LENS Integrated System Camera Head Instructions for Use Rev B April 2016

English

LENS Integrated System Camera Head

The LENS Integrated System and LENS Camera Head are used in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination, visualization, and capture of still and motion pictures of surgical sites within articular cavities, body cavities, hollow organs, and canals. Additionally, the LENS Integrated System and LENS Camera Head are indicated for use in endoscopic surgical procedures in the thoracic cavity when used with an appropriately indicated thoracoscope.

Preface The Smith & Nephew LENS Integrated System Camera Head is part of a family of products specifically designed for multimodal sterilization including autoclave, STERRADT 100S Standard Cycle, STERRAD NXT Standard Cycle, or STERRAD 100NXT DUO Cycle Sterilization Systems. It may also be sterilized with STERIS V‑PRO or V‑PRO 1 PLUS/V‑PRO maX Non-Lumen Cycle (12 minute exposure), or V‑Pro 1 Standard Cycle (32 minute exposure) Sterilization Systems. Prior to using the equipment, read these instructions thoroughly. Pay particular attention to the Warnings and Precautions. These instructions will familiarize the user with the camera head and the steps required for proper setup and maintenance.

Device Description The camera head is a state-of-the-art, high definition video camera head designed for use in endoscopic surgical procedures. It is compatible with the LENS Integrated System Control Unit (REF 72204354 – LENS Integrated System, Wi-Fi; REF 72204685 – LENS Integrated System, non-Wi-Fi). Compatible Endoscopes and Couplers (Must have an industry standard C-mount threading of 1-32-UN- 2B) Arthroscopes: 1.9, 2.7, and 4.0 mm sizes Laparoscopes: 5.0, 5.5, and 10 mm size Hysteroscopes: 4.0, 5.0, 5c, and 8.0 mm Thoracoscopes: 2.8 mm Smith & Nephew surgical equipment is designed for use only by medical professionals who are thoroughly familiar with the appropriate surgical techniques and video procedures.

Intended Use The LENS Integrated System and LENS Camera Head are intended to provide illumination, visualization and capture of still and motion pictures of surgical sites. In addition, the LENS Application is intended to capture still and motion pictures, and provide patient file management and limited redundant control of camera features.

LENS Integrated System Camera Head

Indications for Use

Instructions for Use

The LENS Application, when used in conjunction with the LENS Integrated System Wi-Fi version, is indicated for capture of still and motion pictures, patient file management, and limited redundant control of the LENS Control Unit within articular cavities, body cavities, hollow organs, canals, and the thoracic cavity.

Contraindications None known.

Warnings • The camera head is shipped non-sterile. It must be cleaned and sterilized before the first use. It must be cleaned and sterilized before every subsequent use. • It is the surgeon’s responsibility to be familiar with the appropriate surgical techniques prior to use of this device. • Read these instructions completely prior to use. • Read the Operations/Service Manual for the applicable camera control unit and the Instructions for Use for other components used in the procedure. • To prevent patient burns, do not place the camera head on the patient when it is not in use. The camera head contains heatgenerating components that raise its surface temperature higher than that of the surrounding environment. Prolonged contact with the patient may cause burns. • DANGER: Risk of explosion if used in the presence of flammable anesthetics. • Do not use this device in oxygen rich environments (>25%). • To prevent electric shock, do not disassemble the camera head. There are no user-serviceable parts. Dismantling the equipment will void the warranty. • The camera head is autoclavable and compatible with only one chemical sterilant throughout its lifetime. Once a sterilant has been used, continue to use that same sterilant for the lifetime of that specific camera head. Do not apply multiple chemical sterilants during the lifetime of any single camera head. Use only chemical sterilants from the list of acceptable chemical sterilants.

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English Precautions 

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

• Prior to use, inspect the device to ensure it is not damaged. Do not use a damaged device. • This product may be sterilized with chemical sterilants STERRADT 100S Standard Cycle, STERRAD NXT Standard Cycle, or STERRAD 100NXT DUO Cyle Sterilization Systems. It may also be sterilized with STERIS V‑PRO or V‑PRO 1 PLUS/V‑PRO maX Non-Lumen Cycle (12 minute exposure), or V‑Pro 1 Standard Cycle (32 minute exposure) Sterilization Systems. The product may be sterilized with any of the above-specified chemical sterilization methods. Failure to comply with this caution may result in damage to the product and will void the warranty.

• Do not sterilize damaged equipment, as further damage may result. Clean and disinfect the camera head prior to returning it to Smith & Nephew. • Ensure that there are no deposits on the optical surfaces prior to sterilization. • Allow the camera head to cool to room temperature after it has been autoclaved. • Extreme caution must be taken to dry out mating portions of both the scope and camera head; otherwise trapped moisture may condense on glass surfaces, blurring the image. • Carry and store the cable in loose coils to prevent kinks and stress on the internal wires. Do not carry the camera head by the cable. • Do not pinch or damage the camera head cable (i.e., rolling heavy equipment over it, securing with clamps, pinching in doors, etc.).

• The camera head cannot be sterilized with Steris 1ETM or any other wet sterilant.

• Do not modify this equipment. Attempts to modify this equipment will void the warranty.

• To avoid fogging during surgery, ensure that the videoarthroscope or coupler and the camera head are entirely free of moisture prior to connecting them.

• To minimize any reciprocal interference from or to the System, use a dedicated power outlet during any RF treatment or investigation.

• Use ENZOLT to decontaminate the camera head. If Enzol is not available in your facility a neutral pH cleaner can be used. Non-neutral pH cleaners may cause residue buildup, which may cause interference or damage the optical seals. Such damage will result in internal fogging and image discoloration. • US Customers: Users should only use sterilizers and accessories (such as sterilization wraps, sterilization pouches, chemical indicators, biological indicators, and sterilization containers) that have been cleared by the US FDA for the selected sterilization cycle specifications (time and temperature). • Handle all endoscopic instruments with care. If the camera head is dropped or damaged in any way, it must be returned immediately for service. • Electrical safety testing should be performed by a biomedical engineer or other qualified service person. • Do not point the camera head toward direct sunlight, extremely bright lights, or laser beams for prolonged periods as damage may occur. • Do not plug the camera cable connector into the control unit if wet. Moisture on the card edge of the camera cable will damage the circuitry and void the warranty. Ensure that the card edge is completely dry before plugging the camera head into the camera control unit.

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• This equipment contains electronic printed circuit assemblies. At the end of the useful life of the equipment it should be disposed of in accordance with any applicable national or institutional policy relating to obsolete electronic equipment. • For information regarding electrical emissions and immunity testing, guidance separation, and precautions, refer to the camera control unit’s Operations/Service Manual. • After use, this device may be a potential biohazard and should be handled in accordance with accepted medical practice and applicable local and national requirements.

Unpacking and General Inspection Carefully unpack and inspect all of the components shipped with the camera head. You should have received the following: 1 ea.

LENS Integrated System Camera Head and Cable (REF 72203967)

1 ea.

LENS Integrated System Camera Head Instructions for Use (REF 10601250)

If any parts are missing or damaged, contact an authorized Smith & Nephew representative. Save the carton and packing materials in the event that a component needs to be returned or repaired.

LENS Integrated System Camera Head

Instructions for Use

English Button Function Table 1, “Live Video Functions,” and Table 2, “OSD (Onscreen Display) Menu Functions,” below, summarize the button functions for the camera head for both the Live Video and OSD Menu modes. Refer to the Operations/Service Manual for the applicable camera control unit for more information regarding default and customized button settings and a complete list of the associated functions.

Table 1: Live Video Functions Camera Head Control

Short Press (<1.0 seconds)

Long Press (>1.0 seconds)

Left Button

Single Image Capture (AUX1)

Single Image Capture (CCU)

Middle Button

Brightness (Up/Down)

Main Menu

Right Button

Video Capture (AUX2)

White Balance

Table 2: OSD Menu Functions Camera Head Control

Default Button Function

Left Button

Move the cursor UP to highlight a menu choice.

Middle Button

SELECT the highlighted menu choice.

Right Button

Move the cursor DOWN to highlight a menu choice.

Table 3: Optional Programmable Button Functions* Function

Effect

BRIGHTNESS

Control the luminance level of the video output

ENHANCEMENT

Enhance the sharpness of the displayed video

ZOOM

Digital zoom of field of view

ALT PAUSE

Pause the video while recording to a device connected to a rear panel port

PAUSE VIDEO

Pause the video from camera head.

ALT VIDEO

Start or stop video capture from the secondary input source and save to the iPadT

ALT FRAME

Capture a still picture from the secondary input source and save to the iPad

FRAME CAPTURE

Capture a still picture from the endoscopic field of view and save to the iPad

LIGHT MODE

Activates and deactivates the illumination device on the control unit

STRETCH

Switch between an enhanced visualization mode and normal live video

VIDEO CAPTURE

Start or stop video capture from the endoscopic field of view and save to the iPad

LAST IMAGE

Displays the last known frame captures to the iPad for review.

MENU ACCESS

Access the graphical menu system of the control unit [MAIN MENU]

WHITE BALANCE

Correct for ambient color temperature

Peripheral Port 1 (Top port)

Triggers the accessory connected to the top port

Peripheral Port 2 (Bottom port)

Triggers the accessory connected to the bottom port

* Note: Button-mappable functions may change without notice as a result of changes to the software of the LENS Integrated Camera System.

LENS Integrated System Camera Head

Instructions for Use

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English Instructions for Use The camera head buttons perform a different set of functions depending upon whether the On Screen Display (OSD) Menu or Live Video is displayed on screen (Tables 1 and 2). When the OSD menu is displayed, use the camera head buttons to navigate through the menus.

To connect the camera cable connector to the control unit, plug the card edge connector into the appropriate receptacle on the front of the camera control unit and push in firmly (Figure 2).

When Live Video is displayed, each of the camera head buttons is assigned to default or customized functions for short (less than 1 second) or long (>1 second) presses. The default functions can be changed using the CUSTOMIZE PROCEDURE SETTINGS menu. Each registered press of a button is followed by a beep from the LENS Integrated System. The beep is the same for both short and long presses. Note: The camera head is not specific to any single LENS camera control unit. It is interchangeable among multiple System control units. Refer to the Operations/Service Manual for the applicable System control unit for more information regarding the setup of the control unit and the LENS camera head. Middle button

Figure 2.  Connect the camera head to the control unit

Bezel

Endocoupler focal length determines the image size on the monitor. For optimal image size use endocouplers with a focal length between 17 mm and 20 mm.

Safety and Service Life Checklist Before each case begins, check the following items to ensure that they function properly and are safe to use: Plug in the light guide and ensure that the light illuminates. Left button

Right button

Confirm that the video works correctly and that visualization is correct. Check the OSD status bar to confirm that the Wi-Fi is connected. Check front panel to ensure that all buttons and connectors are functioning properly. Check the OSD status bar to confirm that the light is turned on and detected. Check for any damage to the camera head and cable (burn holes, cracks, button damage, corrosion, buildup or damage to the card edge connector).

Figure 1.  LENS Integrated System Camera Head

Connect the Camera Head CAUTION: Do not plug the camera cable connector into the control unit if wet. Moisture on the connector pins of the camera cable will damage the circuitry and void the warranty. Ensure that the connector pins are completely dry before plugging the camera head into the camera control unit.

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Check that the labeling information on the camera head connector is still readable. Ensure there are no deposits, scratches, or fogging/humidity on the front window of the camera head. Ensure that the system is ready and safe to use.

LENS Integrated System Camera Head

Instructions for Use

English White Balance the Camera When a procedure is selected from the LENS System STARTUP menu, the system automatically starts the White Balance procedure to ensure proper color rendition. The scope and the fiber optic light guide should already be connected in order to perform the White Balance procedure.

CAUTION: Prior to use, inspect the device to ensure it is not damaged. Do not use a damaged device. CAUTION: Use ENZOLT to clean or preclean the camera head. If ENZOL is not available in your facility a neutral pH cleaner can be used. Non-neutral pH cleaners may cause residue buildup, which may cause interference or damage the optical seals. Such damage will result in internal fogging and image discoloration. CAUTION: To avoid fogging during surgery, ensure that the videoarthroscope or coupler and the camera head are entirely free of moisture prior to connecting them.

Figure 3.  White Balance the camera

1. Point the end of the scope at a white object (a 4" x 4” gauze pad or flat white piece of paper) and focus. Fill as much of the screen as possible with the white object, but do not hold the scope close enough to touch the white object. 2. Select the desired procedure from the STARTUP menu. The monitor will display the message WHITE BALANCE IN PROGRESS. 3. Hold the gauze pad or paper in front of the scope until the monitor displays the message WHITE BALANCE COMPLETE and a long tone sounds. If an error occurs during White Balance, the message WHITE BALANCE INCOMPLETE will appear on the display and a chirping tone sounds. To White Balance without restarting system, select WHITE BALANCE from the MAIN MENU or press the WHITE BALANCE button on the front panel of the control unit.

Cleaning and Sterilization Notes: • Disinfection is not a substitution for sterilization. Always inspect for damage and debris prior to sterilization. • The camera head requires sterilization because it is used in the sterile field. No protection is needed for the camera head connector during cleaning and sterilization. The camera head connector must be dry prior to plugging into the camera control unit. Note to US customers: • Sterilizers and wraps used in your sterilization process must be FDA cleared. • Users should only use sterilizers and accessories (such as sterilization wraps, sterilization pouches, chemical indicators, biological indicators, and sterilization containers) that have been cleared by the US FDA for the selected sterilization cycle specifications (time and temperature).

CAUTION: Do not plug the camera cable connector into the camera control unit if wet. Moisture on the card edge connector of the camera head cable will damage the circuitry and void the warranty. Ensure that the card edge connector is completely dry prior to plugging the camera head into the camera control unit. CAUTION: Do not sterilize damaged equipment, as further damage may result. Clean and disinfect the camera head prior to returning it to Smith & Nephew. Cleaning and sterilization requires four steps: 1. Decontamination 2. Equipment inspection 3. Equipment preparation 4. Sterilization

Preparations at the point of use prior to processing Keep instruments moist after use to prevent soil from drying on them. Follow Universal Precautions for handling and transporting contaminated instruments to the designated cleaning area. Contaminated instruments should be transported to the area for cleaning in a way that avoids contamination of personnel and hospital. Prior to cleaning, remove visible debris from the surfaces of the device. Dried-on soil is difficult and sometimes impossible to remove with automatic washing. Clean instruments as soon as possible after use to prevent blood from drying on the devices.

Approved Cleaners/Precleaners Use ENZOL a neutral pH enzymatic cleaner to clean or preclean the camera head. If ENZOL is not available in your facility a neutral pH cleaner can be used.

Water Quality Warm tap water is recommended for cleaning the camera head assembly. Distilled water is recommended for rinsing the camera head assembly.

WARNING: The camera head is autoclavable and compatible with only one chemical sterilant throughout its lifetime. Use only chemical sterilants from the list of acceptable chemical sterilants. Once a sterilant has been used on the camera head, continue to use that same sterilant for the lifetime of that specific camera head. The use of multiple chemical sterilants during the lifetime of any one camera head will reduce the service lifetime of that camera head.

LENS Integrated System Camera Head

Instructions for Use

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English 1. Decontamination

To clean the coupler

Immediately after a procedure, manually decontaminate the camera head to make it safe for further handling. The following steps constitute a general guideline for routine decontamination of the camera head and other equipment, though specific hospital procedures must supersede where appropriate.

For information about how to clean and sterilize the coupler, refer to the Instructions for Use provided with that product.

1. Turn the camera control unit off. 2. Disconnect the light guide from the endoscope and light source. 3. Unplug the camera head cable and unplug any remote controls that were used in the sterile field. Detach the endoscope or endocoupler from the camera head. 4. Contain contaminated instruments for transportation to the decontamination area and preparation for manual decontamination. 5. Do not use germicides or any other agents containing benzene or phenol derivatives. This will damage the camera head cable and will void the warranty.

To clean the card edge connector: 1. Use a soft-bristled brush to manually remove debris from the card edge connector and cable. Never use abrasive powders. Note: It is the responsibility of the hospital to ensure adequate cleaning of the brushes between each use. 2. If residue is visible on the stainless steel ground plates of the card edge connector, use a mildly abrasive plastic scrubbing pad to gently scrub both sides of the ground plate. Ensure that all visible debris is removed. DO NOT scrub the gold fingers on the end of the card edge connector as this will damage the electronic connections and cause the camera head to fail. Figure 4 indicates which areas to scrub and which to avoid.

To clean the camera head Do NOT scrub!

Manual cleaning

Ground plate. Scrub per cleaning instructions.

1. Rinse the camera head assembly in cold tap water for a minimum of 1 minute. 2. Soak in ENZOLT a neutral pH solution for a minimum of 2.5 minutes to prevent coagulation and help remove protein materials and other resistant debris. If ENZOL is not available in your facility a neutral pH cleaner can be used. 3. Clean manually using soft cloths, soft bristled brushes or sponges for a minimum of 1 minute. –– To prevent the scratching of lenses and electrical components, limit the number of items in the sink at any one time. –– Never use scouring pads or abrasive powders. –– Pay particular attention to the button area. To avoid scratching lenses, wipe them in one direction; do not scrub. Note: It is the responsibility of the hospital to ensure adequate cleaning of the brushes between each use. 4. Rinse in purified water for a minimum of 1 minute. 5. Use isopropyl alcohol on the lens for a minimum of 1 minute. Do not allow the exposed lenses and glass surfaces to air dry. Use a cotton applicator dipped in 70% isopropyl alcohol to remove stubborn spots, streaks, and residual debris. 6. Dry thoroughly with a clean applicator. Do not allow to air dry.

Figure 4.  Card edge connector

3. Use distilled water to thoroughly rinse off any residue. Do not use saline as salt can increase pitting or corrosion of surfaces. 4. Use a soft, lint-free cloth to thoroughly dry the connector. 5. Wipe the camera head cable connector with isopropyl alcohol and air dry or dry thoroughly with a sterile, lint-free cloth. Ensure that the connector is completely dry. If moisture is present in the connector, use compressed air to blow out any fluid within the connector. 6. Visually inspect the device to ensure all visible tissue and debris have been removed. If not, repeat steps 1–5. Note: Do not lubricate the camera head or cables.

Automated cleaning

2. Equipment Inspection

1. Place the camera directly on the washer rack being careful to arrange the cables so they have full exposure to the washing/ rinsing action of the washer.

Prior to each use, inspect the camera head to ensure the following: Camera head cable jacket: There are no burn holes, cracks, tears, swelling, etc.

2. Run the automatic washer cycle. The minimum automatic washer parameters are:

Camera head cable connector: There is no corrosion, damaged card edge, etc.

Five (5) minute cold prewash (<43º)

Glass window: There are no scratches and no deposits.

Five (5) minute enzyme wash (neutral pH cleaner)

Bezel: There are no exposed metal surfaces.

Two (2) minute rinse hot water

If any of the listed conditions are present, contact Smith & Nephew as directed in the “Warranty” section of this Instructions for Use. The use of damaged equipment could compound the damage, harm interfacing equipment, or void the warranty.

One (1) minute final rinse with purified water (90º C)

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LENS Integrated System Camera Head

Instructions for Use

English 3. Equipment Preparation After every use, ensure that the camera head has been thoroughly cleaned, inspected, and sterilized according to the directions in this document.

4. Sterilization

Use one of the following methods to sterilize the camera head: WARNING: The LENS Camera head is not compatible with any Liquid Chemical sterilant processes.

Autoclave (Steam Sterilization Parameters)

READ ALL WARNINGS AND CAUTIONS BEFORE STERILIZING.

Method

Cycle

Exposure Temperature

Exposure Time (minutes)

Dry Time (minutes)

WARNING: The camera head is autoclavable and compatible with only one chemical sterilant throughout its lifetime. Once a sterilant has been used, continue to use that same sterilant for the lifetime of that specific camera head. Do not apply multiple chemical sterilants during the lifetime of any single camera head. Use only chemical sterilants from the list of acceptable chemical sterilants.

Steam (wrapped)

Prevacuum

270° F (132 °C)

4

30

Steam (wrapped)

Gravity

270° F (132 °C)

15

30

CAUTION: Allow the camera head to cool to room temperature after it has been autoclaved.

CAUTION: This product may be sterilized with chemical sterilants STERRADT 100S Standard Cycle, STERRAD NXT Standard Cycle, or STERRAD 100NXT DUO Cyle Sterilization Systems. It may also be sterilized with STERIS V‑PRO or V‑PRO 1 PLUS/V‑PRO maX Non-Lumen Cycle (12 minute exposure), or V‑Pro 1 Standard Cycle (32 minute exposure) Sterilization Systems. The product may be sterilized with any of the above-specified chemical sterilization methods. Failure to comply with this caution may result in damage to the product and will void the warranty.

Non US Customer

CAUTION: Ensure that there are no deposits on the optical surfaces prior to sterilization. CAUTION: Allow the camera head to cool at room temperature after it has been autoclaved. CAUTION: Extreme caution must be taken to dry out mating portions of both the scope and camera head; otherwise trapped moisture may condense on glass surfaces, blurring the image. Notes: • Disinfection is not a substitute for sterilization.

Autoclave (Steam Sterilization Parameters) Method

Cycle

Exposure Temperature

Exposure Time (minutes)

Dry Time (minutes)

UK Cycle (wrapped)

NA

134 °C

3

30

World Health Organization (WHO)

NA

135 °C

18

30

Note: The UK cycle is not an FDA cleared sterilization cycle and only for use Internationally. Note: The WHO cycle is not an FDA cleared sterilization cycle and only for use Internationally. CAUTION: Allow the camera head to cool to room temperature after it has been autoclaved.

• Always inspect for damage and debris prior to sterilization.

Chemical Sterilization

For sterilization instructions for light guides, couplers, and endoscopes, refer to the “Sterilization” section of the respective product’s Instructions for Use.

Sterilize the device using any one of the following sterilization systems:

Sterilization Methods WARNING: The camera head is autoclavable and compatible with only one chemical sterilant throughout its lifetime. Once a sterilant has been used, continue to use that same sterilant for the lifetime of that specific camera head. Do not apply multiple chemical sterilants during the lifetime of any single camera head. Use only chemical sterilants from the list of acceptable chemical sterilants.

• STERRADT 100S Standard Cycle –– Device Load: The LENS camera should be wrapped in a FDA cleared sterilization wrap individually or as part of a visualization system. • STERRAD NXT Standard Cycle –– Device Load: The LENS camera should be wrapped in a FDA cleared sterilization wrap individually or as part of a visualization system. • STERRAD 100NXT Duo Cycle –– Device Load: The LENS camera should be wrapped in FDA cleared sterilization wrap individually or as part of a visualization system. • STERIS V‑PROT 1 Cycle (32 minute exposure) • V‑PRO 1 PLUS/V‑PRO maX Non-Lumen Cycle (12 minute exposure)

LENS Integrated System Camera Head

Instructions for Use

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English Follow all recommended directions and warnings included with the sterilization system.

Maintenance

CAUTION: The camera head cannot be sterilized with Steris System 1ET or any other wet sterilant.

Recommended Annual Performance Checks

Note: The camera head can be used immediately after chemical sterilization. Note: These parameters have been validated to ensure sterility. Note: The camera head is validated for sterilization assurance using the sterilant manufacturer’s instructions.

Storage To prevent damage, ensure that camera heads remain immobile while stored.

Service WARNING: Do not modify this equipment. Attempts to modify this equipment will void the warranty.

Smith & Nephew recommends that Dielectric Strength Testing be performed annually to assure continued compliance with applicable safety requirements. These tests should be conducted in accordance with specifications IEC 60601‑1: 2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012 or IEC 60601‑1 2012 (Third Edition), IEC 60601‑2‑18:2009 (Third Edition), EN60601‑1:2006/A1:2013, ANSI/ AAMI ES60601‑1:2005+A2 (R2012) +A1, CSA C22.2 No. 60601.1:2014, CSA C22.2 No. 60601.2.18:2011. CAUTION: Electrical safety testing should be performed by a biomedical engineer or other qualified service person. CAUTION: For information regarding electrical emissions and immunity testing, guidance separation, and precautions, refer to the camera control unit’s Operations/Service Manual. Note: Service life is determined by adherence to general maintenance procedures.

There are no user‑serviceable components in the camera head. Repairs and adjustments are to be performed only by Smith & Nephew authorized service centers. If service becomes necessary, call an authorized Smith & Nephew Customer Service Representative prior to returning the device and request a Return Authorization (RA) number. A representative can also explain the available Service Replacement and Repair programs. Service items should be carefully cleaned and disinfected, repackaged, and returned postpaid to Smith & Nephew. Smith & Nephew Customer Service or an authorized representative can provide additional instructions. Note: Product that has been returned that is found to have been serviced by an unauthorized third party repair facility and/or sterilized with a sterilization method other than the ones approved for it by Smith & Nephew will incur additional costs, regardless of warranty status.

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LENS Integrated System Camera Head

Instructions for Use

English Camera Head Specifications* Equipment Classification

Protection against electrical shock Class 1, type CF equipment, applied part camera head bezel

Video Sensor Technology

1080p High Definition CMOS

Imaging Resolution

Vertical: 1080p native TV lines Horizontal: 1920 TV lines

Video Data Transmission

High-speed, low-voltage differential serial (LVDS), digital transmission via 12-foot camera cable

Video Output Format

Full HD 1080p, 100% compatible with SMPTE‑274M:2005 HDTV standard when used with the LENS Camera Control Unit

Video Field Rate

60 Hz

Operating Temperature

50–86° F (+10– +30 °C)

Operating Humidity

30–75%

Operating Altitude

3000 meters maximum

Transport and Storage Temperature

-20–140° F (-29– +60 °C)

Transport and Storage Humidity

15–85%

Transport and Storage Atmospheric Pressure

60–106 kPa (3000 meters)

Transport Shock and Vibration Compliance

ISTA 3A

Camera Head Dimensions

1.8" x 1.9" x 3.75" (Width x height x length)

Camera Head Weight

1.3 lbs (0.60 kg)

Camera Head Cable

12 ft +/- 3 in., (3.65 m +/- 7.6 cm)

Lens Mount

1" – 32 UN C-mount thread

Compatible Control Units

Smith & Nephew LENS Integrated Camera System

Compliance

Complies with IEC 60601‑1: 2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012 or IEC 60601‑1 2012 (Third Edition), IEC 60601‑2‑18:2009 (Third Edition), EN60601‑1:2006/A1:2013, ANSI/AAMI ES60601‑1:2005+A2 (R2012) +A1, CSA C22.2 No. 60601.1:2014, CSA C22.2 No. 60601.2.18:2011

Modes of Operation

Continuous

*Specifications subject to change without notice.

Environmental Conditions Ambient Temperature

Transport and/or Storage Use

Use

-20– +140° F (-29– +60 °C)

+50–86° F (+10–30 °C)

15–85%

30–75%

60–106 kPa

60–106 kPa

Relative Humidity Atmospheric Pressure

Ordering Information REF 72203967

Smith & Nephew LENS Camera Head

REF 10601250

Smith & Nephew LENS Camera Head Instructions for Use (all countries)

REF 72204725

Coupler, HD, 17.2 mm, Autoclavable

LENS Integrated System Camera Head

Instructions for Use

10601250 Rev. B

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English Warranty

Service Replacement Program

Smith & Nephew products are warrantied to be free from defects in material and workmanship for the warranty period for a particular product, beginning from date of invoice. Refer to the current Smith & Nephew Product Catalog or contact Smith & Nephew Customer Service for specific warranty information.

Smith & Nephew offers a 24-hour Service Replacement Program for its products to minimize downtime in the operating room. Our goal is to ship a service replacement unit within 24 hours** of a call (during normal business hours). For a Return Authorization (RA) number or for additional information on this program, call Customer Service at +1 800 343 5717 in the U.S., or contact an authorized representative.

This limited warranty is restricted to repair or replacement by Smith & Nephew, at its option, of any product found to be defective during the warranty period. Damage inflicted to a product by the user will result in additional charges and may void the warranty. This includes but is not limited to normal use related damage, any attempted repairs by unauthorized service providers, use of a sterilization method not approved by Smith & Nephew, and use of the product in a way that is not intended by Smith & Nephew. All warranties apply to the original buyer only and are not transferable. In no event shall Smith & Nephew be liable for any anticipated profits, consequential damages or loss of time incurred by the buyer with the purchase or use of any product.

**24-hour shipment is not offered in all countries.

Repair Service Program

NO OTHER WARRANTY, EXPRESSED OR IMPLIED, IS GIVEN.

For devices no longer under warranty, repairs can be made by Smith & Nephew or by an authorized agent. Non-warranty repairs will be made at the list price of replacement parts, plus labor. If requested, we will provide an estimate of repair cost and time required for the repair before any work is done. Repair items should be carefully disinfected, repackaged, marked with the Return Authorization (RA) number, and returned postpaid to the appropriate Smith & Nephew Service Center. Smith & Nephew Customer Service or an authorized representative can provide shipping information.

Service Replacement Units Warranty

For Further Information

Smith & Nephew service replacement units are warrantied to be free from defects in material and workmanship for the warranty period for a particular product, beginning from date of invoice. Refer to the current Smith & Nephew Product Catalog or contact Smith & Nephew Customer Service for specific warranty information.

If further information on this product is needed, contact Smith & Nephew Customer Service at +1 800 343 5717 in the U.S., or an authorized Smith & Nephew representative.

All trademarks acknowledged. ©2015, 2016 Smith & Nephew, Inc. All rights reserved.

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LENS Integrated System Camera Head

Instructions for Use

English Symbols Follow instructions for use

Catalog number

Non‑Sterile

Manufacturer

EU: Not for general waste

Date of Manufacture

Type CF Equipment

CE mark

Temperature Limitation

Serial number

Humidity Limitation

Authorized representative in the European community

Environmentally friendly use period

MR Unsafe

Do not plug in wet

LENS Integrated System Camera Head

Instructions for Use

10601250 Rev. B

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Smith & Nephew York Science Park Heslington, York YO10 5DF United Kingdom

Endoscopy Smith & Nephew, Inc. 150 Minuteman Road Andover, MA 01810 USA

www.smith-nephew.com +1 978 749 1000 +1 978 749 1108 Fax +1 800 343 5717 U.S. Customer Service

04/2016 10601250 Rev. B