Intended Use; Patient Target Groups; Indications; Contraindications - Dräger PressurePod Instructions For Use Manual

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WARNING
Risk due to modifications
Modifications to the product may lead to mal-
functions and unforeseen risks. This may re-
sult in injury to the patient or the user or in
property damage.
Do not modify this product.
CAUTION
Risk of overheating
Overheating may cause the following:
– Damage to the device
– Device malfunctions
Keep the medical device away from sources of heat
such as direct sunlight or radiators.
CAUTION
Risk if service is not performed regularly
If service is not performed regularly, malfunctions
may occur, which can result in personal injury and
property damage.
Perform the service in accordance with the chapter
"Service".
Patient safety
The design of the medical device, the accompanying
documentation, and the labeling on the medical de-
vice are based on the assumption that the purchase
and the use of the medical device are restricted to
persons familiar with the most important inherent
characteristics of the medical device.
Instructions and WARNING and CAUTION state-
ments are therefore largely limited to the specifics of
the Dräger medical device.
The instructions for use do not contain any informa-
tion on the following points:
– Risks that are obvious to users
14
– Consequences of obvious improper use of the
medical device
– Potentially negative effects on patients with dif-
ferent underlying diseases
Medical device modification or misuse can be dan-
gerous.
Mandatory reporting of adverse events
Serious adverse events with this product must be re-
ported to Dräger and the responsible authorities.

Intended use

The PressurePod is intended for the extracorporeal
digital conversion of gas pressures acting at its input
ports and for the transmission of digital values to
compatible medical devices.

Patient target groups

The patient target groups of the connected main de-
vice apply to this product. They are listed in the in-
structions for use for the main device.
Depending on the type of pressure measurement
and the third-party accessories used, restrictions
concerning the patient target groups may apply
which can be found in the documentation of the third-
party accessories.

Indications

The PressurePod is intended to be used on patients
where the measurement of gas pressures, such as
the airway, esophageal, and gastric pressures, are of
clinical interest and where the documentation of the
connected main device and the connected third-par-
ty accessories permit the use.

Contraindications

There are no medical contraindications for this prod-
uct.
Contraindications result from the third-party acces-
sories used and the site of pressure measurement.
When using esophageal and gastric probes, pay par-
ticular attention to the contraindications listed in their
documentation.

Environments of use

The PressurePod is intended only for use in hospital
environments in connection with compatible devices.
Only pressure measuring lines with compatible ports
may be used. For further information on the ports,
see "Technical data" (Page 20).
It is used in the immediate vicinity of the patient's
bed.
The PressurePod must not be used:
– During patient transport
– In areas of explosion hazard
– For measuring the pressure of anesthetic gases
– In the presence of strong magnetic fields, e.g.,
MRI
Instructions for use PressurePod