Halyard PMP-SU, Инструкция по эксплуатации

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HALYARD*
Radiofrequency Single-Use Probe
Federal (U.S.A) law restricts this device to sale by or on the order of a physician.
Device Description
The HALYARD* Radiofrequency Single-Use Probe (PMP-SU) is a sterile, single-use
device that delivers radiofrequency (RF) energy. The HALYARD* Radiofrequency
Single-Use Probe is inserted in nervous tissue through a HALYARD* Radiofre-
quency Cannula (sold separately) of the corresponding gauge and length.
Indications For Use
The Radiofrequency Single-Use Probe will be used in conjunction with a
HALYARD* Radiofrequency Generator Connector Cable and the HALYARD*
Radiofrequency Generator or K
imberly
-C
larK
® Radiofrequency Generator (formerly
Baylis Pain Management Generator) to create RF lesions in nervous tissue.
Contraindications
For patients with cardiac pacemakers, a variety of changes can occur during and
after the treatment. In sensing mode the pacemaker may interpret the RF signal
as a heartbeat and may fail to pace the heart. Contact the pacemaker company
to determine if the pacemaker should be converted to fixed-rate pacing during
the radiofrequency procedure. Evaluate the patient’s pacing system after the
procedure.
Check the compatibility and safety of combinations of other physiological
monitoring and electrical apparatus to be used on the patient in addition to the
HALYARD* RF Generator (PMG-115-TD).
If the patient has a spinal cord, deep brain, or other stimulator, contact the
manufacturer to determine if the stimulator needs to be in the bipolar stimula-
tion mode or in the OFF position.
This procedure should be reconsidered in patients with any prior neurological
deficit.
The use of general anesthesia is contraindicated. To allow for patient feedback
and response during the procedure, treatment should be performed under local
anesthesia.
Systemic infection or local infection in area of the procedure.
Blood coagulation disorders or anticoagulant use.
Warnings
• The HALYARD* RF Single-Use Probe is a single-use device.
Do not reuse, reprocess, or resterilize this medical device. Reuse,
reprocessing, or resterilization may 1) adversely affect the known
biocompatibility characteristics of the device, 2) compromise the
structural integrity of the device, 3) lead to the device not perform-
ing as intended, or 4) create a risk of contamination and cause
the transmission of infectious diseases resulting in patient injury,
illness, or death.
• The HALYARD* RF Single-Use Probe must be used with the correct
connector cable. Attempts to use it with other connector cables can
result in electrocution of the patient or operator.
• Laboratory staff and patients can undergo significant x-ray
exposure during radiofrequency procedures due to the continuous
use of fluoroscopic imaging. This exposure can result in acute
radiation injury as well as increased risk for somatic and genetic
effects. Therefore, adequate measures must be taken to minimize
this exposure.
• Discontinue use if inaccurate, erratic or sluggish temperature
readings are observed. Use of damaged equipment may cause
patient injury.
• Do not modify HALYARD* Equipment. Any modifications may
compromise the safety and efficacy of the device.
• When the RF Generator is activated, the conducted and radiated
electrical fields may interfere with other electrical medical equip-
ment.
• The RF Generator is capable of delivering significant electrical
power. Patient or operator injury can result from improper han-
dling of the probes, particularly when operating the device.
• During power delivery, the patient should not be allowed to come
in contact with grounded metal surfaces.
• Do not remove or withdraw the device while energy is being
delivered.
• There is a rare potential for localized skin burn if RF lesion site has
insufficient subcutaneous tissue (<15 mm) or is near a shallow
metal implant.
Precautions
• Do not attempt to use the HALYARD* RF Single-Use Probe before thoroughly
reading the accompanying Instructions for Use and the User’s Manual for the
HALYARD* RF Generator.
• Apparent low power output or failure of the equipment to function properly
at normal settings may indicate: 1) faulty application of the dispersive
electrode or 2) power failure to an electrical lead. Do not increase power
level before checking for obvious defects or misapplication.
• To prevent the risk of ignition, make sure that flammable material is not
present in the room during RF power application.
• Only physicians familiar with RF lesion techniques should use the
HALYARD* RF Single-Use Probe.
• The sterile packaging should be visually inspected prior to use to detect any
compromise. Ensure that the packaging has not been damaged. Do not use
the equipment if the packaging has been compromised.
• It is the physician’s responsibility to determine, assess and communicate to
each individual patient all foreseeable risks of the RF lesion procedure.
Adverse Events
Potential complications associated with the use of this device include but are
not limited to: infection, bleeding, nerve damage, increased pain, failure of
technique, paralysis and death.
Product Specifications
The HALYARD* RF Single-Use Probe is ethylene oxide sterilized and supplied in
sterile packaging. The HALYARD* RF Single-Use Probe should be stored in a cool,
dry place.
HALYARD* RF Single-Use Probe
(Fig. 1)
:
• Shipped sterile
• Supplied with a protective tube
• Black 4-pin, male connector (Probe Plug-in) to connect to the
HALYARD* Radiofrequency Generator Connector Cable.
• Colored back nut which corresponds to the gauge of the cannula it should
be used with:
White = 16G
Yellow = 20G
Green = 21G
Black = 22G (or 18G)
• Black probe cable is used with straight cannula and a white probe cable is
used with curved cannula.
• Model number, PMP-XX-YYY-SU indicates cannula information, where:
XX: indicates gauge of cannula associated with the probe
YYY: indicates length of cannula associated with the probe
C:
If present, indicates that cannula is curved.
Note:
Please contact Halyard Health for a list of all model numbers and sizes.
Inspection Prior To Use
Perform the following checks before the patient is presented for the procedure.
These steps will allow you to verify that the equipment you will use is in proper
working order. Do these tests in a sterile environment.
KEY ITEMS QUESTION? WARNINGS & EXPLANATIONS
Sterility Is the probe
sterile?
Prior to using the HALYARD* RF
Single-Use Probe inspect the packag-
ing to ensure the package has not
been damaged and sterility has not
been compromised.
Visual
Check
Have you done
a visual check
on the entire
system?
Ensure connectors, cable and probes
have no visible damage, such as
discoloration, cracks, label fading,
cable splice or kinks. Do not use
damaged or defective equipment in
the procedure.