Xomed Hydrodebrider System Users Guide Rev H Nov 2014

Contents



Symbols ...4 Illustrations...4 General...5 Definitions...5 When the System Arrives...5 Unpacking and Inspection...5 Warnings and Precautions...6 Warnings...6 Precautions...6 U.S. Customer Care...6 System Description...6 Intended Use...6 Indications for Use...6 Contraindications...6 Components...6 Console ...6 Maxillary Handpiece ...6 Frontal Handpiece ...6 System Configuration...6 Maxillary Handpiece...6 Frontal Handpiece...7 Setup and Operation...7 Irrigant...7 Pump Setup...7 Operative Procedure...7 Maxillary Handpiece...7 Maxillary Handpiece Tip Articulation ...7 Maxillary and Frontal Spray Nozzle Operation...7 Post-Operative Procedure...7 Cleaning...7 Console...7 Service...7 Technical Specifications...7 System Components and Accessories...8 Troubleshooting...8 Guidance and manufacturer’s declaration – electromagnetic immunity ...9 Part I...9 Part II...10 Limited Warranty...10

Xomed® Hydrodebrider® System

3



Symbols

Illustrations

Caution

REF

Catalog Number

SN

Serial Number

A

B

Xomed Hydrodebrider™ System Endoscopic Suction Irrigator

C Date of Manufacture Precaution If the single use symbol is on the device label then this device is designed for single patient use only. Do not reuse, reprocess, or resterilize this product. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device and/or create a risk of contamination of the device, which could result in patient injury, illness, or death.

LOT

Lot Number

D

001

E

D

C

B

A

Flow Direction Indicator

H

I V Bag

E Handpiece

G

002 A

Pinch Hazard

B

E

Type BF Applied Part

C

Fuse DUTY CYCLE FOR APPLIED PART MAX ON 5 SEC

MIN OFF 5 SEC

F

D

Duty Cycle

003 Conforms To ANSI/AAMI ES60601-1; Certified To CSA C22.2 NO. 60601-1

IPX1

Protection classification - protected against vertical water drops

F

A

Input Access by Medtronic service personnel only

Xomed Hydrodebrider™ System Endoscopic Irrigator

E

ROHS - Environmental friendly use period - China (SJ/T113642006.)

D

b1 b1

RF transmitter (interference may occur)

B

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.

EC REP

Authorized representative in the european community This device complies with medical device directive 93/42/EEC Caution: federal law (U.S.A.) restricts this device to sale by or on the order of a physician.

C

004

Follow instructions for use.

4

Xomed® Hydrodebrider® System

 90°

E

A

180°

0°

D

0°

C

b2 b2

0°

B

90°

009

90

0

180°

180

270

005 010

A

006

90

0

180

270

011

General

Alphabetic list (A. B. C. etc.) contain introductory information where Numeric list (1. 2. 3. etc.) are “How To” instructions.

007

Definitions EMC RF EMI OUS -

Electromagnetic Compatibility Radio Frequency Electromagnetic Interference Outside United States

When the System Arrives Unpacking and Inspection

008 Xomed® Hydrodebrider® System

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 Care. 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 Xomed® Hydrodebrider™ System, save the cartons and packing material. If the product is to be shipped from one location to another, use the product shipping package to ensure proper protection. 5



Warnings and Precautions

It is important that the Xomed® Hydrodebrider® operator be familiar with this manual, its precautions, procedures and safety issues. Three labels are used in this manual to identify important concerns, conditions, or procedures: Describes serious adverse reactions and potential Warnings: 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. Identifies special information or to clarify / emphasize Note: important instructions.

Warnings

W1. This medical device complies with 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 electromagnetic interference (EMI) or highly sensitive equipment, interference may be encountered and the user should take whatever steps are necessary to eliminate or reduce the source of the interference. Diminished performance may lengthen operating time for anesthetized patient. W2. Disconnect power from the entire system before cleaning to avoid electrical shock. W3. While using the Xomed® Hydrodebrider® System with electromechanical devices, maintain BF conditions (insulated, earth-free) to prevent electrical shock. W4. Verify suction line of the Maxillary handpiece is working properly to minimize ingestion of irrigation fluid during the procedure. W5. In rare cases, the sinus cavity may be compromised either interoperatively or prior to surgery (for example, dehiscence, erosion, or fistula). In cases where an anatomical anomaly is known or suspected, do not irrigate. In other cases, it is important to monitor the orbit for pressure changes and/or swelling during irrigation and to monitor for changes to vital signs that could be suggestive of increased ocular or cerebral pressure. W6. Ensure irrigation tubing clamp is closed when the system is not in use to avoid inadvertent spray. W7. This equipment is not suitable for use in the presence of flammable mixtures. W8. Care must be taken prior to and during the procedure to ensure drainage when using the Frontal Handpiece. Occlusion of the frontal ostium from fungal debris, bone chips, or other foreign matter could result in irrigant flowing to the brain. W9. Always inspect components for damage before and after use. If damage is observed, do not use damaged part until it is repaired or replaced. W10. To avoid risk of electric shock, this equipment must only be connected to a supply main with protective earth. W11. Do not modify this equipment without autorization of the manufacture.

Precautions P1. P2. P3. P4.

6

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. Use of accessories and cables other than those specified and sold by Medtronic may result in increased emissions and decreased immunity of this product. The console should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the console should be observed to verify normal operation in the configuration in which it will be used

U.S. Customer Care

General Customer Care 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. medtronic.com

System Description

The Xomed® Hydrodebrider® irrigating pump console and handpiece are used to direct and deliver pressurized irrigation solution to a localized site. The system is comprised of two major components (each sold separately): irrigating pump console, and single-use handpiece(s) Maxillary or Frontal (irrigation bag also required). The console is mounted to an irrigation pole with supplied clamp before the surgical procedure. Spray action is initiated by depressing the activation button on the handpiece, producing an irrigation cycle. The system dispenses approximately four to six mL/sec of irrigation solution. The Maxillary handpiece is capable of continuous suction to evacuate excess fluid.

Intended Use

The Xomed® Hydrodebrider® System is intended to irrigate the paranasal sinuses.

Indications for Use

The Xomed® Hydrodebrider® System is indicated for use whenever irrigation of the paranasal sinuses is desired including post Endoscopic Sinus Surgery and office based irrigation. The Xomed® Hydrodebrider® is intended to treat such conditions and disorders as Rhinitis and acute or chronic sinusitis.

Contraindications

There are no known contraindications.

Components Console

See illustration 001. A. Irrigation Pole Clamp. B. System Status Indicator. C. Power On/Off Switch. D. Handpiece (Stereo) Jack. E. Peristaltic Pump.

Maxillary Handpiece

See illustration 002. A. Spray Nozzle and Suction Tube. B. Flex Section. C. Tip Articulation Wheel. D. Nozzle Rotation Wheel. E. Irrigation Tube. F. Suction Tube. G. Control Cable. H. Actuation Button (Trigger).

Frontal Handpiece See illustration 003. A. Spray Nozzle. B. Nozzle Rotation Wheel. C. Control Cable. D. Irrigation Tube. E. Actuation Button (Trigger).

System Configuration Maxillary Handpiece

See illustration 004. A. Handpiece spike and Irrigation Bag. B. Pump. b1. Tube fittings. C. Suction source. D. Handpiece (stereo) plug. E. Irrigation tubing clamp. F. Maxillary handpiece. Xomed® Hydrodebrider® System

 Frontal Handpiece

See illustration 005. A. Handpiece spike and Irrigation Bag. B. Pump. b2. Pump marks: C. Handpiece (stereo) plug. D. Irrigation tubing clamp. E. Frontal handpiece.

Setup and Operation

1. Mount the console on the irrigation pole. • Verify that the On/Off switch on the front of the console is set to the Off (O) position. 2. Connect the power cord to the input on the rear of the console and to a medical grade outlet. 3. Verify the system status indicator (green LED) is NOT illuminated. Insert handpiece (stereo) plug into console (stereo) jack. NOTE: If console power is ON (LED is illuminated) a momentary activation of the peristaltic pump will occur when inserting the handpiece (stereo) plug.

Irrigant

1. Hang irrigation solution bag(s) on the irrigation pole. 2. Adjust the tubing clamp(s) on the irrigation tubing to the closed position. • For single irrigation bag/handpiece configuration, close tubing clamp (A) at handpiece then spike bag. See illustration 006.

Pump Setup

1. Load irrigation pump tubing into the peristaltic pump. See illustrations 007 (Pump marks) and 008 (Tube fittings). (1) Lift the lid on the peristaltic pump and insert the tubing per illustrations. (2) Center the tubing on the pump head. b1. Tube fittings: • Install tubing with one tube fitting on each side of pump. • Allow tubing to lay across roller naturally, do not pull or stretch tubing. b2. Pump marks: • Install tubing with one mark on each side of pump. • Allow tubing to lay across roller naturally, do not pull or stretch tubing. (3) Close the lid on the pump head. 2. Adjust the slide clamp on the irrigation tubing to the OPEN position. 3. Toggle the On/Off switch on the front of the console to the On (l) position and verify the system status indicator is illuminated. 4. Direct the tip of the handpiece over a sponge or collection tray. Depress the actuation (trigger) button until irrigant is observed flowing at the tip. 5. Release the actuation button and adjust the slide clamp on the irrigation tubing to the closed position.

Operative Procedure Maxillary Handpiece Maxillary Handpiece Tip Articulation

See illustration 009 1. Rotating the tip articulation wheel to the right will turn the spray nozzle to the right. 2. Centering the tip articulation wheel will center the spray nozzle. 3. Rotating the tip articulation wheel to the left will turn the spray nozzle to the left.

Maxillary and Frontal Spray Nozzle Operation Maxillary Handpiece and Frontal Handpiece See illustration 010 (Maxillary) and 011 (Frontal) The “Spray Pattern” of the Hydrodebrider® handpieces is from the center of a diameter to the circumference of said diameter (size of diameter increases with distances). Note: There is a 180° difference in the 0°, 90°, 180°, and 270° marks on the two handpieces. 1. Set starting position of spray pattern by rotating nozzle rotation wheel until desired angle (in degrees) is visible in view window on top of handpiece. Xomed® Hydrodebrider® System

2. Depress activation button to activate pump and begin spray pattern. 3. Turn nozzle rotation wheel clockwise/counter-clockwise adjusting spray pattern. 4. Release activation button to stop spray.

Post-Operative Procedure

1. Power down: • Turn the power switch to the Off (O) position. 2. Close all tubing clamps. 3. Disconnect/Remove: • Handpiece stereo plug from console. • Suction tubing from the suction source. • Remove the tubing from peristaltic pump head. 4. Discard the irrigation bag, handpiece and tubing, following healthcare facility guidelines on proper disposal of contaminated materials. Do Not Reuse These Components.

Cleaning Console • • • •

Wipe down the console and pump with standard disinfectant. Do not use alcohol, other solvents, or abrasive cleaners. Dry the product with a clean, non-abrasive cloth. Allow to thoroughly dry before storing.

Service

If the Xomed® Hydrodebrider® System does not function properly, refer to the “Troubleshooting” section of this manual. If troubleshooting attempts do not correct the problem, contact Medtronic Xomed Customer Care; or for international, contact your local Medtronic Xomed office or distributor. The Xomed® Hydrodebrider® System is not user-serviceable, and no preventive maintenance or re-calibration procedures are required except for the directions listed in this manual.

Technical Specifications

This device meets IEC/EN 60601-1-2: 2nd and 3rd edition requirements. This device complies with IEC/EN 60601-1: 2nd and 3rd edition, ANSI/ AAMI ES 60601-1, CSA 22.2 No. 60601-1 Size Console 17.8 cm x 26.7 cm x 24.1 cm Maxillary Handpiece 24.1 cm x 4.6 cm x 11.7 cm Frontal Handpiece 22.86 cm x 2.9 cm x 8.4 cm Weight Console 2.3 kg Maxillary Handpiece 80 g Frontal Handpiece 33 g Recommended Installation Pole Mounted Electrical Input Voltage 100 - 240 VAC, 50/60 Hz, 40 VA Max Internal Fuse 5X20, T, 1AL, 250 V Medical Equipment Classification Mode of Operation

Class I Equipment Type BF Applied Part

Short-Time Operation Protection Against Water Ingress Console IPX1 Irrigation Cycle Control Duty Cycle Front Console Control Front Console Indicators Authorized Service Organization

Activation Button/trigger Maximum On 5 Seconds Minimum Off 5 Seconds Power switch Power/System Indicator Medtronic Xomed, Inc.

7

 Environmental Requirements Operating: Temperature: 10˚ to 40˚ C Humidity: 30 to 75% RH, non-condensing Barometric Pressure: 700 to 1060 hPa Storage and Transportation Temperature: -40˚ to 70˚ C Humidity: 10 to 100% RH, non-condensing Barometric Pressure: 500 to 1060 hPa

System Components and Accessories Capital 1913001 1897821 1895821 1895822 1895823

Xomed® Hydrodebrider® Console North America 110 VAC Power Supply Cord UK 240 VAC Power Supply Cord Continental Europe 230 VAC Power Supply Cord Japan 100 VAC Power Supply Cord

Disposables 1914001 1921002

Xomed® Hydrodebrider® Maxillary Handpiece Xomed® Hydrodebrider® Frontal Handpiece

Troubleshooting Symptom

Issue

Action

System Status Indicator not lit, unit does not operate.

Check power cord installation.

Disconnect power cord from rear of console and reconnect. Ensure power outlet is working properly.

System Status Indicator not lit, unit operates.

LED indicator may have failed.

Call customer care.

System Status Indicator shows green, unit does not operate.

Handpiece installed incorrectly.

Disconnect handpiece from console by unplugging stereo jack. Reconnect stereo jack and ensure it is fully seated in the mating plug.

Motor stall.

Reposition tubing in pump, verify pump lid is fully closed with the fluid flow from left to right.

Electronic failure.

Call customer care.

Blockage in Irrigation Tube.

Inspect irrigation nozzle at distal tip for blockage. Ensure slide clamp on irrigation tube is open.

Irrigation Bag Empty.

Replace bag.

Incorrect Pump Splice installation.

Reposition tubing in pump, verify pump lid is fully closed with the fluid flow from left to right.

Handpiece Activation Button failure.

Turn console power off and disconnect Handpiece from console. Replace Handpiece with a new unit.

Handpiece installed incorrectly.

Disconnect handpiece from console by unplugging stereo jack. Reconnect stereo jack and ensure it is fully seated in the mating plug.

Maxillary suction does not appear to be functioning properly.

Blockage in Suction Tube.

Inspect suction port at distal tip for blockage. Clear any blockages as necessary to increase suction.

Maxillary handpiece Flex Section does not articulate properly.

Mechanical failure.

Replace handpiece with a new unit.

Handpiece Nozzle does not rotate properly.

Mechanical failure.

Replace handpiece with a new unit.

System Status Indicator shows red.

Peristaltic Pump is turning but Handpiece does not spray. Irrigant spray from Handpiece appears to be low. Irrigant spray from Handpiece does not turn off.

8

Xomed® Hydrodebrider® System

Guidance and manufacturer’s declaration – electromagnetic immunity



Part I Guidance and manufacturer’s declaration – electromagnetic immunity – Part I The Xomed® Hydrodebrider® System is intended for use in the electromagnetic environment specified below. The customer or the user of the Xomed® Hydrodebrider® System should assure that it is used in such an environment. IEC/EN60601-1-2 Immunity test Compliance level Electromagnetic environment - guidance test level Floors should be wood, concrete, or ceramic tile. If Electrostatic discharge (ESD) ±6 kV contact ±6 kV contact floors are covered with synthetic material, the relative IEC 61000-4-2 ±8 kV air ±8 kV air humidity should be at least 30 %. Electrical fast transient/burst ±2 kV for power supply lines ±2 kV for power supply lines Mains power quality should be that of a typical IEC 61000-4-4 ±1 kV for input/output lines ±1 kV for input/output lines commercial or hospital environment. Surge ±1 kV differential mode ±1 kV differential mode Mains power quality should be that of a typical IEC 61000-4-5 ±2 kV common mode ±2 kV common mode commercial or hospital environment. <5 % UT (>95 % dip in UT) for <5 % UT (>95 % dip in UT) for Mains power quality should be that of a typical 0.5 cycle 0.5 cycle commercial or hospital environment. If the user of the 40 % UT (60 % dip in UT) for 40 % UT (60 % dip in UT) for Voltage dips, short interruptions and Xomed® Hydrodebrider® System requires continuous 5 cycles 5 cycles voltage variations on power supply input operation during power mains interruptions, it is lines 70 %UT (30 % dip in UT) for 70 % UT (30 % dip in UT) for recommended that the Xomed® Hydrodebrider® IEC 61000-4-11 25 cycles 25 cycles System be powered from an uninterruptible power <5 % UT (>95 % dip in UT) <5 % UT (>95 % dip in UT) for supply or a battery. for 5 sec 5 sec Power frequency magnetic fields should be at Power frequency (50/60 Hz) magnetic field 3 A/m 3 A/m levels characteristic of a typical location in a typical IEC 61000-4-8 commercial or hospital environment. Note: UT is the a.c. mains voltage prior to application of the test level.

Guidance and manufacturer’s declaration – electromagnetic emissions The Xomed® Hydrodebrider® System is intended for use in the electromagnetic environment specified below. The customer or the user of the Xomed® Hydrodebrider® System should assure that it is used in such an environment. Compliance

Electromagnetic environment - guidance

RF emissions CISPR 11

Emissions test

Group 1

The Xomed® Hydrodebrider® System 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 A

Harmonic emissions IEC 61000-3-2

Class A

Voltage fluctuations IEC 61000-3-3

Complies

The Xomed® Hydrodebrider® System is suitable for use in all establishments, other than domestic 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 Xomed® Hydrodebrider® The Xomed® Hydrodebrider® System is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Xomed® Hydrodebrider® System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Xomed® Hydrodebrider® System 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 d = 1.2√P

80 MHz to 800 MHz d = 1.2√P

800 MHz to 2.5 GHz 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

23.0

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.

Xomed® Hydrodebrider® System

9



Part II The Xomed® Hydrodebrider® System is intended for use in the electromagnetic environment specified below. The customer or the user of the Xomed® Hydrodebrider® System should assure that it is used in such an environment. Immunity test

IEC/EN60601-1-2 test level

Compliance level

Electromagnetic environment - guidance Portable and mobile RF communications equipment should be used no closer to any part of the Xomed® Hydrodebrider®, 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

IEC 61000-4-6

150 kHz to 80 MHz

Radiated RF

3V/m

IEC 61000-4-3

80 MHz to 2.5 GHz

3 Vrms

d = 1.2 √P

3V/m

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 NOTE 2 a

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 Xomed® Hydrodebrider® System is used exceeds the applicable RF compliance level above, the Xomed® Hydrodebrider® System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Xomed® Hydrodebrider™.

b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Limited Warranty A. This Limited Warranty provides the following assurance for the customer who purchases a Xomed® Hydrodebrider® Console (hereinafter referred to as a “System Component”) or any of its related handpiece(s), control cables, irrigation tubing, and irrigation with suction tubing (hereinafter referred to as “Single Use Component”). The System Component and the Single Use Component(s) are jointly referred to as the Xomed® Hydrodebrider® System, unless specifically noted otherwise. This Limited Warranty is extended only to the buyer purchasing the System Component or Single Use Component directly from Medtronic or from its affiliate or its authorized distributor or representative. (1) Should a System Component fail to function to Medtronic’s published specifications during the term of this Limited Warranty (one year from the date of sale of a new System Component or 90 days from the date of sale of a refurbished or used System Component), Medtronic will either repair or replace the System Component or any portion thereof. (2) Should a Single Use Component fail to function to Medtronic’s published specifications prior to its “use by” date Medtronic will replace the Single Use Component. B. To qualify for this Limited Warranty, the following conditions must be met: (1) The Xomed® Hydrodebrider® System must be used on or before its “Use By” or “Use Before” date, if applicable. (2) The Xomed® Hydrodebrider® System must be used in accordance with its labeling and may not be altered or subjected to misuse, abuse, accident or improper handling. (3) Medtronic must be notified in writing within thirty (30) days following discovery of a defect. (4) The Xomed® Hydrodebrider® System must be returned to Medtronic within thirty (30) days of Medtronic receiving notice as provided for in (3) above. (5) Upon examination of the Xomed® Hydrodebrider® System by Medtronic, Medtronic shall have determined that: (i) the Xomed® Hydrodebrider® System was not repaired or altered by anyone other than Medtronic or its authorized representative, (ii) the Xomed® Hydrodebrider® System was not operated under conditions other than normal use, and (iii) the prescribed periodic maintenance and services, if applicable, have been performed on the Xomed® Hydrodebrider® System. 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 be liable for any consequential, incidental, prospective or other similar damage resulting from a defect, failure, or malfunction of the Xomed® Hydrodebrider® System, 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.

10

Xomed® Hydrodebrider® System

© 2014 Medtronic, Inc. All rights reserved Printed in the USA 2014-11 68E4038 H

medtronic.com manuals.medtronic.com Medtronic Xomed, Inc. 6743 Southpoint Drive North Jacksonville, FL 32216 USA 800.874.5797

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

© 2014 Medtronic, Inc. All rights reserved Printed in the USA 2014-11 68E4038 H

Medtronic Xomed, Inc. 6743 Southpoint Drive North Jacksonville, FL 32216 USA medtronic.com manuals.medtronic.com Medtronic B.V.

Bakkenstraat 10 EC REP Earl 6422 PJ Heerlen

The Netherlands Tel.: 011-31-45-566-8000 Fax: 011-31-45-566-8668

© 2014 Medtronic, Inc. All rights reserved Printed in the USA 2014-11 68E4038 H

Medtronic Xomed, Inc. 6743 Southpoint Drive North Jacksonville, FL 32216 USA medtronic.com manuals.medtronic.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

Xomed® Hydrodebrider®system

Användarhandbok

© 2014 Medtronic, Inc. All rights reserved Printed in the USA 2014-11 68E4038 H

Medtronic Xomed, Inc. 6743 Southpoint Drive North Jacksonville, FL 32216 USA medtronic.com manuals.medtronic.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

© 2014 Medtronic, Inc. Med enerett Trykt i USA 2014-11 68E4038 H

Medtronic Xomed, Inc. 6743 Southpoint Drive North Jacksonville, FL 32216 USA medtronic.com manuals.medtronic.com

EC REP

Medtronic B.V. Earl Bakkenstraat 10 6422 PJ Heerlen Nederland Tlf.: 011-31-45-566-8000 Faks: 011-31-45-566-8668