Smith & Nephew 450P Instructions d'installation et d'utilisation

Smith & Nephew

450P and 460P

3-CCD Camera

Control Units

Operations/Service Manual

CAUTION: U.S. Federal law restricts this device to sale

by or on the order of a physician.

Power On

Power Off

Up Button

Down Button

MICROPHONE

PROCEDURE

WHITE SET

ENHANCEMENT

SELECT Button

BRIGHTNESS

DO NOT PLUG IN WET

Color Camera

Input

HEAD SELECT Button

Line Input

IEEE-1394 DV/SDI/DVI Output

RGB Analog Output

Video Output

Bidirectional Port

Y/C Analog Output

Serial Number

Equipotentiality

Date of Manufacture

UL Classification

Fuse

Caution: See Instructions for Use

Electrical Shock Hazard

Type CF Equipment

European Representative

EU: Not for general waste

Smith & Nephew 450P and 460P 3-CCD Camera Control Units Operations/Service Manual 10600023 Rev. B 3

Glossary of Symbols

T 1A 250V

Smith & Nephew 450P and 460P 3-CCD Camera Control Units Operations/Service Manual 10600023 Rev. B

Table of Contents

Glossary of Symbols . . . . . . . . . . . . . . .3

Preface . . . . . . . . . . . . . . . . . . . . . . . . . .5

Introduction . . . . . . . . . . . . . . . . . . . . . .5

HERMES-Ready…Camera Control

Unit Information . . . . . . . . . . . . . . . . . . .5

Indications for Use . . . . . . . . . . . . . . . .6

Contraindications . . . . . . . . . . . . . . . . .6

Warnings . . . . . . . . . . . . . . . . . . . . . . . .6

Precautions . . . . . . . . . . . . . . . . . . . .6–7

System Components

Unpacking and General Inspection . . . . . .7

Front Panel Controls . . . . . . . . . . . . . . .8–10

Rear Panel Controls . . . . . . . . . . . . . . .11–12

Camera Head Controls . . . . . . . . . . . .13–14

Preoperative Setup

Prepare the Camera Head . . . . . . . . . . . .15

Inspect the System Components . . . . . . .15

Light Source . . . . . . . . . . . . . . . . . . . . . . .15

Electrical Connections . . . . . . . . . . . . . . .15

Cable Connectors . . . . . . . . . . . . . . . . . . .16

Connect the Camera Head . . . . . . . . . . . .17

Connect the Video Accessories . . . . . . . .17

Recommended System Configuration

IEC 60601-1-1 Compliant System

Configuration . . . . . . . . . . . . . . . . . . . . . .18

Equipment Setups

Customizing Equipment Setups . . . . . . . .19

Setup Configurations Summary . . . . . . . .19

Equipment Setup 1 . . . . . . . . . . . . . . .20–21

Equipment Setup 2 . . . . . . . . . . . . . .22–23

Equipment Setup 3 . . . . . . . . . . . . . .24–25

Equipment Setup 4 . . . . . . . . . . . . . .26–27

Equipment Setup 5 . . . . . . . . . . . . . .28–29

Operation

Turn the Camera On . . . . . . . . . . . . . . . .30

Adjust the Monitor to the Color Bars . . .30

Tips for Adjusting Color Monitors . . . . . .30

Confirm Attachment of Coupler/

Videoendoscope to Camera Head . . . . .30

White Set the Camera . . . . . . . . . . . . . . .31

Camera Control Menus . . . . . . . . . . . . . .32

SELECT Button . . . . . . . . . . . . . . . . . . .32

UP and DOWN Buttons . . . . . . . . . . . .32

Menus and Sub-Menus . . . . . . . .33–34

Zoom (460P CCU Only) . . . . . . . . . . . .35

Power-Up Initialization . . . . . . . . . . . . .35

White Set Menu . . . . . . . . . . . . . .35–36

Enhancement . . . . . . . . . . . . . . . . .36–37

Brightness . . . . . . . . . . . . . . . . . . . . . .37

Procedure . . . . . . . . . . . . . . . . . . . . . .38

Button Setup . . . . . . . . . . . . . . . . .38–39

Language . . . . . . . . . . . . . . . . . . . . . . .39

Program . . . . . . . . . . . . . . . . . . . . .39–41

Custom1 and 2 . . . . . . . . . . . . . . . .41–43

Cleaning and Sterilization

Cleaning the Camera Control Unit . . . . .44

Cleaning and Sterilizing

the Camera Heads . . . . . . . . . . . . . . . . .44

Cleaning the Fan Grill . . . . . . . . . . . . . . .44

Service and Maintenance

Service . . . . . . . . . . . . . . . . . . . . . . . . . .45

Service Philosophy . . . . . . . . . . . . . . .45

Changing Fuses . . . . . . . . . . . . . . . . . .45

Maintenance . . . . . . . . . . . . . . . . . . . . . .45

Recommended Annual

Performance Checks . . . . . . . . . . . . . .45

Electrical Interference . . . . . . . . . . . . . . .45

Environmental Protection . . . . . . . . . . . . .45

Troubleshooting . . . . . . . . . . . . . .46–47

Specifications . . . . . . . . . . . . . . . . . . .48

Ordering Information . . . . . . . . . . .49–50

Glossary . . . . . . . . . . . . . . . . . . . . .51–54

Guidance and Manufacturer’s

Declaration – Electromagnetic

Immunity . . . . . . . . . . . . . . . . . . . .55–56

Guidance and Manufacturer’s

Declaration – Electromagnetic

Emissions . . . . . . . . . . . . . . . . . . . . . . .57

Guidance for Separation Distances . .58

Warranty

Warranty . . . . . . . . . . . . . . . . . . .Back Cover

Service Replacement Program .Back Cover

Figures

1a. Smith & Nephew

450P CCU Front Panel . . . . . . . . . . . .8

1b. Smith & Nephew

460P CCU Front Panel . . . . . . . . . . . .8

2a. Smith & Nephew

450P CCU Rear Panel . . . . . . . . . . . .11

2b. Smith & Nephew

460P CCU Rear Panel . . . . . . . . . . . .11

3a. Smith & Nephew 460H

Three-Button Camera Head . . . . . . .13

3b. Smith & Nephew ED-3

Two-Button Camera Head . . . . . . . . .13

4. Smith & Nephew 470H

Three-Button Camera Head . . . . . . .14

5. Video Cable Connectors . . . . . . . . . .16

6. Camera Head Connection . . . . . . . . .17

7. IEC 60601-1-1 System Configuration .18

8. White Setting the Camera . . . . . . . . .31

Tables

1. Guidance and Manufacturer’s

Declaration - Electromagnetic

Immunity . . . . . . . . . . . . . . . . . .55–56

2. Guidance and Manufacturer’s

Declaration - Electromagnetic

Emissions . . . . . . . . . . . . . . . . . . . . .57

3. Guidance for Separation Distances .58

Smith & Nephew 450P and 460P 3-CCD Camera Control Units Operations/Service Manual 10600023 Rev. B 5

Preface

This manual provides the information you need

to operate and maintain the Smith & Nephew

450P and 460P 3-CCD Camera Control Units.

Prior to using this equipment, please read this

manual thoroughly, paying particular attention

to the operating instructions, warnings, and

cautions. Smith & Nephew surgical equipment is

designed for use only by medical professionals

who are completely familiar with the appropriate

surgical techniques and video procedures.

Introduction

Smith & Nephew 450P and 460P 3-CCD CCUs

(Camera Control Units) are state-of-the-art video

CCUs designed for use in endoscopic surgical

applications. Fingertip control of camera features

(enhancement features and zoom capabilities

[460P camera only]) and accessories (VCRs,

video printers, and still image recorders)

maximize surgeon control over the visualization

system and documentation.

The 450P and 460P CCUs’ advanced 3-CCD

digital circuitry provides superior color rendition

and high-resolution images. Their advanced

automatic features offer enhanced ability to

customize Smith & Nephew cameras to meet

individual procedural requirements. The 450P

and 460P CCUs offer optimum light sensitivity

to ensure sufficient light output at all times in

various endoscopic surgical applications. Their

improved camera shutters allow for smoother

light compensation. Variable controls such as

automatic shutter settings and light adjustments

permit adaptation of the CCU to address

changing conditions during surgery. The

enhancement control gives you the ability to

enhance the contrast and edges of anatomical

features. The digital zoom feature provides visual

access to surgical sites previously difficult to

visualize.

The 460P CCU incorporates four digital output

ports: IEEE-1394 DV (digital video), SDI (serial

digital interface), and two DVI (digital visual

interface) ports. The IEEE-1394 port allows direct

connection with any accessory compatible with

DV format. The SDI port allows high-quality

video to be distributed up to 300 feet using a

single coaxial cable. The DVI ports allow high-

resolution video to be directly displayed on a

1280 x 1024 pixel digital flat panel display.

Smith & Nephew 450P and

460P HERMES-Ready…Camera

Control Units Information

The Smith & Nephew 450P and 460P HERMES-

Ready Control Units are configured to be

connected to the Smith & Nephew HERMES®

Digital O.R. Control Center via the bidirectional

(HERMES-Ready) port, which uses RS-232 serial

communications protocol. When connected, the

system functions may be accessed by direct

voice commands or by manual use of a touch

screen control (HERMES Pendant®).

It is recommended that the physician and

support personnel are thoroughly familiar with

the setup and operation of the Smith & Nephew

HERMES Digital O.R. Control Center. Please refer

to the Smith & Nephew HERMES Digital O.R.

Control Center Operating and Maintenance

Manual for the proper setup, use, and

troubleshooting of the Voice Control Interface

portion of that device.

When the Smith & Nephew HERMES Digital O.R.

Control Center is connected and active, the

function parameters of the Smith & Nephew

450P and 460P HERMES-Ready Control Units

may alternatively be adjusted using the buttons

on the front panel.

For troubleshooting or further information,

please refer to your Smith & Nephew HERMES

Digital O.R. Control Center Operating and

Maintenance Manual.

Preface/Introduction

Smith & Nephew 450P and 460P 3-CCD Camera Control Units Operations/Service Manual 10600023 Rev. B

Indications for Use

The Smith & Nephew 450P and 460P 3-CCD

Camera Control Units are indicated for use in

endoscopic surgical procedures to allow

visualization of the articular cavities, body

cavities, hollow organs and canals when used

with an appropriately indicated endoscope.

Additionally, when used in conjunction with a

Smith & Nephew light source and light cable the

3-CCD Camera Control Units are indicated for

use in endoscopic surgical procedures in the

thoracic cavity when used with an appropriately

indicated thoracoscope.

Contraindications

None known.

Warnings

• 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.

• DANGER: There is a risk of explosion

if used in the presence of flammable

anesthetics.

• To prevent electric shock, do not remove

any covers or screws from the Camera

Control Unit (CCU) or camera head. There

are no user-serviceable components

inside. Dismantling the equipment will

void the warranty.

• If this unit is configured as part of a

system, the entire system should be

tested for compliance with IEC 60601-1-1.

• If the leakage current of the

configured system exceeds the

limits of IEC 60601-1-1, install an

appropriately rated UL 2601-1/

IEC 60601-1 approved isolation

transformer and retest the system.

• The use of accessory equipment not

complying with the equivalent safety

requirements of this equipment may

lead to a reduced level of safety of the

resulting system. Consideration relating

to the choice shall include:

– Use of the accessory in the patient

vicinity.

– Evidence that the safety certification of

the accessory has been performed in

accordance with UL 2601-1/IEC 60601-1

and/or IEC 60601-1-1.

Precautions

U.S. Federal law restricts this device to sale

by or on the order of a physician.

• Do not allow fluids to enter the device.

Damage can result.

• Electrical safety testing should be performed

by a biomedical engineer or other qualified

person.

• All products used in conjunction with this

camera control unit, such as video monitors,

video printers, etc., are likely to have an

inherent leakage current at their video

connections. Thus, their connection to this

camera control unit would likely increase the

leakage current at the camera control unit’s

chassis.

• When looping the video output to more than

one piece of equipment, the termination

switch on the last looping piece of equipment

should be in the 75 Ω (ohm) or the “ON”

position if the equipment provides that

option.

• Do not plug the camera cable connector into

the camera 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 CCU.

Indications for Use/Contraindications/Warnings/Precautions

Smith & Nephew 450P and 460P 3-CCD Camera Control Units Operations/Service Manual 10600023 Rev. B 7

• This equipment is designed and tested to

minimize interference with other electrical

equipment. However, if interference occurs

with other equipment it may be corrected

by one or more of the following measures:

– Reorient or relocate this equipment, the

other equipment, or both.

– Increase the separation between the

pieces of equipment.

– Connect the pieces of equipment into

different outlets or circuits.

– Consult a biomedical engineer.

• 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 related policy relating to obsolete

electronic equipment.

Unpacking and General

Inspection

Prior to using the Smith & Nephew 450P or

460P 3-CCD Camera Control Unit, it is essential

that all system components be inspected for

damage which can negatively impact the

system’s performance. Inspection should include

all equipment to be used in surgery including

endoscopes, cables, and accessories.

1. Remove the CCU and accessories from the

shipping container. Be certain to open and

inspect all boxes and sealed plastic bags to

ensure that all components are accounted

for.

If any parts are missing or damaged, contact

your authorized Smith & Nephew

representative.

Save the carton and packing materials in the

event a component needs to be returned for

repair.

2. Inspect all video components for damage

during shipment. Contact your authorized

Smith & Nephew representative if damage is

noticed. Damage to endoscopes can impact

performance. For more information, consult

the Instructions for Use provided with the

endoscope.

3. Inspect the sheath on the light source fiber

optic cable for damage. Cuts, abrasions or

tears in the silicone sheath will cause a loss

of light.

Precautions (continued)/System Components

Smith & Nephew 450P and 460P 3-CCD Camera Control Units Operations/Service Manual 10600023 Rev. B

System Components (continued)

Figure 1a. Smith & Nephew 450P 3-CCD HERMES-Ready…Camera Control Unit Front Panel

Figure 1b. Smith & Nephew 460P 3-CCD HERMES-Ready…Camera Control Unit Front Panel

Front Panel Controls

Component Controls and Functions

Smith & Nephew 450P and 460P 3-CCD Camera Control Units Operations/Service Manual 10600023 Rev. B 9

System Components (continued)

Front Panel Controls (continued)

Control Function

1. Power Switch Turns the control unit on and off. The power switch is illuminated

green when the control unit is on.

2. MICROPHONE Input

(460P only)

The 460P CCU (Camera Control Unit) includes a microphone input

which accepts standard 1/4" connector microphones. It allows

audio to be added to the DV output so users can add commentary

to video clips produced from the camera control unit DV output.

The rear panel audio line input and front panel microphone input

may be used simultaneously.

3. PROCEDURE Button The PROCEDURE Button is used to sequence through the

procedure setting options, i.e., Arthroscopy, Laparoscopy, Custom,

etc. Each option has predetermined image parameter settings that

are designed to be optimized for a given procedure type. When the

button is pressed, the name of the current procedure appears at

the bottom of the surgical display screen and the image appearing

on the screen utilizes the parameter settings for that particular

procedure. A procedure is selected by pressing the button until the

desired procedure setting is displayed. The default procedure

setting can be set using the OSD (On-Screen Display) Menu.

4. WHITE SET Button The WHITE SET Button automatically adjusts the camera for optimal

white balance when the button is depressed and the camera is

focused on a white object.

5. MENU Button (UP) The UP or DOWN buttons cause the cursor to scroll through the

available menu selections after the OSD Menu has been called up

via the SELECT button. When the end of a menu is reached, the

next UP or DOWN button activation will bring the user either to the

top of the menu or the bottom of the menu.

Smith & Nephew 450P and 460P 3-CCD Camera Control Units Operations/Service Manual 10600023 Rev. B

System Components (continued)

Front Panel Controls (continued)

Control Function

6. MENU Button (SELECT) The SELECT button calls up the top-level OSD Menu.

7. MENU Button (DOWN) The UP or DOWN buttons will cause the cursor to scroll through

the available menu selections after the OSD Menu has been called

up via the SELECT button. When the end of a menu is reached, the

next UP or DOWN button activation will bring the user either to the

top of the menu or the bottom of the menu.

8. BRIGHTNESS Buttons The BRIGHTNESS buttons increase or decrease the brightness of

the image when the ELC (Electronic Shutter Control) is in AUTO

mode.

9. ENHANCEMENT Buttons The ENHANCEMENT function enhances the appearance of detail

in the image. The desired enhancement level is set using the

ENHANCEMENT UP/DOWN buttons. When one of the buttons is

pressed, a bar graph on the left side of the display indicates the

current enhancement level.

10. Camera Cable Connector

Receptacle(s)

Compatible Smith & Nephew camera heads can be connected into

these push-in, keyed receptacle(s). (See ORDERING INFORMATION

for compatible camera heads.)

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