AR-3200-0030 NANOSCOPE Console User Guide Rev 0 Sept 2020

This is not a warranty document. For all warranty information, including disclaimers, exclusions, terms, conditions and related provisions, refer to the Arthrex U.S. Product Warranty section of the Arthrex, Inc. website, found at www.arthrex.com whose provisions are incorporated herein by reference.

Table of Contents 1.0 1.1 1.2 1.3 1.4

2.0 2.1 2.2 2.3

3.0 3.1 3.2 3.3 3.4 3.5

4.0 4.1 4.2 4.3 4.4

5.0 5.1

6.0 6.1

7.0 7.1 7.2 7.3

General Warnings, Training and Safety Notices – Read This First ... 1 Important Safety Conventions ... 1 Information ... 3 Symbol Definitions ... 6 Shipping, Unpacking, and Warranty Information ... 9

Product Description/Features/Intended Use... 10 Product Description ... 10 Product Features ... 11 Intended Use... 12

Technical Specifications ... 13 NanoScope System... 13 Ambient Conditions for Operation ... 14 Ambient Conditions for Storage (in shipping packaging) ... 14 Nano Camera Handpieces ... 15 Safety, EMC, and Regulatory Requirements ... 16

Setup & Use ... 19 Set up the NanoScope Console (Non-Sterile)... 19 Prepare the Nano Camera Handpiece and Accessories (Sterile) ... 21 Performing a NanoScope Procedure ... 22 Ending a NanoScope Procedure ... 22

Cleaning and Disinfecting ... 23 NanoScope Console... 23

Sterilization ... 24 Transmissible Spongiform Encephalopathy Agents ... 24

Maintenance ... 25 Periodic Maintenance ... 25 Service Manual ... 25 Annual Calibration ... 25

8.0

Technical Support... 26

9.0

Troubleshooting ... 27

10.0

Repair Policy ... 29

11.0

End of Life, Environmental Directives... 30

12.0

Electromagnetic Emissions ... 31

i

Table of Figures FIGURE 1

NANOSCOPE CONSOLE ...11

FIGURE 2

NANOSCOPE CONSOLE LOGIN SCREEN AND KEYBOARD ...20

FIGURE 3

NANOSCOPE CONSOLE ON-SCREEN INSTRUCTIONS ...21

Table of Tables TABLE 1 NANO CAMERA HANDPIECES AND ACCESSORIES...10 TABLE 2

ELEMENTS OF THE NANOSCOPE CONSOLE ...12

TABLE 3

NANOSCOPE CONSOLE SPECIFICATIONS ...13

TABLE 4

NANOSCOPE SYSTEM AMBIENT CONDITIONS FOR OPERATION ...14

TABLE 5

NANOSCOPE SYSTEM AMBIENT CONDITIONS FOR STORAGE ...14

TABLE 6

NANOSCOPE* SPECIFICATIONS...15

TABLE 7

NANONEEDLE SCOPE* SPECIFICATIONS ...15

TABLE 8

NANO CAMERA HANDPIECES AND ACCESSORIES COMPATIBILITY ...16

TABLE 9

SAFETY, EMC, AND REGULATORY REQUIREMENTS ...16

TABLE 10

TROUBLESHOOTING: FAULTS, THEIR CAUSES AND SOLUTIONS ...27

TABLE 11

GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMISSIONS ...31

TABLE 12

SYSTEM CABLES...31

TABLE 13

GUIDANCE AND MANUFACTURER'S STATEMENT - ELECTROMAGNETIC IMMUNITY ...31

TABLE 14

GUIDANCE AND MANUFACTURER'S STATEMENT – RECOMMENDED SEPARATION ...35

ii

General Warnings, Training and Safety Notices – Read This First NanoScope Manual

1.0 General Warnings, Training and Safety Notices – Read This First It is imperative that the symbols and conventions listed below be clearly understood. The NanoScope System Manual identifies critical, important, and useful information using these symbols and conventions. 1.1

Important Safety Conventions

Warnings and safety conventions follow IEC 60601-1.

Users of this device are encouraged to contact their Arthrex representative if they require a more comprehensive surgical technique.

W A R N I N G !

The WARNING! is the most important safety symbol. It identifies critical information that must be followed precisely to avoid injury or death. This NanoScope System is designed for use by medical professionals who are completely familiar with the required techniques and instructions for use of the equipment. Prior to using the device, read and follow all warning and precautionary notices and instructions marked on the product and included in this manual. Become familiar with the operation and function of the NanoScope Console and the associated Nano Camera Handpieces and Accessories . Failure to follow these instructions may lead to: • • •

Serious injuries to the patient

Potential injuries to the surgical team, or

Damage or malfunction of the device or accessories

1. Caution: Federal law restricts this device to sale by or on the order of a physician. 2. This device is intended to be used by a trained medical professional.

3. Do not open or attempt to service this system, as this may void your warranty. There are no user-serviceable parts inside the Console or disposable Handpiece.

4. Only the physician can evaluate the clinical factors involved with each patient and determine if the use of this device is indicated. The physician must determine the specific technique and procedure that will accomplish the desired clinical effect. 5. Arthrex provides detailed surgical techniques in print, video, and electronic formats. The Arthrex website also provides detailed surgical technique

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General Warnings, Training and Safety Notices – Read This First NanoScope Manual information and demonstrations. Or, contact your Arthrex representative for an onsite demonstration.

6. Maintain a tested and functioning backup NanoScope Console to ensure procedures can be completed in the event of equipment failure. Always ensure backup Nano Camera Handpieces and Accessories are available in the event of damaged parts in the original package or during use.

7. Do not use in the presence of flammable anesthetics, gases, disinfecting agents, cleaning solutions, or any material susceptible to ignition due to electrical sparking. 8. This device is only for use in normal arthroscopic or endoscopic purposes as described in the User’s Guide.

9. Use this device only under the supervision of a trained and licensed physician. This device should not be used by untrained personnel or used for indications other than those described in this User’s Guide.

10. Use only Arthrex approved electronic accessories. Other accessories may result in increased emissions or decreased immunity of the system. Contact your Arthrex representative for a complete list of accessories. DO NOT modify any accessory. Failure to comply may result in patient and/or operating room staff injury. 11. Equipment grounding is vital for safe operation. Plug the power cord into a properly earthed mains supply outlet whose voltage and frequency characteristics are compatible with those listed on the unit or in this manual.

12. This equipment should not share an electrical outlet or grounding with life supporting or life sustaining equipment.

13. If one or more mains powered units are connected simultaneously to one socket by the means of a distribution box, the sum of the individual leakage currents may exceed the tolerated limits. 14. Do not use if the package is damaged or previously opened.

15. Before use, the outer surfaces of the Nano Camera Handpieces and Accessories should be checked to ensure there are no unintended rough edges, sharp edges or protrusions which may cause injury. 16. Applied Parts of other Medical Electrical Equipment used within the configuration for Endoscopic Application shall be type BF or CF Applied Parts.

17. This equipment/system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the NanoScope System or shielding the location. 18. This equipment is NOT suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen rich or nitrous oxide environment.

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General Warnings, Training and Safety Notices – Read This First NanoScope Manual 19. No modifications of the NanoScope Console or Nano Camera Handpieces and Accessories are allowed.

20. The NanoScope Console contains a rechargeable lithium ion battery. A damaged battery is a risk of excessive heat and potential for spontaneous combustion. If the battery is damaged, disconnect NanoScope Console from the power source. Do not touch the Console. If the Console sparks or is on fire, extinguish the fire with Class C electrical fire suppression. 21. Surface temperatures of the Handpiece or Console may rise during use.

22. Do not re-sterilize the Nano Camera Handpieces and Accessories . A device labeled as a single-use device must never be reused. Reuse may pose health and/or safety risks that can include, but are not limited to cross-infection, breakage, compromised mechanical or video image/optical performance due to wear, lack of or no function, no guarantee of proper cleaning or sterilization of the device. 23. Failure to use this device in accordance with the directions for use below may result in device failure, render the device unsuitable for its intended use, or compromise the procedure. 24. The Console is not an applied part and is not intended to contact the patient.

25. Prevent contact between the patient and any peripherals attached to the Console, not including the Nano Camera Handpieces and Accessories .

26. Never contact the Console or remove an applied Nano Camera Handpiece while the distal portion of the Handpiece is in contact with the patient.

27. Biohazard waste, such as explanted devices, needles and contaminated surgical equipment, should be safely disposed of in accordance with the institutions policy. 28. Serious incidents should be reported to Arthrex Inc., or an in-country representative, and to the health authority where the incident occurred.

29. The maximum temperature of the NanoNeedle Scope may reach as high as 50°C (122°F), assuming a worse case ambient temperature of 30°C (86°F). Do not contact the NanoScope hub of the product directly with the patient. 1.2

Information

1. In CE Accepting Countries: Procedures carried out using these devices may be used on the general population.

2. In CE Accepting Countries: The clinical benefits associated with the use of these devices outweigh the known clinical risks.

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General Warnings, Training and Safety Notices – Read This First NanoScope Manual 3. In CE Accepting Countries: There are no unacceptable residual risks or uncertainties associated with the clinical use of these devices. The PRECAUTION! symbol identifies methods and procedures that must be followed to avoid damaging the device or causing it to malfunction. 1. Do not use for procedures other than those indicated. 2. The warranty could be voided if: • • • • •

Shipping or first-installation damage is not reported within seven (7) business days of receiving the device The device or the accessories are improperly used, prepared or maintained The instructions in the manual are not followed

Non-authorized persons perform repairs, adjustments or alterations Non-authorized persons open the device

Refer also to our General Terms of Business.

3. Receipt of technical documentation from the manufacturer does not authorize individuals to perform repairs, adjustments, or alterations to the device or accessories.

4. The manufacturer will make available on request circuit diagrams, component part lists, descriptions, calibration instructions and other information required for service to any Arthrex Authorized Service & Repair Center.

5. Prior to each use, the NanoScope Console and all associated equipment must be inspected for proper operation. Visually inspect the Nano Camera Handpieces and Accessories to ensure there are no scratches, chips or cracks. 6. Ensure that the available mains voltage matches the mains voltage data on the external power supply.

7. Only use the Power Adapter provided with the NanoScope Console. Use of an alternate or third party adapter may result in decreased battery performance or damage to the Console.

8. Do not expose the NanoScope Console to moisture, or operate it in a wet area, or store liquids above the Console. 9. Do not excessively bend or kink power supply cord.

10. Do not excessively bend or kink the Nano Camera Handpiece cable. DFU-0298-4r0_fmt_en-US Page 4 of 36

General Warnings, Training and Safety Notices – Read This First NanoScope Manual 11. If the Nano Camera Handpieces and Accessories are dropped, or the cable, connector or camera is damaged in any way, do not use. Open a new, undamaged Handpiece and/or Accessory. 12. Never use the Nano Camera Handpiece for an arthroscopy procedure without a cannula in place. The Handpiece tube can easily be bent or broken if leveraged against bone or other anatomy. 13. Store the Nano Camera Handpieces and Accessories in the original protective packaging to prevent sterile package damage during storage.

14. Do not store the NanoScope Console where it will be exposed to temperatures in excess of 122°F (50°C). Long term storage should be controlled at less than 86°F (30°C) or battery life may diminish.

15. Uncontrolled Relative Humidity (RH) environments may require use of Electrostatic Discharge (ESD) precautions. The NanoScope System is ESD certified down to 30% RH. The NanoScope System may be susceptible to static discharge damage when used in drier environments.

16. Do not leave the Lithium Ion battery fully discharged after portable use. This will severely reduce rechargeable battery life. Recharge the batteries by leaving system connected to power supply. See Maintenance for battery servicing. 17. Additional equipment connected to medical electrical equipment must comply with the respective IEC or ISO standards (e.g. 60950 for data processing equipment). Furthermore, all configurations shall comply with the requirements for medical electrical systems (see the 3rd edition of IEC 60601-1). Any person who connects external equipment to signal input and signal output ports or other connectors has formed a system and is therefore responsible for the system to comply with the requirements of IEC 60601-1. If in doubt, contact a qualified biomedical technician or your local representative.

18. The NanoScope Console is provided with a standard VESA MIS-D, 100 mm x 100 mm (3.9 in. x 3.9 in.) threaded hole mounting pattern on the back of the unit intended for vertical mounting. Use M4 mounting fasteners. The blind thread depth is 10 mm (0.39 in.). Use the appropriate length screws for the bracket thickness. This mounting configuration and tip load is qualified for all VESA mounts rated for at least 5 kg (11 lbs.). 19. This equipment has been tested and found to comply with the Class A limits for medical devices to the IEC 60601-1:2005+A1:2012(E) and IEC 60601-1-2:2014. These limits provide reasonable protection against harmful interference in a typical medical installation. 20. This equipment generates and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other device(s) in the vicinity.

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General Warnings, Training and Safety Notices – Read This First NanoScope Manual 21. Interference may occur in any installation environment. To test whether the NanoScope Console, or other devices in the environment are causing interference, turn the equipment off and on and identify the cause. Correct the interference by using one or more of the following measures: • • • •

Reorient or relocate the receiving device.

Increase the separation between devices.

Connect the equipment into an outlet on a separate electrical circuit. Consult the manufacturer or field service technician for help.

22. This unit was not evaluated for use with electrosurgical devices.

23. After each use, thoroughly clean the NanoScope Console unit with a clean cloth dampened with commercially available surfactants or surface disinfectants only. See Cleaning and Disinfecting, 24. NEVER allow the Console receptacles to have any contact with liquids. If there is dust or moisture on the receptacles, remove with dry compressed air. ONLY dry connectors should be plugged into the Console.

25. NEVER use liquid to clean the accessory device connector contacts. Remove dust regularly with dry compressed air. 26. Liquid on the cable connector of the accessory device can damage the device. Before connecting the cable, ensure the receptacles are clean and dry.

After use, gather the Handpiece sterile packaging, the Handpiece, and all Handpiece components and dispose of them in the appropriate biohazard containers. Observe all local, state and national waste management regulations. Do not dispose of Waste Electrical and Electronic Equipment (WEEE) as unsorted municipal waste. 1.3

Symbol Definitions

All of the symbols used on the labeling along with the title, description and standard designation number may be found on our website at www.arthrex.com/symbolsglossary.

Caution: Federal law restricts this device to sale by or on the order of a physician.

Safety Sign

Follow operating instructions

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General Warnings, Training and Safety Notices – Read This First NanoScope Manual The product meets the essential requirements of Medical Device Directive 93/42/EEC

Authorized representative in the European Community

The product meets the essential requirements of Medical Device Directive 93/42/EEC

Fragile, handle with care

Precaution of Warning Notice

This side up

Keep dry

Alternating current

Electrical hazard, dangerous voltages are present. Never attempt to repair the equipment. Only trained service personnel may remove the cover, or obtain access to system components.

Recommended temperature limits for storage and transport

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General Warnings, Training and Safety Notices – Read This First NanoScope Manual Date of Manufacture; year and month.

Pressure Limits for Storage and Transport

Manufacturer

Humidity Limits for storage and transport

WEEE [Waste Electronics and Electrical Equipment Symbol. Regarding European Union End-of-Life of Product.

Type BF Equipment

Quantity Universal Serial Bus [For use ONLY with thumb drive]

SN

RF symbol. Nonionizing electromagnetic radiation Serial Number

Non-Sterile

Do Not Reuse

Catalog Number

Expiration Date

Ethernet

iPad compatible USB Port

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General Warnings, Training and Safety Notices – Read This First NanoScope Manual

1.4

HDMI Output

Input Power

Do not use if package is damaged

UL Certification Mark

On / Off (pushpush)

Regulatory Compliance Mark (RCM)

Shipping, Unpacking, and Warranty Information

Carefully unpack and inspect all components for shipping damage. Any damage could compromise patient safety and should be reported immediately to Arthrex or any authorized Arthrex distributor.

The warranty could be voided if shipping or first-installation damage is not reported within seven (7) business days of receiving the device. Refer also to our General Terms of Business. All defective products will be repaired or replaced at the discretion of Arthrex at no charge. The warranty does not cover damage caused by unlawful use or improper handling of a product. The warranty is not valid if modifications are made to the product or repairs are carried out outside of Arthrex or an authorized Arthrex distributor. Arthrex will answer any questions referring to the quality, reliability, and/or shelf life of any product identified in this User’s Guide.

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Product Description/Features/Intended Use NanoScope Manual

2.0 Product Description/Features/Intended Use Product Description

2.1

The NanoScope System is comprised of the following: Table 1 Nano Camera Handpieces and Accessories Product Code

Description

AR-3200-0030

NanoScope Console

AR-3210-0041

NanoScope Operative High-Flow Sheath Kit

AR-3210-0043

NanoNeedle Scope, 125 MM

AR-3210-0040

Nano Camera Handpieces and Accessories

AR-3210-0042

AR-3210-0044 AR-3210-0045 AR-3210-0050

NanoScope Handpiece Kit

NanoScope Operative High-Fl NanoNeedle Scope, 180 MM

NanoNeedle Scope, 250 MM

125mm 2.26mm Sheath Kit

AR-3210-0051

125mm 3.4 mm Sheath Kit High Flow

AR-3210-0053

180mm 3.4 mm Sheath Kit High Flow

AR-3210-0052

180mm 2.26mm Sheath Kit

AR-3210-0054

180mm 3.4 mm Hip Insertion Sheath Kit

This NanoScope System provides the user with the ability to illuminate and visualize inside a joint or cavity within the body.

The AR-3200-0030 NanoScope Console provides image processing and digital documentation for endoscopic procedures. It is powered by a separate power adapter that allows for rechargeable, battery-powered, operation. The supply main is applied to the power adapter from a detachable power cord. A pivot configurable front panel display is a touch screen that provides physicians with a high resolution graphic user interface, high quality live endoscopic image, captured thumbnails, and access to patient information. The NanoScope Console contains hardware to recognize the Nano Camera Handpieces. The portable Console provides storage of procedure still images and videos. Additional output ports include USB, HDMI video, and Ethernet for network capability.

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Product Description/Features/Intended Use NanoScope Manual The Nano Camera Handpiece provides distal LED illumination to the surgical site using a fiber optic bundle surrounding a high-resolution camera sensor. The disposable Nano Camera Handpieces and Accessories are packaged sterile. The Nano Camera Handpiece has two buttons (front and rear) that can be programmed using the NanoScope Console to serve different functions such as image and video capture. The distal tip of the camera is packaged with a sterile cap that should not be removed until the Nano Camera Handpiece is inserted into the NanoScope Console and calibration is successful (see Setup & Use). The N Nano Camera Handpieces and Accessories are one time use only and must be disposed of after use in a certified biohazard storage container for disposal. 2.2

Product Features

Figure 1 NanoScope Console

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Product Description/Features/Intended Use NanoScope Manual Table 2

Elements of the NanoScope Console

1. Power button

2. Handpiece connector 3. Microphone

4. Ethernet port 5. USB port

6. HDMI output

7. Power cable connector

8. Display & touch screen

9. Power adapter (not shown)

See Nano Camera Handpieces and Accessories DFUs for more detailed information about their contents/features. 2.3

Intended Use

The NanoScope System is intended to be used as an endoscopic video camera in a variety of endoscopic surgical procedures, including but not limited to: orthopedic, laparoscopic, urologic, sinuscopic and plastic surgical procedures. The device is also intended to be used as an accessory for microscopic surgery.

W A R N I N G !

Use this device only under the supervision of a trained and licensed physician. This device should not be used by untrained personnel or used for indications other than those described in this manual and the NanoScope Handpiece Kit Directions For Use.

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Technical Specifications NanoScope Manual

3.0 Technical Specifications 3.1 Table 3

NanoScope System NanoScope Console Specifications

Width

35 cm (13.5 in.)

Depth

30 cm (11 in.)

Height Weight

Water protection Mains cable

External power supply

6 cm (2.25 in.)

4.5 kg (10 lbs.) IP20

10 A/250 V

Universal input 110/240V medical grade 19 V /110 W

AC input

100-240V~, 50/60Hz, 8.0A, Class I

Time to full charge

< 3 hours

Data storage

Non-volatile memory – 600 single frame images, 60 minutes video and 1500 minutes of audio

Applied part type Battery usage

BF Isolation

A minimum of 100 minutes of use when new

Display size

29.3 cm (horizontal) by 16.5 cm (vertical)

Video output

HDMI

Wi-Fi radio

VESA mount

11.5 in. (horizontal) by 6.5 in. (vertical)

IEEE 802.11 compatible network communications 100 mm x 100 mm (3.9 in. x 3.9 in.)

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Technical Specifications NanoScope Manual 3.2 Table 4

Ambient Conditions for Operation NanoScope System Ambient Conditions for Operation

Temperature

Relative humidity Air pressure

3.3 Table 5

10° to 30° C (50° to 86° F)

30% to 75%

700 hPa to 1060 hPa (21 in. Hg to 31.3 in. Hg)

Ambient Conditions for Storage (in shipping packaging) NanoScope System Ambient Conditions for Storage

Temperature- Console

-20° C to 50° C (-4° F to 122° F) up to 1 month;

-20° C to 45° C (-4° F to 113° F) up to 3 months;

-20° C to 30° C (-4° F to 86° F) up to 6 months;

Relative humidity Air Pressure

-20° C to 20° C (-4° F to 68° F) up to 12 months

10% to 90%, non-condensing

500 hPa to 1060 hPa (15 in. Hg to 31.3 in. Hg)

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Technical Specifications NanoScope Manual 3.4 Table 6

Nano Camera Handpieces NanoScope* Specifications

*included as part of AR-3210-0040, AR-3210-0042

Handpiece length (nominal)

25.4 cm (10 in.)

Handpiece weight (nominal)

180 gr (6.3 oz.)

Functions

1 MOS sensor

Handpiece height (nominal) Water protection Image resolution

IPX4

400 X 400 pixels

Frame rate

30 fps

Field of view

120 degrees ≥2 lumens

Illumination

Scope Length (nominal)

Scope Diameter (nominal) Table 7

6.4 cm (2.5 in.)

95 mm (3.7 in.)

1.9 mm (.07 in.)

NanoNeedle Scope* Specifications *included as part of AR-3210-0043, AR-3210-0044, AR-3210-0045

Handpiece length (nominal)

7.6 cm (2.99 in.)

Handpiece weight (nominal)

25 gr (0.88 oz.)

Functions

1 MOS sensor

Handpiece diameter (nominal) Water protection Image resolution

0.9 cm (.35 in.) IPX4

400 X 400 pixels

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Technical Specifications NanoScope Manual Frame rate

30 fps

Illumination

≥2 lumens

Field of view

120 degrees

Scope Length (nominal)

AR-3210-0043: 125 mm (4.9 in.)

AR-3210-0044: 180 mm (7.1 in.)

AR-3210-0045: 250 mm (9.8 in.)

Scope Diameter (nominal) Table 8

1.9 mm (.07 in.)

Nano Camera Handpieces and Accessories Compatibility

Nano Camera Handpiece

Accessories

AR-3210-0040 (Camera Only)

AR-3210-0040 (Accessories Only)

AR-3210-0041

AR-3210-0050

AR-3210-0051

AR-3210-0052

AR-3210-0053

AR-3210-0052

Compatible

Compatible

-

-

-

-

-

AR-3210-0042 (Camera Only)

Compatible

Compatible

-

-

-

-

-

AR-3210-0043

-

-

Compatible

Compatible

-

-

-

AR-3210-0045

-

-

-

-

AR-3210-0044

-

-

3.5 Table 9

-

-

Compatible -

Compatible -

Safety, EMC, and Regulatory Requirements Safety, EMC, and Regulatory Requirements Parameter

System Classification

DFU-0298-4r0_fmt_en-US

IEC 60601-1

FDA Class

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Parameter Value

Class I (protection against electric shock)

Class II

Compatible -