Typographic Conventions; Intended Use; Indications For Use And Clinical Benefit; Contraindications - Inogen Rove 6 Bedienungsanleitung

(Adopted IEC 60601-1:2005, third edition, 2005-
12, including amendment 1:2012, with Canadian
deviations)
1.2.1 MEDICAL EQUIPMENT
CLASSIFICATION
• IEC Class II Equipment
• Type BF Applied Part
• IP22 - Protected from touch by fingers and objects
greater than 0.5 in (12.5 mm). Protected from
dripping water less than 15 degrees from vertical.
• Not suitable for use in the presence of a flammable
anesthetic mixture with air or with oxygen or
nitrous oxide.
• Intended for continuous operation.
1.2.2 IT NETWORK
Important: IT-network is a system composed of wire-
less (Bluetooth) transmission between the device and
the Inogen Connect Application.
• Connection of the device 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

1.3 TYPOGRAPHIC CONVENTIONS

• This user manual contains warnings, cautions, and
notes to help call attention to the most important
safety and operational aspects of the device.
To help identify these items when they occur
in the text, they are shown using the following
typographical conventions:
• WARNING: Statements that describe serious
adverse reactions and potential safety hazards.
• CAUTION: Statements that call attention to
©2022 Inogen, Inc. All rights reserved.
information regarding any special care to be
exercised by the practitioner and/or patient for the
safe and effective use of the device.
• IMPORTANT: Statements calling attention to
additional significant information about the device
or a procedure.

2. INTENDED USE

The Inogen Rove 6 Portable Oxygen Concentrator pro-
vides a high concentration of supplemental oxygen to
patients requiring respiratory therapy on a prescriptive
basis. It may be used in the home, institution, vehicle,
train, airplane, boats and other transport modalities.
2.1 INDICATIONS FOR USE AND
CLINICAL BENEFIT
The Inogen Rove 6 is used on a prescriptive basis by
patients requiring supplemental oxygen to increase
blood oxygen saturation.

2.2 CONTRAINDICATIONS

This device is to be used as an oxygen supplement and
is NOT INTENDED to be life sustaining or life support-
ing. ONLY use this product if the patient is capable of
spontaneous breath and is able to inhale and exhale
without the use of a machine.
• DO NOT use in conjunction with flammable anes-
thetic or flammable materials.
• DO NOT use this device in tracheotomized patients.
• DO NOT use this device in persons whose breath-
ing during normal resting is unable to trigger the
device.

2.3 PATIENT POPULATION

Adults only. Prescription Required.

3. SAFETY INSTRUCTIONS

To ensure the safe installation, assembly and opera-
tion of the concentrator these instructions MUST be
followed. The patient is the intended operator of the
device.
3.1 WARNING
Risk of injury or damage
• Do not use in conjunction with a humidifier,
Page 6 of 356 96-12100-01-01-A