MEDISON
HS40 Service Manual Ver 1.00 April 2017
Service Manual
308 Pages
Preview
Page 1
HS40
Service Manual
Version 1.00
HS40
Service Manual English
SM-HS40-ENG-01
(Empty page)
Safety Requirements Classification – Type of protection against electric shocks: Class I – Degree of protection against electric shocks (when the patient is in physical contact): Type BF or type CF mounting – Degree of protection against the ingress of harmful liquids: General equipment – Degree of safety of use in the presence of flammable anesthetic agent mixed with air, oxygen, or nitrous oxide: Not suitable for use near flammable anesthetic agent mixed with air, oxygen, or nitrous oxide – Mode of operation: Continuous operation Safety standards the device conforms to – Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance [IEC 60601-1:2005/ A1:2012] – Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility – Requirements and Tests [IEC 60601-1-2:2007] – Medical Electrical Equipment - Part 1-6: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability [IEC 60601-1-6:2010] – Medical Electrical Equipment - Part 2-37: Particular Requirements for the Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment [IEC 60601-2-37:2007] – Medical Electrical Equipment - Part 1: General Requirements for Safety [IEC 606011:1988, A1:1991, A2:1995] – Medical Electrical Equipment - Part 1-1: General Requirements for Safety – Collateral Standards: General Requirements for Medical Electrical Systems [IEC 60601-1-1:2000] – Medical Electrical Equipment - Part 1-2: General Requirements for Safety – Collateral Standards: Electromagnetic Compatibility – Requirements and Tests [IEC 60601-12:2001, A1:2004] – Medical Electrical Equipment - Part 1-4: General Requirements for Safety – Collateral Standards: Programmable Electrical Medical Systems [IEC 60601-1-4:1996, A1:1999] – Medical Electrical Equipment - Part 2-37: Particular Requirements for the Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment [IEC 60601-2-37:2001, A1:2004, A2:2005] – Medical Devices – Application of Risk Management to Medical Devices [ISO 14971:2007] – Medical Electrical Equipment - Part 1: General Requirements for Safety [UL 606011:2003] – Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance[CAN/CSA C22.2 No. 60601-1:14]
– Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance [ANSI /AAMI ES60601-1:2005/(R)2012, AND C1:2009 AND A2:2010(R)2012] – Biological Evaluation of Medical Devices – Part 1: evaluation and testing [ISO 10993-1: 2009] – Standard Means for Reporting the Acoustic Output of Medical Diagnostic Ultrasonic Equipment [IEC 61157:2007] Statements
Nemko-CCL mark with the indicators “C” and “US” means that the product is certified for both the U.S. and Canadian markets, to the applicable U.S. and Canadian standards.
This mark certifies that the product conforms to applicable EEC standards and has been certified by the European certification agency.
This mark certifies that the product conforms to applicable EEC standards.
The GMP symbol indicates the Good Manufacturing Practice in accordance with the Korean quality management regulations.
Precautions for Use Be sure to read this Service Manual thoroughly to familiarize yourself with the operation of the product and the relevant safety information before attempting to use the product. •
Keep this service manual near the product and refer to it when using the product.
•
Please familiarize yourself with the safety precautions in “Chapter 2. Safety” and “Chapter 10. Maintenance” in particular.
•
This service manual does not include diagnosis results or opinions. Also, check the reference information for the measured area of the body before using the application’s measurement results in any diagnosis.
•
This product is an ultrasound diagnosis device and cannot be used from the user’s PC. The manufacturer is not responsible for any problems that may be caused by such attempts.
•
This product must only be used by persons who have sufficient knowledge of and/or a qualification in clinical pathology. Unqualified persons are prohibited from using the product.
•
The manufacturer is not responsible for any damage to this product caused by user carelessness and/or neglect.
•
Product orders are based on individually agreed specifications and may not include all functions specified in this service manual.
•
Some functions or options, probes, and the like may not be used in certain countries.
•
All reference material on standards, regulations, and related revisions are valid at the time of the publication of this service manual.
•
Screen images in this service manual are examples and may differ from the actual screen or system.
•
The content of this service manual is subject to change without prior notice.
•
Products that are not manufactured by Samsung Medison are indicated with the trademarks of their respective owners.
•
The following terms are used to highlight precautions that the user must pay particular attention to:
Disregarding this instruction may result in death, serious injury, or other dangerous situations.
DANGER
Follow these instructions to prevent a serious accident or damage to property.
WARNING
Follow these instructions to prevent minor accidents and damage to property.
CAUTION
The accompanying information covers installation, operation, and maintenance procedures that require careful attention from the user, but have little chance of leading directly to a dangerous situation.
NOTE
Revision History The revision history of this service manual is as follows: VERSION
DATE
REASON FOR CHANGE
1.00.00
2017.04.01
Initial Release
If You Need Assistance If you need a service manual or any assistance with the product, please contact the Samsung Medison customer service department or your local vendor.
Patient Privacy Policy Treatment of Patients’ Personal Information One of Samsung Medison’s social responsibilities is to recognize the importance of patient privacy and to handle and protect the personal information provided by our patients in an appropriate manner. Patient information stored in repaired and demo products should be handled as follows: •
Patient Information: Refers to information, such as IDs, names, DOBs, and images, which can be used to identify specific patients.
•
Patient Information Management: Personal information provided by patients must be managed carefully and solely for the purposes of repairs and demonstrations of Samsung Medison products, and they must not be used for unauthorized purposes, be lost, be revised, or be shared with a third party.
Management of Patient Information on Demo and Trade Products •
Patient information stored on a product during the course of its use must be handled as the patient desires. (delete or backup)
•
When completing a demonstration and/or collecting a trade product, patient information must be deleted if so requested by the client, to prevent its unintended distribution to outside parties.
Management of Patient Information on Repaired Hospital Products •
Before removing the product from hospital premises for repairs, all patient information should be backed up to a storage device such as external HDD or memory, and then handed over to the hospital.
•
Before removing the product from hospital premises, each patient should sign the patient privacy agreement.
Request for Repairs and Patient Privacy Agreement Date: YYYY/MM/DD
【Customer Information】 Hospital Handler 【Product Information】 Product name Software version S/N Symptom □ None □ USB
Stored item
Outsourced product
□ Main unit □ Photo
□ HDD □ Other (
□ DVD/CD )
□ None □ Provide details if applicable (
)
【Administration】 Handling date
YY
MM DD
Customer service representative ※ Please sign inside the box below if you agree to the following: □ Data saved on memory devices of products being repaired (e.g., hard disks) may become lost during tests and repairs. □ Data saved on a product being repaired must be backed up by the customer. □ Samsung will not be held responsible for any loss of data not backed up. □ Samsung Medison does not use patient information for unauthorized purposes, modify such information, or provide it to third parties. 【Customer Signature】 I entrust my product to ( Date:
YY/MM/DD
) for repair and agree to the policies above. Name:
(Signature)
Table of Contents
1
Table of Contents Chapter 1 Introduction
1
1.1.
Product Specifications... 2
1.2.
Product Configuration ... 5 1.2.1. 1.2.2. 1.2.3.
Monitor ... 7 Cont rol Panel ... 9 Cons ole ... 16
1.2.4. 1.2.5. 1.2.6.
Peripheral Devices ... 18 Probes... 20 Accessories ... 22
1.2.7. 1.2.8.
Optional Accessories ... 23 Optional Functions ... 24
Chapter 2 Safety 2.1.
Purpose of Use ... 2 2.1.1.
2.2.
2.3.
2.4.
2.2.1. 2.2.2.
Safety Symbols ... 3 Symbols ... 7
2.2.3.
Labels ... 7
Electrical Safety ... 8 2.3.1. 2.3.2. 2.3.3.
Prevention of Electric Shocks ... 8 ECG-Related Information... 10 ESD ... 10
2.3.4. 2.3.5.
EMI ...11 EMC...11
Mechanical Safety ...18 Moving the Equipment ... 18 Precautions for Use ... 19
Biological Safety ...22 2.5.1.
2.6.
Cont raindications ... 2
Safety Information... 3
2.4.1. 2.4.2. 2.5.
1
ALARA Principle... 22
Protecting the Environment ...35 2.6.1.
EU WEEE Directive ... 35
2.6.2. 2.6.3.
EU REACH Regulation ... 35 State of California Proposition 65 Warning (US Only)... 35
2
HS40 Service Manual
Chapter 3. Installing Product 3.1.
3.2.
Transporting ...3 3.1.1. 3.1.2. 3.1.3.
Precautions During Transport ... 3 Brakes ... 3 Precautions on Ramps ... 3
3.1.4.
Humidity and Temperature ... 4
Unpacking the Product ...5 3.2.1. 3.2.2. 3.2.3.
3.3.
3.5.
Caution ... 7
Installing the Product...8 3.4.1.
Installation Safety... 8
3.4.2.
Connecting P eripherals ...10
System Power... 13 3.5.1. 3.5.2.
3.6.
Dismantling the Product's Box ... 5 Accessories ... 6 Release of the Locking Mechanism ... 6
Installation Environment...7 3.3.1.
3.4.
1
Turning the Power On ...13 Shutting Down the System...13
System Settings... 14 3.6.1. 3.6.2.
General System Settings ...15 General ...15
3.6.3. 3.6.4. 3.6.5.
Display ...19 Patient ...20 Quick Preset ...23
3.6.6. 3.6.7. 3.6.8. 3.6.9.
EzExam+...24 Imaging ...27 Application/Preset ...30 Application...32
3.6.10. 3.6.11. 3.6.12.
Measurement Settings...33 Report ...49 Annotation ...52
3.6.13. 3.6.14. 3.6.15.
Body Marker ...57 Customize ...60 Peripherals ...64
3.6.16. 3.6.17. 3.6.18.
Connectivity ...67 Service ...86 Help ...86
Table of Contents
Chapter 4. Product Inspection 4.1.
3
1
Inspecting Functions ... 2 4.1.1.
Basic Inspections ... 2
4.1.2.
Detailed Inspections ... 3
Chapter 5. Product Structure
1
5.1.
Overview ... 3
5.2.
System Block Diagram... 5 5.2.1. 5.2.2.
5.3.
5.4.
5.5.
5.6.
5.7.
Basi c Structure of the Product... 7 5.3.1. 5.3.2.
Electronic Structure ... 7 Ultrasound System Part ... 7
5.3.3. 5.3.4. 5.3.5.
PC Part ... 8 User Interface Part ... 8 Power Part ... 8
Ultra sound System Part ... 9 5.4.1.
Main Functions of PSA (Probe Select Assembly) ... 9
5.4.2. 5.4.3.
Beam Former Board ...11 Back End Board ... 15
PC Part ...20 5.5.1. 5.5.2.
PC Module... 20 Rear IO Board... 21
5.5.3.
Software DS C ... 23
User Interface Part ...24 5.6.1. 5.6.2. 5.6.3.
Cont rol Panel ... 24 Main Monitor ... 26 Touch-Screen... 27
5.6.4.
Display Layout ... 28
Power Part ...29 5.7.1. 5.7.2. 5.7.3.
5.8.
System Block Diagram ... 5 System Rack Design ... 6
ADM... 29 Power Block Diagram ... 30 Specification ... 30
Interconnect Diagram...31 5.8.1.
HS40 Interconnect Diagram ... 31
5.8.2.
Cable Description ... 32
4
HS40 Service Manual
Chapter 6. Service Mode 6.1.
1
Service Mode ...3 6.1.1.
How to Enter the Servic e Mode... 3
6.2.
Service Information ...4
6.3.
Configuration ...5
6.4.
6.5.
6.6.
6.3.1. 6.3.2. 6.3.3.
Clock... 5 Keyboard/Region ... 5 TCP/IP ... 6
6.3.4. 6.3.5. 6.3.6.
Option ... 7 User Account and User Account Management ... 8 Printer ... 9
System ... 10 6.4.1.
Upgrade Software ...10
6.4.2. 6.4.3. 6.4.4.
System Serial Number... 11 Window Explorer...12 Install Recovery System ...13
Diagnostics... 14 6.5.1.
Cont rol Panel Test ...14
6.5.2. 6.5.3. 6.5.4.
Keyboard Test...14 Power On Self Test ...14 Built in Self Test ...14
6.5.5.
Monitor Test ...14
Backup and Re store ... 15 6.6.1. 6.6.2. 6.6.3.
6.7.
Report ... 16 6.7.1.
6.8.
Report ...16
Demo Play... 17 6.8.1.
6.9.
Backup ...15 Restore ...15 Log Backup ...15
Demo Play...17
Enter Installation Key... 18
Table of Contents
Chapter 7. Troubleshooting 7.1.
7.3.
7.2.1.
Nothing Is Displayed on the Screen ... 3
7.2.2.
Screen is Discolored... 3
Error Message s ... 4
2D Mode: There is No IMAGE ECHO or IMA GE FORMAT ... 4 Lines (Noise) Appear in 2D Mode Image ... 4 M, C, PW, CW Mode Trouble ... 4
USB Drive Unrecognized... 5 7.5.1.
7.6.
Error Occurs During Booting ... 4
Image ... 4 7.4.1. 7.4.2. 7.4.3.
7.5.
Power Does Not Turn On ... 2 Power Does Not Turn Off ... 2 Power Turns Off by Itself... 2
Monitor... 3
7.3.1. 7.4.
Failed to recognize the USB (Removable device) device ... 5
Trouble Shooting Tree ... 6
Chapter 8. Disassembly and Assembly 8.1.
8.3.
1
Preparation ... 2 8.1.1.
8.2.
1
Power Issue s... 2 7.1.1. 7.1.2. 7.1.3.
7.2.
5
Preparation ... 2
Product Di sa ssembly ... 3 8.2.1.
Front Side Disassembly ... 3
8.2.2. 8.2.3. 8.2.4.
Rear Side Disassembly ... 6 Cont rol Panel Disassembly ... 7 Touch Panel Disassembly ... 8
8.2.5. 8.2.6. 8.2.7.
Track Ball ... 9 Speaker Disassembly ... 10 Monitor Disassembly ...11
8.2.8.
Monitor A RM Disassembly ... 12
Installation of Optional Parts ...13 8.3.1. 8.3.2. 8.3.3.
Overview of Optional Parts ... 13 Option Parts... 14 Installation of External Physical Keyboard ... 16
8.3.4. 8.3.5. 8.3.6.
Installation of Gel Warmer... 16 Installation of Endo Cavity Holder ... 17 Installation of Holder Chart ... 18
8.3.7.
Installation of Rear Tray ... 18
6
HS40 Service Manual 8.3.8.
Installation of Printer Tray (1/2) ...19
8.3.9.
Installation of Printer Tray (2/2) ...19
Chapter 9 Probes 9.1.
9.2.
10.
1
Probes ...2 9.1.1. 9.1.2.
Probe List ... 2 Ultrasound Transmission Gel ... 9
9.1.3. 9.1.4. 9.1.5.
Sheaths ...10 Probe Safety Precautions ... 11 Cleaning and Disinfecting the Probe...13
Biopsy... 22 9.2.1.
Biopsy Kit Components ...22
9.2.2. 9.2.3. 9.2.4.
Using the Biopsy Kit ...23 Assembling the Biopsy Kit ...26 Cleaning and Disinfecting the Biopsy Kit...30
Maintenance
1
10.1. Operational Environment ...2 10.2. Product Maintenance ...3 10.2.1.
Cleaning and Disinfecting ... 3
10.2.2. 10.2.3. 10.2.4.
Cleaning... 3 Cleaning Air Filters ... 5 Accuracy Checks ... 6
10.3. Data Maintenance ...7 10.3.1.
User Settings Backup ... 7
10.3.2. 10.3.3.
Backing Up Patient Information ... 7 Software... 7
Chapter 11. Service Part List
1
11.1. Body Cover Parts...2 11.2. Control Panel Parts...5
Chapter 1 1. Chapter 1 Introduction
Introduction 1.1. Product Specifications ... 2 1.2. Product Configuration ... 5 1.2.1.
Monitor... 7
1.2.2. 1.2.3. 1.2.4.
Cont rol Panel ... 9 Cons ole ... 16 Peripheral Devices ... 18
1.2.5. 1.2.6. 1.2.7.
Probes ... 20 Accessories... 22 Optional Accessories ... 23
1.2.8.
Optional Functions ... 24
1 – 2 HS40 Service Manual
1.1. Product Specifications
Physical Dimensions
Height: 1,620 mm (with Monitor) Width: 520 mm Depth: 730 mm (with Keyboard) Weight: 54 kg (without accessories) Weight: Approx. 57 kg (with Safe Working Load) 2D Mode M Mode Color M Mode Anatomical Mode Color Doppler Mode Pulsed Wave (PW) Spectral Doppler Mode
Imaging Modes
Continuous Wave (CW) Doppler Mode Tissue Doppler Imaging (TDI) Mode Tissue Doppler Wave (TDW) Mode Power Doppler (PD) Mode ElastoScan Mode 3D/4D/XI STIC imaging Mode Dual Mode Quad Mode Combined Mode Simultaneous Mode Zoom Mode
Gray Scale
256 (8 bits)
Focusing
Transmit focusing, maximum of eight points (four points simultaneously selectable) Digital dynamic receive focusing (continuous) Linear Array LA3-16AD Curved Array CA2-8AD, CF4-9
Probes (Type BF/IPX7)
Phased Array PN2-4 Endo Cavity EVN4-9 3D VN4-8, V5-9
Chapter 1. Introduction 1 – 3 Pencil DP2B Probe Connections
3 Probe Connectors, 4 Probe Connectors for option CW Probe Connector Main Monitor Number of Pixel: 1920 x 1080
Monitor
21.5 inch LCD Monitor (LED Backlight unit, hereafter referred to as “LCD monitor”) Touch Screen Monitor Number of Pixel: 1280 x 800 10.1 inch LCD Monitor (LED Backlight unit, hereafter referred to as “LCD monitor”)
ECG
USB Type (Type CF) Audio Output Port (Right/Left) VGA monitor
Rear Panel Input/Output Connections
LAN USB Port CW HDMI output HDMI Input (HDMI Input is currently not supported.) Maximum 45,000 frames for Cine memory
Image Storage
Maximum 14,000 Lines for Loop memory Image filing system
Application
Obstetrics, Gynecology, Urology, Abdomen, Cardiac, Vascular, Small Parts, TCD, MSK, Pediatric
Electrical Parameters
100 - 240VAC, 620VA, 50/60Hz
Measurement Packages
Abdomen, Obstetrics, Gynecology, MSK, Pediatric, Small Parts, Urology, Vascular, Cardiac * Refer to the ‘Chapter 8. Measurements and Calculations’ for additional information.
Signal Processing (Pre-processing)
Acoustic Power Control Analog TGC Control Dynamic Aperture Control Dynamic Apodization Control
1 – 4 HS40 Service Manual Dynamic LPF Control Digital TGC Control Slider TGC Control
Signal Processing (Postprocessing)
Mode-Independent Gain Control Black Hole/Noise Spike Filtering 1D Lateral/Axial Filtering 2D Edge/Blurring Filtering Frame average M/D Mode Sweep Speed Control Zoom Image View Area Control Image Orientation (left/right and up/down)
Measurement
Trackball operation of multiple cursors • 2D mode: Linear measurements and area measurements using elliptical approximation or trace • M mode: Continuous readout of distance, time, and slope rate • Doppler mode: Velocity and trace DVD Multi-Drive Digital B/W Video Printer Digital Color Video Printer USB Printer
Auxiliary
DVD Recorder Foot switch (IPX8) USB Flash Memory Media USB HDD USB ECG Monitor
User Interface
English, German, French, Spanish, Italian, Russian, Chinese, Portuguese
Pressure Limits
Operating: 700 – 1060hPa Storage: 700 – 1060hPa
Humidity Limits
Operating: 30 – 75% Storage & Shipping: 20 – 90%
Temperature Limits
Operating: 10 – 35°C Storage & Shipping: -25 – 60°C