Disposal Of Equipment And Accessories; Standards Compliance - OxyGo NEXT Manual Del Usuario

Disposal of Equipment and Accessories

Follow your local governing ordinances for disposal and recycling of the OxyGo NEXT and
accessories. If WEEE regulations apply, do not dispose of in unsorted municipal waste.
Within Europe, contact the EU Authorized Representative for disposal instructions. The battery
contains lithium ion cells and should be recycled. The battery must not be incinerated.
OxyGo NEXT Pulse Volumes at Flow Settings
Breaths per
Minute
15
20
25
30
35
40
Total
Volume per
Minute (ml/
min)

Standards Compliance

This device is designed to conform to the following standards:
• IEC 60601-1 Medical Electrical Equipment, Part 1: General Safety Requirements
• IEC 60601-1-2 3.1 Edition, Medical Electrical Equipment, Part 1-2: General Safety
Requirements – Collateral Standard: Electromagnetic Compatibility; Requirements and
Tests
• ISO 8359 Oxygen Concentrators for Medical Use – Safety Requirements. RTCA DO 160
Note: IT-network is a system composed of wireless (Bluetooth) transmission
between the OxyGo NEXT and the My OxyGo Application.
• Connection of the OxyGo NEXT to an IT-Network could result in previously unidentified
risks to patients, operators or third parties.
• Subsequent changes to the IT-network could introduce new risks and require additional
analysis
• Changes to the IT-network include:
º Changes in the IT-network configuration;
º Connection of additional items to the IT-network
º Disconnecting items from the IT-network
º Updating equipment connected to the IT-network
OxyGo NEXT Flow Setting
1 2
14 28
11 21
8 17
7 14
6 12
5 11
mL/breath +/- 15% per ISO 80601-2-67
210 420
3 4
42 56
32 42
25 34
21 28
18 24
16 21
630 840
5 6
70 84
53 63
42 50
35 42
30 36
26 32
1050 1260
24