ASTODIA Instructions for Use
4
1 Introduction
1.1 Information on these instructions
It is imperative that you read these instructions for use before us-
ing this product. Failure to follow the instructions for use can re-
sult in damage to the product or to other property and/or personal
These instructions contain important information on the safe use of
ASTODIA.
Fully read the instructions for use, including the warning and caution information,
before you use ASTODIA. Failure to follow the warnings, cautions, and infor-
mation on use can result in death or severe injury to the patient.
ASTODIA consists of a control unit DIA120, a hand piece DIA130 and a
charger DIA140.
These instructions for use are directed towards trained healthcare personnel and
persons in medical professions.
1.2 Specification of the application
1.2.1 Intended use
The Diaphanoscope ASTODIA serves for searching blood vessels and helps
identify structures filled with air or fluid deep under the skin surface.
1.2.2 Intended medical indications
It serves for the translumination of the biological tissue, to visualize its structures;
e.g. in the over-extentioned, neonatal wrist joint of the dorsopalmar, to punctuate
the radial and ulnar arteries while they are visible and for the quick identification
of a pneumothorax or a hydrocele in the field of paediatrics/neonatology.
Two high-performance light-emitting diodes of different wave length (yellow and
red) are used for a wide range of applications. The thermal load for the transillu-
minated tissue is minimized and regulated by an electronic control unit.
1.2.3 Contraindications
Contraindications for the transillumination of tissue using visible light are not
known for the intended use.
1.2.4 Possible adverse effects
In normal use, no adverse effects arising from ASTODIA are to be expected.
1.2.5 Intended patient group
Paediatrics and preferably for premature babies and neonates.
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