950-0047-04A
Page 5 of 69
read and follow all warning and
precautionary notices and
instructions marked on the product
and included in this manual. Become
familiar with the operation and
function of this device and
associated accessories. Failure to
follow these instructions can lead to:
•
Life-threatening injuries to the patient
•
Severe injuries to the surgical team,
nursing or service personnel, or
•
Damage or malfunction of the device
or accessories.
1. Do not open or attempt to service this
system, as this may void your
warranty. There are no user-
serviceable parts inside. Removing the
cover may introduce an electric shock
hazard by exposing you to dangerous
high voltages or other risks. If the system
malfunctions, return it for service
immediately.
2. For the protection of the patient it is
recommended that a back-up camera system
for the Arthrex Synergy
UHD4
video system be
maintained, sterilized, and ready to be
implemented.
3. For the protection of the patient it is essential
that the endoscopic video system
interconnection is complete and produces a
viable color picture on the surgical monitor
PRIOR to administration of patient
anesthesia.
4. Disconnect camera head and endoscope
from the patient prior to applying cardiac
defibrillation to patient.
5. Only the physician can evaluate the clinical
factors involved with each patient and
determine if the use of this device is
indicated. The physician must determine the
specific technique and procedure that will
accomplish the desired clinical effect.
6. This device and its accessories are to be
used only by physicians and medical
assistants under the direction of a physician
with appropriate technical qualifications.
7. This device shall only be used with original
and manufacturer’s accessories
and replacement parts. Use of
other parts or materials may degrade safety.
8. Do not use in the presence of flammable
anesthetics, gases, disinfecting agents,
cleaning solutions, or any material
susceptible to ignition due to electrical
sparking.
9. Equipment grounding is vital for safe
operation. Plug the power cord into a properly
earthed mains supply outlet whose voltage
and frequency characteristics are compatible
with those listed on the unit or in this manual.
Do not use plug adapters or extension cords;
such devices defeat the safety ground and
could cause injury.
10. This equipment should not share an electrical
outlet or grounding with life supporting or life
sustaining equipment.
11. If one or more mains powered units are
connected simultaneously to one socket by
the means of a distribution box, the sum of
the individual leakage currents may exceed
the tolerated limits.
12. Before each use, the outer surface of the
portions of the Endoscope and any
Endoscopically Used Accessory, which are
intended to be inserted into the patient, should
be checked to ensure there are no unintended
rough edges, sharp edges or protrusions which
may cause a safety hazard.
13. Refer to Insufflation Device Instructions
regarding safety hazards to patients resulting
from gas emboli.
14. The leakage current through the patient could
increase when using endoscopes with
powered accessories.
15. When Endoscopes are used with Energized
Endoscopically Used Accessories, the
Patient Leakage Currents may be additive.
This is particularly true if a CF Applied Part is
used, in which case a Type CF
Endoscopically Used Accessory should be
used to minimize total Patient Leakage
Current.
16. Applied Parts of other ME Equipment used
within the configuration for Endoscopic
Application shall be type BF or CF Applied
Parts.
17. Explosive gas concentrations inside the
patient can cause hazards while using High-
Frequency Endoscopically Used Accessories.
