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2. For the protection of the patient it is
recommended that a back-up camera system
for the Arthrex Synergy
HD3
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 from 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. The scope light guide tip can get extremely
hot as result of high intensity light, giving
rise to high temperatures in front of the light
emission window which may cause severe
burns. Always keep the light source in the
STANDBY mode when not in use.
13. 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.
14. Safety hazards to patients may result from
gas embolism caused by, for example, over-
insufflation of air or inert gas prior to high
frequency surgery or laser assist gas
15. The leakage current through the patient
could increase using endoscopes with
powered accessories.
16. 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.
17. Explosive gas concentrations inside the
patient can cause hazards while using High-
Frequency Endoscopically Used
Accessories.
18. For the protection of service personnel, and
for safety during transportation, all devices
and accessories that are returned for repair
must be prepared for shipment as described
in “Returning the Device” of this manual.
The manufacturer has the right to refuse to
carry out repairs if the product is
contaminated.
19. This equipment/system is intended for use
by healthcare professionals only. This
equipment/system may cause radio
interference or may disrupt the operation of
nearby equipment. It may be necessary to
take mitigation measures, such as re-
orienting or relocating the Synergy
HD3
Video
System or shielding the location.
20. NOT for use in an Oxygen Rich Environment.
21. Applied Parts of other ME Equipment used
within the configuration for Endoscopic
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