DeVilbiss Healthcare Drive 1025DS Guide D'instruction page 12

Catalog Number
Approval Body and Safety Standard
CE mark
EMC Compliance To
CAUTION– The maximum recommended flow is 6 LPM when an oxygen bottle is being filled with oxygen from the auxiliary oxygen port.
**
Specifications subject to change without notice.
Oxygen Concentration vs Flow Rate
Flow L/m
%O
2
87% - 92%
10
87% - 93%
9
87% - 95%
8
87% - 96%
7
87% - 96%
6
87% - 96%
5
87% - 95%
4
87% - 95%
3
87% - 94%
2
ELECTROMAGNETIC COMPATIBILITY INFORMATION
WARNING
MR Unsafe
Do not bring the device or accessories into a Magnetic Resonance (MR) environment as it may cause unacceptable risk to the patient or damage to the oxygen
•
concentrator or MR medical devices . The device and accessories have not been evaluated for safety in an MR environment .
• Do not use the device or accessories in an environment with electromagnetic equipment such as CT scanners, Diathermy, RFID and electromagnetic security systems
(metal detectors) as it may cause unacceptable risk to the patient or damage to the oxygen concentrator . Some electromagnetic sources may not be apparent, if you
notice any unexplained changes in the performance of this device, if it is making unusual or harsh sounds, disconnect the power cord and discontinue use . Contact your
home care provider .
• This device is suitable for use in home and healthcare environments except for near active HF SURGICAL EQUIPMENT and the RF shielded room of an ME SYSTEM
for magnetic resonance imaging, where the intensity of Electromagnetic DISTURBANCES is high .
WARNING
Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation . If such use is necessary, this
equipment and the other equipment should be observed to verify that they are operating normally .
WARNING
Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to
any part of the oxygen concentrator, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
EN - 12
DEVILBISS 10-LITER SERIES
1025DS
TUV
ANSI/AAMI ES60601-1:2005+A2
(R2012) +A1
IEC 60601-1-6:2010
IEC 60601-1-11:2015
ISO 80601-2-69:2014
CAN/CSA-C22 .2 No . 60601-1:14
CAN/CSA-C22 .2 No . 60601-1-6:11
CAN/CSA-C22 .2 No . 60601-1-11:15
CAN/CSA-C22 .2 No . 80601-2-69:16
No
EN60601-1-2
1025KS
TUV
IEC 60601-1:2012
IEC 60601-1-6:2010+A1
IEC 60601-1-11:2015
EN ISO 80601-2-69:2014
Yes
EN60601-1-2
1025UK
TUV
IEC 60601-1:2012
IEC 60601-1-6:2010+A1
IEC 60601-1-11:2015
EN ISO 80601-2-69:2014
Yes
EN60601-1-2
A-1025DS