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medical device labels, labelling and information to be supplied. Part 1: General requirements ● ISO 15223-2 Rev 1.0: 2010
Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. Part 2 ● BS EN ISO
20417: 2021 Medical devices — Information to be supplied by the manufacturer ● EN 15986:2011 Symbol for use in the
labelling of medical devices - Requirements for labelling of medical devices containing phthalates
Manufacturing Standards used: EN ISO 13485:2016+A11:2021 Medical devices – Quality management systems –
Requirements for regulatory purposes.
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), wait at least 2 hours before using the device.
● Opera on Air Humidity: 15 – 95 % ● Opera on 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 % rela ve humidity at +70 °C ● Storage
and transport Ambient pressure: 50 – 106 kPa ● Degree of enclosure protec on: IP21 (Protected against solid objects over
12mm e.g., fingers. Protection against vertical liquid drops) ● Vibra on/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, Strap [23]: 1 year.
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 Firmware version 1.0.9 (510-00006), FlowOx™ 2.0 Pressure Chamber
(900-00018), FlowOx™ 2.0 PC SW version 1.0.7 (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 ● Opera on me: Normal 2h/day ● Power supply:
100-240 V~, 50-60 Hz, 1,4 – 0,7 A ● Power consump on: Max 60 VA ● Ba ery: Lithium cell battery, CR2032, 230MAH, 3V ●
Computer requirements: Min. 1.5 Giga-byte RAM Windows 7 or later ● Min. resolu on: 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: [41] Refer to the instruction manual for power supply connection. Refer to the instruction manual
to ensure correct use of the device ● [42] Keep dry ● [43] Manufacturer ● [44] Batch number ● [45] Type reference ● [46]
Serial number, including manufacturing date ● [47] Do not dispose as general waste ● [48] Recyclable material ● [49]
Warning: Do not open, causes serious eye irritation (Absorgel Pouches [26]) ● [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 Regulation 2017/745 ● [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 such a way so that the foot
symbol is aligned to the left 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 such a way so that the foot symbol is aligned to the right foot of the patient)
● [59] Single patient multiple use ● [60] Patient name ● [61] Medical device ● [62] Unique device identifier ● [63] Date of
manufacture ● [64] Quan ty ● [65] Expiration Date
610-00013 FLOWOX™ 2.0 Instructions for Use (IFU) Manual Rev 20
Date of Issue: 09 OCT 2024
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