General Information; Intended Use - Apex XT Manual De Uso

XT Heated Humidifier/ English
1. Introduction
This manual is provided to explain initial set up and operating instructions.

1.1 General Information

This system has been tested and successfully approved by the following standards.
0197
For US and CANADA only
E348970
53DG
Le produit à été testé avec des équipements médicaux et respecte les normes ANSI/AAMI
ES60601-1 (2005,3rd ed.) and CAN / CSA C22.2 No. 60601-1 (2008, 3
prévenant les choc électrique, le feu et les risques de blessures physiques.
EMC Warning Statement
This equipment has been tested and found to comply with the limits for medical devices for
EN 60601-1-2. These limits are designed to provide reasonable protection against harmful interference in a
typical medical installation. This unit generates, uses and can radiate radio frequency energy and, if not
installed and used in accordance with the instructions, may cause harmful interference to other devices in
the vicinity. However, there is no guarantee that interference will not occur in a particular installation. If
this equipment does cause harmful interference to other devices, which can be determined by turning the
equipment off and on, the user is encouraged to try to correct the interference by one or more of the
following measures:
-
Reorient or relocate the unit.
-
Increase the distance between the conflicting equipment.
-
Connect the unit into an outlet that is on a different circuit than the other device(s).
-
Consult the manufacturer or field service technician for help.

1.2 Intended use

XT Heated Humidifier is intended for use with the XT series CPAP unit. It has been designed to increase the
moisture of the air delivered from the CPAP, relieving symptoms of a dry nose and throat that some people
may experience.
NOTE: This equipment is not suitable for use in the presence of a flammable anesthetic mixture with
oxygen and/or nitrous oxide.
EN60601-1
EN60601-1-2
EN 61000-3-2 Class A
EN 61000-3-3
CISPR 11 Group 1, Class B
Medical Equipment- Heated Humidifier
WITH RESPECT TO ELECTRICAL SHOCK,
FIRE AND MECHANICAL HAZARDS ONLY
IN ACCORDANCE WITH ANSI/AAMI
ES60601-1 (2005,3rd ed.) and CAN / CSA C22.2
No. 60601-1 (2008, 3
rd
ed.) and IEC 60601-1-11
rd
ed.) and IEC 60601-1-11.
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