General Information; Intended Use - Apex Digital Pro-care Auto User Manual

Pro-care Auto / English
1. Introduction
This manual should be used for initial set up of the system and for reference purposes.

1.1 General Information

The system is a high quality and affordable mattress system suitable for treatment and prevention
of pressure ulcers.
The system has been tested and successfully approved to the following standards:
EMC Warning Statement
This equipment has been tested and found to comply with the limits for medical devices to the EN
60601-1-2. These limits are designed to provide reasonable protection against harmful interference in a
typical medical installation. This equipment 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 receiving device.
Increase the separation between the equipment.
Connect the equipment into an outlet on a circuit different from that to which the other device(s) are
connected.
Consult the manufacturer or field service technician for help.

1.2 Intended Use

This product is intended to help and reduce the incidence of pressure ulcers while optimizing patient
comfort. It also provides following purposes:
to help and reduce the incidence of pressure ulcers while optimizing patient comfort.
for long term care of patients suffering from pressure ulcers.
for pain management as prescribed by a physician.
The product can only be operated by personnel who are qualified to perform general nursing procedures
and have received adequate training in knowledge of prevention and treatment of pressure ulcers.
NOTE: The equipment is not suitable for use in the presence of a flammable anesthetic mixture with
air or with oxygen or nitrous oxide.
WARNING: Do not turn or flip patients who have bone fracture or spinal cord injury.
IEC/EN 60601-1
IEC/EN 60601-1-2
IEC/EN 61000-3-2 Class A
IEC/EN 61000-3-3
CISPR 11 Group 1, Class B
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