DIEGO ELITE System Instructions for Use Rev AL March 2022

Diego Elite System Instructions for Use

Table of Contents

Table of Contents 1 Labels ...1 2 Package Contents... 2 2.1 Available Reusable Equipment... 4 2.2 Available Disposables... 4

3 Important Information... 6 3.1 3.2 3.3 3.4 3.5

Indications for Use... 6 Contraindications For Use ... 6 Serious Incident Reporting Process ... 6 Instruction Manual ... 6 User Qualification ...7

3.5.1 Repair and Modification ...7

3.6 Symbols Used in this Document...7

4 Warnings and Cautions ... 8 4.1

General Warnings And Safety Notices... 8

4.1.1 User-Related Error Prevention ... 8 4.1.2 Environmental Conditions ...10 4.1.3 Accessories... 10 4.1.4 Electric Shock ...11 4.1.5 Burns... 12 4.1.6 Fire / Explosion ... 14 4.1.7 Procedural Hazards and Complications ... 14

4.2 Additional Safety Information ...16

4.2.1 Malleable Tonsil / Adenoid Blade... 21 4.2.2 Image Guidance System (IGS) ... 22

5 Nomenclature and Functions ... 23 5.1 5.2 5.3 5.4 5.5 5.6 5.7

Console... 23 Footswitch ... 24 Handpiece... 24 Disposable Blade and Tubeset Features... 25 Declog Tubeset Features... 26 Suction Module... 27 Touch Screen ... 28

5.7.1 Home Screen ... 28

5.8 Settings Menu... 29

6 Installation and Setup ... 30

6.1 Installation of System ... 30 6.2 Connecting Console to an AC Mains Power Supply ... 31 6.3 Menu / Settings... 33

6.3.1 Languages ... 34 6.3.2 Software Version ... 35 6.3.3 Touch Tone... 36 6.3.4 Service ... 36

6.4 Connection of Peripheral Equipment ...37

6.4.1 Touch Screen / Power ...37

6.5 Connection of Footswitch... 38 4434963_AL

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Diego Elite System Instructions for Use

6.6 Handpiece Connection ... 40 6.7 Tubeset Connection... 43 6.8 Blade / Burr Connection ... 44 6.9 Irrigation ... 45 6.10 Grounding Pad...47 6.10.1 Split Type Grounding Pad ... 47 6.10.2 Non-Split Grounding Pad ... 48 6.10.3 Connection of the Grounding Pad ... 48

6.11 Suction Module Setup and Suction Tubing Setup ...51 6.12 Blade / Burr ID... 53

6.12.1 Monopolar Tip Connected ... 53 6.12.2 Tip Without RF Connected ... 54 6.12.3 Blade / Burr Connected... 55 6.12.4 Other Display Screens ...56

6.13 Manual Setup... 57

6.13.1 Handpiece... 57 6.13.2 Manually Select Tip Only... 59

6.14 Image Guidance System Compatibility with Brainlab ... 62 6.15 Nosecone Adapter Grip ... 63

7 Operation ...66 7.1 7.2

Cutting Tissue and RF Activation... 66 Operation Screens... 67

7.3

Malleable Tonsil / Adenoid Blade ...74

7.4 7.5

Clean Shaver Blade Tip... 76 Using The Declog Tubeset Feature ...77

7.6

Procedure After Use ... 78

8.1

Care ... 79

7.2.1 Ready ...68 7.2.2 Cutting Active...69 7.2.3 RF Active ... 70 7.2.4 Cutting and RF Active ...71 7.2.5 Cutting Active with Non-RF Tip... 72 7.2.6 Ready ... 73 7.2.7 Cutting Active... 74 7.3.1 Bending Tip for Tonsillectomy ... 75

7.5.1 Assemble Declog Tubeset to Pressure Bulb... 77 7.5.2 When a Clog is Encountered... 77

8 Care and Storage ... 79 8.1.1 Console, Footswitch, Suction Module and Suction Tubing (Optional) ... 79

8.2 Manual Cleaning of the Handpiece - Following Use ... 80

8.2.1 Cleaning Procedure ...80

8.3 8.4 8.5 8.6 8.7

Automated Cleaning Using a Washer Disinfector ... 83 Steam Sterilization... 84 STERRAD System Sterilization ... 85 Storage ... 85 Disposal ... 86

8.7.1 Console, Suction Module And Footswitch Only...86

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9 Safe Disposal of Hazardous Waste... 87 9.1

Safe Disposal of Waste Electrical and Electronic Equipment (WEEE)... 87

9.1.1 Waste Electrical and Electronic Equipment...87 9.1.2 Safe Disposal of Waste Electrical Equipment...87 9.1.3 User Responsibility and Applicable Standards ...87

9.2 Disposable, Single Use Products... 88 9.3 Disposable Products... 88 9.4 Reusable Products... 90

10 Repair ... 90 11 Troubleshooting...91 11.1 Irrigation ... 91

11.1.1 Pump Open... 91

11.2 Grounding Pad... 92 11.3 Generic Error Message ... 93 11.3.1 Other Alert Messages ... 94 11.3.2 Error without Error Message ... 95

11.4 Maintenance ... 98

11.4.1 Service Inspections to Be Performed before Each Use ... 99 11.4.2 Visual Inspection ... 99 11.4.3 Operation Inspection ...100

11.5 Annual Safety Checks ...100 11.6 Returning the System for Repair ...100

12 Specifications ... 101 12.1 RF System Specifications... 101

12.1.1 Bipolar Specifications...101 12.1.2 Monopolar COAG Specifications ...101

12.2 Transportation, Storage and Operating Environment ...102 12.3 Console...102 12.4 Power Cords ...103 12.5 Footswitch (REF: MDFS100, Single Pedal)...103

13 Compatible Grounding Pads (Neutral Electrodes) ...103 13.0.1 Suction Module...104 13.0.2 Electromagnetic Compatibility (EMC) Information ...104 13.0.3 Electrical Connections ...104 13.0.4 ESD Precautionary Measures ...105 13.0.5 Guidance and Manufacturer’s Declaration - Electromagnetic Emissions ...105 13.0.6 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity ...106 13.0.7 Recommended Separation Distances between Portable and Mobile High Frequency Communication Equipment and the System ...109

14 Reprocessing Instructions Summary... 110 15 Symbols ... 113 16 Sterilization Log ... 119

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List of Figures

Diego Elite System Instructions for Use

List of Figures

Figure 1 Console...1 Figure 2 Suction Module...1 Figure 3 System Chart (Front)... 2 Figure 4 System Chart (Back) ... 3 Figure 5 Console... 23 Figure 6 Footswitch ... 24 Figure 7 Handpiece ...25 Figure 8 Disposable Blade and Tubeset Features ...26 Figure 9 Disposable and Reusable Parts...26 Figure 10 Declog Tubeset ... 27 Figure 11 Suction Module... 27 Figure 12 Home Screen...28 Figure 13 Settings Menu ...29 Figure 14 Typical Set Up - Recommended Heights...31 Figure 15 Connect the Power Cord to the AC Power Socket... 32 Figure 16 Home Screen... 33 Figure 17 Settings Menu... 33 Figure 18 Select Language... 34 Figure 19 Language Confirmation... 34 Figure 20 Software Version ... 35 Figure 21 Touch Tone Menu... 36 Figure 22 Home Screen... 38 Figure 23 Connect Footswitch... 39 Figure 24 Footswitch Connected Screen ... 39 Figure 25 Handpiece Connector ... 40 Figure 26 Handpiece Connected - No Suction Connected ...41 Figure 27 Handpiece Connected - No Suction Connected ...41 Figure 28 Bipolar Error, Check Blade And Handpiece Connections ... 42 Figure 29 Monopolar Error, Check Blade and Handpiece Connections ... 42 Figure 30 Default to a Standard Blade ... 42 Figure 31 Tubeset Assembly ... 44 Figure 32 Blade-Burr Assembly... 45 Figure 33 Irrigation Pump Lever... 46 Figure 34 IV Spike Cover ... 46 Figure 35 Priming Irrigation... 47 Figure 36 Priming Complete... 47 Figure 37 Grounding Pad Socket...50 Figure 38 Grounding Pad Connected...50 Figure 39 Suction Standby Switch...52 Figure 40 Connect Blade or Burr Prompt ... 53 Figure 41 Monopolar Tip Connected... 53 Figure 42 Tip without RF Connected ... 54 Figure 43 Burr Connected ...55 Figure 44 Tip Connected No Footswitch Connected ... 55 Figure 45 Suction OFF ...56 Figure 46 Irrigation OFF...56 Figure 47 Home Screen... 57 iv

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List of Figures

Figure 48 Connect Blade or Burr... 58 Figure 49 Select Tip Type... 58 Figure 50 Manually Selected Microdebrider and Blade... 59 Figure 51 Manually Selected Microdebrider and Burr ... 59 Figure 52 Automatically Identifies Handpiece ... 60 Figure 53 Select Tip Type... 60 Figure 54 Manually Selected Blade ... 61 Figure 55 Manually Selected Burr... 61 Figure 56 Settings Menu ... 61 Figure 57 Reverse Irrigation... 61 Figure 58 Place Optical IGS Sensor on Tubeset ... 63 Figure 59 Tighten Starlink Interface Screw... 63 Figure 60 EM Compatible Bracket ... 63 Figure 61 EM IGS Sensor on Bracket ... 63 Figure 62 Position EM IGS Sensor... 63 Figure 63 Slide Nosecone Adapter Grip over Distal Tip... 64 Figure 64 Snap Nosecone Adapter in Place ... 64 Figure 65 Remove Nosecone Adapter Grip ... 64 Figure 66 Ready ... 69 Figure 67 Cutting Active... 69 Figure 68 RF Active ... 70 Figure 69 Cutting and RF Active... 71 Figure 70 Cutting Active with No RF Tip ...72 Figure 71 Tip without RF Connected...72 Figure 72 Ready ...73 Figure 73 Forward and Reverse Buttons ...73 Figure 74 Cutting Active...74 Figure 75 Microdebrider Shaver Blade Angle for Adenoidectomies ...74 Figure 76 Bending Tip for Tonsillectomy ...76 Figure 77 Insert the Stylet into Shaver...76 Figure 78 Do not Activate with Stylet in Shaver Blade Tip...76 Figure 79 Declog Valve ...77 Figure 80 Tubeset Release ...78 Figure 81 Immerse Handpiece in Handpiece Cleaning Solution ... 81 Figure 82 Large Nylon Bristle Brush ... 81 Figure 83 Actuate Blade Retention Mechanism... 81 Figure 84 Small Nylon Bristle Brush... 82 Figure 85 Scrub the 3-pin Receptacle Pocket... 82 Figure 86 Scrub Shelf with Olympus Logo ... 82 Figure 87 Scrub Under Overhanging Walls... 82 Figure 88 Flush Interior of Handpiece ... 83 Figure 89 Flush Gear Cavity ... 83 Figure 90 Pump Open ... 91 Figure 91 No Grounding Pad... 92 Figure 92 Grounding Pad Connected... 92 Figure 93 Generic Error Message ... 93 Figure 94 Bipolar Load Response ...101 Figure 95 Monopolar Load Response ...101 4434963_AL

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List of Tables

Diego Elite System Instructions for Use

List of Tables

Table 1 Table 2 Table 3 Table 4 Table 5 Table 6 Table 7 Table 8 Table 9 Table 10 Table 11 Table 12 Table 13 Table 14 Table 15 Table 16 Table 17 Table 18 Table 19 Table 20 Table 21 Table 22 Table 23 Table 24 Table 25 Table 26 Table 27 Table 28 Table 29

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Available Reusable Equipment... 4 Available Disposables ... 4 Power Cords ... 24 Image Guidance Systems (IGS) Compatible Blades / Burrs ... 64 Ready Screens...68 Steam Sterilization ... 84 STERRAD Sterilization...85 Waste Electrical and Electronic Equipment... 87 Available Disposables ... 88 Available Reusable Equipment...90 Other Alert Messages... 94 Error without Error Message ...95 Transportation, Storage and Operating Environment... 102 Console... 102 Power Cords ... 103 Footswitch ... 103 Compatible Grounding Pads ... 103 Power Supply ...104 Size, Weight, and Packaging...104 Classification ...104 Guidance and Manufacturer’s Declaration - Electromagnetic Emissions ... 105 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity ... 106 Recommended Separation Distances... 109 Console (Front) ... 113 Console (Pump) ... 113 Touch Screen... 113 Packaging Symbols ... 114 Other Symbols... 118 Sterilization Log... 119

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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 Chapter 15 Symbols. Figure 1 Console

Figure 2

Suction Module

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Package Contents

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Diego Elite System Instructions for Use

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 +1 888 524 7266 or +1 763 416 3000 or www.medical.olympusamerica.com. Figure 3 System Chart (Front)

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Package Contents

The recommended combinations of ancillary equipment and accessories that can be used with the system are shown in Figure 3 System Chart (Front) on Page 2. 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. Figure 4

System Chart (Back)

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Diego Elite System Instructions for Use

2.1

Available Reusable Equipment

Table 1

Available Reusable Equipment

Item

Part Number

Handpieces

MDHP100A MDHP100S

Mulitdebrider handpiece, straight

Tray

MDHPTRAY

Multidebrider handpiece sterilization tray

Console

MDCONS100

Diego Elite System power console

Footswitch

MDFS100

Diego Elite System footswitch

Suction system

MDSM110V

Diego Elite Systemsuction module - 110 VAC

MDSM220V

Diego Elite System suction module - 220 VAC

2.2

Available Disposables

Table 2

Available Disposables

Item Tubeset

Part No.

Multidebrider handpiece, angled

Description

TS100S

MULTIDEBRIDER tubeset, standard, 5/pk

Declog Tubeset

TS101DC

MULTIDEBRIDER tubeset, declog, 5/pk

Suction Tubing

TS102SF

Suction module tube set, suction / filter, 5/pk

EM Compatible Bracket

BEMTS101DC

Bracket, EM Sensor, Diego Elite Tubeset, 5/pk

Nosecone Adapter

NCGRIP

Diego Elite System Blade Nosecone Adapter Grip, 5/pk

4 mm Straight

SB4000SS

Shaver blade, 4 mm, straight, standard, serrated, ds, 5/pk

SB4000SC

Shaver blade, 4 mm, straight, standard, serrated, closed, 5/pk

4 mm Curved

4 mm Rotatable

Turbinate

4

Description

SB4015SS

Shaver blade, 4 mm, 15° standard, serrated, ds, 5/pk

SB4015SC

Shaver blade, 4 mm, 15° standard, serrated, closed, 5/pk

SB4040SS

Shaver blade, 4 mm, 40° standard, serrated, ds, 5/pk

SB4040SC

Shaver blade, 4 mm, 40° standard, serrated, closed, 5/pk

SB4060SS

Shaver blade, 4 mm, 60° standard, serrated, ds, 5/pk

SB4060SC

Shaver blade, 4 mm, 60° standard, serrated, closed, 5/pk

SB4040RS

Shaver blade, 4 mm, 40° rotatable, serrated, ds, 5/pk

SB4040RC

Shaver blade, 4 mm, 40° rotatable, serrated, closed, 5/pk

SB4060RS

Shaver blade, 4 mm, 60° rotatable, serrated, ds, 5/pk

SB4060RC

Shaver blade, 4 mm, 60° rotatable, serrated, closed, 5/pk

SB4075RC

Shaver blade, 4 mm, 75° rotatable, closed, 5/pk

SB4090RS

Shaver blade, 4 mm, 90° rotatable, serrated, ds, 5/pk

SB4090RC

Shaver blade, 4 mm, 90° rotatable, serrated, closed, 5/pk

BB2000SA

Bipolar blade, 2 mm, straight, standard, type A, 5/pk

SB2000SA

Shaver blade, 2 mm, straight, standard, type A, 5/pk

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Table 2

Package Contents

Available Disposables (Continued)

Item

Part No.

Description

4 mm Type A

SB4000SA

Burrs

BUR4070DT

Burr, 4 mm, 70°, diamond taper, 5/pk

BUR4015DT

Burr, 4 mm, 15°, diamond taper, 5/pk

BUR3015DB

Burr, 3 mm, 15°, diamond bullet, 5/pk

BUR4515BB

Burr, 4.5 mm, 15°, ball burr, 5/pk

BUR4215FB

Burr, 4.2 mm, 15°, fluted barrel, 5/pk

BUR4260FB

Burr, 4.2 mm, 60°, fluted barrel, 5/pk

Malleable T/A

2.9 mm Straight

2.9 mm Curved

Bipolar

Laryngeal

4.8 mm Type A

Monopolar Sinus

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Shaver blade, 4 mm, straight, standard, type A, 5/pk

BUR3070DB

Burr, 3 mm, 70°, diamond bullet, 5/pk

MM4000SS

Malleable, standard, monopolar, 4 mm, T/A, ds, 5/pk

MM4000SC

Malleable, standard, monopolar blade, 4 mm, 0°- 40°, serrated, T/A, closed, 5/pk

MS4000SS

Malleable, standard, 4 mm, T/A, ds, 5/pk

MS4000SC

Malleable, standard, 4 mm, O°- 40°, serrated, T/A, closed, 5/pk

SB2900SS

Shaver blade, 2.9 mm, straight, serrated, ds, 5/pk

SB2900SC

Shaver blade, 2.9 mm, straight, standard, serrated, closed, 5/pk

SB2975SS

Shaver blade, 2.9 mm, 75°, standard, serrated, ds, 5/pk

SB2975SC

Shaver blade, 2.9 mm, 75°, standard, serrated, closed, 5/pk

SB2940SS

Shaver blade, 2.9 mm, 40°, standard, serrated, ds, 5/pk

SB2940SC

Shaver blade, 2.9 mm, 40°, standard, serrated, closed, 5/pk

BB4000SS

Bipolar blade, 4 mm straight, standard, serrated, DS, 5/pk

BB4000SC

Bipolar blade, 4 mm straight, standard, serrated, closed, 5/pk

BB4040XS

Bipolar blade, 4 mm 40°, convex, serrated, DS, 5/pk

BB4040XC

Bipolar blade, 4 mm 40°, convex, serrated,T/A, closed, 5/pk

BB4040SS

Bipolar blade, 4 mm 40°, standard, serrated, DS, 5/pk

BB4040SC

Bipolar blade, 4 mm 40°, standard, serrated, closed, 5/pk

LB2922SS

Laryngeal blade, 2.9 mm, 22 cm, standard, superficial, 5/pk

LB2927SS

Laryngeal blade, 2.9 mm, 27 cm, standard, superficial, 5/pk

LB4022SD

Laryngeal blade, 4.0 mm, 22 cm, standard, debulking, 5/pk

LB4027SD

Laryngeal blade, 4.0 mm, 27 cm, standard, debulking, 5/pk

SB4800SA

Shaver blade, 4.8 mm, straight, type A plus, 5/pk

SB4800SC

Shaver blade, 4.8 mm, standard, straight, type A, closed, 5/pk

MB4000SS

Monopolar blade, 4 mm, straight, standard, serrated, DS, 5/pk

MB4000SC

Monopolar blade, 4 mm, straight, standard, serrated, closed, 5/pk

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Important Information

3

Diego Elite System Instructions for Use

Important Information

Please Read Before Use

3.1

Indications for Use

The Diego 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:

3.2

•

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.

3.3

Serious Incident Reporting Process

3.4

Instruction Manual

Report any serious incident relating to the use of this product to Olympus and to the health authority of the country in which it occurred. This applies to any incident where a shortcoming in the performance, usability, or labeling of this product has led, might have led, or could lead to the death or a permanent or temporary deterioration in the state of health of the patient, user, or others. It also applies to any incident that indicates that a serious public health threat exists. 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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Diego Elite System Instructions for Use

3.5

Important Information

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.

3.5.1

Repair and Modification

3.6

Symbols Used in this Document

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 11 Troubleshooting on Page 91. If the problem cannot be resolved using the information in Chapter 11, contact Olympus.

CAUTION Caution identifies procedures that you must follow to avoid compromising processes, to prevent damage to equipment, loss of data, damage to files in software applications, or minor injury. WARNING Warning identifies procedures that you must follow to prevent death or serious injury.

DANGER Danger alerts the operator to a hazard with a high level of risk which, if not avoided, will result in death or serious injury associated with the use or misuse of the device. WARNING Warning Electricity identifies potential Electric Shock Hazards.

NOTE Note alerts the operator to particularly important information.

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Warnings and Cautions

4

Diego Elite System Instructions for Use

Warnings and Cautions WARNING Warning Electricity identifies potential Electric Shock Hazards.

4.1

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.

4.1.1

User-Related Error Prevention DANGER

The Diego Elite System suction module must only be connected to a standard OR suction canister to provide suction for the Diego Elite System 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 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. CAUTION Suction is important in the performance of the DIEGO ELITE system. In order to provide optimal blade and burr performance, the system must be connected to a strong, dedicated vacuum source. In addition, a reduced amount of suction may result in damage to the tubeset and/or handpiece.

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Diego Elite System Instructions for Use

Warnings and Cautions

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 Checkst 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. Section 11.5 Annual Safety Checks on Page 100.

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Warnings and Cautions

4.1.2

Diego Elite System Instructions for Use

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.

Interference with Other Equipment CAUTION • 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 7 Operation on Page 66. • 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. • 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.

Unsuitable Temperature and Humidity CAUTION The system should only be used under the conditions as described in Chapter 12 Specifications on Page 101. Use under other conditions may impede normal performance and / or result in equipment damage.

4.1.3

Accessories

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

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Warnings and Cautions

Damaged and Incompatible Accessories CAUTION • 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.

4.1.4

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

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Warnings and Cautions

Diego Elite System Instructions for Use

Grounding Failure WARNING 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 3pin / 2-pin adapter, as it can impair safe operation of the system.

User Shock WARNING 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.

Injury during Servicing CAUTION 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.

4.1.5

Burns

Burns during RF Mode WARNING • 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.

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Diego Elite System Instructions for Use

Warnings and Cautions

• 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.

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.

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.

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.

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