Stryker 0700010000, 0700410105, 0700010001 User Manual

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Precision AC Video Camera

0700010000

0700010001

0700410105

Contents

Warnings and Cautions ........................................................................... 1

Product Description and Intended Use ................................................. 4

Indications ..................................................................................................................5

Contraindications ....................................................................................................5

The Camera Console ...............................................................................................6

The Camera Head ....................................................................................................8

The C-Mount Coupler ............................................................................................. 9

Setup and Interconnection ................................................................... 10

Setting Up the Console ...................................................................................... 11

PrecisionAC Wiring Diagram ............................................................................ 12

Setting Up the Camera Head ............................................................................ 13

Setting Up the Coupler ....................................................................................... 14

Connecting the DVI Fiber Outputs ................................................................. 16

Installing the Soaking Cap ................................................................................ 16

Operation ............................................................................................... 17

Operating the Camera with a Light Source ................................................. 17

Powering the Console On/O .......................................................................... 18

Controlling Remote Video Accessories ......................................................... 18

Using the Camera Head Buttons ..................................................................... 19

Using the Touchscreen Interface..................................................................... 20

Menu Screen........................................................................................................... 21

Performing the White-Balance Test ................................................................ 22

Advanced Features ............................................................................................... 22

Troubleshooting .................................................................................... 23

Reprocessing ..........................................................................................27

Cleaning the Console .......................................................................................... 27

Cleaning, Disinfecting, and Sterilizing the Camera Head ...................... 28

Limitations on Reprocessing ............................................................................ 29

Materials and Equipment .................................................................................. 30

User Maintenance .................................................................................. 39

Maintenance, Inspection, and Testing .......................................................... 39

Using Sterile Drapes ............................................................................................ 39

Storage ..................................................................................................................... 39

Replacing the Fuses ............................................................................................. 39

Periodic Maintenance Schedule ...................................................................... 40

Expected Service Life .......................................................................................... 40

Disposal and Recycling Information .............................................................. 40

Diagrams .................................................................................................................. 41

Technical Specications ........................................................................ 43

Electromagnetic Compatibility ........................................................................ 45

Symbol Denitions ................................................................................ 49

Warnings and Cautions

Please read this manual and follow its instructions carefully. The words warning, caution, and note carry special meaning and should be carefully reviewed:

Warning Indicates risks to the safety of the patient or user. Failure to follow warnings may result in injury to the patient or user.

Caution Indicates risks to the equipment. Failure to follow cautions may result in product damage.

Note: Claries the instructions or presents additional useful information.

An exclamation mark within a triangle is intended to alert the user to the presence of important operating and maintenance instructions in the manual.

A lightning bolt within a triangle is intended to warn of the presence of hazardous voltage. Refer all service to authorized personnel.

IMPORTANT SAFETY NOTICE: Before operating this device, please read this operating manual thoroughly and carefully. When using this device with a light source, re and/or severe injury may result to the patient, user, or inanimate objects if the instructions in this manual are not followed.

All light sources can generate signicant amounts of heat (exceeding 41°C/106°F) at the scope tip, the scope light post, the light cable tip, and/or near the light cable adapter. Higher levels of brightness from the light source result in higher levels of heat. Always adjust the brightness level of the camera and the monitor before adjusting the brightness level of the light source. Adjust the brightness level of the light source to the minimum brightness necessary to adequately illuminate the surgical site.

In addition, adjust the internal shutter of the camera higher in order to run the light source at a lower intensity. Avoid touching the scope tip or the light cable tip to the patient, and never place them on top of the patient, as doing so may result in burns to the patient or user. In addition, never place the scope tip, the scope light post, the light cable adapter, or the light cable tip on the surgical drapes or other ammable material, as doing so may result in re.

Always place the light source in standby mode whenever the scope is removed from the light cable or the device is unattended. The scope tip, scope light post, light cable adapter, and light cable tip will take several minutes to cool o after being placed in standby mode, and therefore may still result in re or burns to the patient, user, or inanimate objects.

Warnings

To avoid potential serious injury to the user and the patient and/or damage to this device, please note the following warnings:

1. Must be a qualied physician to use this equipment.

2. Carefully unpack this device and check if any damage occurred during shipment. If damage is detected, refer to the standard warranty.

3. Read this operating manual thoroughly, especially the warnings, and be familiar with its contents before connecting and using this device.

4. Ensure that the electrical installation of the relevant operating room complies with the NEC and CEC guidelines.

5. To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.

6. Do not position the console so that it is dicult to disconnect the power cord from the supply mains.

7. Multiple portable socket-outlets shall not be placed on the oor.

8. Test this equipment prior to a surgical procedure. This unit was fully tested at the factory before shipment.

9. Never use the camera system in the presence of ammable or explosive gases.

10. Always treat the camera system with care. The camera system contains sensitive parts that are precisely aligned and may suer damage if dropped or mistreated.

11. The camera head surface may exceed 41°C (106°F) in operating conditions with high ambient temperatures and should be handled with caution.

12. The camera head and coupler are shipped non-sterile. Clean and sterilize these components prior to rst use and after every subsequent use. Follow the cleaning, disinfection, and sterilization instructions provided in these instructions. Any deviation can cause damage.

13. Never autoclave a camera head or coupler unless it is marked AUTOCLAVE. Autoclaving camera heads or couplers that do not bear this marking will result in non-sterile product and permanent device damage. Refer to the “Product Description and Intended Use” section for the location of the AUTOCLAVE marking on the Precision AC Camera.

14. Never sterilize the camera console, because the delicate electronics cannot withstand this procedure.

15. Disconnect the console from the electrical outlet when inspecting fuses.

16. Do not remove covers on the console, as doing so may cause damage to electronics and/or electric shock.

17. Do not disassemble any part of the camera head; doing so may break the seals, causing leakage and/or electric shock.

18. Attempt no internal repairs or adjustments not specically detailed in this operating manual.

19. Ensure that readjustments, modications, and/or repairs are carried out by persons authorized by Stryker Endoscopy.

20. The warranty is void if any of these warnings are disregarded.

Product Description and Intended Use

The Stryker Precision AC Camera System is a high-denition endoscopic camera system that is used to produce still and video images in the surgical eld during surgical procedures. The camera is sensitive in the visible and infrared spectrum. The optical image is transferred from the surgical site to the camera head by a variety of rigid and exible scopes which are attached to the camera head. The system consists of a camera control unit (CCU) and a camera head with an integral cable that connects to the CCU. The camera will provide a high quality image while remaining lightweight and easy to use.

A coupler is also available for attaching a scope to the camera head. The available models for each part are listed below.

Consoles

0700010000 PrecisionAC Camera Control Unit

0700010001 PrecisionAC Camera Control Unit with DVI Fiber Output

Camera Head

0700410105 PrecisionAC Camera Head, C-Mount

Coupler

0700020122 PrecisionAC 20 mm Coupler, C-Mount

Complete instructions are available in Stryker user guide P26183.

The PrecisionAC console is also packaged with the following connection cables:

• Remote cables, 2.5 mm to 3.5 mm (Qty: 2)

• DVI-I cable (Qty: 1)

• Hospital-grade power cord (Qty: 1)

Contact your Stryker representative for availability of other cables that may be required for alternate congurations.

Indications

The PrecisionAC Camera is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherevera laparoscope/endoscope/arthroscope is indicated for use.

A few examples of the more common endoscopic surgeries are listed below.

• laparoscopic cholecystectomy

• laparoscopic hernia repair

• laparoscopic appendectomy

• laparoscopic pelvic lymph node dissection

• laparoscopically assisted hysterectomy

• laparoscopic and thorascopic anterior spinal fusion

• anterior cruciate ligament reconstruction

• knee arthroscopy

• shoulder arthroscopy

• small joint arthroscopy

• decompression xation

• wedge resection

• lung biopsy

• pleural biopsy

• dorsal sympathectomy

• pleurodesis

• internal mammary artery dissection for coronary artery bypass

• coronary artery bypass grafting where endoscopic visualization is

indicated

• examination of the evacuated cardiac chamber during performance of

valve replacement

The users of the camera are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.

Contraindications

There are no known contraindications.

The Camera Console

The camera console—or Camera Control Unit (CCU)—is the control center for the PrecisionAC Camera, and it processes the video and photographic images produced during the surgical procedure.

Front Panel

The console front panel features a touchscreen, where dierent menus can be accessed, including the controls for adjusting the light level, zoom, and white balance, as well as allowing the selection of surgical specialty settings that optimize camera performance for specic surgical procedures. The touchscreen also allows activation of remote outputs, which are commonly used with a Stryker digital capture console to record images and video.

See the “Operation” section for more detail on using the front panel.

21 3

1. Power Switch Powers the camera ON and OFF

2. Touchscreen Allows navigation through dierent menus

for controlling the camera and adjusting the video settings

3. Camera-Connector Port Connects to the PrecisionAC Camera Head

Rear Panel

The console rear panel provides ports for connecting the PrecisionAC Camera to viewing and recording equipment, such as video monitors and Stryker device control consoles.

See the “Product Description” section for the dierent console models that are available. The PrecisionAC Camera Control Unit with DVI Fiber Output (0700010001) is shown below.

87654321

1. Device Control Port Connects to a Stryker device control console (such as the SDC3 or SIDNE®) to enable voice operation and/or graphic tablet control

2. Remote Out 1 Connects to a video accessory remote input

3. Remote Out 2 Connects to a video accessory remote input

4. S-Video Out Analog video output

5. DVI Out 1 Digital video output

6. DVI Out 2 Digital video output

7. Light Source Port Connects to Stryker light source

8. AC Power Inlet Connects to AC mains with separable power

cord

9. Fuse Panel Contains two 1.6A 250V fuses (slow blow, high breaking capacity 1500A, size 5mm x 20mm)

10. Equipotential

Ground Plug

Connects to a potential equalization conductor. The resulting medical electrical system shall follow all applicable IEC 60601-1 requirements.

11. Fiber Outputs

(optical)

DVI output for connection to Lucent connector bers (optional: 0700010001)

The Camera Head

The camera head connects to the camera console and produces video and photographic images, which it relays to the camera console. Several controls are accessible through a button keypad located on the top of the camera head (see the “Operation” section).

“AUTOCLAVE”

1 2 3

1. Soaking Cap Protects the cable connector during cleaning,

disinfection, and sterilization

2. Cable Connector Connects the camera head to the camera console

3. Camera Cable The camera cable length is 10 feet (3.05 m)

4. Camera Head Produces photographic and video images,

provides camera controls, and connects with a focusing coupler. Note that the bottom of the camera head is marked “AUTOCLAVE” to indicate compatibility with steam sterilization.

The C-Mount Coupler

The coupler threads onto the face of the camera head, enabling a scope to be attached to the camera. It provides a focusing ring to adjust image sharpness.

Refer to Stryker user guide P26183 for complete coupler instructions.

1. Rear Adapter Threads onto the camera head

2. Focusing Ring Adjusts the coupler focus

3. Endobody Clamp Secures the scope to the coupler

4. Scope End Receives the endoscope

Setup and Interconnection

Stryker Endoscopy considers instructional training, or inservice, an integral part of the PrecisionAC Camera. Your local Stryker Endoscopy sales representative will perform at least one inservice at your convenience to help set up your equipment and instruct you and your sta on its operation and maintenance. To schedule an inservice, contact your local Stryker Endoscopy representative after your equipment has arrived.

Setting up the PrecisionAC Camera involves three steps:

1. Setting up the console

2. Setting up the camera head

3. Setting up the coupler

• Always connect the console to an appropriate power source, using a hospital-grade power cord. Loss of AC power will cause the camera to shut down and the surgical image to be lost.

• Only connect items to the PrecisionAC Camera that have been specied for use with the camera system. Connecting incompatible equipment may cause unexpected results.

• When the camera system is used with other equipment, leakage currents may be additive. Ensure that all systems are installed according to the requirements of IEC60601-1.

• Equipment which employs RF communications may aect the normal function of the PrecisionAC Camera. When choosing a location for the camera system, consult the “Electromagnetic Compatibility” section to ensure proper function.

• Always set up the console in a location that allows adequate ventilation (airow) to the console. Insucient ventilation may cause the console to overheat and shut down.

Setting Up the Console

Refer to the instructions below and the wiring diagram on the following page for a typical PrecisionAC Camera conguration.

1. Connect the console’s AC power to a hospital-grade outlet.

2. Connect one of the console’s DVI outputs to an available DVI input on a Stryker digital capture console such as the SDC3.

• The PrecisionAC console can also be connected to additional SDC

video inputs or directly to one or more display monitors; the rear panel provides one analog and two digital-video outputs (or three with

0700010001):

Output Type Output Cable Connector

Analog S-VHS 1* S-VHS 4 pin Mini-Din

(push-only connectors)

Digital (standard) DVI-I1** and

DVI-I2**

DVI 29 pin (push-only

connectors, with two tightening knobs)

Digital (optional in 0700010001)

DVI over optical Fiber

Fiber (×4) Lucent connector

ber (×4) (push only)

* On some monitors, S-VHS inputs may be labeled Y/C. ** The DVI connectors can also output analog SXGA signals through a DVI-I to VGA adapter. When using any device with unterminated analog video inputs, connect a cable from the VIDEO OUT of that device to the VIDEO IN on the monitor.

3. Connect the DVI output from the Stryker digital capture console to the DVI input on the display monitor.

4. Using the provided remote cables, connect remote outputs 1 and 2 from the PrecisionAC console to a Stryker digital capture console. (The remote inputs should be connected to the same channel as the video input.)

• Devices connected to the remote outputs can be operated using the

console touchscreen or the P button on the camera head. See the “Operation” section for details.

5. Connect a USB A-to-B cable (also available from Stryker, part 0105187988) from the console’s Light Source output to the SIDNE input on the Stryker L9000 Light Source.

• The PrecisionAC camera head can be programmed to toggle “Run/

Standby” controls on the L9000. Contact a Stryker representative for more information about enabling this advanced feature.

PrecisionAC Wiring Diagram

SDC3

PrecisionAC Camera

L9000 Light Source

VisionPro 26" LED Surgical Display

(underside shown)

Setting Up the Camera Head

Do not severely bend the camera cable or damage may result.

1. Unscrew the soaking cap from the cable connector on the camera head.

2. Align the arrow on the cable connector with the arrow above the cameraconnector port on the front console panel.

3. Push in the connector until it locks in place.

Note: To unplug the camera from the console, grasp the knobbed portion of the connector and pull straight out.

Setting Up the Coupler

Steps 1–3 below provide instructions for connecting the camera head to the coupler.

When using a direct-coupled C-Mount endoscope (a scope that requires no coupler), thread the endoscope directly into the camera head until it forms a tight seal, and skip to step 3.

When attaching or removing the coupler, grip only the rear adapter, as twisting other parts of the coupler with force may result in mechanical damage.

Do not overtighten the coupler (or a direct-coupled C-mount scope), as this may damage the front window of the camera.

1. Attach the coupler to the camera head.

• Gripping the rear adapter, screw the coupler clockwise onto the

camera head until it forms a tight seal.

2. Attach an endoscope to the coupler.

Note: For best results, use the PrecisionAC Camera with Stryker’s PEEK Precision Ideal Eyes™ HD scopes.

Before each use, check the outer surface of the endoscope to ensure there are no rough surfaces, sharp edges, or protrusions.

• Remove the coupler dust cap if it is present.

• Depress the endobody clamp 1 and insert a scope into the

endobody

• Release the endobody clamp to secure the endoscope.

3. Attach a light cable from the light source to the light post on the endoscope

Note: To remove the coupler, grip the rear adapter and unscrew the coupler counterclockwise from the camera head.

Connecting the DVI Fiber Outputs

Using adjustments or performing procedures dierently than specied below may result in hazardous radiation exposure.

The PrecisionAC Camera has the optional upgrade, the ber output, for model 0700010001. This upgrade contains four laser diodes to transmit a DVI output over beroptic cables.

1. Connect four individual bers (terminated in Lucent connectors) to the red (R), green (G), blue (B) and clock (C) laser diodes on the console rear panel.

2. Connect the four bers to a compatible beroptic DVI receiver.

• The four bers should be connected to the camera console in the

labeled order: RGBC

• The bers should be connected to the monitor in one of two

congurations: CBGR (reverse order) or BGRC (R/B switched).

Note: The PrecisionAC Camera Control Unit, model 0700010001, is a Class 1 laser product per IEC60825-1 and 21CFR1040.

Installing the Soaking Cap

Before reprocessing the camera head, the soaking cap must be installed to avoid damaging the cable connector.

Caution: Failure to properly tighten the soaking cap will corrode the

connector pins and void the warranty.

• To install the soaking cap, screw the cap onto the threads of the cable

connector until it forms a tight seal.

• To remove the soaking cap, unscrew the cap and pull it away from the

cable connector.

Operation

Note: Before operating the PrecisionAC Camera, ensure all system

components have been set up according to the instructions in the “Setup and Interconnection” section.

Operating the Camera with a Light Source

IMPORTANT SAFETY NOTICE: Before operating this device,

please read this operating manual thoroughly and carefully. When using this device with a light source, re and/or severe injury may result to the patient, user or inanimate objects if the instructions in this manual are not followed.

All light sources can generate signicant amounts of heat (exceeding 41°C/106°F) at the scope tip, the scope light post, the light cable tip, and/or near the light cable adapter. Higher levels of brightness from the light source result in higher levels of heat. Always adjust the brightness level of the camera and the monitor before adjusting the brightness level of the light source. Adjust the brightness level of the light source to the minimum brightness necessary to adequately illuminate the surgical site.

Powering the Console On/O

Before using the PrecisionAC Camera in a surgical procedure, test all system components to ensure proper function. Ensure that a video image appears on all video monitors before beginning any procedure.

1. Power on the monitor.

2. Press the power switch on the console to power the console on or o.

Note: A color bar pattern will appear on the monitor if the camera head is not connected to the camera console. If the color bar appears, refer to the “Setting Up the Camera Head” section to connect the camera head.

Controlling Remote Video Accessories

The PrecisionAC Camera can remotely control up to two functions of a video accessory, such as a Stryker digital capture console. Commonly this enables the user to capture images or start and stop video recording.

Remote video accessories can be controlled with the camera head’s P button or the console touchscreen. See the following sections, “Using the Camera Head Buttons” and “Using the Touchscreen Interface.”

Note: Controls for capturing photos or recording video require connecting a video accessory to the console. See the “Setup” section for more detail.

Using the Camera Head Buttons

The camera head features a four-button keypad for controlling the PrecisionAC Camera. The button functions are described below.

Up and Down Buttons

The up and down buttons work together to increase or decrease the automatic-shutter light level in eight steps.

P (Picture) Button

The P button controls up to two functions of a remote video accessory. Commonly this enables the user to capture images or start and stop video recording. (See “Controlling Remote Video Accessories” above for connection requirements.)

• Press the P button for less than two seconds to select Remote 1. One beep

will sound. When the camera is connected to a Stryker digital capture console, this will capture a photo.

• Press the P button for more than two seconds to select Remote 2. Two

beeps will sound. When the camera is connected to a Stryker digital capture console, this will start or stop video recording.

W (White-Balance) Button

The W button activates the white-balance function or the zoom-cycle function.

• Press the W button for less than two seconds to activate the zoom-cycle

function. Each press will raise the zoom level in eight steps. When the zoom level has reached its maximum, pressing the button again will cycle the level back to the lowest setting.

• Press the W button for more than two seconds to activate the white-

balance function. White balancing will correct slight color dierences that exist between dierent light sources or endoscopes. See “Performing the White-Balance Test” below.

Using the Touchscreen Interface

The touchscreen interface on the console provides controls for adjusting or capturing the video image. The menus are described below.

Home Screen

The Home Screen is the default screen. It displays the current camera mode and it provides access to subsequent menus and common camera functions.

1. Use the arrows to scroll through preset camera settings designed for surgical specialties. Choose from:

• Arthroscopy

• Cystoscopy

• ENT/Skull

• Flexi-Scope

• Hysteroscopy

• Laparoscopy

• Laser

• Microscope

• Standard

2. Press and hold the WB button for two seconds to activate white balance. See “Performing the White-Balance Test” below for more detail.

A checkmark will appear on the button after the white-balance test is complete.

3. Press the camera button to capture a photo.

A single beep will sound to indicate that a signal for capture/record has been sent to the digital capture console.

4. Press the record button to record a video. Press again to stop recording.

A double beep will sound to indicate that a signal for capture/record has been sent to the digital capture console.

5. Press the Settings button to navigate to the Menu screen.

Menu Screen

The Menu screen provides options for adjusting the camera picture.

1. Press the plus or minus button below the Brightness icon in order to increase or decrease the automatic-shutter light level.

The level is indicated by the green bars in the icon.

2. Press the Light Bulb icon to activate Dynamic Range Enhancement (DRE). DRE increases the brightness of dark backgrounds without causing the foreground image to become too bright.

A green bar in the icon indicates DRE is on. Press the light bulb icon again to turn DRE o.

DRE will function only when the Arthroscopy, ENT/Skull, or Standard surgical specialty is selected.

When DRE mode is turned on, pressing the Up and Down buttons on the camera head for less than two seconds increases and decreases the DRE level, respectively. The remaining button presses function according to the defaults. When DRE mode is turned o, all camera head buttons revert to the previous functions.

3. Press the plus or minus button below the Light Bulb icon in order to increase or decrease the DRE level (low, medium, or high).

The level is indicated by the green bars in the icon.

4. Press the plus or minus button below the Zoom icon in order to increase or decrease the zoom level (magnication).

The level is indicated by the green bars in the icon.

5. Press the Home button to return to the Home Screen.

Performing the White-Balance Test

Before each surgical procedure, perform the white-balance test to adjust the camera’s perception of white so it can display other colors correctly.

1. Ensure that a scope and light source are attached to the camera system, and that the console, light source and monitor are powered on.

2. Point the scope tip at several stacked white gauze pads, a white laparoscopic sponge, or any clean white surface.

3. Look at the monitor and make sure there is no visible glare o of the white surface of the image.

4. Press and hold the camera head W button (or “WB” on the touchscreen) until the monitor displays the message “WHITE BALANCE IN PROGRESS.”

5. Continue pointing the scope at the white surface until the video monitor displays the message “WHITE BALANCE COMPLETE.” The image may change color. If you cannot achieve an acceptable white balance, refer to the “Troubleshooting” section.

Advanced Features

The PrecisionAC Camera has additional features that are not detailed in this guide:

• Video image settings

• Button programming

• Touchscreen language settings

• Light source “Run/Standby” controls

• Other system settings

These advanced features require in-depth knowledge of the device and should be performed only by trained personnel. For access to advanced features, contact a Stryker representative.

Troubleshooting

Problem Possible Solution

E1 error code • Console shut down due to main board error.

• Turn o the console, wait 3 seconds, and turn it back on.

E2 error code • Console shut down due to digital board error.

• Turn o the console, wait 3 seconds, and turn it back on.

E3 error code • Software version mismatch detected.

• Turn o the console, wait 3 seconds, and turn it back on.

E4 error code • Maximum operating temperature of console

exceeded.

• Ensure vent holes on console are not obstructed.

Touchscreen freezes on “Precision AC” splash screen when powering on the console

• Error occurred during console startup.

• Turn o the console, wait 3 seconds, and turn it back on.

“Restart Camera Console” message (Color bar background)

• Camera head temporarily shut down due to overcurrent. Turn o the console, wait 3 seconds, and turn it back on.

• After sterilization, ensure the camera head has cooled down before connecting it to the console.

“System Error” message (Light blue background)

• No video detected.

• After sterilization, ensure the camera head has cooled down before connecting it to the console.

• Return the system for repair.

No color bar • Ensure the video-out from the console is

connected to the video-in on the monitor.

• Ensure all video systems are powered on.

• Ensure that the camera head is not connected to the console.

• Turn o the console, wait 3 seconds, and turn it back on.

Problem Possible Solution

No color bar (Optical DVI Fiber only)

• Same as “No color bar” above.

• See the “Connecting the DVI Fiber Outputs” section.

Incorrect picture color • Perform the white-balance test. (See the

“Performing the White-Balance Test” section.)

• Check the color settings on the monitor.

White-balance quality is not good

• See the solution for “Picture is too dark.”

• See the solution for “Picture is too bright.”

• Perform the white-balance test with the light source connected to the scope. Use metalhalide, xenon, or LED lighting (no uorescent lighting).

Picture is too dark • Increase the camera light level with the

camera head.

• Increase the light-source output.

• Check the beroptic light cable for excessive broken bers.

Picture is too bright • Decrease the camera light level.

• Decrease the light-source output.

Noise or snow on picture when using electrocautery probes

• Plug the electrocautery generator into a separate electrical outlet and separate the PrecisionAC console power cord from the electrocautery power cord.

• Separate the camera cable from the electrocautery cable.

• Reposition the electrocautery grounding pad on the patient.

Noise or snow on picture when not using electrocautery probes

• Conrm all cable connectors are securely attached.

• Check for and replace faulty video cables.

Problem Possible Solution

No video picture when the camera head is plugged in

• Check to ensure that all devices in the video system are plugged in and powered on.

• Check the connector on the camera-head cable for broken pins.

• Detach the camera head from the console and reconnect.

• Turn o the console, wait 3 seconds, and turn it back on.

Image is not well centered

• Release the scope from the coupler and then reconnect it. Make sure the scope is seated correctly in the coupler.

Variability in color reproduction between dierent light sources or peripherals

• Perform the white-balance test. (See the “Performing the White-Balance Test” section.)

• Check the settings on video peripherals.

• Ensure the light source has a proper infrared lter (check with manufacturer specications).

Foggy picture (loss of denition and clarity)

• Refocus the camera.

• Refocus the coupler.

• Clean and dry both the scope and the coupler windows.

• Remove the coupler from the camera head and remove any moisture that has built up between the two components.

Problem Possible Solution

Optics are dirty • Rotate the scope. If dust particles in the

picture rotate, the dust is located on the scope itself. Follow the manufacturer’s instructions for cleaning the eyepiece and negative lens.

• If particles in the picture do not move when you rotate the scope, the particles are located on the coupler or camera. Remove the scope and clean the window on the front of the coupler with a dry or alcohol-tipped cotton swab.

• If dust particles lie between the coupler and camera, remove the coupler and clean the coupler and camera windows.

• Ensure all components are completely dry before reassembling them, or fogging may result.

Blurry picture • Ensure the coupler or C-mount scope is in

focus.

• On the Home screen, ensure the surgical specialty is not set to FLEXI-SCOPE unless you are using a exible scope.

Camera head button error symbol appears on display monitor:

• Return the camera head to Stryker for service.

• If the symbol appears, the camera head buttons are non-functional but the camera head will still provide a video signal to the console. The camera can be operated from the console.

SIDNE device does not recognize camera head

• Contact your Stryker representative for compatibility settings.

Note: If this troubleshooting guide does not resolve the problem, call Stryker Technical Support at 1-877-478-7953 (inside the U.S.) or refer to the standard warranty.

Reprocessing

The camera console is not intended to come into contact with the patient. It may be cleaned, but not sterilized. The camera head and coupler may contact the patient and should both be cleaned and sterilized prior to every use.

Refer to the coupler user guide (Stryker part P26183) for instructions on reprocessing the coupler.

Cleaning the Console

Should the camera console need cleaning, follow the warnings, cautions, and instructions below. The user shall provide the mild detergent (or standard disinfectant) and sterile cloth required for cleaning.

To avoid electric shock and potentially fatal injury, disconnect the console from the AC power source before cleaning.

Observe the following cautions to avoid damaging the console:

• Do not sterilize the console.

• Do not immerse the console in any liquid.

• Do not allow liquid to drip onto the console or collect on any of its surfaces.

• Do not spray cleaning liquid directly onto the console, power buttons, or connectors. Spray the cleaning liquid onto a cloth, and use the cloth to wipe the console.

• Do not use corrosive cleaning solutions to clean the console.

1. Spray a mild detergent or standard disinfectant onto a dry, sterile cloth. Do not saturate the cloth.

2. Wipe the console. Do not allow liquid to drip from the cloth or collect on the console.

3. When cleaning the front LCD screen, use extra care to prevent liquid from dripping or pooling on the bottom of the screen. Excess liquid can enter the console and cause product damage.

Cleaning, Disinfecting, and Sterilizing the Camera Head

These reprocessing instructions are provided in accordance with ISO17664, ISO17665, AAMITIR12, AAMIST79, and AAMIST81. The instructions have been validated by Stryker as being capable of preparing the device for re-use. To achieve the desired result, the processor shall ensure that the following instructions are performed as written in their entirety and as appropriate in the processor’s facility. This normally requires routine monitoring and validation of the facility’s reprocessing procedures. Stryker recommends users observe these standards when reprocessing medical devices.

Overview

Reprocessing the camera head involves manual or automated cleaning with two dierent detergents, optional disinfection, and sterilization.

• Step 1 (required): Cleaning with Enzymatic Detergent

• Step 2 (required): Cleaning with Non-Enzymatic Detergent

• Step 3 (optional): Disinfection

• Step 4 (required): Sterilization

Warnings

• This device must be cleaned and sterilized prior to the rst use and after every subsequent use.

• Separate the camera head, coupler, and scope prior to cleaning, disinfection, or sterilization. Failure to follow this instruction will render the devices non-sterile. (Refer to the coupler and scope product manuals for reprocessing instructions for those devices.)

• Wear appropriate protective equipment: gloves, eye protection, etc.

• To avoid health risks from aerosol contamination, brush the device only when it is submerged in liquid.

• Use only the sterilization cycles outlined in this document. Using unspecied sterilization cycles may damage the device or result in incomplete sterilization.

• Only camera heads marked AUTOCLAVE can withstand steam sterilization. Autoclaving camera heads that do not bear this marking will result in non-sterile product and permanent device damage. Refer to the “Product Description and Intended Use” section for the location of the AUTOCLAVE marking on the PrecisionAC Camera.

Cautions

• Always install the soaking cap prior to processing the camera. Failure to properly tighten the soaking cap will corrode the connector pins and void the warranty. Refer to the “Installing the Soaking Cap” section for more detail about installing the cap.

• Inspect the camera cable for cuts and breaks before soaking in any uid. Return any damaged camera to Stryker for service.

• Never soak the camera in the same tray with sharp instruments.

• Do not use brushes or pads with metal or abrasive tips during manual cleaning, as permanent scoring or damage could result.

• To minimize galvanic corrosion, avoid soaking dissimilar metals in close proximity.

• Allow the camera head to cool before connecting it to the console. Connecting the camera head while it is hot may result in system error.

Limitations on Reprocessing

• Do not cross-sterilize the device. Using multiple sterilization methods may signicantly reduce the performance of the device.

• Do not leave the device in solutions longer than necessary. This may accelerate normal product aging.

• Proper processing has a minimal eect on this device. End of life is normally determined by wear and damage due to use.

• If the camera head is cleaned with the automated cleaning method, steam sterilization is recommended. Repeated automated cleaning when sterilizing with Sterrad or V-Pro can degrade the product’s cosmetic appearance.

• Repeated sterilization via Sterrad 100NX can degrade the product’s cosmetic appearance.

• Damage caused by improper processing is not covered by the warranty.

Materials and Equipment

All materials and equipment required to reprocess the camera head shall be supplied by the user unless otherwise noted

Item Description

All phases

Gloves, eye protection, etc.

Wear protective equipment as required by the medical facility and procedure.

Cleaning

Tray For safe transportation of device within the medical

facility. Not to be used for reprocessing the device unless sterilized rst.

Water basin Large enough to accommodate camera head without

excessive bending of cable

Enzymatic detergent

Used in cleaning solution to remove surgical debris

Tap water To prepare cleaning solutions

Syringe Minimum volume: 50mL

Soft-bristed brush

To clean exterior of device

Reverse osmosis/ deionized water

To rinse device

Clean cloth or ltered pressurized air

To assist with drying

Non-enzymatic detergent

Used in cleaning solution to remove surgical debris

Automated washer For using the automated cleaning procedure

Disinfection

Washer disinfector To perform thermal disinfection

Sterilization

Sterilization system Steam (Autoclave)

Steris®/Amsco® V-PRO® maX, V-PRO 1 Plus, or V-PRO 1

Sterrad® 100S, 200, NX®, or 100NX®

Sterilization wrap

5,6

To maintain sterile barrier

Sterilization tray

Optional. Must be compatible with sterilization method.

Cleaning was validated using Enzol® Enzymatic Detergent at 1 oz/gal.

Cleaning was validated using an M16 brush.

Cleaning was validated using reverse osmosis/deionized (RO/DI) water.

Cleaning was validated using Prolystica® 2x Neutral Detergent at 1/8 oz/gal.

Sterilization was validated using Kimberly-Clark® KC600 KIMGUARD sterilization wrap.

For United States users: when sterilizing the device, use only sterilization wraps and sterilization trays that have been cleared by

the FDA to use with the selected sterilization cycle.

Instructions for Reprocessing

Point of Use

• Disassemble the camera head from the scope and coupler. To disconnect the scope, depress the endobody clamp on the coupler and remove the scope from the coupler. To disconnect the coupler, grip the rear adapter of the coupler and unscrew it counterclockwise from the camera head.

• Wipe any excess soil from the device using a clean sterile cloth.

Containment and Transportation

• Reprocess the device as soon as reasonably practical following use.

• Transport the device in a tray to avoid damage. Follow the facility’s internal procedures for the transportation of contaminated surgical instruments and devices.

Cleaning

Manual Cleaning

1. Soak

• Ensure the soaking cap is installed. Refer to the “Installing the Soaking Cap” section for more detail about installing the cap.

• Prepare a solution of enzymatic detergent and tap water at 35°C. Refer to the manufacturer’s instructions for detergent concentration and any other recommendations.

• Fully immerse the device and use an appropriately-sized syringe to inject any mated surfaces and crevices with at least 50mL of the prepared detergent.

• Soak the device for a minimum of 15minutes.

2. Brush

• Thoroughly brush the exterior of the device with a soft-bristled brush for 90seconds, focusing on any crevices and mated surfaces.

• Inject any mated surfaces and crevices a minimum of 5 times with 50mL of the prepared detergent.

3. Rinse

• Remove the device from the prepared detergent. Rinse the device with reverse osmosis/deionized water at ambient temperature for 90seconds or until all visible detergent residue has been removed.

• Flush any mated surfaces and crevices a minimum of 5times. After all visible detergent residue has been removed, continue to rinse for 30seconds.

• Drain excess water from the device and dry it using a clean cloth or ltered pressurized air.

• Visually inspect the device for cleanliness, paying close attention to hard-to-reach areas. If visible soil remains, repeat steps 1through3.

4. Soak

• Prepare a solution of non-enzymatic detergent and tap water at 35°C. Refer to the manufacturer’s instructions for detergent concentration and any other recommendations.

• Fully immerse the device and use an appropriately-sized syringe to inject any mated surfaces and crevices with at least 50mL of the prepared detergent.

• Soak the device for a minimum of 15minutes.

5. Brush

• Thoroughly brush the exterior of the device with a soft-bristled brush for 90seconds, focusing on any crevices and mated surfaces.

• Inject any mated surfaces and crevices a minimum of 5times with 50mL of the prepared detergent.

6. Rinse

• Flush any mated surfaces and crevices a minimum of 5times. After all visible detergent residue has been removed, continue to rinse for 30seconds.

• Drain excess water from the device and dry it using a clean cloth or ltered pressurized air.

• Visually inspect the device for cleanliness, paying close attention to hard-to-reach areas. If visible soil remains, repeat steps 1through6.

Automated Cleaning

Caution

If the camera head is cleaned with the automated cleaning method, steam sterilization is recommended.

1. Soak

• Ensure the soaking cap is installed. Refer to the “Installing the Soaking Cap” section for more detail about installing the cap.

• Prepare a solution of enzymatic detergent and tap water at 35°C. Refer to the manufacturer’s instructions for detergent concentration and any other recommendations.

• Fully immerse the device and use an appropriate-sized syringe to inject any mated surfaces and crevices with at least 50mL of the prepared detergent.

• Soak the device for a minimum of 15minutes.

2. Brush

• Thoroughly brush the exterior of the device with a soft-bristled brush for 90seconds, focusing on any crevices and mated surfaces.

3. Rinse

• After all visible detergent residue has been removed, continue to rinse for 30seconds.

4. Automated Wash

• Place the device in the washer on an incline to facilitate drainage.

• Program the washer using the following parameters:

Pre-Wash

Recirculation Time 2 Minutes

Water Temperature Cold Tap Water

Detergent Type N/A

Enzyme Wash

Recirculation Time 2 Minutes

Water Temperature Hot Tap Water

Detergent Type Enzymatic Detergent

Wash 1

Recirculation Time 2 Minutes

Water Temperature 66 ˚C Set Point

Detergent Type Non-Enzymatic Detergent

Rinse 1

Recirculation Time 2 Minutes

Water Temperature Hot Tap Water

Detergent Type N/A

Dry Phase

Recirculation Time 7 Minutes

Water Temperature 115 ˚C

Detergent Type N/A

• Filtered pressurized air (≤40psi) can be used to aid in drying.

• Visually inspect the device for cleanliness, paying close attention to hard-to-reach areas. If visible soil remains, repeat steps 1through4.

Drying

• For automated drying, use the drying cycle provided with the washer/ disinfector.

• For manual drying, use a clean, lint-free cloth.

• Filtered pressurized air (≤40psi) can be used to aid in drying any crevices, mated surfaces, and hard-to-reach areas.

Disinfection (Optional)

Thermal Disinfection

The device must be sterilized after disinfection. Failure to sterilize the device before reuse presents an acute infection control risk to the patient.

Follow the steps below to disinfect the device using thermal disinfection.

1. Place the device into the washer disinfector.

2. Program the washer using the following parameters:

Thermal Disinfection

Recirculation Time: 1 Minute

Water Temperature 90°C

Sterilization

After performing the cleaning instructions specied above, perform one of the following sterilization cycles.

Steam

Steam sterilization is intended only for camera heads marked AUTOCLAVE. Steam sterilizing camera heads that do not bear this marking will result in non-sterile product and product damage.

Refer to the “Product Description and Intended Use” section for the location of the AUTOCLAVE marking on the PrecisionAC Camera.

1. Clean and prepare the camera head as recommended in this user

guide. Ensure the soaking cap is installed. Refer to the “Installing the Soaking Cap” section for more detail about installing the cap.

2. If using a sterilization tray (optional), follow any additional

instructions provided with the tray. Use only trays that are compatible with steam sterilization.

3. Double wrap the camera head and cable (or tray) prior to sterilization.

4. Sterilize the camera head and cable using the parameters below.

Note: The water used in the autoclave process must meet standards for clean steam per AAMI ST79 Annex M – Steam Quality.

• For routine reprocessing with steam sterilization, use the following Gravity or Pre-Vacuum cycles.

Gravity

Wrapping Double

Temperature 132 °C (270 °F) 134 °C (274 °F)

Sterilization Time 15 minutes 10 minutes

Dry Time 35 minutes 40 minutes

Pre-Vacuum

Wrapping Double

Temperature 132 °C (270 °F) 134 °C (274 °F)

Sterilization Time 4 minutes 3 minutes

Dry Time 25 minutes 35 minutes

• Immediate-use steam sterilization (IUSS, or “Flash”) is intended only for emergency situations. In the event that immediate-use steam sterilization is required, the following instructions should be used.

Immediate-use steam sterilization should only be used in carefully selected clinical situations (e.g. an instrument needed for a case falls on the oor and no replacement instrument is available). IUSS should not be used due to inadequate inventory.

“Flash” Pre-Vacuum

Wrapping None

Temperature 132 °C (270 °F) 134 °C (274 °F)

Sterilization Time 4 minutes 3 minutes

Dry Time None

5. Allow the camera head, cable, coupler, and scope to completely dry

before reassembly. Any moisture on the threads will cause the camera and coupler windows to fog during use.

• Drying time depends on several variables including: altitude, humidity, type of wrap, preconditioning, size of chamber, mass of load, material of load, and placement in the chamber. Users must verify that drying time set in their autoclave yields dry surgical equipment.

Steris/Amsco V-PRO

1. Clean and prepare the camera head and cable as recommended in this user guide. Ensure the soaking cap is installed. Refer to the “Installing the Soaking Cap” section for more detail about installing the cap.

2. If using a sterilization tray (optional), follow any additional instructions provided with the tray. Use only trays that are approved for sterilization with V-PRO.

3. Double wrap the camera head and cable (or tray) prior to sterilization

4. Sterilize the device using one of the following V-PRO sterilization systems:

• V-PRO maX Sterilizer (Non-Lumen or Standard cycle)

• V-PRO 1 Plus Sterilizer (Non-Lumen or Standard cycle)

• V-PRO 1 Sterilizer (Standard cycle)

Sterrad

2. If using a sterilization tray (optional), follow any additional instructions provided with the tray. Use only trays that are compatible with Sterrad.

Not all sterilization trays are compatible with Sterrad systems. Using an incompatible tray may result in incomplete device sterilization. Consult the instructions that came with your sterilization tray to determine which sterilization method is compatible with your tray and devices. If a compatible tray is not available, the devices can be double wrapped prior to using the Sterrad system.

3. Double wrap the camera head and cable (or tray) prior to sterilization

4. Sterilize the camera head and cable following the instructions of the manufacturer, using the Sterrad 100S, 200, NX, or 100NX Sterilization System. Select the standard cycle.

User Maintenance

Maintenance, Inspection, and Testing

• Inspect the device on a continual basis. If a problem is observed or suspected, the device should be returned for repair.

• Inspect all components for cleanliness. If uid or tissue buildup is present, repeat the above cleaning and disinfection procedure.

• Inspect the camera cable for cuts and breaks. Return any damaged camera to Stryker for service.

Using Sterile Drapes

Using sterile drapes will ensure maximum longevity of your PrecisionAC Camera. For best results, follow the instructions provided by the drape manufacturer.

Storage

Never store the device in a non-ventilated, humid environment such as a carrying case. This can present an infection control risk.

Replacing the Fuses

To avoid the risk of re, use only fuses of the value specied on the fuse label located on the rear panel of the console.

1. Unplug the power cord from the wall outlet and remove the cord from

the transmitter console.

2. Unlatch the fuse holder above the AC inlet and remove it. (You may need

to press the tab on the fuse holder with a slender screwdriver to release the latch.)

3. Replace the fuse with the same value and rating.

4. Reinstall the fuse holder until the tab snaps in place.

Periodic Maintenance Schedule

To ensure safe operation of the PrecisionAC Camera, you should periodically perform the following procedure:

Every 12 months, check the earth leakage current to <500 µA (<300 µA in USA), ground protective earth impedance to <0.1 ohms, and power consumption less than or equal to rated power. Use a true RMS digital multimeter and safety analyzer to perform this test.

Note: Refer calibration and operating diculties not detailed in this manual to your Stryker Endoscopy sales representative.

Expected Service Life

Both models of the PrecisionAC Camera Control Unit have an expected service life of 5years.

The Precision AC Camera Head has an expected service life of 2years, except with repeated use of an automated washer the expected service life is 1year.

Note: If the camera head is cleaned with the automated cleaning method, steam sterilization is recommended. Repeated automated cleaning when sterilizing with Sterrad or V-Pro can degrade the product’s cosmetic appearance.

Disposal and Recycling Information

This product contains electrical waste or electronic equipment. It must not be disposed of as unsorted municipal waste and must be collected separately in accordance with applicable national or institutional related policies relating to obsolete electronic equipment.

Dispose of the camera system according to local laws and hospital practices. Refer to the diagrams below to identify components that must be recycled. (The console is shown with the chassis cover removed for clarity.)

Diagrams

Console (front and rear views)

Item Material Qty. Comments

1 PC Board 1

2 PC Board 1

3 Touchscreen LCD 1

4 Power Supply 1

5 PC Board 1

6 PC Board 1 Located behind LCD

7 PC Board 1

8 PC Board 1 0700010001 only

9 AC Power Cord 1

10 Remote Cable 2

11 DVI Cable 1

Camera Head

1 2

Item Material Qty. Comments

1 Cable 1

2 Camera Head Enclosure

(PC Boards)

1 The camera head enclosure that

contains PC Boards is sealed and cannot be dismantled without special equipment and training.

Technical Specications

60 Hz settings are displayed rst. (50 Hz settings follow in parentheses.)

Imaging System 1/3″ Progressive Scan CCD

High Denition

Scanning System Horizontal: 64.00 kHz (60.00 kHz)

Vertical: 60.02 Hz (50.00 Hz)

Video Outputs

Digital/Analog: Two Digital Video Interface (DVI)/RGBHV

1280 × 1024 (HD), 720p, 1080p (HDTV) format

Connector: 29-pin DVI-I

Y/C: One S-VHS

Connector: 4-pin mini-DIN

Digital Fiber: HD, HDTV (R, G, B, Clk)

Connector: Four Lucent ber connectors with 1.25 mm

ferrules

Mounting Endoscope eyepiece used with C-mount

coupler

C-mount camera head used with C-mount scopes

(C-mount coupler/scope thread: 1-32″ UN 2A)

Auto Shutter Range 1/60 (1/50) – 1/50,000 second

Operating Conditions Temperature: 10–30 °C

Relative Humidity: 25–75%

Transport and Storage Conditions

Temperature: -18–60 °C

Relative Humidity: 15–90%

Input Electrical Ratings 100–240 VAC (0.2–0.7 A) @ 50–60 Hz

Total Shipping Weight 13 lb (6.0 kg) Camera console

0.5 lb (0.226 kg) Coupler

1.5 lb (0.680 kg) Camera head

Dimensions Camera Console:

12.5″ w × 4.0″ h × 15.25″ d

(31.8 cm w × 10.2 cm h × 38.7 cm d)

Camera Head Cable:

10 ft (3.05 m) sealed cable

Classication Class I Equipment

Continuous Operation

Type BF Applied Part

Ingress Protection, IPX0—Ordinary Equipment (PrecisionAC consoles)

Ingress Protection, IPX7—Protected against the eects of temporary immersion in water (PrecisionAC Camera Head)

Complies with Laser Product Standards

Class 1 Laser Product

Contains four 850-nm laser diodes

This product complies with IEC 60825-1:2007.

This product complies with 21 CFR, Subchapter J, Parts 1040.10 and 1040.11, except for deviations pursuant to Laser Notice No. 50, dated July 26, 2001.

Electromagnetic Compatibility

Like other electrical medical equipment, the PrecisionAC Camera requires special precautions to ensure electromagnetic compatibility with other electrical medical devices. To ensure electromagnetic compatibility (EMC), the camera system must be installed and operated according to the EMC information provided in this manual.

Note: The PrecisionAC Camera has been designed and tested to comply with IEC60601-1-2 requirements for EMC with other devices.

• Do not use cables or accessories other than those provided with the PrecisionAC Camera, as this may result in increased electromagnetic emissions or decreased immunity to such emissions.

• If the PrecisionAC Camera is used adjacent to or stacked with other equipment, observe and verify normal operation of the camera system in the conguration in which it will be used prior to using it in a surgical procedure. Consult the tables below for guidance in placing the PrecisionAC Camera.

• Equipment which employs RF communications may aect the normal function of the PrecisionAC Camera.

Guidance and Manufacturer’s Declaration: Electromagnetic Emissions

The Precision AC Camera is intended for use in the electromagnetic environment specied below. The customer or user of the camera system should ensure that it is used in such an environment.

Emissions test Compliance Electromagnetic Environment - guidance

RF emissions CISPR 11 Group 1 The Precision AC Camera 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.

RF emissions CISPR 11 Class B The Precision AC Camera is suitable for use

in all establishments other than domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes, provided the following warning is heeded:

Warning: This system is intended for use by health care professionals only. This system

may cause radio interference or may disrupt

the operation of nearby equipment. It may be necessary to take mitigation measures, such as

reorienting or relocating the system or shielding

the location.

Harmonic emissions

IEC61000-3-2

Class A

Voltage Fluctuations/ icker emissions IEC61000-3-3

Complies

Guidance and Manufacturer’s Declaration: Electromagnetic Immunity

The Precision AC Camera is intended for use in the electromagnetic environment specied below. The customer or user of the camera system should ensure that it is used in such an environment.

Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic

Environment: Guidance

Electrostatic Discharge

(ESD) IEC61000-4-2

±6kV contact

±8kV air

±2,4,6kV contact

±2,4,8kV air

Floors should be wood, concrete, or ceramic tile. If oors are covered with

synthetic material, the relative humidity

should be at least 30%.

Electrical fast transient/

burst IEC61000-4-4

±2kV for power supply

lines

±1kV for input/output

lines

±2kV line to ground

±1kV line to line

Mains power quality should be that of a

typical commercial or

hospital environment.

Surge

IEC61000-4-5

±1kV differential mode

±2kV common mode

±0.5, 1kV differential

mode

±0.5, 1, 2kV common

mode

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

IEC61000-4-11

<5% Ut (>95% dip in Ut) for 0.5 cycle

40% Ut (60% dip in Ut) for 5 cycles

70% Ut (30% dip in Ut) for 25 cycles

<5% Ut (>95% dip in Ut) for 5 sec.

<5% Ut (>95% dip in Ut) for 0.5 cycle

40% Ut (60% dip in Ut) for 5 cycles

70% Ut (30% dip in Ut) for 25 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 the Precision AC Camera requires continued

operation during power

mains interruptions, it is recommended

that the console be powered from an uninterruptible power supply or a battery.

Power frequency (50/60Hz) magnetic eld

IEC 61000-4-8

3 A/m N/A Power-frequency

magnetic elds should be at levels

characteristic of a typical location in a typical commercial or

hospital environment.

NOTE: Ut is the AC mains voltage prior to application of the test level.

Guidance and Manufacturer’s Declaration: Electromagnetic Immunity

The Precision AC Camera is intended for use in the electromagnetic environment specied below. The customer or user of the camera system should ensure that it is used in such an environment.

Immunity Test IEC 60601 Test Level Compliance

Level

Electromagnetic Environment: Guidance

Conducted RF

IEC 61000-4-6

Radiated RF

IEC 61000-4-3

3 Vrms

150 kHz to 80 MHz

3 V/m

80MHz to 2.5 GHz

3 V

3 V/m

Portable and mobile RF

communications equipment

should be used no closer to

any part of the Precision AC

Camera, including its cables, than

the recommended separation distance calculated from the

equation applicable to the frequency of the transmitter.

Recommended Separation Distance

d = 1.17 √P

d = 1.17 √P 80 MHz to 800 MHz

d = 2.23 √P 800 MHz to 2.5 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 meters (m).

Field strengths from xed 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:

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reection from structures, objects, and people.

Guidance and Manufacturer’s Declaration: Electromagnetic Immunity

The Precision AC Camera is intended for use in the electromagnetic environment specied below. The customer or user of the camera system should ensure that it is used in such an environment.

(a) Field strengths from xed 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 xed RF transmitters, an electromagnetic site survey should be considered. If the measured eld strength in the location in which the Precision AC Camera system is used exceeds the applicable RF compliance level above, the Precision AC Camera system should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Precision AC Camera unit.

(b) Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.

Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Precision AC Camera

The Precision AC Camera is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user of the camera system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Precision AC Camera as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power (W) of transmitter

Separation distance (m) according to frequency of transmitter

150 kHz to 80 MHz

d = 1.17 √P

80MHZ to 800 MHz

d = 1.17 √P

800 MHz to

2.5 GHz

d = 2.33 √P

0.01 0.12 0.12 0.23

0.1 0.37 0.37 0.74

1 1.17 1.17 2.33

10 3.70 3.70 7.37

100 11.70 11.70 23.30

For transmitters rated at a maximum output power not listed above, the recommended separation distance (d) in meters (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.

NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reection from structures, objects, and people.

Symbol Denitions

In addition to the cautionary symbols already listed, other symbols found on the PrecisionAC Camera and in this manual have specic meanings that clarify the proper use and storage of the camera system. The following list denes the symbols associated with this product:

Consult instructions for use

Caution (consult instructions for use)

Federal law (USA) restricts this device to use by, or on order of, a physician

Device is shipped non-sterile and must be sterilized before use

Date of manufacture

Legal manufacturer

Product catalog number

Product serial number

The device meets requirements for safety and eectiveness set forth in MDD 93/42/EEC.

Stryker European representative

Denotes compliance to CAN/CSA C22.2 No60601-1 and ANSI/AAMI 60601-1

Type BF applied part

PrecisionAC Camera Head connection

Power on/o (alternates when button is pushed)

CLASS 1 LASER

PRODUCT

APPAREIL A LASER DE

CLASSE 1

Class I laser product

Camera head button error (return for service if this appears on the display monitor)

Equipotentiality

Alternating current

Fuse rating

Device recycling code (applicable in China)

This product contains electrical waste or electronic equipment. It must not be disposed of as unsorted municipal waste and must be collected separately.

Consult instruction manual

Temperature limitation

Relative humidity limitation

Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 USA 1-408-754-2000, 1-800-624-4422 www.stryker.com

Patents: www.stryker.com/patents

Stryker Corporation or its divisions or other corporate aliated entities own, use or have applied for the following trademarks or service marks: SIDNE, Ideal Eyes, and the Stryker logo. All other trademarks are trademarks of their respective owners or holders.

P26182 D

2015/01

Stryker 0700010000, 0700410105, 0700010001 User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual