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Pulsatron II Nerve Stimulator PRODUCT INFORMATION AND INSTRUCTIONS
PRODUCT INFORMATION AND INSTRUCTIONS
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PULSATRON® II NERVE STIMULATOR REF 8262015 PRODUCT INFORMATION AND INSTRUCTIONS DEVICE DESCRIPTION The Medtronic Pulsatron II Nerve Stimulator is a hand-held battery-operated device that supplies timed pulses of electrical current at a rate of approximately 80 pulses per second as the stainless steel probe tip touches tissue. The stimulator is a pulsed, constant-voltage device (3.75 V peak-to-peak maximum) which delivers a maximum current intensity of 0.7 mA depending on tissue impedance. An attached needle electrode (ground) is provided for subcutaneous insertion. The LED light is used to test the device. INTENDED USE / INDICATIONS FOR USE The Medtronic Pulsatron® II Nerve Stimulator is intended for the identification of exposed motor nerves during surgery. CONTRAINDICATIONS The device is not indicated for use when paralyzing anesthetic agents are being used as they will significantly reduce, if not completely eliminate, EMG responses to direct or passive neural stimulation. WARNINGS • • •
• • • • • • • •
Excessive pressure or prolonged stimulator contact with the nerve, as indicated by the LED, could result in neural injury. This device is not designed to determine the degree of neural viability. Due to variations in tissue impedance and, hence, current delivered, activation of the LED may not be always be achieved despite delivering current during surgery. Firmly depress the switch and confirm functionality by touching the probe tip and needle electrode. During surgery, a lit LED confirms delivery of current. If the LED is not activated intraoperatively, the device can be tested by touching the probe tip to the needle electrode. Do not bend the probe tip as the device may become damaged and malfunction. Do not use in the presence of any flammable material, there is a potential for ignition. Improperly placed or bent needle electrodes, and attempts to straighten bent electrodes, increase the risk of the needle breaking off in the patient. False negative responses (failure to locate the nerve) may result from neuromuscular fatigue from prolonged or repeated stimulation. Contaminated single use electrodes and probes must be disposed of in an appropriate sharps container in accordance with user facilities policy. The device should not be used while a NIM™ EMG monitor is in use, as it will cause false positive responses. Stimulating current is most effectively delivered through a single point of tissue contact. Avoid multiple points of tissue contact along the probe shaft, as this will shunt current away from the desired point of stimulation.
PRECAUTIONS • After depressing the tan rubber switch, the device has a useful life of 4-20 hours. Continuous stimulation will result in a useful life of about 4 hours. Typical use (i.e. intermittent stimulation) will result in a useful life of 8-20 hours. • Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this Guide. • Portable and mobile RF communications equipment can affect Medical Electrical Equipment. • The Pulsatron should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the Pulsatron should be observed to verify normal operation in the configuration in which it will be used. INSTRUCTIONS FOR USE . Unwind the ground wire. 2. Firmly depress the tan rubber switch at the rear of the handle until it locks down. Allow five seconds for the device output to stabilize. 3. Remove protective covering from grounding needle and probe tip. 4. Test unit for functionality by touching the probe tip to the needle electrode. This will cause the LED light located beside the rubber switch to illuminate. The LED will turn off when the probe tip and needle electrode are separated. Do not attempt to use a device that fails this test. 5. Ground the stimulator by inserting the needle electrode subcutaneously near the operation site. The device must be grounded to insure a complete circuit. Avoid fatty tissue, as this tends to be a poor conductor.
GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY AND EMISSIONS
Guidance and manufacturer’s declaration – electromagnetic immunity - Part 1 The Pulsatron is intended for use in the electromagnetic environment specified below. The customer or the user of the Pulsatron should assure that it is used in such an environment. Immunity test
EN 60601 test level
Compliance level
Electrostatic discharge (ESD)
±6 kV contact
±6 kV contact
EN 61000-4-2
±8 kV air
±8 kV air
Power frequency (50/60 Hz) magnetic field EN 61000-4-8
3 A/m
3 A/m
Electromagnetic environment guidance Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
Guidance and manufacturer’s declaration – electromagnetic emissions The Pulsatron is intended for use in the electromagnetic environment specified below. The customer or the user of the Pulsatron should assure that it is used in such an environment. Emissions test
Compliance
Electromagnetic environment - guidance
RF emissions CISPR 11
Group 1
The Pulsatron uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment
RF emissions CISPR 11
Class B
Harmonic emissions EN 61000-3-2
N/A
Voltage fluctuations EN 61000-3-3
N/A
The Pulsatron is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings for domestic purpose.
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Recommended separation distances between portable and mobile RF communications equipment and the Pulsatron The Pulsatron is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Pulsatron can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Pulsatron as recommended below, according to the maximum output power of the communications equipment. Rated maximum power of transmitter W
Separation distance according to frequency of transmitter (meters) 150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz
d = 1.2√P
d = 1.2√P
d = 2.3√P
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
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For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
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Guidance and manufacturer’s declaration – electromagnetic immunity - Part II The Pulsatron is intended for use in the electromagnetic environment specified below. The customer or the user of the Pulsatron should assure that it is used in such an environment. Immunity test
EN 60601 test level
Compliance level
Electromagnetic environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of the Pulsatron, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended distance
Conducted RF EN 61000-4-6
3 Vrms 150 kHz to 80 MHz
N/A
Radiated RF EN 61000-4-3
3 V/m 80 MHz to 2.5 GHz
3 V/m
separation
d = 1.2√P d = 1.2√P 80 MHz to 800 MHz d = 2.3√P 800 MHz to 2.5 GHz
where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, (a) should be less than the compliance level in each frequency range. (b) Interference may occur in the vicinity of equipment marked with the following symbol:
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. (a): Field strengths from fixed transmitters, such as base stations for radio (cellular/ cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Pulsatron is used exceeds the applicable RF compliance level above, the Pulsatron should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Pulsatron. (b): Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
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Medtronic Xomed Inc., 6743 Southpoint Drive North Jacksonville, FL 32216-0980 USA 800-874-5797
0123
904-296-9600
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