AccuGuide Muscle Injection Monitor User Guide

0123

Medtronic Xomed INC. 6743 Southpoint Drive North Jacksonville, FL 32216 USA www.medtronicENT.com

EC REP Medtronic B.V. Earl Bakkenstraat 10 6422 PJ Heerlen The Netherlands Tel.: 011-31-45-566-8000 Fax: 011-31-45-566-8668 ™ are trademarks and ® are registered marks of Medtronic Xomed, Inc. Windows® is a registered mark of MicroSoft Corp. © 2006 Medtronic

The information contained in this document was accurate at time of publication. Medtronic reserves the right to make changes in the product described in this manual without notice and without incorporating those changes in any products already sold.

TABLE OF CONTENTS Page Symbols ...1 When the System Arrives ...2 Warnings and Precautions ...2 Customer Service...3 Device Description ...3 System Description ...3 Indications ...3 Contraindications ...3 Monitor Description ...4 Front Panel ...4 Top Panel ...4 Side Panel ...4 Patient Interface Cable ...4 Back Panel (Battery Compartment) ...5 Battery Checking Function...5 Directions For Use...6 Selecting The Language Displayed ...6 Installation of Windows Application Model 82-63001 Only) ...6 Directions for Windows Application (Model 82-63001 Only) ...6 Cleaning ...7 Troubleshooting...7 Limited Warranty ...8 Technical Specifications ...9 Monitor ...9 Patient Interface Cable ...9 Insulated Injector Needle Electrodes ...9 Recommended Environmental Conditions ...9 Parts List ...9 Guidance and manufacturer’s declaration – electromagnetic immunity ...10 NOTICE It is important that you read this entire manual before you use the Accuguide® System. It is unsafe to use this device before you have read and are thoroughly familiar with this document.

SYMBOLS ATTENTION, SEE INSTRUCTIONS FOR USE

TYPE BF APPLIED PART (IEC/ EN60601-1)

REF

CATALOG NUMBER

SN

SERIAL NUMBER

POWER (ON/OFF)

DATE OF MANUFACTURE

USE BY DATE

DO NOT REUSE

SENSITIVITY

VOLUME UP

BATTERY CHECK

VOLUME DOWN

MUTE

LOT

LOT NUMBER

1

RF TRANSMITTER (INTERFERENCE MAY OCCUR)

AUTHORIZED REPRESENTATIVE IN THE EUROPEAN COMMUNITY

CAUTION: FEDERAL LAW IN THE U.S.A. RESTRICTS THE SALE, DISTRISTERILE EO BUTION OR USE OF THIS DEVICE TO, BY OR ON THE ORDER OF A LICENSED MEDICAL PRACTITIONER.

STERILIZED BY ETHYLENE OXIDE. DO NOT USE IF PACKAGE IS OPENED OR DAMAGED.

DO NOT DISPOSE OF THIS PRODUCT IN THE UNSORTED MUNICIPAL WASTE STREAM. DISPOSE OF THIS PRODUCT ACCORDING TO LOCAL REGULATIONS. SEE HTTP:// RECYCLING.MEDTRONIC.COM FOR INSTRUCTIONS ON PROPER DISPOSAL OF THIS PRODUCT.

THIS DEVICE COMPLIES WITH MEDICAL DEVICE DIRECTIVE 93/42/EEC

0123

Rx Only

EC REP

WHEN THE SYSTEM ARRIVES UNPACKING AND INSPECTION As the box is unpacked, check off the contents of the box against the items listed on the packing slip. If the contents are incomplete or if there is damage, notify Customer Service. If the shipping container is damaged, or the cushioning material shows signs of stress, notify the carrier as well. Keep the shipping materials for carrier inspection. After unpacking your new AccuGuide® System, save the cartons and packing material. If the instrument is to be shipped from one location to another, the carefully designed shipping package will provide proper protection. WARNINGS AND PRECAUTIONS It is important that the AccuGuide® operator be familiar with this manual; its precautions, procedures and safety issues. Four labels are used in this manual to identify important concerns, conditions, or procedures: Warning: Describes serious adverse reactions and potential safety hazards that can occur during the proper or improper use of a device. Precautions Any special care to be exercised by a practitioner or patient for the safe and effective use of the device. Important: Identifies conditions or practices which require attention for most desirable results. NOTE: Identifies special information or to clarify / emphasize important instructions. WARNINGS • The use of paralyzing anesthetic agents will significantly reduce, if not completely eliminate, EMG responses. • Auditory and visual monitoring are disabled while muting is in effect. • The AccuGuide® does not control the delivery of medication. Monitoring is only a technical aid for muscle specific injections; it does not replace the surgical skills, experience, and anatomical knowledge necessary to locate muscles and inject them with the proper dosage of medication. • The quantitative accuracy of the LCD bargraph and the WINDOWS graphical display is limited. See “Technical Specifications”. • The AccuGuide® is not suitable for use in the presence of a flammable anaesthetic mixture with air, or with oxygen, or with nitrous oxide. PRECAUTIONS • The AccuGuide® should only be operated intermittently when operating at or near maximum volume. If operating at or near maximum volume, mute after a maximum of 5 minutes of use for a minimum of 1 minute. Failure to operate the device in this manner could cause the battery to overheat. • Do not immerse or sterilize the AccuGuide® monitor or patient interface cable. • Do not immerse the patient interface cable in any solution, except as detailed in the “Cleaning” section of this manual. • Always inspect the AccuGuide® monitor and patient interface cable before and after use for any damage. If damage is observed, do not use until it is repaired. • Do not use any parts other than Medtronic Xomed components as damage or substandard operation could result. • Attempted repair or evidence of attempted repair during the warranty period by anyone other than qualified Medtronic Xomed service personnel will void the equipment warranty. • This medical device complies with IEC/EN 60601-1-2 safety standard for electromagnetic compatibility, requirements and test. However, if this equipment is operated in the presence of high levels of EMI or highly sensitive equipment, interference may be encountered and the user should take whatever steps are necessary to eliminate or reduce the interference.

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CUSTOMER SERVICE INFORMATION U.S. CUSTOMER SERVICE General customer service and technical support are available toll-free: 800-874-5797 or 904-296-9600 Monday - Friday: 8:00 AM – 6:00 PM E.S.T. www.medtronicENT.com MICROELECTRONICS REPAIR Technical Support: 800-872-9877 904-296-6448 (FAX) Monday - Friday 8:00 AM – 5:00 PM E.S.T. www.medtronicENT.com Return Address: Medtronic Xomed, Inc. 6743 Southpoint Drive North Jacksonville, FL 32216-0980 USA Attn.: Service Department CUSTOMER SERVICE INFORMATION For further information regarding the use of this product or to report any problems, please contact Medtronic using the appropriate information provided on the blue and white contact information card packaged with each device; or contact your local distributor. HELPLINE. Should you need immediate help with a technical question or guidance through the appropriate protocol, just call the Medtronic Help Line at 1-800-874-5797. Note: When contacting our Customer Service and Technical Support, please have the appropriate product number, product serial number, date of purchase, and nature of inquiry available. Product Number: Serial Number: Date of Purchase:

___________________________ ___________________________ ___________________________

DEVICE DESCRIPTION SYSTEM DESCRIPTION The AccuGuide® Muscle Injection Monitor is a lightweight handheld EMG monitor designed for use in an ambient office type environment. The AccuGuide® is intended for EMG needle guidance to deliver muscle specific injections. The device aids in the identification of a precise muscle prior to injection by providing auditory and visual EMG information. An insulated injection needle is the active EMG electrode, while surface electrodes are used as references. For a complete list of system components and accessories contact your local Medtronic Xomed representative or call Customer Service at 800-874-5797 or 904-296-9600. INDICATIONS The AccuGuide® is indicated for guiding injections into the muscles identified, including botulinum toxin injections of eye muscles. CONTRAINDICATIONS None known.

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MONITOR DESCRIPTION FRONT PANEL 1 POWER touchpad turns the unit ON or OFF. 2

MUTE touchpad turns the speaker OFF and ON. The default condition is speaker ON.

3

BATTERY CHECK touchpad displays the battery voltage level on the LCD display.

4

LCD DISPLAY indicates peak EMG values, volume level, battery voltage level, software version, and bargraph display sensitivity setting. SENSITIVITY touchpad adjusts the scaling of the LCD bargraph display, green indicator light activation level, and the scaling of the Windows Graphical display. It does not affect the volume or audible amplification of the EMG data. The following ranges can be selected:

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• High Sensitivity: • Medium Sensitivity: • Low Sensitivity:

14 mV peak/segment; 200 mV peak full scale 45 mV peak/segment; 650 mV peak full scale 130 mV peak/segment; 2000 mV peak full scale

6

VOLUME UP touchpad turns the speaker volume up.

7

VOLUME DOWN touchpad turns the speaker volume down.

8

SPEAKER allows the user to hear the EMG.

4

1

5

2

6

3

7

8

TOP PANEL The 5-pin receptacle connects to the Patient Interface Cable which attaches to the patient electrodes. The Green Indicator Light indicates presence of EMG activity above the following levels: > 150 µV peak • High Sensitivity: > 500 µV peak • Medium Sensitivity: > 1500 µV peak • Low Sensitivity: SIDE PANEL An opto-isolated, PC compatible, serial port interface connector is provided on Model 8263001 only. This DB9 / RS-232 connection allows the user to link the device to a personal computer running software included with Model 8263001 that will display the EMG signal in a graphical format. PATIENT INTERFACE CABLE The Patient Interface Cable transmits the EMG signal from the needle electrode to the AccuGuide® Monitor. One end plugs into the 5 pin receptacle of the AccuGuide®. The other end has color-coded connectors that attach to the Adhesive Surface Electrodes on the patient and plugs into the insulated injector needle electrode. Green Ground (clips to a surface electrode) Red Positive (+) (clips to a surface electrode) Black Negative (-) (connects to the female connector of the insulated injector needle electrode)

4

Insulated Injector Needle Electrodes Patient Interface Cable

5 Pin Receptacle Adhesive Surface Electrodes Green Indicator Light

Serial Port

BACK PANEL (BATTERY COMPARTMENT) The Battery Port slides open to provide access to a standard, replaceable 9V battery. The AccuGuide® will operate continuously for 8-12 hours on a lithium 9V battery or 4-6 hours on an alkaline 9V battery. NOTE: Remove the battery when the device will not be in use for more than a few days. BATTERY CHECKING FUNCTION The AccuGuide® periodically checks the battery level. The user can also check the battery level at any time by pressing “BATTERY CHECK”. If an unacceptably low battery level condition is detected, the display will indicate “LOW BATTERY” and the device will not function until the battery is replaced. PRECAUTION The AccuGuide® should only be operated intermittently when operating at or near maximum volume. If operating at or near maximum volume, mute after a maximum of 5 minutes of use for a minimum of 1 minute. Failure to operate the device in this manner could cause the battery to overheat.

Battery Port

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DIRECTIONS FOR USE • Press the POWER touchpad to turn the AccuGuide® ON. • When the device is turned on, the display will briefly indicate the version of software currently installed on the device and the battery voltage level. Next, the device will display peak EMG values in the “HIGH” sensitivity setting. At this point, you may need to adjust the SENSITIVITY and/or VOLUME. • Whenever the Injection Needle Electrode is not in the injection site, it is recommended to mute the AccuGuide® Monitor. Otherwise, excessively loud feedback noise will be experienced. • Prior to setup for the procedure, recheck the battery voltage level by pressing “BATTERY CHECK”. If the battery voltage is not adequate for the procedure, replace the battery before proceeding. • After cleaning the skin with an alcohol wipe, firmly apply two Surface Electrode Adhesives near the injection site. • Clip the green and red connectors of the Patient Cable to the surface electrodes. • Plug the cable into the 5-pin receptacle of the AccuGuide®. • Plug an injection needle electrode into the black connector of the Patient Cable. • Carefully insert the injection needle electrode into the targeted muscle. • Instruct the patient to perform a function that affects the targeted muscle. • Observe variations in the EMG activity. • Once the position of the injection needle electrode is confirmed, deliver the injection through the injection needle electrode. • After the procedure, press the mute touchpad to avoid feedback once the electrode is removed. Remove the electrodes and dispose per standard health care facility policy/procedure. • Remove the battery when the device will not be in use for more than a few days. SELECTING THE LANGUAGE DISPLAYED The AccuGuide® monitor can be configured to display English, French, Italian, German, or Spanish text on the front panel LCD display. The language selection is controlled by 4 switches on the circuit board inside the monitor. To change the language selection, remove the 4 screws on the rear of the monitor, open the monitor and set the switches marked “S1” on the circuit board as desired. See figures below.

2

2

2

3

3

3

4

4

4

French

Italian

ON

1

ON

1 2

2

3

3

4

4

German

ON

1

ON

1

ON

1 Engligh

Spanish

INSTALLATION OF WINDOWS® APPLICATION (MODEL 8263001 ONLY):

Windows® 2000/XP: 1. Place the CD into CD drive. 2. If Installation does not automatically run: Click the Start button and select Run • Click Browse and select <CD drive>:Win200XPsetup.exe. • Windows® 95/98: 1. Place the CD into CD drive. 2. Click the Start button and select Run. 3. Click Browse and select <CD drive>:Win95-98 AccuGuide® V1.0.3a.exe. DIRECTIONS FOR WINDOWS APPLICATION (MODEL 82-63001 ONLY): • Insert the receptacle end of a null modem cable into the serial port of the PC. • Insert the plug end of the null modem cable into the 9-pin port on the side of the AccuGuide®. • Press the battery check key and the sensitivity key simultaneously to begin transmitting data. If this is done correctly the following message will appear on the AccuGuide® LCD display; “Serial Comm On”. NOTE: This will only work on Model 8263001. • Start the Windows Application by double-clicking on the AccuGuide® icon. NOTE: If a window appears stating “ER6

ROR OPENING COM”, change the com port using the Options pull down menu. • The time scale of the graph is changed by clicking the timescale button on the right side of the window. There are three timescales: 10 mS/Div, 50mS/Div, and 100mS/Div. • The voltage scale of the graph is changed by pressing the “SENSITIVITY” touchpad on the AccuGuide® monitor front panel. There are three voltage scales: 50µV/Div., 140µV/Div., and 500µV/Div. • The scrolling of the waveform is halted by clicking the freeze button. Once the waveform is halted, the screen can be saved to a file or printed using the File pull down menu.

CLEANING MONITOR PRECAUTIONS • Be sure to dry off the AccuGuide® Monitor after cleaning. Moisture inside the AccuGuide® Monitor could cause damage. • Do not immerse the AccuGuide® Monitor. 1. Turn the power off before cleaning. 2. Wipe down the AccuGuide® Monitor with standard disinfectant or mild detergent and water. 3. Dry the AccuGuide® Monitor with a clean, non-abrasive cloth. PATIENT INTERFACE CABLE PRECAUTION The patient interface cable is not designed to be sterilized. Soaking or autoclaving will cause damage and will void the warranty. 1. Wipe down the cable with standard disinfectant. 2. Dry the cable with a clean, non-abrasive cloth.

TROUBLESHOOTING SYSTEM MALFUNCTIONS Malfunction

Cause

Corrective Action

Erroneous Screen Data.

Electro-Magnetic Interference.

Cycle power; i.e. turn the power off and back on. If cycling the power does not correct the mal-function, remove the battery for 1 minute, then reinstall.

Excessive Noise

EMI/RFI

Turn off any unnecessary electrical devices in the vicinity of the monitor and cable or move the monitor and cable way from electrical devices, especially fluorescent lights that may be causing interference.

Excessively loud background noise. (50/60 Hz Hum)

Loose cable connection, or needle electrode is not in conductive tissue.

Reseat the Patient Interface Cable into the 5-pin receptacle. Ensure the needle electrode is not in the patient’s airway when performing laryngeal injections.

Low Battery message on screen and the monitor will not respond to key press.

Insufficient battery voltage to perform procedure

Power down the monitor and replace the 9V battery.

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Full scale bargraph deflection in EMG mode.

EMG potentials are too large for the given sensitivity

Reduce the sensitivity setting to “MED” or “LOW”.

Speaker distortion or speaker cut-out.

EMG potentials are too large for the given volume

Lower the volume.

Speaker squeal and feedback noise.

Monitor is too close to needle electrode or surface electrodes, or the Injection Needle is not inserted into injection site.

Move the monitor away from the Needle Electrode injection site. Do not coil the Patient Interface Cable. Ensure the Patient Interface Cable is attached properly. Mute the monitor when the Injection Needle Electrode is not in the injection site

No waveform displayed.

Disconnected serial communication cable or transmission not initiated.

Check serial communication cable connections. Press the Battery Check key and the Sensitivity key simultaneously to initiate data transmission.

Waveform on display is clipped.

EMG potentials are too large for given sensitivity.

Reduce the sensitivity setting to “MED” or “LOW”.

Com port error window encountered.

Windows Application is setup on the wrong com port.

Enter the file pull down menu and select Com ports. Select an available com port and connect the null modem cable to the available com port.

50/60 Hz Hum.

Interference from the PC power line.

Use a power line filter when powering the PC from a wall outlet.

If any of the above malfunctions persist, contact Customer Service, 800-874-5797 or 904-296-9600, or your local Sales Representative.

LIMITED WARRANTY

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A.

This LIMITED WARRANTY provides assurance for the customer who purchases a AccuGuide® System (hereinafter the “Product”) that should the Product fail to function to Medtronic Xomed’s published specifications during the term of this LIMITED WARRANTY (one year from the date of shipment for new Product, 90 days from date of shipment for refurbished or used Product), Medtronic Xomed will either replace, repair, or issue a credit (adjusted to reflect the age of the Product) for the Product or any portion thereof. This LIMITED WARRANTY is extended only to the buyer purchasing the Product directly from Medtronic Xomed or from its affiliate or its authorized distributor or representative.

B.

To qualify for this LIMITED WARRANTY, the following conditions must be met: (1) The Product must be used on or before its “Use By” or “Use Before” date, if applicable. (2) The Product must be used in accordance with its labeling and may not be altered or subjected to misuse, abuse, accident or improper handling. (3) Medtronic Xomed must be notified in writing within thirty (30) days following discovery of a defect. (4) The Product must be returned to Medtronic Xomed within thirty (30) days of Medtronic Xomed receiving notice as provided for in (3) above. (5) Upon examination of the Product by Medtronic Xomed, Medtronic Xomed shall have determined that: (i) the Product was not repaired or altered by anyone other than Medtronic Xomed or its authorized representative, (ii) the Product was not operated under conditions other than normal use, and (iii) the prescribed periodic maintenance and services have been performed on the Product.

C.

This LIMITED WARRANTY is limited to its express terms. THIS LIMITED WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED WHETHER STATUTORY OR OTHERWISE, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. In no event shall Medtronic Xomed be liable for any consequential, incidental, prospective or other similar damage resulting from a defect, failure, or malfunction of the Product, whether a claim for such damage is based upon the warranty, contract, negligence or otherwise.

D.

The exclusions and limitations set out above are not intended to, and should not be construed so as to, contravene mandatory provisions of applicable law. Users may benefit from statutory warranty rights under legislation governing the sale of consumer goods. If any part or term of this LIMITED WARRANTY is held by any court of competent jurisdiction to be illegal, unenforceable, or in conflict with applicable law, the validity of the remaining portion of the LIMITED WARRANTY shall not be affected, and all rights and obligations shall be construed and enforced as if this LIMITED WARRANTY did not contain the particular part or term held to be invalid.

TECHNICAL SPECIFICATIONS MONITOR Part Number: ... 8263001, 8263002 Electrical: Power Requirements: ... 9VDC @ 220 mA Max Input Signal Amplitude Range: ... 0-2000µV Peak Audio Frequency Response: ... 330-5500 Hz ± 6 dB PC Display Frequency Response: ... 330-2100 Hz ± 6 dB Input Signal Coupling: ... AC Accuracy: Bargraph Display: ... ± 1 Segments Green Indicator Light: ... ± 10% Windows Graphical Display: ... ± 12% Size: ... 10 cm Width x 20 cm Height x 4 cm Depth Weight: ... 380 g IEC/EN 60601-1 Classification: ... Internally Powered Equipment Water Ingress:... IPX0, Ordinary Equipment Applied Part Patient Isolation: ... Type BF EMI/RFI:... EN 60601-1-2 CISPR 11 Class B Safety Standards: ... EN 60601-1, UL60601-1 and CAN/CSA c22.2 No 601.1 Operation: ... See “PRECAUTION” in “Battery Checking Function”. PATIENT INTERFACE CABLE Part No. ... 8263003 Size ... 127 cm Length x 5 mm Diameter Weight ... 90 grams INSULATED INJECTOR NEEDLE ELECTRODES Part No. ... 8263210 Size ... 25 mm x 30 G Type ... Straight

8263211 37 mm x 27 G Straight

RECOMMENDED ENVIRONMENTAL CONDITIONS Operating Temperature: 10° to 35°C Humidity: 10% to 90% RH Barometric Pressure: 700 to 1060 hPa Storage Temperature: -40° to 60°C Humidity: 0% to 100% RH Barometric Pressure: 500 to 1060 hPa PARTS LIST Part #

Description

8263001 8263002 8263003 8263004 8263005 8263210 8263211

AccuGuide® Monitor with PC Interface AccuGuide® Monitor (No longer being manufactured). Patient Interface Cable AccuGuide® Monitor User’s Guide AccuGuide® Monitor Software CD Straight Insulated Injector Needle Electrode, 25 mm x 30 G Straight Insulated Injector Needle Electrode, 37 mm x 27 G

NOTE: For a complete list of components and accessories, please contact your local Medtronic Xomed representative or call Medtronic Xomed Customer Service.

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GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY Guidance and manufacturer’s declaration – electromagnetic immunity – Part I The AccuGuide® Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the AccuGuide® Monitor should assure that it is used in such an environment. IEC 60601 test level

Immunity test Electrostatic discharge (ESD) IEC 61000-4-2 Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

Compliance level

±6 kV contact

±6 kV contact

±8 kV air

±8 kV air

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 AccuGuide® Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the AccuGuide® Monitor should assure that it is used in such an environment. Emissions test

Compliance

Electromagnetic environment - guidance

RF emissions CISPR 11

Group 1

The AccuGuide® Monitor 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

The AccuGuide® Monitor 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.

Recommended separation distances between portable and mobile RF communications equipment and the AccuGuide® Monitor The AccuGuide® Monitor is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the AccuGuide® Monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the AccuGuide® Monitor 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

0.10

0.38

0.38

0.73

1.00

1.20

1.20

2.30

10.00

3.80

3.80

7.30

100.00

12.00

12.00

2.30

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 AccuGuide® Monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the AccuGuide® Monitor should assure that it is used in such an environment. Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of the AccuGuide® Monitor, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance

Conducted RF

3 Vrms

3 Vrms

d = 1.2 √P

IEC 61000-4-6

150 kHz to 80 MHz

3V/m

d = 1.2 √P 80 MHz to 800 MHz

Radiated RF IEC 61000-4-3

NOTE 1 NOTE 2 a

b

3V/m 80 MHz to 2.5 GHz

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:

At 80 MHz and 800 MHz, the higher frequency range applies. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

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 AccuGuide® Monitor is used exceeds the applicable RF compliance level above, the AccuGuide® Monitor should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the AccuGuide® Monitor. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

11

Medtronic Xomed, INC. 6743 Southpoint Drive North Jacksonville, FL 32216 USA www.medtronicENT.com

68E3411.E 06/06

REF 8263004

Medtronic Xomed, INC. 6743 Southpoint Drive North Jacksonville, FL 32216 USA www.medtronicENT.com

68E3411.E 06/06

REF 8263004

Medtronic Xomed, INC. 6743 Southpoint Drive North Jacksonville, FL 32216 USA www.medtronicENT.com

68E3411.E 06/06

REF 8263004

Medtronic Xomed, INC. 6743 Southpoint Drive North Jacksonville, FL 32216 USA www.medtronicENT.com

68E3411.E 06/06

REF 8263004

Medtronic Xomed, INC. 6743 Southpoint Drive North Jacksonville, FL 32216 USA www.medtronicENT.com

68E3411.E 06/06

REF 8263004