E-100 Generator User Manual Rev A Nov 2019

Copyright © 2019 Intuitive Surgical, Inc. All rights reserved. Product names are trademarks or registered trademarks of their respective holders.

Trademarks Intuitive Surgical, Intuitive, da Vinci, da Vinci S, da Vinci Si, da Vinci Xi, da Vinci X, and da Vinci Energy are trademarks or registered trademarks of Intuitive Surgical, Inc. Other parties’ trademarks are the property of their respective owners and should be treated as such.

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Contents 1 Introduction... 5 1.2 Compliance and Classifications...5 1.3 About This Manual...5 1.4 Indications for Use/Intended Use...6 1.5 Training Requirements...6 1.6 Compatibility...6 1.7 General Warnings and Cautions...6 High Frequency Electrosurgery Warnings and Cautions... 7 Installation and Service Precautions... 8 1.8 Device Description...9 E-100 Overview... 9 1.9 E-100 Compatible Instruments... 10

2 Preparation and Use... 11 2.1 Inspect... 11 2.2 Prepare for Intraoperative Use... 11 Instrument Energy Modes... 11 E-100 Generator Status... 12 E-100 Error Messages... 13 System Error... 13 11/15/19

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1.1 Contact Information...5

2.3 Intraoperative Use... 14 Precautions for Intraoperative Use... 14 Setup E-100... 14 Install an Instrument... 14 Confirm Compatible Instrument... 16 Activate an Instrument... 16 2.4 Shut Down... 19 Power Off... 19 Clean... 20 Store... 20 2.5 Maintenance... 20 Disposal... 21

3 Troubleshooting... 22 3.1 E-100 Does Not Power On... 22 3.2 E-100 Does Not Activate Instrument... 22

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3.4 Abnormal Neuromuscular Stimulation... 23 3.5 Electrical Interference... 23

A Appendix A: Technical Specifications... 24 A.1 Physical Dimensions... 24 A.2 Environmental Specifications... 24 A.3 Output Characteristics... 25 Output Power vs. Impedance Graphs... 25 A.4 EMC Compatibility... 27 EMC Tables... 27 A.5 Standards and IEC Classifications... 29

B Appendix B: Technical System Information... 30 B.1 Manufacturer Information... 30 B.2 Compliance and Classifications... 30 EMC Certification... 30 Coexistence Information... 30

C Appendix C: Symbols and Icons Reference Table... 31 11/15/19

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3.3 Error Messages... 22 Timeout Reached... 22 Interfering Conductive Material... 23 Inappropriate Tissue Amount... 23 Arc Detected... 23

D Appendix D: Natural Rubber Latex... 33 E Appendix E: Glossary... 34

E-100 Generator

Introduction

This user manual provides details specific to the da Vinci Energy E-100 generator (referred to as the E-100). The E-100 generator is a bipolar electrosurgical unit (ESU) designed to be used with compatible da Vinci instruments and either the da Vinci Xi System (Model IS4000) or the da Vinci X System (Model IS4200), referred to in this document as the “system”. This document is not a reference for surgical techniques. Refer to the appropriate da Vinci System User Manual or da Vinci Instrument User Manual for full information and warnings. Failure to properly follow all instructions, including instructions supplied with the da Vinci System and da Vinci instruments, may lead to injury and result in improper functioning of the device.

1.1 Contact Information For Customer Service and Reporting of Complaints or Adverse Events Use the following information for customer service, including ordering, reporting complaints or adverse events, and general information regarding Intuitive Surgical or our products and services.

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1 Introduction

In the U.S.

In Europe

Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale, CA 94086 USA Toll free: 1.800.876.1310 Direct: 408.523.2100 Fax: 408.523.2377

Intuitive Surgical, Sàrl Chemin des Mûriers 1 1170 Aubonne, Switzerland Toll free: +800.0821.2020 Direct: +41.21.821.2020 Fax: +41.21.821.2021

Technical Support If the system requires maintenance or service, please call our Technical Support line. In the US, call 1.800.876.1310, where phones are staffed 24 hours a day, seven days a week. In Europe, call +41.21.821.2020. Manufacturer Intuitive Surgical, Inc. 1266 Kifer Road Sunnyvale, CA 94086 USA www.intuitivesurgical.com

Intuitive Surgical, Sàrl Chemin des Mûriers 1 1170 Aubonne, Switzerland

1.2 Compliance and Classifications Intuitive Surgical E-100 electrosurgical unit (ESU) is in conformance with the Medical Device Directive 93/42/EEC and is labeled appropriately.

1.3 About This Manual This manual uses the following conventions. • Names of labeled items that appear on hardware or on screen are in bold (Volume).

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Introduction • Blue text is used for cross-references. In electronic versions, cross-references are active, clickable links.

Table 1-1 Note, Caution, and Warning Symbol

Meaning Note: Highlights important information. Caution: Alerts the reader about a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or patient or damage to the equipment or other property. It may also be used to alert against unsafe practices. This includes the special care necessary for the safe and effective use of the device and the care necessary to avoid damage to a device that may occur as a result of use or misuse. Warning: Alerts the reader about a situation which, if not avoided, could result in death or serious injury.

1.4 Indications for Use/Intended Use The E-100 is an electrosurgical generator for use with a compatible da Vinci surgical system. It is an electrosurgical unit intended to deliver high frequency energy (HF) for cutting, coagulation and vessel sealing of tissues. 11/15/19

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This manual presents representative images of the E-100. The representative images provide instruction on the use of the product. In some cases, the aesthetics or dimensions of the device shown in the representative images may be different from the product in use.

1.5 Training Requirements Personnel using the E-100 should receive training specific to the E-100 provided by Intuitive Surgical. Training provided by Intuitive Surgical is limited to the use of da Vinci systems, instruments, and devices including the E-100.

1.6 Compatibility The E-100 is compatible for use with the da Vinci Xi System and the da Vinci X System with software version P9 or higher. For a list of compatible instruments see Table 1-2 on page 10. The E-100 is not compatible for use with other da Vinci systems, such as the da Vinci S or the da Vinci Si Systems. Do not use the E-100 with incompatible da Vinci systems, devices, instruments, or third-party instruments.

1.7 General Warnings and Cautions WARNING: Be sure to read and understand all information, particularly the caution and warning information, found in the applicable user manuals before using these products. Failure to properly follow all instructions, including those supplied with compatible instruments, may lead to injury and result in improper functioning of the ESU.

E-100 Generator

Introduction WARNING: Always have backup equipment available to complete the surgical procedure in case of device failure.

CAUTION: Ensure the E-100 is adequately ventilated to avoid the risk of overheating. CAUTION: Leakage current from interconnected electrical equipment may exceed safe levels. To maintain the safety of patients and users, interconnect only with devices in compliance with IEC 60601-1:2012-08. It is the user’s responsibility to ensure that any interconnected equipment not supplied by Intuitive Surgical maintains compliance with IEC 60601-1:2012-08. CAUTION: The E-100 is intended to be handled and operated in a medical facility by trained personnel. CAUTION: Interference by mobile high-frequency (HF) communication devices may cause the E-100 to perform improperly. NOTE: The E-100 should not be used in the vicinity of magnetic resonance imaging (MRI), computerized tomography (CT), or Electromagnetic Security Systems. The E-100 has not been tested for use in the presence of these devices.

High Frequency Electrosurgery Warnings and Cautions WARNING: Do not use in the presence of flammable anesthetics or oxidizing gases (such as nitrous oxide (N2O) and oxygen) or in close proximity to volatile solvents (such as ether, or alcohol), as explosion may occur. 11/15/19

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CAUTION: The E-100 requires a connection to a dedicated, noise-free, and well-grounded AC power outlet.

WARNING: Do not place instruments near or in contact with flammable materials (such as gauze or surgical drapes). Electrosurgical accessories that are activated or hot from use can cause a fire. WARNING: When not using instruments, place them in a clean, dry, non-conductive and highly visible area not in contact with the patient. Inadvertent contact with the patient may result in burns. WARNING: Do not use in patients who have electronic implants such as cardiac pacemakers without first consulting a qualified professional (for example a cardiologist). A possible hazard exists because interference with the action of the electronic implant may occur, or the implant may be damaged. WARNING: Do not use this device to seal vessels outside of the sealing claim of the instrument. WARNING: Do not use energy based devices (such as electrosurgical pencils or ultrasonic scalpels) to transect seals. WARNING: Connect adapters and accessories to the electrosurgical unit when the energy is off. Failure to do so may result in an injury or electrical shock to the patient or operating room personnel.

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Introduction

WARNING: Failure of the E-100 could result in an unintended increase of output power or activation. WARNING: Avoid energy activation near naturally occurring flammable gases (endogenous) that may accumulate in body cavities such as the bowel. Some materials (such as cotton, gauze), when saturated with flammable gases, may be ignited by sparks produced during energy activation. CAUTION: Do not overfill the jaws of the instrument with tissue, as this may reduce device performance. CAUTION: Do not allow the patient to come into contact with metal parts which are earthed or which have an appreciable capacitance to earth (such as operating table supports, etc.). CAUTION: Avoid skin-to-skin contact (for example between the arms and body of the patient) by insertion of dry gauze. CAUTION: Patient leads should be positioned in such a way that contact with the patient or other leads is avoided. NOTE: When high-frequency (HF) equipment and physiological monitoring equipment are used simultaneously on the same patient, any monitoring electrodes should be placed as far as possible from the surgical electrodes. Needle monitoring electrodes are not recommended. 11/15/19

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WARNING: Due to concerns about the carcinogenic and infectious potential of electrosurgical byproducts (such as tissue smoke plume and aerosols), protective eye wear, filtration masks, and effective smoke evacuation equipment should be used in both open and laparoscopic procedures.

NOTE: Monitoring systems incorporating high-frequency (HF) current-limiting devices are recommended. NOTE: The E-100 provides only bipolar high-frequency (HF) output, and does not require the use of a neutral electrode pad.

Installation and Service Precautions CAUTION: The E-100 requires a connection to a dedicated, noise-free, and well-grounded AC power outlet. CAUTION: The E-100 may only be installed and serviced by Intuitive Surgical personnel. Do not attempt to install or service equipment without Intuitive Surgical personnel. To reduce risk of electric shock, do not open or remove covers.

E-100 Generator

Introduction

1.8 Device Description

Figure 1.1 E-100 generator

E-100 Overview The E-100 front panel (Figure 1.2) includes a Power button, bipolar port, and bipolar port LED. The back panel (Figure 1.3) includes a communications port, power cord connector, power switch, equipotential ground lug, and volume control. 2 1 11/15/19

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The E-100 generator is an electrosurgical unit (ESU) that fits onto the Vision Cart (Figure 1.1). The E-100 connects to the system through the control cable. The functions of the E-100 are initiated by the foot pedals and hand controls (masters) on the Surgeon Console.

3 Figure 1.2 Front panel 1. Power button 2. Bipolar port LED 3. Bipolar port

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Figure 1.3 Back panel 1. Communications port 2. Power cord connector 3. Power switch 4. Equipotential ground lug 5. Volume control

1.9 E-100 Compatible Instruments The E-100 is used in conjunction with single-use instruments. Single-use instruments include the Vessel Sealer Extend and SynchroSeal. See Table 1-2 for a complete list of single-use instruments used with the E-100. Table 1-2 Compatible Instruments Instrument Name

Part Number (PN)

Vessel Sealer Extend

480422

SynchroSeal

480440

For more information, see the applicable Vessel Sealer Extend and SynchroSeal User Manuals. 11/15/19

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E-100 Generator

Preparation and Use

2 Preparation and Use CAUTION: Do not use a defective unit. Inability to activate the E-100 may result in a delay in the surgical procedure. Proper care and handling is essential for satisfactory performance of surgical instruments and accessories. Examine the E-100 generator thoroughly – including all of its housing, components, cables, audio communications, and LEDs – before and after each use. Do not use the device if any abnormality is found. Examples of damage include misaligned, cracked, loose, deformed, missing, contaminated, or bent components. Use the device for its intended purpose only.

2.2 Prepare for Intraoperative Use Instrument Energy Modes The E-100 delivers three energy modes for coagulation, sealing, and transection when used with the da Vinci Energy Vessel Sealer Extend and SynchroSeal. Bipolar or Coag Mode The E-100 Bipolar or Coag mode is a traditional Bipolar mode with a target output of 50 watts. Vessel Sealer Extend refers to this output as Bipolar mode. SynchroSeal refers to this output as Coag mode. (This manual will refer to Bipolar mode for both instruments). Sealing Mode 11/15/19

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2.1 Inspect

The E-100 Sealing mode with Auto Stop is designed to seal vessels and tissue bundles when used with the da Vinci Energy Vessel Sealer Extend and SynchroSeal. The E-100 delivers the required amount of energy necessary to successfully seal vessels and automatically determines when the seal cycle is complete. When used with a compatible instrument, the energy from the E-100 is tailored to optimize sealing performance. Sync Mode The Sync mode with Auto Stop is specifically designed for use with SynchroSeal for single-step sealing and transection of vessels and soft tissue. The Sync mode uses a unique algorithm to control delivery of the energy output to SynchroSeal’s seal and cut electrodes. The E-100 automatically determines when the Sync mode cycle is complete. The result is a single-step hemostatic transection of vessels and soft tissue.

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Preparation and Use Table 2-1 Energy Modes SynchroSeal

Bipolar mode without Auto Stop

Coag mode without Auto Stop

Sealing mode with Auto Stop

Sealing mode with Auto Stop

N/A

Sync mode with Auto Stop

E-100 Generator Status The E-100 alerts the user to several conditions that could affect procedural results. The E-100 status is communicated by illuminating the bipolar port LED and Power button in conjunction with producing audible tones. The bipolar port LED and Power button employ the use of color and flashing to communicate status. In some error or fault conditions, the bipolar port LED status coordinates with a message displayed on the Vision Cart touchscreen and Surgeon Console 3D viewer. The Power button statuses are described in Table 2-2. The bipolar port LED statuses are described in Table 2-3. The audio statuses are described in Table 2-4. Table 2-2 Power Button Status Power Button

Status

Off

Powered down

White, Flashing

Conducting self-test

White, Solid

Powered on and ready to deliver energy

Amber, Flashing

Energy or instrument error

Red, Solid

Non-recoverable fault Table 2-3 Bipolar port LED Status

Bipolar Port LED

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Vessel Sealer Extend

Status

Off

Power is off or no instrument is connected

Yellow then Blue

Conducting self-test

White, Solid

Instrument connected

Blue, Solid

Delivering energy in Bipolar or Sealing mode

Yellow, Solid

Delivering energy in Sync mode

Amber, Flashing

Energy or instrument error, incompatible instrument connected

Red, Solid

Non-recoverable fault

E-100 Generator

Preparation and Use Table 2-4 Audio Status Status Description

Power On

A power on tone indicates the E-100 has been powered on.

Power Off

A power off tone indicates the E-100 has been powered down.

Tone Description Ascending Tone

Descending Tone

Bipolar: Continuous

Activated

An activation tone is provided throughout the Sealing: Continuous duration of energy activation for each of the energy modes. Sync: Alternating

Success

A success tone indicates when the Sealing or Sync mode cycle has been successfully completed.

Error

An error tone indicates an error related to the E-100 has occurred.

Ascending three beeps

Three beeps

E-100 Error Messages In the event of a fault condition, messages appear on the Vision Cart touchscreen and Surgeon Console 3D viewer, see “Troubleshooting” on page 22. 11/15/19

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Status

System Error The system works in conjunction with the E-100 to communicate error conditions. For more information on system errors and audio tones, see the applicable da Vinci System User Manual.

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2.3 Intraoperative Use

WARNING: While in Sealing mode, do not cut sealed tissue unless the desired tissue effect is observed, and the audio tones from the E-100 indicate that the sealing cycle has completed. WARNING: Do not touch the jaws to any clips, sutures, staples or other metal objects while energized. Contact between an active electrode and metal objects may result in alternate site burns or incomplete seals. WARNING: Before applying high-frequency (HF) energy, allow any flammable agents used for disinfecting, cleaning, or as solvents for adhesives, to evaporate. Wipe up any flammable solutions that may have pooled under the patient or in body depressions or cavities. CAUTION: The E-100 requires a connection to a dedicated, noise-free, and well-grounded AC power outlet. CAUTION: Always have backup equipment available to complete the surgical procedure in case of device failure.

Setup E-100 1. Ensure the power switch on the back panel is in the off position.

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Precautions for Intraoperative Use

2. Connect the E-100 power cord to the electrical receptacle on the back panel (Figure 1.3). Connect the power cord to a dedicated, well-grounded AC power outlet. Ensure that the power cord may be easily accessed during the procedure in case an emergency shut down is required. For more information on power supply, see “Power Supply” on page 24 and the applicable System User Manual. 3. Toggle the power switch to the on position. 4. Press the Power button on the front panel. A tone sounds as the E-100 powers on. 5. Verify that the E-100 completes the self-test. See the following steps to verify the self-test. Self-Test • The Power button flashes white for several seconds during the self-test. • The bipolar port LED flashes yellow once and then blue to communicate proper functioning. • If the self-test completes, the Power button illuminates solid white. • If the self-test fails, the Power button flashes amber, an error tone sounds, and an error message displays on the Surgeon Console 3D viewer and Vision Cart touchscreen. If the E-100 does not pass the self-test, see “Troubleshooting” on page 22.

Install an Instrument WARNING: Do not activate the instrument when not in contact with the target tissue, as this may cause injuries due to capacitive coupling with other surgical equipment.

E-100 Generator

Preparation and Use

WARNING: Avoid contact or close proximity of an active monopolar instrument to an instrument connected to E-100. This may cause faults, interference with, or damage to the generator. Follow these steps to install an instrument. 1. Orient the instrument cord connector so that the wide depression in the connector, and the molded arrow faces up (Figure 2.1).

Figure 2.1 Orient instrument connector Insert the instrument cord connector to the bipolar port. Push the instrument cord connector into the bipolar port until it is fully seated (Figure 2.2). The E-100 automatically configures the energy mode for each compatible instrument and cannot be modified. 11/15/19

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WARNING: When installing an instrument, lay the instrument cord as far apart from another instrument cord as possible to avoid capacitive coupling, the transference of energy from an active instrument to the cord of another instrument.

Figure 2.2 Connect instrument cord 2. Install the instrument onto the system. Ensure excess instrument cord is out of the way. The E-100 will not deliver energy until the instrument is correctly installed onto the system. Energy can be controlled by the surgeon when the instrument tip is sufficiently advanced through the tip of the cannula.

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Confirm Compatible Instrument

1. Confirm a compatible instrument is connected, see Table 1-2, “Compatible Instruments,” on page 10.

Figure 2.3 Confirm compatible instrument • If a compatible instrument is connected, reconnect the instrument to both the E-100 and the system. Use firm pressure to insert the instrument cord connector into the bipolar port. Ensure the instrument is properly installed on the system arm. If the condition persists, replace the instrument with a backup instrument. If an instrument is not recognized by the E-100, an error tone sounds, the bipolar port LED flashes amber, and an incompatible instrument message displays on the Surgeon Console 3D viewer. Energy delivery to an incompatible instrument is not possible.

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The E-100 communicates the recognition of a compatible instrument by illuminating the bipolar port LED white. If the bipolar port LED does not illuminate white after connecting a compatible instrument, complete the following steps to confirm a compatible instrument.

Figure 2.4 Incompatible instrument connected Follow these steps if an incompatible instrument message occurs. 1. Confirm a compatible instrument is connected, see Table 1-2, “Compatible Instruments,” on page 10. 2. If a compatible instrument is connected, reconnect the instrument to the E-100 and the system. Use firm pressure to insert the instrument cord connector into the bipolar port. Ensure the instrument is properly installed on the system arm. If the bipolar port LED continues to flash amber, replace the instrument with a backup instrument.

Activate an Instrument WARNING: When applying energy, use the minimum energy necessary to achieve the desired effect. WARNING: Use care, as thermal spread adjacent to target tissue may result in unintended burns. WARNING: Inspect instruments and cables for damage before each use, especially the insulation of laparoscopic or endoscopic instruments. Insulation failures may result in burns or other injuries to the patient or operator.

E-100 Generator

Preparation and Use WARNING: Do not attempt to activate the E-100 using an external foot pedal as this may result in inadequate sealing or unintended injury.

WARNING: Avoid activating energy when the jaws are immersed in conductive fluids. Conductive fluids in direct contact with or in close proximity to an active electrode may carry electrical current or heat away from target tissues, which may compromise the seal or may cause unintended burns to the patient. WARNING: If the active electrodes are contaminated by carbonized tissue prior to sealing, insufficient sealing and tissue sticking can occur. Ensure that the active electrodes are clean during use. WARNING: Do not allow the instrument tip to come into contact with the patient or operator’s skin as this may result in unintended burns. WARNING: Use caution during surgical procedures in which patients exhibit certain types of vascular pathology (atherosclerosis, aneurysmal vessels, etc.). When possible apply the seal to unaffected vasculature. WARNING: Neuro-muscular stimulation (spasms or contraction of muscles and nerves) may result when low frequency currents are delivered or partial rectification of the high-frequency (HF) current occurs. CAUTION: Do not activate the instrument while cleaning away contaminated carbonized tissue, as this may result in injury to operating room personnel.

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WARNING: The surface of the active electrode may remain hot enough to cause burns after the radio-frequency (RF) current is deactivated.

SynchroSeal and Vessel Sealer Extend are activated from the applicable foot pedals and hand controls (masters) on the Surgeon Console (Figure 2.8). The blue pedal activates Coag and Sealing mode for SynchroSeal or Bipolar and Sealing mode for the Vessel Sealer extend, providing bipolar energy to perform coagulation or sealing of vessels. The yellow pedal activates either the Sync mode (cut energy output) for SynchroSeal or the Cut mode (mechanical cutting function) for Vessel Sealer Extend. When a foot pedal is activated, the applicable energy mode will be displayed next to the foot pedal icon in the Surgeon Console 3D viewer and the Vision Cart touchscreen.

Sync mode or Cut mode

Bipolar mode or Coag mode and Sealing mode

Figure 2.5 Surgeon Console foot pedals Bipolar Mode NOTE: See applicable Vessel Sealer Extend or SynchroSeal User Manual for instruction related to grip position and radio-frequency (RF) energy mode.

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Preparation and Use Follow these steps to activate a compatible instrument in Bipolar mode. 1. Press and hold the applicable blue foot pedal to activate energy delivery to the instrument.

2. Release the foot pedal to deactivate energy. There is no success tone for Bipolar mode.

Figure 2.6 Bipolar port LED illuminated blue For more detailed information about instrument Intraoperative Use, see the applicable Instrument User Manual. In case of an Error tone or message, see or “Troubleshooting” on page 22. Sealing Mode Follow these steps to activate a compatible instrument in Sealing mode. 1. Ensure the hand controls are fully closed on the target tissue before applying energy. 2. Press and hold the applicable blue foot pedal to activate energy delivery to the instrument. During activation, the bipolar port LED illuminates blue, and the sealing tone sounds for the duration of energy delivery. When the Sealing mode cycle is complete, energy is automatically deactivated, and a success tone sounds. 11/15/19

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During activation, the bipolar port LED illuminates blue, and the bipolar tone sounds for the duration of energy delivery.

Figure 2.7 Bipolar port LED illuminated blue 3. After the success tone, release the foot pedal. For more detailed information on instrument Intraoperative Use, see the applicable Instrument User Manual. In case of an Error tone or message, see Table 2-4, “Audio Status,” on page 13 or “Troubleshooting” on page 22. Sync Mode Follow these steps to activate a compatible instrument in Sync mode. 1. Ensure the hand controls are fully closed on the target tissue before applying energy. 2. Press and hold the applicable yellow foot pedal to activate energy delivery to the instrument.

E-100 Generator

Preparation and Use

Figure 2.8 Bipolar port LED illuminated yellow 3. After the success tone, release the foot pedal. For more detailed information on instrument Intraoperative Use, see the applicable Instrument User Manual. In case of an Error tone or message, see Table 2-4, “Audio Status,” on page 13 or “Troubleshooting” on page 22.

2.4 Shut Down When the E-100 is no longer needed to produce energy, it should be powered off, cleaned, and stored. Following proper shut down procedures are required to keep the E-100 functioning properly, prepare it for its next use, and ensure safety.

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During activation, the bipolar port LED illuminates yellow, and the sync tone sounds for the duration of energy delivery. When the Sync mode cycle is complete, energy is automatically deactivated, and a success tone sounds.

1. Press and hold the E-100 Power button (Figure 2.9). A power off tone sounds as the E-100 is powered off.

Figure 2.9 Press and hold the Power button 2. Disconnect the power cord from the AC power outlet.

Figure 2.10 E-100 powered off and instrument disconnected

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Clean

CAUTION: Avoid wiping the E-100 with an overly saturated cloth or directly spraying the E-100 to avoid any fluid from entering the housing which could lead to device damage. When cleaning the E-100, use only the following solutions: anti-bacterial soap, 10% bleach solution, 70% isopropyl alcohol, Cavicide, Caviwipes, or Envirocide. Follow procedures approved by your institution or use validated infection control procedures. 1. Ensure the E-100 is powered off, and the power cord has been disconnected from the AC power outlet.

Figure 2.11 Power down the E-100 2. Ensure the instrument cord connector has been disconnected (Figure 2.10) before cleaning the E-100. Using a cloth dampened with one of the cleaning solutions listed above, thoroughly wipe all surfaces of the E-100 and connecting areas of the Vision Cart.

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WARNING: Power off and unplug the device before cleaning to avoid the risk of shock to medical personnel.

Figure 2.12 Wipe E-100 and surrounding areas

Store See Table A-4 on page 25 for more information on storage parameters.

2.5 Maintenance WARNING: Risk of electric shock. The E-100 contains hazardous voltages. Do not open the enclosure. The E-100 does not contain any user serviceable parts.

E-100 Generator