Quest Engineering ART-LAP-0008, Инструкция по эксплуатации

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Quest Spectrum® Laparoscopes
2
1 Health and Safety Compliance
1.1 Important Information
WARNING: Read Before Use
This instruction manual contains essential information on using the Quest
Spectrum® Laparoscopes safely and effectively. Before use, thoroughly review this manual and
use the system as instructed.
Keep this manual in a safe, accessible location. Questions or comments about any information
in this manual should be sent to Quest Medical Imaging B.V.
The following signal words serve to distinguish between warning notes according to the type of
danger:
WARNING: indicates risks to the safety of the patient or user. Failure to
follow
warnings may result in injury to the patient or user.
CAUTION: indicates risks to the equipment. Failure to follow cautions may
result in product damage.
Note: provides special information to clarify instructions or
present additional
useful information.
1.2 Indication for Use
During the examination, diagnosis and/or (in combination with endoscopic accessories)
treatment, Laparoscopes serve exclusively to visualize the abdominal cavity.
WARNING: The Quest Spectrum ® Laparoscope should be used according to
its approved Indication for Use.
1.3 Foreseeable misuse
WARNING: Do not use Laparoscopes for other endoscopic applications.
WARNING: Connect Laparoscopes exclusively to BF devices (body floated
devices).
1.3.1 Contraindications:
 General inoperability
 Ambiguous diagnosis
 Lack of willingness on the part of the patient
 Technical preconditions not met