User Group Requirements; Duties Of The Operating Organization; User Groups - Dräger PressurePod Instrucciones De Uso

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Instructions for use PressurePod de
Instructions for use PressurePod
User group requirements . . . . . . . . . . . . . . . . . 12
Duties of the operating organization . . . . . . . . . . 12
User groups . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
For your safety and that of your patients . . . . 13
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Patient target groups . . . . . . . . . . . . . . . . . . . . . . 14
Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . 14
Environments of use . . . . . . . . . . . . . . . . . . . . . . 14
Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Installation and operation . . . . . . . . . . . . . . . . . 15
Mounting the PressurePod . . . . . . . . . . . . . . . . . 16
Connecting the pressure measuring lines . . . . . . 16
End of use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Reprocessing. . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Safety information . . . . . . . . . . . . . . . . . . . . . . . . 17
Classifications for reprocessing. . . . . . . . . . . . . . 17
Before reprocessing . . . . . . . . . . . . . . . . . . . . . . 18
Patient-specific third-party accessories and
consumables . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Validated reprocessing procedures . . . . . . . . . . . 18
Surface disinfectants . . . . . . . . . . . . . . . . . . . . . . 18
Storage and transport . . . . . . . . . . . . . . . . . . . . . 18
Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Technical data . . . . . . . . . . . . . . . . . . . . . . . . . . 19
12
EMC declaration . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Recommended separation distances from
wireless communication devices . . . . . . . . . . . . . 21
Order list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Trademarks
Trademarks owned by third-party manufacturers
Trademark Trademark owner
®
Dismozon BODE Chemie
®
Oxycide Ecolab USA
Safety information definitions
WARNING
A WARNING statement provides important in-
formation about a potentially hazardous situa-
tion which, if not avoided, could result in death
or serious injury.
CAUTION
A CAUTION statement provides important infor-
mation about a potentially hazardous situation
which, if not avoided, may result in minor or mod-
erate injury to the user or patient or in damage to
the medical device or other property.
NOTE
A NOTE provides additional information intended to
avoid inconvenience during operation.

User group requirements

The term "user group" describes the personnel re-
sponsible who have been assigned by the operating
organization to perform a particular task on a prod-
uct.

Duties of the operating organization

The operating organization must ensure the follow-
ing:
- Every user group has the required qualifications
(e.g., has undergone specialist training or ac-
quired specialist knowledge through experi-
ence).
- Every user group has been trained to perform the
task.
- Every user group has read and understood the
relevant chapters in this document.

User groups

Clinical users
This user group operates the product in accordance
with the intended use.
Users have medical specialist knowledge in the ap-
plication of the product.
Reprocessing personnel
This user group carries out the necessary activities
to reprocess the product.
Reprocessing personnel has specialist knowledge in
the reprocessing of medical devices.
Instructions for use PressurePod