Dräger AGS Gebrauchsanweisung Seite 8

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Instructions for use Anesthetic gas receiving system AGS en/ enUS English/English US
Anesthetic gas receiving system AGS
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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.
8
Reprocessing personnel has specialist knowledge
in the reprocessing of medical devices.
Service personnel
This user group installs the product and performs
the service activities.
Service personnel has specialist knowledge in elec-
trical and mechanical engineering and experience in
the servicing of medical devices.
Where product specific knowledge or tools are re-
quired, the service activities must be carried out by
specialized service personnel. The specialized ser-
vice personnel was trained by Dräger for these ser-
vice activities on this product.
For your safety and that of your
patients
WARNING
Risk of incorrect operation and of misuse
Any use of the medical device requires full un-
derstanding and strict observation of all sec-
tions of these instructions for use. The medi-
cal device must only be used for the purpose
specified under "Intended use".
Strictly observe all WARNING and CAUTION
statements throughout these instructions for
use and all statements on medical device la-
bels. Failure to observe these safety informa-
tion statements constitutes a use of the medi-
cal device that is inconsistent with its intended
use.
WARNING
Risk of malfunction and of patient injury
Modification may damage or impair the proper
functioning of the device and may lead to pa-
tient injury.
Do not modify AGS or use it for any purposes
other than those specified in the intended use.
Service
WARNING
Risk if service is not performed regularly
If service is not performed regularly, malfunc-
tions may occur, which can result in personal
injury and property damage.
Perform the service in accordance with the
chapter "Service".
Accessories
WARNING
Risk due to incompatible accessories
Dräger has tested only the compatibility of ac-
cessories listed in the current list of accesso-
ries. If other, incompatible accessories are
used, there is a risk of patient injury due to
medical device failure.
Dräger recommends that the medical device is
only used together with accessories listed in
the list of accessories.
Connected devices
WARNING
Risk of device malfunction
Any connected devices or device combina-
tions not complying with the requirements
mentioned in these instructions for use may
compromise the correct functioning of the
medical device. Before operating the medical
device, strictly comply with the instructions
for use of all connected devices or device
combinations.
Not for use in areas of explosion hazard
WARNING
Risk of fire
The medical device is not approved for use in
areas where combustible or explosive gas
mixtures are likely to occur.
Mandatory reporting of adverse events
Serious adverse events with this product must be
reported to Dräger and the responsible authorities.
Intended use
The anesthetic gas receiving system AGS is intend-
ed for extracting and removing excess anesthetic
gas and expiratory gas, for reducing the concentra-
tion of anesthetic agent released into the surround-
ings by the anesthesia machine and for scavenging
sample gas from gas measuring monitors.
The anesthetic gas receiving system AGS is a low-
flow system.
The anesthetic gas receiving system AGS may only
be operated with devices complying with the re-
quirements of the ISO standard 80601-2-13.
Use
The anesthetic gas receiving system AGS can be
used with anesthesia workstations of the following
Dräger product families:
– Zeus
– Primus
– Fabius
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.
Overview
H
G
F
A AGS header
B Nozzle for scavenging hose
C Flow tube with float to show scavenging flow
D Particle filter
E Container for buffer volume
F Nozzle for transfer hose
G Nozzle for second transfer hose, closed with
screw cap
H Coupler F for sample gas return line (optional)
The anesthetic gas receiving system AGS operates
as an "open system". The excess anesthetic gas-
es/expiration gases are channelled into the buffer
Instructions for use Anesthetic gas receiving system AGS
A
B
C
D
E