Networking - Dräger Babylog VN500 Instructions For Use Manual

Networking

Device combinations approved by Dräger (see In-
structions for Use of the individual devices or units)
meet the requirements set forth by the following
standards:
– IEC 60601-1 (EN 60601-1)
Medical electrical equipment
Part 1: General requirements for safety
– IEC 60601-1-1 (EN 60601-1-1)
Medical electrical equipment
Part 1-1: General requirements for safety;
Collateral standard: Safety requirements for
medical electrical systems
– IEC 60601-1-2 (EN 60601-1-2)
Medical electrical equipment
Part 1-2: General requirements for safety
Collateral standard: Electromagnetic compati-
bility; Requirements and tests
– IEC 60601-1-4 (EN 60601-1-4)
Medical electrical equipment
Part 1-4: General requirements for safety
Collateral standard: Programmable electrical
medical systems
If Dräger devices or units are connected with other
Dräger devices or third-party devices and the re-
sulting combination is not approved by Dräger, the
operator is responsible for ensuring that the result-
ing system meets the requirements set forth by the
above standards.
Strictly follow Assembly Instructions and Instruc-
tions for Use for each networked device.
Patient safety
The design of the medical device, the accompany-
ing literature, and the labeling on the medical de-
vice take into consideration that the purchase and
use of the medical device are restricted to trained
professionals, and that certain inherent characteris-
tics of the medical device are known to the trained
operator. Instructions, WARNING and CAUTION
statements are limited, therefore, largely to the spe-
cifics of the Dräger medical device.
Instructions for Use Infinity Acute Care System – Babylog VN500 SW 2.n
For Your Safety and that of Your Patients
This publication excludes references to various
hazards which are obvious to a medical profession-
al and operator of this medical device, to the conse-
quences of medical device misuse, and to poten-
tially adverse effects in patients with abnormal con-
ditions. Medical device modification or misuse can
be dangerous.
CAUTION
Patient hazard
Individual measured values und monitoring pa-
rameters should not be used as the sole basis for
therapeutic decisions.
Patient monitoring
The operators of the medical device are responsi-
ble for choosing appropriate safety monitoring that
supplies adequate information on medical device
performance and patient condition.
Patient safety may be achieved through a wide va-
riety of means ranging from electronic surveillance
of medical device performance and patient condi-
tion, to simple, direct observation of clinical signs.
The responsibility for the selection of the best level
of patient monitoring lies solely with the medical de-
vice operator.
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