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Information to the supplement
This document supplements the instructions for use of the follow-
ing products:
–
Infinity Acute Care System
–
Infinity M540 patient monitor
–
Infinity Delta Series
–
Infinity Vista XL
–
Vista family of patient monitoring devices
This supplement provides information about Scio Four modules
with part number 6871801, 6871802, 6871803, and 6871804.
Availability of versions of the listed products and software versions
compatible with the Scio Four Modules is approval and country
specific. Please consult Dräger for compatible product and soft-
ware versions for a specific country.
Product names in use
In this supplement all Scio Four modules (Scio Four, Scio Four
Oxi, Scio Four plus, and Scio Four Oxi plus) are referred to as "gas
analyzer" or "medical device".
Typographical conventions
1
Consecutive numbers indicate steps of action, with the num-
bering restarting with "1" for each new sequence of actions.
Bullet points indicate individual actions or different options for
action.
–
Dashes indicate the listing of data, options, or objects.
(A) Letters in parentheses refer to elements in the related illustra-
tion.
A
Letters in illustrations denote elements referred to in the text.
Safety information definitions
WARNING
A WARNING statement provides important information
about a potentially hazardous situation which, if not
avoided, could result in death or serious injury.
CAUTION
A CAUTION statement provides important information about a
potentially hazardous situation which, if not avoided, may result
in minor or moderate 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 incon-
venience during operation.
Supplement Scio Four modules
User group requirements
The term "user group" describes the personnel responsible who
have been assigned by the operating organization to perform a
particular task on a product.
Duties of the operating organization
The operating organization must ensure the following:
–
Every user group has the required qualifications (e.g., has
undergone specialist training or acquired specialist knowledge
through experience).
–
Every user group has been trained to perform the task.
–
Every user group has read and understood the relevant chap-
ters in this document.
–
The product is used only by authorized personnel and is pro-
tected against unauthorized access.
User groups
Clinical users
This user group operates the product in accordance with the
intended use.
Clinical users have medical specialist knowledge in the field of
anesthesia and intensive care and knowledge of device monitor-
ing and perioperative care.
Reprocessing personnel
This user group carries out the necessary activities to reprocess
the product.
Reprocessing personnel has specialist knowledge in the repro-
cessing of medical devices.
Service personnel
This user group performs service activities.
Service personnel have specialist knowledge in electrical and
mechanical engineering and experience in the servicing of medi-
cal devices.
Where product-specific knowledge or tools are required, the ser-
vice activities must be performed by specialized service person-
nel. The specialized service personnel have been trained by
Dräger for these service activities on this product.
English
3
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