12mm e.g. fingers. Protection against vertical liquid drops) ● Vibration/Shock/Bump: It is possible to transport the system
world- wide by air, road, ship and train ● Drop/Free fall: It is possible to transport the system world- wide by air, road, ship
and train ● EMC/ESD: The FlowOx™ system meets the requirements in accordance with IEC 60601-1-2 Electromagnetic
compatibility ● Life expectancy: Control Unit [4]: 3 years, Pressure Chamber [1]: 1 year, Padding [17]: 3 months, Seal [20]: 3
months.
Note: The pressure cycle of the FlowOx™ system as specified in section "How It Works" may be affected if the system is used
in an environment with excessive electromagnetic interference. Excessive interference may cause erratic behavior and/or
inaccurate vacuum and timing of the treatment cycle. Please see section "EMC Specification" for guidance on electromagnetic
interference and appropriate conditions for use.
Technical specifications: Description: Enhancement of blood flow to lower limbs ● Parts/Names: FlowOx™ 2.0 (900-00012),
FlowOx™ 2.0 Control Unit (900-00017), FlowOx™ 2.0 Pressure Chamber (00018), FlowOx™ 2.0 PC SW (520-00003), Mains
power cord, Instruction manuals, Control Unit dimensions: 340 x 250 x 200 mm ● Pressure Chamber size: Max EU 46 / UK
11½ ● The Pressure Chamber will fit all patients with leg circumference of minimum of 25cm and maximum of 47cm,
measured at 20cm above the lateral malleolus ● Weight: Control Unit: 3 kg, Pressure Chamber: 3 kg ● Pressure accuracy:
±5mmHg ● Operation time: Normal 2h/day ● Power supply: 100-240 V~, 50-60 Hz, 1,4 – 0,7 A ● Power consumption: Max 60
VA ● Battery: Lithium cell battery, CR2032, 230MAH, 3V ● Computer requirements: Min. 1.5 Gbyte RAM Windows 7 or
later ● Min. resolution: 800x600pix. Min. 24 bit colour support
DEFINITION OF SYMBOLS ON THE DEVICE AND PACKAGING
Refer to the symbols from the cover page of this instruction manual.
Display: [9] Smiley Face symbol (indicates that an action has been completed) ● [12] Clock Set symbol (indicates that the
Control Unit [4] time is being set) ● [27] Treatment Ongoing symbol (indicates that the treatment is ongoing) ● [34] Data
Transfer symbol (indicates the transfer of data from Control Unit [4] to the USB Memory Stick [32]) ● [35] General Error
symbol (indicates that an error has occurred) ● [40] Air Leakage symbol (indicates that air is leaking somewhere in the system)
PC software: [14] Cable icon● [15] Clock Set icon ● [37] Folder icon ● [38] Get Data icon ● [39] Trashcan icon
On device and packaging: [42] Keep dry● [43] Manufacturer ● [44] Batch number ● [45] Type reference ● [46] Serial number,
including manufacturing date ● [47] Do not dispose with your general waste ● [48] Recyclable material ● [49] Follow
instructions for use ● [50] Temperature transport conditions ● [51] Type BF applied part ● [52] Humidity transport conditions
● [53] IEC Protection class II ● [54] The Device Complies with Medical Device Directive 93/42/EEC ● [55] Warning: Dangerous
voltage ● [56] General warning sign ● [57] Left Foot symbol (Indicates how to adjust the Positioner [16] for left foot usage.
Positioner [16] should be placed in a way that a foot symbol is aligned to the foot of the patient) ● [58] Right Foot symbol
(Indicates how to adjust the Positioner [16] for right foot usage. Positioner [16] should be placed in a way that a foot symbol
is aligned to the foot of the patient) ● [59] Refer to instruction manual for power supply connection. Refer to instruction
manual to ensure correct use of the device● [60] Warning: Do not open, causes serious eye irritation (Absorbgel Pouches
[26])
FLOWOX™ 2,0 Patient IFU (610-00013) Rev 9
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