Operator's Manual Tracer III Nerve Locator, Model NL-3

IMPORTANT! - IN THIS MANUAL WARNING STATEMENTS: Indicate information or procedures that, if not followed correctly, could cause injury to personnel, and serious injury or death to the patient. CAUTIONS: Indicate information or procedures that, if not followed correctly, could cause improper results or damage to the equipment. Manufactured by: 4235 Greenbriar Dr. Stafford, TX 77477-3995 800-231-9841 281-491-6600 http://www.life-tech.com Administrative / Financial Fax: 281-491-6646 Sales / Customer Service Fax: 281-491-7197 Technical and Clinical Support Fax: 281-491-6852 Made in USA Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

Table of Contents SECTION DESCRIPTION PAGE 1. PRECAUTIONS...1 2. GENERAL DESCRIPTION AND SPECIFICATIONS...2 3. TRACER III DISPLAY, CONTROLS AND INPUTS...3 4. ASSEMBLY...7 5. OPERATING PROCEDURES...8 6. MAINTENANCE Battery Replacement... 12 Cleaning and Disinfection... 13 Required Service... 13 7. LIMITED WARRANTY... 14 Table of Figures SECTION DESCRIPTION PAGE 3.1 DISPLAY, CONTROLS AND INPUTS...3 3.2 TRACER III LCD...4 4.1 PROTECTIVE BOOT (PB)...7 4.2 PROTECTIVE BOOT WITH MOUNTING BRACKET (MB-5)...7 5.1 CONNECTIONS...8 6.1 BATTERY REPLACEMENT... 12

SECTION 1 PRECAUTIONS Warnings: 1. Explosive Atmospheres: Use of the Tracer III in a flammable or explosive atmosphere may result in death or serious injury from accidental explosion or fire. 2. Microshock Hazard: In patients with pacemakers or cardiac abnormalities, the physician in charge must approve the use of the Tracer III as electrical impulses could interfere with the pacemaker or result in cardiac arrhythmia. Caution: 1. Neuromuscular Disease: Patients with symptoms of myasthenia gravis, Bell's palsy, muscle weakness, or paralysis may not respond normally to nerve stimulation. 2. Servicing: The user should not attempt to service the unit beyond that described in the Operator's Manual. All other servicing should be referred to qualified service personnel. 3. Disconnection of Foot Control: Take care to insure that the foot control is NOT disconnected from the unit when it is ON and connected to the patient. Should this occur, the stimulus output will default to the Stimulus Control Knob setting. Environment/Placement: 1. Foreign Material: Tracer III is designed to be drip resistant, in its normal orientation. Protect this instrument from immersion, spills, the impact of falling objects, and exposure to excessive smoke, dust, mechanical vibration, or shock. 2. Electromagnetic Fields: Do not use the Tracer III in close proximity to equipment that produces strong electromagnetic fields (i.e., MRI, radio frequency cautery equipment, microwave equipment and cellular or cordless phones). 3. Stacking: Do not place any heavy objects on top of the instrument. 4. Heat: Situate the unit away from heat sources such as radiators and warming lamps as exposure to high temperatures may affect operation or cause damage.see Section 2, Specifications for temperature recommendations. 5. Battery Leakage: If the unit is going to be stored for a prolonged period of time, we recommend that you remove the battery to protect the unit from damage caused by battery chemical leakage. 6. Sterilization: Do not sterilize the Tracer III or foot control. 1

SECTION 2 GENERAL DESCRIPTION AND SPECIFICATIONS 1. Introduction The Model NL-3 Tracer III is a battery powered nerve locator for regional nerve block procedures. It is classified as a class II medical device by the FDA and according to Council Directive 93/42/EEC. The unit generates constant-current 50, 100, 300, 500 or 1000 microsecond pulses at a rate of 1Hz or 2Hz. Pulse delivery is indicated by the LCD Output Stimulus Pulse Indicator and the audible chirp. The Stimulus Amplitude Control dial provides variable current control (0.05 to 5 milliamps). If your unit fails to meet the following specifications, please contact Life-Tech or your local distributor for service. 2. Specifications Regulatory Standards: Ingress Protection: UL2601-1 CSA22.2No.601.1 CE Marked to MDD EC93/42 EN60601-1 EN60601-1-2 EN61000-4-2 EN61000-4-3 EN61000-4-8 EN55011B, Group 1 IP-21 (Tracer III) IP-07 (Solostim foot control) Size (WxLxH): Pocket size, 3.25" (8.3cm) wide x 6.0" (15.3cm) long x 2.25" (5.7cm) high (including knob) Weight: 9.6 oz (275gm) w/ 9V battery Battery: One 9V Alkaline Battery Output Current: 0.05-5.0mA with + 1% accuracy from 0.20-5.0 ma (into load of 12k Ohms or less) Pulse Width: 50, 100, 300, 500, 1000 microseconds ± 1% Pulse Risetime: Less than 5 microseconds Pulse Frequency: Programmable 1Hz/2Hz ± 1% Storage Environment: -40 o to 70 o Celsius (-40 o to 158 o F) Operating Environment: 10 o to 40 o Celsius (50 o to 104 o F) 3. Meaning of Symbols: These symbols may appear on the unit. Danger- Do Not Use in the presence of flammable anesthetics Type BF Equipment Attention! Please Read Operator's Manual 2 Not User Serviceable Refers to operations with foot control

SECTION 3 TRACER III DISPLAY, CONTROLS AND INPUTS Figure 3.1: Display, Controls and Inputs 3

1 Display: The LCD (Figure 3.2) displays all of the settings programmed into the unit, as well as the status of various functions. Figure 3.2: Tracer III LCD a b Stimulus Range Setting: This field of the LCD displays the maximum stimulus current setting you can achieve by turning the Stimulus Control knob or pressing the foot control. The default range is 0.05mA to 5.0mA and can only be changed to 1.5mA when the unit is used with the optional foot control. Battery Life Indicator:................ Battery Life Remaining 80-100%............................... 60-80%..........................40-60%....................20-40%.............. 0-20% 4

The LED segments of the Battery Life Indicator are solidly illuminated to the level of current battery life during use until the battery life drops below 20% (less than 8 hours of operation remaining) at which time, the lowest segment (as well as the battery outline itself) will flash at a rate of 1Hz. When the battery life is reduced to a voltage that is indicative of less than four hours of operation remaining, the lowest segment (as well as the battery outline itself) will flash at a 2Hz rate. Caution: Operation will cease when battery voltage is insufficient for the unit to function within specifications. c d e f g Stimulus Repetition Rate: This field of the LCD displays the rate (in Hz) at which the stimulus pulses are delivered. The default setting of 2Hz can be changed to 1Hz by pressing the Stimulus Repetition Rate button (6). Pulse Width: This field of the LCD displays the width (duration) of the stimulus pulses. The pulse width selections are: 0.05, 0.1, 0.3, 0.5 or 1.0 millisecond (msec). The default (0.1 msec) or present setting can be changed by pressing the Pulse Width button (Figure 3.1, button 5). Stimulus Setting/Output Display: This field of the LCD displays the stimulus setting/output level of the unit in milliamps (ma). The stimulus output is set either using the Stimulus Control knob (Figure 3.1, number 2) or the optional foot control. Whenever the unit detects an open/disconnected lead condition or is unable to deliver the displayed current setting, it will flash the output level display, and emit an audible 6 chirp alarm. The output level display is static when the unit is paused and when stimulus pulses are being delivered. The audible chirp heard with each stimulus pulse (1 or 2Hz Rate), will change in duration according to the delivered Stimulus Output: Long Chirp - For Current Levels between 1.0mA and 5.0mA. Medium Chirp - For Current Levels between 0.50mA and 0.99mA. Short Chirp - For Current Levels between 0.25mA and 0.49mA. Micro Chirp - For Current Levels below 0.25mA. Pulse Indicator: Flashes whenever a stimulus pulse is delivered. An audible chirp accompanies each flash of the pulse indicator. The stimulus pulse indicator will not flash in either an open lead condition or in pause. Pause Indicator: Vertical bars illuminate when in the Pause mode. The audible chirp ceases when the unit is paused. 5

2 Stimulus Control Knob: Rotation of this knob changes the stimulus setting (if paused or open lead) or the stimulus output current (if connected and not paused). NOTE: In this manual, this symbol (at right) designates operations that only apply when using the Stimulus Control Knob in the absence of the foot control. 3 Chirp Volume-Increase button: Press this button to increase the volume of the chirp that accompanies each stimulus output pulse in increments. Press and hold the button for 4 seconds to reach maximum volume. 4 Chirp Volume-Decrease button: Press this button to decrease the volume of the chirp that accompanies each stimulus output pulse in increments. Press and hold the button for 4 seconds to reach minimum volume. NOTE: There are five levels of chirp volume, the default and four (4) levels up from the default. 5 Pulse Width button: Each time you press the button the pulse width increases to the next higher setting until it cycles back to the lowest setting. 6 Stimulus Repetition Rate button: Press this button to toggle between 2Hz and 1Hz. 7 Pause button: Press this button to pause the stimulus output pulse. 8 On/Off button: Press this button to turn the unit ON and OFF. NOTE: The unit will auto-power off after it has been in an open lead condition or paused for 20 minutes. 9 Foot Control Input Connector: 5-pin connector to attach the optional foot control input cable. NOTE: In this manual, this symbol designates operations that only apply when using the foot control. 10 Patient Lead Output Connector: 4-pin connector to attach the patient lead wire set (RBW-5L). NOTE: The regional lead wire set is connected to the patient lead output connector. 6

SECTION 4 ASSEMBLY 1. To apply the optional Protective Boot, roll the sides of the boot open and slide the unit in, as shown below. Fold the stand out for table-top placement of the unit. Figure 4.1: Protective Boot (PB) 2. To use the optional Mounting Bracket and Protective Boot: a. Remove the stand from the back of the Protective Boot. b. Assemble the two components as shown below. c. Attach to an IV pole. Figure 4.2: Protective Boot with Mounting Bracket (MB-5) 7

SECTION 5 OPERATING PROCEDURES Figure 5.1-Connections 8

1. If the Tracer III is on, press to turn it off. 2. Set the Stimulus Control knob to the minimal current setting (full counter-clockwise). 3. Attach patient/accessory cables. Plug the (reusable) RBW-5L Lead Wire Set into the 4-pin output connector on the side of the unit. CAUTION! Take care that you do NOT attempt to force the 4-pin RBW-5L into the 5-pin foot control input, marked. This will cause the unit to malfunction and could damage the connector on the lead set. And, if using the Plug the foot control cable into the jack marked. WARNING: Take care to insure that the foot control is NOT disconnected from the unit when it is ON and connected to the patient. Should this occur, the stimulus output will revert to the Stimulus Control Knob setting. 4. Position the nerve stimulator such that the display is clearly seen during the procedure. And, if using the Position the foot control on the floor with the cable routed away from the sterile field. Set the foot control starting position as heel down, or depressed, for a minimum current setting when the unit is turned on. 5. Connect the Surface Electrode (Figure 5.1): a. Attach the red lead wire snap to the surface electrode. b. Peel the protective paper off the surface electrode and confirm that the conductive gel on the eletrode has not dried. c. Apply electrode to clean, degreased and shaved skin that is not in the distribution area of the nerve to be blocked. 6. Press the On/Off (I/O) button to turn the unit on. An open lead condition (i.e., the needle, ground electrode, or both, are not yet connected to the patient) will be indicated by the flashing Stimulus Setting/Output display and the audible 6-chirp alarm. 9

And, if using the Verify the range shown on the LCD is the desired range. The foot control operates in two range settings, for better stimulus resolution (control). The ranges are: 0.05mA to 1.5mA (1.5mA on the LCD) - Or - 0.05mA to 5.0mA (5.0mA on the LCD) To switch between the ranges: a. DEPRESS the foot control back until you feel the first stop, and hold in that position until the Stimulus Setting/Output display reads 0.05mA. b. Firmly DEPRESS the foot control further down to the final stop. This action causes a toggle switch within the foot control to change between the two operating ranges. The new setting will now be seen in the Stimulus Range display of the LCD. 7. Set the initial desired stimulus output. If using the Rotate the Stimulus Control knob clockwise to increase current or counter-clockwise to decrease current. Or, if using the Observe the LCD while you: a. PRESS the foot control forward with the toes to increase stimulus output. b. DEPRESS back with the heel to decrease the output. 10

8. Connect the regional block needle (Fig. 5.1) and proceed in accordance with preferred regional block anesthesia techniques. ProBloc and ProLong regional block needles connect directly into the black touch-proof connector on the regional block lead wire set (RBW-5L). 9. Perform procedure following instructions for the regional block needle. 10. When the procedure has been completed, ensure that the unit has been turned off and remove the surface electrode. Disconnect the reusable regional block lead wire set from the stimulating wire of the needle. NOTE: For ease of removal, use a slight twist to disconnect the stimulating lead on the needle from the lead wire set. 11. Dispose of the needle in an approved sharps container following the Center for Disease Control & Prevention and OSHA guidelines, or local equivalent. 12. Clean and disinfect the unit as required by your facility's infection control protocols, using the procedure outlined on page 13 of this manual. 11

SECTION 6 MAINTENANCE 1. General Other than replacing the battery periodically and keeping the unit free of debris and contaminants, Tracer III requires no user maintenance, and is not user serviceable. 2. Battery Replacement Replace the 9V alkaline battery whenever the LCD battery life indicator begins to flash, or every year, whichever comes sooner. NOTE: To maintain the Warranty for your Tracer III, replace batteries with alkaline type only. To replace the battery: a. Remove the battery compartment cover from the back of the unit. b. Remove the old battery by pulling up on it from the bottom end. c, d. Using the graphic in the battery compartment as a guide for orienting the (+) and (-) contacts, insert the new battery, bottom (flat end) first. Then, press down on the top of the battery until the contacts are secured in the clips. e. Replace the compartment cover. Figure 6.1: Battery Replacement 12

3. Cleaning & Disinfection To clean the Tracer III and/or foot control, and/or regional block lead wire set: a. Mix approximately a 1% solution of mild dishwashing detergent and water (1cc of detergent mixed with 100cc of water). b. Turn the unit off. c. Dampen a clean, soft cloth with the detergent solution and wipe to remove visible contaminants from the outside of the unit. NEVER pour or spray cleaning solution directly onto the unit or submerge it in a solution. d. Dampen a clean, soft cloth with sterile or distilled water and wipe to remove all residual detergent solution. e. Dry thoroughly with a clean, dry cloth. To disinfect the Tracer III and/or foot control: a. Turn the Tracer III unit off. b. Dampen a clean, soft cloth with either 90% isopropyl alcohol, or any commercially available solution intended for surface disinfection of medical electrical equipment, and wipe the exterior surface thoroughly. If solution is in spray form, spray it onto the cloth. NEVER pour or spray disinfecting solution directly onto the unit, or submerge it in the solution. c. Allow the solution to air dry for at least one minute, then dry thoroughly with a clean, dry cloth. 4. Required Service: The unit should be serviced by qualified service personnel when: Liquid has ingressed into the instrument. It does not appear to operate normally. It exhibits a marked change in performance. The enclosure is damaged. 13

SECTION 7 LIMITED WARRANTY Refer to LIMITED WARRANTY card for complete information. 14