Essential Performance Characteristics; Target Groups - Dräger Babyleo TN500 Instructions For Use Manual

2.5

Essential performance characteristics

Provided that the essential performance characteristics are functioning correctly,
the product can be used for its intended purpose. The product has the following
essential performance characteristics:
– Skin temperature regulation in incubator operation
The measured central skin temperature is compared with the set value for the
skin temperature and adjusted accordingly, or an alarm is triggered.
– Air temperature regulation in incubator operation
The measured air temperature in the patient compartment is compared with the
set value for the air temperature and adjusted accordingly, or an alarm is
triggered.
– Skin temperature regulation in radiant warmer operation
The measured central skin temperature is compared with the set value for the
skin temperature and adjusted accordingly, or an alarm is triggered.
2.6

Target groups

2.6.1 Definition of target groups
The target groups may only carry out the following activities if they meet the
necessary requirements. For further information, see the following chapter: ''Basic
safety instructions'' (page 11)
2.6.1.1 Users
Users are clinical personnel such as doctors and nursing staff trained in
neonatology.
Activity
Use of the product in accordance with
the intended use
2.6.1.2 Reprocessing personnel
Activity
Reprocessing
2.6.1.3 Service personnel
Service personnel are, e.g., hospital technicians trained in servicing the device.
Activity
Installation
Basic service work (inspection, main-
tenance according to the "Mainte-
nance" chapter)
Instructions for use Babyleo TN500 SW 1.0n
Safety-related information
Requirement
Specialist medical knowledge in neonatol-
ogy
Knowledge of currently known risks and
benefits of warming therapy
Requirement
Specialist knowledge in the reprocessing of
medical devices
Requirement
Specialist knowledge in electrical engineer-
ing and mechanics
Experience in the servicing of medical
devices
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