SunStim and SunStim Plus Instructions for Use Rev 1

1. INDICATIONS FOR USE

3. ACCESSORIES

The SunStim™ and SunStim Plus™ Peripheral Nerve Stimulators are 9 Volt DC batterypowered, non-sterile devices, intended for monitoring the magnitude of neuromuscular block in general anesthesia, by delivering an electrical stimulus near a peripheral motor nerve and assessing the response of the muscle innervated by that nerve.

The SunStim™ and SunStim Plus™ Peripheral Nerve Stimulators are provided with:

2. EQUIPMENT CLASSIFICATION Per IEC 60601-1, Medical Device Equipment, General Requirements for Safety, SunStim™ or SunStim Plus™ Peripheral Nerve Stimulators are classified as follows: Type BF Equipment

• Extension Leadwires • Bipolar Probes 4. EQUIPMENT DISPOSAL Dispose of SunStim™ or SunStim Plus™ Peripheral Nerve Stimulator should be done in accordance with local regulations. 5. WARNING / CAUTION STATEMENTS CAUTION: Federal Law (USA) restricts this device to sale by or on order of a physician or appropriate licensed practitioner.

Type B of equipment provides a particular degree of protection against electrical shock, predominantly regarding allowable leakage current and reliability of the protective earth connection (grounding).

DO NOT: Use SunStim™ or SunStim Plus™ Peripheral Nerve Stimulator for nerve localization for anesthetic regional block.

Type F part applies to extends from the patient into the equipment and is isolated from all other parts of the equipment.

DO NOT: Use SunStim™ or SunStim Plus™ Peripheral Nerve Stimulator on patients with neuromuscular or skin diseases.

Water Ingress Protection = IPX The SunStim™ or SunStim Plus™ Peripheral Nerve Stimulator do not have protection against ingress of water. Continuous Operation The SunStim™ or SunStim Plus™ Peripheral Nerve Stimulator is designed for Continuous Operation. Load Resistance = 510Ω

DO NOT: Use SunStim™ or SunStim Plus™ Peripheral Nerve Stimulator in the proximity of equipment which produces electromagnetic fields, short or micro waves. DO NOT: Use SunStim™ or SunStim Plus™ Peripheral Nerve Stimulator in the presence of a flammable anesthetic mixture with air or in the presence of a flammable anesthetic mixture with oxygen or nitrous oxide. DO NOT: Modify any components of this equipment. DO NOT: Use SunStim™ or SunStim Plus™ Peripheral Nerve Stimulator in case of battery leakage.

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9.4 Electrical stimulus can be performed at the:

9.4.6 Facial Nerve - Leads/bipolar probes are placed:

9.4.1. Ulnar Nerve - Leads/bipolar probes may be placed: 9.4.1.1 Along the medial aspect of the distal forearm (wrist);

9.4.6.1 Negative electrode is placed anterior to the inferior part of the ear lobe, and the positive electrode is placed posterior or inferior to the lobe.

9.4.1.2 Over the sulcus of the medial epicondyle of the humerus (elbow);

9.4.7 Spinal Accessory nerve - Leads/ bipolar probes are placed:

9.4.1.3 On hand, by placing the negative electrode on the palm between the base of the thumb, and the second finger, and the positive electrode in the same position on the dorsal side of the hand. 9.4.2 Median Nerve probes may be placed:

Leads/bipolar

9.4.2.1 Medial to the wrist; 9.4.2.2 At the elbow adjacent to the brachial artery. 9.4.3 Tibial Nerve - Leads/bipolar probes may be placed: 9.4.3.1 Along the lateral side of the popliteal fossa. 9.4.4 Posterior Tibal Nerve - Leads/ bipolar probes are placed: 9.4.4.1 At the medial maleolus and anterior to the Achilles tendon at the ankle. 9.4.5 Peroneal Nerve - Leads/bipolar probes are placed: 9.4.5.1 On the lateral aspect of the knee.

9.4.7.1 Over the between the ramus.

depression

10. MAINTENANCE 10.1 Prior to use, make sure to read and understand provided Instructions for Use. Check condition of the SunStim™ or SunStim Plus™ Peripheral Nerve Stimulator and provided connectors for proper functioning, prior to each use. 10.2 The SunStim™ or SunStim Plus™ Peripheral Nerve Stimulator and all accessories must be visually inspected at regular intervals for any material degradation or battery leakage. 10.3 This device does not require user maintenance/service, except the periodic battery replacement. 10.3.1 Battery Maintenance/Replacement a. This device may be used with Alkaline 9V battery only. b. Battery replacement is needed when the Battery LED flashes during the use. c. Prior to battery replacement, make sure that the device is turned OFF, by rotating the control knob to the “OFF” position.

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8. OPERATION INSTRUCTIONS 8.1 Switching the unit on and off A. The SunStim™ or SunStim Plus™ Peripheral Nerve Stimulator can easily be switched on and off by rotating the rheostat (control knob) clockwise. The rheostat (control knob) is located on the left hand side of the Nerve Stimualtor. Once ON, the device will be in the StandBy mode, and no pulses will be produced. B. The numbered rheostat (control knob) (numbered from 0-10) intended use it to adjust the stimulation amplitude of the output current, which may range from 0 to 70 mA. If the rheostat (control knob) is set to zero, stimulation amplitude will not be delivered. 8.2 Four Panel Touch Switches A. Stimulation frequency patterns may be activated by pressing one of four panel touch switches (SunStim™ – STANDBY, TWITCH, 100 Hz, TOF; SunStim Plus™ – DBS, TWITCH, TETANUS, or TOF). B. Pulse LED will flesh each time a pulse is generated. 8.3 Output Connectors A. Transcutaneosly stimulation can be carried out by using surface electrodes.

E. Provided lead wires with BLACK plug should be connected to the black output connector. This connection will create the negative output.

a) The SunStim™ or SunStim Plus™ Peripheral Nerve Stimulator may be hazardous to patients with implanted electrical, medical devices.

g) The leadwire or bipolar probe electrodes would be attached to the instrument while the numbered control knob is in the OFF position.

F. Provided lead wires with RED plug, should be connected to the red output connector. This connection will create the positive output.

b) It is important to monitor the correlation of nerve reaction stimulation with the patient’s clinical condition, as there may be a discrepancy between the degree of relaxation and of the monitored muscle at the site of surgery.

h) SunStim™ or SunStim Plus™ Peripheral Nerve Stimulator must be used with 9V alkaline battery only.

c) Tetanus nerve stimulation should be performed only after the anesthetic has been administered.

j) Battery should be removed if the Nerve Stimulator is not likely to be used for some time.

d) Stimulus current must be increased gradually, until supramaximal stimulus is achieved. Applying currents greater than necessary for supramaximal stimulation may increase the risk of skin burns.

k) In case of battery leakage, the device should not be used.

G. Bipolar Probe Electrodes can be connected to output connectors, by plugging them directly into the two, RED (positive) and BLACK (negative), located on the top of the SunStim™ or SunStim Plus™ Peripheral Nerve Stimulator case, output connectors. H. It is recommended to create a lead wires loop after they have been attached to electrodes, and a piece of tape placed over them in order to prevent possible electrodes displacement. I. Nerve Stimulator should be connected to electrodes that are positioned over the selected nerve, prior to anesthesia induction. 9. PERIPHERAL NERVE MONITORING SITES 9.1 The site of stimulations should be away from the surgical field and its location accessible to the anesthesia provider.

B. SunStim™ or SunStim Plus™ Peripheral Nerve Stimulator is supplied with metal ball electrodes and lead wires.

9.2 Location of the instrument should approximately five (5) feet above the floor to provide easy viewing of the touch switches and indicators.

C. Two (2) connectors, RED (positive) and BLACK (negative), are located on the top of the SunStim™ or SunStim Plus™ Peripheral Nerve Stimulator case.

9.3 If visual or tactile nerve monitoring is to be used, the site location must be accessible to the anesthesia provider.

e) Prior to SunStim™ or SunStim Plus™ Peripheral Nerve Stimulator usage, patient’s skin should be cleaned and completely dried. This area should be free of excessive hair, scar tissue, or any other lesions. f) This device should not fall into liquids. Liquids should not be spilled over or into the device.

i) The operator of this device cannot touch the actual battery and the patient simultaneously.

l) Prior to each use, check the SunStim™ or SunStim Plus™ Peripheral Nerve Stimulator for proper condition and functioning. m) The SunStim™ or SunStim Plus™ Peripheral Nerve Stimulator should be stored/transport at the room ambient temperature, away from heat. No special ambient temperature range is specified for this device. n) Caution should be used when switching between DBS (Double Burst) and Train-of-Four stimulation. Up to 92 seconds may be required before the responses are stabilized.

D. The output current may reach up to 70 mA, measured with load of 2KOhm load, using a new 9V DC battery.

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7. PANEL TOUCH SWITCHES

6. TECHNICAL DATA Model

SunStim™

SunStim Plus™

Type of Device

BF

BF

Membrane Touch Switch

StandBy Twitch 100 Hz Train-of-Four (TOF)

Double Burst Twitch Tetanus Train-of-Four (TOF)

Pulse Charateristics Pulse Width: Pulse Type:

200 Microseconds Square Wave Monophasic

Tetanus

SunStim™ Pulse

Battery

STANDBY

TWITCH

200 Microseconds Square Wave Monophasic

100 HZ

TOF

100 Hz

50 Hz or 100 Hz

SunStim™

Double Burst Pulses (DOB)

N/A

Two (2) 60 ms bursts of 50 Hz separated by 0.75 seconds

Output Current

Adjustable 0-70mA

Adjustable 0-70mA

Display Pulse LED: Battery LED:

Flash red when pulse is generated Steady green, when the unit is turned ON

Flash red when pulse is generated Steady green, when the unit is turned ON

Battery Power

One 9V alkaline battery. Battery LED flashes when battery voltage is low

One 9V alkaline battery. Battery LED flashes when battery voltage is low

Power Supply

Internally powered ME equipment

Internally powered ME equipment

Power Consumption

Approximately 15.0 mA

Approximately 13.0 mA

Protection Grade

IPX0

IPX0

Operation Mode

Continuous Operation

Continuous Operation

Size

3.75”H x 2.25”W x 1”D

3.75”H x 2.25”W x 1”D

Weight (Including Battery)

0.25 lb

0.25 lb

Rheostat (control knob)

Controls the current

Controls the current

STANDBY: No stimulus pulses are generated. Pulse Battery TWITCH: Produce twitch stimulation, which is automatically repeated (one pulse per second), until the button is released. This button can be turned off, by pressing the STANDBY button. DBS TWITCH 100 Hz: Produce tetanic stimulation when pressed and held down. Tetanic stimulation consists of 100 Hz electrical stimuli. TETANUS TOF Train-of-Four (TOF): Generate four (4) equal intensity single pulses in a period of SunStim Plus™ two (2) seconds. This function can be repeated as often as needed.

Peripheral Nerve Stimulator

Peripheral Nerve Stimulator

SunMed

SunMed

SunStim Plus™ Pulse

Battery

STANDBY

TWITCH

100 HZ

Pulse

Battery

DBS

TWITCH

TETANUS

TOF

TOF

SunStim™

SunStim Plus™

Peripheral Nerve Stimulator

Peripheral Nerve Stimulator

SunMed

SunMed

DBS (Double Burst Pulses): This stimulation produces two short sequences of 50 Hz tetanic stimuli separated by 750 msec. This stimulation should not be repeated at intervals of less than twelve (12) seconds. TWITCH: Produce twitch stimulation, which is automatically repeated (one pulse per second), until the button is released. This button can be turned off by pressing the DBS or TOF button. TETANUS: Produce rapidly repeated stimulation when pressed and held down. Provided electrical stimuli is set for 100Hz. This default can be changed to 50 Hz, by opening the battery cover and removing the battery. 50 Hz/ 100 Hz slide switch is located within the battery compartment. You may move the slide to the desired frequency (50 Hz or 100 Hz). Once this step is completed, reconnect the battery and close the battery cover, prior to start using the SunStim Plus™ unit again. The tetanus stimulation should not be repeated more often than every two (2) minutes, as its affect may fade. Train-of-Four (TOF): Generate four (4) equal intensity single pulses in a period of two (2) seconds. This function can be repeated as often as needed.

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