CLV-190 EVIS LUCERA III XENON LIGHT SOURCE Maintenance Manual Issue 1 April 2012

CLV-190

CONTENTS Chapter 1: Introduction... 1-1 Chapter 2: Product Outline... 2-1 1 2 3 4

Product Overview ... 2-1 Features... 2-2 Restrictions ... 2-3 Specifications ... 2-4

Chapter 3: Specifications ... 3-1 Chapter 4: Installation and Connection... 4-1 Chapter 5: Care, Storage, and Disposal ... 5-1 Chapter 6: Inspection... 6-1 1 Inspection Check Sheet ... 6-1

Chapter 7: Safety check... 7-1 1 Check procedures ... 7-1 2 Check Card... 7-4

Chapter 8: Block Diagram ... 8-1 Chapter 9: Troubleshooting ... 9-1 Chapter 10: Lamp Replacement... 10-1

CONTENTS

1

ISSUE 1

CLV-190

Chapter 1: Introduction Introduction Repair and maintenance of this product requires highly specialized knowledge and techniques. We recommend that you contact an Olympus service center in your area if a problem develops with the product. If repairs or modifications are made by personnel not authorized by Olympus, the warranty is void, and Olympus shall not be liable for damage that occurs to or as a result of use of the modified product. The information contained in this manual is subject to change at any time without notice. Later editions of this manual will contain revised and updated material. Applicable Unit EVIS EXERA III XENON LIGHT SOURCE

CLV-190

Copyright © 2012 Olympus Medical Systems Corp. All rights reserved. Unauthorized reproduction or distribution in part or in whole is prohibited.

Trademarks OLYMPUS is a registered trademark of Olympus Corporation. The company names, product names, and proprietary technical terms in this document are the trademarks or registered trademarks of their respective owners.

ISSUE 1

1-1

Introduction

CLV-190

Chapter 2: Product Outline 1 Product Overview

ISSUE 1

(1)

Intended use The light source is intended to be used with Olympus endoscopes, video system centers, and other ancillary equipment for endoscopic diagnosis, treatment and video observation. Do not use the light source for any purpose other than its intended use.

(2)

Approved combinations This product can be combined with the EVIS series videoscope, 150 series videoscope, fiberscope,light guide for rigid endoscope, flexible videoscope, VISERA flexible videoscope, video converter (OVC-150), camera head (OTV-S7H series, CH-S190 series, OTV-S7Pro series, OTV-S7H series, and OTV-SP1H series), CV-190, and OTV-S190.

2-1

Product Outline

CLV-190

2 Features (1) (2)

Light source exclusively for CV-190/OTV-S190. Mechanical discriminant mechanism on the scope socket allows for automatic adjustment of maximum allowable light intensity suitable for the scope connected. 3 types of connectors may be discriminated: GI system endoscope connector, SP high intensity compatible LG connector and SP high intensity incompatible LG connector. (3) When a videoscope with air-feeding conduit and fiberscope are connected to the endoscope connector, scope end injection light intensity equivalent to the EXERA II system with CLV-180 can be achieved. (4) Electrical contacts on the endoscope connector allow for mechanical and electrical connection with 190 endoscopes by just one action (one-touch connector). (5) When halogen incompatible endoscope and light guide for RF connector (endoscope connector and light guide connector without air-feeding conduit) are connected, the maximum allowable illuminance (white light) equivalent to the injection light intensity of the CLV-180 can be achieved on the LG incident end face. (6) When high intensity compatible scope and light guide for RF connector are used, the high intensity mode is available to realize lighter illuminating radiation. The maximum allowable illuminance (white light) on the LG incident end face, which is equivalent to the CLV-180 normal mode or twice the injection light intensity in the normal mode, can be obtained. In addition, the intensity equivalent to or twice as light as the normal mode can be selected by the intensity mode switch for the high intensity mode. (7) Optical filter available for NBI (Narrow Band Imaging) special observation is installed. When an NBI compatible endoscope is connected, NBI special observation can be performed. (8) Optical filter available for PDD special observation can be installed. In addition, optical filter for other special observation (exclusive use with PDD) can be installed as necessary. (9) Following examination lamp ignition modes can be selected: a) The examination lamp ignites automatically when the power switch is turned ON (auto ignition mode). b) Pressing the lamp switch after turning ON the power switch will ignite the examination lamp (manual ignition mode). *The factory default setting is the manual ignition mode. (10) The examination lamp can be turned ON/OFF by pressing and holding the "Lamp" button (for about one second). (11) Heat discharge direction is rear (rear heat discharge). (12) When ignition fails despite pressing the lamp button, the light source automatically switches to the emergency lamp. When ignition fails or the lamp goes out, brightness required for endoscope withdrawal is obtained as an emergency response. Lighting of this emergency lamp is indicated on the panel. (13) 17-staged level adjustment is available for both automatic brightness adjustment and manual brightness adjustment. (14) Air-feeding can be stopped, or adjusted to three stages (high, medium and low). (15) Self-check for emergency lamp breaking is performed and indicated on the panel, if any. (16) Transillumination function is available from the transillumination button (only for endoscope with air-feeding conduit on the endoscope connector). (17) The panel setting is backed up and applied when the power is reactivated. However, the filter button setting is not backed up and the normal filter (infrared cut + heat absorption) is applied upon power reactivation. (18) Ethanol for disinfection (70% ethyl or isopropyl alcohol) or neutral detergent can be used for bed bath of exterior parts and the control panel.

Product Outline

2-2

ISSUE 1

CLV-190

3 Restrictions (1) (2) (3) (4) (5) (6)

(7)

(8)

ISSUE 1

Applicable video system center CV-190, OTV-S190 Use this product under the supervision of a physician within a medical facility. Direct use on the heart is prohibited (However, it is allowed to use for the heart in combination with equipment with TYPE CF applied part). The exterior must be grounded for safety's sake. Use in flammable atmosphere is prohibited. Combined use of this device and following electrical devices is prohibited: a) Devices that are intended for electrical treatment of patients and whose safety in combined use is not confirmed b) Other devices whose safety with regard to electrical leakage current is not confirmed Power a) Voltage : AC 100 to 240 V b) Input power : 600 VA c) Frequency : 50/60 Hz d) Voltage fluctuation : Within ±10% e) Frequency fluctuation : Within ±1 Hz Environment 1) Operating environment Ambient temperature 10~40°C Relative humidity 30 to 85% (non condensation) Atmospheric pressure 700 to 1060 hPa 2) Transportation and storage environment Ambient temperature -25~+75°C Relative humidity 10~90% Atmospheric pressure 700 to 1060 hPa

2-3

Product Outline

CLV-190

4 Specifications 4-1

Scope of application (1)

(2) (3)

(4) (5)

(6) (7)

(8)

4-2 4-2-1

Lighting function Examination optical path (1)

4-2-2

Type: Xenon short arc lamp (ozone-less type) with radiating endoscope Product code: MAJ-1817 Average life: About 500 hours (continuous) The lamp is automatically turned ON when the "Lamp" button is pressed and held for one second. Pressing and holding the "Lamp" button for one second again will turn the lamp OFF. *The factory default setting is the manual ignition.

Emergency lamp (1) (2)

4-2-4

Emergency lamp automatically goes into the optical path in case of examination lamp failure.

Examination lamp (1) (2) (3) (4)

4-2-3

Videoscope EVIS 100, 130, 140, 150, 170 series EVIS EXERA 145, 160 series EVIS EXERA II 165, 180 series EVIS EXERA III 190 series VISERA videoscope series EUS videoscope EUS 130, 140, 160, 180 series Fiberscope OES 10, 20, 30, 40, 60 series E, E2, E3 series High intensity compatible light guide A3290, A3291, A3293, A3294, A3295, A3296, A3297, A3298 Rigid endoscope Products other than rigid endoscope that can be connected with high intensity compatible light guide are not applicable. High intensity fiberscope CHF-CB30L, CHF-CB30S, URF-P3/P5, LF-TP/DP/GP, CYF-5A, ENF-GP High intensity compatible videoscope TF-V, LTF-V2, LTF-V3, LTF-VP, LTF-VP-S, LTF-VH, LTF-VP2, LTF-VH2, PEF-V2, ENF-NH, LTF-VP2/VH2, PEF-V2, ENF-VH, ENF-V3, CYF-VH, URF-V2, A4804A, A4805A, A50000A, A50001A, A50010A, A50011A, A50020A, A50021A, A50023A, WA50****series Water container MH-884, MA-995, MD-431, MH-970, MAJ-901, MAJ-902

Type: Average life:

Halogen 12 V 35 W (with reflector) About 500 hours

Brightness adjustment method (1) Only manual brightness adjustment is available for fiberscope and rigid endoscope (except in case the video system center and camera head are used). (2) Both automatic and manual brightness adjustment is available for the videoscope. (3) When rigid endoscope and light source cable are used, automatic brightness adjustment is made possible by combination of the video system center and camera head.

Product Outline

2-4

ISSUE 1

CLV-190

4-2-5

NBI special observation mode (1) (2)

4-2-6

SP high intensity mode (1)

(2)

(3)

(4) (5)

4-2-7

By mechanical diaphragm (set on the front panel) 17 steps

Automatic brightness adjustment (1) (2)

4-2-9

When high intensity compatible endoscope is inserted, the mode is switched to the high intensity mode by the intensity mode button. The high intensity mode is not available with other high intensity incompatible endoscope. When a high intensity compatible endoscope is inserted, the intensity mode button is turned ON and the high intensity mode (LED on the top of the button is ON) and normal mode (LED on the top of the button is OFF) can be switched. The intensity mode button condition is saved when the power is turned OFF. When an SP high intensity mode compatible endoscope is inserted, the high intensity mode or normal mode is activated in accordance with the saved intensity mode. The factory default setting is the normal mode. The intensity is equivalent to that with the high intensity mode disabled (normal mode) for CLV-180 when the high intensity mode is disabled (normal mode). In the SP high intensity mode, the intensity becomes twice as intense as that in the SP normal observation mode.

Manual brightness adjustment (1) (2)

4-2-8

The mode is switched to the NBI observation mode by the filter button, etc. when the NBI compatible endoscope is connected to the light source and video system center. In the NBI special observation mode, the NBI special filter is inserted into the optical path. Note: The video system center must be turned ON.

Constant illuminance control (image surface illuminance) by servo-diaphragm system 17 steps

Display method for front panel in the special observation mode Observation mode In NBI special observation mode

In OP. mode

How to display front panel Filter mode changeover button, observation mode ON/STBY display ON and special light observation changeover display NBI dot LED are ON Filter mode changeover button, observation mode ON/STBY display STBY and special OP. dot LED are ON

4-2-10 Device cooling (1)

Forced air cooling with fan (lateral air intake - rear heat discharge)

4-3

Air and water feeding function

4-3-1

Air feeding Air feeding pump: Airflow pressure: Control:

4-3-2

Diaphragm system Three-staged pressure adjustment (high, medium, low and stop) By airflow button setting

Water feeding Water feeding system: Water can be fed from the endoscope end in combination with an endoscope and water container.

4-4 4-4-1

Connection Endoscope, light guide and electrical contacts One-touch connection

ISSUE 1

2-5

Product Outline

CLV-190

4-4-2

Light source cable (MAJ-1941) Connected to CV1 terminal on the rear panel.

4-4-3

Digital light source cable (MAJ-1933) Connected to CV2 terminal on the rear panel.

4-4-4

Communication cable (MAJ-1942/1948) Connected to LINK-OUT terminal on the rear panel.

4-4-5

Foot switch (MAJ-1391) Connected to foot switch terminal on the rear panel.

4-4-6

CLV-UPD cable (MAJ-1898) Connected to UPD terminal on the rear panel.

4-5

Failure indication

4-5-1

Emergency lamp (1)

4-6 4-6-1

Breaking of the emergency lamp and activation of the emergency lamp (when the main lamp is not turned ON) are indicated. ON : Emergency lamp ON (when the main lamp is not turned ON) Blinking : When the breaking of the emergency lamp occurs or the emergency lamp comes off, etc.

Panel Saving the setting value (1)

The setting value before power shut down is saved in the event of power shut down. Manual/automatic brightness adjustment setting Intensity adjustment level High intensity mode setting Indication of absence/presence of the special observation system Lamp life meter (Pressing and holding the counter reset switch when the power is turned ON and the examination lamp is OFF will reset this meter)

Air feeding setting

4-7 4-7-1

Safety Light shielding (1)

4-7-2

Cleaning (1)

4-7-3

Ethanol for disinfection (70% ethyl or isopropyl alcohol), neutral detergent, or sterile water can be used for bed bath of exterior parts.

Warning (1)

4-7-4

During endoscope withdrawal, light emitted from the endoscope connector is shielded by the screen fitted to the endoscope socket.

When the internal temperature exceeds the specified temperature, the temperature switch is turned OFF to block power supply to the lamp for safety's sake. In this case, the device detects that the temperature switch has gone OFF and generates warning beep.

Electric shock (1)

Class I (power 3P plug) equipment.

Product Outline

2-6

ISSUE 1

CLV-190

4-8

Others

4-8-1

Usage restrictions Ambient temperature Humidity Atmospheric pressure Operating atmosphere Format of protection against electric shock Rated voltage Frequency Power fluctuation Frequency fluctuation Power consumption

4-8-2

Power cord

About 18 kg Maximum profile: 390 (W) x 551 (D) x 162 (H) (mm) Basic dimensions: 370 (W) x 476 (D) x 150 (H) (mm) 3-pole cord with hospital grade plug (national, North America) 3P inlet, 3-pole cord plug not included (regions other than the above)

Applicable laws and regulations Place of destination EU/EFTA

Japan US Canada Singapore Australia Brazil Taiwan China Korea

ISSUE 1

Lamp (MAJ-1817) Replacement of emergency lamp and mounting of special filter

Others Weight Profile

4-8-4

Class I, protection level: TYPE BF applied part AC 100 V (national specifications) AC 100 – AC 240 V (other areas) 50/60 Hz ±10% or less ±1 Hz or less 600 VA

Expected replacement parts User service Manufacturer service

4-8-3

10~40°C 30~84% 700 to 1060 hPa Use in flammable atmosphere prohibited

Laws and regulations MDD Class: Class II a (rule: 11-1) CE Marking: CE0197 Pharmaceutical Affairs Law FDC Act Canada Medical Device Regulations Class: Class I Singapore Medical Product Law Australia Medical Device Regulations Brazil Medical Device Law Taiwan Pharmaceutical Affairs Law China Medical Device Supervision and Administration Regulations Korea Medical Device Law

2-7

Product Outline

CLV-190

4-8-5

Applicable outside standards Place of destination Common

EU/EFTA

Japan

US Canada

Product Outline

Outside standard IEC 60601-1 (Safety of Medical Electrical Equipment): 1988 + A1 + A2, 2005 IEC 60601-1-1 (Medical Electric System): 2000 IEC 60601-1-2 (EMC): 2001 + A1, 2007 IEC 60601-2-18 (Safety of Endoscope Equipment): 1996 + A1, 2009 ISO 14971 (Risk Management): 2007 ISO 7000 (Graphic Symbol): 2004 IEC 60417-1: 2002, -2: 1998 (Graphic Symbol) + A1, A2 IEC 60601-1-6 (Usability): 2004, 2006 IEC 62366 (Usability): 2007 IEC 62304 (Software, Program Device): 2006 IEC 60601-1-9 (Environment-Friendly Design): 2007 EN 980 (Graphic Symbol): 2008 EN 1041 (Information on Medical Equipment): 1998 EN 60601-1 (Safety of Medical Electrical Equipment): 1990 + A1, A2 EN 60601-1-1 (Medical Electric System): 2001 EN 60601-1-2 (EMC): 2007 EN 60601-2-18 (Safety of Endoscope Equipment): 1996 + A1 EN 60601-1-6 (Usability): 2004, 2007 EN 62366 (Usability): 2008 EN 62304 (Software, Programmable Device): 2006 JIS T1553 (Medical Endoscope): 2005 JIS T0601-1 (Medical Electrical Equipment = Part 1: General Requirements for Safety): 1999 JIS T0601-1-1 (Medical Electric System): 2005 JIS T0601-1-2 (EMC): 2005 UL 60601-1: 2003 + REV 2003/6/30 + REV 2006/4/26 CAN/CSA-C22.2 No. 601.1-M90: 1990

2-8

ISSUE 1

CLV-190

Chapter 3: Specifications Refer to the “Specifications” of Instruction Manual.

ISSUE 1

3-1

Specifications

CLV-190

Chapter 4: Installation and Connection Refer to the “Installation and Connection” of Instruction Manual.

ISSUE 1

4-1

Installation and Connection

CLV-190

Chapter 5: Care, Storage, and Disposal Refer to the “Care, Storage, and Disposal” of Instruction Manual.

ISSUE 1

5-1

Care, Storage, and Disposal

CLV-190

Chapter 6: Inspection Refer to the “Inspection” of Instruction Manual.

1

Inspection Check Sheet

Please copy and use check sheet on next page. A check item may change with the destination and specifications. There may be a check item which is on this list and is not in the instruction manual. Please refer to the instruction manual (Chapter of Inspection or Inspection Before Use) for an actual check item and the check procedure. There may be a blank column in a Check Sheet. Please utilize this blank column, if needed.

ISSUE 1

6-1

Inspection

Inspection

6-2

Inspector

Inspection of air and water feeding

Inspection of the high intensity mode

Inspection of the transillumination function

Inspection of the NBI observatuion function

Inspection of brightness adjustment

Inspection of the brightness mode selection function

Inspection of the examination light

Checking the lamp usage indicator

Inspection of the power supply

Checking the lamp ignition mode

Day

Inspector

Inspection of air and water feeding

Inspection of the high intensity mode

Inspection of the transillumination function

Inspection of the NBI observatuion function

Inspection of brightness adjustment

Inspection of the brightness mode selection function

Inspection of the examination light

Checking the lamp usage indicator

Inspection of the power supply

Checking the lamp ignition mode

Day

Serial nomber:

16

1

17

2

18

3

CLV-190 INSPECTION CHECK SHEET

19

4

20

5

21

6

22

7

23

8

24

9

25

10

26

11

27

12

28

13

Month & Year

29

14

30

15

/

31

CLV-190

ISSUE 1

CLV-190

Chapter 7: Safety check 1 Check procedures 1-1

Electrical safety test

1-1-1

Standard Conduct the following leakage current inspections. Each value should not exceed the listed values. Leakage current

Under normal conditions (NC) 10 100

Patient leakage DC current AC Enclosure leakage 100 current Earth leakage current 500 300: UL region, 500: other than UL region

1-1-2

Under single failure conditions (SFC) 50 500 300/500* 1000 (μA)

Enclosure leakage current inspection (1) (2) (3) (4)

Connect CLV-190 to the automatic leakage current measuring equipment with the power cord. Connect the clip from the automatic leakage current measuring equipment to the enclosure screw. Set the airflow indicator to "ON" and the airflow regulator indicator to "H". Measure a leakage current using the automatic leakage current measuring equipment. For the measuring method, see the procedure manual of the automatic leakage current measuring equipment. Connect to automatic leakage current measuring equipment

CLV-190

clip connection

ISSUE 1

7-1

Safety check

CLV-190

1-1-3

Patient leakage current inspection (1) (2) (3) (4)

Connect CLV-190 to the automatic leakage current measuring equipment with the power cord. Install the leakage current measuring jig and connect the clip from the automatic leakage current measuring equipment. Lamp “ON”, Set the airflow indicator to "ON" and the airflow regulator indicator to "H". Measure a leakage current using the automatic leakage current measuring equipment. For the measuring method, see the procedure manual of the automatic leakage current measuring equipment.

CV patient connection chart Leakage current measuring jig setting UPD pinNo. SW: all OFF

Connect to clip (yellow)

No connection

UPD patient connection chart Leakage current measuring jig setting UPD pinNo. SW: all ON

Connect to clip (red)

Safety check

No connection

7-2

ISSUE 1

CLV-190

1-1-4

Earth leakage current inspection (1) (2)

1-1-5

Measure the leakage current of the inlet earth terminal. Measure the leakage current using the automatic leakage current measuring equipment. For the measuring method, see the procedure manual of the automatic leakage current measuring equipment.

Earth resistance inspection (1) (2)

As shown below, connect one clip to the ground terminal of the product inlet and the other clip to the external screw of the cover (as far from the inlet location as possible). Measure an earth resistance using the automatic earth resistance measuring equipment. It should be 0.1 Ω or lower at 25 A. For the measuring method, see the procedure manual of the automatic earth resistance measuring equipment.

Enclosure screw

Inlet earth

ISSUE1

7-3

Inspection

CLV-190

2 Check card Date of inspection Product SN Inspected by Checked by Inspection item Exterior leakage current test Patient leakage current test (CV) Patient leakage current test (UPD)

DC AC DC AC

Ground leakage current test Ground resistance test

Safety check

Measurement Equipment No.

Standard 100μA or less 300μA or less (UL region) 500μA or less (Other region) NC 10μA or less SFC 50μA or less NC 100μA or less SFC 500μA or less NC 10μA or less SFC 50μA or less NC 100μA or less SFC 500μA or less NC 500μA or less SFC 1000μA or less 25A, 0.1ohoms or less NC SFC

7-4

Value

Result μA μA μA μA μA μA μA μA μA μA μA μA

ISSUE 1