DIEGO ELITE System Instructions for Use Rev AG July 2017

TABLE OF CONTENTS Labels... 3 Symbols... 4 Package Contents... 6 Available Reusable Equipment... 7 Available Disposables... 8 Important Information – Please Read Before Use... 9 Indications For Use... 9 Contraindications For Use... 9 Instruction Manual... 9 User Qualification... 10 Signal Words... 10 General Warnings And Safety Notices... 10 Additional Safety Information... 15 Chapter 1–Nomenclature and Functions... 22 1.1 Console... 22 1.2 Footswitch... 23 1.3 Handpiece... 24 1.4 Disposable Blade and Tubeset Features (sold separately)... 25 1.5 Declog Tubeset Features (sold separately).. 26 1.6 Suction Module (Optional)... 27 1.7 Touch Screen ... 27 Chapter 2–Installation and Setup... 30 2.1 Flow Chart for Installation Work... 30 2.2 Installation of System... 30 2.3 Connecting Console to an AC Mains Power Supply... 31 2.4 Menu / Settings... 33 2.5 Connection of Peripheral Equipment... 37 2.6 Connection of Footswitch... 39 2.7 Handpiece Connection... 41 2.8 Tubeset Connection... 43 2.9 Blade / Burr Connection... 44 2.10 Irrigation... 45 2.11 Grounding Pad (Only needed with a Monopolar Blade)... 48 2.12 Suction Module Setup and Suction Tubing Setup... 50 2.13 Blade / Burr ID ... 52 2.14 Manual Setup... 56 2.15 Image Guidance System Compatibility with Brainlab... 60 2.16 Nosecone Adapter Grip... 62

Chapter 3–Operation... 64 3.1 Flow Chart for Operation Work... 64 3.2 Cutting Tissue and RF Activation... 64 3.3 Operation Screens... 66 3.3 Malleable Tonsil / Adenoid Blade (Sold Separately)... 72 3.5 Clean Shaver Blade Tip... 73 3.6 Using The Declog Tubeset Feature (Sold Separately)... 74 3.7 Procedure After Use... 75 Chapter 4–Care, Storage and Disposal... 76 4.1 Care... 76 4.2 Manual Cleaning Of The Handpiece – Following Use... 77 4.3 Automated Cleaning Using A Washer Disinfector... 80 4.4 Steam Sterilization... 81 4.5 STERRAD Systems... 81 4.6 Storage... 82 4.7 Disposal... 82 Chapter 5–Troubleshooting... 83 5.1 Irrigation... 83 5.2 Grounding Pad... 84 5.3 Generic Error Message... 85 5.4 Maintenance ... 89 5.5 Returning the System for Repair... 90 Appendix A... 91 RF System Specifications... 91 Transportation, Storage and Operating Environment... 91 Specifications... 92 Console... 92 Power cords ... 92 Footswitch ... 92 Compatible Grounding Pads ... 93 Suction Module... 93 Electromagnetic Compatibility (EMC) Information.. 94 Appendix B... 98 Reprocessing Instructions Summary ... 98 Diego Elite Handpiece Sterilization Log... 100

© 2017 Olympus. All rights reserved. No part of this publication may be reproduced or distributed without the express written permission of Olympus. Gyrus ACMI, Multidebrider, Diego and Olympus are trademarks of Olympus Corporation (Tokyo, Japan) and/or their affiliated entities. STERRAD, NX, and 100NX are trademarks of Johnson & Johnson Corporation. 4434963 REV AG

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Labels

LABELS Safety-related labels and symbols are attached on the locations shown below. If labels or symbols are missing or illegible, contact Olympus. Function-related symbols are described in the following Symbols section. Patient contact Type BF applied parts cTUVus marking Non-ionizing electromagnetic radiation Catalog number Electrical and Electronic Equipment

ESD Sensitive Connection

Follow Instructions for use

CE Marking Console protected against

IP X1 dripping water

Equipotential connector

CONSOLE

cTUVus marking Electrical and Electronic Equipment Follow Instructions for use

CE Marking Console protected against

SUCTION MODULE

IP X1 dripping water

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Symbols

SYMBOLS CONSOLE (FRONT) Power on / off

Footswitch

Handpiece

Output insulated from earth (connection for neutral electrode)

Grounding pad

Patient contact Type BF applied parts

CONSOLE (PUMP) Do not allow fingers to contact moving parts.

TOUCH SCREEN An online-sign.com production

sign ref st821384283749

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Languages

Footswitch

Touch tone on

Grounding pad

Touch tone off

Irrigation

Software version

Suction

Service

Standby

Return to HOME SCREEN

Plus

Previous page

Minus

Next page

Flow rate

Cancel

Menu

OK

Connect blade or bur

Blade, burr, drill

Connect handpiece

Handpiece

Tone Control

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Symbols

Footswitch constant speed

Forward

Reverse

Variable speed

PACKAGING

Lot number Follow Instructions for Use Caution: Consult accompanying documents

Keep dry Quantity

CAUTION

Federal Law (USA) restricts this device to sale by or on the order of a physician.

EU Authorized Representative Temperature limitation

Use by date Manufacturing date

Humidity Limitation

Manufacturer For Single Use Only

2

STERILIZE

Atmospheric Pressure Limitation

Do not resterilize

Electrical and Electronic Equipment

Do not use if package is damaged This way up

Fragile; handle with care Sterilized using ethylene oxide

Catalog Number

Water tight construction, foot switch able to withstand one hour immersed in 150 mm depth in saline solution and activated 50 times.

Listen

OTHER IP 68

Protective Earth

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Package Contents

PACKAGE CONTENTS Contents of each package are described on the carton label. A complete system consists of a console / power cord, footswitch, handpiece (straight or angled), disposable blade / burr and disposable tubeset. Optional accessories include the suction module and the suction tubing. All components are required to use the system. Inspect each item for damage. On the handpiece and footswitch, inspect for cracks of damaged power cord connectors. On the console, inspect for cracks on the housing, irrigation pump or touchscreen. If the system is damaged, a component is missing or you have any questions, do not use the system and contact the manufacturer Gyrus ACMI, Inc. at (800) 262 3540 or www.gyrusacmi.com.

SYSTEM CHART (FRONT) DISPOSABLES BLADE/BURR STERILE SINGLE USE

CONSOLE NON-STERILE REUSABLE

TUBESET STERILE SINGLE USE

Blade

I. V. BAG (NOT SUPPLIED)

5000

Max RPM

HANDPIECE NON-STERILE REUSABLE EXPECTED LIFESPAN: 750 uses / reprocessing cycles

Constant

Monopolar RF

Irrigation

Variable

10 Flow Rate

Prime

Suction

MENU

GROUNDING PAD (NOT SUPPLIED) NON-STERILE SINGLE USE

OLYMPUS SUCTION TUBING (SOLD SEPARATELY) NON-STERILE REUSABLE REPLACE DAILY

FOOTSWICTH NON-STERILE REUSABLE

OPTIONAL MODULE SUCTION MODULE OPTIONAL SUCTION When this not used, is a When not used, is a this standard standard facility wall suction facility wall suction.

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SUCTION CANISTER (NOT SUPPLIED)

SUCTION MODULE (OPTIONAL) NON-STERILE REUSABLE

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Package Contents

The recommended combinations of ancillary equipment and accessories that can be used with the system are shown in the System Chart. In addition, new products released after the introduction of this product may also become compatible with this system. For further details, contact Olympus. WARNING If combinations of equipment other than those shown below are used, the full responsibility is assumed by the medical treatment facility.

SYSTEM CHART (BACK) CONSOLE BACK

SUCTION MODULE (OPTIONAL)

CONSOLE POWER CORD (AC)

COMMUNICATION CABLE HARD WIRED TO SUCTION SYSTEM

SUCTION MODULE POWER CORD (AC)

AVAILABLE REUSABLE EQUIPMENT ITEM

PART NUMBER

DESCRIPTION

Handpieces

MDHP100A MDHP100S

Multidebrider handpiece, angled Mulitdebrider handpiece, straight

Tray

MDHPTRAY

Multidebrider handpiece sterilization tray

Console

MDCONS100

DIEGO ELITE power console

Footswitch

MDFS100 MDSM110V MDSM220V

DIEGO ELITE footswitch DIEGO ELITE suction module - 110 VAC DIEGO ELITE suction module - 220 VAC

Suction system

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Package Contents

AVAILABLE DISPOSABLES ITEM

PART NO.

DESCRIPTION

Tubeset Declog Tubeset Suction Tubing EM Compatible Bracket Nosecone Adapter

TS100S TS101DC TS102SF BEMTS101DC NCGRIP SB4000SS SB4000SC SB4015SS SB4015SC SB4040SS SB4040SC SB4060SS SB4060SC SB4040RS SB4040RC SB4060RS SB4060RC SB4075RC SB4090RS SB4090RC BB2000SA SB2000SA SB4000SA BUR4070DT BUR4015DT BUR3015DB BUR4515BB BUR4215FB BUR4260FB BUR3070DB MM4000SS MM4000SC MS4000SS MS4000SC SB2900SS SB2900SC SB2975SS SB2975SC SB2940SS SB2940SC BB4000SS BB4000SC BB4040XS BB4040XC BB4040SS BB4040SC LB2922SS LB2927SS LB4022SD LB4027SD SB4800SA SB4800SC MB4000SS MB4000SC

MULTIDEBRIDER tubeset, standard, 5/pk MULTIDEBRIDER tubeset, declog, 5/pk Suction module tube set, suction / filter, 5/pk Bracket, EM Sensor, Diego Elite Tubeset, 5/Pk Diego Elite Blade Nosecone Adapter Grip, 5/Pk Shaver blade, 4 mm, straight, standard, serrated, ds, 5/pk Shaver blade, 4 mm, straight, standard, serrated, closed, 5/pk Shaver blade, 4 mm, 15° standard, serrated, ds, 5/pk Shaver blade, 4 mm, 15° standard, serrated, closed, 5/pk Shaver blade, 4 mm, 40° standard, serrated, ds, 5/pk Shaver blade, 4 mm, 40° standard, serrated, closed, 5/pk Shaver blade, 4 mm, 60° standard, serrated, ds, 5/pk Shaver blade, 4 mm, 60° standard, serrated, closed, 5/pk Shaver blade, 4 mm, 40° rotatable, serrated, ds, 5/pk Shaver blade, 4 mm, 40° rotatable, serrated, closed, 5/pk Shaver blade, 4 mm, 60° rotatable, serrated, ds, 5/pk Shaver blade, 4 mm, 60° rotatable, serrated, closed, 5/pk Shaver blade, 4 mm, 75° rotatable, closed, 5/pk Shaver blade, 4 mm, 90° rotatable, serrated, ds, 5/pk Shaver blade, 4 mm, 90° rotatable, serrated, closed, 5/pk Bipolar blade, 2 mm, straight, standard, type A, 5/pk Shaver blade, 2 mm, straight, standard, type A, 5/pk Shaver blade, 4 mm, straight, standard, type A, 5/pk Burr, 4 mm, 70°, diamond taper, 5/pk Burr, 4 mm, 15°, diamond taper, 5/pk Burr, 3 mm, 15°, diamond bullet, 5/pk Burr, 4.5 mm, 15°, ball burr, 5/pk Burr, 4.2 mm, 15°, fluted barrel, 5/pk Burr, 4.2 mm, 60°, fluted barrel, 5/pk Burr, 3 mm, 70°, diamond bullet, 5/pk Malleable, standard, monopolar, 4 mm, T/A, ds, 5/pk Malleable, standard, monopolar blade, 4 mm, O°- 40°, serrated, T/A, closed, 5/pk Malleable, standard, 4 mm, T/A, ds, 5/pk Malleable, standard, 4 mm, O°- 40°, serrated, T/A, closed, 5/pk Shaver blade, 2.9 mm, straight, serrated, ds, 5/pk Shaver blade, 2.9 mm, straight, standard, serrated, closed, 5/pk Shaver blade, 2.9 mm, 75°, standard, serrated, ds, 5/pk Shaver blade, 2.9 mm, 75°, standard, serrated, closed, 5/pk Shaver blade, 2.9 mm, 40°, standard, serrated, ds, 5/pk Shaver blade, 2.9 mm, 40°, standard, serrated, closed, 5/pk Bipolar blade, 4 mm straight, standard, serrated, ds, 5/pk Bipolar blade, 4 mm straight, standard, serrated, closed, 5/pk Bipolar blade, 4 mm 40°, convex, serrated, ds, 5/pk Bipolar blade, 4 mm 40°, convex, serrated,T/A, closed, 5/pk Bipolar blade, 4 mm 40°, standard, serrated, ds, 5/pk Bipolar blade, 4 mm 40°, standard, serrated, closed, 5/pk Laryngeal blade, 2.9 mm, 22 cm, standard, superficial, 5/pk Laryngeal blade, 2.9 mm, 27 cm, standard, superficial, 5/pk Laryngeal blade, 4.0 mm, 22 cm, standard, debulking, 5/pk Laryngeal blade, 4.0 mm, 27 cm, standard, debulking, 5/pk Shaver blade, 4.8 mm, straight, type A plus, 5/pk Shaver blade, 4.8 mm, standard, straight, type A, closed, 5/pk Monopolar blade, 4 mm, straight, standard, serrated, DS, 5/pk Monopolar blade, 4 mm, straight, standard, serrated, closed, 5/pk

4 mm Straight

4 mm Curved

4 mm Rotatable

Turbinate 4 mm Type A

Burrs

Malleable T/A

2.9 mm Straight

2.9 mm Curved

Bipolar

Laryngeal

4.8 mm Type A Monopolar Sinus 4434963 REV AG

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Important Information – Please Read Before Use

IMPORTANT INFORMATION – PLEASE READ BEFORE USE INDICATIONS FOR USE The system, including Image Guided Surgery compatibility, and optional Suction console, is intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT, Sinus / Rhinology, Nasopharyngeal / Laryngology, and Head & Neck procedures.

Specific procedures and applications would include: Sinus / Rhinology: •

FESS (Functional Endoscopic Sinus Surgery)

Including Endoscopic approaches to: Polypectomy, Ethmoidectomy, Sphenoidectomy, Maxillary Antrostomy, Uncinectomy, Frontal Sinusotomy. •

Septal Spur removal

•

Endoscopic DCR

•

Trans-sphenoidal procedures specifically to create access through the sinuses to the Pituitary, Skull base, and CSF leak repair

•

Turbinate Reduction / Turbinoplasty

Including sub mucosal resection

Nasopharyngeal / Laryngeal: •

Adenoidectomy / Tonsillectomy

•

Laryngeal procedures for Recurrent respiratory papilloma, Lesion de-bulking, Polypectomy

Head & Neck: •

Soft tissue shaving

CONTRAINDICATIONS FOR USE • The use of the device is contraindicated for patients with heart pacemakers or other electronic device implants. • There are no known absolute contraindications to the use of radio-frequency surgery. The use of this device is contraindicated when, in the judgment of the physician, electrosurgical procedures would be contrary to the best interests of the patients. • Radio-frequency tissue coagulation may be contraindicated in patients with a compromised immune system.

INSTRUCTION MANUAL This instruction manual contains essential information on using this system safely and effectively. Before use, thoroughly review this instruction manual and the instruction manual of all equipment which will be used during the procedure. Use the equipment as instructed. Keep this and all related instruction manuals in a safe, accessible location. If you have any questions or comments about any information in this instruction manual, please contact Olympus.

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Important Information – Please Read Before Use

USER QUALIFICATION If there is an official standard that defines the qualifications required for medical personnel using this system as defined by a national or local medical administration or other institution, such as an academic society, follow this standard. If there is no such standard, the user must be a physician or medical personnel under supervision of a physician and must have received appropriate training in using powered instrumentation or electrosurgical generators. This instruction manual, therefore, does not explain or discuss surgical procedures. Instruction / training will be provided by authorized representatives of Olympus during installation and commissioning. Federal Law of the USA restricts this device to use by, or on the order of, a physician.

REPAIR AND MODIFICATION This system does not contain any user-serviceable parts. Do not disassemble any reusable equipment, modify, or attempt to repair it; patient or user injury and / or equipment damage may result. Repairs must only be carried out by Olympus or a firm authorized by Olympus. Some problems that appear to be malfunctions may be corrected by referring to Chapter 5–Troubleshooting. If the problem cannot be resolved using the information in Chapter 5, contact Olympus.

SIGNAL WORDS DANGER Indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury. WARNING Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury. CAUTION Indicates a potentially hazardous situation which, if not avoided, may result in

minor or moderate injury. It may also be used to alert against unsafe practices or potential equipment damage. NOTE Indicates additional helpful information.

GENERAL WARNINGS AND SAFETY NOTICES NOTE In this manual, the terms high frequency (HF) and radio frequency (RF) are used interchangeably when referring to the electrosurgical output mode of the system - both monopolar and bipolar. DANGER High frequency leakage current or spark discharge may cause user and / or patient burns. Always prepare for an emergency operation in case of unintentional patient burn, bleeding and perforation. Follow the dangers, warnings and cautions given below when handling this system. This information is to be supplemented by the dangers, warnings and cautions given in each Chapter.

USER-RELATED ERROR PREVENTION DANGER The DIEGO ELITE suction module must only be connected to a standard OR suction canister to provide suction for the DIEGO ELITE handpiece as shown in the System Chart (Front) in the Packaging Contents. In addition, the suction module is intended only to be used with the DIEGO ELITE system for procedures listed in the Indications for Use. Specifically, do not connect this suction module to any patient fluid drainage lines as this could result in serious patient injury or death.

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Important Information – Please Read Before Use

WARNING

Improper use

• The safety and effectiveness of electrosurgical interventions depend not only on the design of the equipment used, but also to a major extent on factors which are under the control of the user. It is therefore extremely important to read, understand and follow the instructions supplied with the system and the accessories in order to ensure safety and effectiveness. • The user should be experienced in open surgical techniques with electrosurgical equipment or obtain training prior to use. • Always use the system as outlined in this instruction manual. Improper use will not only impede functions and prevent optimum performance, but may cause equipment damage and / or complications. Before each use, always inspect the equipment as outlined in this instruction manual. CAUTION Electrosurgery has been employed safely in numerous procedures. Before starting any surgical procedure the physician should be familiar with the medical literature, complications and hazards of electrosurgery in that procedure. CAUTION

Annual safety checks

The console, handpiece, footswitch and optional suction module must undergo a safety check in yearly intervals in accordance with the national statutory regulations. Olympus or a firm authorized by Olympus must be commissioned by the user to perform the yearly safety check. (Refer to Chapter 5– Section 5.4 Maintenance - Annual Safety Checks To Be Performed By Authorized Personnel Only).

ENVIRONMENTAL CONDITIONS CAUTION Studies have shown that smoke generated during electrosurgical procedures can be irritating and potentially harmful to surgical personnel. These studies recommend the use of surgical masks and adequate ventilation of smoke by the use of surgical smoke evacuators or other means. CAUTION

Interference with other equipment

• Be sure that this system is not used adjacent to or stacked with other equipment (other than the components of this system) to avoid electromagnetic interference.

• Interference produced by the operation of high-frequency surgical equipment may influence the operation of other electrical equipment adversely. Refer to Chapter 3–Operation. • Portable and mobile RF communications equipment can affect medical electrical equipment. • The patient should not come into contact with metal parts that are earthed or which have an appreciable capacitance to earth. • Before use, thoroughly confirm the compatibility of all equipment. • The system complies with the electromagnetic compatibility (EMC) standard. Nevertheless, when the system is active it may disturb neighboring electronic equipment. Follow the instructions in Electromagnetic Compatibility (EMC) information in the Appendix regarding electromagnetic ambient conditions. • The console must be placed outside the patient vicinity and must not contact the patient. Do not contact the console and the patient at the same time. • Never loop the cords or bundle cords together with cords belonging to other medical equipment. The high frequency signals or spark discharge noise generated by the system may interfere with the operation of other medical equipment.

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Important Information – Please Read Before Use

• The use of accessories and cables other than those for which the system was designed can significantly degrade emissions and immunity performance. • Do not use the system in a location exposed to strong electromagnetic radiation (microwave or short-wave medical treatment equipment, magnetic resonance imaging, radio or mobile phone equipment). System malfunction can occur. CAUTION Unsuitable temperature and humidity The system should only be used under the conditions as described in Transport, storage and operating environment in the Appendix. Use under other conditions may impede normal performance and / or result in equipment damage.

ACCESSORIES WARNING

Mechanical stress

Do not apply excessive bending, straining or squeezing force to any cords. It may cause malfunction. CAUTION

Damaged and non-compatible accessories

• The system shall only be used with compatible accessories. For a list of compatible grounding pads, refer to Specifications in the Appendix.

• Before use, the system and accessories must be examined for damage. All cables and its plugs must be free of scratches and cracks. Cables and accessories with damaged insulation or connections must not be used.

ELECTRIC SHOCK WARNING To avoid electric shock, this equipment must be connected to a supply mains with protective earth. This equipment is to be used by qualified personnel only . WARNING Grounding failure To prevent the risk of electric shock, the housing of the system must be grounded. Always connect the power cord plug to a properly grounded wall outlet. Do not use a 3-pin / 2-pin adapter, as it can impair safe operation of the system. WARNING User shock To prevent user shock, malfunction and damage of the system, keep liquids away from all electrical equipment. If liquid gets on or into the system, terminate operation immediately and contact Olympus. Do not connect or disconnect blades or grounding pads to the console when RF energy is activated. CAUTION

Injury during servicing

When the housing is opened, there is a danger of electric shock. The system must only be serviced by authorized technicians. Although no return pad is required while servicing the unit, this system should be treated as a high power electrosurgical device.

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Important Information – Please Read Before Use

BURNS WARNING

BURNS (during RF Mode)

• The maximum output voltage characteristics of the system are shown in the diagrams in RF System Specifications in the Appendix.

• The output power selected should be as low as possible. Excessive generator output time or generator level may result in burning of tissue not intended for coagulation. Insufficient generator output time or generator output level may not provide the operator with the desired level of coagulation. • Some applications and / or procedures performed may require increased power settings. The higher the power settings and the longer the energy is applied, the greater the possibility of unintended thermal damage to tissue • Contact with the tip of certain disposables may cause burns when the system is active. • To prevent patient burns, the system and cords should not come in contact with the patient or metal parts of the operating table. Furthermore, the patient should also be kept away from metallic parts of the operating table or other devices. Remove any metallic items from the patient (wristwatches, jewelry, etc.) before starting the electrosurgical system. • If the system is used in conjunction with another system, never use both generators simultaneously. Keep the HF instrument connected to the not-used system away from the target area while the other generator is in operation. Do not activate output of both generators simultaneously. Patient or user injury may occur due to the concentration of electric current. • To prevent patient burns, the patient’s skin surfaces should not touch each other (e.g. bare arm and side of chest) or any metal items in the procedure room. • To prevent patient burns during high frequency treatment, the patient’s clothes must be dry. • During endoscopic treatment the distal end of the endoscope and / or HF instruments must not contact bridging fluids surrounding the target tissue. Electric current may flow to the surrounding normal tissue via these fluids and cause burns. • The endoscopic treatment performed should not include an operation in which part of the treated tissue (polyp head, etc.) or part of the endoscope distal end or endotherapy instrument is in contact with or close to surrounding tissue during high frequency exposure. Otherwise, current flows to the tissue through the part of the treated tissue, the metallic parts at the endoscope’s distal end or endotherapy instrument and may cause burns. • When using cardiac monitoring equipment or other physiological monitoring equipment simultaneously with the device on a patient, any monitoring electrodes should be placed as far away as possible from the electrosurgical grounding pad. Needle monitoring electrodes should not be used, because they may cause patient burns. Physiological monitoring equipment incorporating high-frequency current limiting devices is recommended. • The user and assistant should wear surgical gloves during the procedure. CAUTION

High frequency leakage current

Wherever possible, the patient should not be able to come into contact with electrically conductive components that are grounded. Route all connecting cables so that they are not in direct contact with the patient or other cables. Capacitive coupling may occur.

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Important Information – Please Read Before Use

DANGER

Pacemaker / Defibrillator malfunction

This device may cause malfunction or failure of an active implant when applied to a patient with a pacemaker or other active implants. Before proceeding, always confirm with a cardiologist or the manufacturer of the implant that it is safe to use this device with the implant. WARNING Cardiac emergency Always keep a defibrillator ready in case of a cardiac emergency. During operation of the defibrillator, remove the endoscope and HF instruments from the patient.

FIRE / EXPLOSION DANGER

Ignitable anaesthetics and gases

• Risk of explosion hazard. The sparking and heating associated with electrosurgery has the potential for providing a source of ignition. Observe fire precaution at all times. Do not use in the presence of flammable anesthetics or oxidizing gases such as nitrous oxide or oxygen. Endogenous gases which accumulate in body cavities can also be a source of ignitions. • Ensure all anesthesia circuit connections are leak free before and during use of the system. • Ensure all oxygen circuit connections are leak-free before and during use of system. Ensure endotracheal tubes are leak free and the cuff is properly sealed to prevent oxygen leaks. • Over insufflation of gas prior to high frequency surgery may result in gas embolism. WARNING

Ignitable cleaning- and disinfection agents

• Risk of fire and explosion hazard. Flammable substances such as alcohol based skin prepping agents and tinctures will contribute to increased fire and explosion hazard. Non-flammable agents should be used for cleaning and disinfection and solvents must be allowed to evaporate prior to the application for high frequency surgery. • Non-flammable agents should be used for cleaning and disinfection wherever possible. WARNING

Ignitable materials

• Risk of fire hazard. Do not place active device near or on flammable materials. When not in use place the active device on a clean, dry, non conductive surface away from the patient, surgical personnel or flammable materials. • Tissue build up on tip of an active blade could create embers and pose as a fire hazard, especially in an oxygen enriched environment. Keep blade clean and free of all debris. • When performing electrosurgery, sparks occur which could lead to burning or deflagration of combustible materials..

PROCEDURAL HAZARDS AND COMPLICATIONS WARNING

Electrical stimulation of nerves and muscles

• Neuromuscular stimulation of tissue may occur during RF mode. CAUTION

Generator defect

• To prevent system damage, never short-circuit electrodes (accessories, grounding pads). • In the event of a defect or malfunction in the system, an undesirably high output power may be emitted.

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Important Information – Please Read Before Use

WARNING

Blades, Burrs and Irrigation Tubeset

• Blades, burrs and irrigation tubesets are for single use only. They have not been designed to be reused or resterilized. Reusing and / or reprocessing single use devices can also cause cross-contamination leading to patient infection. These risks may potentially affect patient safety. • Inadvertent activation or movement of the instrument outside the field of vision may result in patient injury. CAUTION • Do not use the monopolar blade as a retractor: Only the tip of the blade should be in contact with the patient during activation. The shaft of this device should not be in contact with metal or any unintended tissue during activation. • Unless otherwise specified in this instruction manual, do not modify this device / equipment. Modification of this device / equipment may result in injury to the patient and / or operator, and damage to the equipment and / or peripheral instruments. This device has no user serviceable parts.

ADDITIONAL SAFETY INFORMATION DANGER • Connect the power plug of the power cord directly to a grounded wall outlet or to a multiple power socket outlet equipped with an insulating transformer of protection class I, conforming to IEC 60601-1. In this case, observe the maximum permitted current or power loading of the multiple power socket outlet and the insulating transformer. • If during operation any irregularity is suspected, do not use the system and refer to Chapter 5 – Troubleshooting. If the irregularity is still suspected after consulting Chapter 5, contact Olympus. Damage or irregularity may compromise patient or user safety and may result in more severe equipment damage. WARNING • If combinations of equipment other than those shown in the System Charts are used, the full responsibility is assumed by the medical treatment facility. • CLEAN AND STERILIZE handpiece before use. Handpiece is shipped from factory NON-STERILE and MUST be cleaned and sterilized before use. See Chapter 4.3–Automated Cleaning Using a Washer Disinfector. • For continued optimal performance of the handpiece: - PLACE PLUG COVER OVER PLUG BEFORE PLACING INTO REPROCESSING EQUIPMENT. - REMOVE THE PLUG COVER BEFORE MANUAL CLEANING. • Do not use a Tubeset after the expiration date. • Inspect the sterile package for tears, inadequate sealing or damage. If the sterile package shows any irregularities the sterile condition of the device may have been compromised. Do not use the device. • Tubesets are supplied STERILE. The outer surfaces of the TyvekTM pouch are not sterile. In order to maintain sterility of the tubeset open the Tyvek pouch ensuring that the tubeset falls onto the sterile field. Do not touch the pouch to the sterile field. • The connection of the tubeset to the handpiece should be performed within the sterile field. • If tubeset is not correctly assembled to the handpiece or is loose, the optical IGS (Image Guidance System) sensor or EM Compatible Bracket that may be attached to the tubeset may not function correctly. This could result in faulty or incorrect navigation results and possible patient injury. - 15 -

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Important Information – Please Read Before Use

• Do not use a blade / burr after the expiration date. • Inspect the sterile package for tears, inadequate sealing or damage. If the sterile package shows any irregularities the sterile condition of the device may have been compromised. Do not use the device. • The connection of the blade or burr to the handpiece should be performed within the sterile field. • Always use split type grounding pads if possible. By using a non-split grounding pad the grounding pad sensor in the console does not work. An unintended detachment of the grounding pad will not be detected and this may result in patient burns. • Unplugging the power cord disconnects the system from the mains. Position the system so unplugging the power cord is accessible. • The suction module is a NON-STERILE item. All connections are made outside of the sterile field. • To prevent patient burns, perforation and bleeding, be sure that you see the tip of the HF instrument in the endoscopic image during activated output in endoscopic procedures. • Do not activate the instrument while adjacent to or in contact with other metallic objects as unintended tissue injury may occur. Damage to the contacted object or device tip may occur. • If output is not required, keep the foot away from the pedal and / or the finger away from the RF activation button to prevent accidental pressing. Otherwise, it may cause user and / or patient burns. • When the Footswitch or the RF Activation Button are not operated and the output tone can be heard, stop the procedure immediately, switch off the system. Otherwise, it may cause perforation, bleeding and user and / or patient burns. • If there is a malfunction at the Footswitch or RF Activation Button, continuous output may cause unintended burns, bleeding and / or perforation of the patient and / or user. • If the output does not stop when the user’s foot is released from the Footswitch Pedal or the user’s finger released from the RF Activation Button, immediately switch off the system to prevent patient burns, perforation and bleeding. • Do not increase the system’s output if a function is not working as expected; doing so could cause patient injury, burns, bleeding and / or perforation. In this case, inspect the cord connections, the contact of the grounding pad and the settings of the system for any abnormalities. • Safe and effective surgery is dependent upon the factors under the control of the user. The user should be experienced in open surgical techniques with electrosurgical equipment or obtain training prior to use. • If visualization of the treatment site or device is lost during the procedure, STOP ACTIVATION IMMEDIATELY. Do not proceed until visibility is restored. • Inadvertent activation or movement of the instrument outside the field of vision may result in patient injury. • Carefully insert and withdraw the device to avoid possible device damage and / or injury to the patient or surgical personnel. • Do not insert or withdraw the instrument from the procedure site while power is being applied. • Do not advance or extend the device abruptly. • Do not touch the instrument tip when power is being applied. • Avoid unnecessary and prolonged activation. This may result in excessive heating to the instrument, which could damage adjacent structures if brought into contact inadvertently or could damage the instrument tip. 4434963 REV AG

2017-07

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Important Information – Please Read Before Use

• The instrument tip and / or shaft may remain hot enough to cause burns after the electrosurgical current is deactivated. • Firmly plug in the power cord so it will not accidentally be dislodged during the procedure. • To prevent malfunction, do not press more than one part on the touch-screen simultaneously. • Touching the touch-screen from an oblique direction may cause malfunction. Always control the touch-screen by viewing from the straight forward direction. • Unintended contact of the touch-screen may cause malfunction. Before activating the output confirm that the present setting is correct. • To prevent malfunction or damage to the touch-screen, do not apply an excessive load on its surface. • Do not control the touch-screen with a pointed object (such as a pen). Otherwise, malfunction or damage may result. • Deposition of dirt and dust between the touch-screen and the front panel may cause malfunction of the touch-screen. To prevent this, wipe the touch-screen with a cloth to remove dirt and dust. • After pressing the Plus button / Minus button, confirm that the output level is changed accordingly. Otherwise, inappropriate output can cause burns to the patient and / or user, patient bleeding and / or perforation. • Connect the footswitch plug securely to the system. Otherwise, output may not be activated. • The footswitch plug is not waterproof, and liquid such as water must not get into the plug. • When connecting or disconnecting the footswitch plug, always hold the plug. Pulling the cable may result in damaging of the wires. • Do not connect products other than the footswitch for this system to the footswitch socket. Otherwise, the footswitch might not function and may cause patient injury and / or damage of the equipment. • The footswitch is not a sterile item. The footswitch connection to the console should be done outside the sterile environment. • Avoid touching the Distal Suction Tip (S) of the blade with your fingers or other instruments. Do not touch or clean the device tip when power is being applied. • Do not allow fingers to contact moving parts. • Do not activate the device with the Stylet (A16) inserted in the shaver blade tip. • Suction sterile water through suction channel as needed. • Always discard used disposable blades, burrs, irrigation tubesets, stylets and grounding pads. Reprocessing single use devices may lead to changes in material characteristics such as metallic corrosion and dulled edges, ceramic and plastic deformation or splitting which may impact the strength of the device and compromise device performance. Reprocessing of single use devices can also cause cross-contamination leading to patient infection. These risks may potentially affect patient safety. • After cleaning the system, dry it thoroughly before storage or using it again. If it is used while still wet, there is a risk of electric shock. • Tissue debris and reprocessing chemicals are hazardous. During cleaning and disinfection, always wear appropriate personal protective equipment, such as eye wear, face mask, moisture-resistant clothing and surgical gloves that fit properly so that your skin is not exposed. Always remove contaminated protective clothing before leaving the reprocessing area. - 17 -

4434963 REV AG

2017-07

Important Information – Please Read Before Use

• Dispose of the blade and tubeset in an appropriate manner. • Do not reuse or attempt to sterilize the disposable accessories. • If the service inspection reveals a defect, or should a unit fault be suspected that could harm the patient, operator, or third parties, immediately notify your Olympus representative. The device should not be used until it has been properly repaired or otherwise serviced by an authorized Olympus technician. CAUTION • Federal Law (USA) restricts this device to sale by or on the order of a physician. • The suction module is built for specific input voltage and there are two options. Model Number MDSM110V MDSM220V

Rated Voltage 100 - 120 VAC 220 - 240 VAC

Please check the model number to ensure that your system is compatible with the local voltage supply at your facility. Electrical damage to the system will occur if the incorrect voltage is supplied to the system. • To reduce the risk of tipping and possible equipment damage, always follow the recommended height guidelines shown in Section 2.2. • To prevent malfunction, do not place the system in the proximity of a wall or other equipment in a way that would block the ventilation openings. • Always use the system in compliance with the environmental conditions during normal operation specified in Transportation, storage and operating environment in the Appendix. Otherwise, the system may not work correctly. • Always carry the console and suction module with the handle provided at the top of each system. • Always use the power cord provided with the system or a cable of similar quality (see Specifications in the Appendix). Never attempt to modify the power cord. • If the same circuit breaker is used to supply power to other electrical equipment, carefully consider the power requirements of the additional equipment and use circuit breakers that have ample capacity. Otherwise, the system does not work correctly. • Portable multiple power socket outlets must not be placed on the floor. Do not use an additional extension cable or other multiple power socket outlets that are not approved by the manufacturer for joint use. • Improper connection of RF-enabled blades may result in arcs, sparks, accessory malfunction or unintended surgical effects. Inspect all accessories and connections to the system before using. • If tubeset is not correctly and completely assembled to the handpiece, damage to the handpiece and / or intermittent blade / burr operation may occur. • Use an electroconductive physiological saline solution. • If blade / burr is not correctly and completely assembled to the handpiece, damage to the handpiece and / or intermittent blade / burr operation may occur. • No error message or audible signal will be generated if an unintended detachment of the non-split grounding pad occurs. Therefore, it is not recommended to use non-split grounding pads. • Apparent low output power at normal operating settings may indicate a faulty application of the grounding pad or poor contact in its connections. Check the connections before selecting a higher output power level. 4434963 REV AG

2017-07

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Important Information – Please Read Before Use

• Use the largest grounding pad that will fit to the patient, especially for obese patients. Otherwise, patient burns may result. The use of large grounding pads is strongly recommended, particularly if high output power levels will be used. • To avoid compression necrosis use only self-adhesive grounding pads. • Do not use capacitive coupling grounding pads as a return path for the high frequency current to avoid incorrect operation of the grounding pad sensor in the console and to prevent patient burns. • Use only original packed grounding pads and check the expiration date of the grounding pad intended to use. If expired grounding pads are used the adhesive may fail to maintain contact with the patient’s skin. Patient burns may result. • Do not use the grounding pad if it has been damaged, modified or has sharp edges. This may cause patient burns. • This system should be used in combination with one of the grounding pads shown in Specifications in the Appendix. • Never attach the grounding pad in the vicinity of a metal implant. The tissue in the vicinity of the metal implant may get burned. • To avoid air entrapment, do not fold or wrinkle the grounding pad and make sure that its surface is smooth. The entire surface of the grounding pad should be in direct contact with the patient’s skin. Incomplete contact between the grounding pad and patient’s skin may result in patient burns. • Apply the grounding pad onto patient's skin with the long edge towards the surgical site. • The site where the grounding pad is intended to be attached must be clean, dry and free of hair. Otherwise the grounding pad can lose contact. Improper contact between the grounding pad and the patient’s skin surface may cause patient burns. If necessary, remove all hair from the area to which the grounding pad will be attached. • When the patient is moved after the grounding pad has been attached, confirm that the grounding pad is still in proper contact with the patient. Otherwise, it may cause patient and / or user burns. • Avoid placing the grounding pad over bony prominences or scar tissue as proper contact might not be obtainable. This may cause patient burns. • The grounding pad should not be reused or repositioned. • If a grounding pad is not connected when a monopolar tip is being used the touchscreen will display a warning “Ground pad not detected. Monopolar RF disabled”. This message cannot be dismissed by the user. It will disappear once a grounding pad is connected or the monopolar tip is removed. • Only bend malleable blades where specified, bending at any other location could cause damage to blade or protective insulation. • When disconnecting plugs or power cords, always hold the plug. Pulling the cable may result in damaging of the wires. • Never immerse the console, footswitch or optional suction module in water, clean or disinfect by immersion, gas sterilization or autoclaving. It may cause equipment damage. • Do not clean footswitch socket, grounding pad socket, handpiece socket or any of the AC power sockets. Cleaning them can deform or corrode the contacts, which could damage the system. • Do not wipe the external surface with hard or abrasive wiping material. The surface will be scratched

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4434963 REV AG

2017-07

Important Information – Please Read Before Use

• HANDPIECE SHOULD BE CLEANED AND STERILIZED PRIOR TO FIRST USE. • CLEAN THE HANDPIECE THOROUGHLY AND IMMEDIATELY AFTER EVERY PROCEDURE. The handpiece is motorized equipment. The reliability and performance of this equipment is highly dependent on proper care and cleaning. • DO NOT AUTOCLAVE THE HANDPIECE UNLESS IT HAS BEEN THOROUGHLY CLEANED ACCORDING TO THE PROCEDURES OUTLINED BELOW. Debris left in the handpiece will be much more difficult to clean and remove after heating in an autoclave and poses an infection risk. The device cannot be rendered sterile if debris remains in the handpiece after cleaning, and patients may suffer infections or other cross-contaminated disease by leftover organic debris. • USE COLD OR COOL DISTILLED WATER FOR RINSING, IF AVAILABLE. COLD OR COOL TAP WATER IS ALSO ALLOWED. • USE WARM WATER FOR ENZYMATIC SOLUTION, OR FOLLOW MANUFACTURER’S INSTRUCTIONS. • ALWAYS WEAR PROTECTIVE EYEWEAR AND POWDER-FREE GLOVES WHILE CLEANING THIS DEVICE. • DO NOT ALLOW FLUID, BLOOD AND TISSUE TO DRY IN THE HANDPIECE PRIOR TO CLEANING OR AUTOCLAVING. Handpiece cleaning should be done immediately following use. • TO CREATE THE HANDPIECE CLEANING SOLUTION: USE ENZYMATIC CLEANER (ENZOL Enzymatic Detergent or CIDEZYME Enzymatic Detergent) AT A SOLUTION MIXTURE OF 2 OUNCES PER GALLON. IF USING A DIFFERENT DETERGENT, FOLLOW THE MANUFACTURER’S INSTRUCTIONS FOR PROPER DILUTION • Always remove blades and tubesets before sterilization of the handpiece. • It is critical to properly clean all reusable devices prior to sterilization. This can be done by using the manual or automated cleaning methods described above. • Do not immerse the handpiece in water (quench) immediately following sterilization as damage to the handpiece may occur • Do not store the system in a location exposed to direct sunlight, x-rays, radioactivity, liquids or strong electromagnetic radiation (e.g. near microwave medical treatment equipment, short-wave medical treatment equipment, magnetic resonance imaging equipment, radio or mobile phones). Damage to the system may result. • Shelf life of the wrapped MDU enclosed in the tray is entirely dependent on the CSR wrap and not the tray. The tray is an optional accessory designed to protect the MDU during sterilization and storage. • Do not subject the system to strong impacts during storage. Doing so will damage the system. • Annual maintenance checks must only be carried out by Olympus or a firm authorized by Olympus. • Before returning the system for repair, disinfect it as described in Chapter 4 – Care, Storage and Disposal . Otherwise cross-contamination of the surrounding environment may result. • Olympus will not assume any liabilities for human injuries or equipment damage caused as a result of servicing or repairs by a person other than the Olympus qualified service personnel.

MALLEABLE TONSIL / ADENOID BLADE (SOLD SEPARATELY) DANGER • DO NOT withdraw the device with blade oscillating or with RF energy activated. • DO NOT attempt to bend the blade while activating RF activation button or footswitch pedal.

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2017-07

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