nCare Medical Video Recorder Instructions for Use V10.4 June 2021

Gyrus ACMI, Inc. 9600 Louisiana Ave. North Brooklyn Park, MN 55445 USA https://medical.olympusamerica.com/ EU Authorized Representative Olympus Europa SE & Co. KG Wendenstraße 20, 20097 Hamburg, Germany Postfach 10 49 08, 20034 Hamburg, Germany LiveStream™, VaultStream™, MedPresence™, EasyView™, EasyCut™, EasyPost™, nCare™, nStream™, EasySuite™, EasyLink™, EasyPort™, StreamGuard™ and TallyLight™ are registered and unregistered Trademarks of Olympus Corporation or its subsidiaries in the U.S. and /or other countries of the world. Other product and company names mentioned herein may be Trademarks of their respective owners in the U.S. and /or other countries of the world. This product is licensed under the AVC Patent Portfolio License for the personal use of a consumer or other uses in which it does not receive remuneration to (i) encode video in compliance with the AVC standard (“AVC video”) and/or (ii) decode AVC video that was encoded by a consumer engaged in a personal activity and/or was obtained from a video provider licensed to provide AVC video. No license is granted or shall be implied for any other use. Additional information may be obtained from MPEG LA, L.L.C. See http://www.mpegla.com © Copyright 2021 Gyrus ACMI, Inc., All rights reserved.

Table of Contents 1 Welcome...8 1.1 Intended Use...8 1.2 Contraindications...8 1.3 Guidelines For Usage...8 1.4 Signal Words...8 1.5 Conventions...9 1.6 Terminology...9 1.7 Manufacturer Information...9 1.8 EU Authorized Representative...9 1.9 Manufacture Date, Serial Number, & Model (REF) Number...10 1.10 Conformance To Standards...10 1.11 Sterilization...10 1.12 Safety...10 1.13 Equipotential Terminal...10 1.13.1 Identification...11 1.13.2 Instruction For Use...11 1.14 Electromagnetic Compatibility (EMC)...11 1.14.1 Guidance And Manufacturer’s Declaration...11 1.14.2 Separation Distance...14 1.14.3 Proximity Fields From Radio Frequency Wireless Communications Equipment...14 1.15 Software Notice...15 1.16 Fragile Electronic Device Notice...15 1.17 Warnings And Cautions...15 1.18 Protective Measures For IT Systems And Networks...17 1.19 Responsibilities For Data Protection And Information Security...18 1.20 Useful Life...18 1.21 End Of Life...18 1.21.1 EU Waste Electrical And Electronic Equipment (WEEE) Directive...18 1.22 Specifications...19 1.23 Operation, Transportation And Storage...19 1.23.1 Remote Connections...20 1.23.2 Printer Support...20 1.23.3 International Keyboard Support...20 1.24 Technical Specifications...21 2 Installation...25 2.1 Parts Identification...25 2.2 Optional Accessories...26 2.3 Installation Notes...27 2.4 Installation Guidelines...27 2.5 Connections...28 2.6 Set Up...29 2.7 Connection of Olympus Devices...30 2.8 Surgical Display Connection Options...31 2.8.1 Direct Connect...31 2.8.2 nCare™ Video Loop Through...32 3 Application Quick Reference...33 3.1 Logging In...33 3.2 Main Menu...33 3.3 Register The Patient...33 3.4 Record The Procedure...34

3.5 Finish The Procedure...35 3.6 Library...36 4 EasyPost™ Video Production...37 4.1 Screen Controls...37 4.2 Using EasyPost™ Video Production...38 5 Application...40 5.1 Logging In...40 5.2 Main Menu...40 5.3 Secure Streaming (option)...41 5.3.1 Enabling Privacy Mode...42 5.4 Physician Presets...43 5.5 Patient Registration...43 5.5.1 Search For Patient...44 5.5.2 Register New Patient...45 5.5.3 Quick Register...46 5.6 Recording...46 5.6.1 Video Recording...48 5.6.2 Video Preview...49 5.6.3 Capture Image...50 5.6.4 AutoLabel (option)...51 5.6.5 AutoClip...52 5.6.6 Reviewing Captured Video During A Procedure...52 5.6.7 Capturing Images During Video Review...54 5.6.8 Video Labels...55 5.6.9 Video Review Keyboard Commands...56 5.6.10 Reviewing Images During A Procedure...57 5.6.11 Image Labels...58 5.6.12 Image Review Keyboard Commands...59 5.6.13 Comparing Current Procedure With Historical Procedure...59 5.6.14 Patient Information...62 5.6.15 Procedure Information/Sharing...63 5.6.16 Printing...64 5.6.17 Finishing The Procedure...66 5.6.18 Customer Satisfaction Survey (if configured)...68 5.6.19 Surgical Display...70 5.6.20 Mobile Connect...70 5.6.21 Thumbnail Information...74 6 Library...76 6.1 Viewing A Historical Procedure...77 6.1.1 Reviewing Historical Video...78 6.1.2 Capturing Images From Historical Procedures...80 6.1.3 Viewing Historical Images...81 6.1.4 Comparing A Historical Procedure...82 6.2 Editing Video...85 6.2.1 Video Clip Types...86 6.2.2 EasyPost™ Video Production Screen Controls...87 6.2.3 Using EasyPost™ Video Production...89 6.3 Patient Information...91 6.4 Procedure Information/Sharing...92 6.5 Printing...93 6.6 Export...94 6.6.1 Export To Server...94 6.6.2 Export To USB...95

6.7 Thumbnail Information...97 7 Maintenance...99 7.1 Logging In...99 7.2 Maintenance Menu...100 7.3 Presets...101 7.4 PACS Settings...104 7.5 System Configuration...106 7.6 Display Settings...109 7.7 Procedure Types...110 7.7.1 Adding A New Procedure...111 7.7.2 AutoLabel...111 7.8 User Administration...114 7.8.1 Adding A New User...115 7.8.2 Editing User Information...116 7.9 Maintenance Actions...117 8 Powering nCare™ On/Off...118 9 Additional Features...119 9.1 Additional Features-Encryption...119 10 MedPresence™ (Option)...120 10.1 MedPresence™ Controls...120 10.1.1 Controls Identification...120 10.2 Starting a MedPresence™ Meeting...121 10.3 Joining While In the Room...122 10.3.1 Join Using QR Code...122 10.3.2 Join Manually...123 10.4 Secure Invite...123 10.4.1 Sending a Secure Invite:...124 10.5 Annotation...125 10.5.1 Annotation Tools...126 10.6 MedPresence™ Version Information...133 11 Video Bypass...134 11.1 Bypassing nCare™ Video...134 12 Cleaning And Maintenance...135 12.1 Cleaning Instructions...135 12.2 Physical Maintenance Instructions...135 13 nCare™ Error Messages...136 14 Best Practices For Patient Privacy...137 14.1 Product Guide...137 14.2 System Use...137 14.3 Backup...137 14.4 Media Handling...138 14.5 Re-use Of Media...138 14.6 Emergency Access...138 14.7 System Access...139 14.8 System Security...140 14.9 Maintenance...140

15 nCare™ Symbol Definitions...141 16 Formatting A USB Drive...143 16.1 Windows 7 & 8...143 16.2 Windows 10...143 17 Glossary...144

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Welcome

1 Welcome 1.1 Intended Use nCare™ is a digital video and still image recording and communication device that assists in the video capture and documentation of medical surgical procedures without controlling or altering the functions or parameters of any connected medical devices. Its intended use is the electronic transfer or exchange of medical device data from a medical device to an electronic storage device for retrieval of medical device data, and to facilitate the electronic conversion of medical device data from one format to another in accordance with a preset specification for the electronic display of medical device data without modifying the data. The captured video recordings and images are only intended for documentation of medical surgical procedures. Video recordings and images are not to be used for diagnosis or treatment. VaultStream™ server is a networked archival and data management server tailored for both clinical and surgical workflow. It enables nCare™ devices to archive patient data, video and still images to a central location. Multiple users can access, review and analyze archived data and images from various locations using either nCare™, VaultStream™ EasyCut™, VaultStream™ EasyView™. nCare™ has been designed to be simple and easy to use through the use of Enterprise class IT interfaces for user management via Active Directory services (Active Directory requires the use of a VaultStream™ Server), and radiology and electronic health record systems for the exchange of information to augment the patient record. Active Directory requires the use of a VaultStream™ server.

1.2 Contraindications There are no known contraindications.

1.3 Guidelines For Usage The nCare™ system and all documentation supporting the system are considered confidential intellectual property of Olympus. Use of these materials must comply with the Olympus Terms and Conditions. Specifications listed are subject to change.

1.4 Signal Words The following signal words may be used throughout this document. WARNING Indicates a potentially hazardous situation which, if not avoided, could result in death, serious injury, loss of data, or damage to equipment.

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NOTICE Indicates a clarification of presented data, or an indication about the system that the user should be aware of.

1.5 Conventions This User Guide has been created to illustrate optimum nCare™ workflow. In addition to a step-by-step explanation of each phase of a procedure, notices, warnings and cautions are included in each section where applicable as indicated below: This is a safety alert symbol. It is used to alert the user to potential physical injury hazards. • Observe all safety messages that follow this symbol to avoid possible injury or damage to equipment. This symbol indicates additional helpful information. A numeration indicates a sequence of actions. 1. 2. • Bullet points indicate individual actions or different options for action. - Dashes indicate the listing of data, options or objects. 1) Numbers with right parenthesis name elements in illustrations.

1.6 Terminology 1.6.1 Terms used in these instructions for use Please see “17 Glossary” on page 144 for a list of terms used in this instruction for use.

1.7 Manufacturer Information Gyrus ACMI, Inc. 9600 Louisiana Ave. North Brooklyn Park, MN 55445 USA https://medical.olympusamerica.com/

1.8 EU Authorized Representative Olympus Europa SE & Co. KG Wendenstraße 20, 20097 Hamburg, Germany Postfach 10 49 08, 20034 Hamburg, Germany

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1.9 Manufacture Date, Serial Number, & Model (REF) Number The Manufacture Date, Serial Number, and Model (REF) Number can be found on labels affixed to the nCare™ system.

2)

1)

Fig. 1 1) Serial Number (see Fig. 1) 2) Model (REF) Number (see Fig. 1)

3) MM/YYYY

Fig. 2 3) Manufacture Date (see Fig. 2)

1.10 Conformance To Standards The electronic components of nCare™ are a combination of off-the-shelf information technology equipment and Olympus designed equipment.

1.11 Sterilization nCare™ components cannot be sterilized. Do not bring these components into the sterile surgical field.

1.12 Safety IEC 60601-1:2005 (Third Edition) + CORR> 1:2006 + CORR. 2:2007 OR IEC 60601-1: 2012 Reprint

1.13 Equipotential Terminal The nCare™ system is equipped with an equipotential bonding point for IEC 60364-7-710 compliance.

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1.13.1 Identification The equipotential bonding terminal is identified on nCare™ using the symbol to the left. 1.13.2 Instruction For Use Where local practice and/or regulations dictate, connect the equipotential bonding terminal on the back of nCare™ to the equipotential bus bar of the facility, or other facility provided equipotential bonding point, using an IEC 60364-7-710 compliant bonding wire. WARNING Risk of Electric Shock According to IEC 60601-1 requirements, this device is equipped with an equipotential conductor. Where local practice and/or regulations dictate, connect the equipotential terminal to the equipotential bus bar of the facility.

1.14 Electromagnetic Compatibility (EMC) IEC 60601-1- 2: 2014 (4th Edition) FCC 47 CFR Part 15, Subpart B, Class A. Operation is subject to the following two conditions: (1) This device may not cause harmful interference. (2) This device must accept any interference received, including interference that may cause undesired operation. 1.14.1 Guidance And Manufacturer’s Declaration Electromagnetic Emissions – For All Medical Electrical Equipment And Medical Electrical Systems nCare™ is intended for use in the electromagnetic environment specified below. The customer or the user of nCare™ should assure that it is used in such an environment. Emissions Test

Compliance

RF Emissions CISPR 11

Group 1

RF Emissions CISPR 11

Class A

Harmonic Emissions IEC 61000-3-2

Not applicable

Voltage Fluctuations / Flicker Emissions IEC 61000-3-3

Not applicable

Electromagnetic Environment - Guidance nCare™ uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

nCare™ is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Electromagnetic Immunity – For All Medical Electrical Equipment And Medical Electrical Systems nCare™ is intended for use in the electromagnetic environment specified below. The customer or the user of nCare™ should assure that it is used in such an environment.

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Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic Environment - Guidance

Electrostatic Discharge (ESD) IEC 61000-4-2

±8 kV contact ±15 kV air

±8 kV contact ±15 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Electrical Fast Transient/ Burst IEC 61000-4-4

±2 kV for power supply lines ±1 kV for input/ output lines

±2 kV for power supply lines ±1 kV for input/output lines

Mains power quality should be that of a typical commercial or hospital environment.

Surge IEC 61000-4-5

±1 kV line(s) to line(s) ±2 kV line(s) to earth

±1 kV line(s) to line(s) ±2 kV line(s) to earth

Mains power quality should be that of a typical commercial or hospital environment.

Voltage Dips, Short Interruptions and Voltage Variations On Power Supply Input Lines IEC 61000-4-11

<5 % UT (>95 % dip in UT) for 0,5 cycle and 1 cycle 70% UT (30% dip in UT) for 30 cycles <5% UT (>95 % dip in UT) for 5 sec.

<5 % UT (>95 % dip in UT) for 0,5 cycle and 1 cycle 70% UT (30% dip in UT) for 30 cycles <5% UT (>95 % dip in UT) for 5 sec.

Mains power quality should be that of a typical commercial or hospital environment, If the user of nCare™ requires continued operation during power mains interruptions, it is recommended that nCare™ be powered from an uninterruptible power supply or a battery.

Power Frequency (50/60 Hz) Magnetic Field IEC 61000-4-8

30 A/m

30 A/m

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

NOTICE UT is the A.C. mains voltage prior to application of the test level.

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Electromagnetic Immunity - For Medical Electrical Equipment And Medical Electrical Systems That Are Not Life-Supporting nCare™ is intended for use in the electromagnetic environment specified below. The customer or the user of nCare™ should assure that it is used in such an environment. Immunity test

IEC 60601 test level

Compliance level

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

Conducted RF IEC61000-4-6

3 Vrms 150 kHz to 80 MHz

3V

Radiated RF IEC 610004-3

3 V/m 80 MHz to 2,7 GHz

3 V/m

80 MHz to 800 MHz 80 MHz to 2,7 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:

NOTICE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTICE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which nCare™ is used exceeds the applicable RF compliance level above, nCare™ should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the [Medical Electrical EQUIPMENT or Medical Electrical SYSTEM]. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m. a

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1.14.2 Separation Distance Recommended Separation Distances Between Portable And Mobile Radio Frequency Communications Equipment And The Medical Electrical Equipment Or Medical Electrical System For Medical Electrical Equipment And Medical Electrical Systems That Are Not LifeSupporting nCare™ is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of nCare™ can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and nCare™ as recommended below, according to the maximum output power of the communications equipment. Recommended separation distances between portable and mobile RF communications equipment and nCare™ Rated maximum output power of transmitter W

Separation distance according to frequency of transmitter m 150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2,7 GHz

0,1

0.12

.12

.23

1

0.38

.38

.73

10

1.2

1.2

2.3

100

3.8

3.8

7.3

12

12

23

0,01

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTICE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTICE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

1.14.3 Proximity Fields From Radio Frequency Wireless Communications Equipment This section applies to nCare™. Proximity Fields From Radio Frequency Wireless Communications Equipment Frequency Range and Level: RF wireless communication equipment Test Frequency (MHz)

Modulation

Immunity Level (V/m)

385

Pulse Modulation: 18 Hz

27

710 745 780 5240 5500 5785

Pulse Modulation: 217 Hz

9

450 810 870 930

Pulse Modulation: 18 Hz

28

1720 1845 1970 2450

Pulse Modulation: 217 Hz

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1.15 Software Notice This system uses open source software and third party software. For further information on the licensing of this software, please refer to https://medical.olympusamerica.com/olympussystems-integration/product-licenses.

1.16 Fragile Electronic Device Notice nCare™ contains fragile electronic components. Failure to use caution when handling the system, or in the event the system must be transported, failure to package the system using the factory supplied materials could result in permanent and costly damage.

1.17 Warnings And Cautions Keep all system components out of the reach of patients. To avoid the risk of electrical shock, do not open up the system. Contact Olympus for authorized service information. Removal of covers will void the warranty. Always disconnect power cords before performing any maintenance work (for authorized service personnel only). Do not use nCare™ or EasyLink™ Adapters in the presence of flammable anesthetics because of risk of explosion. This device is not suitable for use in the presence of flammable mixtures including flammable anesthetic with air, oxygen, or nitrous oxide. Do not store liquid on or near Olympus equipment. Ensure the system is plugged into a properly grounded electrical outlet suitable for devices of this nature. Inspect electrical plug and cord prior to use. Do not use if plug or cord are damaged. Connecting unapproved equipment to Olympus equipment can result in safety hazards. Use of parts or accessories not identified in documentation with Olympus equipment can impair the safe operation of the equipment. If a security warning appears, please contact the facility’s System Administrator. Operator shall not touch any part of the equipment and touch the patient simultaneously. No equipment service, maintenance, or calibration may be performed in the patient environment. Ensure that all interconnecting cables are well managed and positioned to minimize the risks of tripping persons, damaging or interfering with equipment, and damaging cables themselves.

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Any essential video carried through the system that is used in the treatment/therapy of a patient must have an alternate direct source-to-display connection that can be used in the event of any failures leading to procedure delay. nCare™ shall not be used to carry essential video for treatment/therapy where no such alternate path exists. nCare™ shall not be used to control medical equipment not specifically identified in its intended use statement. The facility shall ensure that mains power provided to nCare™ is maintained within the operating specifications of the system at all times while the system is in use. nCare™ system components are Magnetic Resonance Unsafe and shall not be used in MRI environments. Only authorized service personnel should service, maintain, or calibrate nCare™. Use caution to ensure that you are using an appropriate input or output. It is required that the Surgical Safety Bypass Cable be installed prior to starting each procedure. WARNING To avoid the risk of electric shock, this equipment must only be connected to a Supply mains with protective earth.” Front Standby Button illuminated blue indicates system ON and applicable cautions must be observed. See “8 Powering nCare™ On/Off” for more information. WARNING Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. WARNING Use of accessories, transducers, and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. The emissions characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 Class A). If it is used in a residential environment (for which CISPR 11 Class B is normally required) this equipment might not offer adequate protection to radiofrequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment. WARNING Risk of Electric Shock According to IEC 60601-1 requirements, this device is equipped with an equipotential conductor. Where local practice and/or regulations dictate, connect the equipotential terminal to the equipotential bus bar of the facility. WARNING Do not modify this equipment without authorization of the manufacturer.

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Displaying a non 4K source on a 4K display will cause it to be scaled to fit which may cause artifacts or amplification of any flaws present in the signal. When Olympus equipment or any of its component parts reaches the end of its useful life, it should be disposed of in accordance to Federal, State and Local codes. Exercise caution and discretion: media may contain confidential patient information. Consult the facility’s Privacy Policy regarding appropriate handling of this information. United States law restricts this device to sale on or by the order of a surgical medicine practitioner. Incorrect scaling of the video signal may occur if the DVI Output is disconnected or swapped while the system is running, or the system is powered up prior to powering the touch panel up. Restarting the system with the display connected and powered up will correct any scaling inaccuracies. Use caution when inserting a USB drive into the nCare™ system making sure that the USB drive is oriented in the proper direction. Failure to do so could result in damage to the USB port and may cause electrical issues leading to subsequent shutdown and permanent damage to nCare™. nCare™ does not support exporting data to FAT32 formatted USB drives. Only use NTFS formatted USB drives when exporting data. To convert a FAT32 formatted USB drive to NTFS, please see “16 Formatting A USB Drive” on page 143 or contact the facility’s System Administrator. NOTICE: Formatting will erase all data on the USB drive. Backup all data before formatting.

1.18 Protective Measures For IT Systems And Networks This device will not be put on the hospital domain, uses Windows Defender (updates from Windows Server Update Services (WSUS)) for antivirus, and may have Microsoft updates pushed to it using WSUS. The systems hard-drive and any media used for data communication (USB drives) can be encrypted using Windows BitLocker. To ensure this system remains safe and secure from viruses and spyware/malware, the following security procedures are already in place: - The firewall is turned on, and the only exceptions are the ports necessary to run the system. Each of these exceptions is also setup to only talk to specific IP addresses, those of the VaultStream™. - IP exceptions are required for Remote Connect and Mobile Connect see “1.23.1 Remote Connections” on page 20. - If connected to a VaultStream™, the VaultStream™ will have antivirus and all Microsoft patches up to date. - It is the user’s responsibility to ensure that the media used for data communication (USB drive) are free from viruses.

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1.19 Responsibilities For Data Protection And Information Security The user (or IT officer) must ensure that the federal and state regulations relating to data protection are complied with. The operators of IT systems and IT networks are responsible for the definition of the safety standards required, i.e. for the creation of the necessary technical and organizational framework.

1.20 Useful Life Users can expect 7 years if properly maintained.

1.21 End Of Life When this system or any of its component parts reaches the end of its useful life, it should be disposed of in accordance to applicable regulatory requirements. 1.21.1 EU Waste Electrical And Electronic Equipment (WEEE) Directive In August of 2005, the European Union (EU) implemented the EU WEEE Directive 2002/96/ EC and later the WEEE Recast Directive 2012/19/EU requiring Producers of electronic and electrical equipment (EEE) to manage and finance the collection, reuse, recycling and to appropriately treat WEEE that the Producer places on the EU market after August 13, 2005. The goal of this directive is to minimize the volume of electrical and electronic waste disposal and to encourage re-use and recycling at the end of life. If you have purchased Olympus branded electrical or electronic products in the EU and are intending to discard these products at the end of their useful life, please do not dispose of them with your other household or municipal waste. Olympus has labeled its branded electronic products with the WEEE Symbol (see Fig. 3) to alert our customers that products bearing this label should not be disposed of in a landfill or with municipal or household waste in the EU. Instead, please refer to your local electronic and electrical equipment waste regulations for specific disposal requirements or call Olympus Integration Support for proper disposal instructions.

Fig. 3

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1.22 Specifications

1.23 Operation, Transportation And Storage Normal stated conditions for operation should be observed when installing the equipment or bringing equipment online for first use. Please note that this device must be operated and stored within the specifications listed below. WARNING NCare™ and EasyLink™ Adapters are not suitable for use in the presence of flammable mixtures including flammable anesthetic with air, oxygen, or nitrous oxide. Recommended Operating Conditions: The following recommendations should be observed when installing the equipment or bringing equipment online for first use. Please note that this device has no special cooling requirements but must be operated within the specified temperature and humidity range. In addition, equipment should be used in a clean, dry area, and should not be exposed to liquids of any type. 95° F (35° C)

80%

50° F (10° C) 10% - Temperature: 50° F to 95° F (10° C to 35° C) - Humidity: 10% to 80% non-condensing Do not use nCare™ or EasyLink™ Adapters in the presence of flammable anesthetics because of risk of explosion. These devices are not suitable for use in the presence of flammable mixtures including flammable anesthetic with air, oxygen, or nitrous oxide. Recommended Transportation and Storage Conditions: The following recommendations should be observed when transporting or storing nCare™ equipment. Please note that these devices must be stored within the specified temperature and humidity range, in a clean, dry area, and should not be exposed to liquids of any type. 110° F (43° C)

90%

0° F (-18° C) 10% - Temperature: 0° F to 110° F (-18° C to 43° C) - Humidity: 10% to 90% non condensing

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1.23.1 Remote Connections Remote System Minimum Requirements The following minimum system requirements must be met in order for remote access to nCare™. Video playback performance may vary based on the specifications of the remote system being used. Operating System: ������������������� Windows 10 iOS 14 (iPad with screen >=10”) Processor: �������������������������������� Intel Core i5 CPU 1 GHz or faster Graphics Adapter: �������������������� Windows: DirectX 9c compatible with 128+ MB RAM Memory: ����������������������������������� 4 GB RAM (32-bit) 8 GB RAM (64-bit) Hard Drive: ������������������������������ 128 GB Display: ������������������������������������ 1280 × 1024 (1920 × 1080 or 1920 × 1200 preferred) Network: ���������������������������������� Minimum: 100 Mbps Ethernet Preferred: 1 Gbps Web Browser: �������������������������� Windows 10: Internet Explorer 11, Microsoft Edge iOS 14 (iPad with screen >=10”): Mobile Safari During video review, Safari users pressing the “Tab” key to bring up the Labels window, may experience a flash on the screen of the favorites window. To avoid this behavior, the user should use the “L” key instead to invoke the Labels window, or the user should uncheck the “Show Favorites” setting in the Safari Search Preferences, and restart Safari for the change to take effect. *Compatibility View in all versions of Internet Explorer must be disabled. Software rendering must be enabled in Internet Explorer 11. IP exceptions are required for Remote Connect and Mobile Connect. If the I.P. Address of the Apple device has been added to the “Enable Remote View/Control” list of approved connections, the Apple device will be logged into the session, and image and video transfer for inclusion in the clinical record will be enabled. The following browser/operating system combinations are supported by VaultStream™ EasyView™. Video playback performance may vary based on the specifications of the remote system being used. Operating System Browser Windows 7: ������������������������������ IE 11, Chrome Windows 10: ���������������������������� MS Edge, IE11, Chrome Mac OS X 10.15: ��������������������� Safari, Chrome iOS 14 (iPad with screen >=10”): � Mobile Safari 1.23.2 Printer Support Contact Olympus Integration Support for compatible printers. 1.23.3 International Keyboard Support Based on software version, nCare™ may support the use of USB keyboards in the following languages:

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